Patient-reported Outcome Measures Data Research Articles

H-Wave® Device Stimulation for Chronic Neck Pain: A Patient-Reported Outcome Measures (PROMs) Study.

Chronic neck pain (cNP) is one of the leading causes of disability worldwide, often being refractory to conventional forms of treatment. Various forms of electrical stimulation have been proposed to decrease pain and improve function. Patient-reported outcome measures (PROMs) for treatment of cNP have rarely been published. An independent retrospective statistical analysis of PROMs data for users of H-Wave® device stimulation (HWDS), prospectively collected by the device manufacturer over a 4-year period, was conducted. Final surveys for 34,192 pain management patients were filtered for pain chronicity limited to 3-24months and device use of 22-365days, resulting in 11,503 patients with "all diagnoses"; this number was further reduced to 1482 patients with cNP, sprain, or strain. Neck pain was reduced by 3.13 points (0-10 pain scale), with significant (≥20%) relief in 86.6%. Function/activities of daily living (ADL) improved in 96.19%, while improved work performance was reported in 84.76%. Medication use decreased or stopped in 65.42% and sleep improved in 60.39%. Over 95% reported having expectations met or exceeded, service satisfaction, and confidence in device use, while no adverse events were reported. Subgroup analyses found positive benefit associations with longer duration of device use. Near-equivalent outcomes were self-reported by cNP HWDS patients as for (previously published) chronic low back pain (cLBP) patients. HWDS provided effective and safe cNP relief, improvements in function and ADL, along with additional benefits including decreased medication use, better sleep, and improved work performance.

Abstract PO4-11-12: Patient Reported Outcomes from a multi-site, prospective Pivotal study evaluating pegulicianine fluorescence guided surgery (pFGS) for breast cancer lumpectomy procedures using the Lumicell Direct Visualization System (DVS)

Abstract Background: In pegulicianine fluorescence guided surgery (pFGS), a standard of care lumpectomy procedure is performed, and additional tissue is taken from cavity walls at sites of high pFGS signal. This approach been shown to reduce 2nd surgeries and remove additional tumor left by standard surgery, but may remove more tissue, potentially worsening cosmetic outcomes. Patient breast satisfaction surveys were used to assess cosmesis after pFGS. Methods: A prospective Pivotal trial of pFGS in women undergoing lumpectomy surgery for stage 0-III breast cancer was conducted at 14 US sites (NCT03686215). We assessed the safety and efficacy of the Lumicell DVS in identifying and removing residual cancer from the lumpectomy cavity in real time. Patient Reported Outcome Measures (PROM) data was collected as an exploratory endpoint. The BREAST-Q, a validated tool that measures patient perspectives after different breast procedures, was used to collect PROM data. An 11-question BREAST-Q survey was used to measure patients’ breast satisfaction at baseline (pre-surgery) and at multiple timepoints through 6-months post lumpectomy. Descriptive statistics of participating patients’ responses were collected and analyzed. Survey results were analyzed by the distribution of patient ratings for each question and the change in the distribution of ratings over time, with comparison of baseline to post-lumpectomy. Comparison of patient satisfaction with or without additional pFGS-directed tissue removal was performed with Item Response Theory assuming all items equally discriminative of responding patients. For each timeframe, responses to BREAST-Q items were used to create a response score for each patient. Scaled factor scores (0-100) were compared between groups with and without additional tissue removed during pFGS. Results: Of the 357 patients evaluated for efficacy in the primary Pivotal study analysis, 255 patients agreed to participate in the PROM surveys (71%). Approximately 60% of the participating respondents completed a pre- and initial post-lumpectomy survey while only 34% of the participating patients completed a pre- and 6-month post-lumpectomy survey. Most patients responded either “Very Satisfied” or “Somewhat Satisfied” across all surveyed timeframes. No significant difference in patient breast satisfaction was found at any time point between the groups with and without additional pFGS-guided shaves removed (p >0.05). There were 4 patients with scores of 3 or higher pre-surgery but 2 or lower post-surgery. Among these, 1 had no pFGS-guided shaves taken. The remaining 3 had had pFGS-guided shaves taken, but 2 required a second lumpectomy surgery and 1 underwent mastectomy, these additional surgeries likely accounting for decreased cosmetic outcomes. Discussion: Patient perspective of breast satisfaction was not decreased by the amount of extra tissue removed by pFGS. These data suggest that pFGS using the Lumicell DVS does not significantly decrease breast cosmesis. Three of 4 patients with decreased satisfaction had 2nd surgeries, confirming the importance of finding approaches to decrease 2nd surgeries. This data was collected during the COVID-19 pandemic, which may have adversely impacted the compliance rate of survey completion. Studies in larger cohorts with longer follow up are required to better assess the relative impact of 2nd surgeries, radiation, and systemic therapy on breast satisfaction PROM scores after lumpectomy. Citation Format: Kelly Hunt, Irene Wapnir, E Shelley Hwang, David Carr, Peter Blumencranz, Kate Smith, Manna Chang, Jorge Ferrer, Barbara Smith. Patient Reported Outcomes from a multi-site, prospective Pivotal study evaluating pegulicianine fluorescence guided surgery (pFGS) for breast cancer lumpectomy procedures using the Lumicell Direct Visualization System (DVS) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-11-12.

