Subjective Patient-reported Outcomes Research Articles

Correlation of Functional Measures of Mobility with Patient-Reported Outcomes after Total Ankle Arthroplasty

Category: Ankle Introduction/Purpose: Patients undergoing total ankle arthroplasty (TAA) have a proven track record of clinical improvements in subjective patient-reported outcome measures (PROMs) and objective measures with three dimensional gait analysis. Each represents a valid, but different kind of information, and both are important. What is unknown is whether and how objective improvements as measured by gait analysis correlate with the improvements measured by PROMs. The goal of this study was to investigate the correlation between objective function and PROMs in patients undergoing TAA. Methods: Seventy-six patients (28m/48f) aged 61 (37-79) with a mean BMI of 29.60 (19.63-46.64) and greater than 1-year follow-up underwent preoperative and postoperative gait analysis. Temporal-spatial, kinematic, and kinetic parameters of gait were recorded. Patients also completed AOFAS Ankle/Hindfoot scores, visual analog score for pain (VAS), and the MOS 36-Item Short-Form Health Survey (SF-36) questionnaires within two weeks of their preoperative gait analysis and at the one-year postoperative gait analysis. A t-test for dependent means was used to compare preoperative and postoperative outcomes. Additionally, a Pearson correlation coefficient was utilized to measure the strength of association between parameters of gait and PROMs. A p-value of < 0.05 was considered to be statistically significant. Results: Gait Analysis: Patients had a statistically significant improvement in all temporal-spatial parameters of gait, in total range of motion, mean maximum plantarflexion, and ankle power. Patient-reported outcome measures: A statistically significant and clinically meaningful significant improvement was detected for AOFAS score, VAS score, and SF-36-Physical score. Changes in the SF-36-Mental score were not detected to be statistically significant or clinically significant. Correlation: The AOFAS score had a moderate positive correlation with preoperative walking-speed, step-length and ankle-power, postoperative walking-speed, step-length and ankle-power, and improvement in walking-speed, cadence, and ankle-power. The SF-36-Physical score had a weak to moderate positive correlation with preoperative walking speed, step length, and ankle power and postoperative walking speed, step length and ankle power. No correlation between VAS or SF-36-Mental score and function could be detected. Conclusion: There is a moderate correlation with AOFAS and SF-36-Physical scores between walking speed (temporal-spatial parameters), and ankle push-off power (kinetic parameters). PROMs did not correlate with improvements in ROM (kinematic parameters). This may challenge the assumption that preservation of motion is the most important role of TAA. The data may be interpreted to mean cadence, walking-speed, step-length and ankle power are the most important aspects of gait with respect to patients’ perceived outcomes. However, perhaps ROM is important to patient satisfaction – but the outcome measures we use are not sufficiently sensitive/specific to measure the effect of improved or maintained motion.

There is no difference between quadriceps- and hamstring tendon autografts in primary anterior cruciate ligament reconstruction: a 2-year patient-reportedoutcome study.

Graft choice for anterior cruciate ligament (ACL) reconstruction is crucial, however the optimal graft source remains a topic of controversy. The purpose of this study is to compare subjective and functional patient-reported outcomes (PRO) after single-bundle ACL reconstruction using quadriceps tendon (QT) or hamstring tendon (HT) autografts for single-bundle ACL reconstruction. We hypothesize that there is no difference in patient-reported functional outcomes after ACL reconstruction using either HT- or QT autograft. All data were extracted from a prospectively collected ACL registry. A total of 80 patients with at least 2-year follow-up were included in this study. A total of 40 patients with primary ACL reconstruction using a QT autograft harvested via a minimally invasive technique were matched by sex, age and pre-injury Tegner and Lysholm score to 40 patients who received HT autografts. Subjective and functional PRO scores including Lysholm score, Tegner activity level and visual analogue scale for pain were obtained at 6, 12 and 24months after index surgery. No significant difference between the QT and the HT group was seen at any follow-up in regard to any of the PRO scores for function or pain. 24months post-surgery the mean Tegner activity score of the HT group was significantly (p=0.04) lower compared to the pre-injury status. At final follow-up, 27 patients (67.5%) in the QT group and 32 patients (80.0%) in the HT returned to their pre-injury activity level (n.s.). A total of 37 patients (92.5%) of the QT cohort and 35 patients (87.5%) of the HT cohort reported "good" or "excellent" results according to the Lysholm score (n.s.). "No pain" or "slight pain" during severe exertion was reported by 33 patients (82.5%) with QT autograft and 28 patients (82.4%) with HT autograft (n.s.). There is no significant difference between PRO 2years post-operative using either QT or HT autografts. Both QT and HT grafts show acceptable and comparable PRO scores making the QT a reliable graft alternative to HT for primary ACL reconstruction. III.

