Plain language summary
Personalised risk communication for informed decision making about taking screening tests
Screening is generally seen as an effective and safe method to prevent diseases, but there are risks and disadvantages with the procedures involved. It is important for the person undergoing screening to know about the risks of the disease and also how this is relevant to him or her. Such information would help people to make an informed choice about taking up a screening procedure.
In this review we looked at studies that provided personalised risk information for each participant, so that he or she could make a decision about whether to undergo screening, based on their personal risk profile. We found 41 studies with 28,700 participants that provided such personalised risk information to the participants. We integrated the results of all these studies and found that when such a risk profile was included in the intervention, the participants made more informed decisions about screening, compared to people who were provided with more general risk information. Overall 45.2% (592/1309) of participants who received personalised risk information made informed choices as compared to 20.2% (229/1135) of participants who received generic risk information.
We also found that these interventions seemed to increase knowledge and may increase accuracy of risk perception in the trial participants. However they did not significantly affect participants' anxiety. The results also indicated that providing people with personalised risks of the disease resulted in a small increase in the number of people who undertook the screening procedure. The results from this review are dominated by studies screening for breast cancer and colorectal cancer. Caution is required in applying these results to other types of screening.
Communication des risques personnalisée pour une prise de décision éclairée concernant les tests de dépistage
Le dépistage est généralement considéré comme une méthode efficace et sûre pour prévenir les maladies, mais il existe des risques et des inconvénients liés aux procédures utilisées. Il est important que la personne passant un test de dépistage connaisse les risques de la maladie, mais également les raisons pour lesquelles elle est concernée. Ces informations permettraient aux personnes de prendre une décision éclairée quant au fait de suivre une procédure de dépistage.
Dans cette revue, nous avons examiné des études qui fournissaient des informations personnalisées sur les risques pour chaque participant(e), de façon qu'il (elle) puisse décider ou non de passer un test de dépistage en fonction de son profil de risque personnel. Nous avons trouvé 41 études qui portaient sur un total de 28 700 participants et leur fournissaient de telles informations personnalisées sur les risques. Nous avons intégré les résultats de toutes ces études et avons découvert que lorsqu'un tel profil de risque était inclus dans l'intervention, les participants prenaient des décisions plus éclairées quant au dépistage comparé aux personnes recevant des informations plus générales concernant les risques. Globalement, 45,2 % (592/1309) des participants qui recevaient des informations personnalisées sur les risques ont fait des choix éclairés contre 20,2 % (229/1135) des participants qui recevaient des informations générales concernant les risques.
Nous avons également découvert que ces interventions semblaient accroître les connaissances et pouvaient améliorer l'exactitude de la perception des risques chez les participants aux essais. Cependant, elles n'ont pas affecté de façon significative l'anxiété des participants. Les résultats ont également indiqué que le fait de fournir des informations personnalisées sur les risques de la maladie avait entraîné une légère augmentation du nombre de personnes ayant suivi la procédure de dépistage. Les résultats de cette revue sont dominés par des études dépistant le cancer du sein et le cancer colorectal. Il est nécessaire d'être prudent dans l'application de ces résultats à d'autres types de dépistage.
Notes de traduction
Traduit par: French Cochrane Centre 1st March, 2013
Traduction financée par: Pour la France : Ministère de la Santé. Pour le Canada : Instituts de recherche en santé du Canada, ministère de la Santé du Québec, Fonds de recherche de Québec-Santé et Institut national d'excellence en santé et en services sociaux.
Personalisierte Risikokommunikation für eine fundierte Entscheidung über die Durchführung von Screenings
Screening wird allgemein als eine wirksame und sichere Methode zur Vorbeugung gegen Krankheiten angesehen, jedoch sind die angewandten Verfahren mit Risiken und Nachteilen verbunden. Personen, die sich einem Screening unterziehen, möchten wissen, mit welchen Risiken die Krankheit verbunden ist und ob sie für sie relevant sind. Diese Informationen würden den Personen helfen, fundiert zu entscheiden, ob sie sich einem Screening unterziehen möchten.
In diesem Review haben wir Studien betrachtet, bei denen alle Teilnehmer personalisierte Risikoinformationen erhielten, so dass sie die Entscheidung, sich einem Screening zu unterziehen, anhand ihres persönlichen Risikoprofils treffen konnten. In 41 von uns untersuchten Studien erhielten die insgesamt 28.700 Teilnehmer derartige personalisierte Risikoinformationen. Wir haben die Ergebnisse all dieser Studien integriert und festgestellt, dass die Teilnehmer, für die ein solches Risikoprofil Teil der Intervention war, im Vergleich zu Personen, denen allgemeinere Risikoinformationen gegeben worden waren, fundiertere Entscheidungen zum Screening trafen. Insgesamt trafen 45,2 % (592/1309) der Teilnehmer, die personalisierte Risikoinformationen erhalten hatten, fundierte Entscheidungen, im Vergleich zu 20,2 % (229/1135) der Teilnehmer, die allgemeine Risikoinformationen erhalten hatten.
