Confidence In Treatment Decisions Research Articles

The influence of defaecating proctograms on clinical decision-making in pelvic floor disorders.

Defaecating proctogram (DP) studies have become an integral part of the evaluation of patients with pelvic floor disorders. However, their impact on treatment decision-making remains unclear. The aim of this study was to assess the concordance of decision-making by colorectal surgeons and the role of the DP in this process. Four colorectal surgeons were presented with online surveys containing the complete history, examination and investigations of 106 de-identified pelvic floor patients who had received one of three treatment options: physiotherapy only, anterior Delorme's procedure or anterior mesh rectopexy. The survey assessed the management decisions made by each of the surgeons for the three treatments both before and after the addition of the DP to the diagnostic work-up. After the addition of the DP results; treatment choice changed in 219 (52%) of 424 surgical decisions and interrater agreement improved significantly from κ = 0.26 to κ = 0.39. Three of the four surgeons reported a significant increase in confidence. Agreement with the actual treatments patients received increased from κ = 0.21 to κ = 0.28. Intra-anal rectal prolapse on DP was a significant predictor of a decision to perform anterior mesh rectopexy. The DP improves interclinician agreement in the management of pelvic floor disorders and enhances the confidence in treatment decisions. Intra-anal rectal prolapse was the most influential DP parameter in treatment decision-making.

Personalized surgical informed consent with stereoscopic visualization in neurosurgery—real benefit for the patient or unnecessary gimmick?

BackgroundInformed consent of the patient prior to surgical procedures is obligatory. A good and informative communication improves patients’ understanding and confidence, thus may strengthen the patient-doctor relationship. The aim of our study was to investigate the usefulness of additional stereoscopic visualization of patient-specific imaging during informed consent conversation.MethodsPatients scheduled for a brain tumor surgery were screened for this study prospectively. The primary exclusion criteria were cognitive or visual impairments. The participants were randomized into two groups. The first group underwent a conventional surgical informed consent performed by a neurosurgeon including a demonstration of the individual MRI on a 2D computer screen. The second group received an additional stereoscopic visualization of the same imaging to explain the pathology more in-depth. The patients were then asked to fill in a questionnaire after each part. This questionnaire was designed to assess the potential information gained from the patients with details on the anatomical location of the tumor as well as the surgical procedure and possible complications. Patients’ subjective impression about the informed consent was assessed using a 5-point Likert scale.ResultsA total of 27 patients were included in this study. After additional stereoscopic visualization, no significant increase in patient understanding was found for either objective criteria or subjective assessment. Participants’ anxiety was not increased by stereoscopic visualization. Overall, patients perceived stereoscopic imaging as helpful from a subjective perspective. Confidence in the department was high in both groups.ConclusionStereoscopic visualization of MRI images within informed consent conversation did not improve the objective understanding of the patients in our series. Although no objective anatomical knowledge gain was noted in this series, patients felt that the addition of stereoscopic visualization improved their overall understanding. It therefore potentially increases patient confidence in treatment decisions.

Classification and prediction of hypoglycemia in diabetic patients using machine learning techniques

Type 1 diabetics can lower their risk of microvascular and macrovascular problems by carefully regulating their blood glucose levels. The downside is that these measures are incredibly challenging because of the wide diversity across individuals, as well as other factors that affect glycemic management. Keeping glucose levels under control is difficult due to the possibility of severe hypoglycemia in patients receiving intensive insulin therapy. In people with diabetes, hypoglycemia is a common complication, which has a negative impact on overall health and well-being. Improving patient safety by anticipating unfavourable glycemic events has become a practical approach to enhanced patient safety using machine learning decision assistance. This paper suggests the use of three machine learning techniques to solve the problem of diabetic safety: (1) Random Forest for continuous glucose predictions, (2) support vector machines for postprandial period predictions, and (3)artificial neural networks for overnight hypoglycemic predictions. It has the two different categorization and prediction capabilities already established. A major system feature is the overall reduction in bouts of hypoglycemia, which results in an increase in patient safety and provides better confidence in treatment decisions.

Management of Common Infections in German Primary Care: A Cross-Sectional Survey of Knowledge and Confidence among General Practitioners and Outpatient Pediatricians.

