Changes In Patient-reported Outcome Measures Research Articles

Five-Year Results of the Salto XT Revision Ankle Arthroplasty.

The treatment of failed ankle replacements is debated, and little is published about the medium- and long-term results of revision implants. We wanted to examine prosthesis survival and physical function at least 5 years after insertion of the Salto XT revision prosthesis. All consecutive patients operated with a Salto XT revision prosthesis underwent clinical and radiologic examinations preoperatively and after 3, 12, 24, and 60 months. Complications and reoperations are described, and changes in patient-reported outcome measures and clinical scores are reported. Thirty patients were operated with a Salto XT revision prosthesis between March 2014 and March 2017. Three of these were revised (1 to a fusion and 2 to a new prosthesis), and 3 patients were reoperated with screw removal. A concurrent subtalar fusion was performed on 13 patients, and there was 1 case of likely nonunion after these procedures, but no reoperations. The mean AOFAS score increased from 39.2 (95% CI 30.8-47.5) preoperatively to 75.1 (95% CI 67.3-82.9) after 5 years, and the mean improvement was 34.2 points (95% CI 23.8-44.6). Mean EQ-5D increased from 0.36 (95% CI 0.30-0.42) preoperatively to 0.74 (95% CI 0.64-0.85) after 5 years, an improvement of 0.34 (95% CI 0.19-0.49). Radiolucent lines were present in all but 3 patients. Five-year prosthesis survival was 93% (83.6-100). This is the first study to present medium-term results of this implant. We found good improvement in outcome scores and good implant survival, but also a high prevalence of radiolucent lines.

Impact of Pirfenidone on Patient-Reported Outcomes in Patients With Idiopathic Pulmonary Fibrosis From the Pulmonary Fibrosis Foundation Patient Registry

BACKGROUNDPatients with idiopathic pulmonary fibrosis (IPF) experience debilitating symptoms. While antifibrotics may slow lung function decline, their impact on patients’ health-related quality of life (HRQoL) and disease symptoms in the real world remains unknown. RESEARCH QUESTIONWhat is the impact of pirfenidone vs no treatment on HRQoL and IPF-related symptoms of cough, dyspnea, and fatigue? STUDY DESIGN AND METHODSThis retrospective analysis included patients with IPF aged ≥ 55 years enrolled in the Pulmonary Fibrosis Foundation Patient Registry between March 2016 and December 2021. Change from baseline in patient-reported outcome measures (PROMs) including the Leicester Cough Questionnaire (LCQ), University of California, San Diego Shortness of Breath Questionnaire (UCSD SOBQ), Fatigue Severity Scale, and Short Form-6 Dimension questionnaire were assessed at Months 6, 12, and 18 in patients receiving pirfenidone vs no treatment. A marginal structure model (MSM) accounted for time-varying confounding caused by percent predicted forced vital capacity (%FVC) and percent predicted diffusing capacity of the lung for carbon monoxide. RESULTSIn the LCQ population (n = 237; pirfenidone, n = 155; no treatment, n = 82), treatment groups differed in age, insurance, and %FVC. In the unadjusted analyses, mean changes in PROMs differed numerically between treatment groups; however, based on the MSM, there were no significant differences in adjusted mean changes in PROMs. When analyzed by Gender, Age, and Physiology (GAP) score, a clinically meaningful reduction in worsening of pirfenidone vs no treatment was observed in the adjusted mean change of UCSD SOBQ at Month 12 in patients with GAP stage 2/3. INTERPRETATIONSimilar to previous findings, the difference in UCSD SOBQ scores observed in this real-world analysis suggests that patients with more advanced IPF may experience less dyspnea when receiving pirfenidone vs no treatment; further research is needed to confirm this finding.

Patient-reported Outcomes Following Nonoperative Treatment of Pediatric First‐Time Patellar Dislocation