Ferner stellten wir fest, dass diese Interventionen das Wissen erhöhten und vielleicht zu einer genaueren Risikowahrnehmung der Studienteilnehmer führten. Dies hatte jedoch keinen signifikanten Einfluss auf die Besorgnis der Teilnehmer. Die Ergebnisse lassen auch vermuten, dass die Bereitstellung von personalisierten Risiken der Krankheit zu einer geringfügigen Zunahme der Anzahl Personen führte, die sich dem Screening unterzogen. Die Ergebnisse dieses Reviews werden von Studien beherrscht, bei denen es um Screenings auf Brustkrebs und Dickdarmkrebs ging. Bei der Übertragung dieser Ergebnisse auf andere Screening-Arten ist Vorsicht geboten.
Anmerkungen zur Übersetzung
Koordination durch Cochrane Schweiz
Personalizirane informacije o riziku kao pomoć pacijentima za donošenje informiranih odluka o sudjelovanju u testovima probira
Testovi probira (pretrage za rano otkrivanje bolesti) općenito se smatraju djelotvornima i sigurnim metodama za sprječavanje bolesti, ali ti postupci imaju svoje rizike i nedostatke. Važno je da osobe koje prolaze kroz program probira znaju kakav rizik od bolesti imaju te također kako je to važno sa nju ili za njega osobno. Takve informacije bi pomogle osobama u donošenju informiranih odluka o sudjelovanju u programu probira.
U ovom Cochrane sustavnom pregledu analizirane su studije koje su pacijentima davale personalizirane informacije o riziku, tako da pacijenti mogu donijeti odluku o tome hoće li sudjelovati u programu probira ovisno o njihovom vlastitom profilu rizika. Pronađena ja 41 studija s ukupno 28.700 ispitanika u kojima je ispitan učinak takvih personaliziranih informacija o riziku na ispitanike. Rezultati tih studija zajedno su analizirani te se pokazalo da pacijenti koji dobiju personalizirane informacije o vlastitom profilu rizika donose informiranije odluke o probiru u odnosu na osobe koje su dobile općenitije informacije o riziku. Ukupno je 45,2% (592/1309) ispitanika koji su dobili personalizirane informacije o riziku donijelo informirane odluke u usporedbi s 20,2% (229/1135) ispitanika koji su dobili općenite informacije o riziku.
Također je utvrđeno da te informacije povećavaju znanje i mogu povećati točnu percepciju rizika u ispitanika koji su sudjelovali u analiziranim istraživanjima. Međutim, ti programi nisu imali značajan utjecaj na anksioznost ispitanika. Ti rezultati također pokazuju da pružanje personaliziranih informacija o riziku dovodi do malog povećanja broja osoba koje sudjeluju u programu probira. Rezultati iz ovog sustavnog pregleda uglavnom se odnose na studije o probiru za karcinom dojke i debelog crijeva (kolorektalni karcinom). Te podatke je potrebno uzeti s oprezom ako se žele primijeniti na druge vrste probira.
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Risk communication is an integral part of modern healthcare practice. It is important in various strategies to help individuals make the right choices. Be it a public screening programme or a matter of starting a new treatment, providing evidence-based risk and benefit information to patients, and ensuring they understand it, forms the cornerstone of informed decision making (Naik 2012). However, understanding is still limited of how best to present and discuss risks and benefits of health care in general, and screening in particular, for an individual.
Screening: what are the issues around policies and practice?
Screening is defined as "the systematic application of a test or inquiry, to identify individuals at sufficient risk of a specific disorder to warrant further investigation or direct preventive action, amongst persons who have not sought medical attention on account of symptoms of that disorder"(UKNSC 1998).
Many tests and procedures form part of screening programs - programs with the objective of sorting out apparently well persons who probably have a disease, from those who probably do not. They may only highlight a risk of disease, and are not intended to definitely diagnose a disease or condition. Screening is a complex event that can have various outcomes for the participant, some of which can cause unnecessary distress (Collins 2011). Although screening programmes are generally seen as an effective measure to reduce mortality and morbidity in the target populations, there are several issues surrounding them. The evolution of evidence regarding certain screening programmes has led to fierce debate about actual benefits and harms (Bewley 2011; Hackshaw 2012). A recent review of breast cancer screening for example, suggests that it is unclear whether such screening does more harm than good, and that balanced, evidence-based risk-benefit information should be provided to help women make an informed decision about undergoing screening (Gøtzsche 2011). Directly harmful effects of screening include: complications arising from the investigation, adverse effects of treatment, unnecessary treatment of persons with true-positive test results who have inconsequential disease, adverse effects of labelling or early diagnosis, anxiety generated by the investigations and treatment, and the costs or inconvenience incurred during investigations and treatment (Barratt 1999). Other harms, such as failure to detect disease, only apply to those with the condition. In either of these scenarios, Raffle 2001 warns that "harm to uninformed participants leads to anger, bitterness, and potentially to litigation". Furthermore screening can have significant social and psychological costs which are difficult to evaluate and quantify (Stewart-Brown 1997).
These well recognised potential harms have led to increasing debate about the policy and practice of screening. A review of breast cancer screening policy has been proposed in the United Kingdom (UK), prompted by concerns about the accuracy and transparency of information provided to women about the benefits and harms of screening (Richards 2011). The American Cancer Society has also highlighted the confusion created by screening guidelines, and proposes providing the public with clear guidance about the benefits, limitations, and harms associated with taking a screening test (Brawley 2012).
Informed decision making
An informed decision is defined as one where "a reasoned choice is made by a reasonable individual using relevant information about the advantages and disadvantages of all the possible courses of action, in accord with the individual’s beliefs" (Bekker 1999).
