Patient-reported Outcome Measures Questionnaires Research Articles

THE DEVELOPMENT AND FEASIBILITY OF A NOVEL ELECTRONIC PATIENT-REPORTED OUTCOME MEASURES (EPROMS) QUESTIONNAIRE IN PATIENTS WITH PENILE CANCER

BackgroundPenile cancer (PeCa) is a rare cancer with surgical options that affect patients’ quality-of-life. Patient-reported outcome measures (PROMs) are uncommonly utilised in this cohort despite their several patient-centred benefits and there are recommendations to further digitalise PROMs. This prospective, population-based study aimed to report the development and feasibility of a novel electronic patient-reported outcome measures (ePROMs) questionnaire for patients with PeCa. Materials and methodsA novel ePROMs questionnaire was developed and sent to patients three days before outpatient clinic appointments. The questionnaire included up to 30 items on patient symptomology and quality-of-life, including a self-reported quality-of-life score (rated 0 being worst and 100 being best). Data were collected for patients followed up between August 2021 and May 2022. The primary feasibility outcomes, adherence and engagement, were measured by response and drop-out rates. Differences in responders and non-responders were also ascertained. Secondary outcomes explored the clinical utility of the questionnaire. Responders were subcategorised into three groups: circumcision (Ci), partial penectomy (PP) or total penectomy (TP) and differences were analysed. This study was approved by the local Trust Governance Panel, including for ethical considerations. Results220 adult males were sent ePROMs questionnaires, and 141 (64%) responded initially. The mean dropout rate of subsequent questionnaires was 56%. The maximum number of questionnaires sent to and completed by a patient was eight (n=1). Non-responders were older (p<0.0001), with poorer performance status (p<0.0001) and lower body mass index (p=0.0288). TP patients reported the lowest median quality-of-life score 68.50 (8 – 99), followed by the Ci group (72.0, 37 – 94) and the PP group (76.0, 10 – 99). ConclusionsPatients initially engaged and adhered to the ePROMs questionnaire but struggled to maintain this over time. Clinical data gathered by the questionnaire may be utilised to inform patient care. The questionnaire requires additional validation, research, and education. MicroabstractThis study reports the development and feasibility of a novel electronic patient-reported outcome measures questionnaire for patients with penile cancer. 220 adult males were sent questionnaires, and 141 (64%) responded initially. The mean dropout rate of subsequent questionnaires was 56%, displaying that over time patients struggled to maintain adherence and engagement. The questionnaire requires additional validation, research, and education.

Thresholds For Diminishing Returns In Postoperative Range Of Motion After Total Shoulder Arthroplasty

BackgroundSatisfaction following shoulder arthroplasty (TSA), which is commonly reported using patient-reported outcome measures (PROMs), is partially dependent upon restoring shoulder range of motion (ROM). We hypothesized there exists a minimum amount of ROM necessary to perform functional tasks queried in PROM questionnaires, beyond which further ROM may provide no further improvement in PROMs. MethodsA retrospective review of a multicenter international shoulder arthroplasty database was performed between 2004-2020 for patients undergoing anatomic or reverse TSA (aTSA, rTSA) with minimum 2-year follow-up. Our primary outcome was to determine the threshold in postoperative active ROM (abduction, forward elevation [FE], external rotation [ER], and internal rotation [IR] score) whereby additional improvement was not associated with additional improvement in PROMs (Simple Shoulder Test [SST], American Shoulder and Elbow Surgeons [ASES] score, and the Shoulder Pain and Disability Index [SPADI]). For comparison, we also evaluated the Shoulder Arthroplasty Smart (SAS) score, which is not subject to the ceiling effect. ResultsWe included 4,459 TSAs (1,802 aTSAs, 2,657 rTSAs) with minimum 2-year follow-up (mean, 56±32 months). The threshold in postoperative ROM that were associated with no further improvement were: active abduction, 107-113° for PROMs versus 163° for the SAS score; active FE, 149-162° for PROMs versus 176° for the SAS score; active ER, 50-52° for PROMs versus 72° for the SAS score; IR score, 4-5 points for all PROMs versus 6 points for the SAS score. Out of 3,508 TSAs with complete postoperative ROM data, 8.5% achieved or exceeded all ROM thresholds (14.5% aTSAs, 4.8% rTSAs). ConclusionsOur findings demonstrate that postoperative ROM exceeding 113° of abduction, 162° of FE, 52° of ER, and IR to L1 is associated with minimal additional improvement in PROMs. While individual patient needs vary, the thresholds may provide helpful targets for patients undergoing postoperative rehabilitation.

