Minimal Important Change Research Articles

How to interpret patient-reported outcomes? - Stratified adjusted minimal important changes for the EQ-5D-3L in hip and knee replacement patients

BackgroundAs one of the main goals of hip and knee replacements is to improve patients’ health-related quality of life, a meaningful evaluation can be achieved by calculating minimal important changes (MICs) for improvements in patient-reported outcome measures (PROMs). This study aims at providing MICs adjusted for patient characteristics for EQ-5D-3L index score improvements after hip and knee replacements. It adds to existing literature by relying on a large national sample and precise clustering algorithms, and by employing a state-of-the-art methodology for the calculation of improved adjusted MICs.MethodologyA retrospective observational study was conducted using the publicly available National Health Service (NHS) PROMs dataset for primary hip and knee replacements. We used information on 252,331 hip replacements and 279,668 knee replacements from all NHS-funded providers in England between 2013 and 2020. Clusters of patients were created based on pre-operative EQ-VAS, depression status, and sex. Unstratified and stratified estimates for meaningful EQ-5D-3L improvements were obtained through anchor-based predictive MICs corrected for the proportion of improved patients and the reliability of transition ratings.ResultsStratifying patients showed that MICs varied across subgroups based on pre-operative EQ-VAS, depression status, and sex. MICs were larger for patients with worse pre-operative EQ-VAS scores, while patients with better pre-operative scores required smaller MICs to achieve a meaningful change. We show how after stratification the percentage of patients achieving their stratified MIC was better in line with the actual share of improved patients. Larger MICs were found for patients with depression and for female patients. MICs calculated for knee replacements were consistently lower than those for hip replacements.ConclusionsOur findings show the importance of adjusting MICs for patients’ characteristics and should be considered for quality-related choices and policy initiatives.

Psychometric properties of the Thai version of the Simple Knee Value in patients with patellofemoral pain

Purpose This study aimed to translate the Simple Knee Value (SKV) into Thai and evaluate its psychometric properties as a single-question assessment tool. Methods The SKV was translated into Thai according to international guidelines. Psychometric properties were assessed in adults aged 18–50 years with patellofemoral pain. Participants completed questionnaires at baseline, 2 weeks, and 2 months. Results Seventy-six patients with patellofemoral pain (mean age 36.8 ± 8.3 years, 56.6% female) participated in this prospective cohort study. SKV scores were moderately correlated with those of the Knee Injury and Osteoarthritis Outcome Score–Patellofemoral Subscale (KOOS-PF) and the Anterior Knee Pain Scale (AKPS). The test-retest reliability was high, with an intraclass correlation coefficient of 0.79 (95% confidence interval: 0.65–0.88). The SKV change scores effectively differentiated between improved and unimproved patients, with a minimal important change of 12.5 points. Conclusions The SKV demonstrated acceptable psychometric properties for assessing patellofemoral pain in young to middle-aged adults. This single-question patient-reported outcome measure is simple and easy to use in daily clinical practice and can serve as an adjunctive assessment tool in patellofemoral pain research.

Patients Have Acceptable Patient-Reported Outcome Measures After Medial Unicompartmental Knee Arthroplasty Regardless of Age

BackgroundContemporary evidence-based indications no longer consider age regarding eligibility for medial unicompartmental knee arthroplasty (mUKA). This has led to more surgical candidates; however, whether patients still have satisfactory outcomes lacks evidence. This study examined the association between age and change in patient-reported outcome measures (PROMs) after mUKA as well as the achievement of Patient Acceptable Symptom State (PASS) and Minimal Important Change (MIC). MethodsWe included 782 mUKAs performed between February 1, 2016, and April 26, 2023. The mean change from preoperative Oxford Knee Score (OKS), Forgotten Joint Score (FJS), and Activity and Participation Questionnaire (APQ) was assessed at three, 12, and 24 months after surgery. The achievement of 12-month PASS (OKS ≥ 30) and MIC (changes in OKS ≥ 8; FJS ≥ 14) was also assessed. Patients were divided into age groups: < 55, 55 to < 65, 65 to < 75 years (reference group), and ≥ 75 years. There were 432 women (55%), patients had a mean age of 67 years (range, 29 to 93) and a mean BMI of 30 (range, 20 to 53). ResultsMedian OKS, youngest to eldest, were 34, 35, 36, and 35 (three months); 40, 39, 41, and 43 (12 months); 42, 41, 43, and 42 (24 months). We found no differences in change in OKS between groups. Patients aged 55 to < 65 years had lower changes in FJS at 24 months and APQ at 12 and 24 months. Patients ≥ 75 years had lower 24-month change in APQ. We found no association between age and the fraction achieving either PASS or MIC (youngest to eldest, 90, 90, 94, and 95%). ConclusionWe found good PROM improvements and satisfactory outcomes after mUKA in all age groups; however, patients aged 55 to < 65 years had worse changes in FJS and APQ. Results support contemporary indications for mUKA, and applying an age cutoff is unwarranted.

