Short Form-36 Physical Function Research Articles

Effectiveness of a Single High Dose of Platelet-Rich Plasma (PRP) Injection Over Corticosteroid and Hyaluronic Acid Injections on Osteoarthritis, Chronic Tendinitis and Tennis Elbow Treatment

Background: Corticosteroid, hyaluronic acid (HA) injections and Anti-inflammatory agents are considered as non-invasive treatments for knee osteoarthritis (OA), Chronic Tendinitis (CT) and Tennis elbow (TE) that are supposed to provide symptomatic relief and to help surgical delay intervention. Platelet rich plasma (PRP) is a biological component shown to be beneficial for different orthopedic dysfunctionalities treatment. The presence of GFs in PRPs such as transforming growth factor-β, insulin-like growth factor 1co-stimulate the mesenchymal stem cells and fibroblasts secretions and promotes the fibrin matrix formation which effectively drive the healing process, induces regenerative response and lead to the damage structure repair in orthopedics trauma. Methods: Three groups of a total of 30 patients presenting OA, CT and TE diagnosis, non-responding to corticosteroid, HA and non-steroid anti-inflammatory treatments were randomized to undergo one intra-articular injections of single high dose of PRP. The efficacy of Intra-articular PRP Injections was evaluated before the injection and one month after. The efficiency assessment score was based on [1] Knee injury and Osteoarthritis Outcome Score, [2] Physical Function Short Form (KOOS-PS) Arabic (KSA) version LK 1.0, [3] HOOS-Physical Function Short form (HOOS-PS), and [4] Macdermid patient-rated Tennis Elbow. Results: A significant reduction of pain and a marked improvement in movements was observed in the 3 patient’s groups, PRP-injected patients showed significantly higher values compared with baseline: (p < 0.005 vs baseline), improve functional status and reduce clearly the articular dysfunctions over the time. In our study, single High dose injection of PRP provided an overall superior clinical improvement compared with HA and corticosteroid treatments over the time and the different follow-up checkpoints of the study.

Isolated Gastrocnemius Recession for Flexible Adult Acquired Flatfoot Deformity

Category:Hindfoot; Midfoot/ForefootIntroduction/Purpose:Adult acquired flatfoot deformity (AAFD) frequently has an associated gastrocnemius contracture, which is a primary focus of most non-operative treatment protocols. When conservative measures fail, AAFD reconstruction often includes a gastrocnemius recession. Most reconstruction procedures involve a period of post-operative non-weight-bearing, which can be difficult for elderly patients. Beginning in 2011, patients with flexible AAFD patients and at risk of non-compliance with weight-bearing restrictions, were offered a staged approach with initial isolated gastrocnemius recession followed by reconstruction, if required. Gastrocnemius recession may allow passive correction of the deformity, improve orthotic fit and obviate the need reconstruction (Figure). The goal of this study was to retrospectively evaluate patient reported outcomes following an isolated gastrocnemius recession for flexible AAFD.Methods:A total of 49 patients met the inclusion criteria: isolated gastrocnemius recession for flexible AAFD, no previous ipsilateral surgery and >6 months follow-up. Of 49 eligible patients, 29 (31 feet) participated. Pre-operative and post-operative outcomes were compared for Foot and Ankle Ability Measure activities of daily living subscale (FAAM-ADL), visual analog scale (VAS), and the PROMIS Physical Function Short Form 10a (PROMIS PF SF 10a). Additionally, patients were asked about satisfaction, willingness to undergo the procedure again and whether orthotic provided better relief. Mean and standard deviation were compared using a two-tailed paired t-test with significance.Results:FAAM-ADL and PROMIS PF SF 10a significantly improved from 55.9 and 37.3 pre-operatively to 71.6 and 42.0 (p=0.01, p=0.046) respectively. 70% of patients were either satisfied or very satisfied, 67% would undergo the procedure again, and 64.5% of patients had improved relief with use of orthotics post-operatively.Conclusion:A staged approach with initial isolated gastrocnemius recession for the management of flexible AAFD in elderly patients can be effective. These results for patient recorded outcomes, patient satisfaction, willingness to undergo the procedure again and improvement in orthotic relief may guide the shared decision-making process with elderly patients when offered a reconstruction versus staged approach.

