Patient-reported Outcome Measures In Patients Research Articles

Translation and Psychometric Analysis of the Indonesian Versions of the Lysholm and Tegner Scores for Patients With Anterior Cruciate Ligament Injuries.

Background:The Lysholm knee score and Tegner activity scale are frequently used patient-reported outcome measures in patients with anterior cruciate ligament (ACL) injuries because of their excellent psychometric properties. These questionnaires were originally developed in the English language.Purpose:To translate and cross-culturally adapt these measures into the Indonesian language and study their validity and reliability so that they can be used in the Indonesian-speaking population with ACL injuries.Study Design:Cohort study (diagnosis/symptom prevalence); Level of evidence, 2.Methods:After a forward-backward translation procedure and cross-cultural adaptation, validity and reliability were investigated. A total of 253 patients with an ACL injury were sent 4 questionnaires (36-Item Short Form Health Survey, Kujala anterior knee pain scale, Indonesian Lysholm knee score [I-LK], and Indonesian Tegner activity scale [I-TS]). The responses of those patients were analyzed. Following COSMIN guidelines, construct validity, test-retest reliability, internal consistency, floor and ceiling effects, and measurement errors were determined. The Bland-Altman method was used to explore absolute agreement.Results:A total of 106 patients (42% response rate) were included in this study. Construct validity was considered to be good, as more than 75% of the predefined hypotheses on correlations between the I-LK, I-TS, and other measures were confirmed. Reliability proved excellent, with a high test-retest correlation for both questionnaires (intraclass correlation coefficient = 0.99). Bland-Altman analysis showed no systematic bias between testing and retesting. The internal consistency of the I-LK was good (Cronbach alpha = 0.73). For the I-LK and I-TS, floor and ceiling effects were less than 15% (floor: 0% and 4.7%, respectively; ceiling: 12.3% and 3.8%, respectively); the standard error of measurement was 1.8 and 0.9, respectively; the minimal detectable change at the individual level was 5.1 and 0.6, respectively; and the minimal detectable change at the group level was 2.4 and 0.5, respectively.Conclusion:Both the I-LK and I-TS appear to be good evaluation tools for Indonesian-speaking patients with an ACL injury.

Dysphagia Weakly Correlates With Other Patient-Reported Outcomes After Anterior Cervical Discectomy and Fusion.

IntroductionDysphagia is a common complication after anterior cervical discectomy and fusion (ACDF), but it is not a routinely asked question in legacy patient-reported outcome measures (PROMs). This study analyzes whether there are associations between dysphagia and legacy outcome measures.MethodsWe retrospectively reviewed 168 patients who underwent ACDF surgery from 2017 to 2019 at a single institution. Demographics, anthropometric data, Neck Disability Index (NDI), Visual Analog Scale (VAS)-Arm and VAS-Neck Pain scores, Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical and PROMIS-Mental scores, Charlson Comorbidity Index (CCI), and Eating Assessment Tool-10 (EAT-10) were obtained for each patient preoperatively and at one, three, six, and 12 months postoperatively. Pearson’s correlation coefficients were used to evaluate the bivariate correlations between legacy, PROMIS, and EAT-10 measures.ResultsSignificant but weak correlations existed between NDI and EAT-10 at one, three, and six months postoperatively (correlation coefficient (R) = 0.31, 0.42, and 0.34 at one, three, and six months, p < 0.001) and VAS-Neck Pain and EAT-10 scores at one, three, and six months postoperatively (R = 0.27, 0.30, and 0.28 at one, three, and six months, p ≤ 0.004). Both PROMIS-Physical and PROMIS-Mental scores showed significant but weak correlations with EAT-10 scores at three and six months postoperatively (R = -0.29 and -0.25, p ≤ 0.01, at three months and R = -0.25 and -0.28, p < 0.01, at six months). In all comparisons of EAT-10 scores with legacy outcome measures, the significance of correlations disappeared by 12 months postoperatively. In addition, there was a positive association between CCI and EAT-10 score (β = 0.37, p < 0.05).ConclusionWeak correlations exist between self-reported dysphagia scores and legacy patient-reported outcome measures in patients undergoing ACDF. The correlation strength decreases over time; therefore, dysphagia scores should be reported separately when looking at outcomes after ACDF. Patients with more comorbidities are also at increased risk for dysphagia.

Patient-Reported Outcome Measures in Symptomatic, Non-Limb-Threatening Peripheral Artery Disease: A State-of-the-Art Review.

