Arwen H. Pieterse

Shared decision making: Concepts, evidence, and practice

OBJECTIVE Shared decision-making (SDM) is advocated as the model for decision-making in preference-sensitive decisions. In this paper we sketch the history of the concept of SDM, evidence on the occurrence of the steps in daily practice, and provide a clinical audience with communication strategies to support the steps involved. Finally, we discuss ways to improve the implementation of SDM. RESULTS The plea for SDM originated almost simultaneously in medical ethics and health services research. Four steps can be distinguished: (1) the professional informs the patient that a decision is to be made and that the patients opinion is important; (2) the professional explains the options and their pros and cons; (3) the professional and the patient discuss the patients preferences and the professional supports the patient in deliberation; (4) the professional and patient discuss the patients wish to make the decision, they make or defer the decision, and discuss follow-up. In practice these steps are seen to occur to a limited extent. DISCUSSION Knowledge and awareness among both professionals and patients as well as tools and skills training are needed for SDM to become widely implemented. PRACTICE IMPLICATIONS Professionals may use the steps and accompanying communication strategies to implement SDM.

Clarifying Values: An updated review

BackgroundConsensus guidelines have recommended that decision aids include a process for helping patients clarify their values. We sought to examine the theoretical and empirical evidence related to the use of values clarification methods in patient decision aids.MethodsBuilding on the International Patient Decision Aid Standards (IPDAS) Collaboration’s 2005 review of values clarification methods in decision aids, we convened a multi-disciplinary expert group to examine key definitions, decision-making process theories, and empirical evidence about the effects of values clarification methods in decision aids. To summarize the current state of theory and evidence about the role of values clarification methods in decision aids, we undertook a process of evidence review and summary.ResultsValues clarification methods (VCMs) are best defined as methods to help patients think about the desirability of options or attributes of options within a specific decision context, in order to identify which option he/she prefers. Several decision making process theories were identified that can inform the design of values clarification methods, but no single “best” practice for how such methods should be constructed was determined. Our evidence review found that existing VCMs were used for a variety of different decisions, rarely referenced underlying theory for their design, but generally were well described in regard to their development process. Listing the pros and cons of a decision was the most common method used. The 13 trials that compared decision support with or without VCMs reached mixed results: some found that VCMs improved some decision-making processes, while others found no effect.ConclusionsValues clarification methods may improve decision-making processes and potentially more distal outcomes. However, the small number of evaluations of VCMs and, where evaluations exist, the heterogeneity in outcome measures makes it difficult to determine their overall effectiveness or the specific characteristics that increase effectiveness.

Cancer Genetic Counseling: Communication and Counselees’ Post-Visit Satisfaction, Cognitions, Anxiety, and Needs Fulfillment

Little is known about the relation between communication during cancer genetic counseling and outcome. We assessed associations between counselor-counselee communication and counselee satisfaction, cognitions, anxiety, and fulfillment of major needs, corrected for pre-visit levels as appropriate. In total 171 consecutive new counselees, mainly referred for breast or colon cancer, received pre- and post-visit questionnaires assessing needs/fulfillment, knowledge, perceived control (PPC), anxiety (STAI), and satisfaction. Initial visits were videotaped and counselor eye gaze was recorded. Verbal communication was rated by Roter Interaction Analysis System (RIAS). Asking more medical questions was associated with lower satisfaction levels. Receiving more medical information was related to higher correct knowledge scores, higher reported fulfillment of some needs, and unrelated to perceptions of control. Receiving more psychosocial information and longer counselor eye gaze were related to higher anxiety scores. Longer visits were related to higher correct knowledge scores. Providing medical information appears the most powerful communication aspect to increase counselee satisfaction and address needs. More research is needed on how to address adequately (emotional) needs and increase feelings of control.

Benefit from preoperative radiotherapy in rectal cancer treatment: disease-free patients' and oncologists' preferences

Preoperative radiotherapy (PRT) in resectable rectal cancer improves local control but increases probability of faecal incontinence and sexual dysfunction. Consensus was reached in 2001 in the Netherlands on a guideline advising PRT to new patients. Purpose was to assess at what benefit oncologists and rectal cancer patients prefer PRT followed by surgery to surgery alone, and how oncologists and patients value various treatment outcomes. Sixty-six disease-free patients and 60 oncologists (surgical, radiation, medical) were interviewed. Minimally desired benefit from PRT (local control) was assessed using the Treatment Tradeoff Method. Importance of survival, local control, faecal incontinence, and sexual dysfunction in determining treatment outcome preferences was assessed using Adaptive Conjoint Analysis. The range of required benefit from PRT varied widely within participant groups. Seventeen percent of patients would choose PRT at a 0% benefit; 11% would not choose PRT for the maximum benefit of 11%. Mean minimally desired benefit excluding these two groups was 4%. For oncologists, the required benefit was 5%. Also, how strongly participants valued treatment outcomes varied widely within groups. Of the four outcomes, participants considered incontinence most often as most important. Relative treatment outcome importance differed between specialties. Patients considered sexual functioning more important than oncologists. Large differences in treatment preferences exist between individual patients and oncologists. Oncologists should adequately inform their patients about the risks and benefits of PRT, and elicit patient preferences regarding treatment outcomes.

