Changes In Patient-reported Outcome Measures Research Articles

Response shift in patient-reported outcomes: definition, theory, and a revised model

PurposeThe extant response shift definitions and theoretical response shift models, while helpful, also introduce predicaments and theoretical debates continue. To address these predicaments and stimulate empirical research, we propose a more specific formal definition of response shift and a revised theoretical model.MethodsThis work is an international collaborative effort and involved a critical assessment of the literature.ResultsThree main predicaments were identified. First, the formal definitions of response shift need further specification and clarification. Second, previous models were focused on explaining change in the construct intended to be measured rather than explaining the construct at multiple time points and neglected the importance of using at least two time points to investigate response shift. Third, extant models do not explicitly distinguish the measure from the construct. Here we define response shift as an effect occurring whenever observed change (e.g., change in patient-reported outcome measures (PROM) scores) is not fully explained by target change (i.e., change in the construct intended to be measured). The revised model distinguishes the measure (e.g., PROM) from the underlying target construct (e.g., quality of life) at two time points. The major plausible paths are delineated, and the underlying assumptions of this model are explicated.ConclusionIt is our hope that this refined definition and model are useful in the further development of response shift theory. The model with its explicit list of assumptions and hypothesized relationships lends itself for critical, empirical examination. Future studies are needed to empirically test the assumptions and hypothesized relationships.

Changes in pain, function and gait biomechanics 10 years after high tibial osteotomy for medial compartment knee osteoarthritis

Purpose: 1) To evaluate change in patient-reported outcome measures, including OMERACT-OARSI responder criteria, at 2, 5 and 10 years after medial opening high tibial osteotomy (HTO); 2) to evaluate change in gait biomechanics at 2, 5 and 10 years after HTO; 3) to investigate the association between baseline gait biomechanics and changes in pain and function over time.

Patient-Reported Function and Quality of Life After Revision Total Knee Arthroplasty: An Analysis of 10,727 Patients from the NHS PROMs Program

BackgroundThe aim of the study was to investigate changes in patient-reported outcome measures (PROMs) after revision total knee arthroplasty (rTKA). MethodsA total of 10,727 patients undergoing elective rTKA were recruited from the UK National Health Service PROMs data set from 2013 to 2019. PROMs were collected at baseline and six months to assess joint function (Oxford Knee Score, OKS) and quality of life (EQ-5D). Associations with a change in the OKS (COKS) were investigated through multiple linear regression. ResultsThe mean COKS was 12.4 (standard deviation 10.7) points. A total of 6776 of 10,329 (65.6%) patients demonstrated increase in the OKS above the minimal important change of 7.5 points. The median change in the EQ-5D utility was 0.227 (interquartile range 0.000 to 0.554). A total of 4917 of 9279 (53.0%) patients achieved a composite endpoint of improvement greater than the minimal important change for joint function and ‘better’ QoL as per the Paretian analysis. A total of 7477 of 10,727 (69.7%) patients reported satisfaction with rTKA. A total of 7947 of 10,727 (74.1%) patients felt surgery was a success. A total of 4888 of 10,632 (46.0%) patients reported one or more adverse events. A higher preoperative OKS was associated with a lower COKS (coefficient −0.63 [95% confidence interval −0.67 to −0.60]). Other factors associated with a lower COKS were postoperative complication(s), age under 60 years, longer duration of knee problems, patients who identified as disabled, problems in EQ-5D dimensions of anxiety/depression and self-care, comorbid conditions (circulatory problems, diabetes, and depression), and earlier year of procedure in the data set. ConclusionTwo-thirds of patients experienced a meaningful improvement in joint function after rTKA. However, there was a high frequency of patient-reported complications. These findings may enable better informed discussion of the risks and benefits of discretionary rTKA.

Changes in patient reported outcome measures after treatment for female urethral stricture.

There is a paucity of patient reported outcome measure (PROM) data for women with urethral strictures. To address this gap, we aim to evaluate change in PROM among women who underwent surgery for a stricture. American Urological Association Symptom Index (AUA-SI) and Urogenital Distress Inventory (UDI-6) data from a multi-institutional retrospective cohort study of women treated for urethral stricture was assessed. Fifty-seven women had either AUA-SS or UDI-6 and 26 had baseline and postoperative data for either. Most women underwent urethroplasty (77%) and the majority (73%) remained stricture free at median follow-up of 21 months (interquartile range [IQR] 7-37). The median baseline AUA-SI was 21 (IQR 12-28) and follow-up was 10 (IQR 5-24). After treatment, there was a median decrease of 12 (IQR -18 to -2) in AUA-SI (p = 0.003). The median AUA Quality of life (QOL) score at baseline and follow-up were 6 (IQR 4-6) and 3 (IQR 2-5), respectively. There was a median AUA-QOL improvement of 2 points (-5,0; p = 0.007) from a baseline 5 (unhappy) to 3 (mixed). Median UDI-6 scores were 50 (IQR 33-75) at baseline and 17 (IQR 0-39), at follow-up. After treatment, there was a median decrease of 19 (-31 to -11; p = 0.01). Women with urethral strictures have severe lower urinary tract symptoms which improved after surgery. This study substantiates the claims that recognizing and treating women with urethral stricture disease greatly improves lower urinary tract symptoms and QOL.