Outpatient antibiotic use is closely related to antimicrobial resistance and in Germany, almost 70% of antibiotic prescriptions in human health are issued by primary care physicians (PCPs). The aim of this study was to explore PCPs, namely General Practitioners’ (GPs) and outpatient pediatricians’ (PDs) knowledge of guideline recommendations on rational antimicrobial treatment, the determinants of confidence in treatment decisions and the perceived need for training in this topic in a large sample of PCPs from southern Germany. Out of 3753 reachable PCPs, 1311 completed the survey (overall response rate = 34.9%). Knowledge of guideline recommendations and perceived confidence in making treatment decisions were high in both GPs and PDs. The two highest rated influencing factors on prescribing decisions were reported to be guideline recommendations and own clinical experiences, hence patients’ demands and expectations were judged as not influencing treatment decisions. The majority of physicians declared to have attended at least one specific training course on antibiotic use, yet almost all the participating PCPs declared to need more training on this topic. More studies are needed to explore how consultation-related and context-specific factors could influence antibiotic prescriptions in general and pediatric primary care in Germany beyond knowledge. Moreover, efforts should be undertaken to explore the training needs of PCPs in Germany, as this would serve the development of evidence-based educational interventions targeted to the improvement of antibiotic prescribing decisions rather than being focused solely on knowledge of guidelines.

Development of Japanese Versions of the Control Preferences Scale and Information Needs Questionnaire: Role of Decision-Making and Information Needs for Japanese Breast Cancer Patients.

PurposeThe importance of shared decision-making (SDM) between physicians and patients is increasingly recognized. In Japan, patients have shown more willingness to participate in treatment if medical professionals provide sufficient information; however, relationships between physicians and patients have traditionally been asymmetric, with patients accepting information from physicians without discussion. To explore the benefits of SDM in cancer treatment, including confidence in treatment decisions, satisfaction with treatment, and trust in healthcare providers, this study developed Japanese versions of the Control Preference Scale (CPS) and Information Needs Questionnaire (INQ).Patients and MethodsReliability and validity of the CPS and INQ were tested with 49 breast cancer patients.ResultsThe CPS showed good test–retest reliability (kappa coefficient: 0.61, weighted kappa coefficient: 0.61, Kendall’s tau coefficient: 0.61) and acceptable criterion validity. The INQ showed adequate consistency; the mean number of circular triads and coefficient of consistency were 3 (range 0–19) and 0.9 (range 0.37–1), respectively. Using the CPS and INQ to identify patients’ roles in decision-making and information needs, results further suggested that breast cancer patients in Japan want to participate in SDM. Medical issues, including disease spread and cure, were found to be of high interest, while social and psychological issues, including sexual attractiveness, genetic risk, and family impact, tended to be low.ConclusionThe Japanese CPS and INQ can be used to assess patients’ needs to improve care. Further, as patients’ information needs change along the care trajectory, these tools should be used throughout treatment.

Shared decision-making attitudes and practices in multidisciplinary cancer care teams.

180 Background: Patients who engage in decision making are more likely to experience confidence in treatment decisions, satisfaction with treatment, and trust in clinicians. The Association of Community Cancer Centers (ACCC) conducted a survey to explore multidisciplinary team attitudes and practices around shared decision-making (SDM) and health literacy. Methods: ACCC convened a steering committee of multidisciplinary specialists and advocacy representatives to guide this research. The survey included 26 mostly closed-ended questions and was open to multidisciplinary cancer programs from 10/29/19 to 2/20/20. Exploratory analysis was performed on this data set of 305 complete responses. Results: While most respondents reported engaging patients in decision-making to some degree, only 50% reported that SDM is a top organizational priority. 33% reported organizational efforts to formally integrate SDM into the clinical workflow, with only 15% indicating staff opportunities for basic SDM training. The three most frequently cited perceived barriers to engaging in SDM were patients feeling overwhelmed (53%), wanting to defer decisions to clinicians (46%), and having limited health literacy (46%). Only 13% indicated that lack of time was a barrier. Less than half (41%) of respondents reported using patient decision aids to support SDM. Respondents represented a wide range of multidisciplinary team members, though surgical oncologists and general surgeons (20% and 16% respectively) are overrepresented in the results. Conclusions: SDM is commonly accepted as essential to patient engagement but clarity in terminology and prioritizing formal integration of SDM into practice is limited. Strategies to improve integration of SDM into oncology practice should include: 1) Educational initiatives and tools to overcome barriers to SDM, including patient decision aids and SDM training, 2) Initiatives to address health literacy as it relates to patient and caregiver engagement in decision making, 3) Psychosocial support for patients whose emotional upset is a barrier to SDM, 4) Healthcare policies that encourage and incentive providers to engage in SDM. Future analyses will require concurrent assessment of patient, caregiver, healthcare professional, and administrator perspectives.

