Completed Patient-reported Outcome Measures Research Articles

Looking Beyond the Chair: Psycho-Perceptual Predictors of Sexual Distress and Sexual Satisfaction in Individuals with Spinal Cord Injury

ABSTRACT Despite a large body of biomedical research, little is known about the psychological and perceptual predictors of sexual satisfaction (SS) and sexual distress (SD) post spinal cord injury (SCI). Guided by a bio-psycho-perceptual framework, this cross-sectional research aimed at assessing SS and SD in a large SCI sample using validated patient-reported outcome measures (PROM). Significant correlates and predictors of SS and SD were also identified. Ninety-one men and women with SCI completed PROMs of SS and SD, as well as psychological (mood, sexual and body esteem) and perceptual (interoceptive awareness, trait mindfulness, sexual mindfulness) factors. Neurological profiles were also assessed, along with experience of orgasm. Correlates of SS and SD were first identified using Pearson’s correlations, then multiple hierarchical regression models were computed to isolate predictors. Orgasm experience and psychological factors emerged as moderate correlates of both SS and SD, while neurological factors did not. Interoceptive awareness and trait mindfulness showed weak associations with SD and none with SS. Among the tested predictors, experience of orgasm emerged as the strongest for SS (β = -.29, p < .01), followed by mood, which predicted SS and SD. Sexual and body esteem was predictive of SD only. In sexually active participants, sexual mindfulness predicted both SS (β = 0.55, p < .001) and SD (β = -0.56, p < .001) above and beyond all other variables. This study reveals unique aspects of SS and SD postinjury and supports further consideration of psychological and perceptual dimensions of SCI sexuality in rehabilitation research.

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.

Patient adherence to patient-reported outcome measure (PROM) completion in clinical care: current understanding and future recommendations.

Patient-reported outcome measures (PROMs) are increasingly being used as an assessment and monitoring tool in clinical practice. However, patient adherence to PROMs completions are typically not well documented or explained in published studies and reports. Through a collaboration between the International Society for Quality-of-Life Research (ISOQOL) Patient Engagement and QOL in Clinical Practice Special Interest Groups (SIGs) case studies were collated as a platform to explore how adherence can be evaluated and understood. Case studies were drawn from across a range of clinically and methodologically diverse PROMs activities. The case studies identified that the influences on PROMs adherence vary. Key drivers include PROMs administeration methods within a service and wider system, patient capacity to engage and clinician engagement with PROMs information. It was identified that it isimportant to evaluate PROMs integration and adherence from multiple perspectives. PROM completion rates are an important indicator of patient adherence. Future research prioritizing an understanding of PROMs completion rates by patients is needed.

Optimizing PROM Implementation in Orthopedic Clinics for Longitudinal Outcome Monitoring: Lessons from a Multisite Study.

Systematic patient-reported outcome measure (PROM) collection is challenging for clinics, particularly when patients are not in the office. The Arthritis care through Shared Knowledge (ASK) study deployed multimodal approaches to collect PROMs using a clinical microsystem framework. Informed by the clinical microsystem model, the authors coached 12 orthopedic practices to implement shared processes to support best practices for PROM collection and use. Orthopedic sites collected PROMs from new patients before the first office visit; patients completed the PROM from home via an online assessment in a personalized e-mail. Site staff placed follow-up phone reminders. At 6 and 12 months after the visit, PROMs were collected from home, prompted by an e-mail or phone call. Of the 25,043 new patients identified by clinical sites during the study enrollment, approximately 60% completed a pre-visit PROM-36.6% completed the online PROM after receiving a single automated e-mail, and an additional 31.1% completed the PROM after receiving a text, an e-mail, or a phone call from the staff. The remaining 32.2% of PROMs were collected on arrival at the office. Of patients completing PROMs, 11,140 were eligible to participate in longitudinal collection, and 51.3% consented. Of these, approximately 84% completed a 6-month survey, more than 83% completed a 12-month survey, and more than 91% completed either a 6-month PROM, a 12-month PROM, or both. This study illustrates that a multimodal approach to PROM collection using a clinical microsystem approach sustainably supports PROM completion rates. Further efforts are needed to define strategies to engage all patients in understanding and reporting PROMs to inform their care.