Arthroscopic Mechanical Chondroplasty of the Knee Is Beneficial for Treatment of Focal Cartilage Lesions in the Absence of Concurrent Pathology.

Background:Articular cartilage lacks the ability for intrinsic repair after acute injury, and focal articular cartilage lesions cause significant morbidity worldwide. Arthroscopic debridement (chondroplasty) represents the majority of cartilage procedures of the knee; however, limited data exist regarding outcomes after chondroplasty performed in isolation of concurrent procedures or not as a primary treatment for osteoarthritis (OA).Hypothesis:Arthroscopic mechanical chondroplasty is beneficial for patients with a focal cartilage lesion of the knee in the absence of meniscal pathology or OA.Study Design:Case series; Level of evidence, 4.Methods:Potential participants were identified by querying billing data from a 3-year period in a single-surgeon practice, and eligible patients were verified to meet inclusion criteria through electronic medical record review. OA was quantified through Kellgren-Lawrence (KL) scoring. Subjective patient-reported outcome (PRO) scores, including International Knee Documentation Committee (IKDC), Knee injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), Tegner, Lysholm, and Veterans RAND 12-Item Health Survey (VR-12), were collected preoperatively and at follow-up intervals. International Cartilage Repair Society (ICRS) grade and lesion size were determined at arthroscopy. Linear regression was used to determine the effect of baseline score on final follow-up score. Correlated regression equations were used to assess the relationship of covariates and change in PRO scores.Results:Fifty-three of 86 (62%) eligible participants completed postoperative questionnaires at an average of 31.5 months (range, 11.5-57 months). The mean patient age was 37.3 ± 9.7 years and mean body mass index (BMI) was 27.7 ± 5.6 kg/m2; 33 (62%) participants were women. The mean treated lesion size was 3.3 ± 1.9 cm2, of these, 36 (68%) were ICRS grade 2 or 3, and 42 (79%) patients had a KL score of 0 to −2. On average, the cohort demonstrated significant improvement from baseline for almost all PRO scores. Regression analysis of change in score versus baseline indicated participants with lower preoperative scores gained more benefit from chondroplasty. Correlated regression equations showed KL score >0 and male sex had a consistent positive effect on change in PRO scores, high ICRS grade had a consistent negative effect, and lesion size, age, and obesity had no effect. Eight patients (15%) required further surgical intervention within the follow-up period.Conclusion:The clinical efficacy of chondroplasty for repair of focal cartilage defects of the knee has not been studied in isolation from concurrent orthopaedic procedures. Our data show that arthroscopic mechanical chondroplasty is beneficial to patients, and response to surgical intervention is correlated with baseline PRO scores, sex, ICRS grade, and KL score.

Management of Posterior Cruciate Ligament Tibial Avulsion Injuries: A Systematic Review

