Patient-Reported Outcomes Measurement Information System Questionnaires Research Articles

SuRxgWell: study protocol for a randomized controlled trial of telemedicine-based digital cognitive behavioral intervention for high anxiety and depression among patients undergoing elective hip and knee arthroplasty surgery

BackgroundMood disorders (anxiety, depression), sleep disorders, and catastrophizing lead to increased post-operative pain perception, increase in postoperative opioid consumption, decreased engagement with physical activity, and increased resource utilization in surgical patients. Psychosocial disorders significantly affect postoperative outcome. Unfortunately, studies focused on perioperative psychological assessment and treatment are scarce. We propose to test whether digital cognitive behavioral intervention (dCBI) can help surgical patients. dCBI such as RxWell™ is a proven treatment for mood disorders in medical patients such as reducing depression in patients with inflammatory bowel disease. We hypothesize that RxWell™ will also be effective in surgical patients. This study aims to test whether RxWell™ can improve preoperative mood disorders and subsequently reduce postoperative pain and opioid requirement in patients scheduled for primary total hip and knee arthroplasty (THA, TKA). We named the trial as the SuRxgWell trial.MethodsThis is a randomized, controlled trial that will enroll primary and unilateral THA or TKA patients with anxiety and/or depression symptoms before surgery to receive the SuRxgWell dCBI program and investigate its impact on postoperative outcomes including postoperative pain, anxiety, depression, sleep disorder, and catastrophizing. After signing an informed consent, subjects will be screened using the PROMIS questionnaires, and subjects with a T-score of ≥ 60 on the short Patient-Reported Outcomes Measurement Information System (PROMIS) 4a Anxiety and/or short PROMIS 4a Depression questionnaires will be randomized to either usual care (control group) or the cognitive behavioral intervention, RxWell™, plus usual care (intervention group). The control group will receive information on how to locate tools to address anxiety and depression, whereas the intervention group will have access to SuRxgWell 1 month prior to surgery and up to 3 months after surgery. The allocation will be 3:1 (intervention to control). Investigators will be blinded, but research coordinators approaching patients and research subjects will not.The primary outcome will be day of surgery anxiety or depression symptoms measured with the PROMIS Short Form v1.0 -Anxiety 4a/Depression and Generalized Anxiety Disorder Measure (GAD-7) and Patient Health Questionnaire (PHQ-8). Secondary end points include measuring other health-related quality of life outcomes including sleep disturbance, fatigue, ability to participate in social roles, pain interference, cognitive function, pain catastrophizing, and physical function. Other secondary outcomes include collecting data about preoperative and postoperative pain scores, and pain medication usage, and orthopedic functional recovery at baseline, day of surgery, and 1, 2, and 3 months after the surgery with the Pain Catastrophizing Scale, the Knee injury and Osteoarthritis Outcome Score (KOOS), and Hip injury and Osteoarthritis Outcome Score (HOOS). In addition, subjects will be asked to complete a GAD-7 and PHQ-8 questionnaires bi-weekly (via the RxWell™ app for the interventional group or REDCAP for the control group). Data about postsurgical complications, and resource utilization will also be recorded. We will also receive monthly reports measuring the usage and engagement of RxWell use for each participant randomized to that arm. The primary hypotheses will be assessed with intention-to-treat estimates, and differences in primary outcome will be tested using independent two sample t-tests. This trial is registered to the ClinicalTrials.gov database (NCT05658796) and supported by the DAPM, UPMC Health Plan, and the NIH.DiscussionOur trial will evaluate the feasibility of digital cognitive behavioral intervention as a perioperative tool to improve anxiety and depression before and after major orthopedic surgery in comparison to education. If digital cognitive behavioral intervention proves to be effective, this might have important clinical implications, reducing the incidence of chronic postsurgical pain and improving outcomes.

Signficant Femoral Version Abnormalities and Patient-Reported Quality of Life.