BackgroundPatellar instability is a common pediatric knee injury. The purpose of this study was to analyze PROMs (patient-reported outcome measures) after non-operative treatment following a first-time pediatric patellar dislocation. MethodsIn this single-center, retrospective study, patients <18 years old between January 2012 and December 2019 with a first-time patellar dislocation were evaluated. From this cohort, we included all those patients who initially underwent non-operative management and followed up for at least 1 year. Measures of patellar height and patellofemoral dysplasia were collected. Patient-reported outcome measures (PROMs) were collected at the initial and follow-up visit. Univariate and multivariate analyses were utilized to determine the rate and risk factors for recurrence and the changes in PROMs. Results176 knees were included in the initial analysis, and 80 in the pre- and post-PROM analysis. There was a 41% rate of recurrence at a mean of 16.4 months of follow-up. In a multivariate logistic regression model, trochlear dysplasia (OR:4.53, 95%CI: 1.61–12.7, P=0.004), patella alta (OR:4.27, 95%CI: 1.76–10.3, P<0.001), and tibial tubercle trochlear groove (TT-TG) > 15mm (OR:2.49, 95%CI: 1.3–6.03, P<0.001) were significant risk factors for recurrence. Patients with or without recurrence showed significant improvements in PROMs at 1 year follow-up. However, both groups had mean scores below the population average. Regardless of recurrence or not, KOOS-Child QoL scores ranked the lowest among all PROM scores at the final follow-up. ConclusionsThe findings of this study provide further evidence of the high rate of recurrent instability and important associated risk factors to consider. We also found that despite the overall improvement in all PROM subscales 1 year following the initial episode, both recurrence and no-recurrence groups demonstrated lower mean PROM scores than normal values. Furthermore, quality of life subscales showed the smallest improvement among all patients. Our results may be used to counsel patients and families regarding expectations after first-time and recurrent patellar dislocations. Key conceptsPatellar instability is one of the most common pediatric sports injuries with a high risk of recurrence.(1)In the absence of other factors, a first-time patellar dislocation is generally treated non-operatively, but the long-term outcomes are not clear.(2)In this study, we found a high risk of recurrent dislocation. In addition, while the PROMs improved for all patients, even patients without evidence of further instability demonstrated patient-reported outcomes lower than the general population.(3)Future research may reveal subtle residual instability or other factors as the reason for the lower functional status and also compare these outcomes with operative reconstruction. Level of evidenceCase series, Level IV

Hybrid SPEAK OUT! protocol improves aerodynamic measurements and PROMs in Parkinson's disease.

SPEAK OUT! has been shown to enhance various aspects of voice such as intensity, prosody, voice quality and perception of voice. However, their impacts on expiration and communication effectiveness have not yet been evaluated. This study aimed to evaluate the effectiveness of the Hybrid SPEAK OUT! method on aerodynamic measurements and patient-reported outcome measures (PROMs) in individuals with Parkinson's disease (PD). This study included 157 participants with PD who underwent an intensive 8-week multidisciplinary treatment program. The Hybrid SPEAK OUT! method consisted of three sessions per week, including two group sessions and one individual treatment session. Voice-related aerodynamic measures included maximum phonation time (MPT), vocal cord function using the S/Z ratio, and expiratory flow measures including peakexpiratoryflow (PEF) and peak cough flow (PCF). Two PROMs were included: the Hebrew version of the voice handicap index-10 and communication effectiveness questionnaire. The results of 111 participants were analysed. MPT duration increased, PEF and PCF increased, and better scores were found in PROMs. These findings would appear to support the effectiveness of the Hybrid SPEAK OUT! methods improving function, activity and participation in individuals with PD. However, further research is needed. What is already known on the subject Prior research has demonstrated the effectiveness of behavioral therapies, including the SPEAK OUT! program, in managing speech symptoms in individuals with Parkinson's disease (PD). These therapies have shown improvements in voice intensity, fundamental frequency, voice quality, and voice perception. However, the impact on aerodynamic measures, expiratory flow, and patient-reported outcome measures has not been extensively studied. What this paper adds to existing knowledge This study adds to the existing knowledge by demonstrating that a Hybrid SPEAK OUT! approach, can lead to improvements in aerodynamic measures, including maximum phonation time (MPT), expiratory and cough peak flow. In terms of motor learning, we found that two non-speech exhalation-related tasks that were not directly trained improved following the intensive speech training protocol. Furthermore, it shows positive changes in patient-reported outcome measures, with reduced voice-related disability and improved communication efficiency. What are the potential or actual clinical implications of this work? The findings of this study have important clinical implications for the management of speech symptoms in individuals with PD. The Hybrid SPEAK OUT! program, which combines group and individual sessions, can effectively improve voice, aerodynamic measurements and patient-reported outcome measures (PROMs), ultimately enhancing the overall quality of life for patients. These findings support the effectiveness of the Hybrid SPEAK OUT! methods for improving function, activity, and participation in individuals with PD.

Patient-reported outcomes after minimally invasive sacro-iliac joint surgery: a cohort study based on the Swedish Spine Registry.