The UK national guidance confirms that the purpose of information about screening is to ensure that participants can make a fully informed choice about whether to take the test (GMC 1998). The UK National Screening Committee some time ago proposed a new definition for screening to incorporate the importance of informed choice in screening:
"a public health service in which members of a defined population, who do not necessarily perceive they are at risk of, or are already affected by, a disease or its complications, are asked a question or offered a test to identify those individuals who are more likely to be helped than harmed by further tests or treatment to reduce the risk of disease or its complications" (UKNSC 2000)
Jepson and colleagues reiterate this policy and recommend evaluating screening programmes to ensure that people invited for screening are genuinely making informed choices, and explore how comprehensive information affects other variables such as uptake, cost effectiveness, and satisfaction (Jepson 2005).
How can informed decisions be measured?
Briss 2004 provides a conceptual framework for informed decision making which includes: knowledge, participation in decision making at a personally desirable level, and consistency between the decision and individual preferences or values. A systematic review by Mullen et al, on measures of informed decision making in cancer screening, observed no single study measuring all of these three aspects (Mullen 2006). They recommended the development and use of validated measures of informed decision making and the use of theoretical frameworks for such screening studies.
Marteau and colleagues have proposed the multi-dimensional measure of informed choice, which has been validated for Down’s syndrome screening (Michie 2002; Marteau 2001). This is based on assessing the consistency between knowledge, attitudes to tests and choices of uptake of tests. To date, few studies in screening have used this scale as a measure for informed choice (Nagle 2008; Smith 2010; Steckelberg 2011). This scale is promising and could form the basis for development of a universal measure of informed choice for uptake of screening tests. Further research is needed to validate this scale in other areas. Furthermore, increasingly the outcomes described in the literature include 'affective' measures such as satisfaction with the decision made, and 'decisional conflict'. This includes whether an individual feels a decision is consistent with their personal values, and certainty about making the right decision (Edwards 1999a; Holmes-Rovner 1996; Llewelyn-Thomas 1995).
Description of the intervention
What is tailoring and why is personalising risk information important?
Tailored health communication refers to providing information to someone based on characteristics that are unique to that person. Kreuter et al define tailoring as: "Any combination of information or change strategies intended to reach one specific person, based on characteristics that are unique to that person, related to the outcome of interest and have been derived from an individual assessment" (Kreuter 1999a; Kreuter 1999b).
Tailoring could address any characteristics such as the person’s educational background, cultural orientation, and general level of comprehension. Many studies have adopted a theoretically-driven approach and have tailored their interventions on behavioural constructs that are based on behaviour change models (Noar 2007), for example the Transtheoretical Model (Prochaska 1992; Prochaska 1997) and Heath Belief Model (Becker 1974; Rosenstock 1988; Rosenstock 2000).
A high rate of participation is expected in most established screening programmes to ensure that they run effectively. Health authorities may employ a variety of strategies to promote screening and enhance uptake amongst the target populations. Some screening programmes provide information which is personally tailored and more relevant to the person in question. Others provide information about population or 'average' risks of contracting a disease as a basis for discussion or decision making about undergoing screening, or perhaps simply to try to motivate people to attend for tests which are perceived by authorities to be in the person's or population's best interests (Slaytor 1998). Such tactics may be seen as questionable, working against the spirit of informed decision making and consumer autonomy, and amounting to a disregard for the principles of medical ethics and good practice (Beauchamp 2001). Foster and Anderson (Foster 1998) criticise the implementers of the UK's National Cervical Screening Programme, including general practitioners, for their persuasive tactics in getting patients to comply.
According to the Health Belief Model one of the key determinants of health-related behaviour is perceived threat (Becker 1974). This is made up of two components: the individuals perceiving themselves as susceptible to the disease, and the perceived severity of the disease. Tailoring information using an individual’s specific risk factors is what we describe as 'personalised risk communication', sometimes also called 'individualised risk communication'. This may be based on the individual's own risk factors for a condition (such as age or family history). In some cases it is calculated from an individual's risk factors using formulae derived from epidemiological data, with the information presented as an absolute risk or as a risk score, for example the Gail score for the risk of breast cancer (Gail 1989) and Q-risk score for cardiovascular risk (Hippisley-Cox 2008). Risk information may also be categorised into, for example, high, medium or low risk groups. It may be less detailed, involving a listing, for example, of a person's risk factors as a focus for discussion and intervention.
How the intervention might work
Evidence suggests that the format in which risk information is presented affects patients’ understanding and perception of risk (Ahmed 2012). It is assumed that tailored messages are perceived as more relevant to an individual, and are therefore better processed and understood (Barratt 2005). Foster and Anderson (Foster 1998) have emphasised the importance of providing good-quality information to those undergoing cervical screening procedures. They stress that women should be made aware of the risks (discomfort, over-treatment of abnormal smears) and limitations (false positives; false negatives), as well as the benefits of the test. Further, they also point out that people have different risks of contracting the cervical cancer, based on factors such as age, sexual activity, social class and smoking. A systematic review of studies with interventions designed to provide tailored information on cancer risk and screening method has shown that personally-tailored risk information improved subjects' knowledge and realistic perception of cancer risk, compared to the provision of generic risk information only (Albada 2009). Noar et al found in their meta-analytic review that tailored messages outperformed comparison messages in affecting health behaviour change, lending support to claims made by other authors of narrative reviews that tailoring does in fact 'work' (Noar 2007).