Thresholds For Diminishing Returns In Postoperative Range Of Motion After Total Shoulder Arthroplasty

BackgroundSatisfaction following shoulder arthroplasty (TSA), which is commonly reported using patient-reported outcome measures (PROMs), is partially dependent upon restoring shoulder range of motion (ROM). We hypothesized there exists a minimum amount of ROM necessary to perform functional tasks queried in PROM questionnaires, beyond which further ROM may provide no further improvement in PROMs. MethodsA retrospective review of a multicenter international shoulder arthroplasty database was performed between 2004-2020 for patients undergoing anatomic or reverse TSA (aTSA, rTSA) with minimum 2-year follow-up. Our primary outcome was to determine the threshold in postoperative active ROM (abduction, forward elevation [FE], external rotation [ER], and internal rotation [IR] score) whereby additional improvement was not associated with additional improvement in PROMs (Simple Shoulder Test [SST], American Shoulder and Elbow Surgeons [ASES] score, and the Shoulder Pain and Disability Index [SPADI]). For comparison, we also evaluated the Shoulder Arthroplasty Smart (SAS) score, which is not subject to the ceiling effect. ResultsWe included 4,459 TSAs (1,802 aTSAs, 2,657 rTSAs) with minimum 2-year follow-up (mean, 56±32 months). The threshold in postoperative ROM that were associated with no further improvement were: active abduction, 107-113° for PROMs versus 163° for the SAS score; active FE, 149-162° for PROMs versus 176° for the SAS score; active ER, 50-52° for PROMs versus 72° for the SAS score; IR score, 4-5 points for all PROMs versus 6 points for the SAS score. Out of 3,508 TSAs with complete postoperative ROM data, 8.5% achieved or exceeded all ROM thresholds (14.5% aTSAs, 4.8% rTSAs). ConclusionsOur findings demonstrate that postoperative ROM exceeding 113° of abduction, 162° of FE, 52° of ER, and IR to L1 is associated with minimal additional improvement in PROMs. While individual patient needs vary, the thresholds may provide helpful targets for patients undergoing postoperative rehabilitation.

Return to work and activity after rib-fixation for acute chest trauma: first application of a validated patient-reported outcomes assessment tool.

Rib fractures present a heavy pain and functional burden in trauma. Our primary aim was to determine return to work in patients with acute rib fractures requiring surgical stabilization of rib fractures. Our secondary outcomes were pain and quality of life. We also document the first application of the Work Productivity and Activity Impairment Instrument, a validated injury-specific patient-reported outcome measure, for chest wall injury in the literature. A retrospective review was conducted on patients with rib fractures requiring surgical fixation in a single centre between 2008 and 2020. After applying inclusion and exclusion criteria to ensure relevance, all eligible patients were asked to complete patient-reported outcome measure questionnaires. Of 1841 trauma patients with rib fractures, 66 underwent surgical fixation. Thirty-nine patients were eligible and 31 completed the questionnaires. Pre-injury and post-injury answers were compared. The number of patients in employment decreased postoperatively from 22 to 16 (P = 0.006). For those who returned to work, there was no difference in hours missed but reduced weekly hours and productivity scores. There were significantly more patients with pain and on pain relief. There was a lower quality of life score postoperatively. Approximately 1 in 5 patients who require surgical fixation for rib fractures will not return to work. This is the first chest wall trauma study that uses the Work Productivity and Activity Impairment Instrument, a validated tool for work productivity outcomes. We recommend this instrument as a reliable tool for investigating return-to-work outcomes in trauma patients.