Patient-reported outcome measures (PROMs) are health outcomes directly reported by the patient that can be used to measure the effect of disease and treatments on patient perceived well-being. This review summarizes current evidence regarding the validation of PROMs in people with symptomatic, nonlimb-threatening peripheral artery disease. A literature search was conducted to identify studies of symptomatic peripheral artery disease without limb-threatening ischemia that included PROMs and had sample sizes ≥25. PROMs were summarized along a continuum of validation using classical test theory framework and according to whether they fulfilled defined criteria for (1) content validity; (2) psychometric validation; and (3) further validation evidence base expansion. Of 2198 articles identified, 157 (7.1%) met inclusion criteria. Twenty-four PROMs in patients with symptomatic peripheral artery disease were reviewed. Among disease-specific PROMs, 8 of 15 had excellent reliability as measured by a Cronbach alpha ≥0.80. Based on established criteria for PROM responsiveness, 6 of 15 disease-specific PROMs demonstrated excellent sensitivity to change. Of these, the disease-specific peripheral artery questionnaire, vascular quality of life questionnaire, and walking impairment questionnaire met criteria for validation at each stage of the continuum. For generic (nondisease specific) PROMs, the European Quality of Life 5-Dimension and SF-36 had the most extensive evidence of validation. Evidence from this review can inform selection of PROMs aligned with scientific and clinical goals, given the variable degree of validation and potential complementary nature of the measures.

Influence of Preoperative 12-Item Short Form Mental Composite Score on Clinical Outcomes in an Isthmic Spondylolisthesis Population Undergoing Minimally Invasive Transforaminal Lumbar Interbody Fusion

To determine preoperative 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS) influence on minimally important clinical difference (MCID) and patient-reported outcome measures in patients with isthmic spondylolisthesis receiving minimally invasive transforaminal lumbar interbody fusion. Patients with isthmic spondylolisthesis undergoing primary, single-level minimally invasive transforaminal lumbar interbody fusion at L5-S1 were retrospectively identified and divided into preoperative SF-12 MCS <50 and SF-12 MCS ≥50 groups. Visual analog scale (VAS) back/leg, Oswestry Disability Index (ODI), SF-12 Physical Composite Score (PCS), and Patient-Reported Outcome Measurement Information System physical function (PROMIS-PF) were assessed. Improvements from preoperative score were analyzed via paired samples t test. Patient-reported outcome measures and MCID attainment between groups were evaluated using linear regression and χ2, respectively. SF-12 MCS <50 and SF-12 MCS ≥50 groups included 35 and 26 patients, respectively. SF-12 MCS < 50 group had inferior scores for all VAS back time points except 6 weeks, all VAS leg time points except 6 weeks/1 year, all ODI time points, SF-12 PCS at 6 months/2 years, and PROMIS-PF at preoperative/6 months (all P ≤ 0.049). SF-12 MCS <50 group improved for VAS back/leg to 1 year, ODI and SF-12 PCS from 12 weeks to 1 year, and PROMIS-PF at 1 year only (all P ≤ 0.047). SF-12 MCS ≥50 group improved for VAS back from 12 weeks to 1 year, SF-12 PCS 6 months to 2 years, and VAS leg, ODI, and PROMIS-PF 12 weeks to 2 years (all P ≤ 0.018). MCID attainment differed for ODI at 6 weeks and PROMIS-PF at 12 weeks only (both P ≤ 0.035). Patients with SF-12 MCS <50 demonstrated fewer long-term improvements from preoperative to 2 years and inferior patient-reported outcome measures at most time points for pain and disability following minimally invasive transforaminal lumbar interbody fusion. MCID attainment largely did not differ by preoperative mental functioning.

A Psycholgical Intervention Delivered by Automated Mobile Phone Messaging Stabilized Hip and Knee Function During the COVID-19 Pandemic: A Randomized Controlled Trial.

BackgroundWe conducted a randomized controlled trial to evaluate the effectiveness of acceptance and commitment therapy (ACT) delivered via a mobile phone messaging robot to patients who had their total hip arthroplasty or total knee arthroplasty procedures postponed due to the COVID-19 pandemic.MethodsNinety patients scheduled for total hip arthroplasty or total knee arthroplasty who experienced surgical delay due to the COVID-19 pandemic were randomized to the ACT group, receiving 14 days of twice daily automated mobile phone messages, or the control group, who received no messages. Minimal clinically important differences (MCIDs) in preintervention and postintervention patient-reported outcome measures were utilized to evaluate the intervention.ResultsThirty-eight percent of ACT group participants improved and achieved MCID on the Patient-Reported Outcome Measure Information System Physical Health compared to 17.5% in the control group (P = .038; number needed to treat [NNT] 5). For the joint-specific Hip Disability and Osteoarthritis Outcome Score Joint Replacement and Knee Disability and Osteoarthritis Outcome Score Joint Replacement (KOOS JR), 24% of the ACT group achieved MCID compared to 2.5% in the control group (P = .004; NNT 5). An improvement in the KOOS JR was found in 29% of the ACT group compared to 4.2% in the control group (P = .028; NNT 5). Fourteen percent of the ACT group participants experienced a clinical important decline in the KOOS JR compared to 41.7% in the control group (P = .027; NNT 4).ConclusionA psychological intervention delivered via a text messaging robot improved physical function and prevented decline in patient-reported outcome measures in patients who experienced an unexpected surgical delay during the COVID-19 pandemic.Level of Evidence1.