Deciding about (neo-)adjuvant rectal and breast cancer treatment: Missed opportunities for shared decision making

Background. The first step in shared decision making (SDM) is creating choice awareness. This is particularly relevant in consultations concerning preference-sensitive treatment decisions, e.g. those addressing (neo-)adjuvant therapy. Awareness can be achieved by explicitly stating, as the ‘reason for encounter’, that a treatment decision needs to be made. It is unknown whether oncologists express such reason for encounter. This study aims to establish: 1) if ‘making a treatment decision’ is stated as a reason for the encounter and if not, what other reason for encounter is provided; and 2) whether mentioning that a treatment decision needs to be made is associated with enhanced patient involvement in decision making. Material and methods. Consecutive first consultations with: 1) radiation oncologists and rectal cancer patients; or 2) medical oncologists and breast cancer patients, facing a preference-sensitive treatment decision, were audiotaped. The tapes were transcribed and coded using an instrument developed for the study. Oncologists’ involvement of patients in decision making was coded using the OPTION-scale. Results. Oncologists (N = 33) gave a reason for encounter in 70/100 consultations, usually (N = 52/70, 74%) at the start of the consultation. The reason for encounter stated was ‘making a treatment decision’ in 3/100 consultations, and ‘explaining treatment details’ in 44/100 consultations. The option of foregoing adjuvant treatment was not explicitly presented in any consultation. Oncologist’ involvement of patients in decision making was below baseline (Md OPTION-score = 10). Given the small number of consultations in which the need to make a treatment decision was stated, we could not investigate the impact thereof on patient involvement. Conclusion. This study suggests that oncologists rarely express that a treatment decision needs to be made in consultations concerning preference-sensitive treatment decisions. Therefore, patients might not realize that foregoing (neo-)adjuvant treatment is a viable choice. Oncologists miss a crucial opportunity to facilitate SDM.

Dutch Translation and Psychometric Testing of the 9-Item Shared Decision Making Questionnaire (SDM-Q-9) and Shared Decision Making Questionnaire-Physician Version (SDM-Q-Doc) in Primary and Secondary Care

Purpose The SDM-Q-9 and SDM-Q-Doc measure patient and physician perception of the extent of shared decision making (SDM) during a physician-patient consultation. So far, no self-report instrument for SDM was available in Dutch, and validation of the scales in other languages has been limited. The aim of this study was to translate both scales into Dutch and assess their psychometric characteristics. Methods Participants were patients and their treating physicians (general practitioners and medical specialists). Patients (N = 182) rated their consultation using the SDM-Q-9, 43 physicians rated their consultations using the SDM-Q-Doc (N = 201). Acceptability, reliability (internal consistency), and the factorial structure of the instruments were determined. For convergent validity the CPSpost was used. Results Reliabilities of both scales were high (alpha SDM-Q-9 0.88; SDM-Q-Doc 0.87). The SDM-Q-9 and SDM-Q-Doc total scores correlated as expected with the CPSpost (SDM-Q-9: r = 0.29; SDM-Q-Doc: r = 0.48) and were significantly different between the CPSpost categories, with lowest mean scores when the physician made the decision alone. Principal Component Analyses showed a two-component model for each scale. A confirmatory factor analysis yielded a mediocre, but acceptable, one-factor model, if Item 1 was excluded; for both scales the best indices of fit were obtained for a one-factor solution, if both Items 1 and 9 were excluded. Conclusion The Dutch SDM-Q-9 and SDM-Q-Doc demonstrate good acceptance and reliability; they correlated as expected with the CPSpost and are suitable for use in Dutch primary and specialised care. Although the best model fit was found when excluding Items 1 and 9, we believe these items address important aspects of SDM. Therefore, also based on the coherence with theory and comparability with other studies, we suggest keeping all nine items of the scale. Further research on the SDM-concept in patients and physicians, in different clinical settings and different countries, is necessary to gain a better understanding of the SDM-construct and its measurement.

Design Features of Explicit Values Clarification Methods A Systematic Review

Background. Values clarification is a recommended element of patient decision aids. Many different values clarification methods exist, but there is little evidence synthesis available to guide design decisions. Purpose. To describe practices in the field of explicit values clarification methods according to a taxonomy of design features. Data Sources. MEDLINE, all EBM Reviews, CINAHL, EMBASE, Google Scholar, manual search of reference lists, and expert contacts. Study Selection. Articles were included if they described 1 or more explicit values clarification methods. Data Extraction. We extracted data about decisions addressed; use of theories, frameworks, and guidelines; and 12 design features. Data Synthesis. We identified 110 articles describing 98 explicit values clarification methods. Most of these addressed decisions in cancer or reproductive health, and half addressed a decision between just 2 options. Most used neither theory nor guidelines to structure their design. “Pros and cons” was the most common type of values clarification method. Most methods did not allow users to add their own concerns. Few methods explicitly presented tradeoffs inherent in the decision, supported an iterative process of values exploration, or showed how different options aligned with users’ values. Limitations. Study selection criteria and choice of elements for the taxonomy may have excluded values clarification methods or design features. Conclusions. Explicit values clarification methods have diverse designs but can be systematically cataloged within the structure of a taxonomy. Developers of values clarification methods should carefully consider each of the design features in this taxonomy and publish adequate descriptions of their designs. More research is needed to study the effects of different design features.