Correlation and Crosswalks Between Patient-Reported Functional Outcomes and PROMIS Physical Function Among Medically Ill Patients

ObjectivesTo develop scoring crosswalks between a new multidomain patient-reported outcome measure, the Functional Assessment in Acute Care (FAMCAT), with a Patient-Reported Outcomes Measurement (PROMIS) measure of physical function, and examine correlations with existing legacy instruments. DesignCross-sectional, single-group design study. SettingLarge, Midwestern academic teaching hospital. ParticipantsA sample of patients (N=1885; 53% men; average age, 62±16y) hospitalized on the general medical services between May 2016 and June 2017. InterventionNot applicable. Main Outcome MeasuresScores from the FAMCAT administered via computerized adaptive testing were compared with scores on the 8-item PROMIS Physical Function (PROMIS PF) short form. ResultsCorrelations with the FAMCAT and the PROMIS PF were strong for initial scores (MCAT_Mobilty: r=0.78, P<.0001; MCAT_DailyAct: r=0.81, P<.0001). The Applied Cognition scale did not demonstrate adequate correlations and thus was not a candidate for crosswalk scores. Although the MCAT_Mobility scale could be initially linked, subsequent analysis did not support a valid crosswalk. Linking criteria were applied with the Daily Activity scale to developing a final concordance table. ConclusionsThe FAMCAT Daily Activity scale yielded robust correlations to develop crosswalk scores with the PROMIS PF. The resulting crosswalk conversion metric may be useful to compare outcomes across these constructs for assessing functional abilities among patients on general medical services. The Applied Cognition and Basic Mobility scales did not meet the criteria; therefore, alternate legacy instruments are needed to develop additional crosswalks.

Different Designs of Proximal Femoral Stems for Total Hip Arthroplasty: Mid-Term Clinical and Patient-Reported Functional Outcomes.

Introduction: A comprehensive comparison of the performance of different femoral stem geometries in total hip arthroplasty (THA) is yet to be described. The primary aim of this study was to evaluate objective and subjective outcome measures in primary THA with different femoral implant styles.Methods: Stems were classified into the following five classes: cemented, conical, fit and fill, modular, and wedge. The objective outcomes of interest were the length of inpatient hospital stay (LOS), 90-day readmission rate, one-year revision rate, and two-year mortality rate. Preoperative and postoperative patient-reported outcome measures (PROMs), including hip disability and osteoarthritis outcome score (HOOS) - physical function shortform (HOOS-PS), patient-reported outcomes measurement information system physical function short form 10a (PROMIS PF-10a), and patient-reported outcomes measurement information system - short form - mental 10a (PROMIS M-10a) were recorded and compared between different classes.Results: Patients with a wedge stem had a significantly lower LOS versus every other stem group, while patients with a cemented stem had the highest LOS, approximately twofold that of the wedge stem group. Accounting for potential confounders, the conical and fit and fill groups had a significantly higher two-year mortality rate than the wedge stem group. Fit and fill stems conferred a slight risk of revision THA at one-year compared to wedge stems. There was no significant difference in the rates of failure to achieve the minimal clinically important difference (MCID) for the PROMs.Conclusion: Placement of wedge stems resulted in a significantly lower LOS compared to every other stem class and a lower mortality rate than the conical, fit and fill, and modular stems. As for the 90-day readmission, one-year revision, and the rates of failure to achieve the MCID for general or hip-specific PROMs, stem design had no meaningful effect.

The plasma microRNA levels and their relationship with the general health and functional status in female patients with fibromyalgia syndrome.

Objectives The aim of this study was to identify the plasma level of micro-ribonucleic acid (microRNA) expressions and the relationship between plasma microRNA levels with the general health and functional status in female patients with fibromyalgia syndrome (FMS).Patients and methods Thirty-five female patients (mean age: 42.0±11.8 years; range, 21 to 62 years) diagnosed as FMS and 35 sex-and age-matched healthy controls (mean age: 43.7±8.8 years; range, 21 to 56 years) were enrolled in the study. MicroRNA measurements of the participants in plasma were carried out by using the quantitative polymerase chain reaction (qPCR). A total of 11 plasma levels of microRNA expressions were examined in both groups. The general health and functional status of the patients and controls were assessed by the Fibromyalgia Impact Questionnaire (FIQ) and the Short Form-36 (SF-36) scale.Results No significant difference was observed between the plasma levels of microRNA expressions in patients with FMS and healthy controls. The plasma level of miR-320a expression was found to be negatively correlated with the total FIQ score in female patients with FMS (p=0.05, r=-0.34). Negative correlations were also detected between the plasma level of miR-320a and miR-320b expressions and the subscale score of SF-36 physical function in female patients with FMS (p=0.01, r=-0.43 and p=0.01, r=-0.43, respectively). A strong positive correlation was found between miR-142-3p and the subscale score of SF-36 mental symptom score in female patients with FMS (p<0.001, r=1.00).Conclusion The expression levels of microRNAs in plasma between female patients with FMS and controls were not significantly different. Only plasma levels of miR-320a, miR-320b, and miR-142-3p expressions were associated with the general health, functional status, and mental symptom score in female patients with FMS.