Patients\u2019 confidence in treatment decisions for early stage non-small cell lung cancer (NSCLC)

BackgroundIn early-stage Non-Small Cell Lung Cancer (NSCLC) patients, little is known about how to measure patient participation in Shared-Decision Making (SDM). We examined the psychometric properties and clinical acceptability of the Decision Self-Efficacy scale (DSE) in a cohort of patients undergoing to Stereotactic Ablative Radiotherapy (SABR) or Video-assisted Thoracoscopic Surgery (VATS) to capture patient involvement in treatment decisions.MethodsIn the context of a prospective longitudinal study (Life after Lung Cancer-LiLAC) involving 244 patients with early-stage NSCLC, 158 (64.7%) patients completed the DSE either on paper or electronically online prior to treatment with SABR or VATS pulmonary resection. DSE psychometric properties were examined using: principal components analysis of item properties and internal structure, and internal construct validity; we also performed a sensitivity analysis according to Eastern Cooperative Oncology Group Performance Status (ECOG PS), gender, age and treatment received (VATS or SABR) difference.ResultsExploratory factor analysis using polychoric correlations substantiated that the 11 item DSE is one scale accounting for 81% of the variance. We calculated a value of 0.96 for Cronbach’s alpha for the total DSE score.DSE scores did not differ by gender (p = 0.37), between the two treatment groups (p = 0.09) and between younger and older patients (p = 0.4). However, patients with an ECOG PS > 1 have a DSE mean of 73.8 (SD 26) compared to patients with a PS 0–1 who have a DSE mean of 85.8 (SD 20.3 p = 0.002).ConclusionFindings provide preliminary evidence for the reliability and validity of the DSE questionnaire in this population. However, future studies are warranted to identify the most appropriate SDM tool for clinical practice in the lung cancer treatment field.

MammaPrint guides treatment decisions in breast Cancer: results of the IMPACt trial

BackgroundIncreased usage of genomic risk assessment assays suggests increased reliance on data provided by these assays to guide therapy decisions. The current study aimed to assess the change in treatment decision and physician confidence based on the 70-gene risk of recurrence signature (70-GS, MammaPrint) and the 80-gene molecular subtype signature (80-GS, BluePrint) in early stage breast cancer patients.MethodsIMPACt, a prospective, case-only study, enrolled 452 patients between November 2015 and August 2017. The primary objective population included 358 patients with stage I-II, hormone receptor-positive, HER2-negative breast cancer. The recommended treatment plan and physician confidence were captured before and after receiving results for 70-GS and 80-GS. Treatment was started after obtaining results. The distribution of 70-GS High Risk (HR) and Low Risk (LR) patients was evaluated, in addition to the distribution of 80-GS compared to IHC status.ResultsThe 70-GS classified 62.5% (n = 224/358) of patients as LR and 37.5% (n = 134/358) as HR. Treatment decisions were changed for 24.0% (n = 86/358) of patients after receiving 70-GS and 80-GS results. Of the LR patients initially prescribed CT, 71.0% (44/62) had CT removed from their treatment recommendation. Of the HR patients not initially prescribed CT, 65.1% (41/63) had CT added. After receiving 70-GS results, CT was included in 83.6% (n = 112/134) of 70-GS HR patient treatment plans, and 91.5% (n = 205/224) of 70-GS LR patient treatment plans did not include CT. For patients who disagreed with the treatment recommended by their physicians, most (94.1%, n = 16/17) elected not to receive CT when it was recommended. For patients whose physician-recommended treatment plan was discordant with 70-GS results, discordance was significantly associated with age and lymph node status.ConclusionsThe IMPACt trial showed that treatment plans were 88.5% (n = 317/358) in agreement with 70-GS results, indicating that physicians make treatment decisions in clinical practice based on the 70-GS result. In clinically high risk, 70-GS Low Risk patients, there was a 60.0% reduction in treatment recommendations that include CT. Additionally, physicians reported having greater confidence in treatment decisions for their patients in 72% (n = 258/358) of cases after receiving 70-GS results.Trial registration“Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry” (NCT02670577) retrospectively registered on Jan 27, 2016.

