Theory based analysis of the effects of decision aids for surgery in early breast cancer: a systematic review

Rationale, aims and objectives: Little is understood about how decision aids achieve their reported effects or their impact on the decision-making process. We aimed to evaluate the quality of decision aids for women choosing surgery for early breast cancer and to examine how their reported effects may reflect the contribution of components suggested by an extended Theory of Planned Behaviour (TPB) and the Common Sense Model of Illness Representations (CSM) to be required for good quality decision-making in this domain.  We undertook a systematic review to examine the components of decision aids that influence decision-making processes for women choosing surgery for early breast cancer. The quality and theoretical underpinnings of the decision aids were appraised and reported outcomes meta-analysed.  Ten decision aids were obtained; 4 had been evaluated in randomised trials. The quality of the decision aids was similar, with limited evidence of theoretical base. Data linking decision aid components, design, use and outcomes to judge the effects on the decision-making process were inconsistent. Two trials suggested evidence of a reduction in Decision Conflict scores (SMD = -0.35, 95% CI -0.57 to -0.12, p = 0.002). Improvements in knowledge (4 trials) and trends towards breast conservation surgery (3 trials) were not statistically significant.  A greater understanding of how decision aids impact on the decision-making process is needed if we are to design improved interventions that are effective on the core aspects of decision-making in this domain.

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title: Dual equipoise shared decision making: definitions for decision and behaviour support interventions
abstract: BackgroundThere is increasing interest in interventions that can support patients who face difficult decisions and individuals who need to modify their behaviour to achieve better outcomes. Evidence for effectiveness is used to categorise patients care. Effective care is where evidence of benefit outweighs harm: patients should always receive this type of care, where indicated. Preference-sensitive care describes a situation where the evidence for the superiority of one treatment over another is either not available or does not allow differentiation; in this situation, there are two or more valid approaches, and the best choice depends on how individuals value the risks and benefits of treatments.DiscussionPreference-sensitive decisions are defined by equipoise: situations where options need to be deliberated. Moreover, where both healthcare professionals and patients agree that equipoise exists, situations may be regarded as having 'dual equipoise'. Such conditions are ideal for shared decision making. However, there are many situations in medicine where dual equipoise does not exist, where health professionals hold the view that scientific evidence for benefit strongly outweighs harm. This is often the case where people suffer from chronic conditions, and where behaviour change is recommended to improve outcomes. However, some patients, are either ambivalent or find it difficult to sustain optimal behaviours, i.e., patients will be in varying degrees of equipoise. Therefore, situations where dual equipoise exists (or not) help to clarify the definitions of two classes of support, namely, decision and behaviour change support interventions. Decision support interventions help people think about choices they face; they describe where and why choice exists, in short, conditions of dual equipoise; they provide information about options, including, where reasonable, the option of taking no action. These interventions help people to deliberate, independently or in collaboration with others, about options by considering relevant attributes; they support people to forecast how they might feel about short, intermediate, and long-term outcomes that have relevant consequences, in ways that help the process of constructing preferences and eventual decision making appropriate to their individual situation. Whereas, behavioural support interventions describe, justify, and recommend actions that, over time, lead to predictable outcomes over short, intermediate, and long-term timeframes, and that have relevant and important consequences for those who are considering behaviour change.SummaryDecision and behaviour support interventions have divergent aims, different relationships to equipoise, and form two classes of interventions.

title: Decision aids for people facing health treatment or screening decisions.
abstract: Decision aids are interventions that support patients by making their decisions explicit, providing information about options and associated benefits/harms, and helping clarify congruence between decisions and personal values.



To assess the effects of decision aids in people facing treatment or screening decisions.



Updated search (2012 to April 2015) in CENTRAL; MEDLINE; Embase; PsycINFO; and grey literature; includes CINAHL to September 2008.



We included published randomized controlled trials comparing decision aids to usual care and/or alternative interventions. For this update, we excluded studies comparing detailed versus simple decision aids.



Two reviewers independently screened citations for inclusion, extracted data, and assessed risk of bias. Primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were attributes related to the choice made and the decision-making process.Secondary outcomes were behavioural, health, and health system effects.We pooled results using mean differences (MDs) and risk ratios (RRs), applying a random-effects model. We conducted a subgroup analysis of studies that used the patient decision aid to prepare for the consultation and of those that used it in the consultation. We used GRADE to assess the strength of the evidence.