Improvements After Arthroscopic Treatment for Femoroacetabular Impingement Syndrome in High-Level Ice Hockey Players: 2-Year Outcomes by Player Position.

Background:Ice hockey players often undergo arthroscopic treatment for femoroacetabular impingement syndrome (FAIS); however, only a few studies have reported postoperative patient-reported outcomes. It has been debated whether player position is related to FAIS.Purpose:To evaluate the change in patient-reported outcome measures (PROMs) in high-level ice hockey players from presurgery to 2 years after arthroscopic treatment for FAIS. The secondary aim was to evaluate differences in outcomes among player positions and whether stick handedness is related to the side of the symptomatic hip.Study Design:Case series; Level of evidence, 4.Methods:Ice hockey players undergoing treatment for FAIS between 2011 and 2019 were prospectively included. Preoperative and 2-year follow-up scores were collected for the following PROMs: HAGOS (Copenhagen Hip and Groin Outcome Score), iHOT-12 (12-item International Hip Outcome Tool), EQ-5D (EuroQol–5 Dimensions) and EQ-VAS (EuroQol–Visual Analog Scale), Hip Sports Activity Scale, and visual analog scale for overall hip function. Player position and stick handedness were collected from public sources. Preoperative and follow-up outcomes were compared for the entire cohort and among player positions.Results:The cohort included 172 ice hockey players with a mean age of 28 years, a mean body mass index of 25.6, and a mean symptom duration of 46.3 months. In the 120 players with 2-year follow-up data, there was significant improvement in all PROMs as compared with presurgery: HAGOS subscales (symptoms, 47.5 vs 68.0; pain, 57.0 vs 75.8; activities of daily living, 62.5 vs 81.0; sports, 40.0 vs 64.7; physical activity, 30.9 vs 57.2; quality of life, 32.5 vs 57.8), iHOT-12 (45.2 vs 66.7), EQ-5D (0.59 vs 0.75), EQ-VAS (68.3 vs 73.2), and visual analog scale for overall hip function (49.6 vs 69.2) (P < .0001 for all). At 2-year follow-up, 83% reported satisfaction with the procedure. There was no difference in the improvement in PROMs among player positions. Further, there was no significant relationship between stick handedness and side of symptomatic hip; however, because of the number of bilateral procedures and large number of left-handed shooters, no conclusions could be drawn.Conclusion:High-level ice hockey players undergoing arthroscopic treatment for FAIS reported improvements in PROMs 2 years after surgery, regardless of player position.

Percent of Normal: A Pragmatic Patient-Reported Outcome Measure for the Orthopaedic Trauma Clinic.

To compare a single numerical patient-reported outcome measure (PROM) to general health and injury-specific PROMs. Retrospective cohort. Urban Level 1 trauma center. The study included 175 patients with 34 humerus, 54 pelvis, 31 acetabular, and 56 ankle fractures. Patients were administered 3 PROMs: the 12-item short-form (SF-12), an injury-specific PROM (QuickDASH-humerus; Majeed Pelvic Outcome Score (Majeed)-pelvis; modified Merle d'Aubigne score (Merle)-acetabular; Foot and Ankle Disability Index (FADI)-ankle, and the Percent of Normal (PON) PROM, a single numerical PROM, which asked, "How would you rate yourself, if 100% is back to normal?" Floor/ceiling effect, convergent validity, and responsiveness of PROMs were assessed. None of the PROMs demonstrated a floor effect. The Merle was the only PROM with a ceiling effect (19%). The PON had a strong correlation with the QuickDASH (r = 0.78) and Majeed (r = 0.78); a moderate association with the SF-12 physical component score (r = 0.63), Merle (r = 0.67), and FADI (r = 0.55); and a weak association with the SF-12 mental component score (r = 0.22). The regression coefficient for change in PROM over time, a measure of responsiveness, was greater for the PON compared with the SF-12 physical component score/mental component score, Majeed, Merle, and FADI, but not the QuickDASH. The PON is a pragmatic PROM that can be easily administered in clinic by the physician to quickly assess and manage a variety of fractures, avoiding the disadvantages of nonrelative general or region-specific PROMs.