Prospective, multicenter study on the economic and clinical impact of gene-expression assays in early-stage breast cancer from a single region: the PREGECAM registry experience.

The aim of this study is to evaluate the cost-effectiveness and impact of gene-expression assays (GEAs) on treatment decisions in a real-world setting of early-stage breast cancer (ESBC) patients. This is a regional, prospective study promoted by the Council Health Authorities in Madrid. Enrolment was offered to women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, node-negative or micrometastatic, stage I or II breast cancer from 21 hospitals in Madrid. Treatment recommendations were recorded before and after knowledge of tests results. An economic model compared the cost-effectiveness of treatment, guided by GEAs or by common prognostic factors. 907 tests (440 Oncotype DX® and 467 MammaPrint®) were performed between February 2012 and November 2014. Treatment recommendation changed in 42.6% of patients. The shift was predominantly from chemohormonal (CHT) to hormonal therapy (HT) alone, in 30.5% of patients. GEAs increased patients' confidence in treatment decision making. Tumor grade, progesterone receptor positivity and Ki67 expression were associated with the likelihood of change from CHT to HT (P < 0.001) and from HT to CHT (P < 0.001). Compared with current clinical practice genomic testing increased quality-adjusted life years by 0.00787 per patient and was cost-saving from a national health care system (by 13.867€ per patient) and from a societal perspective (by 32.678€ per patient). Using GEAs to guide adjuvant therapy in ESBC is cost-effective in Spain and has a significant impact on treatment decisions.

Involving Patients in the Development and Evaluation of an Educational and Training Experiential Intervention (ETEI) to Improve Muscle Invasive Bladder Cancer Treatment Decision-making and Post-operative Self-care: a Mixed Methods Approach.

This study aims to describe the acceptability and feasibility of an educational and training experiential intervention (ETEI) we developed to enhance muscle invasive bladder cancer (MIBC) patients with treatment decision-making and post-operative self-care. Twenty-five patients were randomized to a control group (N = 8) or ETEI group (N = 17). ETEI group participated in a nurse-led session on MIBC education. The control group received diet and nutrition education. Study questionnaires were completed at baseline and at 1-month post-intervention. Our results showed acceptable recruitment (58%) and retention rates (68%). The ETEI group reported increased knowledge (82% vs. 50%), improved decisional support (64% vs. 50%), improved communication (73% vs. 50%), and increased confidence in treatment decisions (73% vs. 50%) compared to the control group. Patients in the control group reported improved diet (50% v. 27%) as well as maintaining a healthy lifestyle (67% vs. 45%) compared to the ETEI group. Patients in the ETEI group reported a significant decrease in cancer worries and increases in self-efficacy beliefs over time compared to the control group. The ETEI was feasible, acceptable, and showed a potential for inducing desired changes in cancer worries and efficacy beliefs.