The relationship between musculoskeletal health literacy and upper extremity patient-reported outcome measures (PROMs) in the setting of atraumatic shoulder pain

IntroductionPatient-reported outcome measures (PROMs) are commonly utilized to assess patient-derived orthopaedic health status and function. The prevalence of limited musculoskeletal health literacy (MHL) has been demonstrated to be high within the orthopaedic literature. The purpose of this study was to evaluate the association between MHL and upper extremity-specific PROMs and to determine which patient- and symptom-related factors affect baseline PROMs in patients with atraumatic shoulder pain. HypothesisPatients with limited MHL would demonstrate lower median scores on baseline PROMs compared with those with adequate MHL. Materials and methodsNew patients with atraumatic shoulder pain presenting to an academic practice were administered the Literacy in Musculoskeletal Problems (LiMP), in addition to the American Shoulder and Elbow Surgeons (ASES), Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH), and Single Assessment Numeric Evaluation (SANE) questionnaires. A detailed physical exam and history was performed by a fellowship-trained shoulder surgeon. Demographic patient data, in addition to prior imaging and orthopaedic treatment, was tabulated. The association between demographics, pain-related variables, and MHL with the ASES, SANE, and QuickDASH scores were examined using Spearman correlation coefficients for continuous variables and Wilcoxon rank-sum tests for categorical variables. Non-parametric analysis of covariance (ANCOVA) was used to examine the independent association of predictor variables with PROMs. ResultsA total of 439 patients met the inclusion criteria and were enrolled. The mean age was 58.8±12.6years (range: 24–93) with 162 (37%) being men. Overall, 172 patients (39.2%) attained a college degree or higher and 183 (41.7%) were currently employed. MHL was significantly associated with ASES (p=0.03), but not with the QuickDASH (p=0.75) or SANE score (p=0.16). Similarly, age, having been in the medical profession or having previously visited an orthopaedist were not associated with PROMs, while employment status correlated to the SANE score (p=0.002). Visual Analogue Scale (VAS) pain level demonstrated varying strengths of association with each of the scores [ASES (r=−0.729, p<0.001), QuickDASH (r=0.557, p<0.001), and SANE (r=−0.430, p<0.001)]. MHL demonstrated no association with initial patient-derived treatment selection. DiscussionThe SANE and QuickDASH may be administered to patients presenting for atraumatic shoulder pain in the outpatient setting regardless of MHL. Further research should be focused on the utility of the ASES instrument amongst patients with lower educational levels and/or limited MHL. Level of evidenceII; diagnostic.

Standardising the Assessment of Patient-reported Outcome Measures in Localised Prostate Cancer. A Systematic Review

ContextProstate cancer (PCa) is the second most common cancer among men worldwide. Urinary, bowel, and sexual function, as well as hormonal symptoms and health-related quality of life (HRQoL), were prioritised by patients and professionals as part of a core outcome set for localised PCa regardless of treatment type. ObjectiveTo systematically review the measurement properties of patient-reported outcome measures (PROMs) used in localised PCa and recommend PROMs for use in routine practice and research settings. Evidence acquisitionThe psychometric properties of PROMs measuring functional and HRQoL domains used in randomised controlled trials including patients with localised PCa were assessed according to the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) methodology. MEDLINE and Embase were searched to identify publications evaluating psychometric properties of the PROMs. The characteristics and methodological quality of the studies included were extracted, tabulated, and assessed according to the COSMIN criteria. Evidence synthesisOverall, 27 studies evaluating psychometric properties of the Expanded Prostate Cancer Index Composite (EPIC), University of California-Los Angeles Prostate Cancer Index (UCLA-PCI), European Organisation for Research and Treatment of Cancer (EORTC) quality of life core 30 (QLQ-C30) and prostate cancer 25 (QLQ-PR25) modules, International Index of Erectile Function (IIEF), and the 36-item (SF-36) and 12-item Short-Form health survey (SF-12) PROMs were identified and included in the systematic review. EPIC and EORTC QLQ-C30, a general module that assesses patients’ physical, psychological, and social functions, were characterised by high internal consistency (Cronbach’s α 0.46–0.96 and 0.68–0.94 respectively) but low content validity. EORTC QLQ-PR25, which is primarily designed to assess PCa-specific HRQoL, had moderate content validity and internal consistency (Cronbach’s α 0.39–0.87). UCLA-PCI was characterised by moderate content validity and high internal consistency (Cronbach’s α 0.21–0.94). However, it does not directly assess hormonal symptoms, whereas EORTC QLQ-PR25 does. ConclusionThe tools with the best evidence for psychometric properties and feasibility for use in routine practice and research settings to assess PROMs in patients with localised PCa were EORTC QLQ-C30 and QLQ-PR25. Since EORTC QLQ-C30 is a general module that does not directly assess PCa-specific issues, it should be adopted in conjunction with the QLQ-PR25 module. Patient summaryWe reviewed and appraised the measurement properties of patient-reported outcome measure questionnaires used for patients with localised prostate cancer. We found good evidence to suggest that two questionnaires (EORTC QLQ-C30 and QLQ-PR25) can be used to measure urinary, bowel, and sexual functions and health-related quality of life.