Arthroscopic Treatment of Shoulder Stiffness With Rotator Cuff Repair Yields Similar Outcomes to Isolated Rotator Cuff Repair

To compare patient-reported and surgical outcome measures in patients with and without secondary shoulder stiffness (SSS) undergoing rotator cuff repair (RCR). Patients undergoing rotator cuff repair from 2014 to 2020 with complete patient-reported outcome measures (PROMs) by the short-form 12 survey (SF-12) were retrospectively reviewed to identify if operative intervention for SSS was performed alongside the RCR. Those patients with operative intervention for SSS were propensity matched to a group without prior intervention for stiffness by age, sex, laterality, body mass index, diabetes mellitus status, and the presence of a thyroid disorder. The groups were compared by rotator cuff tear (RCT) size, surgical outcomes, further surgical intervention, rotator cuff retear rate, postoperative range of motion (ROM), and SF-12 results at 1 year after surgery. Delta values were calculated for component scores of the SF-12 and ROM values by subtracting the preoperative result from the postoperative result. A total of 89 patients with SSS were compared to 156 patients in the control group at final analysis. The patients in the SSS group experienced a significant improvement in the delta mental health component score (MCS-12) of the SF-12 survey that was not seen in the control group (P= .005 to P= .539). Both groups experienced significant improvement by the delta physical health component score (PCS-12) of the SF-12 survey (SSS: 7.68; P < .001; control: 6.95; P < .001). The SSS group also experienced greater improvement of their forward flexion (25.8° vs 12.9°; P= .005) and external rotation (7.13° vs 1.65°; P= .031) ROM than the control group. Operative intervention of SSS at the time of RCR has equivalent postoperative SF-12 survey outcome scores when compared to patients undergoing RCR without preoperative stiffness despite those patients having lower preoperative scores. Level III retrospective comparative study.

Breast-Q sensory outcomes of non-neurotized, autologous, unilateral breast reconstruction with a minimum of 3-year follow-up

Sensory reinnervation of autologous breast tissue after free flap reconstruction is highly variable. There is no long-term follow-up data exploring spontaneous reinnervation and how this affects patients' quality of life nor the nerve-related symptoms they experience. To address this issue, we invited patients with a minimum of 3 years after non-neurotized, free flap breast reconstruction to complete patient-reported outcome measures exploring sensation, quality of life and breast-related symptoms. We performed a retrospective cohort study of patients undergoing unilateral Muscle-Sparing Transverse Rectus Abdominus Muscle (MS-TRAM) or deep inferior epigastric artery perforator (DIEP) flap breast reconstruction between 01-01-2015 and 31-12-2019 in the Department of Plastic and Reconstructive Surgery at Manchester University NHS Foundation Trust. We invited participants to complete the recently developed Breast-Q© Breast Sensation Module. All patients had undergone unilateral immediate (n= 85) or delayed (n= 82) breast reconstruction after mastectomy using either a free DIEP (n= 150) or TRAM (n= 17) flap reconstruction a minimum of 3 years prior. The median age at operation was 48. Sensation after reconstruction was significantly reduced in the reconstructed breast compared with the contralateral breast (P<0.0001) with a reduction in reported quality of life (immediate (68.0 [54.0, 89.0]) and delayed (68.0 [62.0, 83.8])). The sensation was significantly better in immediate vs delayed procedures (P=0.024). Sensory scores after reconstruction increased with age (P=0.036). Breast sensation after non-neurotized reconstruction with autologous tissue is significantly reduced at long-term follow-up with a reduction in quality of life. A minimum outcome set for quantification of breast sensation is required and future research into the cost-benefit of neurotized, autologous breast reconstruction is needed.

Lateral joint tightness in flexion following cementless mobile-bearing total knee arthroplasty decreases patient-reported outcome measures and postoperative range of motion

PurposeThe purpose of this study was to clarify the association between clinical outcomes and the flexion joint gap following rotating concave–convex (Vanguard ROCC) total knee arthroplasty (TKA). MethodsThis consecutive retrospective series included 55 knees that underwent ROCC TKA. All the surgical procedures were performed using a spacer-based gap-balancing technique. To evaluate the medial and lateral flexion gaps, axial radiographs of the distal femur were obtained using the epicondylar view with a distraction force to the lower leg at 6 months postoperatively. Lateral joint tightness was defined as the lateral gap being greater than the medial gap. To evaluate clinical outcomes, patients were asked to complete patient-reported outcome measures (PROMs) questionnaires preoperatively and during at least 1 year of follow-up postoperatively. ResultsThe median follow-up duration was 24.0 months. Overall, 16.0% of patients had postoperative lateral joint tightness in flexion. The postoperative range of motion and PROMs were lower in patients with lateral joint tightness than in those with a balanced flexion gap or lateral joint laxity. No serious complications, including bearing dislocations, occurred during the observation period. ConclusionLateral joint tightness in flexion following ROCC TKA decreases PROMs and postoperative range of motion. Level of evidence4.

Assessment of patient reported outcomes (PROs) completion patterns in patients with cancer: Examining real-world data.