Prevalence, treatment and correlates of depression in multiple sclerosis

BackgroundThe prevalence of depression in Multiple Sclerosis (MS) is often assessed by administering patient reported outcome measures (PROMs) examining depressive symptomatology to population cohorts; a recent review summarised 12 such studies, eight of which used the Hospital Anxiety and Depression Scale-Depression (HADS-D). In clinical practice, depression is diagnosed by an individual structured clinical interview; diagnosis often leads to treatment options including antidepressant medication. It follows that an MS population will include those whose current depressive symptoms meet threshold for depression diagnosis, plus those who previously met diagnostic criteria for depression and have been treated such that depressive symptoms have improved below that threshold. We examined a large MS population to establish a multi-attribute estimate of depression, taking into account probable depression on HADS-D, as well as anti-depressant medication use and co-morbidity data reporting current treatment for depression. We then studied associations with demographic and health status measures and the trajectories of depressive symptoms over time. MethodsParticipants were recruited into the UK-wide Trajectories of Outcome in Neurological Conditions-MS (TONiC-MS) study, with demographic and disease data from clinical records, PROMs collected at intervals of at least 9 months, as well as co-morbidities and medication. Interval level conversions of PROM data followed Rasch analysis. Logistic regression examined associations of demographic characteristics and symptoms with depression. Finally, a group-based trajectory model was applied to those with depression. ResultsBaseline data in 5633 participants showed the prevalence of depression to be 25.3 % (CI: 24.2–26.5). There were significant differences in prevalence by MS subtype: relapsing 23.2 % (CI: 21.8- 24.5), primary progressive 25.8 % (CI: 22.5–29.3), secondary progressive 31.5 % (CI: 29.0–34.0); disability: EDSS 0–4 19.2 % (CI: 17.8–20.6), EDSS ≥4.5 31.9 % (CI: 30.2–33.6); and age: 42–57 years 27.7 % (CI: 26.0–29.3), above or below this range 23.1 % (CI: 21.6–24.7). Fatigue, disability, self-efficacy and self esteem correlated with depression with a large effect size (>0.8) whereas sleep, spasticity pain, vision and bladder had an effect size >0.5. The logistic regression model (N = 4938) correctly classified 80 % with 93 % specificity: risk of depression was increased with disability, fatigue, anxiety, more comorbidities or current smoking. Higher self-efficacy or self esteem and marriage reduced depression. Trajectory analysis of depressive symptoms over 40 months in those with depression (N = 1096) showed three groups: 19.1 % with low symptoms, 49.2 % with greater symptoms between the threshold of possible and probable depression, and 31.7 % with high depressive symptoms. 29.9 % (CI: 27.6–32.3) of depressed subjects were untreated, conversely of those treated, 26.1 % still had a symptom level consistent with a probable case (CI: 23.5–28.9). ConclusionA multi-attribute estimate of depression in MS is essential because using only screening questionnaires, diagnoses or antidepressant medication all under-estimate the true prevalence.Depression affects 25.3 % of those with MS, almost half of those with depression were either untreated or still had symptoms indicating probable depression despite treatment. Services for depression in MS must be pro-active and flexible, recognising the heterogeneity of outcomes and reaching out to those with ongoing symptoms.

Improvement of Postoperative Quality of Life in Patients Over 80 Years Old With Thoracic Spinal Stenosis.