Patients with more complex ankle fractures are associated with poorer patient-reported outcome: an observational study of 11,733 patients from the Swedish Fracture Register.

Patient-reported outcome measures (PROMs) following ankle fractures, including all fracture types, have not been reported. It is therefore unclear whether fracture morphology correlates with outcome. We aimed to analyze PROMs in patients with an ankle fracture in relation to the Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association (AO/OTA) fracture classification using population-based register data from the Swedish Fracture Register (SFR). All patients aged ≥ 18 years with an ankle fracture (AO/OTA 44A1-C3) registered in the SFR between 2012 and 2019 were retrieved from the register. Patients with completed PROM questionnaires (Short Musculoskeletal Function Assessment and EuroQol-Visual Analogue Scale) on both day 0 (pre-trauma) and 1-year post-trauma were included. The difference in PROMs between day 0 and 1 year was calculated for each patient (delta value) and mean delta values were calculated at group level, based on the AO/OTA fracture classification. 11,733 patients with 11,751 fractures with complete PROMs were included. According to the AO/OTA classification, 21% were A fractures, 67% were B fractures and 12% were C fractures. All groups of patients, regardless of fracture class (A1-C3), displayed an impairment in PROMs after 1 year compared with day 0. Type C fractures displayed a larger impairment in PROMs at group level than type B, which in turn had a greater impairment than type A. The same pattern was seen in groups 3, 2, and 1 for A and B fractures. We found that the AO/OTA classification is prognostic, where more complex fractures were associated with poorer PROMs.

Deep Phenotyping the Anterior Urethral Stricture: Characterizing the Relationship Between Inflammation, Fibrosis, Patient History, and Disease Pathophysiology.

Anterior urethral stricture disease (aUSD) is a complex, heterogeneous condition that is idiopathic in origin for most men. This gap in knowledge rarely affects the current management strategy for aUSD, as urethroplasty does not generally consider etiology. However, as we transition towards personalized, minimally invasive treatments for aUSD and begin to consider aUSD prevention strategies, disease pathophysiology will become increasingly important. The purpose of this study was to perform a deep phenotype of men undergoing anterior urethroplasty for aUSD. We hypothesized that unique biologic signatures and potential targets for intervention would emerge based on stricture presence/absence, stricture etiology, and the presence/absence of stricture inflammation. Men with aUSD undergoing urethroplasty were recruited from one of 5 participating centers. Enrollees provided urethral stricture tissue and blood/serum on the day of surgery and completed patient-reported outcome measure questionnaires both pre- and postoperatively. The initial study had 3 aims: (1) to determine pediatric and adult subacute and repeated perineal trauma (SRPT) exposures using a study-specific SRPT questionnaire, (2) to determine the degree of inflammation and fibrosis in aUSD and peri-aUSD (normal urethra) tissue, and (3) to determine levels of systemic inflammatory and fibrotic cytokines. Two controls groups provided serum (normal vasectomy patients) and urethral tissue (autopsy patients). Cohorts were based on the presence/absence of stricture, by presumed stricture etiology (idiopathic, traumatic/iatrogenic, lichen sclerosus [LS]), and by the presence/absence of stricture inflammation. Of 138 enrolled men (120 tissue/serum; 18 stricture tissue only), 78 had idiopathic strictures, 33 had trauma-related strictures, and 27 had LS-related strictures. BMI, stricture length, and stricture location significantly differed between cohorts (P < .001 for each). The highest BMIs and the longest strictures were observed in the LS cohort. SRPT exposures did not significantly differ between etiology cohorts, with > 60% of each reporting low/mild risk. Stricture inflammation significantly differed between cohorts, with mild to severe inflammation present in 27% of trauma-related strictures, 54% of idiopathic strictures, and 48% of LS strictures (P = .036). Stricture fibrosis did not significantly differ between cohorts (P = .7). Three serum cytokines were significantly higher in patients with strictures compared to stricture-free controls: interleukin-9 (IL-9; P = .001), platelet-derived growth factor-BB (P = .004), and CCL5 (P = .01). No differences were observed in the levels of these cytokines based on stricture etiology. However, IL-9 levels were significantly higher in patients with inflamed strictures than in patients with strictures lacking inflammation (P = .019). Degree of stricture inflammation positively correlated with serum levels of IL-9 (Spearman's rho 0.224, P = .014). The most common aUSD etiology is idiopathic. Though convention has implicated SRPT as causative for idiopathic strictures, here we found that patients with idiopathic strictures had low SRPT rates that were similar to rates in patients with a known stricture etiology. Stricture and stricture-adjacent inflammation in idiopathic stricture were similar to LS strictures, suggesting shared pathophysiologic mechanisms. IL-9, platelet-derived growth factor-BB, and CCL5, which were elevated in patients with strictures, have been implicated in fibrotic conditions elsewhere in the body. Further work will be required to determine if this shared biologic signature represents a potential mechanism for an aUSD predisposition.

