A randomized controlled trial of a skills training for oncologists and a communication aid for patients to stimulate shared decision making about palliative systemic treatment (CHOICE): study protocol.

BACKGROUND: Systemic treatment for advanced cancer offers uncertain and sometimes little benefit while the burden can be high. Hence, treatment decisions require Shared Decision Making (SDM). The CHOICE trial examines the separate and combined effect of oncologist training and a patient communication aid on SDM in consultations about palliative systemic treatment. METHODS: A RCT design with four parallel arms will be adopted. Patients with metastatic or irresectable cancer with a median life expectancy <12 months who meet with a medical oncologist to discuss the start or continuation of palliative systemic treatment are eligible. A total of 24 oncologists (in training) and 192 patients will be recruited. The oncologist training consists of a reader, two group sessions (3.5 h; including modelling videos and role play), a booster feedback session (1 h) and a consultation room tool. The patient communication aid consists of a home-sent question prompt list and a value clarification exercise to prepare patients for SDM in the consultation. The control condition consists of care as usual. The primary outcome is observed SDM in audio-recorded consultations. Secondary outcomes include patient and oncologist evaluation of communication and decision-making, the decision made, quality of life, potential adverse outcomes such as anxiety and hopelessness, and consultation duration. Patients fill out questionnaires at baseline (T0), before (T1) and after the consultation (T2) and at 3 and 6 months (T3 and T4). All oncologists participate in two standardized patient assessments (before-after training) prior to the start of patient inclusion. They will fill out a questionnaire before and after these assessments, as well as after each of the recorded consultations in clinical practice. DISCUSSION: The CHOICE trial will enable evidence-based choices regarding the investment in SDM interventions targeting either oncologists, patients or both in the advanced cancer setting. The trial takes into account the immediate effect of the interventions on observed communication, but also on more distal and potential adverse patient outcomes. Also, the trial provides evidence regarding the assumption that SDM about palliative cancer treatment results in less aggressive treatment and more quality of life in the final period of life. TRIAL REGISTRATION: Netherlands Trial Registry number NTR5489 (prospective; 15 Sep 2015).

Patients with oesophageal cancer report elevated distress and problems yet do not have an explicit wish for referral prior to receiving their medical treatment plan.

OBJECTIVE: This study aims to identify patients with oesophageal cancer's level of distress, type of problems, and wish for referral prior to treatment. To identify the clinical relevance of patients with oesophageal cancer's level of distress and type of problems, we build models to predict elevated distress, wish for referral, and overall survival. METHODS: We implemented the Distress Thermometer and Problem List in daily clinical practice. A score of ≥5 on the Distress Thermometer reflected elevated distress. We first created an initial model including predictors based on the literature. We then added predictors to the initial model to create an extended model based on the sample data. We used the 'least absolute shrinkage and selection operator' to define our final model. RESULTS: We obtained data from 187 patients (47.9%, of 390 eligible patients with oesophageal cancer) which were similar to non-respondents in their demographic and clinical characteristics. One-hundred thirteen (60%) patients reported elevated distress. The five most frequently reported problems were as follows: eating, tension, weight change, fatigue, and pain. Most patients did not have a wish for referral. Predictors for elevated distress were as follows: being female, total number of practical, emotional, and physical problems, pain, and fatigue. For referral, we identified age, the total number of emotional problems, the level of distress, and fear. The level of distress added prognostic information in a model to predict overall survival. CONCLUSIONS: Patients with oesophageal cancer report elevated distress and a myriad of problems yet do not have an explicit wish for referral prior to receiving their medical treatment plan. Copyright © 2016 John Wiley & Sons, Ltd.

Illustrations enhance older colorectal cancer patients' website satisfaction and recall of online cancer information.

