scholarly journals Substantial clinical benefit and patient acceptable symptom states of the Forgotten Joint Score 12 after primary knee arthroplasty

2021 ◽  
Author(s):  
Siri Heijbel ◽  
Annette W-Dahl ◽  
Kjell G Nilsson ◽  
Margareta Hedström

Background and purpose — Knowing how to interpret values obtained with patient reported outcome measures (PROMs) is essential. We estimated the substantial clinical benefit (SCB) and patient acceptable symptom state (PASS) for Forgotten Joint Score 12 (FJS) and explored differences depending on methods used for the estimates. Patients and methods — The study was based on 195 knee arthroplasties (KA) performed at a university hospital. We used 1 item from the Knee injury and Osteoarthritis Outcome Score domain quality of life and satisfaction with surgery, obtained 1-year postoperatively, to assess SCB and PASS thresholds of the FJS with anchor-based methods. We used different combinations of anchor questions for SCB and PASS (satisfied, satisfied with no or mild knee difficulties, and satisfied with no knee difficulties). A novel predictive approach and receiver-operating characteristics curve were applied for the estimates. Results — 70 and 113 KAs were available for the SCB and PASS estimates, respectively. Depending on method, SCB of the FJS (range 0–100) was 28 (95% CI 21–35) and 22 (12–45) respectively. PASS was 31 (2–39) and 20 (10–29) for satisfied patients, 40 (31–47) and 38 (32–43) for satisfied patients with no/mild difficulties, and 76 (39–80) and 64 (55–74) for satisfied patients with no difficulties. The areas under the curve ranged from 0.82 to 0.88. Interpretation — Both the SCB and PASS thresholds varied depending on methodology. This may indicate a problem using meaningful values from other studies defining outcomes after KA. This study supports the premise of the FJS as a PROM with good discriminatory ability in patients undergoing KA.

2021 ◽  
Author(s):  
Qiaolin Wang ◽  
Wenhua Lu ◽  
Yan Luo ◽  
Minjia Tan ◽  
Wu Zhu ◽  
...  

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.


Cartilage ◽  
2018 ◽  
Vol 12 (1) ◽  
pp. 42-50 ◽  
Author(s):  
Takahiro Ogura ◽  
Jakob Ackermann ◽  
Alexandre Barbieri Mestriner ◽  
Gergo Merkely ◽  
Andreas H. Gomoll

Objective Little is known regarding the minimal clinically important difference (MCID) and substantial clinical benefit (SCB) with regard to the Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Lysholm score, and Short Form 12 (SF-12) score of patients who undergo osteochondral allograft transplantation (OCA). We aimed to determine the MCID and SCB associated with those patient-reported outcome measures (PROMs) after OCA. Design We analyzed the data of 86 consecutive patients who underwent OCA and who completed satisfaction surveys at a minimum of 1 year postoperatively and had at least one repeated PROM. MCID was determined using an anchor-based method: the optimal cutoff point for receiver operative characteristic (ROC) curves. If an anchor-based method was inapplicable, distribution-based methods were employed. SCB was determined using ROC curve analysis. Results Based on the ROC curve analysis, MCID was 16.7 for KOOS pain, 25 for KOOS sports/recreation, and 9.8 for IKDC. SCB was 27.7 for KOOS pain, 10.7 for KOOS symptom, 30 for KOOS sports/recreation, 31.3 for KOOS quality of life, 26.9 for IKDC, 25 for Lysholm, and 12.1 for SF-12 physical component summary. No significant association was noted between SCB achievement and the baseline patient factors and baseline PROMs. Conclusion We demonstrated the MCIDs and SCBs of several PROMs in patients undergoing OCA. These results will aid the interpretation of the effect of treatment and clinical trial settings. Moreover, the SCBs will help surgeons in the counseling of patients, where patients expect optimal results rather than minimal improvement.


Author(s):  
Päivi K. Karjalainen ◽  
Nina K. Mattsson ◽  
Jyrki T. Jalkanen ◽  
Kari Nieminen ◽  
Anna-Maija Tolppanen

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.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1919-1920
Author(s):  
L. Uhrenholt ◽  
R. Christensen ◽  
L. Dreyer ◽  
A. Mortensen ◽  
E. M. Hauge ◽  
...  