Physical and psychological aspects of multiple sclerosis: Revisiting the Multiple Sclerosis Impact Scale (MSIS-29)

Background: The MSIS-29 measures the physical and psychological impact of MS. Objective: The associations between MSIS-29 domains and demographic/clinical aspects were examined and trajectories analysed over time. Methods: Data were collected in the Trajectories of Outcome in Neurological Conditions study for a diverse population of people with MS, with follow-up for up to 5 years. Following Rasch analysis, minimal important change (MIC) was computed for ensuing total, physical and psychological domains. Results: Fit to the Rasch model using data from 5921 participants validated physical, psychological and total domains, and the conversion table transforms raw scores to interval-level metric equivalents. These domains showed significant differences across demographic (age, gender, employment, education, and marital status) and clinical (subtype, treatment, and duration) factors with large effect sizes. The MIC scores were physical: 9.1, total: 14.1, which were both above measurement error, and psychological: 5.5 which was not, so 1.6% of participants reported psychological change which was clinically important but not statistically significant. Trajectory analysis showed three groups, one stable and two with significant slopes, improving and deteriorating. Conclusion: The MSIS-29 has shown adequate fit to the Rasch model after accommodating problems with local item dependency, through a bi-factor solution. The domains showed good discrimination across key factors.

Impact of prior knee surgery on change in knee pain, quality of life, and walking speed following supervised education and exercise therapy: an analysis of 30,545 people with knee osteoarthritis

To investigate the impact of prior knee surgery on changes in outcomes following an 8-week supervised patient education and exercise therapy program in patients with knee osteoarthritis. Patients were classified according to knee surgery in the most affected knee joint (yes/no) prior to enrolment in the Good Life with osteoArthritis in Denmark (GLA:D®) program. Between-group differences in outcome changes from baseline to 3 months follow-up were evaluated using linear regression stratified by sex. Outcomes were knee pain intensity (VAS, 0–100 mm), joint related quality of life (Knee Injury and Osteoarthritis Outcome Score Quality of Life subscale score (KOOS QOL, 0–100)) and walking speed (40-m fast-paced walk test). To evaluate clinically relevant between-group differences, proportions of patients reaching a threshold of minimal important change in the surgery and non-surgery groups were compared. Among 30,545 patients, 27% (n, 8254) had prior surgery in the most affected knee. The prior surgery and the non-surgery group experienced improvements in all outcomes with minor between-group differences in change in pain intensity (males, 0.03 95% CI − 0.9 to 1.0; females, 1.3 95% CI 0.6 to 2.1); KOOS QOL (males, 0.3 95% CI − 0.4 to 0.9; females 0.02 95% CI − 0.5 to 0.5); and walking speed (males, 0.01 95% CI − 0.01 to 0.02; females 0.01 95% CI 0.003 to 0.02). The responder analysis showed no clinically relevant between-group differences in improvements. Previous knee surgery does not seem to modify the clinical outcome following exercise therapy and patient education in patients with knee osteoarthritis.Key Points• About one in four patients with knee osteoarthritis participating in an 8-week supervised patient education and exercise therapy program had previous knee joint surgery in the most affected knee.• Those with prior knee surgery were more likely to be males, to have prior knee injury, to have a longer symptom duration, and to have a high physical activity level compared to those without previous knee surgery.• Patients with prior knee surgery did not experience clinically relevant less change in knee pain, joint related quality of life, and walking speed after participation in the intervention, compared to those without previous knee surgery.• Patients with previous knee surgery can expect clinical outcomes following exercise therapy and patient education similar to patients without prior knee joint surgery.

Responsiveness of the P4, Patient Specific Functional Scale 2.0, Satisfaction and Recovery Index, and SF-12 in Patients With Musculoskeletal Disorders.

Background Recently, estimation of intervention effects has been recommended using minimum important change (MIC). This study aimed to investigate the responsiveness of the four-item pain intensity measure (P4), Patient Specific Functional Scale 2.0 (PSFS 2.0), Satisfaction and Recovery Index (SRI), and physical (PCS) and mental component summary (MCS) scores of the SF-12v2® Health Survey Acute (QualityMetric Inc. & Fukuhara S, Kyoto) in patients with musculoskeletal disorders and to estimate their MICs. Methodology Data of outpatients receiving musculoskeletal physical therapy were collected using a survey in multi-center cohorts. The participants completed the first survey before their first physical therapy session and the second survey after the third to seventh sessions. Responsiveness was assessed by investigating the area under the receiver operating characteristic curve (AUC) and by investigating prior hypotheses with correlations between change scores. In the former method, the AUCs of the measures were calculated for discriminating improved cases (i.e., 11-point Global Rating of Change Scale (GRCS) ≥ 2) and non-improved cases (i.e., GRCS < 2). The MIC scores were estimated with GRCS using the predictive modeling method. Results Data from 100 participants were analyzed. The PSFS 2.0 satisfied both acceptable responsiveness criteria, the P4 and SRI satisfied the moderate responsiveness criterion of the construct approach only, and the PCS and MCS satisfied both poor responsiveness criteria. The MICs were 1.64, 2.92, 6.16, 4.49, and 1.67 for the P4, PSFS 2.0, SRI, and PCS and MCS scores, respectively. Conclusion The PSFS 2.0 has acceptable responsiveness and can be used to determine treatment effects in clinical practice, while the P4 and SRI can also be used in some cases.