Automated Text-Messaging After Hip Arthroscopy: A Randomized-Controlled Trial of “Post-Op Buddy”

To assess an automated text-messaging system for patients after hip arthroscopy and its impact at 90 days on the Hip Disability Osteoarthritis Outcome Score Physical Function Short form (HOOS-PS, HOOS-Pain), compliance with rehabilitation guidelines, and patient satisfaction. One hundred twenty-one participants (average age 29 ± 8.7 years, 52% female) undergoing hip arthroscopy at 2 academic institutions were prospectively enrolled and randomized to receive (1) standard perioperative communication or (2) additional automated mobile phone text messages. Inclusion criteria included ability to communicate in written English and access to a mobile phone with text-messaging capability. Patients undergoing revision surgery or simultaneous femoral or acetabular osteotomy were excluded. HOOS-PS and HOOS-Pain were collected preoperatively, and after surgery an automated mobile phone robot sent participants in the therapeutic arm intermittent text messages for 90 days. At 90 days all participants again completed HOOS-PS, HOOS-Pain, and additional survey questions on satisfaction with their experience (10-point scale), communication from the surgical team (10-point scale) and adherence to physical therapy exercises, weight-bearing guidelines, and brace use, The primary outcome assessed was a statistically significant change in HOOS-PS and HOOS-Pain; secondary outcomes included change in satisfaction, communication, and adherence to physical therapy exercises, weightbearing guidelines, or brace use. Wilcoxon rank sum was used to compare HOOS-PS and HOOS-Pain scores at 0 and 90 days. Demographic characteristics and survey variables were compared using Students t test for continuous variables and χ2 or Fisher exact test for categorical variables as appropriate. There were statistically significant and clinically relevant improvements in HOOS-PS and HOOS-Pain in both groups (P < .05). Subjective feedback was strongly positive, with 96% of text message participants reporting they would choose automated messages if it was offered to them again in the future. Ninety days of automated text messaging after hip arthroscopy failed to show a significant difference in HOOS-PS (P= .09), HOOS-Pain (P= .13), patient-reported compliance with postoperative guidelines, or satisfaction with support and communication from the surgical team. I, randomized control trial (RCT).

Remote Management of Patients after Total Joint Arthroplasty via a Web-Based Registry during the COVID-19 Pandemic.

Background: In 2020, due to the outbreak of the COVID-19 (Coronavirus Disease 2019) pandemic, patients who underwent total joint arthroplasty were not able to undergo the proper postoperative surgical and rehabilitative care. This study aims to evaluate the potential of a web-cloud-based database on patients’ follow-up in extraordinary situations, when a traditional in-person follow-up cannot be warranted. Methods: Patients who underwent joint arthroplasty at our Institute between 21 February and 16 March 2020 were included in the study group and were matched to a similar population undergoing joint arthroplasty in February/March 2019. All patients routinely complete questionnaires before and after treatment, including patient-reported outcome measures such as the Visual Analogues Scale (VAS), Knee/Hip Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS/HOOS-PS) and Short-Form Health Survey (SF-12) for the monitoring of clinical improvements. Results: 56 (study group) and 144 (control group) patients were included in the study. Both groups demonstrated significant improvements at 3 months. HOOS-PS improvement was significantly reduced in the 2020 group compared to 2019 (21.7 vs. 33.9, p < 0.001). This reduction was related to intense physical activities. Similarly, the functional score improvement related to these activities was reduced for patients undergoing knee replacement (8 vs. 10, p < 0.05). Conclusions: The web-based Institute Registry emerged as a meaningful and sensitive tool during an extraordinary situation such as the COVID-19 pandemic to monitor patients’ progression after total joint arthroplasties. Thanks to this tool, it was possible to observe that the prevention of usual postoperative care due to pandemic-related restrictions did not alter the benefits observed after joint replacement surgeries, even if this condition reduced the postoperative improvements in the most burdensome physical activities. A broader use of this kind of tool would improve and potentially reduce the burden and costs of postoperative patients’ monitoring in standard and extraordinary conditions. In addition, the systematic remote collection of data would allow for the identification of relevant differences in clinical outcomes in specific conditions or following the modification of treatment and rehabilitation protocols.

Do patient-reported outcome measures improve after aseptic revision total hip arthroplasty?

The purpose of this study was to determine patient-reported outcome measures (PROMs) changes in: (1) pain, function and global health; and (2) predictors of PROMs in patients undergoing aseptic revision total hip arthroplasty (rTHA) using a multilevel model with patients nested within surgeon. A prospective cohort of 216 patients with baseline and 1-year PROMs who underwent aseptic rTHA between January 2016 and December 2017 were analysed. The most common indication for rTHA was aseptic loosening, instability, and implant failure. The PROMs included in this study were HOOS Pain and HOOS Physical Function Short-form (PS), Veterans RAND-12 Physical Component Score (VR-12 PCS), and VR-12 Mental Component Score (MCS). Multivariable linear regression models were constructed for predicting 1-year PROMs. Mean 1-year PROMs improvement for aseptic revisions were 30.4 points for HOOS Pain and 22.1 points for HOOS PS. Predictors of better pain relief were patients with higher baseline pain scores. Predictors of better 1-year function were patients with higher baseline function and patients with a posterolateral hip surgical approach during revision. Although VR-12 PCS scores had an overall improvement, nearly 50% of patients saw no improvement or had worse physical component scores. Only 30.7% of patients reported improvements in VR-12 MCS. Overall, patients undergoing aseptic rTHA improved in pain and function PROMs at 1 year. Although global health assessment improved overall, nearly half of aseptic rTHA patients reported no change in physical/mental health status. The associations highlighted in this study can help guide the shared decision-making process by setting expectations before aseptic revision THA.