Health-Related Quality of Life of Patients with Chronic Myeloid Leukemia as Measured by Patient-Reported Outcomes: Current State and Future Directions.

Tyrosine kinase inhibitors (TKIs) allow many patients with chronic myeloid leukemia (CML) to live normal life spans but have the potential to impact patients' health-related quality of life (HRQOL). Patient-reported outcome (PRO) measures can provide valuable information to inform treatment decision-making. Here, we review pivotal studies that used PRO measures to evaluate HRQOL of patients with CML in the first-line and treatment-free remission (TFR), and identify areas for future research. PRO measures commonly studied in patients with CML include the SF-36, FACT-Leu, EORTC QLQ-CML24, and MDASI CML. Cohort or cross-sectional studies provide the most data on PRO measures in patients with CML, with less information available from randomized controlled trials (RCTs). Patients with CML taking TKIs have worse HRQOL compared to matched controls, with a few studies seeing a larger effect in younger patients (< 60years old). No single TKI consistently has better HRQOL compared to other agents. Fatigue is a predominant symptom associated with impaired HRQOL across many studies. Studies evaluating TFR show stable or improved HRQOL after TKI discontinuation. There are areas of HRQOL detrimental to patients with other types of cancer (e.g., cognition, sexuality) that warrant further evaluation in patients with CML. Understanding the HRQOL of patients with CML is increasingly important as patients live near-normal life expectancies. PRO measures have the potential to inform treatment decisions in this patient population. Future research opportunities include using PRO measures in RCTs and expanding the HRQOL topics studied in patients with CML.

How Should We Use Patient-Reported Outcome Measures at the Point of Care in Hand Surgery?

Despite the importance of collecting patient-reported outcome measures (PROMs), there are few process guidelines for physicians on how to collect and communicate individualized PROMs in patients at the point of care. The purpose of this study was to develop process guidelines on how toroutinely collect and communicate individualized PROMs at the point of care in hand surgery. A consortium of 9 fellowship-trained hand or upper limb surgeons and experts in quality measure development evaluated the importance, feasibility, usability, and scientific acceptability of 12 candidate process guidelines regarding the collection and use of individualized PROMs at the point of care using a modified RAND/University of California Los Angeles Delphi appropriateness method. The panelists evaluated each candidate process guideline in 2 blinded voting rounds with an intervening face-to-face discussion. Predetermined criteria were used to determine panelist agreement or disagreement. The consortium did not reach a consensus on the validity of any of the 12 candidate process guidelines on the routine collection and communication of individualized PROMs at the point of care in hand surgery. The domains of importance and feasibility had greater median scores than those of usability and evidence. To effectively collect and use PROMs to improve care for individual patients, process guidelines for when and how PROM scores should be collected and communicated with patients are needed. The expert consortium was unable to reach an agreement on any of the candidate process guidelines, often because of limitations in evidence supporting the use of PROMs at the point of care. Patient-reported outcome measures continue to guide outcome assessments that reflect patient perspective. Although PROM scores are currently aggregated and used to draw broad conclusions about populations, they can also be used as communication tools or to trigger management decisions (eg, use of therapy) that improve care for individual patients. Process guidelines on how to use PROM scores at the point of care are needed.

Adherence to Telemonitoring by Electronic Patient-Reported Outcome Measures in Patients with Chronic Diseases: A Systematic Review.