Clinical events and patient-reported outcome measures during CKD progression: findings from the Chronic Renal Insufficiency CohortStudy.

Patients with chronic kidney disease (CKD) face risks of not only end-stage kidney disease (ESKD), cardiovascular disease (CVD) and death, but also decline in kidney function, quality of life (QOL) and mental and physical well-being. This study describes the multidimensional trajectories of CKD using clinical events, kidney function and patient-reported outcome measures (PROMs). We hypothesized that more advanced CKD stages would associate with more rapid decline in each outcome. Among 3939 participants enrolled in the Chronic Renal Insufficiency Cohort (CRIC) Study, we evaluated multidimensional disease trajectories by G- and A-stages of enrollment estimated glomerular filtration rate (eGFR) and albuminuria, respectively. These trajectories included clinical events (ESKD, CVD, heart failure and death), eGFR decline and PROMs [kidney disease QOL (KDQOL) burden, effects and symptoms questionnaires, as well as the 12-item short form mental and physical component summaries]. We also evaluated a group-based multitrajectory model to group participants on the basis of longitudinal PROMs and compared group assignments by enrollment G- and A-stage. The mean participant age was 58 years, 45% were women, mean baseline eGFR was 44 mL/min/1.73 m2 and median urine albumin:creatinine ratio was 52 mg/g. The incidence of all clinical events was greater and eGFR decline was faster with more advanced G- and A-stages. While baseline KDQOL and physical component measures were lower with more advanced G- and A-stage of CKD, changes in PROMs were inconsistently related to the baseline CKD stage. Groups formed on PROM trajectories were fairly distinct from existing CKD staging (observed agreement 60.6%) and were associated with the risk of ESKD, CVD, heart failure and death. More advanced baseline CKD stage was associated with a higher risk of clinical events and faster eGFR decline, and was only weakly related to changes in patient-reported metrics over time.

An Analysis of Change in Patient-Reported Outcome Measures Following First Metatarsophalangeal Joint Arthrodesis: Do Baseline Scores or Comorbidities Make a Difference?

Category:Midfoot/ForefootIntroduction/Purpose:First metatarsal phalangeal joint (MTPJ) arthrodesis is a well established procedure in the treatment of end-stage arthritis. Patient reported outcome measures (PROMs) are an important part of the modern healthcare system. The aim of surgery is to improve pain, function and health related quality of life (HRQoL). The Manchester-Oxford Foot Questionnaire (region-specific) and the Euro-QOL 5 dimension (generic) are both PROMs, known to be sensitive to change following foot/ ankle surgery at 6-months post-procedure (Maher & Kilmartin, J of Foot & Ankle Res, 5: 17, 2012). However we don’t know if baseline scores and the presence of comorbidities influence the change in these PROMs. This is important to understand so that we can identify which patients to offer MTPJ arthrodesis surgery to.Methods:Aims 1. To identify the change in two patient-reported outcome measures (PROMs) following MTPJ arthrodesis: The Manchester-Oxford Foot Questionnaire (MOxFQ) and the Euro-QOL 5 dimension tool. Do baseline scores make a difference to the change? 2. To describe the impact of co-morbidities on the change in both PROMs. Data was collected prospectively from patients who had undergone a first MTPJ arthrodesis. Patients with complete pre- and post-PROMs data were included in the analysis. PROMs data was collected on average 5.2 months post-operatively. Surgery notes were crosschecked with radiographic findings. A comparative analysis was done between pre and post-operative data using SPSS (version 20). The MOxFQ generates a total score, as well as 3 sub-domain scores for pain, walking/ standing and social interaction. The EQ5D generates a total score and a health today score (visual analogue scale: VAS from 0-100).Results:90 patients were identified, 52 had complete data. Mean (SD) age 56.9(17.8) years, 78% female. Comorbidities: diabetes 2%, hypertension 21%, rheumatoid arthritis (RA) 43%, current smokers 10%, average (SD) weekly units of alcohol 5.2 (9.1). Most cases were unilateral (94%) and fixed with two screws (87%). 37% had other foot procedures carried out concurrently.Table 1 shows the change in MoxFQ total, domain scores and the EQ5D total score, health today (VAS). The correlation between baseline EQ5D total and the change for this outcome was r=0.6 (p<0.001). The correlation between baseline MOxFQ total and the change for this outcome was r=0.5 (p<0.001). The only comorbidity to have an influence on PROMs was RA- the presence of RA significantly reduced change in EQ5D total (p<0.05).Conclusion:Following MTPJ arthrodesis, statistically and clinically significant changes were observed in EQ5D total score, MOxFQ total scores (and all sub-domains). The EQ5D VAS did not change. Baseline scores in both PROMs were correlated with the change scores following surgery- suggesting that we may be able to identify a baseline score which could predict the outcome in PROMs and target who we offer surgery to as a consequence. Comorbidities had little influence on the change in both PROMs following surgery, other than the presence of RA dampening the change in EQ5D total score. Again this is useful to inform pre- operative discussions.

