scholarly journals Patient-Reported Outcomes and Factors Associated with Achieving the Minimal Clinically Important Difference After ACL Reconstruction

2021 ◽  
Vol 6 (4) ◽  
Author(s):  
Benedict U. Nwachukwu ◽  
Spencer W. Sullivan ◽  
Ryan C. Rauck ◽  
Evan W. James ◽  
Joost A. Burger ◽  
...  
Keyword(s):  
Acl Reconstruction ◽  
Patient Reported Outcomes ◽  
Minimal Clinically Important Difference ◽  
Factors Associated ◽  
Clinically Important Difference ◽  
Patient Reported

Does Obesity Correlate With Worse Patient-Reported Outcomes Following Elective Anterior Cervical Discectomy and Fusion?

Neurosurgery ◽  
2016 ◽  
Vol 79 (1) ◽  
pp. 69-74 ◽  
Author(s):  
John A. Sielatycki ◽  
Chotai Silky ◽  
Kay Harrison ◽  
David Stonko ◽  
Matthew McGirt ◽  
...  
Keyword(s):  
Scale Score ◽  
Patient Reported Outcomes ◽  
Minimal Clinically Important Difference ◽  
Japanese Orthopaedic Association ◽  
Neck Disability Index ◽  
Japanese Orthopaedic Association Score ◽  
Association Score ◽  
Clinically Important Difference ◽  
Patient Reported ◽  
Neck Disability

Abstract BACKGROUND Studies have investigated the impact of obesity in thoracolumbar surgery; however, the effect of obesity on patient-reported outcomes (PROs) following anterior cervical discectomy and fusion (ACDF) is unknown. OBJECTIVE To examine the relationship between obesity and PROs following elective ACDF. METHODS Consecutive patients undergoing ACDF for degenerative conditions were evaluated. Patients were divided into groups with a body mass index ≥35. The EuroQol-5D, Short-Form 12 (SF-12), modified Japanese Orthopaedic Association score, and Neck Disability Index were used. Correlations between PROs and obesity were calculated at baseline and 1 year. RESULTS A total of 299 patients were included, with 80 obese (27%) and 219 nonobese (73%). patients At baseline, obesity was associated with worse myelopathy (modified Japanese Orthopaedic Association score: 10.7 vs 12.2, P = .01), general physical health (SF-12 physical component scale score: 28.7 vs 31.8, P = .02), and general mental health (SF-12 mental component scale score: 38.9 vs 42.3, P = .04). All PROs improved significantly following surgery in both groups. There was no difference in absolute scores and change scores for any PRO at 12 months following surgery. Furthermore, there was no difference in the percentage of patients achieving a minimal clinically important difference for the Neck Disability Index (52% vs 56%, P = .51) and no difference in patient satisfaction (85% vs 85%, P = .85) between groups. CONCLUSION Obesity was not associated with less improvement in PROs following ACDF. There was no difference in the proportion of patients satisfied with surgery and those achieving a minimal clinically important difference across all PROs. Obese patients may therefore achieve meaningful improvement following elective ACDF.

scholarly journals GC-PROM: Validation of a patient-reported outcomes measure for patients with gastric cancer

2019 ◽  
Author(s):  
Xiaojuan Hu ◽  
Fen Zhao ◽  
Hongmei Yu ◽  
Yanhong Luo ◽  
Jinchun Liu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Patient Reported Outcomes ◽  
Minimal Clinically Important Difference ◽  
Test Theory ◽  
Shanxi Province ◽  
Draft Guidance ◽  
Evaluation Instrument ◽  
Clinically Important Difference ◽  
Filling Time ◽  
Patient Reported

