6-month Patient-reported Outcomes Research Articles

Influence of anosognosia on patient-reported outcomes for psychiatric symptoms and quality of life in Huntington's disease

IntroductionAnosognosia, defined as reduced awareness of one's deficit or symptom, is common in Huntington's disease (HD) and detectable at each disease stage. The impact of anosognosia on self-reporting in HD populations is critical to understand given growing use of patient-reported outcomes in HD clinical care and research. We aimed to determine the influence of anosognosia on patient-reported outcome measures assessing psychiatric symptoms and quality of life in HD. MethodsWe enrolled HD patients to complete a battery of patient-reported and rater-administered measures, including the Anosognosia Scale, at baseline and 6 months later. Patient-reported outcome measures included NeuroQoL short forms for depression, anxiety, satisfaction with social roles and activities, and positive affect and well-being and Patient-Reported Outcomes Measurement Information System short forms for emotional distress-anger and sleep-related impairment. Anosognosia Scale-Difference Score indexed patient-clinician agreement on patient motor, cognitive, and behavioral abilities. We conducted multivariable linear regression analyses to quantify the association of baseline anosognosia with 6-month patient-reported outcomes. ResultsOf 79 patients with complete Anosognosia Scale data at baseline, 25 (31.6 %) met the scale's criterion for anosognosia. In the regression analyses, baseline Difference Score improved prediction of 6-month patient-reported outcomes for depression, anxiety, anger, and positive affect and well-being (χ2(1) value range for likelihood ratio tests contrasting models with and without Difference Score: 13.1–20.9, p-values <0.001). Patients with more anosognosia self-reported less severe psychiatric symptoms and more positive affect and well-being. ConclusionStudy results suggest that anosognosia influences patient-reported outcomes for psychiatric symptoms and quality of life in HD populations.

Establishing the Minimal Clinically Important Difference and Patient Acceptable Symptom State Thresholds Following Arthroscopic Capsular Release for the Treatment of Idiopathic Shoulder Adhesive Capsulitis

PurposeTo determine the minimal clinically important difference (MCID) and the patient acceptable symptom state (PASS) threshold for the visual analog scale (VAS), Constant, Single Assessment Numeric Evaluation (SANE), and American Shoulder and Elbow Surgeons (ASES) scores following arthroscopic capsular release for the treatment of idiopathic shoulder adhesive capsulitis. MethodsA retrospective review of prospective collected data was performed in patients undergoing arthroscopic capsular release for the treatment of idiopathic adhesive capsulitis at a single institution from January 2018 through January 2019. Patient-reported outcome measures were collected preoperatively and 6 months’ postoperatively. Delta was defined as the change between preoperative and 6 months’ postoperative scores. Distribution-based and anchored-based (response to a satisfaction question at 1 year) approaches were used to estimate MCIDs and PASS, respectively. The optimal cut-off point where sensitivity and specificity were maximized (Youden index) and the percentage of patients achieving those thresholds were also calculated. ResultsOverall, a total of 100 patients without diabetes who underwent arthroscopic capsular release and completed baseline and 6-month patient-reported outcome measures were included. The distribution-based MCID for VAS, Constant, SANE, and ASES were calculated to be 1.1, 10.1, 9.3, and 8.2, respectively. The rate of patients who achieved MCID thresholds was 98% for VAS, 96% for Constant, 98% for SANE, and 99% for ASES. The PASS threshold values for VAS, Constant, and ASES were ≤2, ≥70, ≥80, and ≥80, respectively. The rate of patients who achieved PASS thresholds was 84% for VAS, 84% for Constant, 89% for SANE, and 78% for ASES. ConclusionsIn patients without diabetes and idiopathic adhesive capsulitis, high rates of MCID and PASS thresholds can be achieved with arthroscopic anteroinferior capsular release Level of EvidenceLevel IV, retrospective cohort study.