Background: Effective telemonitoring is possible through repetitive collection of electronic patient-reported outcome measures (ePROMs) in patients with chronic diseases. Low adherence to telemonitoring may have a negative impact on the effectiveness, but it is unknown which factors are associated with adherence to telemonitoring by ePROMs. The objective was to identify factors associated with adherence to telemonitoring by ePROMs in patients with chronic diseases. Methods: A systematic literature search was conducted in PubMed, Embase, PsycINFO and the Cochrane Library up to 8 June 2021. Eligibility criteria were: (1) interventional and cohort studies, (2) patients with a chronic disease, (3) repetitive ePROMs being used for telemonitoring, and (4) the study quantitatively investigating factors associated with adherence to telemonitoring by ePROMs. The Cochrane risk of bias tool and the risk of bias in nonrandomized studies of interventions were used to assess the risk of bias. An evidence synthesis was performed assigning to the results a strong, moderate, weak, inconclusive or an inconsistent level of evidence. Results: Five studies were included, one randomized controlled trial, two prospective uncontrolled studies and two retrospective cohort studies. A total of 15 factors potentially associated with adherence to telemonitoring by ePROMs were identified in the predominate studies of low quality. We found moderate-level evidence that sex is not associated with adherence. Some studies showed associations of the remaining factors with adherence, but the overall results were inconsistent or inconclusive. Conclusions: None of the 15 studied factors had conclusive evidence to be associated with adherence. Sex was, with moderate strength, not associated with adherence. The results were conflicting or indecisive, mainly due to the low number and low quality of studies. To optimize adherence to telemonitoring with ePROMs, mixed-method studies are needed.

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.

A Comparison of Nerve-Specific, Condition-Specific, and Upper Extremity-Specific Patient-Reported Outcome Measures in Patients With Carpal and Cubital Tunnel Syndrome

Arm-, region-, tissue-, and condition-specific patient-reported outcome measures (PROMs) are available to address idiopathic mononeuropathy. This study compared PROMs with varying specificities in patients with idiopathic neuropathy of the upper extremity with respect to correlations with each another, sources of variation in scores, and floor and ceiling effects. One hundred fifty patients (130 with carpal tunnel syndrome, 30 with cubital tunnel syndrome, and 10 with both conditions) completed a nerve-specific PROM (Impact of Hand Nerve Disorders), a condition-specific PROM (Boston Carpal Tunnel Syndrome Questionnaire and/or Patient-Rated Ulnar Nerve Evaluation), and an upper extremity-specific PROM (Patient-Reported Outcomes Measurement Information System Physical Function Upper Extremity 7). We also gathered demographic and condition-related data (side, electrodiagnostic studies present, muscle atrophy, static loss of sensibility), and patients completed questionnaires measuring self-efficacy, kinesiophobia, and symptoms of depression. Correlation of the PROMs with each another and factors accounting for their variation were assessed, as well as the number of items to complete, time to complete, and floor and ceiling effects. Pearson correlations between PROMs were moderate to strong (0.56-0.90). Self-reported symptoms of depression were best able to account for the variations in symptom intensity and activity intolerance on all PROMs (adjusted R2 between 0.09 and 0.31). The Impact of Hand Nerve Disorders is a long questionnaire and took the most time to complete. All instruments had comparable floor effects; Patient-Reported Outcomes Measurement Information System Physical Function Upper Extremity had a ceiling of effect of 16%. This study adds to the evidence that specific and general PROMs correlate with each another, perhaps in part through their correlation with mental health. Based on this line of evidence and pending testing of potentially greater responsiveness in specific settings, we prefer to use a single simple, brief, and general PROM to quantify symptom intensity and activity intolerance for both routine patient care and research. Prognostic II.

Reliability and validity of the Korean version of the MacNew heart disease Health-related Quality of Life questionnaire

BackgroundMyocardial infarction and unstable angina are prevalent in Korea. The MacNew Heart Disease health-related quality of life questionnaire is a widely used patient-reported outcome measure for patients with heart disease in several countries. In this study, we tested the validity and reliability of the Korean version of the MacNew (K-MacNew).MethodsParticipants were 200 patients who had experienced unstable angina or myocardial infarction, and were recruited from a tertiary hospital in Korea. The K-MacNew was developed using forward–backward translation techniques. Construct validity (including discriminative validity), concurrent validity, and internal consistency reliability of the K-MacNew were assessed. Discriminative validity was assessed by examining the between-group differences in the K-MacNew scores according to functional capacity, anxiety, and depression levels. Concurrent validity was examined by correlating the K-MacNew dimensions with the physical and mental health domains of the 36-item Short Form Health Survey Instrument (SF-36).ResultsFactor analysis results of the K-MacNew demonstrated a three-factor structure (emotional, physical, and social) that explained 57.92% of the variance. Significant differences in the K-MacNew scores were observed according to patients’ functional capacity, anxiety, and depression levels. The SF-36 physical health domain score showed a moderate positive correlation with the physical dimension score of the K-MacNew (r = 0.517, P < 0.001), and the SF-36 mental health domain score showed a strong positive correlation with the emotional dimension of K-MacNew (r = 0.745, P < 0.001). The K-MacNew showed good internal consistency, with a Cronbach’s α of 0.947 for the global scale.ConclusionThe K-MacNew demonstrated good reliability and validity for use as a patient-reported outcome measure and is ready for the assessment of the health-related quality of life of patients with coronary artery disease in Korea. To establish the clinical validity of the K-MacNew, additional studies should be conducted to verify the validity and reliability of the K-MacNew in a number of participants, including those with various types of coronary artery disease.