There is recognition that uptake of tests per se is not necessarily desirable (for example, prostate specific antigen screening and antenatal cystic fibrosis screening are contentious areas). Also some screening tests are only recommended for those who are at high risk for disease susceptibility, for example genetic testing for breast and ovarian cancer (US PSTF 2005). Making an informed choice about taking screening tests, and adherence to the consumer's chosen option, are widely regarded as more desirable goals for risk communication (Edwards 1999a; Liao 1996; Sarfati 1998).
In this light, providing individualised risk information may seem to be more pertinent than providing generic risk information about the disease for which the screening intervention is designed. Personalised risk communication is more likely to be useful in decision making about whether or not to participate in screening, and individuals who perceive their personal risk as high may feel more susceptible to the disease in question. They may weigh this risk information with the harmful effects of screening, leading to an informed choice to take up the test. Similarly, those who consider themselves at low or no risk may opt out of the screening programme.
Why it is important to do this review
Public health impact, the scope and limitations
The UK National Health Service incorporates 11 different screening activities within its national health programme (UK National Screening Portal). In England alone, 2.24 million women were sent invitations to attend breast cancer screening in 2010-11 (NHS Information Centre 2011a). Invitations to attend cervical cancer screening were sent to 1.79 million women (NHS Information Centre 2011b). Significant volumes of screening procedures can also be expected to be taking place within breast and cervical cancer programmes and other screening programmes globally. People invited for such screening procedures should make informed and balanced choices. However, focusing narrowly on this outcome may ignore conflicting implications for uptake, cost-effectiveness and other important public health goals. Stakeholders and policy makers must carefully consider these factors. We attempt to organise such evidence, wherever available, in this systematic review. Further research would certainly be necessary to place the findings of this review in context with existing or planned screening programmes.
Other reviews in the field
Risk communication itself may be subdivided by the dyad involved (for example between agencies and the public, or from individual communicators), as well as according to the nature of the risk, which may be familiar or non-familiar (Vlek 1987). Reviews of 'mass' risk communication, primarily from the environmental health discipline (Covello 1986; Fischhoff 1979; Keeney 1986), and from narrow clinical fields such as familial cancer (Bottorff 1996), are available. Briss 2004 also reviewed interventions that sought to promote informed decisions about cancer screening, but not through 'personalising' risk information. In addressing the effects of personalised methods of risk communication, this review focuses on risk communication which is provided, used and evaluated in healthcare encounters with individuals, couples, or immediate families (for example, parents of young children). As such, the review is broader than previous clinical risk communication reviews (Bottorff 1996) but still aims to be relevant to the community and the clinical needs of healthcare professionals across a range of disciplines. It focuses on the domain of healthcare screening. In contrast, Albada and colleagues (Albada 2009) in their systematic review have reviewed interventions that provided tailored information specifically about cancer risk and screening. Information in the included studies was tailored to the personal characteristics related to behaviour change theories or constructs, and to the participant’s individualised risks. Their main outcome measures were risk perception, cancer knowledge and screening behaviour. A recent systematic review (Stacey 2011) evaluated randomised controlled trials (RCTs) of decision aids that provided information about treatment or screening options and their associated outcomes, compared to standard care. Decision attributes, behavioural, health, and health system effects were studied as outcome measures. Several other reviews have sought to consolidate evidence on the most effective means of increasing screening uptake (Bonfill 2001; Everett 2011; Flight 2004).
This review updates the 2006 version, which identified 22 relevant studies (Edwards 2006).
Summary of main results
This review updates the second (2006) publication of this review (Edwards 2006). Risk communication, particularly in the field of screening, is evolving with time. We have identified 19 new studies with elements of personalised risk communication in screening, which takes the total number of studies in this review to 41. The earlier two versions of this review (Edwards 2003c; Edwards 2006) included studies that measured outcomes that form elements of an informed decision, but identified no studies measuring informed decision as such. This updated review includes three studies (Nagle 2008; Smith 2010; Steckelberg 2011) that specifically have measured informed decision for the uptake of screening tests after personalised risk communication. From these three studies, there was strong evidence that personalised risk communication enhanced informed decision making, although with heterogeneous results. We expected this heterogeneity due to the varied nature of the interventions and the level of risk communication that was used in each of these studies. However, all studies had significant effect sizes, all favouring personalised risk communication.
Other recent studies have sought to address knowledge, perceived risk, and other elements of informed decision making. Overall these studies showed an increase in knowledge and a trend towards more accurate risk perception when personalised risk was included in their interventions. This field of risk communication in screening mirrors other clinical areas of health care, where there is an increasing trend to involve consumers in their own healthcare choices. In the same way that screening recommendations have developed in recent years from simply seeking to maximise uptake, to promotion of informed choice about participation in screening programmes (Holland 2005), the trial literature also now shows some development towards this.
Further, there was weak evidence to suggest that such interventions promote uptake of screening tests, although effects were small.
