Evaluation of a genomic-based prognostic test for metastasis in high-risk post-prostatectomy patients: Does it impact physician decision making?

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 196-196
Author(s):  
Ketan K. Badani ◽  
Darby J. S. Thompson ◽  
Anirban Pradip Mitra ◽  
Mercedeh Ghadessi ◽  
Christine Buerki ◽  
...  

196 Background: Currently, identification of individual patients who are truly at risk of developing lethal prostate cancer after radical prostatectomy (RP) is based on clinical nomograms. A prospectively validated genomic classifier (Decipher) has been shown to more accurately predict metastatic disease post RP than established clinical predictors and can identify patients with adverse pathology who may be cured by RP alone and may therefore not require additional treatment. Methods: An IRB-approved study assessed the impact of a genomic classifier (GC) test in 240 pathologically high-risk post RP case reviews. Twenty (20) urologic oncologists from 18 institutions reviewed 12 cases presented in a randomized, de-identified fashion via a secure online platform to provide treatment recommendations pre- and post- patient GC test results. Possible recommendations included referral to radiation oncologist and/or initiation of adjuvant hormones, close observation, or other. The primary endpoint was any change in treatment recommendation after unblinding of GC test results. Confidence in treatment recommendations was assessed using a 5-point Likert scale. Results: Following unblinding of GC test results, treatment recommendations changed in 43% (95% CI: 37-49) of all cases. Specifically, among cases with a pre-GC recommendation involving treatment, 31% (95% CI: 23-41) of respondents changed their recommendation to observation post-GC.Respondents considered the GC result to have influenced their recommendation in 63% (95% CI: 56-68) of cases. The addition of information provided by the GC result increased decision making confidence in 39% (95% CI: 30-49) of cases where a change of treatment recommendation was made. Following unblinding, physicians reported that the GC result was clinically relevant in 84% (95% CI: 79-84) of cases. Conclusions: GC appears to influence treatment recommendations and decision making confidence for high-risk prostatectomy patients. This study suggests that clinical implementation of GC may potentially impact treatment recommendations.

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Saila Haapasalmi ◽  
Reetta P. Piili ◽  
Riina Metsänoja ◽  
Pirkko-Liisa I. Kellokumpu-Lehtinen ◽  
Juho T. Lehto

Abstract Background Physicians’ decision-making for seriously ill patients with advanced dementia is of high importance, especially as the prevalence of dementia is rising rapidly, and includes many challenging ethical, medical and juridical aspects. We assessed the change in this decision-making over 16 years (from 1999 to 2015) and several background factors influencing physicians’ decision. Methods A postal survey including a hypothetical patient-scenario representing a patient with an advanced dementia and a life-threatening gastrointestinal bleeding was sent to 1182 and 1258 Finnish physicians in 1999 and 2015, respectively. The target groups were general practitioners (GPs), surgeons, internists and oncologists. The respondents were asked to choose between several life-prolonging and palliative care approaches. The influence of physicians’ background factors and attitudes on their decision were assessed. Results The response rate was 56%. A palliative care approach was chosen by 57 and 50% of the physicians in 1999 and 2015, respectively (p = 0.01). This change was statistically significant among GPs (50 vs 40%, p = 0.018) and oncologists (77 vs 56%, p = 0.011). GPs chose a palliative care approach less often than other responders in both years (50 vs. 63% in 1999 and 40 vs. 56% in 2015, p < 0.001). In logistic regression analysis, responding in 2015 and being a GP remained explanatory factors for a lower tendency to choose palliative care. The impact of family’s benefit on the decision-making decreased, whereas the influence of the patient’s benefit and ethical values as well as the patient’s or physician’s legal protection increased from 1999 to 2015. Conclusions Physicians chose a palliative care approach for a patient with advanced dementia and life-threatening bleeding less often in 2015 than in 1999. Specialty, attitudes and other background factors influenced significantly physician decision-making. Education on the identification and palliative care of the patients with late-stage dementia are needed to make these decisions more consistent.