We included 105 studies involving 31,043 participants. This update added 18 studies and removed 28 previously included studies comparing detailed versus simple decision aids. During the 'Risk of bias' assessment, we rated two items (selective reporting and blinding of participants/personnel) as mostly unclear due to inadequate reporting. Twelve of 105 studies were at high risk of bias.With regard to the attributes of the choice made, decision aids increased participants' knowledge (MD 13.27/100; 95% confidence interval (CI) 11.32 to 15.23; 52 studies; N = 13,316; high-quality evidence), accuracy of risk perceptions (RR 2.10; 95% CI 1.66 to 2.66; 17 studies; N = 5096; moderate-quality evidence), and congruency between informed values and care choices (RR 2.06; 95% CI 1.46 to 2.91; 10 studies; N = 4626; low-quality evidence) compared to usual care.Regarding attributes related to the decision-making process and compared to usual care, decision aids decreased decisional conflict related to feeling uninformed (MD -9.28/100; 95% CI -12.20 to -6.36; 27 studies; N = 5707; high-quality evidence), indecision about personal values (MD -8.81/100; 95% CI -11.99 to -5.63; 23 studies; N = 5068; high-quality evidence), and the proportion of people who were passive in decision making (RR 0.68; 95% CI 0.55 to 0.83; 16 studies; N = 3180; moderate-quality evidence).Decision aids reduced the proportion of undecided participants and appeared to have a positive effect on patient-clinician communication. Moreover, those exposed to a decision aid were either equally or more satisfied with their decision, the decision-making process, and/or the preparation for decision making compared to usual care.Decision aids also reduced the number of people choosing major elective invasive surgery in favour of more conservative options (RR 0.86; 95% CI 0.75 to 1.00; 18 studies; N = 3844), but this reduction reached statistical significance only after removing the study on prophylactic mastectomy for breast cancer gene carriers (RR 0.84; 95% CI 0.73 to 0.97; 17 studies; N = 3108). Compared to usual care, decision aids reduced the number of people choosing prostate-specific antigen screening (RR 0.88; 95% CI 0.80 to 0.98; 10 studies; N = 3996) and increased those choosing to start new medications for diabetes (RR 1.65; 95% CI 1.06 to 2.56; 4 studies; N = 447). For other testing and screening choices, mostly there were no differences between decision aids and usual care.The median effect of decision aids on length of consultation was 2.6 minutes longer (24 versus 21; 7.5% increase). The costs of the decision aid group were lower in two studies and similar to usual care in four studies. People receiving decision aids do not appear to differ from those receiving usual care in terms of anxiety, general health outcomes, and condition-specific health outcomes. Studies did not report adverse events associated with the use of decision aids.In subgroup analysis, we compared results for decision aids used in preparation for the consultation versus during the consultation, finding similar improvements in pooled analysis for knowledge and accurate risk perception. For other outcomes, we could not conduct formal subgroup analyses because there were too few studies in each subgroup.



Compared to usual care across a wide variety of decision contexts, people exposed to decision aids feel more knowledgeable, better informed, and clearer about their values, and they probably have a more active role in decision making and more accurate risk perceptions. There is growing evidence that decision aids may improve values-congruent choices. There are no adverse effects on health outcomes or satisfaction. New for this updated is evidence indicating improved knowledge and accurate risk perceptions when decision aids are used either within or in preparation for the consultation. Further research is needed on the effects on adherence with the chosen option, cost-effectiveness, and use with lower literacy populations.

title: Locoregional treatment of primary breast cancer
abstract: Guidelines for the locoregional treatment of primary breast cancer were last published by the US National Institutes of Health in 1991. Since then, new surgical and radiotherapeutic techniques have been developed, clinical trials have provided new evidence, and intriguing long‐term effects have emerged from global metadatabases. A revision of these guidelines is therefore necessary and timely. To address this concern, in October 2008, a group of opinion leaders from Austria, Denmark, France, Germany, Italy, the Netherlands, the United Kingdom, and the United States who have worked and published in the field of locoregional treatment met and collectively prepared and approved the described set of recommendations for the use of surgery and radiotherapy in primary breast cancer outside of clinical trials. Cancer 2010.

title: Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer.
abstract: In 1976, we initiated a randomized trial to determine whether lumpectomy with or without radiation therapy was as effective as total mastectomy for the treatment of invasive breast cancer.



A total of 1851 women for whom follow-up data were available and nodal status was known underwent randomly assigned treatment consisting of total mastectomy, lumpectomy alone, or lumpectomy and breast irradiation. Kaplan-Meier and cumulative-incidence estimates of the outcome were obtained.



The cumulative incidence of recurrent tumor in the ipsilateral breast was 14.3 percent in the women who underwent lumpectomy and breast irradiation, as compared with 39.2 percent in the women who underwent lumpectomy without irradiation (P<0.001). No significant differences were observed among the three groups of women with respect to disease-free survival, distant-disease-free survival, or overall survival. The hazard ratio for death among the women who underwent lumpectomy alone, as compared with those who underwent total mastectomy, was 1.05 (95 percent confidence interval, 0.90 to 1.23; P=0.51). The hazard ratio for death among the women who underwent lumpectomy followed by breast irradiation, as compared with those who underwent total mastectomy, was 0.97 (95 percent confidence interval, 0.83 to 1.14; P=0.74). Among the lumpectomy-treated women whose surgical specimens had tumor-free margins, the hazard ratio for death among the women who underwent postoperative breast irradiation, as compared with those who did not, was 0.91 (95 percent confidence interval, 0.77 to 1.06; P=0.23). Radiation therapy was associated with a marginally significant decrease in deaths due to breast cancer. This decrease was partially offset by an increase in deaths from other causes.