Background:Patient-reported outcome measures (PROMs) are essential to understand the patient’s perception of arthritis activity. In Demark, PROMs are registered on a touchscreen in the outpatient clinic. However, some patients find it inconvenient due to e.g. waiting in queue, lack of privacy, uncomfortable seating position, reduced upper limb strength and dexterity with seeing the touchscreen due to deformity of the cervical spine. The widespread use of smartphones makes it possible for patients to register PROMs via an application (app) on their own device.Objectives:The primary aim is to evaluate the agreement (i.e. similarity) between the two devices assessed by the Health Assessment Questionnaire Disability Index (HAQ-DI) status among patients with inflammatory arthritis.Methods:The study was a randomised, crossover, agreement trial (NCT03486613) conducted at Aalborg University Hospital, Denmark. Participants were recruited through an invitation on the touchscreen in the outpatient clinic. Patients with an established diagnosis (≥ 12 months) of rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) and experience with the PROM questionnaires (≥ 3 previous registrations) were enrolled and randomised in ratio 1:1 (stratified by diagnosis) to PROM registration through the DANBIO app and the touchscreen in random order. Figure 1A and 1B shows the two devices.The sample size calculation was based on a prespecified equivalence margin of ±0.11 HAQ-DI points (i.e. ≤ half of the minimal important difference of 0.22 points) yielding a power of 99.2% for 60 enrolled patients. There was a wash-out period of 1-2 days between the two device registrations to minimise the potential carryover effect.A paired t-test was used to calculate the mean HAQ-DI score for the two devices and the difference in HAQ-DI score with a 95% confidence interval (CI). A Bland-Altman plot was used to assess limits of agreement (LoA).Results:60 patients (20 with RA, 20 with PsA and 20 with axSpA) were randomised of whom 51.7% were male. Mean age was 53.7 years (range 22-77) and mean disease duration was 12.5 years (range 1.0-34.8).Mean HAQ-DI was 0.608 (95%CI 0.437;0.779) for the DANBIO app and 0.614 (95%CI 0.446;0.783) for the touchscreen (Table 1). Agreement between scores obtained with the two devices is illustrated with Bland-Altman plots in figure 2A and 2B. The paired mean difference of HAQ-DI between the two devices was -0.006 (95%CI -0.0424; 0.030); thus the 95% confidence interval for the mean difference was within the prespecified equivalence margin of ±0.11 HAQ-DI points.Table 1.HAQ-DI scores, difference and LoA for the two devices.App, mean (SD)Touchscreen, mean (SD)Difference, mean (95%CI)LoAMissing valuesHAQ-DI (0-3)0.608 (0.656)0.614 (0.646)-0.006 (-0.042;0.030)-0.277;0.2641Conclusion:The current study showed no statistical or clinically important difference in HAQ-DI measurement captured by a smartphone app or outpatient touchscreen. Therefore, we feel confident that the two devices perform similarly enough to be used interchangeably in patients with inflammatory arthritis.Disclosure of Interests:Line Uhrenholt Speakers bureau: Abbvie, Eli Lilly and Novartis (not related to the submitted work), Robin Christensen: None declared, Lene Dreyer: None declared, Annette Mortensen Speakers bureau: MSD and Eli Lilly (not related to the submitted work)., Ellen-Margrethe Hauge Speakers bureau: Fees for speaking/consulting: MSD, AbbVie, UCB and Sobi; research funding to Aarhus University Hospital: Roche and Novartis (not related to the submitted work)., Niels Steen Krogh: None declared, Mikkel Kramme Abildtoft: None declared, Peter C. Taylor Grant/research support from: Celgene, Eli Lilly and Company, Galapagos, and Gilead, Consultant of: AbbVie, Biogen, Eli Lilly and Company, Fresenius, Galapagos, Gilead, GlaxoSmithKline, Janssen, Nordic Pharma, Pfizer Roche, and UCB, Salome Kristensen: None declared