693-P: Diabetes Distress Is Common in Newly Diagnosed Families in the 4T Study and Families Are Receptive to Psychological Services

Psychosocial states significantly impact T1D care and management for youth and their families. As part of a clinical pragmatic study, we report the number of elevated Patient Reported Outcomes (PROs) in newly diagnosed families and track their progress to psychological care. Parents/guardians (PG, n=125/133 4T Study 1 participants) and youth ≥11 years (n=60) were eligible to complete baseline, 3-, and 6-month PROs. PG completed Diabetes Distress Scale - Parent (DDS-P) and youth completed Diabetes Distress Scale (DDS-2) and PROMIS Pediatric Global Health Scale (PGH). Elevated PROs were based on published guidelines and were referred to the clinic's psychological services. Survey completeness was verified by staff to identify false flags. Staff reapproached the participant's psychologist for re-flagged PROs &amp;gt;3 months after the last visit. Over the three study time periods, a total of 99 PROs flags were evaluated (Table). At baseline, there were 32% flagged PROs, which decreased to 27% and 23% at 3 and 6 months, respectively. Elevated DDS-P was the most common reason for referral (75%). Early psychological intervention may explain the reduction in elevated PROs over the study period. With the implementation of systematic PROs in this new onset population, we observed it was common to have diabetes distress and families were receptive to psychological services. Disclosure A.Schneider-utaka: None. F.K.Bishop: None. D.P.Zaharieva: Advisory Panel; Dexcom, Inc., Research Support; Hemsley Charitable Trust, International Society for Pediatric and Adolescent Diabetes, Insulet Corporation, Speaker's Bureau; American Diabetes Association, Ascensia Diabetes Care, Medtronic. P.Prahalad: None. M.Desai: None. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. K.K.Hood: Consultant; Cecelia Health. A.Addala: None. E.Pang: None. A.L.Cortes-navarro: None. I.Balistreri: None. A.Loyola: None. N.Arrizon-ruiz: None. S.A.Alamarie: None. V.Ritter: None. B.Shaw: None. Funding National Institutes of Health (R18DK122422)

Does Preoperative Symptom Duration Impact Clinical Outcomes After Minimally Invasive Transforaminal Lumbar Interbody Fusion in the Ambulatory Setting?

The effect of prolonged symptom duration in patients undergoing ambulatory MIS-TLIF on postoperative clinical outcomes has not been well studied. We aim to compare symptom duration of pain and/or weakness on postoperative outcomes in patients undergoing outpatient MIS-TLIF. Patients undergoing outpatient MIS-TLIF were gathered in a single-surgeon database. Exclusion criteria were patients missing onset of symptoms, date of surgery, or diagnosis of malignancy, trauma, or infection. Patients were grouped by symptoms <1 year or symptoms ≥1 year. Propensity score matching for demographics was utilized. Minimal clinically important difference (MCID) achievement was calculated by comparing change in patient-reported outcome measures (PROMs) to previously established values. Inferential statistics for demographics, perioperative characteristics, PROMs, and MCID were utilized to compare between groups and/or postoperative improvement. After matching, there were a total of 56 patients, with 30 patients with symptoms <1-year. The <1-year cohort reported significant improvement in all time points in VAS back/leg and 12-week/6-months in ODI. The ≥1-year cohort demonstrated significant improvement in 6-month Patient-Reported Outcomes Measurement-Information System Physical Function, 6-week to 1-year VAS back, 6-week VAS leg, and 6-month ODI. The <1-year cohort had higher MCID attainment rates in 1-year VAS back/leg. Independent of symptom duration, patients reported significant improvement in back pain at all postoperative periods. Patients presenting with shorter symptom duration consistently reported significant improvement in leg pain postoperatively. Patients with shorter symptom duration demonstrated greater MCID achievement in back and leg pain. Patients indicated for outpatient MIS-TLIF may benefit more from earlier intervention following onset of symptoms.

Functional Outcomes of a Musculoskeletal Integrated Practice Providing Comprehensive Whole Person Care for Hip Osteoarthritis.

