Although the pain visual analog scale (VAS-pain) is a ubiquitous patient-reported outcome instrument, it remains unclear how to interpret changes or differences in scores. Therefore, our purpose was ...to calculate the minimal clinically important difference (MCID) and substantial clinical benefit (SCB) for the VAS-pain instrument in a nonshoulder hand and upper extremity postoperative population.
Adult postoperative patients treated by 1 of 5 fellowship-trained orthopedic hand surgeons at a single tertiary academic medical center were identified. Inclusion required VAS-pain scores at baseline (up to 3 months before surgery) and follow-up (up to 4 months after surgery), in addition to a response to a pain-specific anchor question at follow-up. The MCID estimates were calculated with (1) the 1/2 standard deviation method; and (2) an anchor-based approach. The SCB estimates were calculated with (1) an anchor-based approach; and (2) a receiver operator curve method that maximized the sensitivity and specificity for detecting a “much improved” pain status.
There were 667 and 148 total patients included in the MCID and SCB analyses, respectively. The 1/2 standard deviation MCID estimate was 1.6, and the anchor-based estimate was 1.9. The anchor-based SCB estimate was 2.2. The receiver operator curve analysis yielded an SCB estimate of 2.6, with an area under the curve of 0.72, consistent with acceptable discrimination.
We propose MCID values in the range of 1.6 to 1.9 and SCB values in the range of 2.2 to 2.6 for the VAS-pain instrument in a nonshoulder hand and upper extremity postoperative population.
These MCID and SCB estimates may be useful for powering clinical studies and when interpreting VAS-pain score changes or differences reported in the hand surgery literature. These values are to be applied at a population level, and should not be applied to assess the improvement, or lack thereof, for individual patients.
Background:
The minimal clinically important difference (MCID) for patient-reported outcome measures (PROMs) expresses both the extent of the improvement and the value that patients place on it. MCID ...use is becoming increasingly widespread to understand the clinical efficacy of a given treatment, define guidelines for clinical practice, and properly interpret trial results. However, there is still large heterogeneity in the different calculation methods.
Purpose:
To calculate and compare the MCID threshold values of a PROM by applying various methods and analyzing their effect on the study results interpretation.
Study Design:
Cohort study (Diagnosis); Level of evidence, 3.
Methods:
The data set used to investigate the different MCID calculation approaches was based on a database of 312 patients affected by knee osteoarthritis and treated with intra-articular platelet-rich plasma. MCID values were calculated on the International Knee Documentation Committee (IKDC) subjective score at 6 months using 2 approaches: 9 methodologies referred to an anchor-based approach and 8 methodologies to a distribution-based approach. The obtained threshold values were applied to the same series of patients to understand the effect of using different MCID methods in evaluating patient response to treatment.
Results:
The different methods employed led to MCID values ranging from 1.8 to 25.9 points. The anchor-based methods ranged from 6.3 to 25.9, while the distribution-based ones were from 1.8 to 13.8 points, showing a 4.1× variation of the MCID values within the anchor-based methods and a 7.6× variation within the distribution-based methods. The percentage of patients who reached the MCID for the IKDC subjective score changed based on the specific calculation method used. Among the anchor-based methods, this value varied from 24.0% to 66.0%, while among the distribution-based methods, the percentage of patients reaching the MCID varied from 44.6% to 75.9%.
Conclusion:
This study proved that different MCID calculation methods lead to highly heterogeneous values, which significantly affect the percentage of patients achieving the MCID in a given population. The wide-ranging thresholds obtained with the different methodologies make it difficult to evaluate the real effectiveness of a given treatment questioning the usefulness of MCID, as currently available, in the clinical research.
•GAD-7 is sensitive to detect change in anxiety severity over course of treatment.•MCID was estimated 4 points on the GAD-7 total score.•The GAD-7 is as an efficient and economical severity measure ...for anxiety symptoms.
Effective treatment requires regular follow-up and monitoring of symptoms. We investigated sensitivity to change and minimal clinically important difference of the Generalized Anxiety Disorder Scale (GAD-7).
This study included all participants from a multisite trial of chronic depression. Baseline and follow-up (12 and 48 weeks) data were used to assess treatment response. Effect sizes (ES) and standardized response means (SRM) of pre- and post-GAD-7 mean changes were calculated for subgroups of patients, who did or did not improve according to ratings in the Hamilton Rating Scale for Depression (HRSD-24).
