A blended learning for general practitioners and nurses on skills to support shared decision-making with patients about palliative cancer treatment: A one-group pre-posttest study.

OBJECTIVE: To evaluate a newly developed blended learning programme for general practitioners (GPs) and nurses in supporting shared decision making (SDM) about palliative cancer treatment in a simulated setting. METHODS: In a pre-posttest study, healthcare professionals (HCPs) participated in the blended learning (i.e. e-learning and (online) training session). HCPs filled out surveys (T0 (baseline), T1 (after e-learning) and T2 (after full blended learning)) and engaged in simulated consultations at T0 and T2. The primary outcome was observed SDM support (Triple-S; DSAT-10 for validation). Secondary outcomes included satisfaction, knowledge about and attitude towards SDM support. Repeated measures General Linear Models were conducted. RESULTS: 33 HCPs (17 GPs and 16 nurses) participated. SDM support significantly improved after training (Triple-S; medium effect). Observers' overall rating of SDM support (medium effect) as well as HCPs' knowledge (large effect) and beliefs about their capabilities (medium effect) improved after training. There was no difference in decision support skills (DSAT-10), HCPs' other clinical behavioural intentions and satisfaction. HCPs evaluated the training positively. CONCLUSION: Blended learning for HCPs on supporting SDM in palliative cancer care improved their skills, knowledge and confidence in simulated consultations. PRACTICE IMPLICATIONS: These first findings are promising for evaluating interprofessional SDM in clinical practice.

Patient and physician shared decision-making behaviors in oncology: Evidence on adequate measurement properties of the iSHARE questionnaires.

OBJECTIVES: We have developed two Dutch questionnaires to assess the shared decision-making (SDM) process in oncology; the iSHAREpatient and iSHAREphysician. In this study, we aimed to determine: scores, construct validity, test-retest agreement (iSHAREpatient), and inter-rater (iSHAREpatient-iSHAREphysician) agreement. METHODS: Physicians from seven Dutch hospitals recruited cancer patients, and completed the iSHAREphysician and SDM-Questionnaire-physician version. Their patients completed the: iSHAREpatient, nine-item SDM-Questionnaire, Decisional Conflict Scale, Combined Outcome Measure for Risk communication And treatment Decision-making Effectiveness, and five-item Perceived Efficacy in Patient-Physician Interactions. We formulated, respectively, one (iSHAREphysician) and 10 (iSHAREpatient) a priori hypotheses regarding correlations between the iSHARE questionnaires and questionnaires assessing related constructs. To assess test-retest agreement patients completed the iSHAREpatient again 1-2 weeks later. RESULTS: In total, 151 treatment decision-making processes with unique patients were rated. Dimension and total iSHARE scores were high both in patients and physicians. The hypothesis on the iSHAREphysician and 9/10 hypotheses on the iSHAREpatient were confirmed. Test-retest and inter-rater agreement were>.60 for most items. CONCLUSIONS: The iSHARE questionnaires show high scores, have good construct validity, substantial test-retest agreement, and moderate inter-rater agreement. PRACTICE IMPLICATIONS: Results from the iSHARE questionnaires can inform both physician- and patient-directed efforts to improve SDM in clinical practice.

Informed Decision-Making and Capabilities in Population-based Cancer Screening.

Informed decision-making (IDM) is considered an important ethical and legal requirement for population-based screening. Governments offering such screening have a duty to enable invitees to make informed decisions regarding participation. Various views exist on how to define and measure IDM in different screening programmes. In this paper we first address the question which components should be part of IDM in the context of cancer screening. Departing from two diverging interpretations of the value of autonomy-as a right and as an ideal-we describe how this value is operationalized in the practice of informed consent in medicine and translate this to IDM in population-based cancer screening. Next, we specify components of IDM, which is voluntariness and the requirements of disclosure and understanding. We argue that whereas disclosure should contain all information considered relevant in order to enable authentic IDM, understanding of basic information is sufficient for a valid IDM. In the second part of the paper we apply the capability approach in order to argue for the responsibility of the government to warrant equal and real opportunities for invitees for IDM. We argue that additional conditions beyond mere provision of information are needed in order to do so.

Measuring shared decision making in oncology: Development and first testing of the iSHAREpatient and iSHAREphysician questionnaires.