64. Impact of depression on patient reported outcomes following primary vs revision ACDF

<h3>BACKGROUND CONTEXT</h3> Depression has been associated with poorer outcomes following anterior cervical discectomy and fusion (ACDF). However, research examining the relationship between depression and patient reported outcome measures (PROMs) in revision ACDF procedures is limited. <h3>PURPOSE</h3> To assess the relationship of depressive symptoms with PROMs in patients undergoing either primary or revision ACDF procedures. <h3>STUDY DESIGN/SETTING</h3> Retrospective cohort. <h3>PATIENT SAMPLE</h3> 143 patients undergoing primary or revision, single- or multilevel ACDF procedures. <h3>OUTCOME MEASURES</h3> Demographic and perioperative characteristics, Patient Health Questionnaire-9 (PHQ-9), visual analog scale (VAS), Neck Disability Index (NDI). <h3>METHODS</h3> A prospective database was retrospectively reviewed for primary or revision, single- or multi-level ACDF procedures from 2016 to 2020. Patients lacking preoperative PHQ-9 surveys were excluded. Demographic and perioperative characteristics were recorded and analyzed using Fisher's exact test or t-test. Patient-reported outcome measures were collected preoperatively and postoperatively. Postoperative improvement from baseline scores (ΔPROM) was calculated at all postoperative timepoints. Differences in mean PROM and ΔPROM between groups and changes from baseline PROM scores within groups were assessed using student's t-test. Linear regression analyzed the impact of preoperative PHQ-9 on ΔPROM among primary and revision patients. <h3>RESULTS</h3> A total of 143 patients (121 primary and 22 revision) were included. Significant differences between groups were demonstrated at the preoperative timepoint for NDI (p=0.022). ΔPROM values did not significantly differ between groups. Regression analysis revealed significant relationships between preoperative PHQ-9 and ΔPHQ-9 at all timepoints, ΔVAS neck at 6-weeks and 6-months, ΔVAS arm at 6-months, and ΔNDI at 6-weeks and 6-months for the primary group (all p<0.05). Regression analysis revealed no significant associations for the revision group. <h3>CONCLUSIONS</h3> Primary or revision ACDF procedures did not significantly differ in depressive symptoms through 1-year. Primary ACDF patients significantly improved in all PROMs through all timepoints, while revision patients had limited improvement in PROMs. Preoperative depression may have a stronger association on postoperative outcomes for primary procedures. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Development and validation of a patient-reported outcome measure for patients with chronic respiratory failure: The CRF-PROM scale.

BackgroundVarious health‐related quality‐of‐life (HRQOL) tools are used to evaluate patients with chronic respiratory failure (CRF), but there is a relative lack of tools available for the evaluation of social support and treatment in these patients. The present study focused on the development of a systematic patient‐reported outcome measure (PROM) tool for use in patients with CRF.MethodsThe CRF‐PROM scale conceptual framework and item bank were generated after reviewing the corresponding literature and HRQOL scales, interviewing CRF patients and focus groups. After creation of the initial scale, the items in the scale were selected through two item selection theories, and the final scale was created. The reliability, validity and feasibility of the final scale were assessed.ResultsThe CRF‐PROM scale includes four domains (i.e., physiological domain, psychological domain, social domain and therapeutic domain) and 10 dimensions. After the item selection process, the final scale included 50 items. Cronbach's α coefficients, which were all above 0.7, indicated the reliability of the scale. The results of structural validity met the relevant standards of confirmatory factor analysis. The response rates of the preinvestigation and the formal investigation were 93.3% and 97.6%, respectively.ConclusionsThe CRF‐PROM scale developed in the present study is effective and reliable. It could be used widely in the posthospital management of patients, in CRF studies and in clinical trials of new medical products and interventions.Patient or Public ContributionParticipants from eight different hospitals and communities participated in the development or validation phase of the CRF‐PROM scale.