Patient-Reported Outcome Measures (Pain, Function, and Quality of Life) After Aseptic Revision Total Knee Arthroplasty.

Despite the growing frequency of revision total knee arthroplasty (rTKA), there is limited information regarding patient-reported outcome measures (PROMs) after that procedure. Therefore, the purpose of this study was to determine (1) PROM improvements in pain, function, quality of life (QOL), and global health and (2) predictors of PROMs for patients undergoing aseptic rTKA as determined using a multilevel model with patients nested within surgeons. A prospective cohort of 246 patients who underwent aseptic rTKA from January 2016 to December 2017 and had baseline and 1-year postoperative PROMs were analyzed. The most common surgical indications were aseptic loosening (n = 109), instability (n = 73), and implant failure (n = 64). The PROMs included in this study were the Knee injury and Osteoarthritis Outcome Score (KOOS)-Pain, -Physical Function Short Form (PS), and -Quality of Life (QOL) as well as the Veterans Rand-12 (VR-12) Physical Component Summary (PCS) and Mental Component Summary (MCS). Multivariable linear regression models with patients nested within surgeons were constructed for predicting change in PROMs from baseline to 1 year. The mean 1-year postoperative improvements in the KOOS-Pain and PS PROMs were 30.3 and 19.15 points, respectively, for the overall rTKA series. Improvement in the KOOS-Pain was associated with older age, baseline arthrofibrosis, lower baseline pain, and non-Medicare/Medicaid insurance and worsening of the scores was associated with multiple prior surgical procedures and instability. Improvement in the KOOS-PS was associated with baseline arthrofibrosis and female sex and worsening was associated with limited baseline function, an instability diagnosis, multiple prior surgical procedures, and increased hospital length of stay (LOS). Overall, the mean KOOS-QOL improved by 29.7 points. Although the mean VR-12 PCS improved, 54.9% of the patients saw no clinical improvement. Additionally, only 31.3% of the patients reported improvements in the VR-12 MCS. A multilevel mixed-effects model with patients/operations nested within surgeons demonstrated that the differences in the surgeons' results were minimal and explained only ∼1.86%, ∼1.12%, and ∼1.65% of the KOOS-Pain, KOOS-PS, and KOOS-QOL variance that was not explained by other predictors, respectively. Overall, patients undergoing aseptic rTKA had improvements in pain, function, and QOL PROMs at 1 year. Although overall QOL improved, other global-health PROMs remained unchanged. The associations highlighted in this study can help guide the preoperative clinical decision-making process by setting expectations before aseptic rTKA. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Does hip preservation fellowship training flatten the learning curve associated with periacetabular osteotomy?

AbstractThe Bernese periacetabular osteotomy (PAO) has been associated with a significant learning curve, with the majority of serious complications reported during the first 20–50 independent procedures. Our aim was to assess whether hip preservation fellowship training flattens the PAO learning curve with respect to complication profiles and 1-year patient-reported outcome measures (PROM). The clinical records of the first 50 PAOs (47 patients, median age 23.5 years) performed by a single surgeon after completion of a 12-month hip preservation fellowship programme were reviewed. The first 25 PAOs were compared with the second 25 PAOs with respect to complication profiles and PROM (modified Harris Hip Score, University of California Los Angeles activity score, pain visual analogue scale) at 12 months post-operatively. There were no significant between-group differences in demographic variables or pre-operative PROM. Twelve months post-operatively, no patients had experienced a major complication (Clavien–Dindo grades III–V). Twenty-three (46%) patients experienced at least one minor complication (grades I–II); 13 (52%) in the first group and 10 (40%) in the second group (no significant difference, P = 0.57). The most common complications were lateral femoral cutaneous nerve neuropraxia [14 patients (28%)] and allogenic blood transfusion [7 patients (14%)]. There were no significant between-group differences with respect to 1-year post-operative PROM or post-operative change in PROM (all P &amp;gt; 0.05). Although it is difficult to definitively conclude that hip preservation fellowship training is solely responsible for the reassuring outcomes in our series, we believe that such training can significantly flatten the learning curve associated with the Bernese PAO.