6609 Background: Use of Patient Reported Outcomes (PROs) in clinical practice plays a major role in improving care, quality of life, hospitalization, emergency room visits and consequently improving overall survival. However, robust information on real-time assessment of PROs in cancer patients is insufficient, as most available data are limited to specific populations enrolled in clinical trials. This thereby increases disparities among minorities of race, age, and socioeconomic status, creating a barrier between the benefits of PROs and these underserved populations. This study examines the response rates, patterns and characteristics of patients completing PROs in a tertiary cancer center. Methods: Patients with a cancer diagnosis and an oncologic provider visit at a tertiary cancer center were offered an opportunity to complete Patient Reported Outcome Measures (PROMs) between August 2020 and July 2022.We used the National Institute of Health’s computer adaptive tests Patient-Reported Outcomes Measurement Information System (PROMIS) instruments in pain interference, physical function, fatigue, and depression. Seven days prior to their clinical appointment, patients were assigned the PROMIS instruments in MyChart, then offered in-clinic completion with a tablet at check-in, if not completed online. A decision tree model was employed to assess the factors that may influence patients' PROMs completion (age, gender, race, marital status, insurance, stage, comorbidity score, and provider specialty and location). Results: A total of 8,535 patients were offered the PROMIS CAT version 2.0 instrument during the study period. The two most important factors that determine whether a patient completed PROMs in order of importance were provider specialty and patient race. Patients were more likely to complete PROMs if they had a visit with a provider in Radiation Oncology (RC) or Surgery specialty compared with Medicine or Supportive Oncology specialty (40.86% versus 29.68%). Among patients who had a visit with a provider in RC or Surgery specialty, there was a better chance of PROMs completion with White race compared to Black or Other races (45.83% versus 33.69%). Of those who had a visit with a provider in Medicine or Supportive Oncology specialty, there was a better chance of PROMs completion with Other or White races compared to Black race (32.40% versus 22.19%). Conclusions: We found that provider specialty and patient race were the most important factors influencing patients’ PROMs completion. In order to realize the full benefit of PROs in patient care, multilevel interventions can be employed to increase patient-provider utilization of PROs. Moreover, efforts should focus on a patient-centered design to address patient and provider barriers impeding PROs accessibility and completion.

Longitudinal changes in patient reported outcome measures in patients with cancer six months prior to death: A case-control study.

1585 Background: Provider assessments consistently fall short in determining when cancer patients enter into the terminal phase of their disease. Despite prior desires to spend their last days outside an institution, patients often seek emergency room care and most report never having a palliative consultation at the time of their terminal admission. Patient reported outcome measures (PROMs) are derived directly from the patient and may provide insight into the experience near the end of life to facilitate earlier involvement of supportive oncology. This study aims to compare PROMs in the 6 months prior to death to those not dying among patients with cancer. Methods: This study uses a routine PROMs program implemented since September 2020 for all patients with a cancer diagnosis at a tertiary care hospital. This study focused on PROMs using 3 domains of the Patient Reported Outcomes Measurement Information System (PROMIS): physical function, pain interference, and fatigue; PROMs frequency mirrored patients’ oncologic visits. Using a retrospective case-control study, patients who had died within 6 months of a PROMs response (cases) were compared to controls who were alive at the time of the case’s death. Cases were matched 1:2 to controls by age at PROMs completion, gender, cancer disease site, and stage. Generalized estimating equation (GEE) models adjusted for age at PROMs completion, gender, cancer disease site, stage, and correlations between individual patient encounters were used to compare mean PROMs scores between cases and controls in each domain. Results: In total, 274 cases were compared to 270 unique controls. Univariate comparisons between cases and controls demonstrated significant differences only in Charlson Comorbidity Index (CCI), with cases demonstrating worse CCI (3.3 ± 2.5) compared to controls (2.3 ±2.2; p &lt; 0.001). Time from diagnosis to PROMs completion was not different between groups (4.08 versus 4.10 years, p = 0.798). Over the 6 months prior to death, 10.5%/15.0%/32.0% cases had severe pain/fatigue/physical function scores compared to 3.3%/3.7%.8.7% in controls (p &lt; 0.001). GEE models demonstrated that cases had a higher mean fatigue score of 5.34 points (95% CI = 3.81 to 6.88), higher mean pain interference score of 4.92 points (95% CI = 3.42 to 6.43), and lower mean physical function score of 7.39 points (95% CI = -8.84 to -5.93) indicating more severe symptom scores for cases in all three domains. Conclusions: On average, patients experiencing death within 6 months of PROMs completion demonstrated worse physical functioning, pain interference, and fatigue scores compared to their age, gender, cancer disease site, and stage matched controls. The differences in PROMs scores represent a first step to improving understanding of PROMs during the terminal stage of disease and may guide indicators for earlier need of supportive oncology support.

Comprehensive 0utcomes for After Cancer Health: COACH.