Performance of the PHQ-9 across conditions and comorbidities: Findings from the Veterans Outcome Assessment survey

BackgroundThe items of the Patient Health Questionnaire-9 (PHQ-9) represent the criterion symptoms for DSM-IV major depression. This study evaluated the extent to which the PHQ-9 functions as a patient-reported outcome measure (PROM) specific to patients with major depressive disorder. MethodData were from the Veterans Outcome Assessment survey for 8848 patients beginning treatment in VA general mental health clinics, including 5754, re-surveyed after 3 months. The PHQ-9’s performance as a PROM was evaluated by comparing rank order correlations between both initial scores and improvements over 3 months between the PHQ-9 and several transdiagnostic PROMs across a range of diagnoses and comorbidities. Performance of PHQ-9-related patient-reported outcome-based performance measures (PROM-PM) were evaluated by comparing rates of response and remission across patient groups. ResultsCorrelations between the PHQ-9 and transdiagnostic measures were significant and comparable in magnitude across a range of diagnoses and for cases with depression with or without comorbidities. Rates of response and remission were comparable across most patient groups. LimitationsLimitations include use of clinical diagnoses as recorded in health records, and the relatively short time between assessments. ConclusionsIn these settings, the PHQ-9 functions more as a general measure of symptoms or distress than as a disease-specific scale. This supports its use as a PROM for patients beyond those with major depression, including those with related diagnoses and those with comorbidities, and use of related PROM-PMs in clinical settings where diagnoses may not be precise and comorbidities may be common.

Measurement properties of patient-reported outcome measures (PROMs) in patients with hyperhidrosis: protocol for a systematic review

BackgroundHyperhidrosis is a chronic skin condition that impairs the patient’s quality of life (QoL). There are several patient-reported outcome measures (PROMs) for patients affected by hyperhidrosis available; however an evidence-based assessment of their quality has not been undertaken so far.ObjectiveIn our systematic review, we aim to identify all existing PROMs that were developed and/or validated for measuring patient-reported outcomes in patients with hyperhidrosis and assess their measurement properties in a transparent and structured way to give a recommendation for future clinical research.Methods/designOur systematic review aims to contain all PROMs developed and/or validated for patients with hyperhidrosis. We will perform a highly sensitive, systematic literature search including the databases MEDLINE (Ovid), EMBASE (Ovid), and Science Citation Index Expanded and Social Sciences Citation Index (Web of Science). Especially studies which evaluate, describe, or compare measurement properties of PROMs for patients with hyperhidrosis will be considered as eligible. Two independent reviewers will judge the eligibility of the studies found in the literature search. The study and PROM characteristics will be summarized in evidence tables. The methodological quality of each study will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Risk of Bias checklist. We will apply predefined and consensus-based quality criteria for good measurement properties. Subsequently, the quality of the evidence will be graded. Furthermore, aspects on interpretability and feasibility will be described. A final recommendation will be given.DiscussionIn our systematic review, we aim to provide a comprehensive description of the quality of all existing PROMs for patients with hyperhidrosis. The assessment of measurement properties, interpretability, and feasibility will serve as a guidance regarding the selection of PROMs for future clinical hyperhidrosis trials.Systematic review registrationPROSPERO CRD42020170247

P116 Development of a new patient-reported outcome measure for patients with complex cryptoglandular fistulas

Abstract Background Complex cryptoglandular fistulas (CCF) arise from infected anal glands and are often associated with substantial morbidity and healthcare utilization. Standarized patient-reported outcome measures (PROMs) for CCF are lacking. Thus, we aimed to develop a disease-specific PROM to assess the burden of symptoms and their impact on daily life in patients with CCF. Methods To develop a conceptual model, a targeted literature review was conducted to identify symptoms and impacts on daily life associated with CCF. Existing PROMs relating to anal fistulas were also sought. Semi-structured interviews with colorectal surgeons (n=5) assessed clinical perspectives on patient experience of CCF. A draft item pool was developed based on the refined conceptual model and using the Quality of Life in Patients with Anal Fistula Questionnaire as a reference. The tool was refined through concept elicitation interviews on the symptoms and impacts of CCF, and cognitive debriefing on the interpretation, understanding and response to each item. Interviews were conducted until concept saturation was achieved and patient feedback suggested no further refinements were required. Results The literature review identified discharge, pain, faecal incontinence and bleeding as the most prevalent symptoms, and embarrassment as the most prevalent impact on daily life. Results from surgeon interviews were then used to revise the initial conceptual model. Twenty US adults (60% female; mean age, 49 years) with clinically confirmed CCF participated in interviews (four waves of n=5). Patients identified 10 salient symptoms and 11 salient impacts on daily life (salient defined as mention by ≥50% of patients and mean disturbance rating ≥5 on a 10-point scale). The final conceptual model included the main symptoms and treatment-related effects, and impacts on daily life. The draft item pool was refined, resulting in a final PROM consisting of 14 items (covering frequency and severity) relating to symptom domains – discharge, incontinence, pain, irritation, odour, abscess – and 6 items relating to health-related quality of life domains – functional, physical, psychological, social health. The PROM features a 7-day recall period, with responses mostly given on a 5-point verbal rating scale. Cognitive debriefing confirmed that the PROM was clear, easy to understand and relevant to patients’ experiences. Conclusion The 20-item CCF questionnaire (CCFQ-20) is a new PROM that has been developed and tested for content validity, following expert guidance and regulatory best practices. It addresses a comprehensive set of salient symptoms and impacts experienced by patients with CCF. Psychometric testing is required to fully evaluate this PROM. Sponsor: Takeda Pharmaceuticals USA, Inc.

