scholarly journals Investigating the patient acceptable symptom state cut-offs: longitudinal data from a community cohort using the shoulder pain and disability index

2019 ◽  
Vol 40 (4) ◽  
pp. 599-605 ◽  
Author(s):  
Gui Tran ◽  
Bright Dube ◽  
Sarah R. Kingsbury ◽  
Alan Tennant ◽  
Philip G. Conaghan ◽  
...  
Keyword(s):  
Shoulder Pain ◽  
Operating Characteristic ◽  
Characteristic Curve ◽  
Patient Reported Outcome ◽  
Percentile Method ◽  
Cumulative Response ◽  
Severity Scores ◽  
Patient Reported ◽  
Patient Acceptable Symptom State ◽  
First Time

AbstractThis prospective study aimed to determine the patient acceptable symptom state (PASS) cut-off for the patient reported outcome measure shoulder pain and disability index (SPADI), and evaluate predictors of PASS achievement following standard shoulder care. Patients with shoulder pain, referred for shoulder ultrasound were recruited from a community cohort. Patients completed both SPADI (scored 0–130) and a question on symptom state and followed-up at 6 months. PASS was calculated from Rasch-transformed scores using 2 methods: the 75th percentile of the cumulative response curve and the receiver operating characteristic curve (ROC). Logistic regression was used to identify factors associated with PASS. 304 participants (169 females, mean age 57.2 years) were included. At 6 months, 193 (63%) reported PASS. The association between SPADI at 6 months and PASS depended on baseline SPADI (interaction p = 0.036). Those with higher baseline scores had higher 6 months PASS cut-offs. Using the 75th percentile method, the 6 months total SPADI cut-off was 49.2 in those starting in the highest tertile at baseline compared to 39.4 in the lowest tertile: 46.4 vs. 36.7 for pain, 46.8 vs. 25.1 for disability. The ROC method yielded similar results. We have shown for the first time that the PASS cut-off for SPADI is dependent on baseline severity scores. Understanding the SPADI PASS threshold is important for clinical research to allow standardised reporting of shoulder intervention success at the patient level.

scholarly journals Development and validation of a set of patient reported outcome measures to assess effectiveness of asthma prophylaxis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yalini Guruparan ◽  
Thiyahiny S. Navaratinaraja ◽  
Gowry Selvaratnam ◽  
Nalika Gunawardena ◽  
Shalini Sri Ranganathan
Keyword(s):  
Asthma Control ◽  
Operating Characteristic ◽  
Characteristic Curve ◽  
Patient Reported Outcome ◽  
Forced Expiratory Volume ◽  
Alpha Coefficient ◽  
Focus Group Discussions ◽  
Group Discussions ◽  
Resource Limited ◽  
Patient Reported

