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

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.

2012 ◽  
Vol 24 (7) ◽  
pp. 1127-1134 ◽  
Author(s):  
Rikke Guldberg ◽  
Ulrik Schiøler Kesmodel ◽  
Jesper Kjær Hansen ◽  
Kim Oren Gradel ◽  
Søren Brostrøm ◽  
...  

Author(s):  
Titus A. A. Beentjes ◽  
Steven Teerenstra ◽  
Hester Vermeulen ◽  
Peter J. J. Goossens ◽  
Maria W. G. Nijhuis-van der Sanden ◽  
...  

Abstract Purpose Complementary interventions for persons with severe mental illness (SMI) focus on both personal recovery and illness self-management. This paper aimed to identify the patient-reported outcome measures (PROMs) associated with the most relevant and meaningful change in persons with SMI who attended the Illness Management and Recovery Programme (IMR). Methods The effect of the IMR was measured with PROMs concerning recovery, illness self-management, burden of symptoms and quality of life (QoL). From the QoL measures, an anchor was chosen based on the most statistically significant correlations with the PROMs. Then, we estimated the minimal important difference (MID) for all PROMs using an anchor-based method supported by distribution-based methods. The PROM with the highest outcome for effect score divided by MID (the effect/MID index) was considered to be a measure of the most relevant and meaningful change. Results All PROMs showed significant pre–post-effects. The QoL measure ‘General Health Perception (Rand-GHP)’ was identified as the anchor. Based on the anchor method, the Mental Health Recovery Measure (MHRM) showed the highest effect/MID index, which was supported by the distribution-based methods. Because of the modifying gender covariate, we stratified the MID calculations. In most MIDs, the MHRM showed the highest effect/MID indexes. Conclusion Taking into account the low sample size and the gender covariate, we conclude that the MHRM was capable of showing the most relevant and meaningful change as a result of the IMR in persons with SMI.


2020 ◽  
Author(s):  
Titus Beentjes ◽  
Steven Teerenstra ◽  
Hester Vermeulen ◽  
Maria W.G. Nijhuis-van der Sanden ◽  
Betsie G.I. van Gaal ◽  
...  

Abstract Background: Complementary interventions for persons with severe mental illness (SMI) provide broad strategies for recovery and illness self-management. It is not known which outcome measure can be considered to be relevant for persons with SMI. This knowledge can motivate a professional to offer and stimulate a person to participate in that intervention. This paper aimed to identify the outcome measures that determine the most relevant and meaningful change and capture the benefits of a complementary intervention. Methods: By using anchor-based and distribution-based methods, we estimated the minimal important difference (MID) to determine which outcome measure persons improved in beyond the MID to reflect a relevant change in pre-post effect of a complementary intervention, in casu the Illness Management and Recovery programme (IMR).Results: The anchor MID was based on the results of the measure Rand General Health Perception (Rand-GHP). On all MIDs, the Mental Health Recovery Measure (MHRM) had the highest score on the effect compared to its MIDs, and also on all MIDs the MHRM had the highest percentages of participants that scored above the MID. Conclusion: The Rand-GHP is considered to be an excellent measure for investigating the MID as a result of an intervention. The results of our study can be used in shared decision-making processes to determine which intervention is suitable for a person with SMI. A person who desires a recovery outcome, as measured by the MHRM, can be recommended to do the IMR programme.


2021 ◽  
Vol 2 (4) ◽  
pp. 249-280
Author(s):  
Catrin Griffiths ◽  
Philippa Tollow ◽  
Danielle Cox ◽  
Paul White ◽  
Timothy Pickles ◽  
...  

The CARe Burn Scales are a portfolio of burn-specific PROMs for people affected by burns, including a Child Form (for children < 8 years (parent-proxy)), a Young Person Form (for young people aged 8–17 years), an Adult Form, and a Parent Form (for parents/carers of children aged 0–17 years). This study aimed to determine the responsiveness and minimal important difference (MID) values of the three scales developed for use in paediatric burn services and research. Participants were recruited by 15 UK Burn Services. Participants completed the appropriate CARe Burn Scale and a set of appropriate comparison validated measures, at three time points: 4 weeks (T1), 3 months (T2) and 6 months (T3) post-burn injury. Spearman’s correlation analysis and effect sizes based on Cohen’s d thresholds were reported and MID values were calculated. At baseline, 250 participants completed the Child Form, 69 completed the Young Person Form, and 320 completed the Parent Form. A total of 85–92% of participants were retained at follow up. The tested CARe Burn Scales were all responsive to change over time. MID values were created for all subscales and ranged from 2 to 11 for the Child Form, 3 to 14 for the Young Person Form and 3 to 10 for the Parent Form. The CARe Burn Scales for children, young people and parents are responsive to change over time. The scales are freely available for clinical and research use.


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.


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 ◽  
Vol 47 (1) ◽  
Author(s):  
Beth McDougall ◽  
Mike Reid ◽  
Souvik Mitra ◽  
Bradley Johnston

Understanding core concepts in epidemiology and biostatistics is crucial for evidence-based clinical practice and policy. In this second installment of our two-part series on threshold concepts, we transition from understanding the ubiquitous p-value to tools and measures for decision making among clinicians-in-training, highlighting the growing importance of utilizing explicit and evidence-based approaches to make appropriate and efficient decisions. We review two related decision-making concepts: (1) Minimal Important Difference (MID) estimates and (2) Decision Thresholds, focusing specifically on patient-reported outcome measures (PROMs). These terms and many other related expressions are used regularly, and often interchangeably, but what are they? Why are they valuable? And how can they be used to support evidence-based decision-making in clinical contexts and develop strong clinical practice guidelines? We conclude our brief review on the utility of these measures with a spotlight on a local example of how the theory underlying MID estimates and decision thresholds is currently being embedded in electronic platforms in primary care contexts targeting depression in Nova Scotia.


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