This study aims to investigate the effects of illustrations in online cancer information on older cancer patients' website satisfaction (i.e. satisfaction with the attractiveness, comprehensibility and emotional support from the website) and recall of information. In an online experiment, 174 younger (<65 years) and older (≥65 years) colorectal cancer patients were randomly exposed to a webpage about transanal endoscopic microsurgery consisting of either text-only information, text with two cognitive illustrations or text with two affective illustrations. In general, adding cognitive illustrations compared with text-only information improved the satisfaction with the attractiveness of the website in both younger and older patients. For older patients in particular, cognitive illustrations facilitated recall of cancer information: whereas older patients recalled less information overall compared with younger patients (39% vs. 50%), no statistically significant differences in age on recall were observed when cognitive illustrations were added to text. Furthermore, older patients were more satisfied with the emotional support from the website than younger patients, especially when affective illustrations were present. Our results suggest that effective online cancer communication for ageing populations involves considering both cognitive and affective illustrations to enhance website satisfaction and recall of cancer information.

Delphi survey to identify topics to be addressed at the initial follow-up consultation after oesophageal cancer surgery.

BACKGROUND: There is no consensus among patients and healthcare professionals (HCPs) on the topics that need to be addressed after oesophageal cancer surgery. The aim of this study was to identify these topics, using a two-round Delphi survey. METHODS: In round 1, patients and HCPs (surgeons, dieticians, nurses) were invited to rate the importance of 49 topics. The proportion of panellists that considered a topic to be of low, moderate or high importance was then calculated for each of these two groups. Based on these proportions and the i.q.r., topics were categorized as: 'consensus to be included', 'consensus to be excluded' and 'no consensus'. Only topics in the first category were included in the second round. In round 2, panellists were provided with individual and group feedback. To be included in the final list, topics had to meet criteria for consensus and stability. RESULTS: There were 108 patients and 77 HCPs in the round 2 analyses. In general, patients and HCPs considered the same topics important. The final list included 23 topics and revealed that it was most important to address: cancer removed/lymph nodes, the new oesophagus, eating and drinking, surgery, alarming new complaints and the recovery period. CONCLUSION: The study provides surgeons with a list of topics selected by patients and HCPs that may be addressed systematically at the initial follow-up consultation after oesophageal cancer surgery.

A decision aid regarding treatment options for patients with an asymptomatic abdominal aortic aneurysm: a randomised clinical trial.

OBJECTIVE: Abdominal aortic aneurysm patients tend to be informed inconsistently and incompletely about their disorder and the treatment options open to them. The objective of this trial was to evaluate whether these patients are better informed and experience less decisional conflict regarding their treatment options after viewing a decision aid. DESIGN: A six-centre, randomised clinical trial comparing a decision aid plus regular information versus regular information from the surgeon. METHODS: Included patients had recently been diagnosed with an asymptomatic abdominal aortic aneurysm at least 4 cm in diameter. The decision aid consisted of a one-time viewing of an interactive CD-ROM elaborating on elective surgery versus watchful waiting. Generally, the decision aid advised patients with aneurysms less than 5.5 cm to agree to watchful waiting, for larger aneurysms the decision aid provided insight into the balance of benefit and harm of surgical and conservative approaches, taking into account age, co-morbidity and size of the aneurysm. The primary outcome was patient decisional conflict measured at 1 month follow-up (Decisional Conflict Scale). Secondary outcomes were patient knowledge, anxiety and satisfaction. RESULTS: In 178 aneurysm patients, decisional conflict scores did not differ significantly between the decision aid and the regular information groups (22 vs. 24 on the 0-100 Decisional Conflict Scale; p = .33). Patients in the decision aid group had significantly better knowledge (10.0 vs. 9.4 out of 13 points; p = .04), whereas anxiety levels (4.4 and 5.0 on a 0-21 scale; p = .73) and satisfaction scores (74 and 73 on a 0-100 scale; p = .81) were similar in both groups. CONCLUSION: In addition to regular patient-surgeon communication, a decision aid helps to share treatment decisions with abdominal aortic aneurysm patients by increasing their knowledge about the disorder and available treatment options without raising anxiety levels; however, it does not reduce decisional conflict, nor does it improve satisfaction.

Meta-analysis shows clinically relevant and long-lasting deterioration in health-related quality of life after esophageal cancer surgery.