TPS12141 Background: The landscape for cancer survivors continues to evolve as individuals live longer following primary therapy. For some, treatment is complete; for others, active surveillance or maintenance therapy may be indicated. Individual survivorship needs are diverse, influenced by tumor and treatment type, as well as social determinants of health. Digital interventions may support survivors in achieving personalized health goals throughout survivorship. The Comprehensive Outcomes for After Cancer Health (COACH) Study (NCT05349227) explores the feasibility of a digital health coaching (DHC) program for individuals enrolled with diverse tumor types and geographic regions. Methods: COACH is a multi-center, randomized, wait-list control trial enrolling 550 individuals ≥18 years old who are within 1-year of completion of primary cancer therapy at enrollment. Up to 100 participants, will be recruited at each of 6 study sites, of which 3 are currently enrolling. Consented individuals are randomized to 6 months of DHC or 6 months of data collection only, then cross-over for follow-up to 12-months. Both groups wear an activity tracker; complete patient reported outcome measures; and provide fecal specimens. The DHC program includes weekly Health Advisor calls and supplemental delivery of evidenced-based content via text, email or mobile platform. Topics fall in health domains of physical, mental/emotional, financial, social, and sexual, and emphasize nutrition, physical activity, sleep, and screening for recurrent or de novo cancer. Feasibility for this study is defined as a retention rate greater than or equal to 70%, and acceptability will be defined as less than or equal to 20% scoring “not at all helpful.” Trends over time will be assessed using linear mixed models using time as a fixed effect, as well as any covariates and interactions of interest. Descriptive statistics will be used to evaluate exploratory endpoints. A cross-cohort end-point related to physical function as measured by the PROMIS Physical Function 10a, will also be evaluated. To date, 72 individuals have enrolled, with Nebraska as the lead site, including 71 women, with a mean age of 61.78 (Range 33-74), from the U.S. Midwest (n = 57) and Northeast (n = 15). 4 identify as African American/Black, 68 as White. 50 have a breast, 13 ovarian, 8 endometrial, 1 gastric diagnosis. Nine have completed the first 6 months of the study. The study is novel in the breadth of data collected and potential to understand variability in patient experiences and provide insights into the feasibility, acceptability, and efficacy of a DHC intervention supporting individuals after primary cancer treatment. Clinical trial information: NCT05349227 .

Patient reported outcomes (PROs) collection modalities among patients diagnosed with cancer: Online vs in-person.

6612 Background: Patient reported outcomes (PRO) can be valuable clinical tools to embed the voice of patients into the clinical assessment. PROs provide important metrics to guide treatment decision making, improve quality of life, reduce acute care, and extend survival in cancer patients. Different modalities for collecting patient reported outcome measures (PROMs) exist (e.g., electronic, paper, telephone); yet little is known about factors associated with PROMs completion modality. More information on PROMs completion modality may determine addressable barriers. We sought to determine whether patients’ sociodemographic and clinical factors differed by completion modality. Methods: Beginning in 2021 all patients diagnosed with cancer who had a visit with an oncologic provider at a tertiary cancer center were assigned the National Institute of Health’s computer adaptive tests Patient-Reported Outcomes Measurement Information System (PROMIS) instruments in pain interference, physical function, fatigue, and depression through the MyChart patient portal 7 days prior to the visit. If this was not completed at the time of the visit, it was available for completion on a tablet during check-in. The outcome variable was completion modality defined as the method a patient used to complete their PROMs (MyChart vs. In-Person). Multivariable logistic regression model was used to estimate the association between patients’ sociodemographic and clinical factors (age, sex, race/ethnicity, marital status, insurance type, stage, provider specialty) and completion modality. Results: A total of 2915 patients completed PROMs, of which 54% completed using MyChart and 46% completed in-person. The average age of patients was 59.6 (SD=12.4) years, most were females (63.1%), White (69.4%) and married (59.2%). Compared to male patients, females were less likely to complete PROMs in-person (aOR=0.80, 0.67–0.95). However, patients were more likely to complete PROMs in-person if they were of Black race (aOR=1.85, 1.52–2.24) or Other race (aOR=1.48, 1.12–1.96) vs. White; single (aOR=1.30, 1.05–1.62) vs. married; or have Medicaid/other insurance (aOR=1.52, 1.15–2.01) vs. private insurance. Patients who had visits with a radiation oncology provider (aOR=1.50, 1.20–1.86) or surgical oncology provider (aOR=1.32, 1.07–1.62) were more likely to complete PROMs in-person compared to those who had visits with a medical oncology provider. Conclusions: Almost half of the patients completed PROMs in-person during check-in, which was unexpected in the context of trends toward mobile-based patient engagement. Patients in underserved populations were the most likely to complete PROMs in-person. Although offering PROMs remotely may be more efficient and allow monitoring between visits, offering an in-person option helps to capture PROs from underserved populations.

Anatomic shoulder arthroplasty in Walch type C glenoid deformity: mid- to long-term outcomes.