Does Implant Selection Affect Patient-Reported Outcome Measures After Primary Total Hip Arthroplasty?

Total hip arthroplasty (THA) is a reliable operation, but it is critical that orthopaedic surgeons characterize which surgical factors influence patient-reported outcomes. The purpose of this study was to determine whether implant selection at the time of THA affects the odds of having (1) inadequate improvement according to patient-reported pain, function, and activity; (2) failure to achieve a substantial clinical benefit (SCB) with respect to pain; or (3) failure to achieve a patient-acceptable symptomatic state (PASS) according to pain and function. Prospective data were collected from 4,716 patients who underwent primary THA (from July 2015 to August 2018) in a single health-care system with standardized care pathways. Patients were categorized according to the type of femoral and acetabular components and bearing surface used. Outcomes included 1-year postoperative patient-reported outcome measures (PROMs) and improvement in the Hip disability and Osteoarthritis Outcome Score (HOOS) and the University of California at Los Angeles (UCLA) activity score. Inadequate improvement was defined as PROMs that changed by less than the minimal clinically important difference (MCID) for the HOOS pain and physical function short form (PS) and as failure to improve beyond a mostly homebound activity status for the UCLA activity score (a score of ≤3). The MCID and SCB thresholds were set at values reported in the literature. One-year PROM data were available for 3,519 patients (74.6%). There were no differences in the proportion of patients who attained the MCID in terms of HOOS pain, HOOS PS, or UCLA activity scores at 1 year for all analyzed implant parameters. Multivariate regression demonstrated that implant selection was not a significant driver of inadequate improvement, according to HOOS pain and HOOS PS (p > 0.05). Larger (36-mm) femoral heads demonstrated lower odds of inadequate improvement versus 28-mm femoral heads according to UCLA activity scores (odds ratio [OR]: 0.64; 95% confidence interval, 0.47 to 0.86; p = 0.003). Implant-related criteria were not significant drivers of attaining a PASS or achieving an SCB with respect to HOOS pain. For the most part, THA implant characteristics are not drivers of inadequate improvement with respect to pain and function. Surgeons should utilize implants with an acceptable track record that allow stable fixation and restoration of hip biomechanics. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

A prospective study of the relation of patient-reported outcome measures with lumbar disc surgery for herniated lumbar disc

Introduction: The aim of this 6-month prospective study was to seek out the factors affecting surgical outcome, predictors of treatment response and their correlates in open discectomy for herniated lumbar disc. Methods and Materials: Eighty patients who fulfilled the required criteria were chosen. Socio-demographic, clinical data proforma, Visual Analogue Scale for pain (VAS), Japanese Orthopedic Association (JOA) Scale for subjective and objective pain related QoL, General Health Questionnaire-12 (GHQ-12) for screening mental health, Short Form-36 (SF-36) Health Survey for assessing Health-related Quality of Life (HRQOL) and Montgomery Asberg Depression Rating Scale (MADRS) for measurement of clinical depression were used at the preoperative stage and reassessed again at 1 month, 3 months and 6 months post-discectomy. Results: Postoperatively, VAS and JOA Scale scores continued to show improvement at each follow up (p&lt;0.001). Majority of the SF-36 subscales showed significant improvement at 3-months and 6-months of the postoperative period. A significant correlation was seen between the duration of pain symptoms and depression scores at 6 months (rho 0.301 p&lt;0.01). Baseline VAS score had a significant negative correlation with baseline Physical Functioning and General Health scores at 6 months. The duration and severity of pain symptoms before surgery predicted the depression scores at 6 months (adjusted R square 0.056 p&lt;0.001) postoperatively. Conclusion: The discectomy procedure resulted in significant improvement in baseline subjective pain symptoms and overall HRQOL. Greater the duration and intensity of pain symptoms at baseline, greater was the depression scores and lesser was the SF-36 physical functioning and general health at 6-month postoperative period.

Cross-cultural adaptation and psychometric validation of the Indonesian version of the Oxford Hip Score.