PURPOSE: The purpose of the study is to (1) estimate the direction, clinical relevance, and duration of health-related quality of life (HRQL) change in the first year following esophageal cancer surgery and (2) to assess the robustness of the estimates by subgroup and sensitivity analyses, and an exploration of publication bias. METHODS: A systematic literature search in MEDLINE, EMBASE, CINAHL, PsychINFO, and CENTRAL to identify randomized and non-randomized studies was performed. We compared the baseline HRQL data with 3-, 6-, 9-, or 12-month follow-ups to estimate the magnitude and duration of HRQL change. These estimates were then classified as trivial, small, medium, or large. Primary outcomes were role functioning, eating, and fatigue. Secondary outcomes were physical and social functioning, dysphagia, pain, and coughing problems. We conducted subgroup analysis for open surgery, open surgery preceded by neo-adjuvant therapy, and minimally invasive surgery. Sensitivity analyses assessed the influence of study design, transformation/imputation of the data, and HRQL questionnaire used. RESULTS: We included data from 15 studies to estimate the change in 28 HRQL outcomes after esophageal cancer surgery. The main analysis showed that patients' social functioning deteriorated. Symptoms of fatigue, pain, and coughing problems increased. These changes lasted for 9-12 months, although some symptoms persisted beyond the first year after surgery. For many other HRQL outcomes, estimates were only robust after subgroup or sensitivity analyses (e.g., role and physical functioning), or remained too heterogeneous to interpret (e.g., eating and dysphagia). CONCLUSIONS: Patients will experience a clinically relevant and long-lasting deterioration in HRQL after esophageal cancer surgery. However, for many HRQL outcomes, more and better quality evidence is needed.

Meta-analysis shows clinically relevant and long-lasting deterioration in health-related quality of life after esophageal cancer surgery.

PURPOSE: The purpose of the study is to (1) estimate the direction, clinical relevance, and duration of health-related quality-of-life (HRQL) change in the first year following esophageal cancer surgery and (2) to assess the robustness of the estimates by subgroup and sensitivity analyses, and an exploration of publication bias. METHODS: A systematic literature search in MEDLINE, EMBASE, CINAHL, PsychINFO, and CENTRAL to identify randomized and non-randomized studies was performed. We compared the baseline HRQL data with 3-, 6-, 9-, or 12-month follow-ups to estimate the magnitude and duration of HRQL change. These estimates were then classified as trivial, small, medium, or large. Primary outcomes were role functioning, eating, and fatigue. Secondary outcomes were physical and social functioning, dysphagia, pain, and coughing problems. We conducted subgroup analysis for open surgery, open surgery preceded by neoadjuvant therapy, and minimally invasive surgery. Sensitivity analyses assessed the influence of study design, transformation/imputation of the data, and HRQL questionnaire used. RESULTS: We included the data from 15 studies to estimate the change in 28 HRQL outcomes after esophageal cancer surgery. The main analysis showed that patients' social functioning deteriorated. Symptoms of fatigue, pain, and coughing problems increased. These changes lasted for 9-12 months, although some symptoms persisted beyond the first year after surgery. For many other HRQL outcomes, estimates were only robust after subgroup or sensitivity analyses (e.g., role and physical functioning), or remained too heterogeneous to interpret (e.g., eating and dysphagia). CONCLUSIONS: Patients will experience a clinically relevant and long-lasting deterioration in HRQL after esophageal cancer surgery. However, for many HRQL outcomes, more and better quality evidence is needed.

Quality of life in relation to tamoxifen or exemestane treatment in postmenopausal breast cancer patients: a Tamoxifen Exemestane Adjuvant Multinational (TEAM) Trial side study.

Tamoxifen and aromatase inhibitors are associated with side effects which can significantly impact quality of life (QoL). We assessed QoL in the Tamoxifen Exemestane Adjuvant Multinational (TEAM) Trial and compared these data with reported adverse events in the main database. 2,754 Dutch postmenopausal early breast cancer patients were randomized between 5 years of exemestane, or tamoxifen (2.5-3 years) followed by exemestane (2.5-2 years). 742 patients were invited to participate in the QoL side study and complete questionnaires at 1 (T1) and 2 (T2) years after start of endocrine treatment. Questionnaires comprised the EORTC QLQ-C30 and BR23 questionnaires, supplemented with FACT-ES questions. 543 patients completed questionnaires at T1 and 454 patients (84%) at T2. Overall QoL and most functioning scales improved over time. The only clinically relevant and statistically significant difference between treatment types concerned insomnia; exemestane-treated patients reported more insomnia than tamoxifen-treated patients. Discrepancy was observed between QoL issue scores reported by the patients and adverse events reported by physicians. Certain QoL issues are treatment- and/or time-specific and deserve attention by health care providers. There is a need for careful inquiry into QoL issues by those prescribing endocrine treatment to optimize QoL and treatment adherence.