Definition of the Post-COVID syndrome using a symptom-based Post-COVID score in a prospective, multi-center, cross-sectoral cohort of the German National Pandemic Cohort Network (NAPKON).

The objective examination of the Post-COVID syndrome (PCS) remains difficult due to heterogeneous definitions and clinical phenotypes. The aim of the study was to verify the functionality and correlates of a recently developed PCS score. The PCS score was applied to the prospective, multi-center cross-sectoral cohort (in- and outpatients with SARS-CoV-2 infection) of the "National Pandemic Cohort Network (NAPKON, Germany)". Symptom assessment and patient-reported outcome measure questionnaires were analyzed at 3 and 12months (3/12MFU) after diagnosis. Scores indicative of PCS severity were compared and correlated to demographic and clinical characteristics as well as quality of life (QoL, EQ-5D-5L). Six hundred three patients (mean 54.0years, 60.6% male, 82.0% hospitalized) were included. Among those, 35.7% (215) had no and 64.3% (388) had mild, moderate, or severe PCS. PCS severity groups differed considering sex and pre-existing respiratory diseases. 3MFU PCS worsened with clinical severity of acute infection (p = .011), and number of comorbidities (p = .004). PCS severity was associated with poor QoL at the 3MFU and 12MFU (p < .001). The PCS score correlated with patients' QoL and demonstrated to be instructive for clinical characterization and stratification across health care settings. Further studies should critically address the high prevalence, clinical relevance, and the role of comorbidities. The cohort is registered at www. gov under NCT04768998.

The state of art on the use of patient reported outcomes in migraine.

This review aims to explore the use of patient-reported outcome measures (PROMs) in migraine. Traditionally assessed through specific features, recent adoption of PROMs allows for a more objective and quantifiable evaluation. PROMs, which are standardized questionnaires collecting health information directly from a patients' perspective, cover various aspects, including migraine specific aspects. The review focuses on delineating the applications and interpretation of commonly used PROMs in migraine research, with an emphasis on their integration in clinical care. Generic and migraine-specific PROMs play a crucial role in clinical research, particularly in assessing health-related quality of life, disability, impact, and associated comorbidities. Some of these measures are strongly recommended to be used by the International Guidelines and are, in fact, mandated by the FDA for product labeling. Recently, there has been an expansion in the use of PROMs to assess migraine in diverse populations, in particular pediatric patients. However, the application of these measures in clinical care shows considerable heterogeneity, and some have not been validated specifically for migraine. The existing multitude of PROMs, coupled with ongoing development of new ones to better capture patient concerns, creates complexity in their research and clinical application. To address these challenges, it becomes imperative to streamline their use, focusing on those that are more validated and better aligned with the patients' perspective including different populations' needs. The utilization of PROMs in evaluating migraine enables a more holistic assessment, helps quantify the impact of the disease facilitating change measurement, improves communication between healthcare providers and patients and, guides treatment decisions for improved outcomes. However, the increasing number of PROMs questionnaires, underscores the importance of validating these tools for migraine and, the dynamic nature of the disease makes it relevant to decide with whom, why and when these should be used.