AimsThe aim of this study was to perform a cross-cultural adaptation of Oxford Hip Score (OHS) to Indonesian, and to evaluate its psychometric properties.MethodsWe performed a cross-cultural adaptation of Oxford Hip Score into Indonesian language (OHS-ID) and determined its internal consistency, test-retest reliability, measurement error, floor-ceiling effect, responsiveness, and construct validity by hypotheses testing of its correlation with Harris Hip Score (HHS), vsual analogue scale (VAS), and Short Form-36 (SF-36). Adults (> 17 years old) with chronic hip pain (osteoarthritis or osteonecrosis) were included.ResultsA total of 125 patients were included, including 50 total hip arthroplasty (THA) patients with six months follow-up. The OHS questionnaire was translated into Indonesian and showed good internal consistency (Cronbach’s alpha = 0.89) and good reliability (intraclass correlation = 0.98). The standard error of measurement value of 2.11 resulted in minimal detectable change score of 5.8. Ten out of ten (100%) a priori hypotheses were met, confirming the construct validity. A strong correlation was found with two subscales of SF-36 (pain and physical function), HHS (0.94), and VAS (-0.83). OHS-ID also showed good responsiveness for post-THA series. Floor and ceiling effect was not found.ConclusionThe Indonesian version of OHS showed similar reliability and validity with the original OHS. This questionnaire will be suitable to assess chronic hip pain in Indonesian-speaking patients.Cite this article: Bone Jt Open 2021;2(9):765–772.

Use and detailed metric properties of patient-reported outcome measures for rheumatoid arthritis: a systematic review covering two decades

IntroductionThe importance of patient-reported outcome measures (PROMs) for rheumatoid arthritis (RA) clinical studies has been recognised for many years. The current study aims to describe the RA PROMs used over...

Effect of Baseline Mental Health on 1-Year Outcomes After Hip Arthroscopy: A Prospective Cohort Study.

Background:Patient factors, including mental health, sex, and smoking, have been found to be more predictive of preoperative hip pain and function than intra-articular findings during hip arthroscopy for femoroacetabular impingement (FAI); however, little is known about how these factors may influence patients’ postoperative outcomes.Hypothesis:We hypothesized that lower patient-reported mental health scores would be significant risk factors for worse patient-reported outcomes (PROs) 1 year after arthroscopic hip surgery for FAI and that baseline intra-articular pathology would fail to demonstrate an association with outcomes 1 year after FAI surgery.Study Design:Cohort study; Level of evidence, 2.Methods:A prospective cohort of patients undergoing hip arthroscopy for FAI were electronically enrolled. Baseline and 1-year follow-up PROs were collected, including Hip disability and Osteoarthritis Outcome Score for pain (HOOS-Pain), HOOS–Physical Function Short Form (HOOS-PS), and Veterans RAND 12-Item Health Survey–Mental Component Score (VR-12 MCS). Intra-articular operative findings and treatment were documented at the time of surgery. Proportional odds logistic regression models were built for 1-year outcomes (HOOS-Pain, HOOS-PS, and VR-12 MCS). Risk factors included patient characteristics and intraoperative anatomic and pathologic findings.Results:Overall, 494 patients underwent hip arthroscopy for FAI, and 385 (78%) were evaluated at 1 year with at least 1 PRO. The median patient age was 33 years, mean body mass index was 25.5 kg/m2, and 72% were female. Multivariable analysis demonstrated that better baseline HOOS-Pain, HOOS-PS, and VR-12 MCS were significantly associated with improvement in the 1-year scores for each PRO. Higher VR-12 MCS was significantly associated with better 1-year HOOS-Pain and HOOS-PS, while current and former smokers had worse 1-year outcomes than those who never smoked. In ranking each variable’s relative importance, baseline HOOS-Pain and HOOS-PS and baseline VR-12 MCS were identified as the strongest predictors of 1-year HOOS-Pain and HOOS-PS in our multivariable model.Conclusion:During hip arthroscopy for FAI, patient factors, including baseline hip pain and function, mental health, and smoking, were independently associated with 1-year PROs of hip pain and function, while intra-articular pathology such as the presence of labral tear and its treatment, tear size, tear location, and anchors placed were not independently associated.

Quantitative Testing of the Myelofibrosis Symptom Assessment Form Version 4.0, a Harmonized Patient-Reported Outcome Measure for Collecting Key Secondary Endpoint Data in Myelofibrosis Clinical Trials