Abstract Background In the local setting, asthma control is assessed by symptoms and signs elicited by clinicians because of the limited availability of spirometry. Hence, we intended to develop a patient reported outcome measure (PROM) with more holistic interpretation that could also serve as a tool to measure the asthma control in resource limited settings. Therefore, this study was carried out in Northern Sri Lanka to develop and validate the Asthma Control PROM (AC-PROM) Tamil to measure the effectiveness of asthma prophylaxis based on symptoms, exacerbation and limitation of activity which could also serve as an easy measure of asthma control to the provider. Methods The AC-PROM Tamil was developed in 3 steps: item generation, item reduction and psychometric evaluation. Items were generated through thematic analysis from focus group discussions among patients with asthma. Items were converted to an interviewer administered questionnaire in Tamil in the format of 5-point Likert scale. Item reduction was done by two rounds of online Delphi surveys among 10 experts and an exploratory factor analysis among 200 patients with asthma. The face and content validity were assessed by a panel of experts during Delphi survey and patients during the pre-test of the tool. Criterion validity of the tool was assessed against the forced expiratory volume in one second of 187 patients with asthma. The cut-off value to assess the asthma control was determined by receiver operating characteristic curve. Reliability was verified by Cronbach’s alpha coefficient. Results From thematic analysis of focus group discussions 10 items were generated. One item was removed during Delphi survey. Exploratory factor analysis indicated removal of another item with 8 items categorised into two factors. Cronbach’s alpha coefficient of factors 1 and 2 were 0.821 and 0.903 respectively, indicating good reliability. Observations made by experts and responses made by patients were incorporated to improve the clarity and relevance of the items. Criterion validity was demonstrated by significant correlation between the AC-PROM Tamil and forced expiratory volume in one second (r = 0.66, p = 0.001). The cut-off value of the AC-PROM Tamil to detect asthma control was 28.5 with 79% (95% CI 71.3–86.9) sensitivity and 71% (95% CI 61.9–79.6) specificity. The AC-PROM Tamil showed moderate accuracy (the area under the receiver operating characteristic curve = 0.796; 95% CI 0.73–0.86). Response rate of the AC-PROM Tamil was 100% and time taken to complete was 3–4 min. Conclusion The AC-PROM Tamil is a simple, feasible and reasonably accurate tool to assesses the effectiveness of asthma prophylaxis, particularly in resource limited settings.

scholarly journals Update on Outcome Measure Development in Large-vessel Vasculitis: Report from OMERACT 2018

2019 ◽  
Vol 46 (9) ◽  
pp. 1198-1201 ◽  
Author(s):  
Sibel Z. Aydin ◽  
Joanna C. Robson ◽  
Antoine G. Sreih ◽  
Catherine Hill ◽  
Fatma Alibaz-Oner ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Patient Reported Outcome ◽  
Large Vessel Vasculitis ◽  
Large Vessel ◽  
Disease States ◽  
Core Set ◽  
Patient Reported ◽  
Delphi Exercise ◽  
Patient Acceptable Symptom State ◽  
Selection Of

Objective.The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group seeks to develop validated outcome measures for use in trials for large-vessel vasculitis (LVV).Methods.An international Delphi exercise conducted among investigators identified items considered important to measure active disease. In parallel, qualitative research with patients was conducted, including interviews and focus groups.Results.Next steps prioritized by the group for LVV include (1) defining disease states (remission, flare, and patient-acceptable symptom state) and (2) selection of patient-reported outcome tools.Conclusion.The ultimate goal is to develop an OMERACT-endorsed core set of outcome measures for use in clinical trials of LVV.

scholarly journals Minimal important difference and patient acceptable symptom state for PFDI-20 and POPDI-6 in POP surgery

2020 ◽  
Author(s):  
Päivi K. Karjalainen ◽  
Nina K. Mattsson ◽  
Jyrki T. Jalkanen ◽  
Kari Nieminen ◽  
Anna-Maija Tolppanen
Keyword(s):  
Pelvic Organ Prolapse ◽  
Roc Curve ◽  
Minimal Important Difference ◽  
Patient Reported Outcome Measures ◽  
Pelvic Organ ◽  
Population Based ◽  
Patient Reported Outcome ◽  
Pop Surgery ◽  
Patient Reported ◽  
Patient Acceptable Symptom State

Abstract Introduction and hypothesis Patient-reported outcome measures are fundamental tools when assessing effectiveness of treatments. The challenge lies in the interpretation: which magnitude of change in score is meaningful for the patients? The minimal important difference (MID) is defined as the smallest difference in score that patients perceive as important. The Patient Acceptable Symptom State (PASS) represents the value of score beyond which patients consider themselves well. We aimed to determine the MID and PASS for Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6) in pelvic organ prolapse (POP) surgery. Methods We used data from 2704 POP surgeries from a prospective, population-based cohort. MID was determined with three anchor-based and one distribution-based method. PASS was defined using two different methods. Medians of the estimates were identified. Results The MID estimates with (1) mean change, (2) receiver-operating characteristic (ROC) curve, (3) 75th percentile, and (4) distribution-based method varied between 22.9–25.0 (median 24.2) points for PFDI-20 and 9.0–12.5 (median 11.3) for POPDI-6. The PASS cutoffs with (1) 75th percentile and (2) ROC curve method varied between 57.7–62.5 (median 60.0) for PFDI-20 and 16.7–17.7 (median 17.2) for POPDI-6. Conclusion A mean difference of 24 points in the PFDI-20 or 11 points in the POPDI-6 can be used as a clinically relevant difference between groups. Postoperative scores ≤ 60 for PFDI-20 and ≤ 17 for POPDI-6 signify acceptable symptom state.