A retrospective comparative study was conducted to analyze the outcome of surgical and conservative treatment for patients over 80 years old with thoracic spinal stenosis (TSS). To evaluate the safety and efficiency of posterior spinal cord decompression surgery for over 80-year-old patients with TSS. Concerned about the risk of surgery, over 80-year-old patients with TSS are usually treated conservatively, which often leads to a decline in quality of life. So far as we know, no study demonstrates the risk and benefit of spine surgery for these patients. Over 80 years of age who underwent dorsal decompression surgery or conservative treatment due to TSS between January 2010 and November 2020 were analyzed. Sixty-four patients who completed follow-up PROM (patient-reported outcome measure) data were collected, including the mJOA (modified Japanese Orthopedic Association score) scoring system, VAS (visual analogue scale), questionnaire-based assessment of the ODI (Oswestry disability index), BI (Barthel index), and SF-36v2 (Short Form-36v2) Health Survey. The clinical characteristics, preoperative and postoperative imaging findings, operative records, complications, and individual outcomes were analyzed. Of the 64 patients, 38 underwent posterior decompression, pedicle screw fixation, and posterolateral fusion; another 26 chose conservative treatment. The baseline characteristics of the TSS patients in 2 groups show no significant differences. The clinical symptoms and imaging outcomes showed a significant improvement in the surgical group compared with the nonsurgical group, according to mJOA, VAS, ODI, BI, and SF-36v2. Cerebrospinal fluid leakage occurred in 6 patients, and transient neurological impairment occurred in 2 patients. Posterior decompression surgery for over 80-year-old patients with TSS is a safe and effective treatment, it has a good clinical outcome as well as an acceptable complication rate. However, there were no obvious improvements in quality of life or pain with conservative treatment.

Patient-reported outcome measures in hip fracture patients.

The aims of this study were to assess quality of life after hip fractures, to characterize respondents to patient-reported outcome measures (PROMs), and to describe the recovery trajectory of hip fracture patients. Data on 35,206 hip fractures (2014 to 2018; 67.2% female) in the Norwegian Hip Fracture Register were linked to data from the Norwegian Patient Registry and Statistics Norway. PROMs data were collected using the EuroQol five-dimension three-level questionnaire (EQ-5D-3L) scoring instrument and living patients were invited to respond at four, 12, and 36 months post fracture. Multiple imputation procedures were performed as a model to substitute missing PROM data. Differences in response rates between categories of covariates were analyzed using chi-squared test statistics. The association between patient and socioeconomic characteristics and the reported EQ-5D-3L scores was analyzed using linear regression. The median age was 83 years (interquartile range 76 to 90), and 3,561 (10%) lived in a healthcare facility. Observed mean pre-fracture EQ-5D-3L index score was 0.81 (95% confidence interval 0.803 to 0.810), which decreased to 0.66 at four months, to 0.70 at 12 months, and to 0.73 at 36 months. In the imputed datasets, the reduction from pre-fracture was similar (0.15 points) but an improvement up to 36 months was modest (0.01 to 0.03 points). Patients with higher age, male sex, severe comorbidity, cognitive impairment, lower income, lower education, and those in residential care facilities had a lower proportion of respondents, and systematically reported a lower health-related quality of life (HRQoL). The response pattern of patients influenced scores significantly, and the highest scores are found in patients reporting scores at all observation times. Hip fracture leads to a persistent reduction in measured HRQoL, up to 36 months. The patients' health and socioeconomic status were associated with the proportion of patients returning PROM data for analysis, and affected the results reported. Observed EQ-5D-3L scores are affected by attrition and selection bias mechanisms and motivate the use of statistical modelling for adjustment.

Using Machine Learning to Predict Unplanned Hospital Utilization and Chemotherapy Management From Patient-Reported Outcome Measures.

Adverse effects of chemotherapy often require hospital admissions or treatment management. Identifying factors contributing to unplanned hospital utilization may improve health care quality and patients' well-being. This study aimed to assess if patient-reported outcome measures (PROMs) improve performance of machine learning (ML) models predicting hospital admissions, triage events (contacting helpline or attending hospital), and changes to chemotherapy. Clinical trial data were used and contained responses to three PROMs (European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire [QLQ-C30], EuroQol Five-Dimensional Visual Analogue Scale [EQ-5D], and Functional Assessment of Cancer Therapy-General [FACT-G]) and clinical information on 508 participants undergoing chemotherapy. Six feature sets (with following variables: [1] all available; [2] clinical; [3] PROMs; [4] clinical and QLQ-C30; [5] clinical and EQ-5D; [6] clinical and FACT-G) were applied in six ML models (logistic regression [LR], decision tree, adaptive boosting, random forest [RF], support vector machines [SVMs], and neural network) to predict admissions, triage events, and chemotherapy changes. The comprehensive analysis of predictive performances of the six ML models for each feature set in three different methods for handling class imbalance indicated that PROMs improved predictions of all outcomes. RF and SVMs had the highest performance for predicting admissions and changes to chemotherapy in balanced data sets, and LR in imbalanced data set. Balancing data led to the best performance compared with imbalanced data set or data set with balanced train set only. These results endorsed the view that ML can be applied on PROM data to predict hospital utilization and chemotherapy management. If further explored, this study may contribute to health care planning and treatment personalization. Rigorous comparison of model performance affected by different imbalanced data handling methods shows best practice in ML research.