Background: Tibial-sided avulsion injuries of the posterior cruciate ligament (PCL) generally require surgical intervention. No consensus exists concerning the optimal surgical treatment approach for these injuries. Purpose: To perform a systematic review investigating the open and arthroscopic surgical treatment modalities, outcomes, and complications of PCL tibial-sided bony avulsions. Study Design: Systematic review; Level of evidence, 4. Methods: The authors performed a systematic review of the literature utilizing PubMed and EMBASE from 1975 to present outlining open versus arthroscopic surgical repair of PCL bony avulsion injuries and comparing subjective and objective postoperative patient-reported outcomes, including Tegner, IKDC (International Knee Documentation Committee), and Lysholm scoring systems, as well as rates of patient complications. The quest was performed in June 2016, and searched terms included posterior cruciate ligament, PCL, bony, avulsion(s), tibial-sided, open, and arthroscopic. Inclusion criteria included English-language studies involving surgical fixation strategies for PCL tibial-sided bony avulsions. Exclusion criteria included non-English language, case studies/case series, and subject matter not pertaining to PCL bony avulsions. Results: Twenty-eight articles comprising 637 patients met the criteria and were included in the final review. PCL injuries with a tibial-sided avulsion were the result of motor vehicle accidents in 68.4% of patients, with 59.0% of these injuries resulting from motorcycle accidents. The arthroscopic group had better IKDC grade A scores (78.9%), indicating a normal knee postoperatively, as compared with the open group (65.9%). The postoperative Lysholm scores were similar between the groups, with a mean of 95.0 in the arthroscopic group and 92.8 in the open group. The arthroscopic group also reported 100% return to preinjury level of activity, compared with 86.2% in the open group. The most common complication in both groups was arthrofibrosis, which was reported more often in the arthroscopic group (0%-35%) versus the open treatment group (0%-25%). Conclusion: In patients with displaced tibial-sided PCL avulsion fractures treated operatively, surgical approaches render similar outcomes and risks. While the arthroscopic group had somewhat higher subjective and objective knee outcome scores, it demonstrated a slightly higher rate of arthrofibrosis. The clear advantage of the arthroscopic approach is that concomitant intra-articular injuries seen on preoperative magnetic resonance imaging, such as meniscal tears or osteochondral loose fragments, can be addressed at the time of the index operation.

Magnetic Resonance Imaging Characterization and Clinical Outcomes After NeoCart Surgical Therapy as a Primary Reparative Treatment for Knee Cartilage Injuries

Background: Autologous cartilage tissue implants, including the NeoCart implant, are intended to repair focal articular cartilage lesions. Short-term results from United States Food and Drug Administration (FDA) phase I and phase II clinical trials indicated that the NeoCart implant was safe when surgically applied as a cell-based therapy and efficacious compared with microfracture. Hypothesis: Quantitative magnetic resonance imaging (MRI) analysis would reveal NeoCart tissue maturation through to 60-month follow-up. Study Design: Case series; Level of evidence, 4. Methods: Patients with symptomatic full-thickness cartilage lesions of the distal femoral condyle were treated with NeoCart in FDA clinical trials. Safety and efficacy were evaluated prospectively by MRI and clinical patient-reported outcomes (PROs) through to 60-month follow-up. Qualitative MRI metrics were quantified according to modified MOCART (magnetic resonance observation of cartilage repair tissue) criteria, with an independent evaluation of repair tissue signal intensity. Subjective PROs and objective range of motion (ROM) were obtained at baseline and through to 60 months. Results: Twenty-nine patients treated with NeoCart were observed over a mean of 52.0 ± 15.5 months (median, 60 months). MOCART analyses indicated significant improvement (P < .001) in cartilage quality from 3 to 24 months, with stabilization from 24 to 60 months. Signal intensity of the repair tissue evolved from hyperintense at early follow-up to isointense after 6 months and to hypointense after 24 months. The temporal progression toward hypointense T2 signals at later time points observed here indicated a further reorganization of the repair tissue toward a dense tissue that was less similar to the surrounding native tissue. However, 80% of patients showed evidence of subchondral bone changes on MRI at all time points; 4 patients (14%) showed no improvement of MRI criteria. Compared with baseline values, significant improvement (P < .001) was seen in PROs (mean [±SD] baseline to mean [±SD] final follow-up), including the International Knee Documentation Committee score (47.9 ± 17.4 to 75.5 ± 22.1), physical component summary of the Short Form–36 (40.5 ± 7.2 to 51.4 ± 8.1), and all 5 domains of the Knee injury and Osteoarthritis Outcome Score (Pain: 64.8 ± 12.1 to 86.1 ± 17.3; Activities of Daily Living: 75.5 ± 14.8 to 91.6 ± 13.8; Quality of Life: 28.6 ± 15.5 to 69.4 ± 28.0; Symptoms: 65.8 ± 13.8 to 86.6 ± 13.4; Sports and Recreation: 41.4 ± 24.3 to 72.4 ± 28.8). Significant (P < .0001) decreases from baseline scores for the visual analog scale for pain (34.6 ± 22.5) were seen by 6 months and sustained at final follow-up (14.3 ± 18.4). ROM significantly (P < .0001) improved from baseline (131.5° ± 7.9°) to final follow-up (140.7° ± 6.3°). Conclusion: Longitudinal MRI analysis demonstrated that NeoCart-based repair tissue is durable and evolves over time. For a majority of patients, this progression trended from an initial hyperintense signal to a hypointense signal at later follow-ups. Changes in radiographic measures over time corresponded with improvement in clinical measures, with maximum benefits experienced at 24-month follow-up. Similarly, clinical efficacy for the total cohort, determined by clinical outcome scores, reached a maximum at 24 months without decline to 60 months. Results from safety and exploratory clinical trials indicate that NeoCart is a safe and effective treatment for articular cartilage lesions through to 5-year follow-up. Registration: NCT00548119 (ClinicalTrials.gov identifier).