Assessing cancer patients' trust in their oncologist: development and validation of the Trust in Oncologist Scale (TiOS).

PURPOSE: The aim of this study was to develop and validate the Trust in Oncologist Scale (TiOS), which aims to measure cancer patients' trust in their oncologist. Structure, reliability and validity were examined. METHODS: Construction of the TiOS was based on a multidimensional theoretical framework. Cancer patients were surveyed within a week after their consultation. Trust, satisfaction, trust in health care, self-reported health and background variables were assessed. Dimensionality, internal consistency, test-retest reliability and construct validity were investigated. RESULTS: Data of 423 patients were included (response rate = 65%). After item reduction, the TiOS included 18 items. Trust scores were high. Exploratory factor analysis suggested one-dimensionality. Confirmatory factor analysis nevertheless indicated a reasonable fit of our four-dimensional theoretical model, distinguishing competence, fidelity, honesty and caring. Internal consistency and test-retest reliabilities were high. Good construct validity was indicated by moderate correlations of trust (TiOS) with satisfaction, trust in health care, willingness to recommend and number of consultations with the oncologist. Exploratory analyses suggested significant correlations of trust with ethnicity and age. CONCLUSIONS: The TiOS reliably and validly assesses cancer patients' trust in their oncologist. The questionnaire can be employed in both clinical practice and future research of cancer patients' trust.

Maintenance of physical activity and body weight in relation to subsequent quality of life in postmenopausal breast cancer patients.

BACKGROUND: We prospectively examined the association between physical activity, body weight and quality of life in Dutch postmenopausal early breast cancer patients treated with adjuvant endocrine therapy. PATIENTS AND METHODS: In this side study of a large clinical trial, lifestyle and quality-of-life questionnaires were filled out 1 and 2 years after the start of endocrine therapy (T1 and T2, respectively) and included a pre-diagnosis lifestyle assessment (T0). A total of 435 breast cancer patients returned both questionnaires. RESULTS: Individuals with a physical activity level above the median who maintained this level from T0 to T1 reported the best global quality of life and physical functioning and the least fatigue at T2, as compared with individuals with low levels of physical activity which further decreased after diagnosis (difference of +16, +14, and -22 points on a 0-100 quality-of-life scale, respectively; P < 0.01). Overweight or obese women who gained body weight after diagnosis reported worst quality of life and most fatigue as compared with women who maintained a stable body weight (difference of -8, -10 and +2 points, respectively; P < 0.01). CONCLUSION: Maintaining high pre-diagnosis physical activity levels and a healthy body weight is associated with better quality of life after breast cancer.

Information communicated with patients in decision making about their abdominal aortic aneurysm.

OBJECTIVES: To explore what kind of information surgeons communicate with patients diagnosed with an abdominal aortic aneurysm, and if the information provided regarding the disorder and treatment options available complies with legal requirements. METHODS: Dutch vascular surgeons sound-recorded consultations with their patients. Recordings were scored using a checklist based on ethical considerations and five statutory categories of information on: (1) the disorder, (2) procedure and aim of surgery, (3) consequences and risks of surgery, (4) watchful observation and (5) individual prognosis regarding state of health. Each category was represented by several information items, which were scored dichotomously ('not mentioned' or 'mentioned'). A category was considered sufficiently addressed if at least one of its items was mentioned. RESULTS: Thirty-five consultations were recorded (13 patients with aneurysmal diameter <5.5 cm and 22 with diameter >or=5.5 cm). In a minority of recordings, all five categories were addressed: 1/13 (8%) and 9/22 (41%), respectively. None of the information items was discussed consistently in every recording. Although most patients were informed about the proposed treatment option (11/13; 85% and 19/22; 86%), the alternative treatment option was mentioned only occasionally (4/13; 31% and 14/22; 64%). CONCLUSIONS: Patients with an abdominal aneurysm are informed inconsistently about their disorder and treatment options. Information is often less than that legally required. This may hinder shared decision making.

