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Results of a Qualitative Study to Develop a Patient Reported Outcome Measure for Patients with 4 Subtypes of Soft Tissue Sarcoma.

ABSTRACT: OBJECTIVE:The objective of this research was to develop a disease-specific symptom inventory for soft tissue sarcoma. METHODS:Literature review and clinical expert and patient interviews were conducted to determine disease-specific symptoms important to patients with one of the four STS subtypes. Clinical experts identified the most relevant STS symptom items from the item pool developed from literature review. Concept elicitation interviews were conducted with patients to elicit their STS symptom experiences followed by a completion of the draft symptom list via web survey. A cognitive interview was conducted on the comprehension and importance of the symptom items. RESULTS:Eighty-three symptom items were compiled and discussed with three clinical experts who identified 26 symptoms specific to the four STS subtypes. A total sample of 27 STS participants with self-reported leiomyosarcoma (74%), undifferentiated sarcoma (15%), synovial sarcoma (7%), or liposarcoma (4%) diagnosis completed the web survey and 10 were interviewed. The draft 12-item STS-specific symptom inventory includes abdominal pain, pressure in abdomen, early satiety, bloating, gastrointestinal pain, muscle pain, bone pain, heavy menstrual flow, shortness of breath, chest pain, cough, and painful menstruation. CONCLUSION:A number of symptoms are common across STS subtypes and may form a single STS symptom inventory.

SUBMITTER: Skalicky AM

PROVIDER: S-EPMC5446879 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Results of a Qualitative Study to Develop a Patient Reported Outcome Measure for Patients with 4 Subtypes of Soft Tissue Sarcoma.

Skalicky Anne M AM Ghate Sameer R SR Perez Jose Ricardo JR Rentz Anne M AM

Sarcoma 20170514

<h4>Objective</h4>The objective of this research was to develop a disease-specific symptom inventory for soft tissue sarcoma.<h4>Methods</h4>Literature review and clinical expert and patient interviews were conducted to determine disease-specific symptoms important to patients with one of the four STS subtypes. Clinical experts identified the most relevant STS symptom items from the item pool developed from literature review. Concept elicitation interviews were conducted with patients to elicit ...[more]

PMID: 28588396

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Project description:IntroductionPain and fatigue are commonly reported by patients with soft tissue sarcoma (STS) as distressing symptoms, yet no patient-reported outcome (PRO) measures have been validated or developed specifically for STS. This study aimed to develop novel PRO scales using existing item banks to measure pain and fatigue in STS.MethodsA three-stage mixed-methods approach was used. Stage 1: a literature review examined the development and validation of the European Organization for Research and Treatment of Cancer (EORTC) library, Patient-Reported Outcomes Measurement Information System (PROMIS) pain/fatigue item banks, Functional Assessment of Cancer Therapy-General, and FACIT-Fatigue. Conceptual models were developed for pain and fatigue. Stage 2: semi-structured interviews were conducted with clinical experts (n = 3) and STS patients (n = 28) to ensure conceptual coverage and cognitively debrief the selected PRO items. Stage 3: exploratory Rasch measurement theory (RMT) analyses were performed to examine the measurement properties of the proposed scales.ResultsStage 1: The conceptual model for fatigue was organized into two overarching domains: fatigability and fatigue, further split into two subdomains: symptoms and impact. The conceptual model for pain had one overarching domain split into two subdomains: descriptors and impact. Pain (n = 56) and fatigue (n = 40) items were selected from the EORTC item library. Stage 2: qualitative findings ensured conceptual coverage, provided insight into the relevance and comprehension of the items, and informed subsequent item reduction. Stage 3: The total item number was reduced to 43 (pain n = 18, fatigue n = 25). Exploratory RMT analyses supported the final scales' psychometric properties.ConclusionsThis mixed-methods research generated important information on the experience of pain and fatigue in specific subtypes of STS. Five novel PRO scales have been developed through careful item selection in consultation with experts and supported by qualitative and quantitative evidence. These scales may be of value to future clinical trials for STS.