The european organisation for research and treatment of cancer head and neck cancer module (EORTC QLQ-HN43): Estimates for minimal important difference and minimal important change

IntroductionMinimal important change estimates (MIC) are useful for interpreting results of clinical research with quality of life (QoL) as an endpoint. For the European Organisation for Research and Treatment of Cancer head and neck cancer module, the EORTC QLQ-HN43, no such thresholds are established. MethodsHead and neck cancer patients under active treatment (n = 503) from 15 countries completed the EORTC QLQ-HN43 three times (t1: before treatment, t2: three months after t1, t3: six months after t1). A subgroup completed a Subjective Significance Questionnaire (SSQ), indicating experienced change from the previous time point in four QoL domains. QoL was assumed to deteriorate after t1 and improve again until t3. The MIC was established using the average of mean differences in SSQ groups (MICmean) and estimates based on logistic regressions (MICpredict). Additionally, minimal detectable changes (MDC) were computed using 0.5 standard deviation and standard error of the mean. ResultsFor swallowing, speech, dry mouth, and global QoL, the MIC for deterioration were 13, 14, 26, and 10 respectively. The MIC for improvement were 8 (swallowing), 6 (dry mouth), and 5 (global QoL); no MIC for speech improvement can be presented because of insufficient correlation between change score and anchor. The MDC estimates for deterioration were 15, 14, 15, and 11. For improvement, the MDC estimates were 13, 14, 14, and 11. ConclusionsOur results underline that no single MIC or MDC can be applied to all EORTC QLQ-HN43 scales, and that the MIC for deterioration seems larger than those for improvement.

A 7-item Tampa Scale for Kinesiophobia in people with femoroacetabular impingement syndrome: evaluation of structural validity, hypothesis testing, internal consistency and minimally important change

BackgroundThe 17-item Tampa Scale for Kinesiophobia (TSK) is a commonly used patient-reported outcome measure (PROM) to assess kinesiophobia, but the measurement properties of the TSK in people with femoroacetabular impingement syndrome (FAIS) are unknown. Objectives1) Revise the existing TSK by removing items, as needed, with inadequate functioning to optimise the TSK for people with FAIS, and 2) evaluate construct validity (both structural validity and hypothesis testing), internal consistency, and minimal important change. MethodsCross-sectional cohort study including 153 young adults with FAIS. Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were used to evaluate structural validity and the TSK was revised to remove items with poor function, improving CFA model fit. Hypothesis testing, internal consistency (Cronbach's α) and minimal important change (distribution-based method) were also evaluated. ResultsA 7-item version of the TSK provided the best CFA model fit with 10-items functioning poorly and needing to be removed. The 7-item TSK was uni-dimensional (single factor in EFA) and had adequate structural validity (Standardised Root Measure Square = 0.0771). The 7-item TSK had insufficient hypothesis testing with moderate correlations to 8/14 PROMs measuring different constructs. The 7-item TSK had adequate internal consistency (α = 0.783). The minimal important change of the 7-item TSK was 6.00 points (0–100 point scale). ConclusionWe found that the ‘7-item TSK for FAIS’, had superior structural validity to the original 17-item scale, suggesting that it may be more appropriate for use in this population. Further studies should evaluate other measurement properties of the 7-item scale.

Proximal Hamstring Avulsions: Surgical Versus Conservative Treatment Using a Shared Decision-Making Strategy