Setting priorities for improving the preoperative assessment clinic: the patients' and the professionals' perspective.

BACKGROUND: The quality of the preoperative assessment clinic (PAC) is determined by many factors. Patients' experiences are important indicators, but often overlooked. We prepare to set priorities to improve the PAC by obtaining detailed patients' feedback on the quality of the PAC, and establishing the value patients and professionals attach to different care aspects, using the Patient Experiences with the Preoperative Assessment Clinic questionnaire. METHODS: The PAC's standard of service was determined for five care aspects (dimensions), using patients' feedback. The importance of a dimension to patients was determined by calculating the effects of the dimensions on patients' overall appraisal. In addition, professionals were asked to rate the importance of the different care aspects. RESULTS: Patients had the most positive experiences with the nurse, and the least positive experiences with waiting. However, waiting was least important to patients. When combining the PAC's standard of service with the value given to the dimensions by patients and professionals separately, we found in both instances that waiting was in greatest need of improvement. This was followed by reception, the anaesthetist, remaining experiences, and finally the nurse. CONCLUSIONS: Quality improvement of the PAC can be achieved by obtaining patients' feedback on the quality, determine a PAC's standard of service, recognize service areas that require improvement, and identify actions appropriate to bring about improvement. The value patients and professionals attach to different aspects of care can then be used to prioritize improvements.

Making a gender difference: case studies of gender mainstreaming in medical education.

BACKGROUND: Curricula are accommodated to the interests of new groups after pressure from social movements outside institutions. A Dutch national project to integrate gender-gender mainstreaming (GM)-in all medical curricula started in 2002 and finished in 2005. GM is a long-term strategy which aims at eliminating gender bias in existing routines for which involvement of regular actors within the organization is required. AIMS: In this paper, the challenges of GM in medical education are discussed. Three case studies of medical schools are presented to identify key issues in the change process. METHOD: Steps taken in the national project included the evaluation of a local project, establishing a digital knowledge centre with education material, involving stakeholders and building political support within the schools and national bodies, screening education material and negotiating recommendations with course organizers, and evaluating the project with education directors and change agents. Data are gathered from interviews and document analysis. RESULTS: Factors playing a role are distinguished at three levels: (1) policy level, such as political support and widespread communication of this support; (2) organizational level such as a problem-based curricula and procedures for curriculum development and evaluation; and (3) faculty's openness towards change in general and towards feminist influences in particular, and change agents' position as well as personal and communicative skills. CONCLUSIONS: Successful GM in medical education is both a matter of strategy as well as how such strategy is received in medical schools. A time-consuming strategy could overcome resistance as well as dilemmas inherent in GM. More female teachers than male teachers were openly accepting. However, women were situated in less visible and less powerful positions. Hence, GM is accelerated by alliances between women aiming for change and senior (male) faculty leadership.

Patient Experiences with the Preoperative Assessment Clinic (PEPAC): validation of an instrument to measure patient experiences.

BACKGROUND: Presently, no comprehensive and validated questionnaire to measure patient experiences of the preoperative assessment clinic (PAC) is available. We developed and validated the Patient Experiences with the Preoperative Assessment Clinic (PEPAC) questionnaire, which can be used for quantitative measurements of patient experiences of the PAC. METHODS: We adapted the National Health Service outpatient questionnaire, incorporating questions specific for anaesthesiology. To make the PEPAC appropriate for quantitative measurements, dimensions and single items suitable for statistical analysis were constructed. Each dimension consists of multiple items measuring the same aspect of care. Reliability was established by computing Cronbach's alpha coefficients. Construct validity was assessed by correlating the dimensions with the patient's overall appraisal (Pearson's r). These dimensions should explain a substantial level of variance of the patients' overall appraisal; therefore, regression analysis was performed. RESULTS: After a pilot phase, the questionnaire was sent to 700 consecutive patients (response 74%). Five scales measuring five dimensions of patient experiences were constructed. Cronbach's alpha ranged from 0.56 to 0.84, supporting reliability of the PEPAC. Correlations between the dimensions and patients' overall appraisal ranged from 0.22 to 0.56. Collectively, the five scales explained 51% of patients' overall appraisal. CONCLUSIONS: The PEPAC is a comprehensive, reliable, and validated questionnaire to measure patient experiences with the PAC. It might be a useful tool to identify the service areas of the PAC that require improvement and to determine which actions can bring about improvement.

