scholarly journals Developing a Scale for the Evaluation of People With Post-prandial Distress Syndrome

2021 ◽  
Vol 9 ◽  
Author(s):  
Mengli Xiao ◽  
Jiake Ying ◽  
Yingpan Zhao ◽  
Yang Zhao ◽  
Ying Liu ◽  
...  
Keyword(s):  
Distress Syndrome ◽  
Group Discussion ◽  
Reliability And Validity ◽  
Target Population ◽  
Patient Reported Outcome ◽  
Second Step ◽  
Clinical Trial Registration ◽  
Intervention Measures ◽  
Patient Reported ◽  
Significant Comparison

Background: Functional dyspepsia (FD) is one of the most critical health problems worldwide. Although there has been an increased intervention to improve FD symptoms, it is difficult to compare the effect of intervention measures with the existing methods of reporting the outcome, and it is a lack of clinical evaluation tools that can be used to evaluate patients' symptoms and treatment. One way of potentially addressing this way is to offer a patient-reported symptom scoring scales, which can be self-reported by patients to highlight interventions' authenticity and reliability. Nevertheless, there is still a lack of validated patient-reported outcome instruments for post-prandial distress syndrome (PDS). This study aims to establish a symptom scoring scale to evaluate the effectiveness of interventions for PDS.Methods: The study consists of two steps. The first step was to formulate the scale. Through a systematic literature review and group discussion, an item pool and scale framework were formed. Then, through the expert consultation and pre-investigation, the formal version of the scale was formed. The second step is to test the reliability and validity of the scale. The scale is tested in the target population to determine whether the reliability and validity of the scale.Discussion: The improvement in patients' self-reported symptoms had a significant impact on the researchers' evaluation of the intervention's authenticity. Therefore, we develop a symptom scoring scale for reporting studies evaluating the effectiveness of PDS interventions. The scale will be used for a more significant comparison to evaluate PDS interventions' effectiveness. The scale also improves trial reporting, reducing research waste by prioritizing the collection and reporting of critical results for all relevant stakeholders.Clinical Trial Registration: ChiCTR, ChiCTR2100044489. Registered on March 22, 2021.

Development of PRO-PMs assessing symptoms following completion of curative-intent chemotherapy.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 171-171
Author(s):  
Katherine Eresian Chenok ◽  
Feifei Ye ◽  
Kristen K. McNiff Landrum ◽  
Emma Hoo ◽  
Valerie Kong ◽  
...  
Keyword(s):  
Demographic Data ◽  
Reliability And Validity ◽  
Psychometric Testing ◽  
Target Population ◽  
Patient Reported Outcome ◽  
Quality Data ◽  
Patient Centered ◽  
Curative Intent ◽  
Lung Cancers ◽  
Patient Reported

171 Background: Few patient-reported outcome performance measures (PRO-PMs) have been validated for the cancer population. The testing that has occurred mostly focuses on advanced cancers despite the fact that the majority of people with cancer are diagnosed with earlier stage disease. We developed and tested PRO-PMs to assess quality of life, pain and fatigue in adult patients completing curative-intent chemotherapy for breast, colon and non-small cell lung cancers. Our goal is to develop measures that target symptoms that impact entry into the survivorship phase. Methods: We recruited 20 diverse test sites from the Michigan Oncology Quality Collaborative (MOQC) and the Alliance of Dedicated Cancer Centers (ADCC). Test sites enrolled patients, administered surveys, and collected clinical and demographic data. A Technical Expert Panel and the Patient and Caregiver Council selected PROMs and provided testing guidance. We assessed data collection feasibility and clinician/staff/patient burden throughout the testing process. Results: PROMIS instruments were selected due to psychometric testing in the target population, public availability and acceptability to patients and test sites. 1,753 patients were enrolled between 10/1/19 – 3/31/21. The COVID public health emergency disrupted testing and resulted in lower than expected enrolled patients/completed surveys; however, adaptations led to expansions in survey administration methods. Preliminary practice-level performance results from 10 sites show variation across sites for pain interference (mean = 50.5, SD = 2.8, with a range of 44.6—54.6) and fatigue (mean 49.2, SD = 2.8, with a range of 44.6--54.3). Some test sites reported PRO implementation to be burdensome; however, most patients evaluated did not find survey completion to be burdensome. Conclusions: Next steps include testing risk adjustment variables/model, creating adjusted performance scores, reliability and validity testing. Despite the consensus goal of PRO-PMs in oncology, barriers to implementation persist and important methodologic barriers exist (e.g., ability to achieve sufficient sample size in an oncology practice; defining the most appropriate numerator calculation that reports the desired quality concept and is appropriate for the PROM being used; analytic best practices for PRO-PM adjustment/testing). This project is contributing to the knowledge base as we seek to ensure that PRO-PMs provide meaningful, actionable, patient-centered quality data with benefits that outweigh the burden of implementation.