Lumpectomy followed by breast irradiation continues to be appropriate therapy for women with breast cancer, provided that the margins of resected specimens are free of tumor and an acceptable cosmetic result can be obtained.

title: Quality of life after breast cancer surgery: What have we learned and where should we go next?
abstract: Treatment options for women with newly diagnosed breast cancer include breast conservation therapy and mastectomy with or without reconstruction, which provide equivalent cancer outcomes in properly selected patients. Although multiple studies have evaluated breast surgery quality‐of‐life outcomes, the data are inconsistent. This factor is important to consider when counseling patients and defining surgical quality measures.

title: Randomized Trials of Breast-Conserving Therapy Versus Mastectomy for Primary Breast Cancer: A Pooled Analysis of Updated Results
abstract: We have undertaken a pooled analysis of the 6 major randomized trials comparing mastectomy (MT) and breast-conserving therapy (BCT) in the treatment of primary breast cancer. Specifically, these trials compared the 2 most widely used options in local treatment: mastectomy and axillary dissection (MT) versus breast-conserving surgery, axillary dissection, and breast radiotherapy (BCT). The early results of these 6 trials formed the basis for a 1990 National Institutes of Health Consensus statement. However, most of these trials have recently published long-term follow-up results, and this pooled analysis incorporates the updated results of these 6 trials. For each of these trials, the observed number of treatment events was compared with that expected under the null hypothesis, given the number of patients per arm and the total number of events. Approximate odds ratios were computed using the observed and expected number of events, and the variance of the observed number of events. These were then pooled across trials to give overall odds ratios for the risk of locoregional recurrence, total recurrence, and death. Four of the 6 trials show that MT significantly reduces the risk of locoregional recurrence when compared with BCT, and the pooled odds ratio also shows a significant benefit for MT (odds ratio [OR], 1.561; 95% confidence interval [CI], 1.289–1.890; P <0.001). However, only 1 trial shows a statistically significant benefit for MT in reducing mortality, and the pooled odds ratio shows no significant difference between MT and BCT (OR, 1.070; 95% CI, 0.935–1.224; P = 0.33). This pooled analysis confirms that MT and BCT have comparable effects on mortality, even after long-term follow up. However, BCT is associated with a significantly greater risk of locoregional recurrence.

title: Why do hospital mastectomy rates vary? Differences in the decision-making experiences of women with breast cancer
abstract: Hospital mastectomy rates vary. This study explores the relationship between mastectomy rates and breast cancer patients’ consultation and decision-making experiences with specialist clinicians.Qualitative semi-structured interviews were conducted with 65 patients from three purposively selected breast units from a single UK region. Patients provided with a choice of breast cancer surgery (breast conservation therapy (BCT) or mastectomy) were purposively recruited from high, medium and low case-mix-adjusted mastectomy rate units.Low mastectomy rate unit patients’ consultation and decision-making experiences were markedly different to those of the medium and high mastectomy rate breast units. Treatment variation was associated with patients’ perception of the most reassuring and least disruptive treatment; the content and style of information provision (equipoise or directed); level of patient participation in decision making; the time and process of decision making and patient autonomy in decision making. The provision of more comprehensive less directive information and greater autonomy, time and support of independent decision making were associated with a lower uptake of BCT.Conclusion:Variation in hospital mastectomy rates was associated with differences in the consultation and decision-making experiences of breast cancer patients. Higher mastectomy rates were associated with the facilitation of more informed autonomous patient decision making.

title: Predictors of patients’ choices for breast-conserving therapy or mastectomy: a prospective study
abstract: A study was undertaken to describe the treatment preferences and choices of patients with breast cancer, and to identify predictors of undergoing breast-conserving therapy (BCT) or mastectomy (MT). Consecutive patients with stage I/II breast cancer were eligible. Information about predictor variables, including socio-demographics, quality of life, patients’ concerns, decision style, decisional conflict and perceived preference of the surgeon was collected at baseline, before decision making and surgery. Patients received standard information (n=88) or a decision aid (n=92) as a supplement to support decision making. A total of 180 patients participated in the study. In all, 72% decided to have BCT (n=123); 28% chose MT (n=49). Multivariate analysis showed that what patients perceived to be their surgeons’ preference and the patients’ concerns regarding breast loss and local tumour recurrence were the strongest predictors of treatment preference. Treatment preferences in itself were highly predictive of the treatment decision. The decision aid did not influence treatment choice. The results of this study demonstrate that patients’ concerns and their perceptions of the treatment preferences of the physicians are important factors in patients’ decision making. Adequate information and communication are essential to base treatment decisions on realistic concerns, and the treatment preferences of patients.

title: Can women with early-stage breast cancer make an informed decision for mastectomy?
abstract: The purpose of this study was to measure the degree to which informed women chose mastectomy, and to reveal their reasons for this choice.