scholarly journals Determining Success or Failure After Foot and Ankle Surgery Using Patient Acceptable Symptom State (PASS) and Patient Reported Outcome Information System (PROMIS)

2018 ◽  
Vol 39 (8) ◽  
pp. 894-902 ◽  
Author(s):  
Michael R. Anderson ◽  
Judith F. Baumhauer ◽  
Benedict F. DiGiovanni ◽  
Sam Flemister ◽  
John P. Ketz ◽  
...  
Keyword(s):  
Patient Outcome ◽  
Patient Outcomes ◽  
Roc Analysis ◽  
Patient Reported Outcome ◽  
Foot And Ankle ◽  
Chi Square ◽  
Ankle Surgery ◽  
Patient Reported ◽  
Patient Acceptable Symptom State ◽  
Chi Square Analysis

Background: As the role of generic patient-reported outcomes (PROs) expands, important questions remain about their interpretation. In particular, how the Patient Reported Outcome Measurement Instrumentation System (PROMIS) t score values correlate with the patients’ perception of success or failure (S/F) of their surgery is unknown. The purposes of this study were to characterize the association of PROMIS t scores, the patients’ perception of their symptoms (patient acceptable symptom state [PASS]), and determination of S/F after surgery. Methods: This retrospective cohort study contacted patients after the 4 most common foot and ankle surgeries at a tertiary academic medical center (n = 88). Patient outcome as determined by phone interviews included PASS and patients’ judgment of whether their surgery was a S/F. Assessment also included PROMIS physical function (PF), pain interference (PI), and depression (D) scales. The association between S/F and PASS outcomes was evaluated by chi-square analysis. A 2-way analysis of variance (ANOVA) evaluated the ability of PROMIS to discriminate PASS and/or S/F outcomes. Receiver operator curve (ROC) analysis was used to evaluate the ability of pre- (n = 63) and postoperative (n = 88) PROMIS scores to predict patient outcomes (S/F and PASS). Finally, the proportion of individuals classified by the identified thresholds were evaluated using chi-square analysis. Results: There was a strong association between PASS and S/F after surgery (chi-square <0.01). Two-way ANOVA demonstrated that PROMIS t scores discriminate whether patients experienced positive or negative outcome for PASS ( P < .001) and S/F ( P < .001). The ROC analysis showed significant accuracy (area under the curve > 0.7) for postoperative but not preoperative PROMIS t scores in determining patient outcome for both PASS and S/F. The proportion of patients classified by applying the ROC analysis thresholds using PROMIS varied from 43.0% to 58.8 % for PASS and S/F. Conclusions: Patients who found their symptoms and activity at a satisfactory level (ie, PASS yes) also considered their surgery a success. However, patients who did not consider their symptoms and activity at a satisfactory level did not consistently consider their surgery a failure. PROMIS t scores for physical function and pain demonstrated the ability to discriminate and accurately predict patient outcome after foot and ankle surgery for 43.0% to 58.8% of participants. These data improve the clinical utility of PROMIS scales by suggesting thresholds for positive and negative patient outcomes independent of other factors. Level of Evidence: II, prospective comparative series.

scholarly journals Minimal important differences for improvement in shoulder condition patient-reported outcomes: a systematic review to inform aBMJRapid Recommendation