Author(s):  
N. Sandhya Rani ◽  
M. Sarada Devi

Empowerment of tribal women is one of the central issues in the process of development all over the world. Empowerment is the process that allows one to gain the knowledge and attitude needed to cope with the changing world and the circumstances in which one lives [1]. Women empowerment is a process in which women gain greater share of control over material, human and intellectual resources as well as control over decision-making in their home, community, society and nation. Given the need to analyze the empowerment status of tribal women, the present study aimed to enhance the empowerment status through enhancing decision-making skills of tribal working women in India. The specific objective is to study the impact of intervention on enhancing status of empowerment through decision-making skills of tribal working women in Utnoor Mandal Adilabad district. The total sample population for the study was 50 tribal working women, and data was analyzed using a paired t test. Results revealed that at pretest, majority of the women were at average level of decision-making skills (78%), 12% were at low level and only 10% were at high level. After the intervention, post test results revealed that 74% of the women were high in decision making skills and remaining 26% were at average level. Interestingly, none of the respondents had low level of life skills. Thus, intervention found to be effective among women respondents to develop and enhance their empowerment status through decision-making skills.


Circulation ◽  
2015 ◽  
Vol 131 (suppl_1) ◽  
Author(s):  
Michel Krempf ◽  
Ross J Simpson ◽  
Dena R Ramey ◽  
Philippe Brudi ◽  
Hilde Giezek ◽  
...  

Objectives: Little is known about how patient factors influence physicians’ treatment decision-making in hypercholesterolemia. We surveyed physicians’ treatment recommendations in high-risk patients with LDL-C not controlled on statin monotherapy. Methods: Physicians completed a questionnaire pre-randomization for each patient in a double-blind trial (NCT01154036) assessing LDL-C goal attainment rates with different treatment strategies. Patients had LDL-C ≥100 mg/dL after 5 weeks’ atorvastatin 10 mg/day and before randomization. Physicians were asked about treatment recommendations for three scenarios: (1) LDL-C near goal (100-105 mg/dL), (2) LDL-C far from goal (120 mg/dL), then (3) known baseline LDL-C of enrolled patients on atorvastatin 10 mg/day. Factors considered in their choice were specified. Physicians had been informed of projected LDL-C reductions for each treatment strategy in the trial. Regression analysis identified prognostic factors associated with each scenario, and projected LDL-C values for physicians’ treatment choices were compared to actual LDL-C values achieved in the trial. Results: Physicians at 296 sites completed questionnaires for 1535 patients. The most common treatment strategies for all three scenarios were: 1) not to change therapy, 2) double atorvastatin dose, 3) add ezetimibe, 4) double atorvastatin dose and add ezetimibe. Doubling atorvastatin dose was the most common treatment recommendation in all scenarios (43-52% of patients). ‘No change in therapy’ was recommended in 6.5% of patients when LDL-C was assumed far from goal. Treatment recommendations were more aggressive if actual LDL-C was known or considered far from goal. When compared with the ‘no change in therapy’ recommendation, CV risk factors and desire to achieve a more aggressive LDL-C goal were generally considered in decision-making for each treatment choice, regardless of LDL-C scenario. Patients randomized to a more aggressive regimen than recommended by physicians had larger reductions in LDL-C: the actual reduction in LDL-C in patients randomized to ‘add ezetimibe’ was -20.8% versus a projected reduction of -10.0% when physicians recommended ‘doubling atorvastatin dose’. Conclusions: This study provides insight into physicians’ perspectives on clinical management of hypercholesterolemia and highlights a gap in knowledge translation from guidelines to clinical practice. Targeting lower LDL-C and CV risk were key drivers in clinical decision-making but, generally, physicians were more conservative in their treatment choice than guidelines recommend, which may result in poorer LDL-C reduction. When compared with actual outcomes, projected LDL-C control was better if physicians used more comprehensive strategies rather than simply doubling the statin dose.


BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e033277
Author(s):  
Clarabelle T Pham ◽  
Catherine L Gibb ◽  
Robert A Fitridge ◽  
Jon Karnon ◽  
Elizabeth Hoon

ObjectivePatients with comorbidities can be referred to a physician-led high-risk clinic for medical optimisation prior to elective surgery at the discretion of the surgical consultant, but the factors that influence this referral are not well understood. The aims of this study were to understand the factors that influence a surgeon’s decision to refer a patient to the clinic, and how the clinic impacts on the management of complex patients.DesignQualitative study using theoretical thematic analysis to analyse transcribed semi-structured interviews.SettingInterviews were held in either the surgical consultant’s private office or a quiet office/room in the hospital ward.ParticipantsSeven surgical consultants who were eligible to refer patients to the clinic.ResultsWhen discussing the factors that influence a referral to the clinic, all participants initially described the optimisation of comorbidities and would then discuss with examples the challenges with managing complex patients and communicating the risks involved with having surgery. When discussing the role of the clinic, two related subthemes were dominant and focused on the management of risk in complex patients. The participants valued the involvement of the clinic in the decision-making and communication of risks to the patient.ConclusionsThe integration of the high-risk clinic in this study appears to offer additional value in supporting the decision-making process for the surgical team and patient beyond the clinical outcomes. The factors that influence a surgeon’s decision to refer a patient to the clinic appear to be driven by the aim to manage the uncertainty and risk to the patient regarding surgery and it was seen as a strategy for managing difficult and complex cases.


2020 ◽  
Vol 58 (6) ◽  
Author(s):  
Antonios Kritikos ◽  
Julien Poissy ◽  
Antony Croxatto ◽  
Pierre-Yves Bochud ◽  
Jean-Luc Pagani ◽  
...  

ABSTRACT The 1,3-beta-d-glucan (BDG) test is used for the diagnosis of invasive candidiasis (IC) in intensive care units (ICUs). However, its utility for patient management is unclear. This study assessed the impact of BDG test results on therapeutic decisions. This was a single-center observational study conducted in an ICU over two 6-month periods. All BDG test requests for the diagnosis of IC were analyzed. Before the second period, the ICU physicians received a pocket card instruction (algorithm) for targeted BDG testing in high-risk patients. The performance of the BDG test for IC diagnosis was assessed, as well as its impact on antifungal (AF) prescription. Overall, 72 patients had ≥1 BDG test, and 14 (19%) patients had an IC diagnosis. The BDG test results influenced therapeutic decisions in 41 (57%) cases. The impact of the BDG test was positive in 30 (73%) of them, as follows: AF abstention/interruption following a negative BDG result (n = 27), and AF initiation/continuation triggered by a positive BDG test result and subsequently confirmed IC (n = 3). In 10 (24%) cases, a positive BDG test result resulted in AF initiation/continuation with no further evidence of IC. A negative BDG result and AF abstention with subsequent IC diagnosis were observed in one case. The positive predictive value (PPV) of BDG was improved if testing was restricted to the algorithm’s indications (80% versus 36%, respectively). However, adherence to the algorithm was low (26%), and no benefit of the intervention was observed. The BDG result had an impact on therapeutic decisions in more than half of the cases, which consisted mainly of safe AF interruption/abstention. Targeted BDG testing in high-risk patients improves PPV but is difficult to achieve in ICU.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e11014-e11014
Author(s):  
Allan Andresson Lima Pereira ◽  
Fernando Costa Santini ◽  
Andrea Kazumi Shimada ◽  
Ellen Caroline Nascimento ◽  
Artur Katz ◽  
...  