Some data also show that when the personalised risk information disclosed is more detailed, the uptake of tests is lower than when the risk communication is less detailed or numerically unspecific (i.e. when categorised into risk groups). Significant heterogeneity was noted among studies that merely listed the personal risk factors in their intervention. Test uptake thus becomes unpredictable when less specific ways of communicating personal risk factors are used. This may reflect the differences in perception of actual risk among participants between studies when such less specific methods of personalised risk communication are employed, but may also reflect the different nature of screening programme where some are more controversial (e.g. mammography and PSA testing) that the others (e.g. colorectal cancer screening).
High risk status an effect modifier
The effects of interventions on screening uptake appeared greater among consumers or patients deemed to be at higher risk of a disease than average. In this group of studies, most favoured the intervention, irrespective of the level of risk communication. This suggests that the 'high risk status' of the consumer may be an important effect modifier for personalised risk communication. There appears to be potential for substantial modification of choices made among this group of consumers. It may be appropriate that the scope for interventions to influence decisions is large in this group of consumers. Equally, however, interventions could be harmful if they are not introduced carefully. Healthcare professionals must take steps to ensure that they are achieving informed decision making by these consumers.
Overall completeness and applicability of evidence
We have used a highly-sensitive search strategy (Matthews 1999) to identify as many papers as possible in this field, from all relevant databases. The search covers studies published until March 2012, in an effort to outline the most contemporary evidence at the time of publication. To further increase the completeness of this search, we have followed this up by handsearching journals and reference lists, and also have looked at other similar reviews in the field to identify any papers missed in the initial search. This updated review presents a significant increase in the number of included studies, compared to the previous versions. Notably, however, the interventions used in these studies cover a range of methods to deliver the personalised element of risk communication. In addition, the measures of components of informed decision vary widely across studies. The settings in which the studies were conducted include a diverse range of screening programmes. Therefore, data from this review do not allow us to draw a firm conclusion about the best interventions to deliver personalised risk st= in enhancing informed decisions. The results are dominated by findings from the topic area of mammography and colorectal cancer. Caution is therefore required in generalising from these results, particularly for clinical topics other than mammography and colorectal cancer screening.
Further, in all studies the effects are a measure of the ('complex') intervention as a whole rather than that of personalised risk communication per se. However, isolating the effect of personalised risk communication on informed decisions or the uptake of tests, and drawing firm conclusions based on this, poses a great challenge to researchers working in this field.
Quality of the evidence
We included 41 studies in this review. It is difficult to draw general conclusions from this review because these studies varied widely according to interventions provided, outcomes measured, the screening programme, and duration of interventions and follow-up. A substantial number of people are included in this review (28,700), and the number of participants within each study varied widely, from 140 to 3152 people.
The studies that reported direct measures of informed decision were few (n = 3) in number, but were of very good methodological quality. Most other studies that measured other outcomes (i.e. components of informed decision) were not explicit in reporting elements that could introduce biases into their design, although studies reporting several of the knowledge outcomes were also of high quality. Only five studies (Lerman 1995; Lerman 1997; Manne 2010; Nagle 2008; Smith 2010) provided information of the validity of scales used to measure the outcomes of interest.
We have illustrated the quality of evidence for our main outcomes using GRADE Working Group recommendations (Guyatt 2008) in Summary of findings for the main comparison and Summary of findings 2.
Overall, the outcome ‘informed decision’ and several of the knowledge outcomes were subject to less risk of bias and provide better quality of evidence than the other reported outcomes (in particular, screening uptake, accuracy of perceived risk, and anxiety).
Potential biases in the review process
Despite the extensive search strategy, we may have missed some studies of interventions including personalised risk communication for screening tests if they were not indexed in the bibliographic databases appropriately to be identified by our search terms. We made significant efforts to contact trial authors for further data, where these were not available, and for further details of how the risks were personalised. Some data that were not extractable or were unclear were not included, if we did not receive further clarification from the authors.
As expected, the other main limitation of this review lies in the fact that we did not find any studies that examined the effect of personalised risk communication in isolation. All studies studied the effect of their interventions which included personalised risk communication. The interventions as such were diverse in nature, and it is hard to draw firm conclusions on the weight of effect that personalised risk communication has contributed to. There was considerable heterogeneity in some of the groups, in which case we did not pool these data. Many studies that were unclear on the risk of bias items are still included within the overall meta-analyses, and we present a sensitivity analysis by excluding such studies. Lastly, ways to measure the outcomes were also diverse which may have biased the review. Common validated methods of measuring informed decision are yet to be developed for wider use.
Agreements and disagreements with other studies or reviews
We are not aware of any other systematic reviews that assessed specifically the effect of personalised risk communication on measures of informed decision. Albada 2009 was the most similar review assessing the effects of tailored information based on theoretical (behavioural) constructs and providing cancer risk for individuals undergoing screening. The authors assessed the effects on risk perception, knowledge and screening behaviour. They concluded that interventions based on theoretical constructs increased risk perception and knowledge of cancer as compared to generic interventions, and information tailored to individual risk specifically increased realistic risk perceptions. As with our review, they found limited evidence for enhancing screening behaviour. A recent review (Stacey 2011) also found that decision aids that are tailored to support individual healthcare decisions increased people's involvement, and improved knowledge and realistic perception of outcomes, but had variable effect on choice behaviour.
Noar et al presented the first meta-analytic review of tailored print interventions for health behaviour change. In contrast with our review, their findings suggest that tailored print information focusing on preventive health behaviours out-perform generic interventions. However a host of behaviour change studies other than screening are included in their review (Noar 2007).