Introducing a value-based healthcare approach for women with premature ovarian insufficiency (POI): Recommendations for patient-centered outcomes in clinical practice

ObjectiveTo establish a set of clinician and patient-reported outcome measures (PROMs) and present the initial findings of a value-based healthcare (VBHC) program in patients with premature ovarian insufficiency (POI). MethodsEmploying a four-phase approach, we identified the most crucial domains for patients with POI and translated these into PROMs. Prior to each visit, patients completed questionnaires to evaluate: depression (BDI-II), menopausal symptoms (GCS), work ability (WAS) and infertility (FertiQoL). During the visits, cardiovascular health assessments and dual-energy X-ray absorptiometry (DEXA) scans to measure bone mineral density were performed. Data at intake is presented, and comparisons are drawn between women using and those not using hormone replacement therapy (HRT). Patient-reported experience measures (PREMs) were evaluated by a questionnaire. ResultsA total of 267 POI patients completed the PROM questionnaires, of whom 58.1 % were using HRT at intake. Over half of the patients (53.5 %), had a BDI-II score of 14 or higher, indicating mild to severe depression. The mean total GCS score was 20.9 (SD 11.3). The median work ability score was 7.5 (IQR 6.0–8.0) and the mean FertiQoL score 63.9 (SD 15.7). Additionally, 22.7 % of patients presented with hypertension, 6.2 % with hypercholesterolemia, and almost 50 % had low bone mass. Patients rated the VBHC program with a mean of 8.6 (SD 1.2). ConclusionsThese findings underscore the necessity of a multidisciplinary VBHC program incorporating standardized screening and psychological treatment. We advocate for the implementation of patient-centered outcomes for clinical practice, which have been found to be highly relevant by patients with POI.

Brazilian portuguese validation of the patient-reported outcome measure for urethral stricture surgery (USS-PROM) questionnaire.

Urethral stricture is a common, albeit complex, condition that predominantly affects men. The aim of this study was to translate, culturally adapt, and validate the Patient-Reported Outcome Measure questionnaire for patients undergoing urethroplasty (USS-PROM) into Brazilian Portuguese using validated psychometric criteria. The process involved translating and culturally adapting the original USS-PROM into Brazilian Portuguese (USS-PROMbr), synthesizing, back-translating, cross-culturally adapting, and analyzing the pre-final version with experts from our committee. This pre-version was administered to 10 patients who had undergone urethroplasty by the Reconstructive Urology team at the Hospital de Clínicas de Porto Alegre for face validation, linguistic, and semantic adjustments, resulting in the final USS-PROMbr version. Subsequently, well-established psychometric criteria, including content validity, internal consistency, and test-retest reproducibility, were assessed after administering the questionnaire to a total of 56 patients, with 50 of them responding to the test and retest. Evaluation of the pre-final version identified 15 questions as clear, and only one question was considered somewhat unclear necessitating modifications based on patient suggestions and subsequent reassessment by the research team. Psychometric criteria demonstrated good content validity, with a content validity index exceeding 0.80 for all questions; good internal consistency, Cronbach's alpha of 0.77, ranging from 0.70 to 0.78 with the exclusion of any item, and item-total correlations ranging from 0.33 to 0.67. The test-retest intraclass correlation coefficient was 0.74 for the lower urinary tract symptoms construct (Q1-Q6). The USS-PROMbr demonstrated acceptable cross-cultural adaptation and psychometric properties, making it a valid and useful tool for evaluating patients undergoing urethroplasty.