Outcomes of hip osteoarthritis (OA) management within integrated practice units (IPUs) are lacking. This study reports 6-month and 1-year patient-reported outcomes (PROs) of IPU care, the proportion of patients achieving minimal clinically important difference (MCID) and substantial clinical benefit (SCB) at 1 year, and baseline factors associated with the likelihood of achieving MCID and SCB. We retrospectively evaluated 1009 new patients presenting to an IPU with hip OA between October 2017 and June 2020. Patients experienced multidisciplinary team-based management. Individuals with baseline and 6-month PROs or baseline and 1-year PROs (Hip Disability and Osteoarthritis Outcome Score Joint Replacement, HOOS JR) were included. We used anchor-based MCID and SCB thresholds and multivariable binary logistic regression models to identify baseline factors associated with achieving 1-year MCID and SCB. HOOS JR increased from baseline to 6 months (Δ= 19.1±2.1, P= .065) and baseline to 1 year (Δ= 35.8±2.9, P < .001). At 1 year, 72.7% (IPU only) and 88% (IPU-based total hip arthroplasty [THA]) achieved MCID (P < .001), and 62.3% (IPU only) and 88% (IPU-based THA) achieved SCB (P < .001). In multivariable regression, lower baseline HOOS JR scores (r= 0.96, P= .04), undergoing THA (r= 0.213, P < .001), and fewer symptoms of generalized anxiety (r= 0.932, P= .018) were independently associated with achieving MCID at 1 year. The same factors were independently associated with achieving SCB at 1 year. Lower baseline anxiety (Generalized Anxiety Disorder Questionnaire-7 item) and greater hip-related preoperative limitations result in greater likelihood of achieving MCID and SCB. Significant improvements in patient outcomes can be achieved by IPUs providing comprehensive care for hip OA including the management of psychological distress. Future prospective studies should compare the outcomes of IPUs with traditional care in managing diverse patient phenotypes.

Time to Achievement of Clinically Significant Outcomes After Isolated Arthroscopic Partial Meniscectomy: A Multivariate Analysis

PurposeTo define the time required to achieve the minimally clinically important difference (MCID), substantial clinical benefit (SCB) and patient acceptable symptomatic state (PASS) for isolated arthroscopic partial meniscectomy (APM), and define preoperative and intraoperative factors that predict both early and late achievement of the stated metrics.MethodsPatients who underwent isolated APM between 2014 and 2017 were retrospectively included. Patients without preoperative and 6-month patient-reported outcome measure scores, revision procedures, and significant concomitant procedures were excluded. The MCID, SCB, and PASS were calculated for knee-based patient-reported outcome measure scores using receiver operating curve analysis. Kaplan-Meier survival analysis established the time required to achieve MCID, SCB and PASS. Hazard ratios from multivariate Cox regression allowed for the isolation of demographic and intraoperative factors predictive of the delayed time required to achieve MCID, SCB and PASS.ResultsA total of 126 patients (42.86% female, age: 48.9 ± 12.4 years) were included. Overall achievement rates ranged between 73.0% and 89.7% for MCID, 43.7% and 68.2% for SCB, and 50.8% and 68.3% for PASS. Median achievement time for MCID was 5.68-5.78 months, 5.73-6.05 months for SCB and 6.54-7.72 months for PASS. Multivariate Cox regression identified older age, workers’ compensation status, diabetes, and various tear types (i.e., longitudinal, transverse, bucket handle, complex) as predictors of early clinically significant outcome achievement (hazard ratio: 1.02-24.72), whereas subsequent steroid injection, higher preoperative scores and root and flap tears predicted delays in clinically significant outcome achievement (hazard ratio: 0.12-0.99).ConclusionsThe majority of patients undergoing APM achieve benefit within 6 months of surgery, with diminishing proportions at later timepoints. Important factors for consideration of the the timeline of achieving clinically significant outcome include age, diabetes, workers’ compensation, preoperative score, and tear type. The timeline for achieving improvement that was established by this study may aid in setting patient expectations and designing future outcome studies involving APM.Study designLevel IV, Therapeutic Case Series.

Preoperative Hip Extension Strength Is an Independent Predictor of Achieving Clinically Significant Outcomes After Hip Arthroscopy for Femoroacetabular Impingement Syndrome.