This was a prospective cohort study of patients radiographically and pathologically eligible for either mastectomy or breast-conserving surgery (BCS; n = 125). Participants completed questionnaires at three time points: baseline, after viewing a decision aid, and after a surgical consultation. Questionnaires assessed clinical history, preference for participation in decision making, information comprehension, values, decisional conflict, and preferred treatment.



Of 125 participants, 44 (35%) chose mastectomy. Most understood that BCS and mastectomy offer an equivalent survival benefit (98%) and that BCS has a slightly higher local recurrence risk (63%); most accurately identified the magnitude of ipsilateral local recurrence risk (91%). Values assigned to three treatment attributes/outcomes ("remove breast for peace of mind," "avoid radiation," and "keep breast") clearly discriminated between patients choosing mastectomy or BCS. High decisional conflict scores improved after both the decision aid and surgical consultation.



Although conventional wisdom may view BCS as the preferred treatment, a notable proportion of well informed women choose mastectomy. Whereas prior studies have linked objective factors to treatment choice, this study reveals subjective preferences that underlie decision making. The systematic use of a decision aid before the surgical consultation may help women make informed, values-based decisions, while clearly reducing decisional conflict.

title: Decision aids and breast cancer: do they influence choice for surgery and knowledge of treatment options?
abstract: To describe the effect of decision aids on the choice for surgery and knowledge of surgical therapy among women with early-stage breast cancer.



A systematic review was conducted between years 1966 to 2006 of all studies designed to assess the effect of decision aids on surgical therapy. MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health (CINAHL), the Cochrane Network, HAPI databases, and bibliographies were searched. Of the 123 studies screened, 11 studies met criteria. Meta-analyses were performed to assess the pooled relative risk for surgical choice and the pooled mean difference in patient knowledge.



Results from randomized controlled trials indicated that women who used a decision aid were 25% more likely to choose breast-conserving surgery over mastectomy (risk ratio, 1.25; 95% CI, 1.11 to 1.40). Decision aids significantly increased patient knowledge by 24% (P = .024). The data also suggested that decision aids decreased decisional conflict and increased satisfaction with the decision-making process. Decision aids were well received by surgeons and patients, facilitated patients' desire for shared decision making, and were feasible to implement into practice.



Decision aids are important adjuncts for counseling women with early-stage breast cancer. Their use increases the likelihood that women will choose breast-conserving surgery, and enhances patient knowledge of treatment options.

title: Understanding why decision aids work: linking process with outcome.
abstract: Decision aids help patients make treatment choices. There is little empirical evidence to explain how they work. The results from this randomised controlled trial comparing routine with decision-aided consultations in the prenatal diagnosis for Down's syndrome context are used to describe the strategies employed during decision making, to assess the impact of a decision aid on decision processes, and to investigate decision process and outcome associations. Data were elicited from two content analyses of consultation transcripts and questionnaires assessing knowledge, anxiety, decisional conflict, reasons, and information usefulness. 68/106 women completed measures at consultation and follow-up. Decision-aided women employed more cognitive and emotional strategies during decision making. More negative evaluations during decision making were associated with better outcomes. Decision-aided consultations facilitated the employment of strategies associated with more effective choices. These consultations take longer and elicit greater expressions of negative affect, so may be less rewarding encounters for health professionals.

title: An approach to measuring the quality of breast cancer decisions.
abstract: To explore an approach to measuring the quality of decisions made in the treatment of early stage breast cancer, focusing on patients' decision-specific knowledge and the concordance between patients' stated preferences for treatment outcomes and treatment received.



Candidate knowledge and value items were identified after an extensive review of the published literature as well as reports on 27 focus groups and 46 individual interviews with breast cancer survivors. Items were subjected to cognitive interviews with six additional patients. A preliminary decision quality measure consisting of five knowledge items and four value items was pilot tested with 35 breast cancer survivors who also completed the control preferences scale and the decisional conflict scale (DCS).



Preference for control and knowledge did not vary by treatment. The mean of the participants' knowledge scores was 54%. There was no correlation between the knowledge scores and the informed subscale of the DCS (Pearson r = .152, n = 32, p = 0.408). Patients who preferred to keep their breast were over five times as likely to have breast-conserving surgery than those who did not (OR 5.33, 95% CI (1.2, 24.5), p = 0.06). Patients who wanted to avoid radiation were six times as likely to choose mastectomy than those who did not (OR 6.4, 95% CI (1.34, 30.61), p = 0.04).



Measuring decision quality by assessing patients' decision-specific knowledge and concordance between their values and treatment received, is feasible and important. Further work is necessary to overcome the methodological challenges identified in this pilot work.



