Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach

AbstractBackgroundThere are no universally monitored outcomes relevant to men with advanced prostate cancer, making it challenging to compare health outcomes between populations.ObjectiveWe sought to develop a standard set of outcomes relevant to men with advanced prostate cancer to follow during routine clinical care.Design, setting, and participantsThe International Consortium for Health Outcomes Measurement assembled a multidisciplinary working group to develop the set.Outcome measurements and statistical analysisWe used a modified Delphi method to achieve consensus regarding the outcomes, measures, and case mix factors included.Results and limitationsThe 25 members of the multidisciplinary international working group represented academic and nonacademic centers, registries, and patients. Recognizing the heterogeneity of men with advanced prostate cancer, the group defined the scope as men with all stages of incurable prostate cancer (metastatic and biochemical recurrence ineligible for further curative therapy). We defined outcomes important to all men, such as overall survival, and measures specific to subgroups, such as time to metastasis. Measures gathered from clinical data include measures of disease control. We also identified patient-reported outcome measures (PROMs), such as degree of urinary, bowel, and erectile dysfunction, mood symptoms, and pain control.ConclusionsThe international multidisciplinary group identified clinical data and PROMs that serve as a basis for international health outcome comparisons and quality-of-care assessments. The set will be revised annually.Patient summaryOur international group has recommended a standardized set of patient-centered outcomes to be followed during routine care for all men with advanced prostate cancer

A qualitative analysis of algorithm-based decision support usability testing for symptom management across the trajectory of cancer care: one size does not fit all

Abstract Background Adults with cancer experience symptoms that change across the disease trajectory. Due to the distress and cost associated with uncontrolled symptoms, improving symptom management is an important component of quality cancer care. Clinical decision support (CDS) is a promising strategy to integrate clinical practice guideline (CPG)-based symptom management recommendations at the point of care. Methods The objectives of this project were to develop and evaluate the usability of two symptom management algorithms (constipation and fatigue) across the trajectory of cancer care in patients with active disease treated in comprehensive or community cancer care settings to surveillance of cancer survivors in primary care practices. A modified ADAPTE process was used to develop algorithms based on national CPGs. Usability testing involved semi-structured interviews with clinicians from varied care settings, including comprehensive and community cancer centers, and primary care. The transcripts were analyzed with MAXQDA using Braun and Clarke’s thematic analysis method. A cross tabs analysis was also performed to assess the prevalence of themes and subthemes by cancer care setting. Results A total of 17 clinicians (physicians, nurse practitioners, and physician assistants) were interviewed for usability testing. Three main themes emerged: (1) Algorithms as useful, (2) Symptom management differences, and (3) Different target end-users. The cross-tabs analysis demonstrated differences among care trajectories and settings that originated in the Symptom management differences theme. The sub-themes of “Differences between diseases” and “Differences between care trajectories” originated from participants working in a comprehensive cancer center, which tends to be disease-specific locations for patients on active treatment. Meanwhile, participants from primary care identified the sub-theme of “Differences in settings,” indicating that symptom management strategies are care setting specific. Conclusions While CDS can help promote evidence-based symptom management, systems providing care recommendations need to be specifically developed to fit patient characteristics and clinical context. Findings suggest that one set of algorithms will not be applicable throughout the entire cancer trajectory. Unique CDS for symptom management will be needed for patients who are cancer survivors being followed in primary care settings

Algorithm-based decision support for symptom self-management among adults with Cancer: results of usability testing

Abstract Background It is essential that cancer patients understand anticipated symptoms, how to self-manage these symptoms, and when to call their clinicians. However, patients are often ill-prepared to manage symptoms at home. Clinical decision support (CDS) is a potentially innovative way to provide information to patients where and when they need it. The purpose of this project was to design and evaluate a simulated model of an algorithm-based CDS program for self-management of cancer symptoms. Methods This study consisted of three phases; development of computable algorithms for self-management of cancer symptoms using a modified ADAPTE process, evaluation of a simulated model of the CDS program, and identification of design objectives and lessons learned from the evaluation of patient-centered CDS. In phase 1, algorithms for pain, constipation and nausea/vomiting were developed by an expert panel. In phase 2, we conducted usability testing of a simulated symptom assessment and management intervention for self-care (SAMI-Self-Care) CDS program involving focus groups, interviews and surveys with cancer patients, their caregivers and clinicians. The Acceptability E-scale measured acceptability of the program. In phase 3, we developed design objectives and identified barriers to uptake of patient-centered CDS based on the data gathered from stakeholders. Results In phase 1, algorithms were reviewed and approved through a consensus meeting and majority vote. In phase 2, 24 patients & caregivers and 13 clinicians participated in the formative evaluation. Iterative changes were made in a simulated SAMI-Self-Care CDS program. Acceptability scores were high among patients, caregivers and clinicians. In phase 3, we formulated CDS design objectives, which included: 1) ensure patient safety, 2) communicate clinical concepts effectively, 3) promote communication with clinicians, 4) support patient activation, and 5) facilitate navigation and use. We identified patient barriers and clinician concerns to using CDS for symptom self-management, which were consistent with the chronic care model, a theoretical framework used to enhance patient-clinician communication and patient self-management. Conclusion Patient safety and tool navigation were critical features of CDS for patient self-management. Insights gleaned from this study may be used to inform the development of CDS resources for symptom self-management in patients with other chronic conditions

Additional file 1 of A qualitative analysis of algorithm-based decision support usability testing for symptom management across the trajectory of cancer care: one size does not fit all

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