Sham surgical procedures for pain intervention result in significant improvements in pain: systematic review and meta-analysis

ObjectiveTo perform a systematic review and meta-analysis to study the magnitude of the placebo effect associated with sham surgery procedures. Study Design and SettingWe conducted a systematic search for randomized controlled clinical trials comparing any type of surgery to a corresponding sham placebo group and compared improvements in the sham treatment arms in subjective, objective, categorical, and continuous outcomes, as well as complication rates and mortality. Effect sizes were reported as standardized mean differences (SMDs). This is a systematic review and meta-analysis. ResultsThe overall effect size for pain improvement after sham surgery was SMD = 0.22 (95% confidence interval [CI] = 0.08–0.35) with improvement most marked at 1 month (SMD = 0.34, 95% CI = 0.26–0.43). There was a higher rate of improvement in subjective outcomes compared to objective outcomes for both dichotomized (number of patients with improvement) (42.8% compared to 27.1%) and continuous outcomes (SMD = 0.12, 95% CI = −0.05, 0.30 vs. SMD = −0.01, 95% CI = −0.05, 0.03). There were no deaths in the sham treatment arms and major complications were very rare (0.2%, 95% CI = 0.0–0.6%). ConclusionSham surgery is associated with a large improvement in pain and other subjective patient-reported outcomes but with relatively small effect on objective outcomes. Sham surgeries are overwhelmingly safe. The magnitude of this effect should be used when planning future sham-controlled surgery trials.

日本人原発性胆汁性胆管炎患者の自覚症状および患者報告アウトカムの評価

原発性胆汁性胆管炎（primary biliary cholangitis；PBC）の自覚症状として皮膚掻痒，疲労，口腔・眼の乾燥が知られているが，日本人患者におけるその実態は明らかになっていない．我々はPBC特異的QOL評価尺度“PBC-40”日本語版を作成し，外来通院中の日本人PBC患者180例を対象として，PBC-40，健康関連QOL評価尺度SF-36，疲労症状評価尺度FFSS，抑うつ・不安評価尺度HADS，以上4種の客観的QOL評価尺度への記入を依頼し，日本語版PBC-40の妥当性を検証するとともに日本人PBC患者の自覚症状を解析した．その結果，疲労・皮膚掻痒・乾燥それぞれの症状について26%，31%，54%のPBC患者が中等度以上という評価をしており，すべての症状に対して「なし」，あるいは軽度という評価をしたのは全体の32%であった．皮膚掻痒は肝硬変の有無と，乾燥は年齢との間に相関がみられた．SF-36による全般的QOL評価では，「全体的健康感」「日常役割機能（身体）」「活力」「心の健康」の4ドメインにおいて健常人に比較してQOLが低下していた．

Assessment of physical function following total hip arthroplasty: Inertial sensor based gait analysis is supplementary to patient-reported outcome measures