BACKGROUND: Existing measures to assess shared decision making (SDM) have often been developed based on an ill-defined underlying construct, and many assess physician behaviours only or focus on a single patient-physician encounter. OBJECTIVE: To (a) develop a patient and a physician questionnaire to measure SDM in oncology and (b) determine their content validity and comprehensibility. METHODS: A systematic review of SDM models and an oncology-specific SDM model informed the domains of the SDM construct. We formulated items for each SDM domain. Cancer patients and physicians rated content validity in an online questionnaire. We assumed a formative measurement model and performed online field-testing in cancer patients to inform further item reduction. We tested item comprehension in cognitive interviews with cancer patients and physicians. RESULTS: We identified 17 domains and formulated 132 items. Twelve cancer patients rated content validity at item level, and 11 physicians rated content validity at domain level. We field-tested the items among 131 cancer patients and conducted cognitive interviews with eight patients and five physicians. These phases resulted in the 15-item iSHAREpatient and 15-item iSHAREphysician questionnaires, covering 13 domains. CONCLUSIONS: We thoroughly developed the iSHARE questionnaires. They both assess patient and physician behaviours and cover the entire SDM process rather than a single consultation.

Key components of shared decision making models: a systematic review.

OBJECTIVES: To (1) provide an up-to-date overview of shared decision making (SDM)-models, (2) give insight in the prominence of components present in SDM-models, (3) describe who is identified as responsible within the components (patient, healthcare professional, both, none), (4) show the occurrence of SDM-components over time, and (5) present an SDM-map to identify SDM-components seen as key, per healthcare setting. DESIGN: Systematic review. ELIGIBILITY CRITERIA: Peer-reviewed articles in English presenting a new or adapted model of SDM. INFORMATION SOURCES: Academic Search Premier, Cochrane, Embase, Emcare, PsycINFO, PubMed, and Web of Science were systematically searched for articles published up to and including September 2, 2019. RESULTS: Forty articles were included, each describing a unique SDM-model. Twelve models were generic, the others were specific to a healthcare setting. Fourteen were based on empirical data, 26 primarily on analytical thinking. Fifty-three different elements were identified and clustered into 24 components. Overall, Describe treatment options was the most prominent component across models. Components present in >50% of models were: Make the decision (75%), Patient preferences (65%), Tailor information (65%), Deliberate (58%), Create choice awareness (55%), and Learn about the patient (53%). In the majority of the models (27/40), both healthcare professional and patient were identified as actors. Over time, Describe treatment options and Make the decision are the two components which are present in most models in any time period. Create choice awareness stood out for being present in a markedly larger proportion of models over time. CONCLUSIONS: This review provides an up-to-date overview of SDM-models, showing that SDM-models quite consistently share some components but that a unified view on what SDM is, is still lacking. Clarity about what SDM constitutes is essential though for implementation, assessment, and research purposes. A map is offered to identify SDM-components seen as key. TRIAL REGISTRATION: PROSPERO registration CRD42015019740.

Do Shared Decision-Making Measures Reflect Key Elements of Shared Decision Making? A Content Review of Coding Schemes.

Background. There is a growing need for valid shared decision-making (SDM) measures. We aimed to determine whether the items of extant SDM observer-based coding schemes assess the 4 key elements of SDM. Methods. Items of SDM coding schemes were extracted and categorized. Except for the 4 key elements of SDM (fostering choice awareness, informing about options, discussing patient preferences, and making a decision), (sub)categories were created inductively. Two researchers categorized items independently and in duplicate. Results. Five of 12 coding schemes assessed all 4 SDM elements. Seven schemes did not measure "fostering choice awareness," and 3 did not measure "discussing patient preferences." Seventy of 194 items (36%) could not be classified into one of the key SDM elements. Items assessing key SDM elements most often assessed "informing about options" (n = 57/124, 46%). Conclusion. Extant SDM coding schemes often do not assess all key SDM elements and have a strong focus on information provision while other crucial elements of SDM are underrepresented. Caution is therefore needed in reporting and interpreting the resulting SDM scores.

Shared decision making in oncology: A model based on patients', health care professionals', and researchers' views.