Abstract S04-01: Famotidine use and quantitative symptom tracking for COVID-19 in nonhospitalized patients: A case series

Abstract Objective: Treatment options for nonhospitalized patients with coronavirus disease 2019 (COVID-19) to reduce morbidity, mortality, and spread of the disease are an urgent global need. The over-the-counter histamine-2 receptor antagonist famotidine is a putative therapy for COVID-19. We quantitively assessed longitudinal changes in patient-reported outcome measures in nonhospitalized patients with COVID-19 who self-administered high-dose famotidine orally. Design: Patients were enrolled consecutively after signing written informed consent. Data on demographics, COVID-19 diagnosis, famotidine use, drug related side-effects, temperature measurements, oxygen saturations, and symptom scores were obtained using questionnaires and telephone interviews. Based on an NIH-endorsed Protocol to research Patient Experience of COVID-19, we collected longitudinal severity scores of five symptoms (cough, shortness of breath, fatigue, headaches, and anosmia) and general unwellness on a 4-point ordinal scale modeled on performance status scoring. All data are reported at the patient level. Longitudinal combined normalized symptom scores were statistically compared. Results: Ten consecutive patients with COVID-19 who self-administered high-dose oral famotidine were identified. The most frequently used famotidine regimen was 80mg three times daily (n=6) for a median of 11 days (range: 5 to 21 days). Famotidine was well tolerated. All patients reported marked improvements of disease-related symptoms after starting famotidine. The combined symptom score improved significantly within 24 hours of starting famotidine and peripheral oxygen saturation (n=2), and device recorded activity (n=1) increased. Conclusions: The results of this case series suggest that high-dose oral famotidine is well tolerated and associated with improved patient reported outcomes in nonhospitalized patients with COVID-19. A blinded outpatient trial is planned. The findings may be transferable and relevant to the treatment of patients with cancer and COVID-19. Citation Format: Tobias Janowitz, Eva C. Gablenz, David J. Pattinson, Timothy C. Wang, Joseph Conigliaro, Kevin J. Tracey, David A. Tuveson. Famotidine use and quantitative symptom tracking for COVID-19 in nonhospitalized patients: A case series [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2020 Jul 20-22. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(18_Suppl):Abstract nr S04-01.

Positive association between physical outcomes and patient-reported outcomes in late-onset Pompe disease: a cross sectional study

BackgroundPompe disease is a rare, progressive metabolic myopathy. The aim of this study is to investigate the associations of physical outcomes with patient-reported outcome measures (PROMs) in late-onset Pompe disease.MethodsWe included 121 Dutch adult patients with Pompe disease.Physical outcomes comprised muscle strength (manual muscle testing using Medical Research Council [MRC] grading, hand-held dynamometry [HHD]), walking ability (6-min walk test [6MWT]), and pulmonary function (forced vital capacity [FVC] in upright and supine positions).PROMs comprised quality of life (Short Form 36 health survey [SF-36]), participation (Rotterdam Handicap Scale [RHS]) and daily-life activities (Rasch-Built Pompe-Specific Activity [R-PAct] Scale).Analyses were cross-sectional: the time-point before, and closest to, start of Enzyme Replacement Therapy was chosen. Associations between PROMs and physical outcomes were investigated using linear regression models.ResultsRHS and R-PAct scores were better in patients with higher FVC supine and upright, HHD, MRC and 6MWT scores, accounting for the effect of sex, disease duration, use of wheelchair and ventilator support. While the SF-36 Physical Component Summary (PCS) was correlated positively with FVC upright, HHD, MRC and 6MWT scores, there was no significant relationship between the SF-36 Mental Component Summary (MCS) and any of the physical outcomes.ConclusionsParticipation, daily-life activities, and the physical component of quality of life of adult Pompe patients are positively correlated to physical outcomes. This work serves as a first step towards assessing how changes over time in physical outcomes are related to changes in PROMs, and to define the minimal change in physical outcomes required to make an important difference for the patient.

Analysis of change in patient-reported outcome measures with floor and ceiling effects using the multilevel Tobit model: a simulation study and an example from a National Joint Register using body mass index and the Oxford Hip Score.