Multicenter Outcomes After Primary Hip Arthroscopy: A Comparative Analysis of Two-Year Outcomes After Labral Repair, Segmental Labral Reconstruction, or Circumferential Labral Reconstruction

(1) To report minimum 2-year follow-up patient-reported outcome measures in patients undergoing labral repair (LR), segmental labral reconstruction (SLR), or circumferential labral reconstruction (CLR) in the primary setting; and (2) to compare minimum 2-year follow-up patient-reported outcome measures among these groups. A retrospective review of a prospectively maintained multicenter database of patients undergoing hip arthroscopy was performed. Inclusion criteria were patients undergoing hip arthroscopy for treatment of labral tear and femoroacetabular impingement syndrome between January 2014 and October 2017, and completion of minimum 2-year postoperative outcome scores. Exclusion criteria were patients undergoing revision hip surgery, labral treatment limited to debridement, lateral center-edge angle <20°, osteoarthritis (Tönnis grade > 1), slipped capital femoral epiphysis, workers compensation status, and patients undergoing concomitant gluteus medius and/or minimus repair. Labral reconstruction patients were matched (1:3) with labral repair patients on age, sex, and body mass index. The labral reconstruction group was further stratified into SLR, and CLR groups. Patient demographic characteristics and clinical outcomes including Hip Outcome Score - Activities of Daily Living, Hip Outcome Score - Sport Subscale, modified Harris Hip Score, international Hip Outcome Tool, and visual analog scale for pain were analyzed, as well as achievement of the minimal clinical improvement difference (MCID). A P-value less than .05 indicated statistical significance. A total of 416 patients were included (LR, n= 312; SLR, n= 53; CLR, n= 51). The age, body mass index, and sex of the matched cohort were 42.3 ± 11.2 years, 24.7 ± 3.7, and 55.0% female. At a minimum of 2-year after hip arthroscopic surgery, no differences were found in preoperative, postoperative, or the delta visual analog scale for pain, modified Harris Hip Score, Hip Outcome Score - Activities of Daily Living, Hip Outcome Score - Sport Subscale, or international Hip Outcome Tool. Subsequently, the proportion of patients achieving the MCID and the PASS at latest follow-up were analyzed. This analysis revealed that no significant differences in the rate of MCID or PASS achievement for any outcome measure existed based on labral treatment. In this multicenter study on labral treatment in the primary setting, patients undergoing LR, SLR, and CLR demonstrated no difference in preoperative or postoperative scores, nor the proportion of patients achieving clinically significant outcome improvement. III; therapeutic outcome study with controls.

Can Generic Outcome Questionnaires Replace QuickDASH in Monitoring Clinical Outcome Following Surgical Treatment of Distal Radius Fractures?

In contrast to region-specific patient-reported outcome measures (PROMs), generic PROMs can be argued to have an added benefit of enabling cost-utility analyses and allowing for comparisons to be made across different conditions. The aim of this study was to assess the responsiveness and strength of the association between region-specific and generic PROMs in patients treated operatively for a displaced intra-articular distal radius fracture. Over a 4-year period, 166 patients aged 18-70 years with a displaced intra-articular fracture of the distal radius were treated with either a volar locking plate or external fixation augmented by K-wires and followed-up prospectively for 2 years. The main outcome measure was the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score, but EuroQol-5D (EQ-5D) and 36-Item Short Form Survey (SF-36) were also employed. The associations between the QuickDASH score and EQ-5D and between the QuickDASH score and SF-36 were assessed using a linear mixed model. There was a significant positive association between the QuickDASH score and EQ-5D and between the QuickDASH score and SF-36 throughout the follow-up period, although wide dispersion existed for the outcome measures at an individual level. However, the association between the QuickDASH score and SF-36 was significantly weaker at 6 weeks and 3 months than that at baseline, indicating that EQ-5D more closely mirrors changes in the QuickDASH score in the early postoperative period. The study demonstrates that the QuickDASH score and EQ-5D correlate well on a group level, but large individual variations exist. The SF-36 had decreased sensitivity for the changes in the QuickDASH score at 6 weeks and 3 months. Our findings indicate that generic PROMs cannot fully replace the region-specific QuickDASH score when evaluating the outcomes of distal radius fractures.