Hypoplastic glenoid morphology in the setting of glenohumeral osteoarthritis is a rare yet complex surgical problem. Treatment of this patient population with anatomic total shoulder arthroplasty (aTSA) remains controversial. Furthermore, there is no gold-standard approach, with limited guidance for surgeons on the need for glenoid version correction in the setting of a dysplastic glenoid. The purpose of this study was to evaluate mid- to long-term outcomes and reoperation rates of aTSA for the treatment of primary glenohumeral osteoarthritis with Walch type C glenoid deformity. This observational, retrospective cohort study identified patients with a Walch type C glenoid who underwent aTSA at 2 institutions between 2007 and 2016. Patients were contacted to complete updated patient-reported outcome measures at a minimum of 5.5 years postoperatively. The outcome measures collected included the American Shoulder and Elbow Surgeons (ASES) score and Single Assessment Numeric Evaluation (SANE) score. Secondary outcomes included any additional surgical procedures on the operative shoulder, patient satisfaction, and willingness to undergo aTSA again. In total, 30 patients met the inclusion criteria, of whom 26 (86.7%) were able to be contacted to undergo final outcome evaluations. The mean age at the time of surgery was 61.3 years (range, 40.9-75.5 years), and 20 patients (76.9%) were men. The mean follow-up period was 8.5 years (range, 5.5-11.3 years) after surgery. Treatment was performed with an augmented component in 9 patients and with a standard component in 17. Of the 17 patients with non-augmented components, 9 underwent partial correction with asymmetrical reaming, 3 received a mini-inset glenoid component, and 2 had an anteriorly offset humeral component. At final follow-up, patients had a mean ASES score of 83.6 ± 16.7, ASES pain score of 24.7 ± 20.8, SANE score of 80.4 ± 20.9, and patient satisfaction rate of 84.1%. No statistically significant differences in any outcome measure were observed between patients with augmented glenoid components and those with non-augmented glenoid components. One revision to reverse shoulder arthroplasty was performed for instability at 7 years postoperatively after a traumatic dislocation. All patients reported that they would be willing to undergo the same surgical procedure again. Despite variance in glenoid reconstructive approach, aTSA provides satisfactory and sustained improvements in patient-reported outcomes in patients with glenoid dysplasia and primary glenohumeral osteoarthritis with a low revision rate at a mean of 8.5 years. Anatomic shoulder arthroplasty should remain a surgical option in patients with Walch type C glenoid deformity.

GCIG SB-001/NSGO-CTU-PEACE/ANZGOG 1923/2020: Palliation in gynae-oncology—Patients' expectations and assessment of care.

TPS5635 Background: Patients with advanced gynaecological cancers who are approaching end of life (EOL) have a high symptom burden and following several prior lines of therapy, a low likelihood of response to further anti-cancer treatment. Despite this, 20-30% of women with gynecological cancer received chemotherapy in the last 30 days of life, with potentially detrimental effects on health and quality of life. Little is known about patients' and carers' perceptions and preferences in this phase of illness. Eliciting patient’s values and preferences for EOL care and shared decision-making are central elements of GCIG SB-001/NSGO-CTU-PEACE with the aim of improving patient-centered EOL care. The primary aim of PEACE is to assess the feasibility of collecting data on patient satisfaction towards EOL. Secondary aims include collecting data on patient and carer satisfaction with care, as well as prospective collection of details of their care. Methods: PEACE will prospectively enroll patients in Norway and Australia. Key eligibility criteria include: Patients with gynaecological cancer at an advanced stage with a predicted life expectancy of approximately 4 months. Patients may be on anti-cancer treatment or may be under observation/palliative care. In addition, the patient must be able (both physically and cognitively) to complete patient-reported outcome measures independently. The study will also include an appointed carer (not mandatory). Patient and carer satisfaction with care and the importance of domains of care will be assessed with the CANHELP-Lite individualized (Canadian Health Care Evaluation Project) instrument and FACIT (Functional Assessment of Chronic Illness Therapy). Carer’s perception of the bereavement period and the quality of the patient’s death will be assessed with the CANHELP lite bereavement and the Quality of Death and Dying questionnaire. The study will prospectively collect data on EOL treatment. Patient and carer satisfaction with care and quality of the dying process will be summarized by standard descriptive statistical measures. A sample size of 65 patients would have at least 80% power with 95% confidence to rule out a 60% completion rate in favour of the more interesting 75% rate. Assuming a 10% drop-out rate, PEACE will enrol 73 patients. Enrolment commenced in December 2022. ClinicalTrials.gov Identifier: NCT05142150 Clinical trial information: NCT05142150 .

CRUSE - What the first 100 days have taught us.