N = 261 patients were included in the analyses. In the subgroup of patients who improved according to HRSD-24, GAD-7 scores were significantly lower after 12 weeks (t = −6.31, df = 120, p < .001; ES = −0.51, SRM = −0.57), and 48 weeks of treatment (t = −12.68, df = 141, p < .001; ES = −1.0, SRM = −1.7), when compared to admission. In the group who worsened, GAD-7 scores were significantly higher after 12 weeks (t = 2.96, df = 41, p = .005; ES = 0.30, SRM = 0.46), and increased after 48 weeks (t = 1.99, df = 21, p = .059; ES = 0.37, SRM = 0.43), when compared to baseline. The unchanged group showed no significant difference between baseline and follow-up. MCID was estimated 4 points on the GAD-7 total score.
Confirmation of these findings and further investigation of the GAD-7 in populations and trials focusing on anxiety-specific treatment is highly recommended.
Results show that the GAD-7 is sensitive to detect change in psychopathology over the course of treatment.
Background:
There has been increasing interest in defining clinically meaningful outcomes in patient reported outcomes following orthopaedic surgery. Little is known about the factors associated with ...clinically meaningful outcomes after hip arthroscopy for femoroacetabular impingement.
Study Design:
Case-control study; Level of evidence, 3.
Purpose:
To report on a large, prospectively collected consecutive series of patients who underwent comprehensive arthroscopic treatment of femoroacetabular impingement (FAI) and capsular management with greater than 2-year follow-up. The objectives were to determine (1) what percentage of patients achieve clinically significant outcomes after hip arthroscopic surgery for FAI as determined by the minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) and (2) what factors are associated with achieving the MCID and PASS.
Methods:
Data from an institutional repository of consecutive patients undergoing primary hip arthroscopic surgery with routine capsular closure for FAI that had failed nonsurgical management between January 2012 and January 2014 were prospectively collected and analyzed. Of 474 patients during the enrollment period, 386 (81.4%) patients were available for a minimum 2-year follow-up. Demographics, radiographic measurements, intraoperative characteristics, and patient-reported outcome scores were collected. The primary outcome measure was achieving published thresholds for the MCID and PASS for the Hip Outcome Score (HOS)–Activities of Daily Living (ADL) in patients with FAI. The HOS–Sport-Specific Subscale (SSS), complications, and reoperations were secondary outcome measures. Multivariate regression analyses were conducted to identify factors associated with achieving the MCID and PASS.
Results:
At a minimum of 2-year follow-up, the patients had statistically significant improvements in all patient-reported outcomes (HOS-ADL, HOS-SSS, and modified Harris Hip Score mHHS; P < .001 for all), with a 1.2% rate of revision hip arthroscopic surgery and 1.7% rate of conversion to total hip arthroplasty. The MCID was achieved by 78.8% of patients for the HOS-ADL, and the PASS was achieved by 62.5% for the HOS-ADL. Younger age (P = .008), Tönnis grade 0 (P = .022), and lower preoperative HOS-ADL score (P < .001) were associated with successfully achieving the MCID for the HOS-ADL. Younger age (P < .001), larger medial joint space width (P = .028), and higher preoperative HOS-ADL score (P < .001) were associated with achieving the PASS for the HOS-ADL. Younger age (P < .001), lower body mass index (P = .006), non–workers’ compensation status (P = .020), and lower preoperative HOS-SSS score (P < .001) were associated with achieving the MCID for the HOS-SSS. Younger age (P = .001), Tönnis grade 0 (P = .014), running (P = .008), and higher preoperative HOS-SSS score (P < .001) were associated with achieving the PASS for the HOS-SSS. Overall, 49.4% of patients achieved all 4 clinically significant outcomes: both the MCID and PASS for the HOS-ADL and HOS-SSS.
Conclusion:
The majority of patients undergoing hip arthroscopic surgery with routine capsular closure for FAI experienced clinically significant outcomes that met the MCID or PASS criteria, with low rates of revision and conversion to total hip arthroplasty. Factors associated with these successful outcomes on multivariate analyses included younger age with a normal joint space. Patients with lower preoperative HOS scores were more likely to achieve the MCID, whereas patients with higher preoperative HOS scores were more likely to achieve the PASS.
A retrospective analysis.
The aim of this study was to elucidate the psychometric properties of the original Japanese Orthopaedic Association (JOA) score, including the minimum detectable change ...(MDC), minimum clinically important difference (MCID), and patient-accepted symptom state (PASS).
Despite the worldwide popularity of modified JOA score (mJOA), the original JOA score is still commonly used in East Asian countries, including Japan. However, unlike mJOA score, the psychometric properties of JOA score remain poorly understood.
We retrospectively reviewed a consecutive series of laminoplasty for degenerative cervical myelopathy patients in a single academic institution. Pre- and postoperative JOA scores were collected, and the recovery rate was calculated. Anchor-based methods were used to determine the cut-off values by a receiver operating characteristic (ROC) curve analysis. The patients were also asked to answer an anchor question analyzing their postoperative health transition used for the MDC and another question assessing the patient satisfaction used for the MCID and PASS.