BackgroundFunctional outcome assessment after total hip arthroplasty often involves subjective patient-reported outcome measures whereas analysis of gait is more objective. The study's aims were to compare subjective and objective functional outcomes after total hip arthroplasty between patients with low and high self-reported levels of pre-operative physical function. MethodsPatients undergoing total hip arthroplasty (n=36; m/f=18/18; mean age=63.9; SD=9.8years; BMI=26.3; SD=3.5) were divided into a low and high function subgroup, and prospective measures of WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) function score and gait were compared at baseline and 3 and 12months post-operatively. FindingsWOMAC function scores significantly improved in both low and high function subgroups at 3months post-operatively whereas gait parameters only improved in patients with a low pre-operative function. Between 3 and 12months post-operatively, WOMAC function scores had not significantly further improved whereas several gait parameters significantly improved in the low function group. WOMAC function scores and gait parameters were only moderately correlated (Spearman's r=0.33–0.51). InterpretationIn a cohort of patients undergoing total hip arthroplasty, pre-operative differences in mean WOMAC function scores and gait parameters between low and high function subgroups disappeared by 3months post-operatively. Gait parameters only improved significantly during the first 3 post-operative months in patients with a low pre-operative function, highlighting the importance of investigating relative changes rather than the absolute changes and the need to consider patients with high and low functions separately.

Self-reported post-operative recovery in children: development of an instrument.

According to the United Nations (1989), children have the right to be heard and to have their opinions respected. Since post-operative recovery is an individual and subjective experience and patient-reported outcome measures are considered important, our aim was to develop and test an instrument to measure self-reported quality of recovery in children after surgical procedures. Development of the instrument Postoperative Recovery in Children (PRiC) was influenced by the Quality of Recovery-24, for use in adults. Eighteen children and nine professionals validated the items with respect to content and language. A photo questionnaire was developed to determine whether the children's participation would increase compared with the text questionnaire. The final instrument was distributed consecutively to 390 children, ages 4-12 years, who underwent tonsil surgery at four hospitals in Sweden. A total of 238 children with a mean age of 6.5 years participated. According to the parents, 23% circled the answers themselves and 59% participated to a significant degree. However, there was no significant difference in participation between those who received a photo versus a text questionnaire. Psychometric tests of the instrument showed that Cronbach's alpha for the total instrument was 0.83 and the item-total correlations for 22 of the items were ≥0.20. Our results support use of the PRiC instrument to assess and follow-up on children's self-reported post-operative recovery after tonsil operation, both in clinical praxis as well in research.

Psychosexual development in men with congenital hypogonadotropic hypogonadism on long-term treatment: a mixed methods study.

IntroductionCongenital hypogonadotropic hypogonadism (CHH) is a rare, genetic, reproductive endocrine disorder characterized by absent puberty and infertility. Limited information is available on the psychosocial impact of CHH and psychosexual development in these patients.AimThe aim of this study was to determine the impact of CHH on psychosexual development in men on long-term treatment.MethodsA sequential mixed methods explanatory design was used. First, an online survey (quantitative) was used to quantify the frequency of psychosexual problems among CHH men. Second, patient focus groups (qualitative) were conducted to explore survey findings in detail and develop a working model to guide potential nursing and interdisciplinary interventions.Main Outcome MeasuresPatient characteristics, frequency of body shame, difficulty with intimate relationships, and never having been sexually active were assessed. Additionally, we collected subjective patient-reported outcomes regarding the impact of CHH on psychological/emotional well-being, intimate relationships, and sexual activity.ResultsA total of 101 CHH men on long-term treatment (>1 year) were included for the analysis of the online survey (mean age 37 ± 11 years, range 19–66, median 36). Half (52/101, 51%) of the men had been seen at a specialized academic center and 37/101 (37%) reported having had fertility-inducing treatment. A high percentage of CHH men experience psychosexual problems including difficulty with intimate relationships (70%) and body image concerns/body shame (94/101, 93%), and the percentage of men never having been sexually active is five times the rate in a reference group (26% vs. 5.4%, P < 0.001). Focus groups revealed persisting body shame and low self-esteem despite long-term treatment that has lasting impact on psychosexual functioning.ConclusionsCHH men frequently experience psychosexual problems that pose barriers to intimate relationships and initiating sexual activity. These lingering effects cause significant distress and are not ameliorated by long-term treatment. Psychosexual assessment in CHH men with appropriate psychological support and treatment should be warranted in these patients. Dwyer AA, Quinton R, Pitteloud N, and Morin D. Psychosexual development in men with congenital hypogonadotropic hypogonadism on long-term treatment: A mixed methods study. Sex Med 2015;3:32–41.

