Patient decision aids to support clinical decision making: evaluating the decision or the outcomes of the decision.

Decision aids (DAs) are tools to support patients make informed health decisions with their practitioner. They aim to improve patient knowledge of options, incorporate patient preferences and values, and increase patient involvement in health decision making. Increasingly, the debate about DAs concerns how they should be implemented in practice, with the view that DAs are superior to usual clinical care in facilitating health decisions. The authors challenge this view and suggest that DA research has focused on measures of decision process, leaving the effects on the outcome of the decision relatively unknown. It is still unclear in which conditions DAs are better for patient health and well-being than clinician-led decisions. The authors present a new randomized design to examine the effects of DA-supported patient choice on patient-centered outcomes to identify where DAs are best implemented in clinical practice. In this design, patients are randomized to 1 of 4 arms: intervention A, intervention B, choice of either intervention supported by a clinician, or choice of either intervention supported by a decision aid. Health and quality of life measured over the long term are presented as the primary outcomes. The authors propose that this design will allow the proper assessment of different modes of decision making.     

The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial

ABSTRACT: BACKGROUND: Shared decision making contributes to high quality healthcare by promoting a patientcentered approach. Patient involvement in selecting the components of a diabetes medication program that best match the patient's values and preferences may also enhance medication adherence and improve outcomes. Decision aids are tools designed to involve patients in shared decision making, but their adoption in practice has been limited. In this study, we propose to obtain a preliminary estimate of the impact of patient decision aids vs. usual care on measures of patient involvement in decision making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization. In addition, we propose to identify, describe, and explain factors that promote or inhibit the routine embedding of decision aids in practice. METHODS: We will be conducting a mixed-methods study comprised of a cluster-randomized, practical, multicentered trial enrolling clinicians and their patients (n = 240) with type 2 diabetes from rural and suburban primary care practices (n = 8), with an embedded qualitative study to examine factors that influence the incorporation of decision aids into routine practice. The intervention will consist of the use of a decision aid (Statin Choice and Aspirin Choice, or Diabetes Medication Choice) during the clinical encounter. The qualitative study will include analysis of video recordings of clinical encounters and in-depth, semi-structured interviews with participating patients, clinicians, and clinic support staff, in both trial arms. DISCUSSION: Upon completion of this trial, we will have new knowledge about the effectiveness of diabetes decision aids in these practices. We will also better understand the factors that promote or inhibit the successful implementation and normalization of medication choice decision aids in the care of chronic patients in primary care practices. Trial registration NCT00388050.     

Dangerous omissions: the consequences of ignoring decision uncertainty

Institutions with the responsibility for making adoption (reimbursement) decisions in health care often lack the remit to demand or commission further research: adoption decisions are their only policy instrument. The decision to adopt a technology also influences the prospects of acquiring further evidence because the incentives to conduct research are reduced and the ethical basis of further clinical trials maybe undermined. In these circumstances the decision maker must consider whether the benefits of immediate access to a technology exceeds the value of the evidence which maybe forgone for future patients. We outline how these expected opportunity losses can be established from the perspective of a societal decision maker with and without the remit to commission research, and demonstrate how these considerations change the appropriate decision rules in cost‐effectiveness analysis. Importantly, we identify those circumstances in which the approval of a technology that is expected to be cost‐effective should be withheld, i.e. when an ‘only in research’ recommendation should be made. We demonstrate that a sufficient condition for immediate adoption of a technology can provide incentives for manufacturers to reduce the price or provide additional supporting evidence. However, decisions based solely on expected net benefit provide no such incentives, may undermine the evidence base for future clinical practice and reduce expected net health benefits for the patient population. Copyright © 2010 John Wiley & Sons, Ltd.     

Participation in medical decision making: the patients' perspective.