Development and evaluation of a patient-reported outcome measure specific for Gaucher disease with or without neurological symptoms in Japan

BackgroundPatients with Gaucher disease (GD), a rare lysosomal storage disorder, have reduced health-related quality of life (HRQOL). A patient-reported outcome measure (PROM) for HRQOL developed for type 1 GD (GD1) is not appropriate for patients with neuronopathic GD (nGD) types 2 (GD2) and 3 (GD3). In this study, we developed a new PROM for use in all GD types. We previously reported the qualitative analysis of interviews with Japanese patients with nGD, which was used to create nGD-specific PROM items. Here we evaluated the full PROM combining the type 1 questionnaire with the new nGD-specific items.MethodsPatients with confirmed GD were recruited (Association of Gaucher Disease Patients in Japan or leading doctors) for pre-testing (May 2021) or the main survey (October–December 2021). The PROM had three parts: Parts 1 and 2 were translated into Japanese from the pre-existing GD1 PROM, whereas Part 3 was newly developed. Patients (or their caregivers, where necessary) completed the PROM questionnaire on paper and returned it by mail. Mean scores were determined overall and by GD type. Inter-item correlations, content consistency (Cronbach’s alpha), and test–retest reliability (Cohen’s kappa; main survey only, taken 2 weeks apart) were calculated.ResultsSixteen patients (three with GD1; six with GD2; seven with GD3) and 33 patients (nine with GD1; 13 with GD2; 11 with GD3) participated in the pre-test and main survey, respectively. All GD2 patients and one-third (6/18) of GD3 patients required caregivers to complete the questionnaire. Mean scores indicated that the burden was highest in GD2 and lowest in GD1. In the main survey, internal consistency was high (Cronbach’s alpha = 0.898 overall, 0.916 for Part 3), and test–retest reliability was high for Part 3 (kappa > 0.60 for 13/16 items) but low for Part 1 (kappa < 0.60 for 12/15 items).ConclusionsWe have developed a flexible and reliable PROM that can be tailored for use in all types of GD and propose using Parts 1 and 2 for GD1, Parts 2 and 3 for GD2, and Parts 1, 2, and 3 for GD3.

Preoperative Predictors of Arthroscopic Partial Meniscectomy Outcomes: The APM Index Score

Background: Preoperative risk factors contributing to poor outcomes after arthroscopic partial meniscectomy (APM) have not yet been consolidated and codified into an index scoring system used to predict APM success. Purpose: To create an index score using available preoperative factors to predict the likelihood of favorable postoperative outcomes after APM. Study Design: Case-control study; Level of evidence, 3. Methods: A consecutive cohort of patients undergoing primary APM were enrolled in this study. Patients completed pre- and postoperative patient-reported outcome measure (PROM) questionnaires that included the Knee injury and Osteoarthritis Outcome Score (KOOS), visual analog scale (VAS) for pain, Veterans RAND 12-Item Health Survey (VR-12 Physical and Mental), and Marx Activity Rating Scale (MARS). Multivariable logistic regression models were performed to evaluate independent predictors of KOOS Pain, Symptoms, and Activities of Daily Living scores and achievement of the minimal clinically important difference (MCID) and substantial clinical benefit (SCB). The authors assigned points to each variable proportional to its odds ratio, rounded to the nearest integer, to generate the index score. Results: In total, 468 patients (mean age, 49 years [SD, 10.4 years; range, 19-81 years]) were included in this study. In the univariate analysis, shorter symptom duration, lower Kellgren-Lawrence (KL) grade, lower preoperative KOOS Pain value, and lower VR-12 Physical score were associated with a higher likelihood of clinical improvement at 1 year. In the multivariable model for clinical improvement with MCID, symptom duration (<3 months: OR, 3.00 [95% CI, 1.45-6.19]; 3-6 months: OR, 2.03 [95% CI, 1.10-3.72], compared with >6 months), KL grade (grade 0: OR, 3.54 [95% CI, 1.66-7.54]; grade 1: OR, 3.04 [95% CI, 1.48-6.26]; grade 2: OR, 2.31 [95% CI, 1.02-5.27], compared with grade 3), and preoperative KOOS Pain value (score <45: OR, 3.00 [95% CI, 1.57-5.76]; score of 45-60: OR, 2.80 [95% CI, 1.47-5.35], compared with score >60) were independent significant predictors for clinical improvement. The scoring algorithm demonstrated that a higher total score predicted a higher likelihood of achieving the MCID: 0 = 40%, 1 = 68%, 2 = 80%, 3 = 89%, and 4 = 96%. Conclusion: Using this model, the authors developed an index score that, using preoperative factors, can help identify which patients will achieve clinical improvement after APM. Longer symptom duration and higher KL grade were associated with a decreased likelihood of clinical improvement as measured by KOOS Pain at 1 year postoperatively.