e11014 Background: The Oncotype Dx recurrence score (RS) assay quantifies the risk of distant recurrence (rDR) and its use has increased despite the lack of prospective studies. Methods: This is a cross sectional retrospective study of consecutive patients (PTS) from our institution with histologically confirmed invasive breast cancer who underwent surgery with curative intent and in whom Oncotype was performed. The main objectives were to compare (1) the predicted rDR by RS and Adjuvant! (2) Risk allocation by RS and St Gallen Criteria, (3) chemotherapy indication according to RS results and NCCN guidelines and (4) to evaluate the impact of RS results on the recommendation of adjuvant chemotherapy (aCT). Results: Between October/2006-June/2011, 74 PTS were evaluated. Forty seven (63,5%) were EC IA and all had estrogen receptor positive; axillary lymph node involvement was seen in 19 PTS (13 micro and 6 macrometastasis). The rDR by RS was low in 50 PTS (67%), intermediate in 19 (26%) and high in 5 (7%). According to Saint Gallen, 7 (9%), 51 (69%) and 14 PTS (19%) were classified as low, intermediate and high risk, respectively. There was a statistical significant discordance between risk allocation according to RS and Saint Gallen (Kappa coefficient=-0.002; p=0.971). Among the 55 node-negative PTS, there was also a statistical significant discordance between the predicted average rDR, obtained from Oncotype, and Adjuvant! with median risk of 8,5% vs 15,7%, respectively (p = 0.00001 rank sum Mann Whitney test). The NCCN 2011 would have indicated aCT to 62 PTS. Among 55 classified as low and high risk by RS, the NCCN would have indicated aCT to 46 PTS. In other words, 89% (41) of PTS who would receive aCT by NCCN were classified as low risk by RS, with a statistically significant discordance (Kappa coefficient=0.035, p=0.328). Conclusions: Oncotype changed the medical management in 28 (55%) of 51 PTS in which the initial intention of the physician was known. Of these, 93% were spared aCT. We found no statistical significant concordance among the Saint Gallen, Adjuvant! or NCCN guidelines with Oncotype Dx. The rDR may be overestimated by clinicopathological-based classifications.


2021 ◽  
Vol 936 (1) ◽  
pp. 012043
Author(s):  
Meiga Nugrahani ◽  
Purnama Budi Santosa

Abstract According to information of areas at high risk of drought provided by Central Java disaster risk assessment in 2016 - 2020, Klaten Regency is in the top ten at high risk of drought in Central Java. Drought is an annual disaster in this region, which usually occurs during the dry season. The impact of the drought has caused some areas to experience a lack of clean water. For the purpose of disaster mitigation in anticipating and minimizing drought disasters losses, it is necessary to analyze the level of drought with a decision-making system by comparing two methods, namely the AHP with TOPSIS. Both methods are decision-making methods that are composed of various criteria to obtain an alternative sequence of choices. Both the AHP and TOPSIS methods produces weight values and a positive ideal solution value, respectively. These are used as input data in the mapping of drought vulnerability analysis with Geographical Information Systems (GIS). The results of the analysis are visualized with a map that shows the level of drought vulnerability. AHP and TOPSIS method decision making generates the order of the drought classes in predicting the distribution of areas experiencing drought. To validate the model, the authors compare the results of the analysis of drought vulnerability of the two methods with drought data from BPBD (Local Agency for Disaster Prevention) and DPUPR (Public Works and Public Housing Department). The results show that AHP provides better results than TOPSIS based on results validation with BPBD and DPUPR data. By comparing the two models with BPBD data, the results show that the percentage of AHP suitability is higher than TOPSIS at 47,619% and 19,048% respectively.


2021 ◽  
pp. 1003-1011
Author(s):  
André Mattar ◽  
Guilherme R. Fonseca ◽  
Murilo B. A. Romão ◽  
Jorge Y. Shida ◽  
Vilmar M. de Oliveira ◽  
...  