Patient-Reported Outcome and Experience Measures in Advanced Nursing Practice: What Are Key Considerations for Implementation and Optimized Use?

ObjectiveTo discuss the opportunities and challenges of implementing patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) within advanced practice nursing services in cancer care. MethodsThis discussion paper has been informed by an environmental scan of evidence from systematic reviews and primary studies evaluating the use and implementation of PROMs and PREMs. Literature from the contexts of cancer and chronic disease, including nursing and multidisciplinary supportive care literature, has been included. ResultsAdvanced practice nurses are well-positioned to evaluate and respond to PROMs and PREMs data; several studies have highlighted improved patient outcomes concerning quality of life, symptom distress, and functional status within nurse-led services. Nevertheless, the implementation of PROMs and PREMs in cancer care and nurse-led services is variable. Previous studies have highlighted implementation challenges, which can hinder comparability and generalizability of PROMs and PREMs instruments. Advanced practice nurses should consider these challenges, including ways to use standardized PROM instruments. Electronic PROMs, while efficient, may exclude individuals at risk of inequity. Complex, lengthy, and frequent administration of PROMs may also overburden people living with or after cancer, with people affected by cancer expressing preference for flexible use in some studies. Therefore, the involvement of people affected by cancer in planning for PROMs/PREMs implementation may overcome this challenge. Finally, organizational considerations in implementation should address financial investments, including initial costs for technology and training and consideration of the operationalization of PROMs within existing infrastructure for the seamless utilization of PROMs data. ConclusionDespite the potential of advanced practice nursing services to enhance patient-reported outcomes and experiences, variability in the implementation of PROMs and PREMs poses challenges. Use of validated measures, electronic or paper-based instruments, and the preferences of people affected by cancer for the use of PROMs and PREMs must be carefully considered in consultation with end users for successful implementation. Implications for PracticeIn planning for the implementation of PROMs and PREMs within nurse-led services, implementation risks may be mitigated through establishing clear guidelines for their use, investment in the development of the required infrastructure, user education, and rigorous implementation processes, including patient involvement in PROMs/PREMs selection.

Mid-Term Follow Up of the Nexel Total Elbow Arthroplasty

IntroductionAseptic loosening is one of the most common complications of total elbow arthroplasty (TEA). Modern implants, such as the Nexel, have been designed in an attempt to decrease loosening. The present study aims to report implant survivorship, radiographic assessment of loosening and lucency, and patient-reported outcome measures (PROMs) in patients treated with the Nexel TEA at mid-term follow-up. MethodsConsecutive series of adult patients underwent TEA using the Nexel by a single surgeon via standardized technique. Patients with minimum 3 year follow-up with radiographic and PROM data were included. Survivorship was defined by the absence of revision. Loosening was assessed via Wrightington method by three independent fellowship-trained shoulder and elbow surgeons. Lucency was analyzed across individual radiographic zones on orthogonal radiographs. PROMs included the Quick Dash (QDASH), Patient Rated Elbow Evaluation (PREE), and EuroQoL (EQ5D). Results38 consecutive patients (22 female, 16 male) with mean age of 67 underwent TEA via triceps-sparing isolated medial window approach. Mean follow-up was 5.5 years (range 3-9). Primary diagnoses were: 19 osteoarthritis (OA), 9 rheumatoid arthritis (RA), 9 post-traumatic arthritis (PA), 1 conversion of elbow arthrodesis. Overall survivorship was 97.4%, with one patient undergoing revision for infection. Loosening was found in 5.3% of elbows, averaged across three observers. Lucency was most pronounced at the level of the humeral condyles. PROMs demonstrated significant and clinically meaningful improvements in 76%, 92%, and 73% of patients for QDASH, PREE, and EQ5D, respectively. No significant correlations were found between patient age, gender, loosening, lucency, and PROMs. ConclusionAt mid-term follow-up, the Nexel TEA demonstrated excellent overall survivorship and low rate of implant loosening. The single failure requiring revision for infection was conversion of a prior elbow arthrodesis. PROMs overall exhibited marked and consistent improvement from preop to final postop follow-up. Although promising, these results should be interpreted with some caution as long term data regarding this prosthesis are still lacking.