Abstract P6-13-04: IMPACt trial: MammaPrint and BluePrint molecular subtyping guide treatment decisions in breast cancer

Abstract Background: IMPACt is a prospective, case-only study to measure the effect of MammaPrint (MP) and BluePrint (BP) on treatment decisions in breast cancer patients. Here, we report the results of the primary objective in women aged ≥18 years with histologically proven invasive stage I-II, hormone receptor (HR) positive, and HER2-negative breast cancer. Methods: The study included 369 women from 18 US institutions. The recommended treatment plan was captured before and after receiving results for MP and BP. Treatment was started after obtaining results. In addition to the effect of results on physician treatment decisions involving chemotherapy (CT) and physician confidence, the distribution of MP High Risk (HR) and Low Risk (LR) patients was also evaluated. Results: MP classified patients to 62% (n=228) LR and 38% (n=141) HR. Treatment decisions were changed for 25% (n=92) of women after receiving MP and BP results. Of the LR patients initially prescribed CT, 68% (45/66) had CT removed from their treatment recommendation. Of the HR patients who initially were not prescribed CT, 66% (42/64) had CT added. Overall, 89% (202/228) of LR patients did not receive CT, and likewise 84% (119/141) of HR patients did receive CT after receiving MP. Among those who did not change treatment (n=277), 68% of physicians reported having greater confidence in their prescribed therapy. Conclusions: The IMPACt trial shows MP generates a 25% overall treatment change in clinical practice. The highest impact is for women with LR results, where 68% are spared chemotherapy in favor of endocrine therapy alone. Additionally, 73% of physicians report having higher confidence in treatment decisions for their patient after MP. Table 1: Treatment changesTreatment Decision Pre- to Post-MPMP HRMP LRTotalCT to CT772198no CT tp CT42547CT to no CT04545no CT to no CT22157179Total141228369 Citation Format: Soliman H, Rehmus E, Shah V, Srkalovic G, Mahtani R, Levine E, Mavromatis B, Srinivasiah J, Kassar M, Gabordi R, Yoder E, Qamar R, Audeh W, IMPACt Investigators Group I. IMPACt trial: MammaPrint and BluePrint molecular subtyping guide treatment decisions in breast cancer [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-13-04.

Abstract P1-06-05: Clinical practice and mortality in patients with oncotype DX intermediate score: What do we know about the gray zone?

Abstract BACKGROUND: The 21 gene expression signature Oncotype DX (ODX) is a powerful predictor of disease outcome in early stage hormone receptor positive breast cancer. ODX can be used for better risk stratification of patients who may benefit from chemotherapy. ODX testing increases confidence in treatment decisions especially when ODX recurrence score (RS) is low or high. However, for the intermediate RS, decisions on receiving chemotherapy or not is a joint decision made by the physician and patient, in part because results from the TAILORx and RxPONDER randomized clinical trials addressing this very important clinical question has yet to be published. OBJECTIVE: To examine “real world” oncology practice and survival outcome for breast cancer patients with ODX RS score in the intermediate range. METHODS: A retrospective cohort of women diagnosed with early stage, hormone receptor positive breast cancer whose ODX score was in the intermediate range was established using the National Cancer Data Base (NCDB), 2009-2013. We assessed the relationship of overall survival with chemotherapy receipt and RS score using Cox proportional hazards models adjusted for patient characteristics, including age, race/ethnicity, grade, year of diagnosis, Charlson Co-morbidity Index, lymphovascular invasion, nodal involvement, tumor size, and histology. Intermediate RS score was analyzed as both continuous variable and categorical variables (18-20, 21-23, 24-26, and 27-30). RESULTS: Of 24,945 females reported to have intermediate ODX score, 10,179 (41.4%) received chemotherapy. Receipt of chemotherapy depended on ODX score monotonically, ranging from 19.1% in patients with RS = 19 to 76.1% in patients with RS = 30. In total, 426 patients have died from all causes. Overall, chemotherapy receipt was associated with a statistically significant reduction in the risk of death (hazard ratio=0.77; 95% confidence interval [CI]: 0.62-0.96, p=0.02) in multivariable Cox model. RS score was statistically positively associated with increased risk of death, with one unit increment in RS corresponding to 6.2% increased mortality risk (95% CI 3.2%- 9.2%, p&amp;lt;0.0001). Using a categorical scale, we found patients with intermediate ODX scores in RS 27-30 range had 1.64-fold increased risk of death (95% CI: 1.13-2.37) compared to patients with ODX scores in RS 18-20 range.. The association between ODX score and overall survival was more pronounced in women younger than 50 (hazard ratio per 1 unit increment = 1.28, 95% CI: 1.17-1.40) than in women 50 years or older (hazard ratio per 1 unit increment = 1.04, 95% CI: 1.01-1.07). CONCLUSION: Our analysis revealed the ODX score in the intermediate range still has prognostic value for overall survival especially for young-onset breast cancer patients, which is independent of other clinopathologic factors. As we eagerly await results from randomized clinical trials, young women with intermediate RS should be counseled to consider more aggressive treatment including chemotherapy, ovarian function suppression or participation in ongoing clinical trials of CDK inhibitors to improve overall survival outcomes. Citation Format: Ibraheem AF, Press D, Dezheng H, Olopade F. Clinical practice and mortality in patients with oncotype DX intermediate score: What do we know about the gray zone? [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P1-06-05.