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e028777 ◽  
Author(s):  
Qiukui Hao ◽  
Tahira Devji ◽  
Dena Zeraatkar ◽  
Yuting Wang ◽  
Anila Qasim ◽  
...  
Keyword(s):  
Systematic Review ◽  
Shoulder Pain ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Decompression Surgery ◽  
Subacromial Decompression ◽  
Review Team ◽  
Patient Reported ◽  
Minimal Important Differences

ObjectivesTo identify credible anchor-based minimal important differences (MIDs) for patient-reported outcome measures (PROMs) relevant to aBMJRapid Recommendations addressing subacromial decompression surgery for shoulder pain.DesignSystematic review.Outcome measuresEstimates of anchor-based MIDs, and their credibility, for PROMs judged by the parallelBMJRapid Recommendations panel as important for informing their recommendation (pain, function and health-related quality of life (HRQoL)).Data sourcesMEDLINE, EMBASE and PsycINFO up to August 2018.Study selection and review methodsWe included original studies of any intervention for shoulder conditions reporting estimates of anchor-based MIDs for relevant PROMs. Two reviewers independently evaluated potentially eligible studies according to predefined selection criteria. Six reviewers, working in pairs, independently extracted data from eligible studies using a predesigned, standardised, pilot-tested extraction form and independently assessed the credibility of included studies using an MID credibility tool.ResultsWe identified 22 studies involving 5562 patients that reported 74 empirically estimated anchor-based MIDs for 10 candidate instruments to assess shoulder pain, function and HRQoL. We identified MIDs of high credibility for pain and function outcomes and of low credibility for HRQoL. We offered median estimates for the systematic review team who applied these MIDs in Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence summaries and in their interpretations of results in the linked systematic review addressing the effectiveness of surgery for shoulder pain.ConclusionsOur review provides anchor-based MID estimates, as well as a rating of their credibility, for PROMs for patients with shoulder conditions. The MID estimates inform the interpretation for a linked systematic review and guideline addressing subacromial decompression surgery for shoulder pain, and could also prove useful for authors addressing other interventions for shoulder problems.PROSPERO registration numberCRD42018106531.

Patient Acceptable Symptom State in Knee Osteoarthritis Patients Succeeds Across Different Patient-reported Outcome Measures Assessing Physical Function, But Fails Across Other Dimensions and Rheumatic Diseases

2017 ◽  
Vol 45 (1) ◽  
pp. 122-127 ◽  
Author(s):  
Elien A.M. Mahler ◽  
Nadine Boers ◽  
Johannes W.J. Bijlsma ◽  
Frank H.J. van den Hoogen ◽  
Alfons A. den Broeder ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Physical Function ◽  
Outcome Measures ◽  
Rheumatic Diseases ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Knee Oa ◽  
Cutoff Values ◽  
Patient Reported ◽  
Patient Acceptable Symptom State

Objective.The aims of this study are (1) to establish the Patient Acceptable Symptom State (PASS) cutoff values of different patient-reported outcome measures (PROM) assessing physical function in patients with knee osteoarthritis (OA), and (2) to assess the influence of sex, age, duration of symptoms, and presence of depressive feelings on being in PASS.Methods.Patients fulfilling the clinical American College of Rheumatology knee OA criteria received standardized nonsurgical treatment and completed different questionnaires at baseline and 3 months assessing physical function: Knee Injury and Osteoarthritis Outcome Score, Lequesne Algofunctional Index, Lower Extremity Functional Scale, numerical rating scale, and the physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index. PASS values were defined as the 75th percentile of the score of questionnaires for those patients who consider their state acceptable.Results.Of the 161 included patients, 62% were women with a mean age of 59 years (SD 9) and body mass index of 30 kg/m2 (SD 5). Standardized PASS values (95% CI) for different questionnaires for physical function varied between 48 (44–54) and 54 (50–56). Female patients and patients feeling depressed were found to have a lower probability to be in PASS for physical function, with OR (95% CI) varying from 0.45 (0.23–0.91) to 0.50 (0.26–0.97) and from 0.27 (0.14–0.55) to 0.38 (0.19–0.77), respectively.Conclusion.PASS cutoff values for physical function are robust across different PROM in patients with knee OA. Our results indicate that PASS values are not consistent across dimensions and rheumatic diseases, and that the use of a generic PASS value for patients with OA or even patients with other rheumatic diseases might not be justifiable.