Mid-term outcomes of a kinematically designed cruciate retaining total knee arthroplasty.

Advances in implant material and design have allowed for improvements in total knee arthroplasty (TKA) outcomes. A cruciate retaining (CR) TKA provides the least constraint of TKA designs by preserving the native posterior cruciate ligament. Limited research exists that has examined clinical outcomes or patient reported outcome measures (PROMs) of a large cohort of patients undergoing a CR TKA utilizing a kinematically designed implant. It was hypothesized that the studied CR Knee System would demonstrate favorable outcomes and a clinically significant improvement in pain and functional scores. To assess both short-term and mid-term clinical outcomes and PROMs of a novel CR TKA design. A retrospective, multi-surgeon study identified 255 knees undergoing a TKA utilizing a kinematically designed CR Knee System (JOURNEY™ II CR; Smith and Nephew, Inc., Memphis, TN) at an urban, academic medical institution between March 2015 and July 2021 with a minimum of two-years of clinical follow-up with an orthopedic surgeon. Patient demographics, surgical information, clinical outcomes, and PROMs data were collected via query of electronic medical records. The PROMs collected in the present study included the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) and Patient-Reported Outcomes Measurement Information System (PROMIS®) scores. The significance of improvements in mean PROM scores from preoperative scores to scores collected at six months and two-years postoperatively was analyzed using Independent Samples t-tests. Of the 255 patients, 65.5% were female, 43.8% were White, and patients had an average age of 60.6 years. Primary osteoarthritis (96.9%) was the most common primary diagnosis. The mean surgical time was 105.3 minutes and mean length of stay was 2.1 d with most patients discharged home (92.5%). There were 18 emergency department (ED) visits within 90 d of surgery resulting in a 90 d ED visit rate of 7.1%, including a 2.4% orthopedic-related ED visit rate and a 4.7% non-orthopedic-related ED visit rate. There were three (1.2%) hospital readmissions within 90 d postoperatively. With a mean time to latest follow-up of 3.3 years, four patients (1.6%) required revision, two for arthrofibrosis, one for aseptic femoral loosening, and one for peri-prosthetic joint infection. There were significant improvements in KOOS JR, PROMIS Pain Intensity, PROMIS Pain Interference, PROMIS Mobility, and PROMIS Physical Health from preoperative scores to six month and two-year postoperative scores. The evaluated implant is an effective, novel design offering excellent outcomes and low complication rates. At a mean follow up of 3.3 years, four patients required revisions, three aseptic and one septic, resulting in an overall implant survival rate of 98.4% and an aseptic survival rate of 98.8%. The results of our study demonstrate the utility of this kinematically designed implant in the setting of primary TKA.

Validation of the Oswestry Disability Index in Adult Spinal Deformity.

Retrospective cohort. To examine the validity of the Oswestry Disability Index (ODI) in patients with adult spinal deformity (ASD) treated with surgery. The ODI is a patient-reported outcome measure of low back pain and disability. Although nearly ubiquitous in ASD research, the measure has not been validated in this patient population. A registry of patients with ASD was queried for baseline and 1-year PROM data, including the ODI, the Scoliosis Research Society-22r (SRS-22r), and the Patient Reported Outcomes Measurement Information System-Pain Interference (PI) and Physical Function (PF) CATs. Internal reliability was assessed with Cronbach alpha, where values ≥0.7 are considered reliable. Validity was assessed with Spearman correlation coefficients calculated for the ODI against validated Patient-Reported Outcomes Measurement Information System (PROMIS)-PI and PF, and legacy measures SRS-Pain and SRS-Activity. Responsiveness to change was measured with the adjusted effect size. A total of 325 patients were enrolled, with 208 completing baseline and 1-year patient-reported outcome measures. The majority (149, 72%) were females and White (193, 93%), median Charlson Comorbidity Index 0 (interquartile range: 0-2). The majority of cases included sagittal plane deformity [mean T1PA: 24.2° (13.9)]. Cronbach alpha showed excellent internal reliability (baseline = 0.89, 1 yr = 0.90). ODI was valid, with strong correlations between PROMIS-PI, PROMIS-PF, SRS-Pain, and SRS-Activity at baseline and 1-year follow-up. All measures were responsive to change, with the ODI showing greater responsiveness than PROMIS-PI, PROMIS-PF, and SRS-Activity. The ODI is a valid measure of disability as measured by pain and function in patients with ASD. It is responsive to change in a manner not different from validated PROMIS-CAT or the SRS-22r legacy measure. It is multidimensional, however, as it assesses both pain and function simultaneously. It does not measure disability related to self-image and may not account for all disease-related disability in patients with ASD.