Briss 2004 studied interventions that were generally consistent in improving individuals’ knowledge about the disease, accuracy of risk perceptions, or knowledge and beliefs about the pros and cons of screening and treatment options. They reported insufficient evidence that such interventions promote informed decisions, due to a paucity of studies that fully measured this outcome. They recommended further research in this area, providing a conceptual framework to evaluate this outcome. We have found only three studies that used informed decision as an outcome measure, reiterating the recommendations proposed by Briss 2004.
The review authors thank the many people who commented on the project protocol and Cochrane protocol and review at various stages, helping to make them feasible. In particular this includes the 1998 consumer advisory group established for this review by the Cochrane Consumers and Communication Review Group (comprising Hilda Bastian and Genny Nolan (Australia), Teenah Handiside (New Zealand), and Christine Brunswick (USA)); Professors Theresa Marteau (then University of London) and Alex Barratt (University of Sydney) for discussions about screening programmes; Silvana Unigwe and Rhodri Evans for work on the previous versions of the review; the original Contact Editor - the late Dominique Broclain, the current Contact Editor Sandy Oliver, the editors of the Cochrane Consumers and Communication Review Group, Managing Editor Megan Prictor, Coordinating Editor Sophie Hill, former Trials Search Coordinator Judy Stoelwinder, and external peer reviewers. We also thank current Trials Search Coordinator John Kis-Rigo for his help in amending our search strategy, and the UK Cochrane Centre for their support through well-organised review courses for our authors. We gratefully acknowledge the financial support from the Cochrane Health Promotion and Public Health Field which enabled completion of the first published version of this review in 2003 (Edwards 2003c) and the UK Department of Health for its support (via the Review Group) to speed up completion of the updated review in 2006. Finally we thank the members of the Support Unit for Research Evidence (SURE), Cardiff University for all the support extended during the process of this review update.
Appendix 1. Search Strategy: CENTRAL
The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 3, 2012)
#1 MeSH descriptor Risk explode all trees
#2 MeSH descriptor Disease Susceptibility explode all trees
#3 (tailor* near counsel*) or (tailor* near message*) or (tailor* near material*) or (tailor* near intervention*) or (personal* near counsel*) or (personal* near message*) or (personal* near material*) or (personal* near intervention*) or (individual* near counsel*) or (individual* near message*) or (individual* near material*) or (individual* near intervention*)
#4 tailored or tailoring or individualised or personalised
#5 risk* or susceptib*
#6 (#1 OR #2 OR #3 OR #4 OR #5)
#7 MeSH descriptor Communication, this term only
#8 MeSH descriptor Persuasive Communication, this term only
#9 MeSH descriptor Counseling, this term only
#10 MeSH descriptor Genetic Counseling, this term only
#11 MeSH descriptor Health Promotion, this term only
#12 MeSH descriptor Health Education, this term only
#13 MeSH descriptor Patient Education as Topic, this term only
#14 MeSH descriptor Health Knowledge, Attitudes, Practice, this term only
#15 MeSH descriptor Attitude to Health, this term only
#16 MeSH descriptor Informed Consent explode all trees
#17 MeSH descriptor Patient Acceptance of Health Care, this term only
#18 MeSH descriptor Decision Making, this term only
#19 (informed near consent) or (informed near choice) or (informed near decision*)
#20 (#7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19)
#21 (#6 AND #20)
#22 (risk* near notifi*) or (risk* near inform*) or (risk* near communicat*) or (risk* near counsel*) or (risk* near appraisal*) or (risk* near assesment*) or (risk* near perception*) or (risk* near perciev*)
#23 (#21 OR #22)
#24 MeSH descriptor Mass Screening explode all trees
#25 (screen* or test* or testing or detection or early diagnosis)
#26 MeSH descriptor Early Diagnosis explode all trees
#27 MeSH descriptor Diagnostic Techniques and Procedures explode all trees
#28 MeSH descriptor Laboratory Techniques and Procedures explode all trees
#29 MeSH descriptor Tumor Markers, Biological explode all trees
#30 MeSH descriptor Predictive Value of Tests, this term only
#31 (mammography or mammogram* or colonoscopy or sigmoidoscopy or occult blood or vaginal smear* or pap* smear* or prostate specific antigen* or brca* or chest x-ray or tomograph* or bronchoscop*)
#32 prostate* and psa
#33 (#24 OR #25 OR #26 OR #27 OR #28 OR #29 OR #30 OR #31 OR #32)
#34 (#23 AND #33)
#35 (#34), from 2006 to 2011
Appendix 2. Search Strategy: CINAHL