Background: Surgical treatment of patients with proximal hamstring avulsions provides good results; however, less is known about the outcome in patients who are offered conservative treatment. Purpose: To investigate the effect of surgical or conservative treatment (decided by a shared decision strategy) of proximal hamstring avulsions. Study Design: Cohort study; Level of evidence, 2. Methods: A total of 24 patients with magnetic resonance imaging–verified proximal hamstring avulsion were included and had either surgical treatment (11 patients, 45% women; mean age, 50 ± 16 years) or conservative treatment (13 patients, 46% women; mean age, 50 ± 17 years). At baseline, 6 months and 12 months, all patients answered the Perth Hamstring Assessment Tool (PHAT) (0-100 scale) and Hip Sports Activity Scale (0-8 scale). Patients had their maximal hip extension strength and maximal strength at 30° and 90° of knee flexion measured in newton meters per kilogram using a handheld dynamometer. A minimal important change in PHAT was considered &gt;7 points and a minimal important change in strength was considered &gt;0.15 N·m/kg, respectively. Results: The surgical group had a shorter time from injury to initiation of treatment compared with the conservative group (median: 15 vs 64 days; P = .02). The surgical group had a greater amount of retraction of the tendons compared with the conservative group (3 vs 2 cm; P = .04). From baseline to 12-month follow-up, the surgical and conservative groups improved their mean PHAT scores (35 points [95 CI, 24-45 points] and 20 points [95% CI, 9-31 points], respectively) reaching a median of 79 points (interquartile range [IQR], 66-95 points) in the surgical group and 75 points (IQR, 66-85 points) in the conservative group at the 12-month follow-up. Their Hip Sports Activity Scale levels at 12 months were 3 points (95% CI, 1-4 points) and 1 point (95% CI, 0-3 points) (not significant). Furthermore, the surgical and conservative groups improved their maximal hip extension strength by 0.61 N·m/kg (IQR, 0.42-0.80 N·m/kg) and 0.62 N·m/kg (IQR, 0.13-1.10 N·m/kg), respectively. Their maximal knee flexion strength at 30° improved by 0.52 N·m/kg (IQR, 0.29-0.74 N·m/kg) and 0.32 N·m/kg (IQR, 0.12-0.52 N·m/kg) and their maximal knee flexion strength at 90° improved by 0.28 N·m/kg (IQR, 0.19-0.37 N·m/kg) and 0.22 N·m/kg (IQR, 0.02-0.41 N·m/kg). At the 12-month follow-up, the side-to-side difference in maximal muscle strength was 6% and 7%, respectively, during hip extension and 19% to 25% and 16% to 17%, respectively, during knee flexion. Conclusion: Twelve months after treatment of proximal hamstring avulsion, good clinical outcomes were seen when using a shared decision strategy regardless of whether the strategy led to surgical or conservative treatment.

Translation and cross-cultural adaptation to Spanish of the Anterior Cruciate Ligament Return to Sport after Injury Scale (SP ACL‑RSI): Measurement properties and responsiveness in a multisport sample.

The aim was to translate and adapt The Anterior Cruciate Ligament Return to Sport after Injury Scale (ACL-RSI) to Spanish and provide evidence of its psychometric properties and responsiveness in a both sexes multisport sample. ACL-RSI Spanish version (SP ACL-RSI) was obtained by forward-back-translation method. Internal consistency, test-retest reliability, construct validity and responsiveness were assessed. Standardized response mean (SRM), smallest detectable change (SDC) and minimally important change (MIC) were obtained by anchor-based method. The sample consisted of n = 132 multisport patients who underwent ACL-RSI. Sixty-seven patients (Group A) completed test-retest of the SP ACL-RSI within 15 days and 65 patients (Group B) fulfilled SP ACL-RSI, the Tampa Scale of Kinesiophobia (TSK-11), the International Knee Documentation Committee-Subjective Knee Form (IKDC-SF 2000), the Knee Osteoarthritis Outcome Score (KOOS) preoperative, 6 and 12 months. The SP ACL-RSI shows satisfactory internal consistency (Cronbach's α = 0.95) and test-retest reliability (ICC = 0.92), with acceptable floor (9%) and ceiling (6%) effects. Convergent validity was supported with moderate positive correlations with KOOS and IKDC-SF 2000 dimensions, and a negative correlation with the TSK (p < 0.001). For SDC responsiveness, a high effect was observed with SRM = 0.97 at 12 months, and the MIC for SP ACL-RSI was 15. The SP ACL-RSI is as valid and reliable as the original for measuring emotions, confidence in performance, and re-injury risk on return to sport after ACL-R in Spanish-speaking multisport practitioners of both sexes. Moreover, it shows acceptable responsiveness, performing better at the group level than the individual level. A cohort study (diagnosis); Level II of evidence.

Hip Arthroscopy for Femoroacetabular Impingement Syndrome in High-Level Athletes: A 10-Year Follow-up.