Author(s):  
Eric R. Levasseur ◽  
Kevin D. Dames ◽  
Mark A. Sutherlin ◽  
Alyson Dearie ◽  
Sonya Comins

Collegiate- and elite-level swimmers can see extraordinary volumes in training throughout a season. Consequentially, injury and dysfunction in the shoulder are common in competitive swimmers. This study investigated whether preseason Kerlan-Jobe Orthopedic Clinic Questionnaire scores could identify collegiate swimmers who sustained a shoulder injury during an athletic season. A Kerlan-Jobe Orthopedic Clinic Questionnaire score of ≥81 was able to identify swimmers who did not sustain an injury versus those who did. The receiver operating characteristics demonstrated an area under the curve of 0.820, p < .004. A Kerlan-Jobe Orthopedic Clinic Questionnaire score of 81 had a sensitivity of 1.00 and specificity of 0.333. The current findings suggest that selective preseason patient-reported outcome measures could be utilized as a preparticipation screening tool to investigate athlete readiness to compete.


2015 ◽  
Vol 97 (1) ◽  
pp. 63-65 ◽  
Author(s):  
TC Biggs ◽  
LR Fraser ◽  
MJ Ward ◽  
VS Sunkaraneni ◽  
PG Harries ◽  
...  

Introduction Surgical procedures incorporating a cosmetic element such as septorhinoplasty and otoplasty are currently under threat in the National Health Service (NHS) as they are deemed to be procedures of ‘limited clinical benefit’ by many primary care providers. Patient reported outcome measures (PROMs), which assess the quality of care delivered from the patients’ perspective, are becoming increasingly important in documenting the effectiveness of such procedures. Methods The Rhinoplasty Outcomes Evaluation (ROE) questionnaire, a validated PROM tool, was used to assess patient satisfaction in 141 patients undergoing septorhinoplasty surgery over a 90-month period at the University Hospital Southampton NHS Foundation Trust. Results Overall, 100 patients with a mean follow-up period of 36 months completed the study. The mean ROE score was 73.3%. In addition, 75% of patients questioned were happy with the final result of their operation and 83% would undergo the procedure again if required. These benefits occurred irrespective of age, sex and primary versus revision surgery, and were maintained for up to 71 months following surgery. Conclusions This study has shown that patients are generally satisfied with their functional and cosmetic outcomes following septorhinoplasty surgery. These results help support the case for septorhinoplasty surgery to continue being funded as an NHS procedure.


2020 ◽  
pp. 105566562096412
Author(s):  
Mia Stiernman ◽  
Kristina Klintö ◽  
Martin Persson ◽  
Magnus Becker

Objective: The primary aim of this study was to compare corresponding scores between 2 existing cleft-specific patient-reported outcome measures (PROMs)—Cleft Hearing Appearance and Speech Questionnaire (CHASQ) and CLEFT-Q. The second aim of the study was to investigate patient opinion on the 2 PROMs. Design: Cross-sectional questionnaire study. Setting: Participants were recruited from a University Hospital. They answered CHASQ and CLEFT-Q either in the hospital or at home. Participants: Thirty-three participants with cleft lip and/or palate, aged 10 to 19 years. Main Outcome Measure: CHASQ and CLEFT-Q. Results: The CHASQ scores and the corresponding CLEFT-Q scores on appearance correlated significantly. Corresponding scores regarding speech did not correlate significantly. A majority, 15 (58%) participants, answered that they liked CLEFT-Q more than CHASQ, 18 participants (69%) thought CHASQ was easier to complete, and 19 (76%) thought CLEFT-Q would better inform health care professionals. Conclusion: Both instruments showed strengths and limitations. Clinicians will have to consider each instrument’s respective qualities when choosing to implement either PROM.


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 ◽  
...  

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.


2019 ◽  
Vol 47 (5) ◽  
pp. 1159-1167 ◽  
Author(s):  
José F. Vega ◽  
Cale A. Jacobs ◽  
Gregory J. Strnad ◽  
Lutul Farrow ◽  
Morgan H. Jones ◽  
...  