ObjectivesThis study has three objectives. (1) Investigate the association between body mass index (BMI) and the efficacy of primary hip replacement using a patient-reported outcome measure (PROMs) with a measurement floor and ceiling, (2) Explore the performance of different estimation methods to estimate change in PROMs score following surgery using a simulation study and real word data where data has measurement floors and ceilings and (3) Lastly, develop guidance for practising researchers on the analysis of PROMs in the presence of floor and ceiling effects.DesignSimulation study and prospective national medical device register.SettingNational Register of Joint Replacement and Medical Devices.MethodsUsing a Monte Carlo simulation study and data from a national joint replacement register (162 513 patients with pre- and post-surgery PROMs), we investigate simple approaches for the analysis of outcomes with floor and ceiling effects that are measured at two occasions: linear and Tobit regression (baseline adjusted analysis of covariance, change-score analysis, post-score analysis) in addition to linear and multilevel Tobit models.Primary outcomeThe primary outcome of interest is change in PROMs from pre-surgery to 6 months post-surgery.ResultsAnalysis of data with floor and ceiling effects with models that fail to account for these features induce substantial bias. Single-level Tobit models only correct for floor or ceiling effects when the exposure of interest is not associated with the baseline score. In observational data scenarios, only multilevel Tobit models are capable of providing unbiased inferences.ConclusionsInferences from pre- post-studies that fail to account for floor and ceiling effects may induce spurious associations with substantial risk of bias. Multilevel Tobit models indicate the efficacy of total hip replacement is independent of BMI. Restricting access to total hip replacement based on a patients BMI can not be supported by the data.

Changes in Patient-Reported Outcome Measures With a Technology-Supported Behavioral Lifestyle Intervention Among Patients With Type 2 Diabetes: Pilot Randomized Controlled Clinical Trial.

BackgroundIn the United States, more than one-third of the adult population is obese, and approximately 25.2% of those aged ≥65 years have type 2 diabetes (T2D), which is the seventh leading cause of death. It is important to measure patient-reported outcomes and monitor progress or challenges over time when managing T2D to understand patients’ perception of health and quantify the impact of disease processes or intervention effects. The evaluation of patient-reported outcome measures (PROMs) is especially important among patients with multiple chronic conditions in which clinical measures do not provide a complete picture of health.ObjectiveThis study examined the feasibility of collecting Patient-Reported Outcome Measurement Information System (PROMIS) measures, and preliminarily evaluated changes in PROMIS scores and compared the scores with standard scores of the general US population. The parent study is a pilot randomized controlled clinical trial testing three different modes (mobile health [mHealth], paper diary, and control) of self-monitoring in a behavioral lifestyle intervention among overweight or obese patients with T2D.MethodsPatients with comorbid overweight or obesity and a diagnosis of T2D for at least 6 months were recruited from a diabetes education program. Participants were randomized to the following three groups: mHealth, paper diary, and control (standard of care) groups. Paper diary and mHealth experimental groups received additional behavioral lifestyle intervention education sessions, as well as tools to self-monitor weight, physical activity, diet, and blood glucose. All participants completed PROMIS-57 and PROMIS-Global Health (GH) version 1.0 questionnaires during visits at baseline, 3 months, and 6 months. The PROMIS-57 includes the following seven domains: anxiety, depression, fatigue, pain interference, physical function, satisfaction with participation in social roles, and sleep disturbance. The PROMIS-GH is composed of the following two domains: global mental health and global physical health.ResultsA total of 26 patients (mHealth, 11; paper diary, 9; control, 6) were included in our analysis. The study sample was predominantly African American (68%) and female (57%), with a mean age of 54.7 years and a mean BMI of 37.5 kg/m2. All patients completed the PROMIS-57 and PROMIS-GH questionnaires, and we compared the mean scores of the three groups to investigate potential differences. No relevant differences were noted across the groups. However, positive trends were noted in both intervention (mHealth and paper diary) groups in the middle (month 3) and end (month 6) of the study.ConclusionsOur pilot study provides evidence for the feasibility of using PROMIS questionnaires to record important components of T2D-related symptoms among overweight or obese individuals. The results from our study support the use of PROMIS questionnaires to provide clinicians and researchers with a benchmark for assessing the overall need for symptom management and determining the success or challenges of an intervention.Trial RegistrationClinicalTrials.gov NCT02858648; https://clinicaltrials.gov/ct2/show/NCT02858648

Patient-Reported Outcome Measures and Health-Related Quality-of-Life Scores of Patients Undergoing Anatomic Total Shoulder Arthroplasty.