The role of muscle degeneration and spinal balance in the pathophysiology of lumbar spinal stenosis: Study protocol of a translational approach combining in vivo biomechanical experiments with clinical and radiological parameters.

To describe a study protocol for investigating the functional association between posture, spinal balance, ambulatory biomechanics, paraspinal muscle fatigue, paraspinal muscle quality and symptoms in patients with symptomatic lumbar spinal stenosis (sLSS) before and 1-year after elective surgical intervention. Single-centre prospective, experimental, multimodal (clinical, biomechanical, radiological) study with three instances of data collection: baseline (study visit 1), 6-month follow-up (remote) and 1-year follow-up (study visit 2). Both study visits include an in vivo experiment aiming to elicit paraspinal muscle fatigue for postural assessment in a non-fatigued and fatigued state. At baseline and 1-year follow-up, 122 patients with sLSS will be assessed clinically, perform the back-performance scale assessment and complete several patient-reported outcome measure (PROMs) questionnaires regarding overall health, disease-related symptoms and kinesiophobia. Posture and biomechanical parameters (joint kinematics, kinetics, surface electromyography, back curvature) will be recorded using an optoelectronic system and retroreflective markers during different tasks including overground walking and movement assessments before and after a modified Biering-Sørensen test, used to elicit paraspinal muscle fatigue. Measurements of muscle size and quality and the severity of spinal stenosis will be obtained using magnetic resonance imaging (MRI) and sagittal postural alignment data from EOS radiographies. After each study visit, physical activity level will be assessed during 9 days using a wrist-worn activity monitor. In addition, physical activity level and PROMs will be assessed remotely at 6-month follow-up. The multimodal set of data obtained using the study protocol described in this paper will help to expand our current knowledge on the pathophysiology, biomechanics, and treatment outcome of degenerative sLSS. The results of this study may contribute to defining and/or altering patient treatment norms, surgery indication criteria and post-surgery rehabilitation schedules. The protocol was approved by the regional ethics committee and has been registered at clinicaltrials.gov (NCT05523388).

Do Patients who Undergo Fixation for Pilon Fracture Develop Symptoms Comparable to Primary Ankle OA?

Category: Ankle Arthritis Introduction/Purpose: Pilon fractures are challenging to manage and have poor functional outcomes and high complication rates. A significant proportion of these patients go on to develop post-traumatic ankle arthritis. Our aim was to assess the long term patient reported outcomes following pilon fracture fixation and how this compares to patients with end stage ankle osteoarthritis requiring surgical intervention in the form of total ankle arthroplasty. Methods: We retrospectively identified all patients who underwent pilon fracture fixation between April 2012 and December 2015 (Group A). Group B consisted of patients with primary ankle osteoarthritis awaiting elective total ankle replacement between 2015 and 2017. Patients completed a Patient Reported Outcome Measures questionnaire (MOX-FQ, EQ-5D and FAOS scores) pre and post-operatively. The average follow up was 8 years. Results: There were 18 patients in Group A and 22 in Group B. Ankle arthritis patients reported significantly worse score for MOXFQ Pain (P vs. AA; 39.0 ±29.5 vs. 68.0 ±27.1; p=0.001), Difficulty with Walking/ Standing (38.3±26.0 vs. 56.4±26.5; p=0.037) and difficulty with social activities (24.0 ±25.6 vs. 49.4 ±31.3; p=0.007) and FAOS domains of symptoms (68.7 vs. 52.1; p=0.005), ability to do Activities of Daily Living (18.9 vs. 27.5; p= 0.003) and Quality of life (56.6 vs. 32.5; p=0.012). There was no difference between groups for EQ-5D general health scores (78.8 vs. 68.8; p=0.156). Ankle arthritis group patients reported worse scores for mobility, ability to self-care and performed activities of daily living (p=0.012) compared to the pilon fracture group. Conclusion: Our 8 year follow up demonstrate good long term outcomes for patients following pilon fracture fixation. Patients did not develop symptomatic arthritis comparable to end stage ankle arthritis requiring surgical intervention and we therefore recommend primary treatment with fixation, irrespective of fracture severity.