Clinical usefulness of diquafosol for real-world dry eye patients: a prospective, open-label, non-interventional, observational study.

This study was designed to evaluate the efficacy and safety of 3% diquafosol ophthalmic solution in dry eye patients in clinical practice. Subjects were dry eye patients who had never used diquafosol, and observation was conducted prospectively over 2 months. The corneal and conjunctival fluorescein staining score, tear film break-up time, 12 dry eye-related subjective symptoms, patient-reported outcomes, and adverse events were investigated. Data were collected from 465 medical institutions for 3,196 patients. Diquafosol led to significant improvement in all subjective symptoms and objective findings (P < 0.001, paired t test). Diquafosol was effective regardless of the degree of severity according to the corneal and conjunctival fluorescein staining score or therapeutic pattern. Overall, 76.0% patients responded that their condition had improved. Adverse reactions were observed in 6.3% of patients. The major adverse reactions were eye discharge, eye irritation, and eye pain. Diquafosol was effective for various dry eye patients in clinical practice, and no significant safety-related problems occurred.

Recovery in knee range of motion reaches a plateau by 12 months after total knee arthroplasty.

The primary aim of this study was to identify the time point at which improvements in knee range of motion reach a plateau, if any. The secondary aim of this study was to investigate the correlation between the improvements in knee range of motion and patient-reported outcomes [Oxford knee score (OKS) and SF-36]. The hypothesis is that there is a time point at which the recovery in the knee range of motion after total knee arthroplasty (TKA) plateaus. A prospective study of 145 patients who underwent TKA was conducted. All TKAs were performed by the same surgeon. OKS and SF-36 scores were measured preoperatively and at 6, 12, and 24 months. Range of motion was measured preoperatively and at 1, 3, 6, 12, and 24 months postoperatively. This study shows that for surgeon/therapist reported range of motion, a plateau in recovery was reached at 12 months after TKA. It was also found that range of extension is significantly correlated with OKS, whereas range of flexion was not significantly correlated with OKS. Knowledge of when patients fully recover after TKA will allow appropriate counseling of patients during preoperative consultation. Also, this knowledge will enable surgeons/therapists to better monitor the rehabilitation progress of TKA patients, and make adjustments to the rehabilitation protocol. In addition, our study shows that objective surgeon-/therapist-measured outcome (range of motion) has a significant correlation with subjective patient-reported outcomes (OKS). Hence, both outcome measures should be employed in the postoperative monitoring of patient progress. Prospective case series, Level IV.

PC-FACS

PC-FACS

Predictors of deterioration of symptoms and quality of life in patients with sarcoidosis

Introduction. The most frequent clinical outcomes in sarcoidosis patients are typically focused on the objective measurements of functions of the involved organs, but, generally, they do not take into account the individual perception of patients? everyday functioning. The aim of this study was to determine the type of association between the subjective disease outcomes and other objective conventional parameters in patients with sarcoidosis. Material and Methods. In the cross-sectional study including 172 sarcoidosis patients (122 females), quality of life was measured by a generic instrument, i.e. fifteen-dimensional measure of health-related quality of life together with a respiratory specific instrument, i.e. St George?s Respiratory Questionnaire; symptoms of fatigue were measured by Fatigue Scale and dyspnea was measured by the Basal Dyspnea Index. Body-mass index and the course of the disease (acute vs. chronic) were also evaluated. Pulmonary function was assessed by spirometry. Results. Acute sarcoidosis was present in 48 (28%) patients. Mean body mass index was 27.01?5.2. Only 20 (12%) patients had lower forced expiratory volume in one second values (&lt;80%) that indicated the existance of obstructive ventilatory impairment. Multivariate linear regression analysis revealed that body mass index, clinical course of disease and spirometric parameter forced expiratory volume in one second were the significant predictors (R2=0.929, p&lt;0.01) of sarcoidosis related fatigue (B=0.061, B=0.406, B=0.452; respectively). Body mass index and forced expiratory volume in one second were the only parameters that significantly predicted both patients? quality of life (R2=0.932; B=0.017, B=0.263) and dyspnea (R2=0.847; B=0.025, B=0.668). Conclusions. It is important to measure both subjective patient-reported outcomes and objective disease parameters in sarcoidosis since they represent different aspects of the disease. All applied measuring instruments for the examined subjective outcomes demonstrated good measuring properties.