Health-related quality-of-life (HRQoL) scores are required for cost-effectiveness and health-care value analysis. We evaluated HRQoL scores and patient-reported outcome measures (PROMs) in patients with advanced glenohumeral osteoarthritis treated with anatomic total shoulder arthroplasty to establish values of HRQoL scores that can be used for cost-effectiveness and value analysis and to assess relationships between HRQoL scores and shoulder and upper-extremity PROMs. We analyzed 143 patients (143 shoulders) with glenohumeral osteoarthritis treated with anatomic total shoulder arthroplasty; 92 patients had 1-year follow-up. Preoperative and postoperative functional outcomes were assessed with the Disabilities of the Arm, Shoulder and Hand (DASH) score, the American Shoulder and Elbow Surgeons (ASES) score, the Simple Shoulder Test (SST), and a visual analog scale (VAS) for shoulder pain and function. Health utility was assessed with the EuroQol-5 Dimensions (EQ-5D), Short Form-6 Dimensions (SF-6D), and VAS Quality of Life (VAS QoL). HRQoL score validity was determined through correlations between the PROMs and HRQoL scores. The responsiveness of HRQoL scores was measured through the effect size and the standardized response mean. There were significant improvements in all PROMs and HRQoL scores (p < 0.001) at 1 year after the surgical procedure. The changes in VAS QoL (very weak to moderate), EQ-5D (weak), and SF-6D (weak) were significantly correlated (p < 0.05) with the changes in PROMs, demonstrating comparably acceptable validity. There were large effect sizes in the VAS QoL (1.843), EQ-5D (1.186), and SF-6D (1.084) and large standardized response mean values in the VAS QoL (1.622), EQ-5D (1.230), and SF-6D (1.083), demonstrating responsiveness. The effect sizes of all PROMs were larger than those of the HRQoL scores. PROMs and HRQoL scores are not interchangeable, and studies of the cost-effectiveness and value of shoulder arthroplasty should incorporate both shoulder and upper-extremity PROMs and HRQoL scores. The findings of this study provide data on HRQoL scores that are specific to the treatment of advanced glenohumeral osteoarthritis with anatomic total shoulder arthroplasty and can be used for future cost-effectiveness and value analysis studies. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Knee osteoarthritis development five years following arthroscopic partial meniscectomy or exercise therapy for degenerative meniscal tears: the odense-oslo meniscectomy versus exercise trial

Purpose: Degenerative meniscal tears per se and partial meniscectomy are strong risk factors for knee osteoarthritis (OA) development. Several randomized controlled trials have found that partial meniscectomy provides no clinically relevant benefit compared to exercise therapy for degenerative meniscal tears. However, long-term follow-up studies of randomized controlled trials are lacking. Hence, the aim of this five-year follow-up of the Odense-Oslo Meniscectomy versus Exercise (OMEX) trial was to compare progression of individual radiographic features of the knee, incident radiographic knee OA and changes in patient-reported outcome measures following partial meniscectomy or exercise therapy for degenerative meniscal tears.

CAPAbility: comparison of the JOURNEY II Bi-Cruciate Stabilised and GENESIS II total knee arthroplasty in performance and functional ability: protocol of a randomised controlled trial

BackgroundOsteoarthritis of the knee is a common condition that is expected to rise in the next two decades leading to an associated increase in total knee replacement (TKR) surgery. Although there is little debate regarding the safety and efficacy of modern TKR, up to 20% of patients report poor functional outcomes following surgery. This study will investigate the functional outcome of two TKRs; the JOURNEY II Bi-Cruciate Stabilised knee arthroplasty, a newer knee prosthesis designed to provide guided motion and improve knee kinematics by more closely approximating a normal knee, and the GENESIS II, a proven existing design.AimTo compare the change in Patient-reported Outcome Measures (PROMs) scores of the JOURNEY II BCS and the GENESIS II from pre-operation to 6 months post operation.MethodsCAPAbility is a pragmatic, blinded, two-arm parallel, randomised controlled trial recruiting patients with primary osteoarthritis due to have unilateral TKR surgery across two UK hospitals. Eligible participants (n = 80) will be randomly allocated to receive either the JOURNEY II or the GENESIS II BCS knee prosthesis. Baseline measures will be taken prior to surgery. Patients will be followed at 1 week, 6 to 8 weeks and 6 months post-operatively. The primary outcome is the Oxford Knee Score (OKS) at 6 months post-operatively. Secondary outcomes include: other PROMs, biomechanical, radiological (computerised tomography, (CT)), clinical efficacy and safety outcomes. An embedded qualitative study will also investigate patients’ perspectives via interview pre and post surgery on variables known to affect the outcome of TKR surgery. A sub-sample (n = 30) will have additional in-depth interviews to explore the themes identified. The surgeons’ perspectives on the operation will be investigated by a group interview after all participants have undergone surgery.DiscussionThis trial will evaluate two generations of TKR using PROMS, kinematic and radiological analyses and qualitative outcomes from the patient perspective.Trial registrationInternational Standard Randomised Controlled Trials Number Registration, ID: ISRCTN32315753. Registered on 12 December 2017.