PURPOSE: Variability in reports of patients' preferences to participate in decision making may be due in part to a lack of understanding about how patients conceptualize their participation. The authors sought to learn more about how patients view their involvement in decisions related to their health care. METHODS: The authors conducted individual interviews to allow patients to frame the decision-making process from their own perspective. The constant comparative-method approach to analysis was employed to ensure that the analysts defined the codes in a consistent manner. RESULTS: Twenty-six persons were interviewed. The main themes discussed by the participants reflecting how they viewed their involvement in medical decision making are the following: 1) decision making is often an ongoing process in which patient participation may change over time, 2) decision making is performed within an extended social context, 3) the decisions patients report being involved in are often distinct from those traditionally studied (choice of treatment or screening strategies), 4) patient involvement in decision making occurs in response to physicians' recommendations, and 5) patients make choices in the context of their specific illness perceptions. CONCLUSIONS: Participants in this study view their participation in decision making as including ideas distinct from those traditionally discussed by researchers. These findings suggest that the variability in patient participation noted in previous studies may be due in part to limitations in study design.     

Authoritarian physicians and patients' fear of being labeled 'difficult' among key obstacles to shared decision making

Relatively little is known about why some patients are reluctant to engage in a collaborative discussion with physicians about their choices in health care. To explore this issue further, we conducted six focus-group sessions with forty-eight people in the San Francisco Bay Area. In the focus groups, we found that participants voiced a strong desire to engage in shared decision making about treatment options with their physicians. However, several obstacles inhibit those discussions. These include the fact that even relatively affluent and well-educated patients feel compelled to conform to socially sanctioned roles and defer to physicians during clinical consultations; that physicians can be authoritarian; and that the fear of being categorized as "difficult" prevents patients from participating more fully in their own health care. We argue that physicians may not be aware of a need to create a safe environment for open communication to facilitate shared decision making. Rigorous measures of patient engagement, and of the degree to which health care decisions truly reflect patient preferences, are needed to advance shared decision making in clinical practice.     

Observing decision‐making in the general practice consultation: who makes which decisions?

OBJECTIVE: To investigate opportunities for, and types of decision making in the general practice (primary care) consultation, and examine differences in skills of those doctors who are successful at meeting their patients' preferences and those who are less successful. DESIGN: Observation study of doctor-patient consultations in general practice. PARTICIPANTS: Patients attending for routine appointments in 12 general practice surgeries across Oxfordshire. METHODS: A total of 212 doctor-patient consultations were video-recorded. The patients involved completed a questionnaire to elicit their perceptions of how decisions were made. The video-taped recordings were coded with a new instrument, the Evidence Based Patient Choice Instrument (EBPCI), to classify the number and type of decision-making opportunities arising during each consultation. A total of 149 recordings were coded using the Oxbridge Rating Scale to assess the doctors' consultation styles. RESULTS: There was a range of decision-making opportunities in addition to those involving medical treatment. With the exception of 'fitness for work', decisions were generally 'doctor led'. There was only moderate agreement between patient perceptions of their level of involvement in decision making and the objective ratings using the EBPCI. There was wide variation in the ability of doctors to meet their patients' preferences for involvement. CONCLUSIONS: There are many decisions made in primary care consultations, in addition to those about medical treatments, in which patients could be involved to a greater extent than they currently are. Some doctors are significantly better than others at meeting different patients' preferences for their decision-making role. Patients' perceptions of shared decision making appears to be influenced by the doctors' general consultation skills.     

The Mental Capacity Act 2005: implications for dietetic practice

The Mental Capacity Act (MCA) 2005 will be implemented in England and Wales in 2007 and have consequences for dietitians who work with people who may lack capacity to make specific decisions. This paper will explore issues arising from the introduction of the Act and considers the implications for dietitians involved in the delivery of clinical care, using enteral feeding as an illustrative example. If patients lack capacity to make specific decisions, dietitians will be required to record if, how and why they reached a decision, how they are involved in the decision making process and need to be able to justify their actions in relation to those decisions. This paper discusses the importance of dietitians' involvement in best interests decision making and considers the implications of decision making where people have drawn up a Lasting Power of Attorney. The role of such advance decisions is discussed and consideration is given to the potential compatibility of perspectives between the patient and family that may give rise to disputes. Dietitians may be well placed within multidisciplinary team working to ensure patients and their carers are part of the decision making process through effective communication and support for patients. Dietitians in England and Wales must consider the implications of the MCA upon their clinical practice and others outside these jurisdictions may like to reflect on the relevance of such developments in their own contexts.     