Impact of response shift on longitudinal quality-of-life assessment in cancer clinical trials

The assessment of longitudinal change in subjective patient-reported outcomes such as health-related quality of life (HRQoL) is a key component of many clinical and research evaluations. A major goal of measuring patient-reported HRQoL is to determine to what extent changes in HRQoL reports over time represent true changes in HRQoL due to treatment or cancer and to what extent they reflect measurement error. Indeed, the subjective assessment of HRQoL change is subject to response-shift effects, whereby health changes lead to shifts in internal standards (i.e., ‘recalibration’), values (i.e., ‘reprioritization’) and conceptualization (i.e., ’reconceptualization’) of key HRQoL domains. Response shift is a naturally occurring process that could distort the interpretation of change in HRQoL scores over time in interventional studies. Assessing response shift may therefore be needed to obtain a valid and sensitive assessment of change over time. Several methods to detect and measure the size and the direction of response shift are available. In this article, we summarize the methods used to assess and adjust for the response-shift effect in clinical trials. Nevertheless, our understanding of the parameters and processes associated with response shift is very limited. Further research is still needed to better understand how to measure the different components of response shift and how to take them into account in cancer research.

Cartilage Injury After Acute, Isolated Anterior Cruciate Ligament Tear

Background: Anterior cruciate ligament (ACL) tears have been implicated in the development of osteoarthritis. Limited data exist on longitudinal follow-up of isolated ACL injury. Hypotheses: All isolated ACL tears are associated with some degree of cartilage injury that will deteriorate over time. There is a threshold of magnetic resonance imaging (MRI)–detectable cartilage injury that will correlate with adverse change in subjective patient-reported outcome measures. Study Design: Cohort study, Level of evidence, 2. Methods: The authors conducted a prospective, observational analysis of 42 knees in 40 patients with acute, isolated ACL injury (14 treated nonoperatively, 28 by reconstruction) with imaging at the time of injury and yearly follow-up for a maximum of 11 years. Morphologic MRI and quantitative T2 mapping was performed with validated outcome measures. Results: All patients sustained chondral damage at initial injury. The adjusted risk of cartilage loss doubled from year 1 for the lateral compartment and medial femoral condyle (MFC) and tripled for the patella. By years 7 to 11, the risk for the lateral femoral condyle was 50 times baseline, 30 times for the patella, and 19 times for the MFC. There was increased risk of cartilage degeneration over the medial tibial plateau (MTP) (P = .047; odds ratio = 6.23; 95% confidence interval [CI], 1.03-37.90) and patella (P = .032; odds ratio = 4.88; 95% CI, 1.14-20.80) in nonsurgical patients compared with surgically treated patients. Size of the bone-marrow edema pattern was associated with cartilage degeneration from baseline to year 3 (P = .001 to .039). Each increase in the MFC Outerbridge score resulted in a 13-point decrease in the International Knee Documentation Committee subjective knee score (P = .0002). Each increase in the MTP resulted in a 2.4-point decrease in the activity rating scale (P = .002). Conclusion: All patients with acute, traumatic ACL disruption sustained a chondral injury at the time of initial impact with subsequent longitudinal chondral degradation in compartments unaffected by the initial “bone bruise,” a process that is accelerated at 5 to 7 years’ follow-up.