Guidelines for early stage breast cancer emphasize the importance of including patients' preferences in decisions about treatment. The ability of doctors and patients to make decisions that reflect the considered preferences of well-informed patients can and should be measured.

title: Deliberation before determination: the definition and evaluation of good decision making
abstract: In this article, we examine definitions of suggested approaches to measure the concept of good decisions, highlight the ways in which they converge, and explain why we have concerns about their emphasis on post‐hoc estimations and post‐decisional outcomes, their prescriptive concept of knowledge, and their lack of distinction between the process of deliberation, and the act of decision determination.

title: Challenges for designing and implementing decision aids.
abstract: Decision aids are tools intended to help patients with decisions about their health-care. We have developed three decision aids to help patients with treatment decisions for: locally advanced non-small cell lung cancer (LA-NSCLC), advanced non-small cell lung cancer (A-NSCLC), and early-stage prostate cancer (ES-PC). In developing the aids, we carried out studies to provide them with an empirical basis, and to evaluate their potential for impact. In this paper we report results that challenge common assumptions and typical practice that currently occurs in the development of decision aids. The challenges relate to: how the content of the aid is defined, how the information is presented, how to incorporate decision aids into the dynamic, complex process of making such decisions, and how to evaluate the aids. We conclude that critical appraisal of issues related to the design and implementation of decision aids is required.

title: From Theory to Intervention: Mapping Theoretically Derived Behavioural Determinants to Behaviour Change Techniques
abstract: Theory provides a helpful basis for designing interventions to change behaviour but offers little guidance on how to do this. This paper aims to illustrate methods for developing an extensive list of behaviour change techniques (with definitions) and for linking techniques to theoretical constructs. A list of techniques and definitions was generated from techniques published in two systematic reviews, supplemented by “brainstorming” and a systematic search of nine textbooks used in training applied psychologists. Inter-rater reliability of extracting the techniques and definitions from the textbooks was assessed. Four experts judged which techniques would be effective in changing 11 theoretical constructs associated with behaviour change. 
Thirty-five techniques identified in the reviews were extended to 53 by brainstorming and to 137 by consulting textbooks. Agreement for the 53 definitions was 74.7 per cent (15.4% cells completed and 59.3% cells empty for both raters). Agreement about the link between the 35 techniques and theoretical constructs was 71.7 per cent of 385 judgments (12.2% agreement that effective and 59.5% agreement that not effective). This preliminary work demonstrates the possibility of developing a comprehensive, reliable taxonomy of techniques linked to theory. Further refinement is needed to eliminate redundancies, resolve uncertainties, and complete technique definitions.

title: Where is the theory? Evaluating the theoretical frameworks described in decision support technologies.
abstract: To identify and describe the extent to which theory or theoretical frameworks informed the development and evaluation of decision support technologies (DSTs).



The analysis was based on the decision technologies used in studies included in the Cochrane systematic review of patient decision aids for people facing health screening or treatment decisions. The assumption was made that DSTs evaluated by randomized controlled trials, and therefore included in the updated Cochrane review have been the most rigorously developed.



Of the 50 DSTs evaluated only 17 (34%) were based on a theoretical framework. Amongst these, 11 decision-making theories were described but the extent to which theory informed the development, field-testing and evaluation of these interventions was highly variable between DSTs. The majority of the 17 DSTs that relied on a theory was not explicit about how theory had guided their design and evaluation. Many had superficial descriptions of the theory or theories involved. Furthermore, based on the analysis of those 17 DSTs, none had reported field-testing prior to evaluation.



The use of decision-making theory in DST development is rare and poorly described. The lack of theoretical underpinning to the design and development of DSTs most likely reflects the early development stage of the DST field.



The findings clearly indicate the need to give more attention to how the most important decision-making theories could be better used to guide the design of key decision support components and their modes of action.

title: Understanding surgery choices for breast cancer: how might the Theory of Planned Behaviour and the Common Sense Model contribute to decision support interventions?
abstract: To describe the evidence about factors influencing breast cancer patients’ surgery choices and the implications for designing decision support in reference to an extended Theory of Planned Behaviour (TPB) and the Common Sense Model of Illness Representations (CSM).

title: Anticipated regret as an additional predictor in the theory of planned behaviour: a meta-analysis.
abstract: This paper details the results of a meta-analysis incorporating all the appropriately augmented TPB studies in order to statistically determine the additive effects of anticipated regret (AR) both to the prediction of intentions after the TPB variables and to the direct impacts on behaviour. Over a number of studies there was a strong AR-intention relationship (r(+)=.47, k=25, N=11,254), and AR significantly and independently added to the prediction of intentions over and above the TPB variables; there was a moderate relationship between AR and behaviour (r(+)=.28, k=8, N=2,035) with AR having a direct and significant impact on prospective behaviour, and there was support for the unique contribution of AR even when accounting for attitude. Implications and issues for further research are discussed.