Arthroscopic treatment for femoroacetabular impingement syndrome (FAIS) has previously been reported to have favorable short-term results in high-level athletes. Less is known about long-term outcomes. To report outcomes 10 years after hip arthroscopy for FAIS in high-level athletes using validated patient-reported outcome measures (PROMs). Case series; Level of evidence, 4. Patients who underwent hip arthroscopy between November 2011 and January 2013 were included in a local hip arthroscopy registry and completed preoperative PROMs. At 10-year follow-up, the same PROMs were completed. Inclusion criteria were age <40 years at time of surgery, no prior hip surgeries, and a pre-symptomatic Hip Sports Activity Scale (HSAS) level of 7 or 8. The exclusion criterion was total hip arthroplasty at follow-up. The PROMs included the international Hip Outcome Tool-12 items (iHOT-12), the Copenhagen Hip and Groin Outcome Score (HAGOS), visual analog scale (VAS) for overall hip function, European Quality of Life-5 Dimensions questionnaire (EQ-5D) and European Quality of Life-visual analog scale (EQ-VAS), HSAS, and a single question on patient satisfaction. The rates of patients achieving minimal important change and reporting Patient Acceptable Symptom State (PASS) were reported for HAGOS and iHOT-12. For iHOT-12, preoperative results were compared with 1, 5, and 10-year follow-ups. A total of 45 patients (34 men, 11 women; 70 hips; mean age 24.4 years at time of surgery) were included, with 77 patients eligible for inclusion. Significant improvements (P < .001) were seen at 10-year follow-up in all HAGOS subscales: Symptoms, Pain, Daily Activity, Sports, Physical Activity, Quality of Life (50.3 vs 78.6, 59.2 vs 86.8, 65.9 vs 88.8, 37.1 vs 81.1, 24.4 vs 81.1, 32.1 vs 79.3), iHOT-12 (40.1 vs 81.6), EQ-5D (0.59 vs 0.89), EQ-VAS (65.6 vs 80.4), and VAS for overall hip function (48 vs 79). For iHOT-12, the largest change was seen between preoperative and 1-year follow-up values, with consistent results over time. There was no statistically significant difference between HSAS levels preoperatively and at 10-year follow-up (HSAS level 4), with 24% of patients reporting a HSAS level 7 or 8 at the follow-up. Of the patients, 93% reported satisfaction with the surgery. PASS was achieved in 82% for iHOT-12, with a range of 76% to 91% for HAGOS subscales. Furthermore, 93% exceeded the minimal important change for iHOT-12, and a range of 67% to 84% for HAGOS. In a high-level athletic population, significant improvements in long-term outcomes are reported after hip arthroscopy for FAIS, with patients reporting a high satisfaction rate. The results also show that the largest improvement occurs within the first postoperative year, with results being maintained for 10 years.

Clinical relevance of patient-reported outcome measures in patients who have undergone total hip arthroplasty: a systematic review.

In orthopaedic research, it is crucial to determine changes that are statistically significant and clinically meaningful. One approach to accomplish this is by calculating the Minimal Clinically Important Difference (MCID), the Clinically Important Differences (CID), the Minimum Detectable Change (MDC), the Minimal Important Change (MIC), and the Patient Acceptable Symptom State (PASS) values. These tools assist medical professionals in comprehending the patient's viewpoint, enabling them to establish treatment objectives that align with patients' desires and expectations. The present systematic review investigated the MCID, MIC, CID, MDC, and PASS of the most used PROMs to assess patients who have undergone THA. This systematic review followed the 2020 PRISMA guidelines. Web of Science, Embase, and PubMed were accessed in March 2024 without time constraints or additional filters. All the clinical investigations which evaluated data tools (MCID, MIC, CID, MDC, and PASS) to assess the clinical relevance of PROMs in THA were accessed. Articles in Spanish, Italian, German, and English were eligible. Studies with levels of evidence I to III were eligible. Data from 100,824 patients were collected. All relevant demographic data were analysed and summarised. In addition, the MCID, MIC, CID, MDC and PASS of the COMI, HOOS, SF-36, OHS, Oxford-12, PROMIS-PF, SF-12, and WOMAC scores for THA were determined. Current evidence recommends to collect MCIDs based on anchors routinely. These values should be used as complementary tools to determine the clinical effectiveness of a treatment instead of solely relying on statistically significant improvements. Level IV, systematic review and meta-analysis.

Long-Term Outcomes of Primary Cemented Total Hip Arthroplasty with Acetabular Bone Graft for Protrusio Acetabuli: Minimum 10-Year Follow-Up.