scholarly journals Development and Validation of a Patient-Reported Outcome Scale for Tension-Type Headache

2021 ◽  
Vol 12 ◽  
Author(s):  
Jinke Huang ◽  
Weichi Guo ◽  
Hui Li ◽  
Runsheng Xie ◽  
Min Shen ◽  
...  
Keyword(s):  
Group Discussion ◽  
Reliability And Validity ◽  
Patient Reported Outcome ◽  
Tension Type Headache ◽  
Test Theory ◽  
Clinical Test ◽  
Small Range ◽  
Patient Reported ◽  
Initial Scale ◽  
Type Headache

Objective: To validate a patient-reported outcome (PRO) measure for patients with tension-type headache (TTH).Methods: Literature analysis, interview, and group discussion were performed to develop an initial TTH-PRO. Thereafter, the initial scale was pre-evaluation in a small range of patients with TTH, and the expert panel made necessary adjustments based on the content feedback. The clinical test was carried out by using the adjusted initial scale. Based on the test results, the items were screened by the method of classical test theory to form the final scale, and the performance evaluation indicators such as validity, reliability, and responsiveness of the final scale were tested.Results: The final formed TTH-PRO scale contained three domains, six dimensions, and 30 items. The split-half reliability, Cronbach's α coefficients, and construct validity of the scale were acceptable, as was feasibility. The responsiveness in the physiological domain was fair, but the overall responsiveness still needed further clinical validation.Conclusions:The TTH-PRO scale has been developed with extensive patient input and demonstrates evidence for reliability and validity. It is complementary to existing evaluation indicators of TTH, emphasizing the patient's experience. Further studies are needed to optimize its items and to verify its clinical applicability for population in more regions and countries.

scholarly journals What Is Sufficient Evidence for the Reliability and Validity of Patient-Reported Outcome Measures?

2007 ◽  
Vol 10 ◽  
pp. S94-S105 ◽  
Author(s):  
Marlene H. Frost ◽  
Bryce B. Reeve ◽  
Astra M. Liepa ◽  
Joseph W. Stauffer ◽  
Ron D. Hays
Keyword(s):  
Outcome Measures ◽  
Reliability And Validity ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Sufficient Evidence ◽  
Patient Reported

scholarly journals The use of patient-reported outcome measures in primary care: applications, benefits and challenges

2021 ◽  
Vol 5 (S2) ◽  
Author(s):  
Krista Brower ◽  
Margo Schmitt-Boshnick ◽  
Michel Haener ◽  
Shea Wilks ◽  
Allison Soprovich
Keyword(s):  
Primary Care ◽  
Outcome Measurement ◽  
Local Population ◽  
Target Population ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Full Potential ◽  
System Quality ◽  
Allied Health Professionals ◽  
Patient Reported

AbstractPROMs use in primary care has expanded from simply describing patient populations to contributing to decision-making, in response to the increasingly complex, ever-changing healthcare environment. In Alberta, primary care is organized into primary care networks (PCNs), where family physicians are grouped geographically and supported by allied health professionals. PCNs implement programs and services in response to local population health needs with frequent evaluation, often incorporating PROMs for this purpose. As PCN programs and services vary greatly across Alberta, so do their use of PROMs. An area of commonality is the use of the EQ-5D-5L instrument; 29 out of 41 PCNs are registered and licensed to use the instrument. It is often administrated by paper, pre- and post-program, and in combination with other specific measures, depending on the program or target population. Some PCNs share programming and therefore outcome measurement, but often the selection, implementation (including training and administration procedures) and evaluation/reporting of PROMs are unique to the PCN. As well, data analysis is largely dependent on the size and capacity of the PCN. Using PROMs for PCN program evaluation supports clinical understanding and complements clinical outcomes. PROMs describe the population attending a program, as well as provide an element of consistency when examining trends across multiple programs or timepoints. This contributes to inquiries and decisions around program development, components, administrative features, resource allocation and delivery. Challenges of PROMs use in primary care include the absence of cohesive data capture technology. This limits data capabilities and presents difficulties with data fidelity, storage, export, and analysis. Additionally, this real-world application lacks a control arm and presents methodological challenges for comparative research purposes. Furthermore, capturing long term patient outcomes poses administrative challenges of multiple follow ups. More research is required into best reporting mechanisms to ensure the data is used to its full potential. To overcome these challenges, leadership and clinician engagement are key. As well, determining consistent PCN PROM reporting requirements will ensure data are comparable across PCNs and contribute to provincial level evaluations, further supporting the movement towards overall health system quality improvement.