scholarly journals The Relationship Between Patient Acceptable Symptom State and Disease Scores in Psoriasis

2021 ◽  
Author(s):  
Qiaolin Wang ◽  
Wenhua Lu ◽  
Yan Luo ◽  
Minjia Tan ◽  
Wu Zhu ◽  
...  
Keyword(s):  
Patient Characteristics ◽  
Severity Index ◽  
Patient Reported Outcome ◽  
Operating Characteristics ◽  
Exposed Skin ◽  
Receiver Operating Characteristics Curve ◽  
Patient Reported ◽  
Patient Acceptable Symptom State ◽  
The Relationship ◽  
Head Neck

Abstract Patient acceptable symptom state (PASS) is a patient-reported outcome that reflects patient’s perspective well. The relationship between the PASS and disease scores in psoriasis has not been described. This study of 198 patients with psoriasis, assessed PASS using a binary question on patient’s feeling on their symptom. The disease scores including Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA) affected by lesions and other patient characteristics were collected. Logistic regression was used to investigate the associations. 71.4% patients with mild psoriasis based on PASI and 76.3% based on BSA considered their symptom state acceptable. Female (adjusted OR=0.47; 95% CI: 0.42–0.92) and patients with exposed skin (head, neck, and hands) involved (adjusted OR=0.38; 95% CI: 0.19–0.76) were less likely to report acceptable symptom state. Receiver-Operating Characteristics curve showed that both PASI and BSA have limited capability in differentiating acceptable symptom state in psoriasis, which further indicated the unique value of PASS in the management of psoriasis.

scholarly journals Synovial-Fluid miRNA Signature for Diagnosis of Juvenile Idiopathic Arthritis

Cells ◽  
2019 ◽  
Vol 8 (12) ◽  
pp. 1521 ◽  
Author(s):  
Nadége Nziza ◽  
Eric Jeziorski ◽  
Marion Delpont ◽  
Maïlys Cren ◽  
Hugues Chevassus ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Synovial Fluid ◽  
Operating Characteristic ◽  
High Throughput Sequencing ◽  
Characteristic Curve ◽  
Mirna Signature ◽  
Serum Samples ◽  
Diagnostic Biomarkers ◽  
Differentially Expressed Mirnas ◽  
First Time

Juvenile idiopathic arthritis (JIA) is the most common chronic inflammatory rheumatism in childhood; microRNAs (miRNAs) have been proposed as diagnostic biomarkers. Although joints are the primary targets for JIA, a synovial fluid-based miRNA signature has never been studied. We aim to identify miRNA biomarkers in JIA by comparing synovial fluid and serum samples from children with JIA and K. kingae septic arthritis (SA). With next-generation high-throughput sequencing, we measured the absolute levels of 2083 miRNAs in synovial fluid and serum from an exploratory cohort of children and validated differentially expressed miRNAs in a replication study by using RT-qPCR. We identified a 19-miRNA signature only in synovial fluid samples that was significantly deregulated, with at least 2-fold change in expression, in JIA versus SA (p < 0.01). The combination of miR-6764-5p, miR-155, and miR-146a-5p expression in synovial fluid yielded an area under the receiver operating characteristic curve of 1 (95% CI 0.978 to 1), thereby perfectly differentiating JIA from SA in children. We propose, for the first time, a synovial fluid-specific miRNA signature for JIA and associated signaling pathways that may indicate potential biomarkers to assist in the classification and differential diagnosis of JIA and help in understanding JIA pathogenesis.

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