Background: This study reports the long-term survivorship of primary total hip arthroplasty (THA) for protrusio acetabuli. Methods: Patients undergoing THA utilising cement and bone graft acetabular reconstruction for protrusio acetabuli in a university teaching hospital during the period 2003 to 2014 were included. Kaplan-Meier survival estimates were calculated with 95% confidence intervals (CI) up to 15 years following surgery. PROMs were collected pre- and post-operatively for hip-specific function (Oxford Hip Score [OHS]) and health-related quality of life (HRQoL) using the EQ-5D-3L. Results: 129 consecutive THAs (96 patients) performed for protrusio acetabuli were identified (median age 69, IQR 61-75; female 115 [89.1%]; 38 [29.5%] inflammatory arthritis) with a mean follow-up of 15.7 years (range: 10.1-20.1 years). At the final follow-up, fifty-six (43.4%) patients had died and there were eleven (8.5%) reoperations, of which eight (6.2%) involved the revision of the acetabular component. The fifteen-year Kaplan-Meier any-reoperation survival estimate was 91.3% (95% CI 85.9-97.0). When considering all-cause acetabular revision only, the 15-year survival estimate was 93.1% (95% CI 88.2-98.3). The median pre-operative OHS improved significantly from baseline to 1 year post-THA, beyond the minimal important change (mean difference 28, 95% CI 25-30, p < 0.001). Similarly, there were clinically relevant improvements in HRQoL at 1 year post surgery (mean difference 0.10, 95% CI 0.06-0.15, p < 0.001). Conclusions: This study demonstrates that primary cemented THA utilising acetabular bone graft for reconstruction in patients with protrusio acetabuli was associated with 15-year survival rates of 93.1% and clinically relevant improvements in hip-specific function and HRQoL.

Several factors predict the achievement of the patient acceptable symptom state and minimal clinically important difference for patient-reported outcome measures following anterior cruciate ligament reconstruction: A systematic review.

To summarize the predictors of the patient acceptable symptom state (PASS), minimal clinically important difference (MCID) and minimal important change (MIC) for patient-reported outcome measures (PROMs) following anterior cruciate ligament reconstruction (ACLR). MEDLINE, PubMed and Embase were searched from inception to 5 January 2024. The authors adhered to PRISMA/R-AMSTAR guidelines, and the Cochrane Handbook for Systematic Reviews of Interventions. Data on statistical associations between predictive factors and PROMs were extracted. Inverse odds ratios (ORs) and confidence intervals (reverse group comparison) were calculated when appropriate to ensure comparative consistency. Thirteen studies comprising 21,235 patients (48.1% female) were included (mean age 29.3 years). Eight studies comprising 3857 patients identified predictors of PASS, including lateral extra-articular tenodesis (LET) (OR = 11.08, p = 0.01), hamstring tendon (HT) autografts (OR range: 2.02-2.63, p ≤ 0.011), age over 30 (OR range: 1.37-2.28, p ≤ 0.02), male sex (OR range: 1.03-1.32, p ≤ 0.01) and higher pre-operative PROMs (OR range: 1.04-1.21). Eight studies comprising 18,069 patients identified negative predictors of MCID or MIC, including female sex (OR = 0.93, p = 0.034), absence of HT autografts (OR = 0.70, p < 0.0001), higher pre-operative PROMs (OR = 0.76-0.84, p ≤ 0.01), meniscectomy (OR = 0.67, p = 0.014) and collision sports (OR = 0.02-0.60, p ≤ 0.05). Higher pre-operative PROMs, age over 30, male sex, LETs and HT autografts predicted PASS achievement. Lower pre-operative PROMs, male sex, non-collision sports, and lack of meniscectomies predicted MCID/MIC achievement. This review provides a comprehensive understanding of the predictors of clinically significant post-ACLR outcomes, thus improving clinical decision-making and the management of patient expectations. Level IV.

Outcomes Following Staged Bilateral Total Knee Replacements: The Influence of First-Side Surgery on Results of the Second Side.

Background In the UK, the vast majority of bilateral total knee replacements (BTKRs) are performed as staged procedures. Historically, the second-operated knee, in patients undergoing staged BTKRs, has poorer outcomes compared with the first-operated knee. The aim was to review patient-reported outcome measures (PROMs) for staged BTKRs. To further assess if outcomes from the first side of surgery can predict results on the second side. Methods A retrospective analysis was conducted on a consecutive cohort of staged BTKRsusing the same approach and techniquefrom August 2009 to January 2020. PROMs were recorded by means of Oxford Knee Scores (OKS) preoperatively, at six weeks postoperatively, and at one year. The minimal important change (MIC) in PROMs was set at ≥5. Results A total of 186 consecutive staged BTKRswere carried out in 93 patients. The average interval between surgeries was 28 months, ranging from 3 to 100 months. The mean age was 65.3 years for the first side and 67.7 years for the second side, with 58.1% of the patients (54/93) being female. The mean body mass index (BMI) was 35.1 for the first side and increased to 35.8 for the second side (p=0.503). One-year follow-up PROMswere available for 97.8% of the first-side surgeries and 89.2% of the second-side surgeries. The average improvement in PROMs at one year was 18.3 for the first side and 15.8 for the second side (p=0.108). A total of 95.6% of patients achieved the MICfor the first side, while 87.9% achieved it for the second side (p=0.340). Fourteen TKRs performed in 13 patients did not achieve MIC at one year. Among these 13 patients, three (23.1%) did not reach MIC after the first-side surgery, compared to nine (61.5%) after the second-side surgery. One patient did not achieve MIC for either side. Of the 14 TKRs that failed to reach MIC in one year, 10 eventually met MIC in two years. The four TKRs that did not achieve MIC at two years were performed on females with high BMIs. Conclusion This study found no significant difference in PROMs improvements between the first and second sides of staged BTKRs at one-year follow-up. A failure to reach the MICon one side does not affect the success of the other side. Most patients who do not achieve MIC in one year are likely to reach it in two years. Persistent poor scores were associated with high BMI and female sex.