Abstract Background: There is increasing recognition that PROs are important in the estimation of the burden of long-term survival among patients with gastric cancer. The study aimed to develop a disease-specific instrument to assess patient-reported outcomes for patients with gastric cancer. Method: Following the FDA's draft guidance for patient-reported outcome, conceptual framework and item pool were defined based on relevant existing work. A draft scale was formed after revising some items based on feedback from experts and patients with gastric cancer. The pre-survey and formal survey were conducted in eight different hospitals in Shanxi Province, and two item-selection process based on classical test theory and item response theory. Finally, the patient-reported outcomes measure for patients with gastric cancer (GC-PROM) was validated in terms of reliability, validity, and feasibility. The minimal clinically important difference was determined by distribution-based method. Results: The final GC-PROM consisted of 38 items, 13 subdomains, and 4 domains. Reliability was verified by Cronbach’s alpha coefficient for four domains and 13 subdomains respectively. The validity results showed that the multidimensional scale fulfilled expectations. In the formal survey, the completion rate was 96.16%, and the average filling time was less than half an hour. The values of the minimal clinically important difference were 4.14, 3.41, 3.37, and 3.28 in the four domains. Conclusions: The GC-PROM had good reliability, validity, and feasibility and thus can be considered an effective clinical evaluation instrument for patients with gastric cancer.

scholarly journals Practical issues encountered while determining Minimal Clinically Important Difference in Patient-Reported Outcomes

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Pascal Woaye-Hune ◽  
Jean-Benoit Hardouin ◽  
Paul-Antoine Lehur ◽  
Guillaume Meurette ◽  
Antoine Vanier
Keyword(s):  
Patient Reported Outcomes ◽  
Minimal Clinically Important Difference ◽  
Clinically Important Difference ◽  
Patient Reported

scholarly journals GC-PROM: Validation of a patient-reported outcomes measure for Chinese patients with gastric cancer

2019 ◽  
Author(s):  
Xiaojuan Hu ◽  
Fen Zhao ◽  
Hongmei Yu ◽  
Yanhong Luo ◽  
Jinchun Liu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Patient Reported Outcomes ◽  
Minimal Clinically Important Difference ◽  
Test Theory ◽  
Chinese Patients ◽  
Shanxi Province ◽  
Draft Guidance ◽  
Clinically Important Difference ◽  
Filling Time ◽  
Patient Reported

Abstract Background: There is increasing recognition that PROs are important in the estimation of the burden of long-term survival among patients with gastric cancer. The study aimed to develop a disease-specific instrument to assess patient-reported outcomes for Chinese patients with gastric cancer. Method: Following the FDA’s draft guidance for patient-reported outcome, conceptual framework and item pool were defined based on relevant existing work. A draft scale was formed after revising some items based on feedback from experts and Chinese patients with gastric cancer. The pre-survey and formal survey were conducted in eight different hospitals in Shanxi Province, and two item-selection process based on classical test theory and item response theory. Finally, the patient-reported outcomes measure for Chinese patients with gastric cancer (GC-PROM) was validated in terms of reliability, validity, and feasibility. The minimal clinically important difference was determined by distribution-based method. Results: The final GC-PROM consisted of 38 items, 13 subdomains, and 4 domains. Reliability was verified by Cronbach’s alpha coefficient for four domains and 13 subdomains respectively. The validity results showed that the multidimensional scale fulfilled expectations. In the formal survey, the completion rate was 96.16%, and the average filling time was less than half an hour. The values of the minimal clinically important difference were 4.14, 3.41, 3.37, and 3.28 in the four domains. Conclusions: The GC-PROM had good reliability, validity, and feasibility and thus can be considered an effective clinical evaluation instrument for Chinese patients with gastric cancer.

A High-Sensitivity International Knee Documentation Committee Survey Index From the PROMIS System: The Next-Generation Patient-Reported Outcome for a Knee Injury Population

2021 ◽  
pp. 036354652110415
Author(s):  
Matthew S. Tenan ◽  
Richard J. Robins ◽  
Andrew J. Sheean ◽  
Travis J. Dekker ◽  
James R. Bailey ◽  
...  
Keyword(s):  
Physical Function ◽  
Predictive Models ◽  
Patient Reported Outcomes ◽  
Minimal Clinically Important Difference ◽  
Prediction Models ◽  
International Knee Documentation Committee ◽  
Index Score ◽  
Pain Interference ◽  
Clinically Important Difference ◽  
Patient Reported