Introduction: Health apps play an increasing role in everyday healthcare, especially for chronic diseases. The Chronic Urticaria Self Evaluation (CRUSE) is a new mobile health app for chronic spontaneous urticaria (CSU) patients, which replaces disease tracking via paper and pen, thus making disease monitoring more convenient, increasing tracking compliance, and improving data quality and access. Methods: CRUSE enables patients to complete patient-reported outcome measures on their smartphone and send the results, along with current medication and pictures, to their treating physician via email. CRUSE captures the urticaria (UAS) and angioedema activity (AAS) scores and the urticaria and angioedema control tests (UCT and AECT). In this work, a descriptive analysis of CRUSE users and reported days was performed. The global network of Urticaria Centers of Reference and Excellence (UCARE) provides the app and its data. Results: CRUSE is now available in Germany, Switzerland, Austria, the UK, Italy, Spain, France, and Turkey. Of 620 newly registered users (from July 1st until November 18th of 2022), 72 % were female, and the mean age was 36.6 years (17 - 78 years). The average daily UAS and AAS value (mean ± standard deviation) were 2.1 ± 1.9 and 7.2 ± 3.3, respectively. Most CRUSE patients had poorly controlled disease, with mean UCT values of 7.0 ± 4.4 and mean AECT values of 8.1 ± 4.5. Conclusion: The first days of patients with CSU using CRUSE confirm the high need for an app that helps to monitor disease activity, impact, and control. The first results indicate low levels of disease control in most CRUSE users, with low UCT and AECT values. Future analyses will assess follow-up documentation data and evaluate the effects of treatment changes on CSU activity, impact, and control.

Hip resurfacing arthroplasty in women: A novel ceramic device enables near normal gait function

BackgroundGait function improves after Total Hip Arthroplasty (THA) but is not restored to normal levels. Metal-on-metal Resurfacing Arthroplasty (MoM-HRA) is an alternative to THA and has shown to restore normal levels gait function and physical activity but has been restricted to men owing to problems of metal-ion release. Ceramic HRA (cHRA) removes the cobalt-chrome bearing surfaces, thereby eliminating these specific metal-ion concerns and aiming to be safe for females. Research questionIs there a difference in gait function of female cHRA patients compared to female THA using subjective and objective measures? MethodsFifteen unilateral cHRA and 15 unilateral THA, age and BMI matched, completed patient reported outcome measures (PROMs) (Oxford Hip Score, EQ5d and MET score) and underwent gait analysis using an instrumented treadmill pre- (2–10 weeks) and post-operatively (52–74 weeks). Maximum walking speed (MWS), Vertical GRF of the stance phase, GRF symmetry index (SI) and spatiotemporal gait measures were recorded. Patients were compared to age, gender and BMI healthy controls (CON). ResultsThere were no differences in PROMs or gait function between groups pre-operatively. Post- operatively, cHRA had a higher MET score (11.2 vs 7.1, p = 0.02) and a higher MWS (6.2 vs 6.8 km/hr, p = 0.003) compared to THA. cHRA had a similar GRF profile to CON, whereas THA had a reduced push-off force at 70–77 % of the stance phase compared to CON. At faster walking speeds of 6 km/hr walking speed, THA displayed an asymmetric GRF profile (SI<4.4 %) whereas the cHRA patients continued to display a symmetrical gait profile. cHRA was able to increase step length from pre-op levels (63 vs 66 cm, p = 0.02) and produced a larger step length compared to THA (73 vs 79 cm, p = 0.02). SignificanceFemale cHRA returned to levels of gait function and activity similar to healthy controls unlike female THA.

The role of socioeconomic factors as barriers to patient reported outcome measure completion following lumbar spine fusion

BACKGROUND CONTEXTAlthough incorporating patient reported outcomes (PROMs) into practice allows healthcare systems to evaluate the value of care provided, research and policy reflecting PROMs can only be valid if they represent all patients. Few studies have evaluated socioeconomic barriers to PROM completion, and none have done so in a spine patient population. PURPOSETo identify patient barriers to PROM completion one year following lumbar spine fusion. STUDY DESIGN/SETTINGRetrospective single-institution cohort study. PATIENT SAMPLEA total of 2,984 patients undergoing lumbar fusion between 2014 and 2020 OUTCOME MEASURESCompletion of Mental Component Score (MCS-12) and Physical Component Score (PCS-12) of Short Form-12 questionnaire 1 year postoperatively. METHODSA retrospective review was conducted of all patients undergoing 1-3-level lumbar fusion at a single urban tertiary center. PROMs were queried from our prospectively managed electronic outcomes database. Patients were considered to have complete PROMs if 1-year outcomes were available. Community-level characteristics were collected from patients’ zip codes using the Economic Innovation Group Distressed Communities Index. Bivariate analyses were performed to assess factors associated with PROM incompletion along with multivariate logistic regression to control for confounders. RESULTSA total of 1,968 (66.0%) had incomplete 1-year PROMs. Patients with incomplete PROMs were more likely to be Black (14.5% vs 9.3%, p<.001), Hispanic (2.9% vs 1.6%, p=.027), reside in a distressed community (14.7% vs 8.5%, p<.001), and be active smokers (22.4% vs 15.5%, p<.001). On multivariate regression, Black race (OR: 1.46, p=.014, Hispanic ethnicity (OR: 2.19, p=.027), distressed community status (OR: 1.47, p=.024), workers’ compensation status (OR: 2.82, p=.001), and active smoking (OR:1.31, p=.034) all were independently associated with PROM incompletion. Surgical characteristics, including primary surgeon, revision status, approach, and levels fused were not associated with PROM incompletion. CONCLUSIONSSocial determinants of health impact completion of PROMs. Patients completing PROMs are overwhelmingly White, non-Hispanic, and reside in wealthier communities. Efforts should be taken to provide better education regarding PROMs and ensure closer follow-up of certain subgroups of patients to avoid furthering disparities in PROM research.