OBJECTIVE: To construct a model of shared decision making (SDM) about cancer treatment by conducting an extensive consultation of stakeholders, informed by the literature. METHODS: We interviewed 76 stakeholders: cancer patients, potential future patients, oncologists, nurses, and SDM-researchers. We asked, "If I say 'Doctors and patients making decisions together about cancer treatment,' what does this make you think about?" Ideas were further solicited by presenting 19 cards each describing a possible SDM element. Interviews were inductively coded and analysed, and the emerging themes were integrated into a model. RESULTS: The model that was based on participants' views assigns specific roles in SDM to both oncologists and patients. Oncologists determine possible treatments, emphasise the importance of patients' opinion, explain treatment options, get to know patients, guide patients, and provide treatment recommendations. Patients ask questions, express thoughts and feelings, consider options, offer opinions, and decide or delegate decisions to oncologists. Outside consultations, patients search for information, prepare questions, and consider options. CONCLUSIONS: Next to oncologists' role, cancer patients also have a clear role in SDM about cancer treatment, during and outside consultations. Patients should receive the support they need to fulfil this requirement.

The quality of instruments to assess the process of shared decision making: A systematic review.

OBJECTIVE: To inventory instruments assessing the process of shared decision making and appraise their measurement quality, taking into account the methodological quality of their validation studies. METHODS: In a systematic review we searched seven databases (PubMed, Embase, Emcare, Cochrane, PsycINFO, Web of Science, Academic Search Premier) for studies investigating instruments measuring the process of shared decision making. Per identified instrument, we assessed the level of evidence separately for 10 measurement properties following a three-step procedure: 1) appraisal of the methodological quality using the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist, 2) appraisal of the psychometric quality of the measurement property using three possible quality scores, 3) best-evidence synthesis based on the number of studies, their methodological and psychometrical quality, and the direction and consistency of the results. The study protocol was registered at PROSPERO: CRD42015023397. RESULTS: We included 51 articles describing the development and/or evaluation of 40 shared decision-making process instruments: 16 patient questionnaires, 4 provider questionnaires, 18 coding schemes and 2 instruments measuring multiple perspectives. There is an overall lack of evidence for their measurement quality, either because validation is missing or methods are poor. The best-evidence synthesis indicated positive results for a major part of instruments for content validity (50%) and structural validity (53%) if these were evaluated, but negative results for a major part of instruments when inter-rater reliability (47%) and hypotheses testing (59%) were evaluated. CONCLUSIONS: Due to the lack of evidence on measurement quality, the choice for the most appropriate instrument can best be based on the instrument's content and characteristics such as the perspective that they assess. We recommend refinement and validation of existing instruments, and the use of COSMIN-guidelines to help guarantee high-quality evaluations.

Screening and treatment of psychological distress in patients with metastatic colorectal cancer: study protocol of the TES trial.

BACKGROUND/INTRODUCTION: Psychological distress occurs frequently in patients with cancer. Psychological distress includes mild and severe forms of both anxious and depressive mood states. Literature indicates that effective management of psychological distress seems to require targeted selection of patients (T), followed by enhanced care (E), and the application of evidence based interventions. Besides, it is hypothesized that delivering care according to the stepped care (S) approach results in an affordable program. The aim of the current study is to evaluate the (cost)-effectiveness of the TES program compared to usual care in reducing psychological distress in patients with metastatic colorectal cancer (mCRC). METHODS: This study is designed as a cluster randomized trial with 2 treatment arms: TES program for screening and treatment of psychological distress versus usual care. Sixteen hospitals participate in this study, recruiting patients with mCRC. Outcomes are evaluated at the beginning of chemotherapy and after 3, 10, 24, and 48 weeks. Primary outcome is the difference in treatment effect over time in psychological distress, assessed with the Hospital Anxiety and Depression Scale. Secondary outcomes include quality of life, patient evaluation of care, recognition and management of psychological distress, and societal costs. DISCUSSION: We created optimal conditions for an effective screening and treatment program for psychological distress in patients with mCRC. This involves targeted selection of patients, followed by enhanced and stepped care. Our approach will be thoroughly evaluated in this study. We expect that our results will contribute to the continuing debate on the (cost-) effectiveness of screening for and treatment of psychological distress in patients with cancer. TRIAL REGISTRATION: This trial is registered in the Netherlands Trial Register NTR4034.

Associations between life stress and subclinical cardiovascular disease are partly mediated by depressive and anxiety symptoms.