There is conflicting evidence regarding treatment outcomes after minimally invasive sacroiliac joint fusion for long-lasting severe sacroiliac joint pain. The primary aim of our cohort study was to investigate change in patient-reported outcome measures (PROMs) after minimally invasive sacroiliac joint surgery in daily practice in the Swedish Spine Registry. Secondary aims were to explore the proportion of patients reaching a patient acceptable symptom score (PASS) and the minimal clinically important difference (MCID) for pain scores, physical function, and health-related quality of life outcomes; furthermore, to evaluate self-reported satisfaction, walking distance, and changes in proportions of patients on full sick leave/disability leave and report complications and reoperations. Data from the Swedish Spine Registry was collected for patients with first-time sacroiliac joint fusion, aged 21 to 70 years, with PROMs available preoperatively, at 1 or 2 years after last surgery. PROMs included Oswestry Disability Index (ODI), Numeric Rating Scale (NRS) for low back pain (LBP) and leg pain, and EQ-VAS, in addition to demographic variables. We calculated mean change from pre- to postoperative and the proportion of patients achieving MCID and PASS. 68 patients had available pre- and postoperative data, with a mean age of 45 years (range 25-70) and 59 (87%) were female. At follow-up the mean reduction was 2.3 NRS points (95% confidence interval [CI] 1.6-2.9; P < 0.001) for LBP and 14.8 points (CI 10.6-18.9; P < 0.001) for ODI. EQ-VAS improved by 22 points (CI 15.4-30.3, P < 0.001) at follow-up. Approximately half of the patients achieved MCID and PASS for pain (MCID NRS LBP: 38/65 [59%] and PASS NRS LBP: 32/66 [49%]) and physical function (MCID ODI: 27/67 [40%] and PASS ODI: 24/67 [36%]). The odds for increasing the patient's walking distance to over 1 km at follow-up were 3.5 (CI 1.8-7.0; P < 0.0001), and of getting off full sick leave or full disability leave was 0.57 (CI 0.4-0.8; P = 0.001). In the first 3 months after surgery 3 complications were reported, and in the follow-up period 2 reoperations. We found moderate treatment outcomes after minimally invasive sacroiliac joint fusion when applied in daily practice with moderate pain relief and small improvements in physical function.

PERFECTRA: a pragmatic, multicentre, real-life study comparing treat-to-target strategies with baricitinib versus TNF inhibitors in patients with active rheumatoid arthritis after failure on csDMARDs

ObjectiveTo compare the effectiveness of a strategy administering baricitinib versus one using TNF-inhibitors (TNFi) in patients with rheumatoid arthritis (RA) after conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) failure in a...

Change in Lumbar Lordosis after Decompressive Surgery in Lumbar Spinal Stenosis Patients and Associations with Patient Related Outcomes 2 Years after Surgery. Radiological and Clinical Results from the NORDSTEN Spinal Stenosis Trial.

A prospective cohort study. The aim was to investigate changes in lumbar lordosis (LL) and its association to changes in patient reported outcome measures (PROMs) after decompressive surgery for lumbar spinal stenosis (LSS). Few studies have addressed change in LL after decompression surgery for LSS in relation to outcomes. Pre- and postoperative data from 310 patients having standing x-ray both before and 2 years after surgery were included. The patients were grouped based on the change in LL preoperatively to 2 years after surgery; group 1: <5 degrees (n=196), group 2: ≥5 <10 degrees (n=55) or group 3: ≥10 degrees (n=59) of change in LL. The changes in function, disability and pain were assessed by the Oswestry Disability Index (ODI), Numeric Rating Scale (NRS), and the Zurich claudication questionnaire (ZCQ). The three groups were compared regarding baseline variables using the ANOVA test for continuous variables and the chi-square test for categorical variables. The groups were further compared with a likelihood ratio test in relation to changes in PROMs 2 year after surgery and outcomes were adjusted for respective baseline PROMs, age, sex, smoking, BMI, Schizas and Pfirrmann scores. LL was significantly changed at group level 2 years after surgery with a mean difference of 2.2 (SD 9.4) degrees ( P =0.001). The three LL change groups did not show any significant differences in patient characteristics, function, disability, and pain at baseline. The two groups with a change of more than 5 degrees in LL 2 year after surgery (group 2 and 3) had significantly greater improvements in ODI ( P =0.022) and ZCQ function ( P =0.016) in the adjusted analyses, but was not significant for back and leg pain. Changed LL after decompressive surgery for LSS was associated with improved ODI and physical function.

Psoas Muscle Health is Correlated with Time to Achieve MCID in Patients with Predominant Axial Back Pain Following Decompression Surgery: Early Results.