title: Adjuncts or adversaries to shared decision-making? Applying the Integrative Model of behavior to the role and design of decision support interventions in healthcare interactions
abstract: BackgroundA growing body of literature documents the efficacy of decision support interventions (DESI) in helping patients make informed clinical decisions. DESIs are frequently described as an adjunct to shared decision-making between a patient and healthcare provider, however little is known about the effects of DESIs on patients' interactional behaviors-whether or not they promote the involvement of patients in decisions.DiscussionShared decision-making requires not only a cognitive understanding of the medical problem and deliberation about the potential options to address it, but also a number of communicative behaviors that the patient and physician need to engage in to reach the goal of making a shared decision. Theoretical models of behavior can guide both the identification of constructs that will predict the performance or non-performance of specific behaviors relevant to shared decision-making, as well as inform the development of interventions to promote these specific behaviors. We describe how Fishbein's Integrative Model (IM) of behavior can be applied to the development and evaluation of DESIs. There are several ways in which the IM could be used in research on the behavioral effects of DESIs. An investigator could measure the effects of an intervention on the central constructs of the IM - attitudes, normative pressure, self-efficacy, and intentions related to communication behaviors relevant to shared decision-making. However, if one were interested in the determinants of these domains, formative qualitative research would be necessary to elicit the salient beliefs underlying each of the central constructs. Formative research can help identify potential targets for a theory-based intervention to maximize the likelihood that it will influence the behavior of interest or to develop a more fine-grained understanding of intervention effects.SummaryBehavioral theory can guide the development and evaluation of DESIs to increase the likelihood that these will prepare patients to play a more active role in the decision-making process. Self-reported behavioral measures can reduce the measurement burden for investigators and create a standardized method for examining and reporting the determinants of communication behaviors necessary for shared decision-making.

title: Interactive patient decision aids for women facing genetic testing for familial breast cancer: a systematic web and literature review.
abstract: A systematic review to identify and appraise interactive decision aids that are designed for consumer use, in the field of hereditary breast cancer and genetic testing.



An Internet (Google, Alta Vista) and literature search (Medline) was conducted for suitable decision aids. The decision aid had to (inclusion criteria): be about genetic testing for familial breast cancer; fulfil the criteria of a decision aid; use multimedia IT; be interactive (user does something that influences the decision pathway); and be for patient/public use. Exclusion criteria were decision aids that: had no interactivity (e.g. leaflet, video); discussed management decisions after gene status confirmed; non-English; aids that required membership/subscription. Once aids had been selected for further appraisal they were assessed against a recognized framework for the evaluation of decision aids--the International Patient Decision Aid Standards (IPDAS) criteria.



On Google 595 web pages were assessed, as were 382 Google directory entries. Alta Vista revealed fewer results and revealed no new sites. Twenty-four web sites and four CD-ROMs with the most potential as stand alone decision aids were then selected for further assessment. On Medline 776 citations were reviewed, of these only one CD-ROM and no web sites were found. After initial appraisal only two CD-ROMs and one web site met the criteria for further consideration. Assessed against the IPDAS criteria, the decision aids scored poorly with no aid scoring more than 50%.



Although there is a significant amount of interest in genetic testing to determine whether a woman is at high risk of breast cancer, the current genetic services are having difficulty coping with the demand. Alternatives such as decision aids have been suggested. There are many sources of information available, but few are truly interactive or designed for patient use. Of the three evaluated, all were from the USA and are likely to require modification for patients elsewhere.

title: Developing a quality criteria framework for patient decision aids: online international Delphi consensus process
abstract: To develop a set of quality criteria for patient decision support technologies (decision aids).  Two stage web based Delphi process using online rating process to enable international collaboration. Participants Individuals from four stakeholder groups (researchers, practitioners, patients, policy makers) representing 14 countries reviewed evidence summaries and rated the importance of 80 criteria in 12 quality domains ona1to9 scale. Second round participants received feedback from the first round and repeated their assessment of the 80 criteria plus three new ones.  Aggregate ratings for each criterion calculated using medians weighted to compensate for different numbers in stakeholder groups; criteria rated between 7 and 9 were retained.  212 nominated people were invited to participate. Of those invited, 122 participated in the first round (77 researchers, 21 patients, 10 practitioners, 14 policy makers); 104/122 (85%) participated in the second round. 74 of 83 criteria were retained in the following domains: systematic development process (9/9 criteria); providing information about options (13/13); presenting probabilities (11/13); clarifying and expressing values (3/3); using patient stories (2/5); guiding/coaching (3/5); disclosing conflicts of interest (5/5); providing internet access (6/6); balanced presentation of options (3/3); using plain language (4/6); basing information on up to date evidence (7/7); and establishing effectiveness (8/8).  Criteria were given the highest ratings where evidence existed, and these were retained. Gaps in research were highlighted. Developers, users, and purchasers of patient decision aids now have a checklist for appraising quality. An instrument for measuring quality of decision aids is being developed.

title: Meta-analysis in clinical trials.
abstract: This paper examines eight published reviews each reporting results from several related trials. Each review pools the results from the relevant trials in order to evaluate the efficacy of a certain treatment for a specified medical condition. These reviews lack consistent assessment of homogeneity of treatment effect before pooling. We discuss a random effects approach to combining evidence from a series of experiments comparing two treatments. This approach incorporates the heterogeneity of effects in the analysis of the overall treatment efficacy. The model can be extended to include relevant covariates which would reduce the heterogeneity and allow for more specific therapeutic recommendations. We suggest a simple noniterative procedure for characterizing the distribution of treatment effects in a series of studies.