Longer-term influence of breast cancer genetic counseling on cognitions and distress: Smaller benefits for affected versus unaffected women

OBJECTIVE To evaluate outcomes of breast cancer genetic counseling in women with and without breast cancer. METHODS Seventy-seven first-time attendees (n=44 affected) completed questionnaires assessing cognitions (risk accuracy, knowledge, perceived personal control [PPC]) and distress (state anxiety [STAI], cancer-related stress reactions [IES]) from immediately before to immediately and six months after completing counseling. Data were analyzed using multilevel repeated measures and trend analyses. RESULTS In affected counselees, mean cognitions did not significantly differ over time, anxiety significantly decreased, and IES levels were increased immediately post-counseling. In unaffected counselees, cognitions significantly improved over time except for knowledge. Distress levels showed similar patterns as in affected women. Improvements in cognitions and distress were significantly smaller in affected versus unaffected women. CONCLUSION Overall, counseling educates women about breast cancer risk and alleviates their anxiety. Importantly, benefits gained at immediate follow-up seem maintained over time. PRACTICE IMPLICATION Affected women seem to benefit less from counseling. Counselors may need to devote more effort into educating these women and addressing their anxieties. Future studies should confirm the unexpected finding that cancer-related distress increased immediately post-counseling.

Decision consultations on preoperative radiotherapy for rectal cancer: large variation in benefits and harms that are addressed.

Background:For shared decision making to be successful, patients should receive sufficient information on possible benefits and harms of treatment options. The aim of this study was to evaluate what information radiation oncologists provide during the decision consultation about preoperative radiotherapy with rectal cancer patients.Methods:Decision consultations of 17 radiation oncologists with 81 consecutive primary rectal cancer patients, eligible for short-course radiotherapy followed by a low-anterior resection, were audio taped. Tapes were transcribed and analysed using the ACEPP (Assessing Communication about Evidence and Patient Preferences) coding scheme.Results:A median of seven benefits/harms were addressed per consultation (range, 2–13). This number ranged within and between oncologists and was not clearly associated with the patient’s characteristics. A total of 30 different treatment outcomes were addressed. The effect of radiotherapy on local control was addressed in all consultations, the effect on survival in 16%. The most important adverse effects are bowel and sexual dysfunction. These were addressed in 82% and 85% of consultations, respectively; the latter significantly less often in female than in male patients. Four out of five patients did not initiate discussion on any benefits/harms.Conclusions:Our results showed considerable inconsistency between and within oncologists in information provision, which could not be explained by patient characteristics. This variation indicates a lack of clarity on which benefits/harms of radiotherapy should be discussed with newly-diagnosed patients. This suboptimal patient information hampers the process of shared decision making, in which the decision is based on each individual patients’ weighing of benefits and harms.

Treatment preferences and involvement in treatment decision making of patients with endometrial cancer and clinicians

Background:Vaginal brachytherapy (VBT) in high–intermediate-risk endometrial cancer (EC) provides a significant reduction in the risk of local cancer recurrence, but without survival benefit and with increased mucosal atrophy. Five-year local control is estimated to be similar for VBT and a watchful waiting policy (WWP), in which patients receive VBT combined with external radiation in case of a recurrence. Our aim was to assess treatment preferences of EC patients and clinicians regarding VBT and WWP, and to evaluate their preferred and perceived involvement in treatment decision making.Methods:Interviews were held with 95 treated EC patients. The treatment trade-off method was used to assess the minimally desired benefit from VBT in local control. Patients’ preferred and perceived involvement in decision making were assessed using a questionnaire. Seventy-seven clinicians completed a questionnaire assessing their minimally desired benefit and preferred involvement in decision making.Results:Minimally desired benefit of VBT was significantly lower for patients than for clinicians (median=0 vs 8%, P<0.001), for irradiated than for non-irradiated patients (median=0 vs 6.5%, P<0.001), and for radiation oncologists than for gynaecologists (median=4 vs 13%, P<0.001). Substantial variation existed within the groups of patients and clinicians. Participants preferred the patient and clinician to share in the decision about VBT. However, irradiated patients indicated low perceived involvement in actual treatment decision making.Conclusions:We found variations between and within patients and clinicians in minimally desired benefit from VBT. However, the recurrence risk at which patients preferred VBT was low. Our results showed that patients consider active participation in decision making essential.