The effect of preoperative hip strength on outcomes after hip arthroscopy for femoroacetabular impingement syndrome (FAIS) is unclear. The purpose of this study was to determine whether preoperative isometric hip strength is associated with outcome scores at 6 months as well as achieving the minimal clinically important difference (MCID) and patient acceptable symptomatic state (PASS) in patients undergoing hip arthroscopy for FAIS. Increased preoperative isometric strength will be correlated with short-term postoperative outcomes and will be predictive of achieving higher functional status. Case series. Level 4. Data from 92 consecutive patients undergoing primary hip arthroscopy for treatment of FAIS from March through August 2018 were analyzed. All patients included in the analysis had preoperative measures of isometric hip strength on both affected and unaffected limbs, as well as preoperative and 6-month patient-reported outcome (PRO) scores. Analysis was performed to determine correlations between normalized isometric hip strength measurements and PROs and whether strength measurements were predictive of achieving MCID or PASS. A total of 74 (80.4%) patients had 6-month PROs and were included in the final analysis. Hip extension strength on both sides was correlated with all postoperative PROs (all P > 0.05). Abduction strength on both sides was correlated with postoperative Hip Outcome Score-Activities of Daily Living subscale score, achieving MCID on at least 1 score threshold, and reaching the international Hip Outcome Tool-12 threshold score for achieving PASS (all P < 0.05). Regression analysis showed that extension strength on the affected side was the only strength measurement predictor of achieving PASS (1.043; P = 0.049). Preoperative isometric hip extension and abduction strength are correlated with 6-month postoperative PRO scores. Furthermore, hip extension strength is a predictor of achieving clinically meaningful outcomes. This study highlights the possible importance of preoperative optimization of hip function to maximize outcomes in patients undergoing hip arthroscopy for FAIS.

Patient-reported outcomes 6\xa0months after enhanced recovery after colorectal surgery

BackgroundEnhanced recovery after surgery (ERAS) programs have been established as perioperative strategies associated with improved outcomes. However, intermediate and long-term patient-reported outcome data for patients undergoing ERAS interventions remain limited. We utilized an automated telephone survey 6 months post-colorectal surgery from patients who participated in an ERAS program to determine 6-month patient-reported outcomes and associated predictive factors.MethodsWe conducted a prospective observational study, using an automated telephone survey and researcher-administered telephone questionnaire 6 months after patients underwent abdominal colorectal surgery. Six-month significant outcomes were defined by persistent pain, hospital readmission, and patient satisfaction. Patients reporting these outcome variables were compared with patients who met none of these criteria. Additionally, analysis was performed to determine differences between patients that did and did not respond to the 6-month survey. A chi-square test was used to determine any relationship for categorical variables, a two independent sample t test for length of procedure/stay, and a Wilcoxon-Mann-Whitney test for pain scores.ResultsOne hundred fifty-four of 324 patients contacted 6 months after surgery completed the automated telephone survey (47.53%). There was no statistical difference between patient populations completing and not completing the survey. Hospital 6-month readmission was associated with patients with a diagnosis of cancer (P = .049) and with a longer mean length of index procedure (282 vs. 206 minutes, P = .006). Median 6-month pain scores were higher for patients that underwent an open procedure compared to laparoscopic (Z = − 2.06, P = .04).ConclusionsLong-term benefits of an ERAS program were mostly confirmed. Longer procedure time and patients with cancer correlated with an increased likelihood of hospital 6-month readmission, suggesting that perioperative outcomes in complex cancer patients need to be evaluated over a longer time frame. In addition, invasiveness of procedure continues to have a significant effect on pain scores even 6 months later.

The “Promoting Resilience in Stress Management” (PRISM) intervention for adolescents and young adults: A pilot randomized controlled trial.