How oncologists' communication improves (analogue) patients' recall of information. A randomized video-vignettes study.

OBJECTIVE: Cancer patients need information provision to cope with their disease. However, only 20-60% of information provided during consultations is remembered. This study aimed to investigate whether oncologists' use of trust-conveying communication, characterized by communicating competence, honesty and caring, enhances patients' memory. Moreover, we aimed to investigate if this hypothetical relationship is mediated by a reduction in psychophysiological arousal during the consultation. METHODS: An experimental design was used, allowing for conclusion about causality. Two versions of a scripted video-taped consultation were used in which the oncologist adopted either a standard or a trust-conveying communication style. 97 cancer-naive individuals acted as analogue patients and were randomly assigned to watch one of the consultations. RESULTS: Free recall, assessed 24-28h after viewing, was higher (p=0.039) in the trust-conveying condition (65.3% versus 59.5%). Recognition did not differ (p=0.502). Psychophysiological assessment during watching showed a smaller heart rate response in the trust-conveying condition (p=0.037). No mediation effect nor an effect on electrodermal activity was found. CONCLUSION: These results suggest that oncologists' use of trust-conveying communication could increase patients' free recall of information and diminish their cardiovascular response. PRACTICE IMPLICATIONS: The underlying mechanisms by which oncologists' communication influences information recall warrants further investigation.

Using standardized video cases for assessment of medical communication skills: reliability of an objective structured video examination by computer.

OBJECTIVE: Using standardized video cases in a computerized objective structured video examination (OSVE) aims to measure cognitive scripts underlying overt communication behavior by questions on knowledge, understanding and performance. In this study the reliability of the OSVE assessment is analyzed using the generalizability theory. METHODS: Third year undergraduate medical students from the Academic Medical Center of the University of Amsterdam answered short-essay questions on three video cases, respectively about history taking, breaking bad news, and decision making. Of 200 participants, 116 completed all three video cases. Students were assessed in three shifts, each using a set of parallel case editions. About half of all available exams were scored independently by two raters using a detailed rating manual derived from the other half. Analyzed were the reliability of the assessment, the inter-rater reliability, and interrelatedness of the three types of video cases and their parallel editions, by computing a generalizability coefficient G. RESULTS: The test score showed a normal distribution. The students performed relatively well on the history taking type of video cases, and relatively poor on decision making and did relatively poor on the understanding ('knows why/when') type of questions. The reliability of the assessment was acceptable (G = 0.66). It can be improved by including up to seven cases in the OSVE. The inter-rater reliability was very good (G = 0.93). The parallel editions of the video cases appeared to be more alike (G = 0.60) than the three case types (G = 0.47). DISCUSSION: The additional value of an OSVE is the differential picture that is obtained about covert cognitive scripts underlying overt communication behavior in different types of consultations, indicated by the differing levels of knowledge, understanding and performance. The validation of the OSVE score requires more research. CONCLUSION AND PRACTICE IMPLICATIONS: A computerized OSVE has been successfully applied with third year undergraduate medical students. The test score meets psychometric criteria, enabling a proper discrimination between adequately and poorly performing students. The high inter-rater reliability indicates that a single rater is permitted.

Palliative chemotherapy or watchful waiting? A vignettes study among oncologists.