Time to Navigate: A Practical Objective Clinical Measure for Freezing of Gait Severity in People With Parkinson Disease

ObjectivesTo provide an easy-to-use measure, as existing objective assessments for freezing of gait (FOG) severity may be unwieldy for routine clinical practice, this study explored time taken to complete the recently validated FOG severity tool and its components. DesignA cross-sectional study. SettingOutpatient clinics of a tertiary hospital. ParticipantsPeople with Parkinson disease who could independently ambulate 8-meters, understand instructions, and without co-morbidities affecting gait were consecutively recruited. Thirty-five participants were included (82.9% [n=29] male; median [IQR]: age of 73.0 [11.0] years and disease duration of 4.0 [4.5] years). InterventionsNot applicable. Main Outcome MeasuresParticipants were assessed with the FOG severity tool in a test-retest design, with time taken for each component recorded using a stopwatch during video-analysis. Validity of total FOG severity tool time, time taken to complete its turning and narrow-space components (i.e., time to navigate [TTN]), and an adjusted TTN were examined through correlations with validated FOG severity outcomes. To facilitate clinical interpretation, the TTN cut-off was determined using scatterplot smoothing regression, whereas minimal important change was calculated using predictive modeling. ResultsThe FOG severity tool time, TTN, and adjusted TTN similarly demonstrated moderate correlations with the FOG questionnaire and percentage-FOG, and very high correlations with FOG severity tool–revised. The TTN was nonlinearly related to FOG severity, with a positive relationship observed in the first 300 seconds and plateauing after. minimal important change for TTN was 15.4 seconds reduction in timing (95% CI, 3.2-28.7). ConclusionsThe TTN is a feasible, interpretable, and valid test of FOG severity. In busy clinical settings, TTN can provide a viable alternative when use of existing objective FOG measures is (often) unfeasible.

Effect of present state bias on minimal important change estimates: a simulation study.

The minimal important change (MIC) in a patient-reported outcome measure is often estimated using patient-reported transition ratings as anchor. However, transition ratings are often more heavily weighted by the follow-up state than by the baseline state, a phenomenon known as "present state bias" (PSB). It is unknown if and how PSB affects the estimation of MICs using various methods. We simulated 3240 samples in which the true MIC was simulated as the mean of individual MICs, and PSB was created by basing transition ratings on a "weighted change", differentially weighting baseline and follow-up states. In each sample we estimated MICs based on the following methods: mean change (MC), receiver operating characteristic (ROC) analysis, predictive modeling (PM), adjusted predictive modeling (APM), longitudinal item response theory (LIRT), and longitudinal confirmatory factor analysis (LCFA). The latter two MICs were estimated with and without constraints on the transition item slope parameters (LIRT) or factor loadings (LCFA). PSB did not affect MIC estimates based on MC, ROC, and PM but these methods were biased by other factors. PSB caused imprecision in the MIC estimates based on APM, LIRT and LCFA with constraints, if the degree of PSB was substantial. However, the unconstrained LIRT- and LCFA-based MICs recovered the true MIC without bias and with high precision, independent of the degree of PSB. We recommend the unconstrained LIRT- and LCFA-based MIC methods to estimate anchor-based MICs, irrespective of the degree of PSB. The APM-method is a feasible alternative if PSB is limited.

The gap between statistical and clinical significance: time to pay attention to clinical relevance in patient-reported outcome measures of insomnia

