When study site contributes to outcomes in a multi-center randomized trial: a secondary analysis of decisional conflict in men with localized prostate cancer.
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ABSTRACT:
SUBMITTER: Underhill ML
PROVIDER: S-EPMC4213457 | biostudies-literature | 2014 Oct
REPOSITORIES: biostudies-literature
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When study site contributes to outcomes in a multi-center randomized trial: a secondary analysis of decisional conflict in men with localized prostate cancer.
Underhill Meghan L ML Hong Fangxin F Berry Donna L DL
Health and quality of life outcomes 20141025
<h4>Purpose</h4>Evaluate baseline factors that may explain the influence of study site on decisional conflict (DC) in men from the Personal Patient Profile: Prostate (P3P) randomized trial.<h4>Materials and methods</h4>476 cases from 5 P3P sites were included. Participants completed baseline demographic assessments, 4 subscales of the DC scale at baseline (uncertainty, informed, values clarity, and support), the Expanded Prostate Cancer Index Composite (short form) and the State-Trait Anxiety In ...[more]
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Project description:BACKGROUND:Decisional conflict is associated with decision quality and may affect decision outcomes. In the health sciences literature, the Decisional Conflict Scale is widely used to measure decisional conflict, yet limited research has described the psychometric properties of the Decisional Conflict Scale subscales and of the low literacy version of the scale. The purpose of this secondary data analysis was therefore to examine properties of the original (DCS-12) and low literacy (LL DCS-10) Decisional Conflict Scales using Classical Measurement Theory and Item Response Theory. METHODS:Data from two multi-site trials of men with prostate cancer were used to analyze the DCS-12, LL DCS-10, and an aggregated DCS-12 dataset in which five response options were aggregated into three. Internal consistency was estimated with Cronbach's alphas. Subscale correlations were evaluated with Pearson's correlation coefficient. Item difficulty, item discrimination, and test information were evaluated using Graded Response Modeling (GRM). The likelihood ratio test guided model selection. RESULTS:Cronbach's alphas for the total scales and three of four subscales were ≥ 0.85. Alphas ranged from 0.34-0.57 for the support subscales. Subscale correlations ranged from 0.42-0.71 (P < 0.001). Items on the DCS-12 exhibited the widest range of difficulty. Two items on the support subscale had low to moderate discrimination and contributed little information. Only the DCS-12 was informative across the full range of decisional conflict values. CONCLUSIONS:Lack of precision in the support subscale raises concerns about subscale validity. The DCS-12 is most capable of discriminating between respondents with high and low decisional conflict. Evaluation of interventions to reduce decisional conflict must consider the above findings.
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Project description:OBJECTIVE:The purpose of this trial was to compare usual patient education plus the Internet-based Personal Patient Profile-Prostate, vs. usual education alone, on conflict associated with decision making, plus explore time-to-treatment, and treatment choice. METHODS:A randomized, multi-center clinical trial was conducted with measures at baseline, 1-, and 6 months. Men with newly diagnosed localized prostate cancer (CaP) who sought consultation at urology, radiation oncology, or multi-disciplinary clinics in 4 geographically-distinct American cities were recruited. Intervention group participants used the Personal Patient Profile-Prostate, a decision support system comprised of customized text and video coaching regarding potential outcomes, influential factors, and communication with care providers. The primary outcome, patient-reported decisional conflict, was evaluated over time using generalized estimating equations to fit generalized linear models. Additional outcomes, time-to-treatment, treatment choice, and program acceptability/usefulness, were explored. RESULTS:A total of 494 eligible men were randomized (266 intervention; 228 control). The intervention reduced adjusted decisional conflict over time compared with the control group, for the uncertainty score (estimate -3.61; (confidence interval, -7.01, 0.22), and values clarity (estimate -3.57; confidence interval (-5.85,-1.30). Borderline effect was seen for the total decisional conflict score (estimate -1.75; confidence interval (-3.61,0.11). Time-to-treatment was comparable between groups, while undecided men in the intervention group chose brachytherapy more often than in the control group. Acceptability and usefulness were highly rated. CONCLUSION:The Personal Patient Profile-Prostate is the first intervention to significantly reduce decisional conflict in a multi-center trial of American men with newly diagnosed localized CaP. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of a CaP treatment that is consistent with the patient values and preferences.