Background: The original 20-item Myelofibrosis Symptom Assessment Form (MFSAF) was developed to assess patient-reported symptom improvement in MF treatment trials (Mesa et al, 2009). The MFSAF was expanded to 27 items for use in myeloproliferative neoplasms (MPNs) including essential thrombocythemia (ET) and polycythemia vera (PV; MPN-SAF, Scherber et al, 2011), and later reduced to a 10-item version called the MPN-10 (Emanuel et al, 2012; scale 0-100). At the same time, investigators developed a modified version of the MFSAF called the MFSAF v2.0 diary (6 items, scale 0-60) for use in an MF treatment trial (Falcone and Levy, 2012). As part of next generation JAK1/2 inhibitor trials, various pharma companies collaborated with the US FDA to develop other versions (e.g., MFSAF-revised; 7 items, scale 0-70). Variability across versions (e.g., item wording, recall periods, response scales) increases uncertainty when selecting a measure for use in trials and when comparing findings across trials. To mitigate this uncertainty, the 7-item MFSAF v4.0 (scale 0-70) was recently developed through a harmonization process including stakeholders and the developers of the legacy measures (Gwaltney et al, 2017).Methods: To compare the MFSAF v4.0 to previous versions, an online REDCap survey was developed to assess symptoms (four symptom measures using 24-hour recall), physical functioning (PROMIS® Physical Function-Short Form 10a [PROMIS-PF]), and preference-based health status (EQ-5D-5L Index). Subjects were randomized to complete the (1) MFSAF v4.0 twice (for test-retest reliability) and MFSAF v2.0; or the (2) MFSAF v4.0, MFSAF v2.0, and MPN-10+MFSAF-revised. The three measures in each arm were administered in random order. PROMIS-PF and EQ-5D-5L were used as distractors between the 1st/2nd and 2nd/3rd symptom measures, respectively. The survey was promoted via multiple MPN-related websites and their affiliated Facebook pages June-July 2017. Differences between groups were assessed by ANOVA F-tests and within subjects by paired t-tests. Pearson correlations were computed for the entire sample and then within MF patients only. Cronbach's alphas assessed internal consistency and intraclass correlation coefficients assessed test-retest reliability.Results: 636 subjects accessed the survey of which 513 (81%) were eligible, consented, and attempted at least one of the symptom measures. Respondents with ET (37%), PV (41%), or MF (22%) were 81% female, 95% white, 68% residing in US, and 14% high school education or less with median age 59 (range 27-90). Among 511 with spleen information, 10/511 (2%) reported a prior splenectomy and 175/511 (34%) reported an enlarged spleen (91 [18%] unsure). Similar to other versions, MFSAF v4.0 Total Symptom Score (TSS; overall mean 20.4, SD 14.5, range 0-69) did not significantly differ across disease groups (ET mean 21.1, SD 15.4; PV mean 20.6, SD 14.4; MF mean 18.8, SD 12.9; p=.43) but did significantly differ between subjects with (mean 23.9, SD 14.8) and without enlarged spleen (mean 15.7, SD 12.1; p<.001). MFSAF v4.0 TSS was significantly correlated with the MFSAF v2.0 TSS (overall r=.96, MF r=.97), MPN-10 TSS (overall r=.92, MF r=.85), MFSAF-revised TSS (overall r=.97, MF r=.96), EQ-5D-5L Index (overall r=-.63, MF r=-.61), and PROMIS-PF (overall r=-.60, MF r=-.65; all p<.001). For individual symptoms, correlation among symptoms within the MFSAF v4.0 ranged from .40-.54 (MF .36-.63). Correlations between corresponding items on the different versions were similarly high (.84-.97). Three items of the MPN-10 and 1 item of the MFSAF v2.0 have higher mean scores, and 1 item of each of the MFSAF v2.0 and MFSAF-revised have a lower mean score relative to the MFSAF v4.0 (all p<.05). Internal consistency (overall .86, MF .84) and test-retest reliability (overall .98, 95% CI .97-.98; MF .98, .97-.99) of the MFSAF v4.0 TSS were high.Conclusions: The content validity of the MFSAF v4.0 was established through the harmonization process. Results of this study demonstrate favorable reliability and cross-sectional validity of the MFSAF v4.0 and a high level of comparability to the previous versions, both overall and for individual symptoms. The uniform use of this harmonized version in clinical trials may reduce the uncertainty of assessing symptom improvement and enable comparison across trials. The MFSAF v4.0 is now publicly available for use through the Critical Path Institute. DisclosuresPierson:Janssen: Employment. Trudeau:Janssen Global Services, LLC: Employment, Equity Ownership. Mesa:Ariad: Consultancy; Promedico: Research Funding; Celgene Corporation: Research Funding; CTI BioPharma Corp.: Research Funding; Galena Biopharma, Inc.: Consultancy; Incyte Corporation: Research Funding; Gilead Sciences, Inc.: Research Funding; Novartis Pharmaceuticals Corporation: Consultancy.

Simultaneous bilateral opening-wedge high tibial osteotomy with structural allograft impaction results in excellent early recovery and pain reduction similar unilateral osteotomy