Project description:BackgroundVarious fusion strategies (feature-level fusion, matrix-level fusion, and image-level fusion) were used to fuse PET and MR images, which might lead to different feature values and classification performance. The purpose of this study was to measure the classification capability of features extracted using various PET/MR fusion methods in a dataset of soft-tissue sarcoma (STS).MethodsThe retrospective dataset included 51 patients with histologically proven STS. All patients had pre-treatment PET and MR images. The image-level fusion was conducted using discrete wavelet transformation (DWT). During the DWT process, the MR weight was set as 0.1, 0.2, 0.3, 0.4, …, 0.9. And the corresponding PET weight was set as 1- (MR weight). The fused PET/MR images was generated using the inverse DWT. The matrix-level fusion was conducted by fusing the feature calculation matrix during the feature extracting process. The feature-level fusion was conducted by concatenating and averaging the features. We measured the predictive performance of features using univariate analysis and multivariable analysis. The univariate analysis included the Mann-Whitney U test and receiver operating characteristic (ROC) analysis. The multivariable analysis was used to develop the signatures by jointing the maximum relevance minimum redundancy method and multivariable logistic regression. The area under the ROC curve (AUC) value was calculated to evaluate the classification performance.ResultsBy using the univariate analysis, the features extracted using image-level fusion method showed the optimal classification performance. For the multivariable analysis, the signatures developed using the image-level fusion-based features showed the best performance. For the T1/PET image-level fusion, the signature developed using the MR weight of 0.1 showed the optimal performance (0.9524(95% confidence interval (CI), 0.8413-0.9999)). For the T2/PET image-level fusion, the signature developed using the MR weight of 0.3 showed the optimal performance (0.9048(95%CI, 0.7356-0.9999)).ConclusionsFor the fusion of PET/MR images in patients with STS, the signatures developed using the image-level fusion-based features showed the optimal classification performance than the signatures developed using the feature-level fusion and matrix-level fusion-based features, as well as the single modality features. The image-level fusion method was more recommended to fuse PET/MR images in future radiomics studies.

Project description:OBJECTIVES: Despite a documented clinical need, no patient reported outcome (PRO) symptom measure meeting current regulatory requirements for clinically relevant end points is available for the evaluation of treatment benefit in diarrhea-predominant IBS (IBS-D). METHODS: Patients (N=113) with IBS-D participated in five study phases: (1) eight concept elicitation focus groups (N=34), from which a 17-item IBS-D Daily Symptom Diary and four-item IBS-D Symptom Event Log (Diary and Event Log) were developed; (2) one-on-one cognitive interviews (N=11) to assess the instrument's comprehensiveness, understandability, appropriateness, and readability; (3) four data triangulation focus groups (N=32) to confirm the concepts elicited; (4) two hybrid (concept elicitation and cognitive interview) focus groups (N=16); and (5) two iterative sets of one-on-one cognitive interviews (N=20) to further clarify the symptoms of IBS-D and debrief a revised seven-item Diary and four-item Event Log. RESULTS: Of thirty-six concepts initially identified, 22 were excluded because they were not saturated, not clinically relevant, not critical symptoms of IBS-D, considered upper GI symptoms, or too broad or vaguely defined. The remaining concepts were diarrhea, immediate need (urgency), bloating/pressure, frequency of bowel movements, cramps, abdominal/stomach pain, gas, completely emptied bowels/incomplete evacuation, accidents, bubbling in intestines (bowel sounds), rectal burning, stool consistency, rectal spasm, and pain while wiping. The final instrument included a daily diary with separate items for abdominal and stomach pain and an event log with four items completed after each bowel movement as follows: (1) a record of the bowel movement/event and an assessment of (2) severity of immediacy of need/bowel urgency, (3) incomplete evacuation, and (4) stool consistency (evaluated using the newly developed Astellas Stool Form Scale). Based on rounds of interviews and clinical input, items considered secondary or nonspecific to IBS-D (rectal burning, bubbling in intestines, spasms, and pain while wiping) were excluded. CONCLUSIONS: The IBS-D Symptom Diary and Event Log represent a rigorously developed PRO instrument for the measurement of the IBS-D symptom experience from the perspective of the patient. Its content validity has been supported, and future work should evaluate the instrument's psychometric properties.

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Results of a Qualitative Study to Develop a Patient Reported Outcome Measure for Patients with 4 Subtypes of Soft Tissue Sarcoma.

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Results of a Qualitative Study to Develop a Patient Reported Outcome Measure for Patients with 4 Subtypes of Soft Tissue Sarcoma.

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