Online Patient-Reported Outcome Measure Engagement is Dependent on Demographics and Locality: Findings From an Observational Cohort.

Online patient-reported outcome measures (PROMs) enable remote collection of perceptions of health status, function, and well-being. We aimed to explore patterns of PROM completion in patients with early inflammatory arthritis (EIA) recruited to the National Early Inflammatory Arthritis Audit (NEIAA). NEIAA is an observational cohort study design; we included adults from this cohort with a new diagnosis of EIA from May 2018 to March 2020. The primary outcome was PROM completion at baseline, 3 months, and 12 months. Mixed effects logistic regression and spatial regression models were used to identify associations between demographics (age, gender, ethnicity, deprivation, smoking, and comorbidity), clinical commissioning groups, and PROM completion. Eleven thousand nine hundred eighty-six patients with EIA were included, of whom 5331 (44.5%) completed at least 1 PROM. Patients from ethnic minority backgrounds were less likely to return a PROM (adjusted odds ratio [aOR] 0.57, 95% CI 0.48-0.66). Greater deprivation (aOR 0.73, 95% CI 0.64-0.83), male gender (aOR 0.86, 95% CI 0.78-0.94), higher comorbidity burden (aOR 0.95, 95% CI 0.91-0.99), and current smoker status (aOR 0.73, 95% CI 0.64-0.82) also reduced odds of PROM completion. Spatial analysis identified 2 regions with high (North of England) and low (Southeast of England) PROM completion. We define key patient characteristics (including ethnicity) that influence PROM engagement using a national clinical audit. We observed an association between locality and PROM completion, with varying response rates across regions of England. Completion rates could benefit from targeted education for these groups.

What Factors Identified in Initial Osteoarthritis Management Are Associated With Poor Patient-reported Outcomes After THA? A Register-based Study.

Some patients report long-term pain or no improvement in health-related quality of life (HRQoL) or are dissatisfied after THA. However, factors associated with these poorer patient-reported outcomes after surgery are inconsistent and have typically been studied in the late phase of hip osteoarthritis (OA) among patients already eligible for surgery. Earlier identification of risk factors would provide time to address modifiable factors, helping to improve patients' pain, HRQoL, and satisfaction after surgery and reduce the burden on orthopaedic clinics by referring patients who are better prepared for surgery. We analyzed data from patients with hip OA referred to a first-line OA intervention program in primary healthcare at a stage when they had not been referred for THA, and asked: (1) What percentage of patients who proceed to THA report lack of improvement in pain, lack of improvement in HRQoL as measured by the EQ-5D, or are not satisfied with surgery 1 year after THA? (2) What associations exist between baseline factors at referral to this first-line OA intervention program and these poorer patient-reported outcomes 1 year after THA? We included 3411 patients with hip OA (mean age 67 ± 9 years, 63% [2160 of 3411] women) who had been referred for first-line OA interventions between 2008 and 2015 and subsequently underwent THA for OA. All patients were initially identified through the Swedish Osteoarthritis Register, which follows and evaluates patients in a standardized national first-line OA intervention program. Then, we identified those who were also registered in the Swedish Arthroplasty Register with a THA during the study period. We included only those with complete patient-reported outcome measures for pain, HRQoL, and satisfaction preoperatively and 1-year postoperatively, representing 78% (3411 of 4368) of patients, who had the same baseline characteristics as nonrespondents. Multiple logistic regression was used to assess the associations between 14 baseline factors and the aforementioned patient-reported outcomes of pain, HRQoL, and satisfaction 1 year after THA, adjusted for all included factors. Five percent (156 of 3411) of the study population lacked improvement in pain, 11% (385 of 3411) reported no improvement in HRQoL, and 10% (339 of 3411) reported they were not satisfied with surgery 1 year after THA. Charnley Class C (multiple-joint OA or another condition that affects the ability to walk) was associated with all outcomes: lack of improvement in pain (OR 1.84 [95% CI 1.24 to 2.71]; p = 0.002), lack of improvement in HRQoL (OR 1.83 [95% CI 1.42 to 2.36]; p < 0.001), and not being satisfied (OR 1.40 [95% CI 1.07 to 1.82]; p = 0.01). Older age was associated with a lack of improvement in pain (OR per year 1.03 [95% CI 1.01 to 1.05]; p = 0.02), lack of improvement in HRQoL (OR per year 1.04 [95% CI 1.03 to 1.06]; p < 0.001), and not being satisfied (OR per year 1.03 [95% CI 1.01 to 1.05]; p < 0.001). Depression was associated with a lack of improvement in pain (OR 1.54 [95% CI 1.00 to 2.35]; p = 0.050) and with not being satisfied (OR 1.50 [95% CI 1.11 to 2.04]; p = 0.01) but not with a lack of improvement in HRQoL (OR 1.04 [95% CI 0.76 to 1.43]; p = 0.79). Having four or more comorbidities was associated with a lack of improvement in HRQoL (OR 2.08 [95% CI 1.39 to 3.10]; p < 0.001) but not with a lack of improvement in pain and not being satisfied. The results of this study showed that older age, Charley Class C, and depression in patients with first-line OA interventions were risk factors associated with poorer outcomes regarding pain, HRQoL, and satisfaction after THA. Screening patients with hip OA for depression early in the disease course would provide increased time to optimize treatments and may contribute to better patient-reported pain, HRQoL, and satisfaction after future THA. Further research should focus on identifying the optimal time for surgery in patients with depression, as well as what targeted interventions for depression can improve outcome of surgery in these patients. Level III, therapeutic study.