Inside the black box of shared decision making: distinguishing between the process of involvement and who makes the decision

BACKGROUND: Shared decision making has practical implications for everyday health care. However, it stems from largely theoretical frameworks and is not widely implemented in routine practice. AIMS: We undertook an empirical study to inform understanding of shared decision making and how it can be operationalized more widely. METHOD: The study involved patients visiting UK general practitioners already well experienced in shared decision making. After these consultations, semi-structured telephone interviews were conducted and analysed using the constant comparative method of content analysis. RESULTS: All patients described at least some components of shared decision making but half appeared to perceive the decision as shared and half as 'patient-led'. However, patients exhibited some uncertainty about who had made the decision, reflecting different meanings of decision making from those described in the literature. A distinction is indicated between the process of involvement (option portrayal, exchange of information and exploring preferences for who makes the decision) and the actual decisional responsibility (who makes the decision). The process of involvement appeared to deliver benefits for patients, not the action of making the decision. Preferences for decisional responsibility varied during some consultations, generating unsatisfactory interactions when actual decisional responsibility did not align with patient preferences at that stage of a consultation. However, when conducted well, shared decision making enhanced reported satisfaction, understanding and confidence in the decisions. CONCLUSIONS: Practitioners can focus more on the process of involving patients in decision making rather than attaching importance to who actually makes the decision. They also need to be aware of the potential for changing patient preferences for decisional responsibility during a consultation and address non-alignment of patient preferences with the actual model of decision making if this occurs.     

When the business of sharing treatment decisions is not the same as shared decision making: A discourse analysis of decision sharing in general practice

Although shared decision making (SDM) in general practice continues to be promoted as a highly desirable means of conducting consultations it is rarely observed in practice. The aim of this study is to identify the discursive features and conversational strategies particular to the negotiation and sharing of treatment decisions in order to understand why SDM is not yet embedded into routine practice. Consultations from Scottish general practices were examined using discourse analysis. Two themes were identified as key components for when the doctor and the patient were intent on sharing decisions: the generation of patient involvement using first-person pronouns, and successful and unsuccessful patient requesting practices. This article identifies a number of conversational activities found to be successful in supporting doctors' agendas and reducing their responsibility for decisions made. Doctor's use of 'partnership talk' was found to minimize resistance and worked to invite consensus rather than involvement. The information from this study provides new insight into the consultation process by identifying how treatment decisions are arrived at through highlighting the complexities involved. Notably, shared decision making does not happen with the ease implied by current models and appears to work to maintain a biomedical 'GP as expert' approach rather than one in which the patient is truly involved in partnership. We suggest that further research on the impact of conversational activities is likely to benefit our understanding of shared decision making and hence training in and the practice of SDM.     

On the suitability of fast and frugal heuristics for designing values clarification methods in patient decision aids: a critical analysis

Background Increasingly, patient decision aids and values clarification methods (VCMs) are being developed to support patients in making preference‐sensitive health‐care decisions. Many VCMs encourage extensive deliberation about options, without solid theoretical or empirical evidence showing that deliberation is advantageous. Research suggests that simple, fast and frugal heuristic decision strategies sometimes result in better judgments and decisions. Durand et al. have developed two fast and frugal heuristic‐based VCMs. Objective To critically analyse the suitability of the ‘take the best’ (TTB) and ‘tallying’ fast and frugal heuristics in the context of patient decision making. Strategy Analysis of the structural similarities between the environments in which the TTB and tallying heuristics have been proven successful and the context of patient decision making and of the potential of these heuristic decision processes to support patient decision making. Conclusion The specific nature of patient preference‐sensitive decision making does not seem to resemble environments in which the TTB and tallying heuristics have proven successful. Encouraging patients to consider less rather than more relevant information potentially even deteriorates their values clarification process. Values clarification methods promoting the use of more intuitive decision strategies may sometimes be more effective. Nevertheless, we strongly recommend further theoretical thinking about the expected value of such heuristics and of other more intuitive decision strategies in this context, as well as empirical assessments of the mechanisms by which inducing such decision strategies may impact the quality and outcome of values clarification.     

Clinical decision making--what every non-clinician manager should know but was never taught.

The management of a health care system requires making decisions and establishing policies that can affect the process of patient care. Clinicians often complain that these decisions and policies are made by people without clinical training. Clinical knowledge is not a prerequisite for a career in health policy or management. Even graduates of accredited health administration programs are not required to understand the process of clinical decision making or the nature of medical practice. Much of the health services literature advocates a shared decision-making model for clinicians and managers. However, most of the literature focuses on how to involve physicians in management decision making; almost none discusses management involvement in clinical decisions. This paper briefly examines how non-clinician managers can support the clinical decision-making process and then specifies the knowledge and skills required for them to play this role.     