BackgroundPatients suffering from bilateral combined medial osteoarthritis and varus alignment of the knee are eligible for bilateral high tibial osteotomy (HTO) in two-staged surgery. The impact of bilateral HTO surgery on rehabilitation and early outcomes have not yet been reported in the literature, even though these features are decisive in establishing whether a patient is preferably treated in one or two stages. MethodsA total of 29 patients were followed after simultaneous bilateral HTO surgery. Numeric Rating Scale (NRS), Knee injury and Osteoarthritis Outcome Score – Physical Function Short Form (KOOS-PS) and Lysholm scores were recorded at 3, 6 and 12 months. Results were compared with outcomes of unilateral HTO surgery to asses the additional impact of simultaneous bilateral HTO surgery on the early rehabilitation and recovery of simultaneous bilateral HTO surgery. ResultsThree months after surgery, NRS pain scores decreased from 60.5 to 40.9 and subsequently to 30.4 and 24.3 after 6 and 12 months, respectively. KOOS-PS scores improved from 50.0 to 44.3 after 3 months, to 33.9 and 29.8 after 6 and 12 months, respectively. Lysholm scores did not improve after 3 months (45.2–44.2), but significantly improved after 6 and 12 months (66.1 and 75.7, respectively). Compared with unilateral HTO surgery, similar improvements were seen after 6 and 12 months. ConclusionSimultaneous bilateral HTO surgery generates similar clinical outcomes compared with unilateral HTO surgery and moreover it does not excessively prolong time to achieve these outcomes. It is safe and presumably a more effective approach to treat patients suffering bilateral medial osteoarthritis and varus alignment of the knee compared with two-staged surgery.

Lumbar Fusion With Polyetheretherketone Rods Use for Patients With Degenerative Disease.

Polyetheretherketone (PEEK) rods for lumbar fusion have been available since 2007. However, literature about their utility is sparse and of mixed outcomes. A retrospective review of PEEK rod lumbar fusion cases was performed. Data were analyzed from 108 patients of the senior author Donald Ross who underwent PEEK lumbar fusion. There were 97 single and 11 2-level fusions. Rates of tobacco use, diabetes mellitus, low bone density, depression, and immunosuppression were 23.1%, 24.1%, 14.8%, 32.4%, and 6.5%, respectively. In the study population, the mean age was 60.2 years, body mass index was 30.1, and there was a mean 31.3 months for follow-up. There were no wound infections or new neurologic deficits. Of 81 patients with > 11 months of follow-up, 70 (86.4%) had an arthrodesis, 8 (9.9%) had no arthrodesis, and 3 (3.7%) were indeterminate. No patients had revision fusion surgery and 2 patients had adjacent level fusions at 27 and 60 months. One patient had an adjacent segment laminectomy at 18 months and one a foraminotomy at 89 months, resulting in a 3.7% adjacent segment surgery rate. Mean preoperative Short Form-36 (SF-36) physical functioning (PF) score and Oswestry Disability Index (ODI) score were 28.9 and 24.8, respectively. Mean SF-36 PF postoperative score at 1 and 2 years were 59.3 and 65, respectively. Mean ODI postoperative score at 1 year was 14.5. In a large patient cohort lumbar fusion with PEEK rods can be undertaken with low complication rates, satisfactory clinical improvements, low rates of hardware failure or need for revision surgery. Longer follow-up is needed to confirm findings.

Sustained physical activity in peripheral artery disease: Associations with disease severity, functional performance, health-related quality of life, and subsequent serious adverse events in the LITE randomized clinical trial.

This study investigated cross-sectional associations of peripheral artery disease (PAD) severity (defined by the ankle-brachial index (ABI)) and amounts of daily sustained physical activity (PA) (defined as > 100 activity counts per minute lasting 5 consecutive minutes or more). This study also investigated associations of amounts of daily sustained PA with 6-minute walk (6MW) distance and the Short Form-36 physical functioning domain (SF-36 PF) score in cross-sectional analyses and with serious adverse events (SAEs) in longitudinal analyses of people with PAD. PA was measured continuously for 10 days using a tri-axial accelerometer at baseline in 277 participants with PAD randomized to the LITE clinical trial. In regression analyses, each 0.15 lower ABI value was associated with a 5.67% decrease in the number of daily bouts of sustained PA (95% CI: 3.85-6.54; p < 0.001). Every additional bout of sustained PA per day was associated with a 4.56-meter greater 6MW distance (95% CI: 2.67-6.46; p < 0.0001), and a 0.81-point improvement in SF-36 PF score (95% CI: 0.34-1.28; p < 0.001). Participants with values of daily bouts of sustained PA below the median had higher rates of SAEs during follow-up, compared to participants above the median (41% vs 24%; p = 0.002). In conclusion, among participants with PAD, lower ABI values were associated with fewer bouts of daily sustained PA. A greater number of bouts of daily sustained PA were associated with better 6MW performance and SF-36 PF score, and, in longitudinal analyses, lower rates of SAEs. Clinicaltrials.gov ID: NCT02538900.