Background: The length of most patient-reported outcome measures creates significant response burden, which hampers follow-up rates. The Patient Acceptable Symptom State (PASS) is a single-item, patient-reported outcome measure that asks patients to consider all aspects of life to determine whether the state of their joint is satisfactory; this measure may be viable for tracking outcomes on a large scale. Hypothesis: The PASS question would identify clinically successful anterior cruciate ligament reconstruction (ACLR) at 1-year follow-up with high sensitivity and moderate specificity. We defined “clinically successful” ACLR as changes in preoperative to postoperative scores on the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale and the KOOS knee-related quality of life subscale in excess of minimal clinically important difference or final KOOS pain or knee-related quality of life subscale scores in excess of previously defined PASS thresholds. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Patients enrolled in a prospective longitudinal cohort completed patient-reported outcome measures immediately before primary ACLR. At 1-year follow-up, patients completed the same patient-reported outcome measures and answered the PASS question: “Taking into account all the activity you have during your daily life, your level of pain, and also your activity limitations and participation restrictions, do you consider the current state of your knee satisfactory?” Results: A total of 555 patients enrolled in our cohort; 464 were eligible for this study. Of these, 300 patients (64.7%) completed 1-year follow-up, of whom 83.3% reported satisfaction with their knee after surgery. The PASS question demonstrated high sensitivity to identify clinically successful ACLR (92.6%; 95% CI, 88.4%-95.6%). The specificity of the question was 47.1% (95% CI, 35.1%-59.5%). The overall agreement between the PASS and our KOOS-based criteria for clinically successful intervention was 81.9%, and the kappa value indicated moderate agreement between the two methods (κ = 0.44). Conclusion: The PASS question identifies individuals who have experienced clinically successful ACLR with high sensitivity. The limitation of the PASS is its low specificity, which we calculated to be 47.1%. Answering “no” to the PASS question meant that a patient neither improved after surgery nor achieved an acceptable final state of knee health. The brevity, interpretability, and correlation of the PASS question with significant improvements on various KOOS subscales make it a viable option in tracking ACLR outcomes on a national or global scale.


Cartilage ◽  
2018 ◽  
Vol 11 (4) ◽  
pp. 412-422 ◽  
Author(s):  
Takahiro Ogura ◽  
Jakob Ackermann ◽  
Alexandre Barbieri Mestriner ◽  
Gergo Merkely ◽  
Andreas H. Gomoll

Objective We sought to determine the minimal clinically important difference (MCID) and substantial clinical benefit (SCB) associated with the Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Lysholm, and Short Form–12 (SF-12) after autologous chondrocyte implantation (ACI). Design Ninety-two patients with satisfaction surveys at a minimum of 2 years postoperatively and at least 1 repeated patient-reported outcome measure (PROM) were analysed. The MCID was determined using 4 anchor-based methods: average change, mean change, minimally detectable change, and the optimal cutoff point for receiver operating characteristic (ROC) curves. If an anchor-based method was not applicable, standard deviation–based and effect size–based estimates were used. SCB was determined using ROC curve analysis. Results The 4 anchor-based methods provided a range of MCID values for each PROM (11-18.8 for the KOOS pain, 9.2-17.3 for the KOOS activities of daily living, 12.5-18.6 for the KOOS sport/recreation, 12.8-19.6 for the KOOS quality of life, 10.8-16.4 for the IKDC, and 6.2-8.2 for the SF-12 physical component summary). Using the 2 distribution-based methods, the following MCID value ranges were obtained: KOOS symptom, 3.6 to 8.4; the Lysholm, 4.2 to 10.5; and the SF-12 mental component summary, 1.9 to 4.6. SCB was 30 for the KOOS sport/recreation and 34.4 for the IKDC, which most accurately predict substantial improvement. No significant association was noted between SCB achievement and the baseline PROMs. Conclusion The MCID and SCB determined in our study will allow interpretation of the effects of treatment in clinical practice and trials. Given the varied MCID values in this study, standardisation of the most appropriate calculation methods is warranted.


Sign in / Sign up

Export Citation Format

Share Document