176 Background: Adolescents and Young Adults (AYAs) with cancer are at risk for poor psychosocial outcomes, perhaps because they have yet to learn the skills needed to navigate the burdens of illness. We aimed to determine if a novel, brief, age-appropriate, skills-based intervention would improve psychosocial outcomes. Methods: “Promoting Resilience in Stress Management” (PRISM) is a manualized, brief intervention targeting stress management, goal-setting, cognitive reframing, and meaning-making. It consists of 4, 30-60 minute, in-person, 1:1 sessions plus a facilitated family-meeting. English-speaking AYAs (ages 12-25 years) with new or newly recurrent cancer were randomized to receive either PRISM or non-directive usual psychosocial care. Participants completed patient-reported outcome (PRO) surveys at the time of enrollment and 6 months later. We used mixed effects regression modeling to estimate associations between PRISM and the primary outcome (patient-reported resilience, measured by the Connor-Davidson Resilience Scale [CDRISC-10]) and secondary outcomes (health-related quality of life [PedsQL 4.0 Quality of Life Inventory], hope [Snyder Hope Scale], and psychological distress [Kessler-6 Psychological Distress Scale]) at 6 months. Results: N = 100 AYAs enrolled (78% of approached, n = 50 PRISM, n = 50 usual care) and 92 completed baseline responses (48 PRISM and 44 usual care). Of those who completed baseline, 73% were aged 13-17 years and 27% aged 18-25 years, and 43% were female. Attrition was similar in each arm and primarily due to medical complication and/or death; n = 36 (72%) PRISM and n = 38 (76%) usual care participants completed 6-month PROs. After adjusting for baseline scores, PRISM was associated with improvements in all instruments: Resilience (+2.3, 95% CI 0.7,4.0), quality of life (+6.3 (95% CI -0.8, 13.5), hope (+2.8, 95% CI 0.5, 5.1), and distress (-1.6, 95% CI -3.3, 0.0). Conclusions: A targeted intervention targeting skills for AYAs with cancer was effective in improving patient-centered outcomes. Clinical trial information: NCT02340884.

The Use of Intraoperative Sensors Significantly Increases the Patient-Reported Rate of Improvement in Primary Total Knee Arthroplasty.

Albeit multifactorial, patient satisfaction is predominantly driven by postoperative pain and function. Unfortunately, approximately 20% of total knee arthroplasty (TKA) recipients are dissatisfied with the outcome of their surgery. Objective balancing of the soft tissue envelope may contribute to significant decrease in pain and increase in function when compared with traditional subjective methods. In an effort to confirm this, a cohort of manual TKA patient outcomes was compared with sensor-assisted TKA outcomes. One hundred fourteen patients (57 manual, 57 sensor assisted) received primary TKA. Both cohorts were matched for confounding variables. The dependent variables in this study were 6-month patient-reported outcome measures, including Knee Society Score and Oxford Knee Score. The range of motion and incidence of arthrofibrosis were also captured for both cohorts. The rate of improvement of all patient-reported outcome scores and subscores and range of motion was significantly higher in the sensor-assisted cohort. The rate of arthrofibrosis was lower in the sensor-assisted cohort but not statistically significant. The authors rejected the null hypothesis and concluded that the rate of improvement in objective, patient-reported outcome measures was higher in the sensor-assisted cohort than the manual cohort from preoperatively to 6 months postoperatively. [Orthopedics. 2017; 40(4):e648-e651.].

Inception of an Australian Spine Trauma Registry: the Minimum Dataset

Background The establishment of a spine trauma registry collecting both spine column and spinal cord data should improve the evidential basis for clinical decisions. This is a report on the pilot of a spine trauma registry including development of a minimum dataset. Methods A minimum dataset consisting of 56 data items was created using the modified Delphi technique. A pilot study was performed on 104 consecutive spine trauma patients recruited by the Victorian Orthopaedic Trauma Outcomes Registry (VOTOR). Data analysis and collection methodology were reviewed to determine its feasibility. Results Minimum dataset collection aided by a dataset dictionary was uncomplicated (average of 5 minutes per patient). Data analysis revealed three significant findings: (1) a peak in the 40 to 60 years age group; (2) premorbid functional independence in the majority of patients; and (3) significant proportion being on antiplatelet or anticoagulation medications. Of the 141 traumatic spine fractures, the thoracolumbar segment was the most frequent site of injury. Most were neurologically intact (89%). Our study group had satisfactory 6-month patient-reported outcomes. Conclusion The minimum dataset had high completion rates, was practical and feasible to collect. This pilot study is the basis for the development of a spine trauma registry at the Level 1 trauma center.