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Project description:Current surgical and ablative treatment options for prostate cancer (PCa) may result in a high incidence of (temporary) incontinence, erectile dysfunction and/or bowel damage. These side effects are due to procedure related effects on adjacent structures including blood vessels, bowel, urethra and/or neurovascular bundle. Ablation with irreversible electroporation (IRE) has shown to be effective and safe in destroying PCa cells and also has the potential advantage of sparing surrounding tissue and vital structures, resulting in less impaired functional outcomes and maintaining men's quality of life.In this randomized controlled trial (RCT) on IRE in localized PCa, 200 patients with organ-confined, unilateral (T1c-T2b) low- to intermediate-risk PCa (Gleason sum score 6 and 7) on transperineal template-mapping biopsies (TTMB) will be included. Patients will be randomized into focal or extended ablation of cancer foci with IRE. Oncological efficacy will be determined by multiparametric Magnetic Resonance Imaging, Contrast-Enhanced Ultrasound imaging if available, TTMP and Prostate Specific Antigen (PSA) follow-up. Patients will be evaluated up to 5 years on functional outcomes and quality of life with the use of standardized questionnaires.There is critical need of larger, standardized RCTs evaluating long-term oncological and functional outcomes before introducing IRE and other focal therapy modalities as an accepted and safe therapeutic option for PCa. This RCT will provide important short- and long-term data and elucidates the differences between focal or extended ablation of localized, unilateral low- to intermediate-risk PCa with IRE.Clinicaltrials.gov database registration number NCT01835977. The Dutch Central Committee on Research Involving Human Subjects registration number NL50791.018.14.
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Project description:OBJECTIVES:The study's goals were to characterize decisional conflict and preparedness for making the decision about having CPM among breast cancer patients considering CPM who do not carry cancer-predisposing mutation and to evaluate correlates of decisional conflict and preparedness. METHODS:93 women considering CPM completed a survey of decisional conflict and preparedness for the CPM decision, knowledge, perceived risk, self-efficacy, reasons for CPM, input from others and discussion with the doctor about CPM, and cancer worry. RESULTS:Between 8% and 27% of women endorsed elevated decisional conflict. Most women were satisfied with preparatory information that they were provided. Knowledge was low. Top reasons for choosing CPM were the desire for peace of mind, lowering the chance of another breast cancer, and improving survival. CONCLUSIONS:Decisional conflict is elevated in a subset of patients considering CPM. A more well-informed decision may be fostered by a comprehensive discussion about CPM with the patient's clinician, fostering self-efficacy in managing cancer worry, and helping patients understand their motivations for CPM. PRACTICE IMPLICATIONS:Clinicians working with breast cancer patients considering CPM should discuss the CPM decision, foster self-efficacy in managing cancer worry, and help patients understand their motivations for the surgery.
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Project description:Introduction:Initiating disease-modifying treatments (DMTs) in multiple sclerosis (MS) is a major decision for people with (pw)MS but little is known about how the decision is perceived by the individual. Objectives:The aim of the study was to determine if decisional conflict (DC) and decisional regret reflect different stages of the decision-making process when initiating DMTs. Methods:This was a cross-sectional study of three cohorts of pwMS (n = 254), a 'MS conference attendees', 'on treatment' and an 'offered treatment' cohort. Questionnaires assessing DC, decisional regret and control preference were performed. Results:Forty-four per cent (113/254) of pwMS were dissatisfied with their treatment status and 53% (135/254) had DC. DC (p = 0.013) and decisional regret (p = 0.027) increase in treatment-naïve pwMS and also in those 'offered treatment' dissatisfied with their treatment status (p < 0.0001), whilst those 'on treatment' have low Decisional Regret Scale (DRS) score (p = 0.0005). DC and DRS were only correlated with treatment status in those on treatment and not in treatment-naïve patients. F (58/135) pwMS satisfied with treatment had DC. DC (n = 236, adjusted R 2 0.137, p = 0.000) and DRS (n = 235, adjusted R 2 0.232, p = 0.000) were increased by dissatisfaction with treatment, lower potency treatment, being from the 'MS conference attendees' cohort and reliance on the doctor's decision, with DC additionally associated with being employed. Conclusions:DC and decisional regret vary in populations at different stages of initiating DMTs and are impacted by non-treatment issues.
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Project description:Cataract is the leading cause of non-refractive preventable blindness, and comprehensive strategies to increase cataract surgery rates are imperative, including high-quality supportive patient education. We evaluated the effectiveness of non-physician pre-surgical counselors teaching patients about cataract and cataract surgery in improving patient knowledge, decisional conflict, and satisfaction.A survey was given before and after 61 newly-diagnosed cataract patients underwent pre-surgical counseling at the Aravind Eye Hospital, Madurai, India. The survey measured change in cataract knowledge and decisional conflict, a measure of anxiety surrounding the decision to undergo surgery, along with patient satisfaction. Multiple regression was used to identify factors that influenced change in knowledge.Both patient knowledge scores and decisional conflict scores improved following counseling (mean difference +2.0, p?=?0.004 and +8.4, p?<?0.0001, respectively). Multiple regression analysis identified female sex (??=?2.5, p?<?0.001) and being illiterate (??=?1.7, p?=?0.04) as important predictors of increased knowledge post-counseling.Counseling both improved knowledge and reduced decisional conflict about cataract surgery, particularly among patients who had traditionally had more limited access to healthcare such as women and illiterate patients. Increased use of high quality counseling might help to further reduce the global burden of cataract and other forms of blindness.
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