Patient-reported outcomes for bone regenerative procedures.

Evidence-based dentistry used for decision-making and assessment of treatment includes three components: evidence from the literature, clinical expertise, and patient expectations. Patient satisfaction embraces affability, availability, and ability and can be examined using questionnaires or structured questions to the patient to evaluate patient perception of the treatment. The questions can be quantified using dichotomous, point, or visual analog scales. This would be a straightforward patient-reported outcome measure (PROM). Validated and specific oral health-related quality of life (OHRQoL) questionnaires such as the oral health impact profile (OHIP), oral impact on daily performance (OIDP), or the dental impact on daily living (DIDL) can be used as PROMs, and these measures are appropriate for population studies, where you can measure changes over time and differences between treatment groups. PROMs have shown to enhance patient engagement when integrated into clinical care. PROMs for bone regenerative procedures are mainly used as secondary outcome and are concentrating on the prosthetic outcome more than the pain, discomfort, anxiety, and cost of the surgical procedures. Surprisingly, most patients are satisfied and willing to have the procedures performed again. Whether this is recall bias or not and how the information's from the dentist and the team influence the patients answers to PROMs questionnaires are discussed. The importance of patient perspectives in bone regeneration procedures is obvious and combined with clinical outcome measures, it increases our ability to provide better care. Studies using PROMs as a primary outcome variable are required.

Patient Satisfaction and Scar Quality Following Upper Blepharoplasty Using a Simplified Preoperative Marking Technique.

One of the most popular plastic surgical interventions both abroad and in Kazakhstan is blepharoplasty. Plastic surgeons continue to debate various methods for performing this operation; however, some of the methods used by plastic surgeons for preoperative marking of the upper eyelid skin may not be suited to the type of incision that should be used on the eyelids of individuals from Kazakhstan. For this reason, the surgery may not achieve the desired results. We conducted a study of patients from Kazakhstan who underwent upper blepharoplasty using a simplified technique for eyelid marking that we developed at our plastic surgery center. We used the Patient-Reported Outcome Measure Questionnaire (PROM-Q) to measure patient satisfaction and the Patient and Observer Scar Assessment Scale (POSAS) to measure scar quality. The results of our study showed that the majority of patients who underwent upper blepharoplasty performed by surgeons using our method of preoperative marking were extremely satisfied with the effect. The patients noted rapid tissue repair and minimal scarring. We concluded that the use of a simplified marking technique can significantly help aesthetic surgeons performing upper blepharoplasty by reducing the risk for negative postoperative effects.

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.

‘It’s just a finger isn’t it…’: patients’ perspectives of recovery following finger fractures and participation in surgical trials – a qualitative interview study

ObjectivesTo (1) generate detailed, person-centred data about the experience of finger injury and treatment and (2) understand the patients’ perspectives of research involvement with a view to informing better designed...

Women’s experiences with using patient-reported outcome and experience measures in routine perinatal care in the Netherlands: a mixed-methods study

ObjectivesTo gain insight into the experiences of women with completing and discussing patient-reported outcome measures (PROM) and patient-reported experience measures (PREM), and tailoring their care based on their outcomes.DesignA mixed-methods...

Progress (patient reported outcomes in genital reconstructive surgeries) a validated patient reported outcome measure questionnaire to assess post operative functional improvement following feminising genital reconstructive surgery

Progress (patient reported outcomes in genital reconstructive surgeries) a validated patient reported outcome measure questionnaire to assess post operative functional improvement following feminising genital reconstructive surgery