CINAHL (EBSCO) (2006 to March 2012)
|S49||S36 and S46||Limiters - Published Date from: 20060101-20111231; Exclude MEDLINE records |
Search modes - Boolean/Phrase
|S48||S36 and S46||Limiters - Published Date from: 20060101-20111231 |
Search modes - Boolean/Phrase
|S47||S36 and S46||Search modes - Boolean/Phrase|
|S46||S37 or S38 or S39 or S40 or S41 or S42 or S43 or S44 or S45||Search modes - Boolean/Phrase|
|S45||TI (singl* or doubl* or tripl* or trebl*) and TI (blind* or mask*)||Search modes - Boolean/Phrase|
|S44||AB (singl* or doubl* or tripl* or trebl*) and AB (blind* or mask*)||Search modes - Boolean/Phrase|
|S43||AB (random* or trial or placebo*) or TI (random* or trial or placebo*)||Search modes - Boolean/Phrase|
|S42||MH Quantitative Studies||Search modes - Boolean/Phrase|
|S41||MH Placebos||Search modes - Boolean/Phrase|
|S40||MH Random Assignment||Search modes - Boolean/Phrase|
|S39||MH Clinical Trials+||Search modes - Boolean/Phrase|
|S38||PT Clinical Trial||Search modes - Boolean/Phrase|
|S37||"randomi?ed controlled trial*"||Search modes - Boolean/Phrase|
|S36||S27 and S35||Search modes - Boolean/Phrase|
|S35||S28 or S29 or S30 or S31 or S32 or S33 or S34||Search modes - Boolean/Phrase|
|S34||TX prostate* and psa||Search modes - Boolean/Phrase|
|S33||TX (mammography or mammogram* or colonoscopy or sigmoidoscopy or occult blood or vaginal smear* or pap* smear* or prostate specific antigen* or brca* or chest x-ray or tomograph* or bronchoscop*)||Search modes - Boolean/Phrase|
|S32||(MH "Predictive Value of Tests")||Search modes - Boolean/Phrase|
|S31||(MH "Tumor Markers, Biological+")||Search modes - Boolean/Phrase|
|S30||TX (screen* or test? or testing or detection or early diagnosis)||Search modes - Boolean/Phrase|
|S29||(MH "Early Diagnosis+")||Search modes - Boolean/Phrase|
|S28||(MH "Cancer Screening") OR (MH "Health Screening+") OR (MH "Genetic Screening") OR (MH "Health Screening (Iowa NIC)")||Search modes - Boolean/Phrase|
|S27||S25 or S26||Search modes - Boolean/Phrase|
|S26||TX (risk* n3 notifi*) or (risk* n3 inform*) or (risk* n3 communicat*) or (risk* n3 counsel*) or (risk* n3 appraisal*) or (risk* n3 assesment*) or (risk* n3 perception*) or (risk* n3 perciev*)||Search modes - Boolean/Phrase|
|S25||S6 and S24||Search modes - Boolean/Phrase|
|S24||S7 or S8 or S9 or S10 or S11 or S12 or S13 or S14 or S15 or S16 or S17 or S18 or S19 or S20 or S21 or S22 or S23||Search modes - Boolean/Phrase|
|S23||TX health behaviour model or trans theoretical model or trans-theoretical model or transtheoretical model||Search modes - Boolean/Phrase|
|S22||(MH "Health Behavior+")||Search modes - Boolean/Phrase|
|S21||(MH "Health Beliefs") OR (MH "Health Belief Model")||Search modes - Boolean/Phrase|
|S20||TX (informed n2 consent) or (informed n2 choice) or (informed n2 decision*)||Search modes - Boolean/Phrase|
|S19||(MH "Consent+")||Search modes - Boolean/Phrase|
|S18||(MH "Decision Making") OR "decision making" OR (MH "Decision Making, Patient") OR (MH "Decision-Making Support (Iowa NIC)")||Search modes - Boolean/Phrase|
|S17||(MH "Patient Attitudes")||Search modes - Boolean/Phrase|
|S16||"health practice"||Search modes - Boolean/Phrase|
|S15||(MH "Attitude to Health")||Search modes - Boolean/Phrase|
|S14||(MH "Health Knowledge")||Search modes - Boolean/Phrase|
|S13||(MH "Patient Education")||Search modes - Boolean/Phrase|
|S12||(MH "Health Education")||Search modes - Boolean/Phrase|
|S11||(MH "Health Promotion")||Search modes - Boolean/Phrase|
|S10||(MH "Genetic Counseling")||Search modes - Boolean/Phrase|
|S9||(MH "Counseling")||Search modes - Boolean/Phrase|
|S8||TX (persuasive communication)||Search modes - Boolean/Phrase|
|S7||(MH "Communication")||Search modes - Boolean/Phrase|
|S6||S1 or S2 or S3 or S4 or S5||Search modes - Boolean/Phrase|
|S5||TX (risk* or susceptib*)||Search modes - Boolean/Phrase|
|S4||TX (tailored or tailoring or individuali?ed or personali?ed)||Search modes - Boolean/Phrase|
|S3||TX (tailor*n2 counsel*) or (tailor* n2 message*) or (tailor* n2 material*) or (tailor* n2 intervention*) or (personal* n2 counsel*) or (personal* n2 message*) or (personal* n2 material*) or (personal* n2 intervention*) or (individual* n2 counsel*) or (individual* n2 message*) or (individual* n2 material*) or (individual* n2 intervention*)||Search modes - Boolean/Phrase|
|S2||(MH "Disease Susceptibility")||Search modes - Boolean/Phrase|
|S1||"risk"||Search modes - Boolean/Phrase|
Appendix 3. Search Strategy: EMBASE
EMBASE (OvidSP) (2006 to March 2012)
1. risk/ or cancer risk/ or cardiovascular risk/ or coronary risk/ or genetic risk/ or high risk patient/ or high risk population/ or population risk/ or risk assessment/ or risk benefit analysis/ or risk factor/
2. exp disease predisposition/
3. ((tailor* or personal* or individual*) adj2 (counsel* or message* or material* or intervention*)).tw.