New CMS Policy on the Mandatory Collection of Patient-Reported Outcome Measures for Total Hip and Knee Arthroplasty by 2027

Abstract The Centers for Medicare & Medicaid Services (CMS) has finalized a landmark national policy to standardize and expand the collection and reporting of patient-reported outcome measures (PROMs) following total hip arthroplasty (THA) and total knee arthroplasty (TKA). This policy will be rolled out through phased implementation, beginning with voluntary reporting starting in 2023 and transitioning to mandatory reporting starting in 2025, which will be tied to hospital payment determinations in fiscal year 2028. The overarching goal of this policy is to gather meaningful pre- and postoperative PROM data directly from patients to enhance clinical care, shared decision-making, and quality measurement for these common elective procedures. This national initiative underscores the value of incorporating patient perspectives and priorities into assessments of surgical care quality. For orthopaedic surgeons and hospitals, participating in the initial voluntary reporting period provides an opportunity to integrate PROM collection into clinical workflows and to leverage these data to improve patient care. The achievement of robust PROM response rates and a strong performance on the underlying THA/TKA Patient-Reported Outcome-Based Performance Measure may have increasing relevance as payment models shift toward value-based care. The aim of the present forum was to provide an in-depth review of this new CMS policy and key details regarding required PROM instruments, data-collection time frames, and other specifications that surgical teams should understand as they prepare for implementation. The goal was to equip orthopaedic surgeons with actionable information as they embark on this new era of national PROM collection and reporting.

How Would We Know Whether Joint Replacements Are Successful if We Do Not Ask Patients?

Joint replacements are among the most effective and most frequently performed surgeries in Canada. Patient-reported outcome measures (PROMs) are measurement instruments completed by patients about aspects of their health status, including pain and function. PROMs data from three provinces show that approximately nine in 10 patients report higher PROM scores after joint replacement surgery. These data can help identify factors that lead to better care and opportunities to further understand what contributes to a patient's perception of surgical success. Expanding the collection of PROMs to more patients and more provinces is needed to help healthcare planners and clinicians understand these important outcomes.

Randomized controlled trial comparing traditional versus enhanced-fixation designs of a novel cemented total knee arthroplasty tibial component.

A novel enhanced cement fixation (EF) tibial implant with deeper cement pockets and a more roughened bonding surface was released to market for an existing total knee arthroplasty (TKA) system.This randomized controlled trial assessed fixation of the both the EF (ATTUNE S+) and standard (Std; ATTUNE S) using radiostereometric analysis. Overall, 50 subjects were randomized (21 EF-TKA and 23 Std-TKA in the final analysis), and had follow-up visits at six weeks, and six, 12, and 24 months to assess migration of the tibial component. Low viscosity bone cement with tobramycin was used in a standardized fashion for all subjects. Patient-reported outcome measure data was captured at preoperative and all postoperative visits. The patient cohort mean age was 66 years (SD seven years), 59% were female, and the mean BMI was 32 kg/m2 (SD 6 kg/m2). Mean two-year subsidence of the EF-TKA was 0.056 mm (95% confidence interval (CI) 0.025 to 0.086) versus 0.006 mm (95% CI -0.029 to 0.040) for the Std-TKA, and the two-year maximum total point motion (MTPM) was 0.285 mm (95% upper confidence limit (UCL) ≤ 0.363) versus 0.346 mm (95% UCL ≤ 0.432), respectively, for a mean difference of -0.061 mm (95% CI -0.196 to 0.074). Inducible displacement also did not differ between groups. The MTPMs between 12 and 24 months for each group was below the published threshold of 0.2 mm for predicting early aseptic loosening (p < 0.001 and p = 0.001, respectively). Both the enhanced fixation and the standard tibial implant design showed fixation with a predicted low risk of long-term aseptic loosening.

H-Wave® Device Stimulation for Chronic Low Back Pain: A Patient-Reported Outcome Measures (PROMs) Study.