Stepped care versus center-based cardiopulmonary rehabilitation for older frail adults living in rural MA: Design of a feasibility randomized controlled trial

BackgroundCardiac and pulmonary rehabilitation programs are grossly underutilized, and participation is particularly low in rural regions. MethodsWe are conducting a 2-arm, randomized controlled feasibility trial. Eligible participants include older frail adults with cardiac or pulmonary disease living in a predominantly rural county in western Massachusetts. Participants are randomized 1:1 to treatment as usual or stepped care. Patients randomized to treatment as usual participate in twice weekly center-based rehabilitation sessions over eight weeks and are encouraged to exercise at home in between sessions. Patients randomized to the stepped-care arm are offered/enrolled in the center-based rehabilitation program followed by possible step up to three interventions based on prespecified non-response criteria: 1) Transportation-assisted center-based rehabilitation, 2) Home-based telerehabilitation, and 3) Community health worker-supported home-based telerehabilitation. The primary feasibility outcomes are average number of eligible patients randomized per month, baseline measure completion, proportion attending at least 70% of the prescribed sessions, average number of sessions attended in the stepped-care arm, and proportion in the stepped-care arm completing patient reported outcome measures. Each of these process indicators is evaluated by preset “Stop” and “Go” thresholds. ConclusionThe proposed stepped-care model is an efficient, patient-centered, approach to expanding access to cardiac and pulmonary rehabilitation. Meeting the “Go” thresholds for the prespecified process indicators will justify conducting a definitive full-scale randomized controlled trial to compare the effectiveness and value (cost-effectiveness) of stepped-care versus center-based rehabilitation in older frail adults living rural counties.

Comparison between two patient-reported outcome measures for patients with cervical radiculopathy: A think-aloud study

BackgroundThe Cervical Radiculopathy Impact Scale (CRIS) and Patient Specific Functional Scale 2.0 (PSFS 2.0) are patient-reported outcome measures (PROMs) used to assess activity limitations in patients with cervical radiculopathy (CR). This study a) compared the CRIS subscale 3 and the PSFS 2.0 in patients with CR with respect to completeness and patient preference, b) established the correlation between both PROMs in assessing the individual patient's level of functional limitations and c) assessed the frequency of reported functional limitations. MethodsParticipants with CR participated in semi-structured, individual, face-to-face interviews as part of a “think-aloud” process; verbalising their thoughts while completing both PROMs. Sessions were digitally recorded and transcribed verbatim for analysis. ResultsTwenty-two patients were recruited. The most frequently reported functional limitation on the CRIS was: ‘working at a computer’ (n = 17) and overhead activities' (n = 10) for the PSFS 2.0. There was significant moderate positive correlation between the scores on the PSFS 2.0 and the CRIS (Spearman's r = 0.55, n = 22 p = .008). Most patients (n = 18; 82%) preferred the ability to present their own individual functional limitations of the PSFS 2.0. Eleven participants (50%) preferred the 11-point scale of the PSFS 2.0 over the 5-point Likert scale scoring option of the CRIS. ConclusionBoth easy to complete PROMs capture functional limitations in patients with CR. Most patients prefer the PSFS 2.0 over the CRIS. The wording and layout of both PROMs need refinement to enhance user-friendliness and avoid misinterpretation.