title: Cluster-randomized trials
abstract: Cluster-randomized trials represent an important experimental design, supplementing ordinary randomized clinical trials. They are particularly relevant when evaluating interventions at the level of clinic, hospital, district or region. They are necessary when it is not feasible to randomize individual patients, and desirable when there may be contamination between clusters. But they also carry serious design and analysis implications, and the use of clusters as the unit of randomization must be justified. Sample sizes will usually need to be greatly increased, an adequate number of clusters is essential, and the statistical analysis must allow for the cluster design. And one should rigorously guard against selection bias.

title: Randomized Trial of a Patient Decision Aid for Choice of Surgical Treatment for Breast Cancer
abstract: A decision aid for the surgical treatment of early breast cancer was evaluated in a randomized controlled trial. The decision aid, a tape and workbook, includes explicit presentation of probabilities, photographs and graphics, and a values clarification exercise. Community surgeons were randomized to use the decision aid or a control pamphlet. Patients completed a questionnaire prior to using the decision aid, after reviewing it but prior to surgery, and 6 months after enrollment. There was no difference in anxiety, knowledge, or decisional regret across the 2 groups. There was a nonsignificant trend toward lower decisional conflict in the decision aid group. A subgroup of women who were initially leaning toward mastectomy or were unsure had lower decisional conflict. Although the decision aid had minimal impact on the main study outcomes, a subgroup may have benefited. Such subgroups should be identified, and appropriate decision support interventions should be developed and evaluated.

title: Patient Participation in Deciding Breast Cancer Treatment and Subsequent Quality of Life
abstract: This investigation of patients with early breast cancer examined relationships among patient involvement in deciding treatment (i.e., whether to undergo breast removal or breast conservation), perceptions of control over treatment decisions, and subsequent health-related quality of life. It was predicted 1) that patients who more actively participated in consultations to decide treatment would perceive more decision control than would more passive patients and 2) that patients who perceived greater decision control would report better health-related quality of life following treatment than would patients perceiving less decision control. Sixty patients with stage I or II breast cancer allowed their consultations with surgeons to be audiorecorded. Following these visits, patients reported on their involvement in the consultation, optimism for the future, knowledge about treatment, and two aspects of perceived decision control, the perception of having a choice for treatment and the extent to which the doctor or patient was responsible for the decision. Six and 12 months postoperatively, 51 patients (85%) returned a follow-up survey assessing perceived decision control and health-related quality of life. The first prediction received some support. The patients who had more actively participated in their consultations, particularly in terms of offering opinions, assumed more responsibility for treatment decisions during the year following surgery than did less expressive patients. Also, the patients who reported more involvement in their consultations later believed they had had more of a choice for treatment. The second hypothesis was partially supported. Six and 12 months following treatment, the patients who believed they were more responsible for treatment decisions and believed they had more choice of treatment reported higher levels of quality of life than did the patients who perceived themselves to have less decision control. However, perceived control at the time of treatment did not predict later quality of life. Theoretical and clinical implications are discussed.  decision control; patient participation; breast cancer; health-related quality of life.

title: Increasing patient involvement in choosing treatment for early breast cancer
abstract: This investigation examined factors affecting patient involvement in consultations to decide local treatment for early breast cancer and the effectiveness of two methods of preconsultation education aimed at increasing patient participation in these discussions.

title: Effect of a decision aid on knowledge and treatment decision making for breast cancer surgery: a randomized trial.
abstract: The long-term results of randomized trials have demonstrated equivalent survival rates for mastectomy and breast-conserving therapy for the treatment of early stage breast cancer. Consequently, the choice of treatment should be based on a patient's preferences.



To evaluate the impact of a decision aid regarding the different surgical treatment options on patient decision making.



A cluster randomized trial for which general surgeons in the communities of central-west, and eastern Ontario, Canada, were randomly assigned to use the decision aid or not in the surgical consultation. Patients received the decision aid or not based on the surgeon seen.



Twenty surgeons participated in the study. Of the 208 eligible women with newly diagnosed clinical stage I or II breast cancer seen by study surgeons, 201 agreed to be evaluated: 94 were assigned to the decision board and 107 to usual practice. Patients were recruited from November 1999 to April 2002.



The decision board is a decision aid designed to help physicians inform their patients about different treatment options and to enable patients to express a preference for treatment.



Patient knowledge about the surgical treatment of breast cancer; decisional conflict; satisfaction with decision making; and the treatment decision following the consultation.



Patients in the decision board group had higher knowledge scores about their treatment options (66.9 vs 58.7; P<.001), had less decisional conflict (1.40 vs 1.62, P =.02), and were more satisfied with decision making (4.50 vs 4.32, P =.05) following the consultation. Patients who used the decision board were more likely to choose BCT (94% vs 76%, P =.03).