Chronic low back pain (cLBP) is a problem globally, creating a tremendous economic burden. Since conventional treatments often fail, various forms of electrical stimulation have been proposed to improve function and decrease pain. Patient-reported outcome measures (PROMs) have not been adequately reported in the electrical stimulation literature. A retrospective independent statistical analysis was conducted on PROMs data for users of H-Wave® device stimulation (HWDS) collected by the device manufacturer over a period of 4years. Final surveys for 34,192 pain management patients were filtered for pain chronicity limited to 3-24months and device use of 22-365days, resulting in 11,503 patients with "all diagnoses"; this number was then reduced to 2711 patients with nonspecific cLBP, sprain, or strain. Reported pain was reduced by 3.12 points (0-10 pain scale), with significant (≥ 20%) relief in 85.28%. Function/activities of daily living (ADL) improved in 96.36%, while improved work performance was reported in 81.61%. Medication use decreased or stopped in 64.41% and sleep improved in 59.76%. Over 96% reported having expectations met or exceeded, service satisfaction, and confidence in device use, while no adverse events were reported. Subgroup analyses found positive associations with longer duration of device use, home exercise participation, and working, whereas older age and longer pain chronicity resulted in reduced benefit. Similar analysis of the larger all-diagnoses cohort demonstrated near-equivalent positive outcomes. Treatment outcomes directly reported by cLBP HWDS patients demonstrated profound positive effects on function and ADL, robust improvement in pain perception, and additional benefits like decreased medication use, better sleep, and improved work performance, representing compelling new evidence of treatment efficacy.

Patient-Reported Outcome Measures in High-Risk Medical Device Registries: A Scoping Review.

Abstract Little is known about the methods and outcomes of patient-reported outcome measure (PROM) use among high-risk medical device registries. The objective of this scoping review was to assess the utility and predictive ability of PROMs in high-risk medical device registries. We searched Ovid Medline, Embase, APA PsychINFO, Cochrane Library, and Scopus databases for published literature. After searching, 4323 titles and abstracts were screened, and 262 full texts were assessed for their eligibility. Seventy-six papers from across orthopedic (n = 64), cardiac (n = 10), penile (n = 1), and hernia mesh (n = 1) device registries were identified. Studies predominantly used PROMs as an outcome measure when comparing cohorts or surgical approaches (n = 45) or to compare time points (n = 13) including pre- and postintervention. Fifteen papers considered the predictive ability of PROMs. Of these, 8 treated PROMs as an outcome, 5 treated PROMs as a risk factor through regression analysis, and 2 papers treated PROMs as both a risk factor and as an outcome. One paper described PROMs to study implant survival. To advance methods of PROM integration into clinical decision-making for medical devices, an understanding of their use in high-risk device registries is needed. This scoping review found that there is a paucity of studies using PROMs to predict long-term patient and clinical outcomes in high-risk medical device registries. Determination as to why PROMs are rarely used for predictive purposes in long-term data collection is needed if PROM data are to be considered suitable as real-world evidence for high-risk device regulatory purposes, as well as to support clinical decision-making. Level of Evidence: 4

Validation of Claims Data for Absorbing Pads as a Measure for Urinary Incontinence after Radical Prostatectomy, a National Cross-Sectional Analysis.

The use of healthcare insurance claims data for urinary incontinence (UI) pads has the potential to serve as an objective measure for assessing post-radical prostatectomy UI rates, but its validity for this purpose has not been established. The aim of this study is to correlate claims data with Patient Reported Outcome Measures (PROMs) for UI pad use. Patients who underwent RP in the Netherlands between September 2019 and February 2020 were included. Incontinence was defined as the daily use of ≥1 pad(s). Claims data for UI pads at 12-15 months after RP were extracted from a nationwide healthcare insurance database in the Netherlands. Participating hospitals provided PROMS data. In total, 1624 patients underwent RP. Corresponding data of 845 patients was provided by nine participating hospitals, of which 416 patients were matched with complete PROMs data. Claims data and PROMs showed 31% and 45% post-RP UI (≥1 pads). UI according to claims data compared with PROMs had a sensitivity of 62%, specificity of 96%, PPV of 92%, NPV of 75% and accuracy of 81%. The agreement between both methods was moderate (κ = 0.60). Claims data for pads moderately align with PROMs in assessing post-prostatectomy urinary incontinence and could be considered as a conservative quality indicator.