The purpose of this study was to determine how the Limb Deformity-Modified Scoliosis Research Society (LD-SRS) and Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire scores differ between patients with femoral version abnormalities and healthy control subjects. A retrospective database review identified patients with femoral version abnormalities between December 2018 and September 2022. A total of 21 adult patients scheduled for femoral derotational osteotomy and 33 control subjects were included. All individuals completed the LD-SRS and PROMIS questionnaires. Patients with femoral version abnormalities reported significantly worse scores than control subjects on all LD-SRS and PROMIS domains: LD-SRS (Total [3.46 ± 0.66 vs. 4.58 ± 0.37, P < 0.001]; Function/Activity [3.48 ± 0.83 vs. 4.44 ± 0.4, P < 0.001]; Mental Health [3.41 ± 0.96 vs. 4.3 ± 0.73, P < 0.001]; Pain [3.55 ± 0.9 vs. 4.81 ± 0.31, P < 0.001]; and Self-Image/Appearance [3.37 ± 0.79 vs. 4.75 ± 0.43, P < 0.001]) and PROMIS (Function [41.6 ± 7.58 vs. 60.0 ± 7.28, P < 0.001]; Pain Intensity [45.85 ± 8.04 vs. 33.7 ± 4.89, P < 0.001]; Pain Interference [56.78 ± 9.63 vs. 42.8 ± 6.6, P < 0.001]; Global Mental Health [47.97 ± 9.68 vs. 55.3 ± 7.81, P = 0.004]; and Global Physical Health [45.23 ± 7.49 vs. 58.2 ± 7.07, P < 0.001]). Patients with femoral version abnormalities reported markedly worse quality of life as measured on the LD-SRS and PROMIS scores compared with healthy control subjects. The combination of these two surveys effectively captures the multifaceted quality-of-life-deficit individuals with excessive femoral version may experience.

Health-Related Qualities of Life in School-Aged Children with Bronchopulmonary Dysplasia

To determine health-related quality of life (HRQOL) of school-aged children with bronchopulmonary dysplasia (BPD) using the standardized Patient-Reported Outcomes Measurement Information System (PROMIS) assessment tools. The Indoor Air Quality and Respiratory Morbidity in Children with BPD Study is an ongoing observational study of school-aged children with BPD. HRQOL is assessed at enrollment by 3 PROMIS questionnaires, Parent Proxy Scale-Global Health 7, Parent Proxy Psychological Stress Experiences-Short Form, and the Parent Proxy Profile-Profile-25. PROMIS data were tested for significant deviation from the standardized T-Score references for normative populations of children. Eighty-nine subjects enrolled in the AERO-BPD study had complete outcome data for HRQOL. The mean age was 9 (±2) years and 43% were female. Mean days on respiratory support totaled 96 (±40). Across all domains, school-aged children with BPD reported similar or slightly better outcomes than the reference sample. Statistically significant findings of lower depression (P<.0001), fatigue (P<.0001), and pain (P<.0001) scores were found; there was no difference in psychological stress experiences (P=.87), global health (P=.06), anxiety (P=.08), relationships (P=.80), and mobility (P=.59) domains. This study demonstrated that children with BPD may have less depression, fatigue, and pain HRQL than the general population. Once validated, these findings may offer reassurance to parents and providers caring for children with BPD.

Faces Scales for Anxiety and Anger: A National Study of Measurement Properties.

Importance: Faces scales are used worldwide to assess pain, but robust faces scales for anxiety and anger do not exist. These scales are urgently needed, because an estimated two-thirds of patients have difficulty reading written questionnaires. Objective: To develop and evaluate measurement properties of faces scales to monitor two mental health symptoms in US adults (anxiety and anger) in accordance with the COnsensus-based Standards for health Measurement INstruments (COSMIN). Methods: The development process included population identification, scale generation, and pretesting. The evaluation process included assessment of content validity, construct validity, criterion validity, test-retest reliability, and measurement error using 5 order-randomized, positively controlled online survey studies conducted between April and June 2020. We recruited national purposive samples of US adults representative on age, gender, and race. For each faces scale, participants assessed relevance, comprehensibility, and comprehensiveness (study 1, n = 300), strength-of-association (study 2, n = 300), convergent validity against the visual analog scale (VAS; study 3, n = 305), convergent validity against the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires (study 4, n = 1,000), and test-retest reliability and measurement error (study 5, n = 853). Results: The anxiety and anger faces scales showed high relevance (95%–96%), comprehensibility (93%–97%), comprehensiveness (94%–97%), and strength-of-association (74%–96%). We found very high agreement with the VAS (ρ = 0.94–0.95) and high agreement with PROMIS questionnaires (ρ = 0.74–0.79). Scales showed adequate test-retest reliability (intraclass correlation = 0.70–0.78) and measurement error (standard error of measurement = 1.14–1.22). Conclusions: Faces scales to monitor anxiety and anger show adequate measurement properties, including content validity, construct validity, criterion validity, test-retest reliability, and measurement error. The recommended use is non-diagnostic monitoring of anxiety and anger, particularly when mental health is an ancillary but important outcome of treatment.