PURPOSE: To determine the preferences of oncologists for palliative chemotherapy or watchful waiting and the factors considered important to that preference. METHODS: Sixteen vignettes (paper case descriptions), varying on eight patient and treatment characteristics, were designed to assess the oncologists' preferences. Their strength of preference was rated on a 7-point scale. An orthogonal main effects design provided a subset of all possible combinations of the characteristics, allowing estimations of the relative weights of the presented characteristics. A written questionnaire was sent to a random sample of oncologists (N = 1,235). RESULTS: The response rate was 67%, and 697 questionnaires were available for analysis. Eighty-one percent of the respondents were male. The mean age was 46 years. We found considerable variation among the oncologists. No major associations between physician characteristics and preferences were found. Of the patient and treatment characteristics affecting treatment preference, age was the strongest predictor, followed by the patient's wish to be treated and the expected survival gain. Other patient and treatment characteristics had a limited effect on preferences, except for psychologic distress, which had no independent impact. CONCLUSION: Patients will encounter different decisions depending on their oncologists' preferences and their own personal background. Therefore, to ensure adequate information for decision-making processes, decision aids are proposed.

Quality of life after transhiatal compared with extended transthoracic resection for adenocarcinoma of the esophagus.

PURPOSE: To assess 3 years of quality of life in patients with esophageal cancer in a randomized trial comparing limited transhiatal resection with extended transthoracic resection. PATIENTS AND METHODS: Quality-of-life questionnaires were sent at baseline and at 5 weeks; 3, 6, 9, and 12 months; and 1.5, 2, 2.5, and 3 years after surgery. Physical and psychological symptoms, activity level, and global quality of life were assessed with the disease-specific Rotterdam Symptom Checklist. Generic quality of life was measured with the Medical Outcomes Study Short Form-20. RESULTS: A total of 199 patients participated. Physical symptoms and activity level declined after the operation and gradually returned toward baseline within the first year (P < .01). Psychological well-being consistently improved after baseline (P < .01), whereas global quality of life showed a small initial decline followed by continuous gradual improvement (P < .01). Quality of life stabilized in the second and third year. Three months after the operation, patients in the transhiatal esophagectomy group (n = 96) reported fewer physical symptoms (P = .01) and better activity levels (P < .01) than patients in the transthoracic group (n = 103), but no differences were found at any other measurement point. For psychological symptoms and global quality of life, no differences were found at any follow-up measurement. A similar pattern was found for generic quality of life. CONCLUSION: No lasting differences in quality of life of patients who underwent either transhiatal or transthoracic resection were found. Compared with baseline, quality of life declined after the operation but was restored within a year in both groups.

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 patient's opinion is important; (2) the professional explains the options and their pros and cons; (3) the professional and the patient discuss the patient's preferences and the professional supports the patient in deliberation; (4) the professional and patient discuss the patient's 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.

Quality of life in breast cancer patients aged over 70 years, participating in the EORTC 10850 randomised clinical trial.

Mastectomy and breast-conserving treatment have proven equally effective in terms of survival in early breast cancer, but studies continue to provide evidence that patients undergoing breast-conserving procedures have a better quality of life (QOL). Age is not considered to be a contraindication for breast-conserving treatment, but retrospective studies have indicated that elderly patients are less likely to be treated conservatively. In the present study, survival, QOL and treatment preference have been investigated in a multicentre, randomised clinical trial of elderly patients with early breast cancer undergoing mastectomy or tumour excision plus tamoxifen. Eligible patients were aged 70 years or more and had histologically- or cytologically-confirmed operable breast cancer. A QOL questionnaire consisting of 36 items was constructed covering 9 scales assessing different QOL domains. Patients completed their assessment between 2 and 12 months after randomisation. 136 patients (65 in the mastectomy arm and 71 in the local excision arm) from six centres filled out a QOL form during the first year of follow-up. No significant difference in the duration of survival between the two treatment arms was observed when including patients included in the QOL sub-study (P=0.33). Patients undergoing tumour excision and tamoxifen did not differ from those undergoing mastectomy in terms of fatigue, emotional functioning, fear of recurrence, social support, physical functioning and leisure time activities. However, conservatively treated patients reported fewer arm problems (P=0.04) and a shift, although borderline significant, in the direction of a benefit in body image (P=0.06). As QOL seems to be better after conservative treatment, such treatment is to be preferred in both elderly and younger patients.