Annular Closure Device Reduces Symptomatic Reherniation Rates: Results of a Meta-analysis

Background: The scope of existing annular closure device (ACD) studies examining long-term follow-up data is limited. There is a paucity of studies that report and analyze recent outcomes data following ACD use. Purpose: We sought to summarize the available long-term follow-up data on postoperative outcomes of the Barricaid (Intrinsic Therapeutics) ACD. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, the PubMed, Cochrane, and OVID databases were searched to identify studies after 2015 that include direct evaluation of an ACD in a clinical context with a minimum of 2 years of follow-up and inclusion of reherniation and complication rates, while excluding case reports, reviews, and meta-analyses. Outcome measures included patient demographics, study characteristics, surgical technique, defect measurement technique, perioperative statistics, radiographic assessments, complications, patient-reported outcome measures (PROMs), and postoperative outcomes. Results: Five studies—2 randomized controlled trials (RCTs), 2 retrospective studies, and 1 prospective cohort study—were included. Symptomatic reherniation rates in the ACD populations ranged from 3% to 18.8%. Two studies found that control groups herniate significantly more than their ACD counterparts (ACD 18.8% vs non-ACD 31.6% and ACD 3.33% vs non-ACD 20.0%). No significant differences were found in reoperation rates. Of the 4 studies that reported PROMs data, all observed relative improvement in each cohort, although pooled analysis did not find significant differences between ACD and non-ACD groups for Oswestry Disability Index and visual analogue scale–leg pain at 2-year follow-up. Conclusions: For patients undergoing diskectomy for lumbar disk herniation, the Barricaid device is effective in reducing symptomatic reherniation but does not appear to alter postoperative PROMs or reoperation rates. Surgeons must consider that device-related complications can occur.

What is the optimal assessment of speech? A multicentre, international evaluation of speech assessment in 2500 patients with a cleft

ObjectivesSpeech problems in patients with a cleft palate are often complex and multifactorial. Finding the optimal way of monitoring these problems is challenging. The International Consortium of Health Outcomes Measurement...

Challenging the Status Quo: Debunking the Necessity of 5-Year to 10-Year Patient-Reported Outcome Measures in Total Hip and Knee Arthroplasties

BackgroundIn the current shift toward value-based healthcare, patient-reported outcome measures (PROMs) have become essential to assess the effectiveness of medical interventions. However, elucidation of the optimal timeframe for PROMs evaluation remains crucial. This study aimed to (1) determine the proportion of patients who experienced clinically meaningful improvements in PROMs scores at each follow-up visit after total hip arthroplasty (THA) and total knee arthroplasty (TKA) and (2) calculate and apply the clinical relevance ratio (CRR) for these long-term PROM collections postoperatively. MethodsA total of 12 independent studies reporting THA (n = 8 studies) and TKA (n = 4 studies) postoperative PROM data with up to 10 years of follow-up in Europe or the United States were aggregated. A distribution-based minimal clinically important difference threshold and CRR were used to determine which patients had clinically meaningful improvements in PROMs at 1, 5, and 10 years. ResultsThe proportion of patients who had clinically meaningful improvements in PROM scores stabilized after 1 year following both THA and TKA. Overall, the CRR decreased over time for all PROMs, with the CRR beginning to decrease at 1-year follow-up, bringing into question the robustness and clinical relevance of long-term PROMs data. ConclusionsThe present study challenges the utility of requiring PROMs with a minimum follow-up of 2 years for THA and TKA. Research efforts should be focused on registries evaluating implant survivorship at longer-term follow-up, while PROMs should be better assessed up to 1-year follow-up. Reconsidering the long-term PROMs assessment would lead to more efficient and cost-effective research in orthopedic outcomes, without compromising data quality.

A Qualitative Study Exploring the Regional Feasibility of Patient-Reported Outcome Measures (PROMs) Data Collection for Orthopedic Trauma Patients.

Behavioral health has been shown to impact both short- and long-term health outcomes in trauma patients. Recommendations for screening for behavioral health concerns in the acute setting exist, but longitudinal data collection is infrequently performed. The Trauma Quality Improvement Program describes the importance of patient-reported outcome measures (PROMs), including behavioral health data. In thisqualitative feasibility study, a multidisciplinary team participated inone-hour virtual focus groups; a semi-structured interview guide was used to ascertain feedback on a proposed PROMs study design. This study utilized a qualitative methodology to reveal thematic results from the staff feedback to determine the feasibility of the proposed study design. Three virtual one-hour focus groups consisting of a combination of seven trauma program managers and orthopedic practice managers were asked questions related to the feasibility of a PROMs study design before thematic saturation was reached.Through the analysis, four themes emerged: barriers, possible improvements, representation and research design. Themes included subthemes as well. Noteworthy results included the impact of an integrated orthopedic practice and the technological options available for use. This study revealed the barriers that would exist in the implementation of PROMs for orthopedic trauma patients, which may be useful when designing data collection procedures for PROMs. The results related to barriers may assist other trauma centers or regional trauma systems in designing an optimal methodology for PROMs data. Furthermore, the American College of Surgeons might consider these results prior to any mandated implementation of PROMs for trauma centers to avoid any possible burden on staff and systems.