79 Factors Predicting Burn Survivor Group Interest in an Outpatient Burn Clinic

IntroductionOutpatient peer support groups have been demonstrated to help patients reintegrate with the community and improve self-acceptance following burn injury. Despite this, there is little data examining who desires participation. This is especially true for minority and socio-disadvantaged populations. The purpose of this study is to examine factors that influence desire to participate in burn survivor groups and actual participation rates.MethodsPatients attending outpatient clinic were asked about participation in burn survivor group, interest in joining a group, and administered National Institute of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Managing Emotions (ME) and Managing Social Interactions (MSI) questionnaires. Patient demographics, total body surface area burned (TBSA), initial hospital length of stay (LOS), and surgical intervention were collected from the medical record. While controlling for age and gender, indicators of injury severity and scores on PROMIS questionnaires were each examined for associations with survivor group interest using Firth or standard binary logistic regression.Results70 patients completed surveys in English (60%, 42/70) and Spanish (40%, 28/70). Current or past participation in burn survivor group was low (n=3/70, 4.2%), with greater interest in joining burn survivor group (n=20/66, 30.3%). Most patients interested in burn survivor group were Spanish speaking (65%, 13/20). Interest in joining a burn survivor group was associated with all collected measures of injury severity (Table 1). Scores on ME and MSI were not significantly associated with burn survivor group interest (ME p=.636, MSI p=.133).ConclusionsThere is a gap between interest and participation in burn survivor group, particularly among Spanish speaking patients. Patients with increase in TBSA, LOS, and undergoing surgery were more likely to express interest in burn survivor group participation. Interestingly, patients’ self-reported outcomes on emotional distress and interactions with others were not related to interest in burn survivor group.

Early Improvement in Patient-Reported Outcome Scores After Operative Treatment of Osteochondritis Dissecans of the Humeral Capitellum

Outcome measures that lack sensitivity for the detection of clinical changes early after surgery for capitellar osteochondritis dissecans (OCD) make it difficult to determine the optimal treatment for these defects. We sought to evaluate the early responsiveness of patient-reported outcomes measurement information system (PROMIS) scores in a cohort of patients operatively treated for capitellar OCD. Four PROMIS questionnaires (mobility, upper extremity [UE], pain interference, and peer relations) were electronically administered to patients treated for capitellar OCD at a single tertiary academic medical center between January 1, 2015, and July 1, 2018. The questionnaires were administered at the initial preoperative outpatient clinic visit as well as at the 2-week, 6-week, and final return-to-play (RTP) visits. Twenty-nine patients (31 elbows, mean age 12.9 years) with available preoperative and postoperative PROMIS data were included. The mean final follow-up period was 26 weeks. Compared with that before surgery, there was a significant improvement in the mobility, pain interference, and UE scores at 6 weeks following surgery. The scores improved most significantly by 6 weeks, reached a relative plateau, and remained significantly improved through the RTP visit thereafter. Patients with preoperative, intra-articular loose bodies scored significantly better than those without them during the 6-week and RTP visits. Patients with lesions >1 cm2, compared with those with lesions ≤1 cm2, demonstrated greater improvement in the UE scores during the RTP visit. In patients undergoing operative treatment for capitellar OCD, a significant improvement in the PROMIS domains of mobility, pain interference, and UE can be expected early in the postoperative period, with majority of patients reaching their greatest improvement in scores by 6 weeks following surgery. This is important information for preoperative counseling. In addition, this information is helpful in confirming that PROMIS scores are responsive in the detection of changes in outcomes during the early postoperative period in this population.

Correlation of Patient-Reported Outcomes Measurement Information System Questionnaires With the Brief Michigan Hand Questionnaire in Patients With 5 Common Hand Conditions

We evaluated the concurrent validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mental Health (GMH), Global Physical Health (GPH), Upper Extremity (UE), Pain Interference (PI), and Self-Efficacy for Managing Medications and Treatment (SE-MMT) by analyzing correlation to the brief Michigan Hand Questionnaire (bMHQ) in patients with 5 common hand conditions: carpal tunnel syndrome, Dupuytren contracture, trigger finger, thumb carpometacarpal osteoarthritis, and wrist ganglion cysts. Our cohort included 11,782 unique visits representing 4,401 patients. Patient demographics, PROMIS Computer Adaptive Test questionnaires, and bMHQ were collected prospectively at all visits for all patients. Spearman rank correlation was used to evaluate the relationship between the PROMIS and bMHQ scores. Multivariable linear regression models were used to evaluate the relationship between questionnaires and patient demographics. The PROMIS UE and PI showed strong correlations to the bMHQ. The PROMIS GPH showed moderate correlation to the bMHQ. The PROMIS GMH and SE-MMT were weakly correlated with the bMHQ. These results for the overall group were consistent across subgroup analysis for each condition, and regression models confirmed these correlation findings when controlling for demographic variables. The bMHQ had the smallest ceiling and floor effects compared with the PROMIS questionnaires. The PROMIS UE, PI, and SE-MMT took significantly less time to complete than the bMHQ. Correlations between the PROMIS questionnaires and the bMHQ were similar regardless of condition. Given their moderate-to-strong correlations with the bMHQ and consistency across conditions, the PROMIS UE and PI may be adequate replacements for the bMHQ for evaluating these domains in both clinical and research applications in patients with these common upper extremity pathologies. The PROMIS GPH, GMH, and SE-MMT, in conjunction with the bMHQ, may provide more information regarding patient's physical and mental health and ability to manage medications and treatment without substantially increasing patient burden. Clinicians and researchers can use these findings to guide questionnaire selection based on the clinical or research question(s) of interest.