Bringing social structure back into clinical decision making

Although research in the past twenty years has resulted in an increasingly sophisticated understanding of clinical decision making processes, the dominant approach in this area of inquiry remains limited. Most studies emphasize normative models of how decisions ought to be made, others attempt to describe physicians' thinking, but few take the social context of decision making systematically into account. Research models typically assume that physicians are autonomous professionals practicing in socially insular clinical settings--an approach that is consistent with classic formulations of the social structure of medical practice, but they ignore 30 years of sociological research on research on patient-physician relationships and major historical changes in the structure of medical practice. Eisenberg's still timely advice to students of clinical decision making--that they need to describe decision making in the context of 'sociologic influences' (including patient, physician and practice setting characteristics)--is expanded in the present discussion. Recent studies are reviewed, highlighting important dimensions of social structure impinging on physicians' decision making. Findings indicate that the process of clinical decision making is likely influenced by patients' age, gender, socioeconomic status, and race, physicians' professional training and experience, as well as by larger structural features of organized clinical settings. Our review of these studies on the social context of clinical decision making, however, reveals major methodological limitations including those inherently imposed by secondary data analysis, normative approaches, written case vignettes, small, non-random samples and the inadequate control of confounding influences. We present a feasible, alternative research strategy, built on a factorial experimental design. Illustrative findings indicate how complex social structural influence on clinical decision making may be disentangled in an unconfounded manner.     

Validation of a decision regret scale.

BACKGROUND: As patients become more involved in health care decisions, there may be greater opportunity for decision regret. The authors could not find a validated, reliable tool for measuring regret after health care decisions. METHODS: A 5-item scale was administered to 4 patient groups making different health care decisions. Convergent validity was determined by examining the scale's correlation with satisfaction measures, decisional conflict, and health outcome measures. RESULTS: The scale showed good internal consistency (Cronbach's alpha = 0.81 to 0.92). It correlated strongly with decision satisfaction (r = -0.40 to -0.60), decisional conflict (r = 0.31 to 0.52), and overall rated quality of life (r = -0.25 to -0.27). Groups differing on feelings about a decision also differed on rated regret: F(2, 190) = 31.1, P < 0.001. Regret was greater among those who changed their decisions than those who did not, t(175) = 16.11, P < 0.001. CONCLUSIONS: The scale is a useful indicator of health care decision regret at a given point in time.     

Randomized controlled trial of a patient decision aid for colorectal cancer screening.

PURPOSE: To conduct a pilot test of a decision aid designed to help patients choose among currently recommended colorectal cancer screening programs. METHODS: Randomized controlled trial comparing a patient decision aid based on multicriteria decision-making theory with a simple educational intervention. PATIENT POPULATION: 96 patients at average risk for colorectal cancer seen in an Internal Medicine practice in Rochester, New York. OUTCOME MEASURES: The two primary outcome measures were patient decision process and the decision outcome. Patient decision process was assessed using the decisional conflict scale. Decision outcome was defined as the proportion of colorectal cancer screening plans carried out. RESULTS: After controlling for the effects of the physicians in a factorial analysis of variance, patients who used the decision aid had lower decisional conflict regarding colorectal cancer screening decisions (F ratio 6.47, P = 0.01) due to increased knowledge, better clarity of values, and higher ratings of the quality of the decisions they made. There was no difference between the groups in decision outcomes: 52% of patients in the control group and 49% in the experimental group completed planned screening tests (P = 1.0). CONCLUSIONS: In a pilot study, a multicriteria-based patient decision aid for colorectal cancer screening improved patients' decision-making processes but had no effect on the implementation of screening plans.     