A new symptom measure in gastrointestinal stomal tumors.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17508-e17508 ◽  
Author(s):  
Loretta A. Williams ◽  
Dejka M. Araujo ◽  
Tito R. Mendoza ◽  
Mary L Sailors ◽  
Nazim N Ali ◽  
...  
Keyword(s):  
Symptom Severity ◽  
Clinical Care ◽  
Reliability And Validity ◽  
Symptom Burden ◽  
Patient Reported Outcome ◽  
Response To Therapy ◽  
Major Barrier ◽  
Specific Symptom ◽  
Disease Information ◽  
Patient Reported

e17508 Background: Symptom burden is the combined impact of disease- and treatment-related symptoms on daily functioning. A major barrier to effective symptom management in gastrointestinal stromal tumors (GIST) is inadequate assessment. Our aim was to develop a short, valid, reliable patient-reported outcome measure of GIST symptoms for research and practice. Methods: After giving IRB-approved informed consent, 110 patients with GIST completed the 13 symptom severity and 6 interference items of the core MD Anderson Symptom Inventory (MDASI) plus 9 GIST-specific symptom items generated from patient and expert input. Items were measured on a 0-10 scale (0 = none, 10 = worst imaginable). 65 patients completed the same items 1 day later. Patients also answered a single overall quality-of-life (QOL) question. Demographic and disease information was collected on all patients. Psychometric procedures determined reliability and validity of the MDASI-GIST. Results: Mean subject age was 59.2 years (standard deviation [sd] = 11.9). 54% of the subjects were female, 85% were white, 47% were employed, 55% were on imatinib, and 30% had no evidence of disease. Mean overall QOL rating was 8.1 (best = 10, sd = 2.0). Symptoms reported as most severe were fatigue (mean [M] = 2.65, sd = 2.66), drowsiness (M = 2.36, sd = 2.55), disturbed sleep (M = 2.18, sd = 2.55), and muscle soreness/cramping (M = 2.18, sd = 2.67). Two items (abdominal swelling and malaise) were eliminated for redundancy. Internal consistency (Cronbach α) and test-retest reliability of the 20 symptom items were 0.94 and 0.93, respectively, and of the 6 interference items were 0.94 and 0.87, respectively. The mean severity of the 20 symptom items was significantly correlated with QOL rating (correlation = -0.7, P < 0.001). Mean GIST-specific symptom severity and symptom interference discriminated between patients who were employed and patients who were disabled (P = 0.05 and 0.03, respectively). Conclusions: We have validated an analytic tool, the MDASI-GIST, to quantify GIST symptom burden, assess side effects in treatment trials, and monitor symptoms in clinical care. Additional research on the longitudinal symptom burden of GIST, including differences based on type of therapy and response to therapy, is ongoing.

scholarly journals Questionnaires in otology: a systematic mapping review

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Koen Viergever ◽  
Jeroen T. Kraak ◽  
Els. M. Bruinewoud ◽  
Johannes C. F. Ket ◽  
Sophia E. Kramer ◽  
...  
Keyword(s):  
Hearing Loss ◽  
English Language ◽  
English Literature ◽  
Adult Population ◽  
Target Population ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Comprehensive Overview ◽  
Ear Diseases ◽  
Patient Reported

Abstract Background Patient-reported outcome measures (PROMs) are valuable tools in assessing the quality of health care from a patient perspective and are increasingly used by otologists. However, selecting the right questionnaire has proven to be a difficult and time-consuming task. To facilitate this process, we will provide a comprehensive overview of existing questionnaires. Methods A systematic literature search has been conducted on August 26, 2019, using the EMBASE and PubMed medical databases. 13,345 unique records were extracted. Questionnaires addressing any otologic complaint (tinnitus, hearing loss, earache, otorrhoea, and ear-related pressure sensation, vertigo, itch, or dysgeusia) were identified. All questionnaires were evaluated for eligibility by two independent researchers. Inclusion criteria were adult population, closed-ended questions, English language of the questionnaire, and the availability of the original article describing the development of the instrument or a validation paper describing the validation process written in English. Objective Create a comprehensive overview of all validated closed-ended otology questionnaires for adults and demonstrate their basic characteristics. Main outcome measure The number of questionnaires in English literature for the adult population, subdivided per symptom and target population. Results A total of 155 unique questionnaires were selected: 33 tinnitus questionnaires, 23 vertigo questionnaires, 84 hearing loss questionnaires, and 15 multiple complaint questionnaires. A protocol for further questionnaire comparison is presented. Discussion Two separate sequential searches were needed to identify unique questionnaires and to identify their development/validation paper. Although many ear diseases create multiple symptoms, the majority of the questionnaires were symptom specific. Conclusion Many questionnaires concerning ear-related symptoms exist and predominantly concern hearing loss, vertigo, or tinnitus. Only a few questionnaires cover the multiple complaints that ear diseases can create. The presented overview is the most comprehensive overview of otology questionnaires in literature to date. It will serve as a basis for questionnaire selection by professionals and could serve as a protocol for questionnaire selection in other fields. Systematic review registration PROSPERO CRD42017058155

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