PURPOSE We evaluated the impact of 21-gene test results on treatment decisions for patients with early-stage breast cancer treated under the public health care system in Brazil, Sistema Único de Saúde. METHODS Eligible patients treated at Hospital Pérola Byington and Santa Casa de Misericórdia de São Paulo in Brazil were required to have the following characteristics: postsurgery with hormone receptor–positive, human epidermal growth factor 2–negative, node-negative and node-positive, and T1/T2 breast cancer and patients with these characteristics were candidates for adjuvant systemic therapy. Treatment recommendations, chemotherapy plus hormonal therapy (CT + HT) or HT alone, were captured before and after 21-gene test results. RESULTS From August 2018 to April 2019, 179 women were enrolled. The mean age was 58 years (29-86 years), 135 (76%) were postmenopausal, and 58 (32%) had node-positive breast cancer. Most patients (61%) had a tumor > 2 cm, including 7% with tumors > 4 cm. Using Recurrence Score (RS) result cut points on the basis of the TAILORx trial, 40 (22%) had RS 0-10, 91 (51%) had RS 11-25, and 48 (27%) had RS 26-100. Before 21-gene testing, 162 of 179 (91%) patients were recommended for CT. After testing, 117 of 179 patients (65%) had changes in CT recommendation: 112 (63%) who were initially recommended CT received HT alone and five (3%) who were initially recommended HT alone received CT + HT. After 21-gene testing, 99% of physicians reported strong confidence in their treatment recommendations. CONCLUSION The change in clinical practice at these public hospitals was greater than expected: 66% of initial treatment recommendations were changed to omit CT with 21-gene test results. Clinicopathologic features did not correlate well with 21-gene test results and did not adequately identify those most likely to benefit from CT.


2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 273-273 ◽  
Author(s):  
Howard I. Scher ◽  
Ryon P Graf ◽  
Nicole A. Schreiber ◽  
Eric Winquist ◽  
Brigit McLaughlin ◽  
...  

273 Background: A previous analysis of 161 patients (pts) tested for nuclear-localized AR-V7(+) CTCs showed a therapy interaction between AR-V7 positivity and improved overall survival (OS) on taxane chemotherapy vs. androgen receptor signaling inhibitors (ARSI). To validate the use of the biomarker result for physician decision making, we prospectively analyzed an independent, multicenter, blinded, cross-sectional cohort (n = 225) to confirm a therapy interaction with AR-V7. We corrected for possible pt selection bias by the treating physician by analyzing the association of therapy to OS in low and high risk groups defined by the test cohort. Methods: Two analyses were performed: (1) the validation of a therapy interaction between AR-V7 positivity and superior OS benefit for pts treated with taxanes in the context of use for 2nd+ line pts; and (2) as the choice between ARSI or taxanes was at the discretion of the attending physician, pt risk was incorporated into the predictive biomarker assessment. A pt-specific risk score was developed from line of therapy and other covariates to stratify pts as low and high risk, and the association of AR-V7 status and OS was performed within each risk group to correct for physician decision making and address possible confounding with treatment assignment. Results: (1) A therapy interaction between AR-V7(+) pts and lower risk of death on taxanes vs. ARSI (HR: 0.23, p = 0.003, 95% CI: 0.09 – 0.61) was validated. (2) In the validation cohort, high risk AR-V7(+) pts had an OS benefit when treated with taxanes (p = 0.02) and the AR-V7(-) pts had an improved OS with ARSI therapy (p = 0.02). AR-V7 incidence was low in the low risk pts, precluding the analysis for this sub-cohort. Conclusions: The results validate that the nuclear-localized AR-V7(+) biomarker has an interaction with therapy and improved survival on taxanes. Further, when adjusting for pt risk, the biomarker is predictive of OS in the high risk group. Nuclear-localized AR-V7 protein in CTCs can aid in the decision between ARSI and taxane chemotherapy in the 2nd or greater line of therapy for mCRPC.


Sign in / Sign up

Export Citation Format

Share Document