Translating clinical trials into clinical practice: a survey assessing the potential impact of the Pediatric Heart Network Infant Single Ventricle Trial.

A few studies have evaluated the impact of clinical trial results on practice in paediatric cardiology. The Infant Single Ventricle (ISV) Trial results published in 2010 did not support routine use of the angiotensin-converting enzyme inhibitor enalapril in infants with single-ventricle physiology. We sought to assess the influence of these findings on clinical practice. A web-based survey was distributed via e-mail to over 2000 paediatric cardiologists, intensivists, cardiothoracic surgeons, and cardiac advance practice nurses during three distribution periods. The results were analysed using McNemar's test for paired data and Fisher's exact test. The response rate was 31.5% (69% cardiologists and 65% with >10 years of experience). Among respondents familiar with trial results, 74% reported current practice consistent with trial findings versus 48% before trial publication (p<0.001); 19% used angiotensin-converting enzyme inhibitor in this population "almost always" versus 36% in the past (p<0.001), and 72% reported a change in management or improved confidence in treatment decisions involving this therapy based on the trial results. Respondents familiar with trial results (78%) were marginally more likely to practise consistent with the trial results than those unfamiliar (74 versus 67%, p=0.16). Among all respondents, 28% reported less frequent use of angiotensin-converting enzyme inhibitor over the last 3 years. Within 5 years of publication, the majority of respondents was familiar with the Infant Single Ventricle Trial results and reported less frequent use of angiotensin-converting enzyme inhibitor in single-ventricle infants; however, 28% reported not adjusting their clinical decisions based on the trial's findings.

The West German Study Group Breast Cancer Intrinsic Subtype study: a prospective multicenter decision impact study utilizing the Prosigna assay for adjuvant treatment decision-making in estrogen-receptor-positive, HER2-negative early-stage breast cancer

Purpose: The West German Study Group (WSG) Breast Cancer Intrinsic Subtype (BCIST) study was designed to assess the influence of Prosigna gene signature assay results on physicians’ adjuvant treatment recommendations by determining the extent of change in pre-test treatment recommendations following assay results. Secondary objectives were to assess the influence of Prosigna results on physicians’ confidence in their therapeutic recommendations and on patients’ decisional conflict status, anxiety levels, and functional status. Methods: This prospective, observational, decision impact study enrolled consecutive postmenopausal patients with estrogen-receptor (ER)-positive, HER2-negative, lymph-node-negative early-stage breast cancer in 11 centers in Germany. Physicians based their pre-test adjuvant treatment recommendations on standard clinico-pathological parameters. Tumor specimens were assayed using the Prosigna test in a WSG central pathology laboratory following manufacturer’s guidelines. An independent pathology laboratory performed subsequent Prosigna assays on tumor sections to assess assay result concordance with the central laboratory. Physicians completed treatment confidence questionnaires prior to and after receiving Prosigna test results. Patients completed standardized questionnaires on decisional conflict, anxiety, and health status both before and after Prosigna testing. Results: The present study population consisted predominantly of low-to-intermediate risk patients (N = 198). Prosigna had 29.3% discordance in intrinsic subtyping with local immunohistochemistry test results. After Prosigna test results, a change in the adjuvant therapy recommendation occurred in 36 (18.2%) patients; 22 (11.1%) patients switched from no chemotherapy to chemotherapy. After Prosigna test results, physicians expressed increased confidence in their prognostic assessment in 87.9% of patients, and increased confidence in their treatment recommendation in 89.4%. Patients reported improved anxiety and emotional/functional well-being after receiving Prosigna test results. Conclusions: Use of the Prosigna assay led to a change in 18.2% of adjuvant treatment decisions. Prosigna testing was associated with increased patient and physician confidence in treatment decisions, and with decreased patient anxiety and improved well-being. Any comparison of the therapeutic decision-making impacts of different genomic assays must account for potential confounding factors.