Comprehensiveness and validity of a multidimensional assessment in patients with chronic low back pain: a prospective cohort study

BackgroundChronic low back pain is a multidimensional syndrome affecting physical activity and function, health-related quality of life and employment status. The aim of the study was to quantify the cross-sectional and longitudinal validity of single measurement scales in specific construct domains and to examine how they combine to build a comprehensive outcome, covering the complex construct of chronic low back pain before and after a standardized interdisciplinary pain program.MethodsThis prospective cohort study assessed 177 patients using the Short Form 36 (SF-36), the Multidimensional Pain Inventory (MPI), the Symptom Checklist-90-Revised (SCL-90-R), the Oswestry Disability Index (ODI), and 2 functional performance tests, the Back Performance Scale (BPS) and the 6-Minute Walking Distance (6MWD). The comprehensiveness and overlap of the constructs used were quantified cross-sectionally and longitudinally by bivariate correlations, exploratory factor analysis, and effect sizes.ResultsThe mean age of the participants was 48.0 years (+/− 12.7); 59.3% were female. Correlations of baseline scores ranged from r = − 0.01 (BPS with MPI Life control) to r = 0.76 (SF-36 Mental health with MPI Negative mood). SF-36 Physical functioning correlated highest with the functional performance tests (r = 0.58 BPS, 0.67 6MWD) and ODI (0.56). Correlations of change scores (difference of follow-up – baseline score) were consistent but weaker. Factor analysis revealed 2 factors: “psychosocial” and “pain & function” (totally explained variance 44.0–60.9%). Psychosocial factors loaded strongest (up to 0.89 SCL-90-R) on the first factor, covering 2/3 of the explained variance. Pain and function (ing) loaded more strongly on the second factor (up to 0.81 SF-36 Physical functioning at follow-up). All scales showed improvements, with effect sizes ranging from 0.16–0.67.ConclusionsOur results confirm previous findings that the chronic low back pain syndrome is highly multifactorial and comprises many more dimensions of health and quality of life than merely back-related functioning. A comprehensive outcome measurement should include the predominant psychosocial domain and a broad spectrum of measurement constructs in order to assess the full complexity of the chronic low back syndrome. Convergence and divergence of the scales capture the overlapping contents and nuances within the constructs.

Prospective investigation of Oswestry Disability Index and short form 36 subscale scores related to sagittal and coronal parameters in patients with degenerative lumbar scoliosis.

This study investigated relationships of Oswestry Disability Index (ODI) and Short Form 36 (SF-36) total and subscale scores with global spinal parameters in patients with degenerative lumbar scoliosis (DLS). This was a prospective single-center study of 126 consecutive patients with DLS. Disability was evaluated using the ODI and SF-36 total and subscale scores. Sagittal and coronal parameters were measured. Pearson's correlation analysis was performed to determine relationships between disability and radiographic parameters. The study population included 76 women and 15 men (mean age, 70.2 ± 8.4years). Mean Cobb angle was 18.9° ± 8.0°. The ODI total score and SF-36 physical component score were only correlated with coronal parameters. ODI pain intensity, personal care, lifting, sitting, and sex life domains were only correlated with coronal parameters. The walking, standing, social life, and traveling domain scores were correlated with coronal and sagittal parameters. The SF-36 bodily pain and vitality domain scores were only correlated with coronal parameters. The SF-36 physical function domain score was correlated with both coronal and sagittal parameters. Among the clinical and radiographic parameters, the personal care score and the coronal vertical-axis had the strongest correlation (r = 0.425), although the r2 value was only 0.18. ODI total score and most of the subscale scores were significantly, but weakly correlated with coronal parameters. Sagittal parameters were only correlated with some of the ODI and SF-36 subscale scores. Analysis using ODI and SF-36 subscale scores may aid in understanding and treatment of disability in patients with DLS.

Patient-reported outcome measures used in patients undergoing total knee arthroplasty.

Patient-reported outcome measures (PROMs) are being used increasingly in total knee arthroplasty (TKA). We conducted a systematic review aimed at identifying psychometrically sound PROMs by appraising their measurement properties. Studies concerning the development and/or evaluation of the measurement properties of PROMs used in a TKA population were systematically retrieved via PubMed, Web of Science, Embase, and Scopus. Ratings for methodological quality and measurement properties were conducted according to updated COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Of the 155 articles on 34 instruments included, nine PROMs met the minimum requirements for psychometric validation and can be recommended to use as measures of TKA outcome: Oxford Knee Score (OKS); OKS–Activity and Participation Questionnaire (OKS-APQ); 12-item short form Knee Injury and Osteoarthritis Outcome (KOOS-12); KOOS Physical function Short form (KOOS-PS); Western Ontario and McMaster Universities Arthritis Index-Total Knee Replacement function short form (WOMAC-TKR); Lower Extremity Functional Scale (LEFS); Forgotten Joint Score (FJS); Patient’s Knee Implant Performance (PKIP); and University of California Los Angeles (UCLA) activity score. The pain and function subscales in WOMAC, as well as the pain, function, and quality of life subscales in KOOS, were validated psychometrically as standalone subscales instead of as whole instruments. However, none of the included PROMs have been validated for all measurement properties. Thus, further studies are still warranted to evaluate those PROMs. Use of the other 25 scales and subscales should be tempered until further studies validate their measurement properties.Cite this article: Bone Joint Res 2021;10(3):203–217.