Establishing the minimal clinically important difference (MCID) of the Zurich Chronic Middle Ear Inventory (ZCMEI-21) in patients treated for chronic middle ear disease

AimTo determine the minimal clinically important difference (MCID) of the Zurich Chronic Middle Ear Inventory (ZCMEI-21), a questionnaire assessing health-related quality of life (HRQoL) in chronic otitis media (COM).MethodsIn this longitudinal study, 103 patients completed the ZCMEI-21 before and after surgery for chronic otitis media. An anchor-based method including a global rating of change (GRC) was used to assess the MCID of the ZCMEI-21.ResultsA total of 103 patients were included. The mean preoperative and postoperative ZCMEI-21 scores were 28.6 (SD 13.6), and 21.8 (SD 12.8), respectively. The mean change was 6.8 (SD 0.8; p < 0.0001). A significant correlation between the ZCMEI-21 scores and the GRC was found (r = − 0.5; p < 0.001). Using the anchor-based method, the MCID of the ZCMEI-21 was estimated at 5.3 (SD 12.0).ConclusionsKnowledge of values indicating a clinically relevant change in patient-reported outcome measures is important when interpreting effects of different treatment modalities. This is the first study assessing the MCID of a questionnaire measuring HRQoL in COM, i.e. the ZCMEI-21. We recommend a MCID of 5 in COM patients undergoing surgical treatment. This information substantially increases the usefulness of the ZCMEI-21 as an outcome measure in COM as changes can be assessed with regard to their clinical meaningfulness.

The arthroscopic Latarjet: a multisurgeon learning curve analysis

The open Latarjet procedure is a standard surgical treatment option for anterior shoulder instability in patients with a high risk of failure following soft tissue stabilization. The arthroscopic technique has potential advantages of minimal invasiveness, reduced postoperative stiffness, and faster rehabilitation but is regarded as technically challenging with concern over surgical risk during the learning curve. The aim of this study was to undertake a multisurgeon, large-volume learning curve analysis of the arthroscopic Latarjet procedure using continuous learning curve analysis. Individual patient data from 12 surgeons across 5 countries were retrospectively reviewed. A total of 573 patients undergoing the arthroscopic Latarjet procedure were included. Outcome measures of learning were collected, including operative time, computed tomography (CT) bone-block positioning, complications, and patient-reported outcome measures (PROMs). A segmented linear regression modeling technique was used for learning curve analysis. High-volume surgeons converged to an operative time steady state after 30-50 cases. Surgeons completing fewer procedures demonstrated a constant reduction in operative time without reaching a plateau. Low-volume surgeons completing fewer than 14 operations did not demonstrate a reduction in operative time. Accuracy of bone-block positioning on postoperative CT demonstrated constant improvement without reaching a plateau after 53 cases. There was no change in PROMs or complications with increased operative volume. Specialist shoulder surgeons require 30-50 arthroscopic Latarjet procedures to attain steady-state operative efficiency, during which there is improvement in bone-block positioning. Only surgeons expecting to undertake the arthroscopic Latarjet in high volume should consider adopting this procedure.

Return to Sport and Outcomes After Concomitant Lateral Meniscal Allograft Transplant and Distal Femoral Varus Osteotomy

To evaluate the time and rate of return to sport (RTS), as well as outcomes, in young and active patients receiving concomitant lateral meniscal allograft transplantation (MAT) and distal femoral varus osteotomy (DFVO) for lateral meniscal deficiency and valgus malalignment. This was a retrospective study of consecutive patients who underwent concomitant MAT and DFVO by a single surgeon. The exclusion criteria were any concomitant procedures other than cartilage restoration procedures for focal full-thickness cartilage defects of the lateral femoral condyle and less than 2years of follow-up. At final follow-up, patients were asked to complete a subjective sports questionnaire, the Marx Activity Rating Scale, a visual analog scale (VAS), the Single Assessment Numeric Evaluation, and a satisfaction questionnaire. Changes in patient-reported outcome measures were assessed using nonparametric statistical testing. A total of 21 patients met the inclusion criteria, of whom 17 were included for analysis at an average follow-up of 7.5years (range, 2.2-13.3years). The average age at the time of surgery was 23.3years (range, 16.9-36.2years), and 76.5% of patients were female patients. The average VAS score decreased from 5.7 preoperatively to 2.6 postoperatively (P= .02). Of the 15 patients who participated in sports within 3years prior to their surgical procedure, 14 (82.4%) returned to 1 or more sports at an average of 16.9months (range, 6-36months); however, only 46.7% were able to return to their preinjury level of participation or higher. Furthermore, 88.2% of patients reported being satisfied with their sport-related outcomes. Direct rates of sport-specific return were as follows: weightlifting, 100%; skiing, 100%; running, 66.7%; and basketball, 50%. In our study population, concomitant MAT and DFVO afforded a high rate of RTS at an average of 16.9months postoperatively, as well as a significant decrease in VAS pain scores. These findings are essential to note when counseling patients receiving these procedures who wish to resume sports and physical activities so that they may expect an extensive recovery process before they can RTS. Level IV, case series.