A decision impact, decision conflict and economic assessment of routine Oncotype DX testing of 146 women with node-negative or pNImi, ER-positive breast cancer in the UK

Background:Tumour gene expression analysis is useful in predicting adjuvant chemotherapy benefit in early breast cancer patients. This study aims to examine the implications of routine Oncotype DX testing in the UK.Methods:Women with oestrogen receptor positive (ER+), pNO or pN1mi breast cancer were assessed for adjuvant chemotherapy and subsequently offered Oncotype DX testing, with changes in chemotherapy decisions recorded. A subset of patients completed questionnaires about their uncertainties regarding chemotherapy decisions pre- and post-testing. All patients were asked to complete a diary of medical interactions over the next 6 months, from which economic data were extracted to model the cost-effectiveness of testing.Results:Oncotype DX testing resulted in changes in chemotherapy decisions in 38 of 142 (26.8%) women, with 26 of 57 (45.6%) spared chemotherapy and 12 of 85 (14.1%) requiring chemotherapy when not initially recommended (9.9% reduction overall). Decision conflict analysis showed that Oncotype DX testing increased patients' confidence in treatment decision making. Economic analysis showed that routine Oncotype DX testing costs £6232 per quality-adjusted life year gained.Conclusion:Oncotype DX decreased chemotherapy use and increased confidence in treatment decision making in patients with ER+ early-stage breast cancer. Based on these findings, Oncotype DX is cost-effective in the UK setting.

Bipolar Disorder Clinical Synthesis: Where Does the Evidence Lead?

Bipolar disorder is a common condition diagnosed by the occurrence of pathological mood elevation but most often dominated by dysphoria states. Over the past 10 years, understanding of bipolar disorder and the number of evidence-based treatments have increased dramatically. This article offers strategies for improving diagnostic confidence and simple benchmarks that facilitate integrating principles of evidence-based medicine into the management of patients with bipolar disorder. Simple systematic assessment techniques such as focusing the evaluation to assess the most extreme episode of mood elevation and longitudinal factors such as age of onset and course of illness can avoid errors of omission and raise diagnostic confidence. An iterative measurement-based treatment model that aims to bring patients and their supports into the collaborative care process for progressively better outcomes is recommended.

Confidence and Uncertainty Long After Initial Treatment for Early Prostate Cancer: Survivors' Views of Cancer Control and the Treatment Decisions They Made

The many years most men diagnosed with early prostate cancer live after diagnosis allow evolving assessments of their cancer control and their treatment choices, but little is known of these outcomes or the factors that influence them. We surveyed an established, prospective cohort that had initiated treatment for early prostate cancer 4 to 8 years previously. We assessed perceived cancer control, quality of treatment decisions, and other domains of quality of life, along with treatment-related urinary, bowel, and sexual dysfunction. Most men reported high confidence in cancer control and their treatment decisions, but many reported misgivings about one or both. The diagnostic, treatment, and quality-of-life factors associated with these two outcomes were distinct. Perceived cancer control was lower among those with adverse medical factors: higher pretreatment Gleason scores, subsequent rises in prostate-specific antigen (PSA), and secondary androgen ablation therapy. Confidence in treatment decisions was unrelated to these factors and was higher in men who opted for radical prostatectomy or brachytherapy, reported close attention to current PSA, had high masculine self-esteem and little distress from sexual dysfunction, and were married. Although perceptions of cancer control and the quality of their treatment decisions are linked, men can distinguish between these two outcomes. They incorporate objective indicators of high risk and adverse outcomes when assessing their cancer control; confidence in treatment decisions represents a more complex psychosocial adjustment to the persistent uncertainty that originates with their diagnosis.