A total of 101 patients were included in the analysis. The mean preoperative JOA score was 10.3 standard deviation (SD): 2.4), and the mean postoperative JOA score was 13.4 (SD: 2.5). The mean recovery rate was 44%. A total of 68% of the patients admitted that their health condition was at least "somewhat better" than their preoperative condition, and 66% were at least "somewhat satisfied" with the treatment results. On the basis of ROC curve analyses, the MDC and MCID for JOA score in degenerative cervical myelopathy patients were calculated to be 2.5. The PASS was estimated to be 14.5, and the MCID for JOA recovery rate was 52.8%.
The MDC, MCID, and PASS for JOA score for degenerative cervical myelopathy patients were reported by anchor-based ROC curve analyses.
4.
The ability to detect changes in patient-perceived pain after total joint arthroplasty (TJA) is critical to manage postoperative pain. The minimal clinically important difference (MCID) for visual ...analog scale for pain (VAS-P) has not been investigated in this population. This study investigated the MCID for VAS-P in the TJA population.
Postoperative pain scores were collected on 139 total hip arthroplasty (THA) and 165 total knee arthroplasty (TKA) patients. VAS-P was measured and Likert scores for changes in pain recorded together throughout the hospitalization per patient. Using a linear mixed model, the mean difference between preceding and current VAS-P was calculated and correlated with Likert score, when the patient reported at least slight improvement or worsening in pain, defining the MCID. Minimal detectable change was calculated using the VAS-P standard error of the means for patients reporting “no change.”
For THA, the overall mean and average highest VAS-P were 35.0 mm and 50.4 mm, respectively. For TKA, the overall mean and average highest VAS-P were 42.6 mm and 61.1 mm, respectively. The minimal detectable change in VAS-P was 14.9 mm for THA and 16.1 mm for TKA. The MCID for THA and TKA pain improvement was −18.6 mm and −22.6 mm, respectively, and for worsening was 23.6 mm and 29.1 mm, respectively.
In the postoperative TJA population, VAS-P MCID changes depend on the type of surgical intervention, and whether pain is improving or worsening. Statistically significant VAS-P, improving −18.6 mm and −22.6 mm for THA and TKA patients, respectively, sets a reasonable threshold to identify clinically meaningful pain intervention with high specificity.
The minimal clinically important difference (MCID) of a patient-reported outcome measure (PROM) represents a threshold value of change in PROM score deemed to have an implication in clinical ...management. The MCID is frequently used to interpret the significance of results from clinical studies that use PROMs. However, an understanding of the many caveats of the MCID, as well as its strengths and limitations, is necessary. The objective of this article is to provide a review of the calculation, interpretation, and caveats of MCID.
MEDLINE and PubMed Central.
Literature search-including primary studies, review articles, and consensus statements-pertinent to the objectives of this review using PubMed.
The MCID of a PROM may vary depending on the patients and clinical context in which the PROM is given. The primary approaches for calculating MCID are distribution-based and anchor-based methods. Each methodology has strengths and limitations, and the ideal determination of a PROM MCID includes synthesis of results from both approaches. The MCID of a PROM is also not perfect in detecting patients experiencing a clinically important improvement, and this is reflected in its accuracy (eg, sensitivity and specificity).
Interpretation or application of MCID requires consideration of all caveats underlying the MCID, including the patients in whom it was derived, the limitations of the methodologies used to calculate it, and its accuracy for identifying patients who have experienced clinically significant improvement.
Minimal clinically important difference (MCID) is the smallest change in an outcome, which a patient identifies as meaningful. Although the 2 most frequently applied Parkinson's disease (PD) "quality ...of life" questionnaires (the PDQ-39 and PDQ-8) provide encouragingly similar results, their MCID thresholds appear to be vastly different. Our aim was to calculate the MCID estimates for both PDQ-39 and PDQ-8 Summary Indices (PDQ-39-SI and PDQ-8-SI) by the utilization of both anchor- and distribution-based techniques.
Nine hundred eighty-five paired investigations of 365 patients were included. Three different techniques were used simultaneously to calculate the MCID values.
First, we replicated the previously published results demonstrating how both PDQ-39-SI and PDQ-8-SI provide similar values and respond in a similar way to changes. Subsequently, we calculated the MCID thresholds. The most optimal estimates for MCID thresholds for PDQ-39-SI were -4.72 and +4.22 for detecting minimal clinically important improvement and worsening. For PDQ-8-SI, these estimates were -5.94 and +4.91 points for detecting minimal clinically important improvement and worsening respectively.
Our study is the first one that directly compared the MCID estimates for both PDQ-39-SI and PDQ-8-SI on a large pool of patients including all disease severity stages. These MICD estimates varied across PD severity.
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