Abstract 21: Validation Of The PROMIS Questionnaires And Brief MHQ In Patients With Upper Extremity Illness At A Quaternary Hand Center

Purpose: Health care is transitioning to value-based care, using patient-reported outcomes (PROs) as an indicator of care quality, affecting hospital ratings as well as reimbursement. The brief Michigan Hand Questionnaire (bMHQ) is a validated and widely used questionnaire; it assesses function, efficacy, and pain in patients with upper extremity illness. The Patient-Reported Outcomes Measurement Information System (PROMIS) instruments include measures of overall physical and mental health, as well as disease-specific measures, and are increasingly used. However, the correlation between PROMIS questionnaires and the bMHQ have not been investigated to validate the use of PROMIS in patients with upper extremity illness. We analyzed the relationship between the PROMIS Global Mental Health (GMH), Global Physical Health (GPH), Upper Extremity (UE), Pain Interference (PI), Self-Efficacy for Managing Chronic Conditions (SE) and bMHQ questionnaires in 5 common hand conditions: carpal tunnel syndrome (CTS), Dupuytren’s contracture, trigger finger (TF), thumb carpometacarpal (CMC) osteoarthritis (OA), and wrist ganglion cysts. Methods: All patients over 18 years of age seen at our hand center between January 1, 2018 and May 31, 2019 with CTS, TF, thumb CMC OA, Dupuytren’s contracture, and wrist ganglion cysts were included. Patient demographics, PROMIS, and bMHQ were collected for all patients. Spearman’s rank correlation was used to evaluate the relationship between the different PROMIS and bMHQ questionnaire scores. Results: Our cohort included 4,401 patients. Median age was 55.0 (40.3 - 64.5) years with 2414 (54.8) % females and 1987 (45.1) % males. Patients had a median of 2 (IQR 1 - 4) visits. Majority of patients had TF (N = 2200). The PROMIS GMH showed weak correlation with the bMHQ (ρ = 0.38, P <0.001). The PROMIS GPH showed moderate correlation with the bMHQ (ρ = 0.58, P <0.001). Both the PROMIS UE and PI questionnaires had strong correlations to the bMHQ. The PROMIS SE showed a very weak correlation to the bMHQ (ρ = 0.12, P <0.001). These correlation results for the overall group were consistent across subgroup analysis for each condition. Conclusion: This study demonstrates how the PROMIS instruments compare with a previously validated and widely-used questionnaire in patients with common upper extremity illnesses. The PROMIS GPH, UE, and PI showed moderate to strong correlations with the bMHQ. The PROMIS SE and bMHQ were very weakly correlated as expected, as bMHQ does not gauge patients’ ability to manage their medication or treatments. Notably, the correlations between the PROMIS questionnaires and bMHQ were similar, regardless of condition. Given their moderate to strong correlations with the bMHQ and consistency across conditions, the PROMIS GPH, UE, and PI can be used for both clinical and research purposes in patients with these common upper extremity illnesses.

A Mixed Methods Analysis of Acute Upper Extremity Pain as Measured by the Patient Reported Outcomes Measurement Information System