BACKGROUND: Stress experienced during childhood or adulthood has been associated with cardiovascular disease (CVD), but it is not clear whether associations are already prevalent on a subclinical cardiovascular level. This study investigates associations between indicators of life stress and subclinical CVD, and whether these are mediated by depression and anxiety. METHODS: Subjects were 650 participants of the Netherlands Study of Depression and Anxiety, aged 20-66 years, with or without (27.5%) depressive and anxiety disorders. Life stress included childhood trauma, negative life events and recently experienced daily hassles or job strain. Subclinical CVD was measured as 1) carotid atherosclerosis (intima-media thickness and the presence of plaques) using B-mode ultrasonography, and 2) central arterial stiffness (heart rate normalized augmentation index) using calibrated radial applanation tonometry. RESULTS: Increased central arterial stiffness was shown in subjects who had experienced childhood trauma (per SD increase: ß=.07; p=.01), or reported recently experienced daily hassles (per SD increase: ß=.06; p=.02), negative life events (per SD increase: ß=.05; p=.03), or job strain (high versus low: ß=.09; p=.01). Associations between life stress and arterial stiffness appeared to be partly mediated by severity of depressive and anxiety symptoms. No significant associations were found for childhood life events, nor between indicators of life stress and carotid atherosclerosis. CONCLUSIONS: Childhood trauma and recent life stress were associated with increased central arterial stiffness. This suggests that life stress - partly via depression and anxiety - might enhance the development and progression of CVD.

Prediction of mortality in adolescents with cystic fibrosis.

INTRODUCTION: Lung function, nutritional status, and parameters of exercise capacity are known predictors of mortality in patients with cystic fibrosis (CF). The aim of the current study was to use these important parameters to develop a multivariate model to predict mortality in adolescent patients with CF. METHODS: A total of 127 adolescents with CF (57 girls) with a mean age of 12.7 ± 0.9 yr and a mean percentage of predicted forced expired volume in 1 s (FEV1% predicted) of 77.7% ± 15.6% were included. Cardiopulmonary exercise testing-derived parameters, nutritional status, and resting lung functions were dichotomized according to the criterion value determined using receiver operating characteristic curves. Body mass index (BMI), FEV1%predicted, predicted peak oxygen uptake corrected for body weight (VO2 peak/kg%predicted), peak minute ventilation (VE peak), peak VE/VO2, peak VE/VCO2, and breathing reserve were included in a multivariate model. The Cox proportional hazards model was used to determine the combination of parameters that best predicted mortality and/or lung transplantation. RESULTS: The mean duration of follow-up was 7.5 ± 2.7 yr, during which, nine of the 127 patients (7.1%) died and six (4.7%) underwent lung transplantation. Mortality in this population was best predicted by the model that included FEV1%predicted (hazard ratio, 17.13; 95% confidence interval (CI), 3.76-78.06), peak VE/VO2 (hazard ratio, 5.92; 95% CI, 1.27-27.63), and BMI (hazard ratio, 5.54; 95% CI, 1.82-16.83). CONCLUSIONS: The currently developed model consisting of BMI, FEV1%predicted, and VE/VO2 is a strong predictor of mortality rate in adolescents with CF. This prediction equation may be useful in clinical practice to detect patients with a high risk of mortality and to provide them with additional therapy earlier.

Parental illness perceptions and medication perceptions in childhood asthma, a focus group study.

AIM: Asthma treatment according to guidelines fails frequently, through patients' nonadherence to doctors' advice. This study aimed to explore how differences in asthma care influence parents' perceptions to inhaled corticosteroids (ICS). METHODS: We conducted six semistructured focus groups, including 44 parents of asthmatic children (2-12 years of age, treated in primary or specialist care). Verbatim transcripts were analysed with standard qualitative research methods. RESULTS: Parents decided deliberately whether ongoing ICS use was useful for their child. This decision was based on their perceptions about illness and medication. In primary care, this issue was hardly ever discussed with the health care provider because regular scheduled follow-up was unusual. In specialist care, regular scheduled follow-up was usual, and parental perceptions about illness and medication were discussed and modified when needed. Parent-reported adherence was lower in primary care than in specialist care. CONCLUSION: This focus group study illustrates how strongly parental perceptions of illness and medication influence adherence to health care providers' advice and that such perceptions can be modified within a strong doctor-patient partnership, improving adherence.