Background: Patient-reported outcomes (PROs) measure progression and quality of care. While legacy PROs such as the International Knee Documentation Committee (IKDC) survey are well-validated, a lengthy PRO creates a time burden on patients, decreasing adherence. In recent years, PROs such as the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function and Pain Interference surveys were developed as computer adaptive tests, reducing time to completion. Previous studies have examined correlation between legacy PROs and PROMIS; however, no studies have developed effective prediction models utilizing PROMIS to create an IKDC index. While the IKDC is the standard knee PRO, computer adaptive PROs offer numerous practical advantages. Purpose: To develop a nonlinear predictive model utilizing PROMIS Physical Function and Pain Interference to estimate IKDC survey scores and examine algorithm sensitivity and validity. Study Design: Cohort study (diagnosis); Level of evidence, 3. Methods: The MOTION (Military Orthopaedics Tracking Injuries and Outcomes Network) database is a prospectively collected repository of PROs and intraoperative variables. Patients undergoing knee surgery completed the IKDC and PROMIS surveys at varying time points. Nonlinear multivariable predictive models using Gaussian and beta distributions were created to establish an IKDC index score, which was then validated using leave-one-out techniques and minimal clinically important difference analysis. Results: A total of 1011 patients completed the IKDC and PROMIS Physical Function and Pain Interference, providing 1618 complete observations. The algorithms for the Gaussian and beta distribution were validated to predict the IKDC (Pearson = 0.84-0.86; R2 = 0.71-0.74; root mean square error = 9.3-10.0). Conclusion: The publicly available predictive models can approximate the IKDC score. The results can be used to compare PROMIS Physical Function and Pain Interference against historical IKDC scores by creating an IKDC index score. Serial use of the IKDC index allows for a lower minimal clinically important difference than the conventional IKDC. PROMIS can be substituted to reduce patient burden, increase completion rates, and produce orthopaedic-specific survey analogs.

scholarly journals GC-PROM: Validation of a patient-reported outcomes measure for Chinese patients with gastric cancer

2019 ◽  
Author(s):  
Xiaojuan Hu ◽  
Fen Zhao ◽  
Hongmei Yu ◽  
Yanhong Luo ◽  
Jinchun Liu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Patient Reported Outcomes ◽  
Minimal Clinically Important Difference ◽  
Test Theory ◽  
Chinese Patients ◽  
Shanxi Province ◽  
Draft Guidance ◽  
Clinically Important Difference ◽  
Filling Time ◽  
Patient Reported

Abstract Background: There is increasing recognition that PROs are important in the estimation of the burden of long-term survival among patients with gastric cancer. The study aimed to develop a disease-specific instrument to assess patient-reported outcomes for Chinese patients with gastric cancer. Method: Following the FDA's draft guidance for patient-reported outcome, conceptual framework and item pool were defined based on relevant existing work. A draft scale was formed after revising some items based on feedback from experts and Chinese patients with gastric cancer. The pre-survey and formal survey were conducted in eight different hospitals in Shanxi Province, and two item-selection process based on classical test theory and item response theory. Finally, the patient-reported outcomes measure for Chinese patients with gastric cancer (GC-PROM) was validated in terms of reliability, validity, and feasibility. The minimal clinically important difference was determined by distribution-based method. Results: The final GC-PROM consisted of 38 items, 13 subdomains, and 4 domains. Reliability was verified by Cronbach’s alpha coefficient for four domains and 13 subdomains respectively. The validity results showed that the multidimensional scale fulfilled expectations. In the formal survey, the completion rate was 96.16%, and the average filling time was less than half an hour. The values of the minimal clinically important difference were 4.14, 3.41, 3.37, and 3.28 in the four domains. Conclusions: The GC-PROM had good reliability, validity, and feasibility and thus can be considered an effective clinical evaluation instrument for Chinese patients with gastric cancer.

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