A systemic perspective of life-prolonging treatment decision making

This ethnographic, ethnomethodological study prospectively examined eight life-prolonging treatment decisions in two long-term care centers in Quebec. This study distinguishes itself from prior empirical studies in this domain by the qualitative methods and the systemic perspective used. The results, contrasting with prior studies, illustrate that the participation of long-term care residents in their life-prolonging treatment decisions is not dependent simply on the communication between the physician and his patient. In fact, the opportunity of long-term care residents to participate in their life-prolonging treatment decisions can be facilitated by effective communication between members of a system of persons found in this setting. These results shift the focus of future inquiry, for both research and clinical practice, from the communication between physician and resident to the patterns of communication between all persons in the clinical setting who know the resident's treatment wishes.     

Improving the quality of surgeons'' treatment decisions: a comparison of clinical decision making with a computerised evidence based decision analytical model

OBJECTIVES: The purpose of this study is to demonstrate to what extent an evidence based decision model can improve physicians' decisions and whether a selective use of the decision model is feasible. METHODS: Four experienced vascular surgeons were asked to make a treatment decision for 137 "paper patient" cases with asymptomatic abdominal aneurysms. Their decisions were compared with the optimal treatment as calculated by a computerised evidence based decision analytical model. RESULTS: Surgeons agreed with the model's advice based on life expectancy in 81% of the cases, and decided to operate in only 12% of the cases for which there was no agreement. Surgeons' decisions differed from the decision model's calculated optimal treatment, in particular, for older patients with aneurysms of intermediate size and with many risk factors, and for younger patients with small aneurysms and few risk factors. Not all these decisions, however, were reported to be more difficult. CONCLUSION: Use of a decision analytical model might lead to more appropriate decisions and a better quality of care. Selective use of the decision tool for difficult decisions only would be more efficient but is not yet feasible because reported decision difficulty is not strongly related to disagreement with the decision tool.     

Value Assessment at the Point of Care: Incorporating Patient Values throughout Care Delivery and a Draft Taxonomy of Patient Values

Incorporation of patient values is a key element of patient-centered care, but consistent incorporation of patient values at the point of care is lacking. Shared decision making encourages incorporation of patient values in decision making, but associated tools often lack guidance on value assessment. In addition, focusing on patient values relating only to specific decisions misses an opportunity for a more holistic approach to value assessment that could impact other aspects of clinical encounters, including health care planning, communication, and stakeholder involvement. In this commentary, we propose a taxonomy of values underlying patient decision making and provide examples of how these impact provision of health care. The taxonomy describes four categories of patient values: global, decisional, situational, and external. Global values are personal values impacting decision making at a universal level and can include value traits and life priorities. Decisional values are the values traditionally conceptualized in decision making, including considerations such as efficacy, toxicity, quality of life, convenience, and cost. Situational values are values tied to a specific moment in time that modify patients’ existing global and decisional values. Finally, discussion of external values acknowledges that many patients consider values other than their own when making decisions. Recognizing the breadth of values impacting patient decision making has implications for both overall health care delivery and shared decision making because value assessments focusing only on decisional values may miss important patient considerations. This draft taxonomy highlights different values impacting decision making and facilitates a more complete value assessment at the point of care.     

Guidelines for the clinical and economic evaluation of health care technologies

The health care system is routinely confronted with promising new technologies. In the past, most new technologies have been integrated into clinical practice without a rigorous demonstration of their effectiveness or efficiency. In order to provide a more rational approach to the adoption and utilization of health technology a comprehensive set of guidelines for both clinical and economic evaluation is proposed. While conceived of as an ideal that is unlikely to be universally met in practice, it is argued that decision making can be improved by striving towards this goal. The clinical guidelines stress the advantages of subjecting major new technologies to randomized controlled trials and insisting upon a demonstration of patient benefit in the application of diagnostic technologies. The economic guidelines stress comparisons with relevant alternative uses of the resources and the assessment of the impact on the quality of life. While application of the guidelines will produce rigorous and useful evidence, the final decisions concerning the allocation of health care resources must rest fundamentally on social value judgements and not solely, or even primarily, on informed expert opinion.     

Using an integrated point of care system: a nursing perspective

Nurses at LDS Hospital, Salt Lake City, Utah, have had the ability to document patient data and nursing care on a bedside computer for over nine years. This ability has had numerous ramifications for the medical record, nursing practice, and clinical decision making. This article is an effort to describe how and why certain decisions were made, the implications of these decisions, mistakes that were made and their solutions, and the tremendous impact on clinical decision making and improved patient outcomes that is only beginning to be realized by computerization of the medical record.