4. (tailored or tailoring or individuali#ed or personali#ed).tw.
6. interpersonal communication/
7. patient information/
8. medical information/
9. persuasive communication/
11. genetic counseling/
12. parent counseling/
13. patient counseling/
14. exp health education/
15. attitude to health/
16. patient attitude/
17. patient compliance/
18. informed consent/
19. decision making/
20. (informed adj2 (consent or choice or decision*)).tw.
22. 5 and 21
23. (risk* adj3 (notif* or inform* or communicat* or counsel* or apprais* or assessment or perception* ot perceiv*)).tw.
24. 22 or 23
25. exp screening/
26. (screen* or test? or testing or detection or early diagnosis).tw.
27. exp diagnosis/
28. exp tumor marker/
29. (mammography or mammogram* or colonoscopy or sigmoidoscopy or occult blood or vaginal smear* or pap* smear* or pap* test* or prostate specific antigen* or (prostat* and psa) or brca* or chest x-ray or tomograph* or bronchoscop* or bone density or absorptiometry).tw.
31. 24 and 30
32. randomized controlled trial/
33. controlled clinical trial/
34. single blind procedure/ or double blind procedure/
35. crossover procedure/
37. ((singl* or doubl*) adj (blind* or mask*)).tw.
38. (crossover or cross over or factorial* or latin square).tw.
39. ((allocat* or assign*) adj4 (experiment* or intervention* or control* or group*)).tw.
41. nonhuman/ not (human/ and nonhuman/)
42. 40 not 41
43. 31 and 42
44. limit 43 to yr="2006 -Current"
Appendix 4. Search Strategy: MEDLINE
MEDLINE (OvidSP) (2006 to March 2012)
1. exp risk/
2. exp disease susceptibility/
3. ((tailor* or personal* or individual*) adj2 (counsel* or message* or material* or intervention*)).tw.
4. (tailored or tailoring or individuali#ed or personali#ed).tw.
5. (risk* or susceptib*).tw.
8. persuasive communication/
10. genetic counseling/
11. health promotion/
12. health education/
13. patient education as topic/
14. health knowledge, attitudes, practice/
15. attitude to health/
16. exp informed consent/
17. patient acceptance of health care/
18. decision making/
19. (informed adj2 (consent or choice or decision*)).tw.
21. 6 and 20
22. (risk* adj3 (notif* or inform* or communicat* or counsel* or appraisal or assessment or perception* or perceiv*)).tw.
23. 21 or 22
24. exp mass screening/
25. (screen* or test? or testing or detection or early diagnosis).tw.
26. exp early diagnosis/
27. exp "diagnostic techniques and procedures"/
28. exp "laboratory techniques and procedures"/
29. exp tumor markers biological/
30. predictive value of tests/
31. (mammography or mammogram* or colonoscopy or sigmoidoscopy or occult blood or vaginal smear* or pap* smear* or prostate specific antigen* or (prostat* and psa) or brca* or chest x-ray or tomograph* or bronchoscop*).tw.
33. 23 and 32
34. randomized controlled trial.pt.
35. controlled clinical trial.pt.
38. clinical trials as topic.sh.
42. exp animals/ not humans.sh.
43. 41 not 42
44. 33 and 43
45. limit 44 to yr=2006 to 2011
Appendix 5. Search Strategy: PsycINFO
PsycINFO (OvidSP) (2006 to March 2012)
1. risk factors/
2. risk assessment/
3. risk perception/
4. at risk populations/
5. "susceptibility (disorders)"/
7. (risk* or susceptib*).ti,ab,id.
9. ((tailor* or personal* or individual*) adj2 (counsel* or message* or material* or intervention*)).ti,ab,id.
10. (tailored or tailoring or individuali#ed or personali#ed).ti,ab,id.
13. persuasive communication/
17. genetic counseling/
18. health promotion/
19. health education/
20. client education/
21. individualized instruction/
22. health knowledge/
23. health attitudes/
24. informed consent/
25. treatment compliance/
26. decision making/
27. (informed adj2 (consent or choice or decision*)).ti,ab,id.
29. 11 and 28
30. (risk* adj3 (notif* or inform* or communicat* or counsel* or apprais* or assessment or perception* ot perceiv*)).ti,ab,id.
31. 29 or 30
33. exp health screening/
34. exp screening tests/
35. (screen* or test? or testing or detection or early diagnosis).ti,ab,id.
36. exp diagnosis/
37. biological markers/
38. (mammography or mammogram* or colonoscopy or sigmoidoscopy or occult blood or vaginal smear* or pap* smear* or pap* test* or prostate specific antigen* or (prostat* and psa) or brca* or chest x-ray or tomograph* or bronchoscop* or bone density or absorptiometry).ti,ab,id.
40. 31 and 39
45. ((singl* or doubl* or trebl* or tripl*) and (blind* or mask*)).ti,ab,hw,id.
46. (cross over or crossover or factorial* or latin square).ti,ab,hw,id.
47. (assign* or allocat* or volunteer*).ti,ab,hw,id.
48. treatment effectiveness evaluation/
49. mental health program evaluation/
50. exp experimental design/
53. 40 and 52
54. limit 53 to yr="2006 -Current"