BackgroundAppropriately defining and using the minimal important change (MIC) and the minimal clinically important difference (MCID) are crucial for determining whether the results are clinically significant. The aim of this study is to survey the status of randomized controlled trials (RCTs) for insomnia interventions to assess the inclusion and interpretation of MIC/MCID values.MethodsWe conducted a cross-sectional study to survey the status of RCTs for insomnia interventions to assess the inclusion and appropriate interpretation of MIC/MCID values. A literature search was conducted by searching the main sleep medicine journals indexed in PubMed, the Excerpta Medica Database (EMBASE), and the Cochrane Central Register of Controlled Trials (CENTRAL) to identify a broad range of search terms. We included RCTs with no restriction on the intervention. The included studies used the Insomnia Severity Index (ISI) or the Pittsburgh Sleep Quality Index (PSQI) questionnaire as the outcome measures.Results81 eligible studies were identified, and more than one-third of the included studies used MIC/MCID (n = 31, 38.3%). Among them, 21 studies with ISI as the outcome used MIC defined as a relative decrease ranging from 3 to 8 points. The most frequently used MIC value was a 6-point decrease (n = 7), followed by 8-point (n = 6) and 7-point decrease (n = 4), a 4 to 5-points decrease (n = 3), and a 30% reduction from baseline; 6 studies used MCID values, ranging from 2.8 to 4 points. The most frequently used MCID value was a 4-point decrease in the ISI (n = 4). 4 studies with PSQI as the outcome used a 3-point change as the MIC (n = 2) and a 2.5 to 2.7-point difference as MCID (n = 2). 4 non-inferiority design studies considered interval estimation when drawing clinically significant conclusions in their MCID usage.ConclusionsThe lack of consistent MIC/MCID interpretation and usage in outcome measures for insomnia highlights the urgent need for further efforts to address this issue and improve reporting practices.

'A Meaningful Difference, but Not Ultimately the Difference I Would Want': A Mixed-Methods Approach to Explore and Benchmark Clinically Meaningful Changes in Aphasia Recovery.

Outcome measurement instruments (OMIs) are used to gauge the effects of treatment. In post-stroke aphasia rehabilitation, benchmarks for meaningful change are needed to support the interpretation of patient outcomes. This study is part of a research programme to establish minimal important change (MIC) values (the smallest change above which patients perceive themselves as importantly changed) for core OMIs. As a first step in this process, the views of people with aphasia and clinicians were explored, and consensus was sought on a threshold for clinically meaningful change. Sequential mixed-methods design was employed. Participants included people with post-stroke aphasia and speech pathologists. People with aphasia were purposively sampled based on time post-stroke, age and gender, whereas speech pathologists were sampled according to their work setting (hospital or community). Each participant attended a focus group followed by a consensus workshop with a survey component. Within the focus groups, experiences and methods for measuring meaningful change during aphasia recovery were explored. Qualitative data were transcribed and analysed using reflexive thematic analysis. In the consensus workshop, participants voted on thresholds for meaningful change in core outcome constructs of language, communication, emotional well-being and quality of life, using a six-point rating scale (much worse, slightly worse, no change, slightly improved, much improved and completely recovered). Consensus was defined a priori as 70% agreement. Voting results were reported using descriptive statistics. Five people with aphasia (n = 4, > 6 months after stroke; n = 5, < 65 years; n = 3, males) and eight speech pathologists (n = 4, hospital setting; n = 4, community setting) participated in one of four focus groups (duration: 92-112 min). Four themes were identified describing meaningful change as follows: (1) different for every single person; (2) small continuous improvements; (3) measured by progress towards personally relevant goals; and (4) influenced by personal factors. 'Slightly improved' was agreed as the threshold of MIC on the anchor-rating scale (75%-92%) within 6 months of stroke, whereas after 6 months there was a trend towards supporting 'much improved' (36%-66%). Our mixed-methods research with people with aphasia and speech pathologists provides novel evidence to inform the definition of MIC in aphasia rehabilitation. Future research will aim to establish MIC values for core OMIs. This work is the result of engagement between people with lived experience of post-stroke aphasia, including people with aphasia, family members, clinicians and researchers. Engagement across the research cycle was sought to ensure that the research tasks were acceptable and easily understood by participants and that the outcomes of the study were relevant to the aphasia community. This engagement included the co-development of a plain English summary of the results. Advisors were remunerated in accordance with Health Consumers Queensland guidelines. Interview guides for clinicians were piloted by speech pathologists working in aphasia rehabilitation.

Responsiveness and minimal important change of specific and generic patient-reported outcome measures for back patients: the Norwegian Neck and Back Register

PurposeTo evaluate responsiveness and minimal important change (MIC) of Oswestry Disability Index (ODI), pain during activity on a numeric rating scale (NRSa) and health related quality of life (EQ-5D) based on data from the Norwegian neck and back registry (NNRR).MethodsA total of 1617 patients who responded to NNRR follow-up after both 6 and 12 months were included in this study. Responsiveness was calculated using standardized response mean and area under the receiver operating characteristic (ROC) curve. We calculated MIC with both an anchor-based and distribution-based method.ResultsThe condition specific ODI had best responsiveness, the more generic NRSa and EQ-5D had lower responsiveness. We found that the MIC for ODI varied from 3.0 to 9.5, from 0.4 to 2.5 for NRSa while the EQ5D varied from 0.05 to 0.12 depending on the method for calculation.ConclusionIn a register based back pain population, the condition specific ODI was more responsive to change than the more generic tools NRSa and EQ5D. The variations in responsiveness and MIC estimates also indicate that they should be regarded as indicative, rather than fixed estimates.