The decision board was helpful in improving communication and enabling women to make a choice regarding treatment. Such instruments should be considered by surgeons when communicating the different surgical options to women with breast cancer.

title: Impact of an Educational Video on Patient Decision Making in Early Breast Cancer Treatment
abstract: Previous research suggests that patient education programs promoting shared decision making (SDM) may improve patient satisfaction and outcomes, yet controlled clinical trials are lacking. The authors evaluate the impact of an early breast cancer treatment educational video on patients' decisional preferences and behavior. Newly diagnosed stage I/stage II breast cancer patients were assigned to SDM video program or control groups in alternating months. Surveys were administered prior to the provider visit and 1 week following the treatment decision. Variables assessed included autonomy preferences, perceived involvement in care, satisfaction, and treatment choice. There were no significant intervention effects on informational/decisional preferences, anxiety, knowledge, or satisfaction. Although 25% of SDM patients chose mastectomy compared to 14% of controls, this difference was not statistically significant. Eventhough enthusiasm for SDM programs remains high among some patients and providers, this study found only modest benefits.

title: Utilizing Computerized Entertainment Education in the Development of Decision Aids for Lower Literate and Naïve Computer Users
abstract: Decision aids have been developed by using various delivery methods, including interactive computer programs. Such programs, however, still rely heavily on written information, health and digital literacy, and reading ease. We describe an approach to overcome these potential barriers for low-literate, underserved populations by making design considerations for poor readers and naïve computer users and by using concepts from entertainment education to engage the user and to contextualize the content for the user. The system design goals are to make the program both didactic and entertaining and the navigation and graphical user interface as simple as possible. One entertainment education strategy, the soap opera, is linked seamlessly to interactive learning modules to enhance the content of the soap opera episodes. The edutainment decision aid model (EDAM) guides developers through the design process. Although designing patient decision aids that are educational, entertaining, and targeted toward poor readers and those with limited computer skills is a complex task, it is a promising strategy for aiding this population. Entertainment education may be a highly effective approach to promoting informed decision making for patients with low health literacy.

title: Social Foundations of Thought and Action: A Social Cognitive Theory
abstract: 1. Models of Human Nature and Casualty. 2. Observational Learning. 3. Enactive Learning. 4. Social Diffusion and Innovation. 5. Predictive Knowledge and Forethought. 6. Incentive Motivators. 7. Vicarious Motivators. 8. Self-Regulatory Mechanisms. 9. Self-Efficacy. 10. Cognitive Regulators.

title: A Theoretical Agenda for Entertainment—Education
abstract: With the growing number of entertainment—education (E—E) interventions worldwide, and the extensive evaluation research on their impacts, the time is ripe to explore in—depth the theoretical underpinnings of entertainment—education. This introductory article provides a historical background to this special issue of Communication Theory on entertainment—education, and charts a 5—pronged theoretical agenda for future research on entertainment—education. Theoretical investigations of entertainment—education should pay greater attention to the tremendous variability among entertainment—education interventions and to the various resistances to entertainment—education interventions. E theorizing will also benefit from close investigations of the rhetorical, play, and affective aspects of E—E. Further, E—E “effects” research should consider employing a broader understanding of individual, group, and social—level changes and be more receptive to methodological pluralism and measurement ingenuity.

title: Entertainment-Education: A Communication Strategy for Social Change
abstract: Entertainment-education is the process of designing and implementing media messages to entertain and educate for the purposes of increasing an audiences knowledge about educational issues creating favorable attitudes and changing overt behavior. This book chronicles the origins of entertainment-education in current times documenting applications of the strategy around the globe. It serves as a resource for people concerned with the communication process offering a comprehensive discussion of the entertainment-education strategy and establishes a foundation on which to base further study and application. Major figures events and turning points in the evolution of the entertainment-education strategy are presented; theories and concepts explaining the effectiveness of implementing this strategy are documented. In addition research methodologies for studying the effects of such programs are provided and the lessons learned in utilizing such an approach are summarized. In order to present a balanced perspective of the approach its limitations are identified and the ethical problems that may accompany efforts to bring about social change are considered.

title: Contextual factors in shared decision making: a randomised controlled trial in women with a strong suspicion of breast cancer
abstract: Decision aids in North American breast cancer outpatients have been shown to assist with treatment decision making and reduce decisional conflict. To date, appropriate delivery formats to effectively increase patient participation in newly diagnosed breast cancer inpatients have not been investigated in the context of German health care provision. The impact of a decision aid intervention was studied in patients (n=111) with a strong suspicion of breast cancer in a randomised controlled trial. The primary outcome variable was decisional conflict. Participants were followed up 1 week post-intervention with a retention rate of 92%. Analyses revealed that the intervention group felt better informed (ηp2=0.06) but did not experience an overall reduction in decisional conflict as compared with the control group. The intervention had no effect on uptake rates of treatment options, length of consultation with the surgeon, time point of treatment decision making, perceived involvement in decision making, neither decision related nor general patient satisfaction. Patients who received the decision aid intervention experienced a small benefit with regards to how informed they felt about advantages and disadvantages of relevant treatment options. Results are discussed in terms of contextual factors and individual differences as moderators of treatment decision aid effectiveness.