AbstractIntroductionChronic pain affects U.S. service member’s (SMs) more disproportionately than individuals in the general public. SMs have unique cultural pressures to ignore or deny acute pain; therefore, the beliefs and behaviors of this group may cause them to self-report their acute pain in a specific manner. This study evaluated the strength of the relationship of the patient reported outcomes measurement information system (PROMIS) upper extremity computer adaptive test (CAT) and assessed U.S. active duty SMs experience of acute pain and function compared to the quick disabilities of the arm, shoulder, and hand (QuickDASH). In addition, the PROMIS pain interference CAT, PROMIS pain behavior CAT, and PROMIS anxiety CAT were correlated to the PROMIS upper extremity CAT and QuickDASH questionnaires.Materials and MethodsThis mixed methods, sequential, explanatory study included a convenience sample of 26 participants from two occupational therapy clinics. Participants were administered five self-report questionnaires at initial evaluation and at follow up (30–90 day). At follow up, 12 participants completed a semi-structured interview. Categorical variables were summarized using percentages and analyzed using a chi-square goodness of fit test. A Pearson correlation coefficient was used to analyze the linear relationship between the QuickDASH and specified PROMIS questionnaires. This study was approved by the Institutional Review Board at Brooke Army Medical Center, reference number C.2017.173d.ResultsThe initial and follow up scores from the self-report questionnaires demonstrated a good to excellent correlation between the PROMIS upper extremity CAT and the QuickDASH (r = –0.65; r = –0.81; p &amp;lt; 0.001). Qualitative data were gathered during a semi-structured interview of 12 participants after the follow up and were analyzed using thematic analysis. Three themes emerged from qualitative analysis of data: (1) impact of military culture, (2) psychosocial effects of acute pain, and (3) therapist contributions to disability awareness.ConclusionsThis study demonstrates several cultural and psychosocial influences concerning the experience of SMs with acute UE disability and pain, which were not previously reported for this population.

Fecal urgency is common in constipated patients and is associated with anxiety.

Fecal urgency is a symptom generally associated with diarrhea but is also reported by patients with constipation. Our aim was to (a) assess the prevalence and burden of fecal urgency in constipated patients (b) evaluate gastrointestinal and psychiatric predictors of moderate to severe fecal urgency in these patients. Patients presenting consecutively to a tertiary outpatient gastroenterology clinic with constipation were included. Patients were considered to have moderate to severe fecal urgency if ≥50% of bowel movements (BMs) in the past 3months were associated with fecal urgency. Anxiety, depression, and sleep disturbance were diagnosed using a Patient-Reported Outcomes Measurement Information System (PROMIS) t-score of ≥60. Abdominal pain and constipation severity were also assessed using PROMIS questionnaires. Univariable and stepwise logistic regression were used to identify predictors of moderate to severe fecal urgency. Of 139 constipated patients, 70.8% reported experiencing fecal urgency in the past 3months and 25.8% reported being significantly bothered by it. Moderate to severe fecal urgency was reported by 27% of 139 patients. Frequency of loose stools (OR 1.5, 95% CI 1.1, 2.0) and presence of anxiety (OR 2.3, 95% CI 1.1, 5.0) were independent predictors of moderate to severe fecal urgency. Fecal urgency is common in patients with constipation and is frequently bothersome to many patients. We identified clinical and psychiatric factors associated with moderate to severe fecal urgency in constipated patients with potential therapeutic implications if validated in future studies.

Validity and responsiveness of PROMIS in adult spinal deformity: The need for a self-image domain

BACKGROUND CONTEXTValidity and responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS) have been investigated in several orthopaedic subspecialties. PROMIS has shorter completion time and greater research flexibility for the heterogeneous adult spinal deformity (ASD) population versus the Oswestry Disability Index (ODI) and Scoliosis Research Society 22-item questionnaire (SRS-22r). PURPOSEEvaluate the validity and responsiveness of PROMIS in ASD surgery, during the early postoperative period. DESIGNProspective, longitudinal study. PATIENT SAMPLEOne hundred twenty-three patients with complete SRS-22r and PROMIS data. OUTCOME MEASURESValidity and responsiveness of PROMIS versus the ODI and SRS-22r. METHODSWe identified patients who completed SRS-22r, ODI, and PROMIS questionnaires. Spearman's correlation was used to assess validity, paired-samples t tests to assess responsiveness, and Cohen's d to assess measure of effect. The authors report no conflicts of interests. No funding was received in support of this study. RESULTSOne hundred twenty-three patients with SRS-22r and PROMIS data from the preoperative visit were included in the validity analysis. Seventy-six patients with preoperative and early postoperative (6-week to 3-month) data were included in the responsiveness analysis. The SRS-22r function, self-image, pain, and mental health scores were moderately to strongly correlated with the following PROMIS domains: physical function (r = 0.53), satisfaction with participation in social roles (r = 0.51), pain (r = −0.60), and anxiety (r = −0.73). All SRS-22r domains, PROMIS domains, and ODI scores changed significantly from preoperatively to postoperatively (p < 0.05). Compared with the SRS-22r, PROMIS showed superior responsiveness across all domains except self-image. CONCLUSIONSOur results indicate that PROMIS is a valid measure with comparable responsiveness to that of the SRS-22r and ODI during the early period after ASD surgery. However, a domain that reflects how ASD patients perceive their self-image should be developed and validated.