Retrospective cohort study. To determine the impact of psoas muscle health (cross-sectional area, CSA) on achieving minimal clinically important differences (MCID) in patient-reported outcome measures (PROMs) following laminectomy for patients with predominant back pain (PBP) and leg pain (PLP). Psoas muscle health is linked to postoperative outcomes in decompression patients, with MRI-based grading of psoas CSA correlating with these outcomes. However, evidence on its impact on symptomatic recovery, measured by PROMs, is lacking. 106 patients with PBP (VAS back >VAS leg) and 139 patients with PLP (VAS leg >VAS back) who underwent laminectomy from 2017-2021 were included. Axial T2 MRI images were analyzed for psoas CSA using a validated method. Based on the lowest-quartile normalized total psoas area (NTPA) thresholds, patients were divided into "Good" and "Poor" muscle health groups. The correlation analyses were performed between the psoas CSA and changes in PROMs. Kaplan-Meier survival analysis was conducted to determine the probability of achieving MCID as a function of time. Of 106 PBP patients, 83 (78.3%) had good muscle health, 23 (21.6%) had poor muscle health. Of 139 PLP patients, 54 (38.8%) had good muscle health, 85 (61.1%) had poor muscle health. In the PBP group, older age was associated with poor muscle health (69.70±9.26 vs. 59.92±15.01, P=0.0002). For both cohorts, there were no differences in the rate of MCID achievement for any PROMs between the good and poor muscle health groups. In the PBP group, Kaplan-Meier analysis showed patients with good psoas health achieved MCID-VAS back and Oswestry Disability Index (ODI) in median times of 14 and 42 days (P=0.045 and 0.015), respectively. Good psoas muscle health is linked to faster attainment of MCID, especially in patients with PBP compared to PLP after decompression surgery. 3.

Repeat Discectomy or Instrumented Surgery for Recurrent Lumbar Disk Herniation: An Overview of French Spine Surgeons' Practice.

Retrospective multicenter cohort study. Recurrent lumbar disc herniation (ReLDH) is a common condition requiring surgical intervention in a large proportion of cases. Evidence regarding the appropriate choice between repeat microdiscectomy (RD) and instrumented surgery (IS) is lacking. To understand the indications for either of the procedures and compare the results, we aimed to provide an overview of spine surgeon practice in France. This retrospective, multicenter analysis included adults who underwent surgery for ReLDHs between December 2020 and May 2021. Surgeons were asked which of the following factors determined their therapeutic choice: radio-clinical considerations, non-discal anatomical factors, patient preference, or surgeon background. Data on preoperative clinical status and radiologic findings were collected. Patient-reported outcome measures (PROMs) were assessed and compared using propensity scores preoperatively and at 3 and 12 months postoperatively. The study included 150 patients (72 IS and 78 RD). Radioclinical elements, anatomical data, patient preferences, and surgeon background influenced the choice of RD in 57.7%, 1.3%, 25.6%, and 15.4% of the cases, respectively, and IS in 34.7%, 6.9%, 13.9%, and 44.5% of the cases, respectively. At 12 months, patient satisfaction, return to work, and changes in PROMs were not significantly different between the groups. The decision-making process included both objective and subjective factors, resulting in patient satisfaction in 80.3% to 81.5% of cases, with significant clinical improvement in radicular symptoms in 75.8% to 91.8% of cases, and quality of life in 75.8% to 84.9% of cases, depending on the procedure performed.

Responsiveness and sensitivity of PROMs to change in disease activity status in early and established rheumatoid arthritis.

To determine whether patient reported outcome measures (PROMs) capturing activity limitations, health impact, pain, fatigue and work ability are responsive and sensitive to changes in disease activity status in patients with early and established rheumatoid arthritis (RA). All early RA patients (n = 557) from the tREACH-trial and established RA patients (n = 188) from the TARA-trial were included. Both studies were multicentre, single-blinded trials with a treat-to-target management approach. The following PROMs were studied: Health Assessment Questionnaire Disability Index(HAQ-DI), morning stiffness severity, EQ-5D, general health, 36-item short form(SF-36), joint pain, fatigue and productivity loss. Mean changes in PROMs between two consecutive visits were compared with changes in disease activity status(remission, low disease activity and active disease) using linear mixed models and standardised response means. Additionally, the proportion of individual observations that showed an expected PROM response to disease activity status alterations was calculated. HAQ-DI, morning stiffness severity, general health, EQ-5D and joint pain demonstrated responsiveness to improvement or worsening of disease activity status in both early and established RA. SF-36 physical and mental component scale, fatigue and productivity loss did not show this effect in both groups. Across nearly all PROMs, the magnitude of change and the proportion of individual observations that reflect a shift from and to active disease remained low. HAQ-DI, morning stiffness severity, EQ-5D, general health and joint pain are responsive to disease activity status alterations on a group level in both early and established RA. For the individual patient the responsiveness of these PROMs is poor. tREACH trial (www.isrctn.com, ISRCTN26791028) and TARA trial (www.onderzoekmetmensen.nl, NTR2754).

Impact of Depression and Anxiety on Patient Reported Outcomes Measures after Lumbar Fusion

Depression and anxiety are common in patients undergoing spinal surgery and might negatively impact outcomes. This study investigates the possible effect of these diagnoses on patient reported outcomes following lumbar fusion. Retrospective review of a registry containing prospectively collected data of lumbar fusion procedures at a single institution was performed from May 23, 2012 to June 15, 2022. Patients with a minimum of two year follow-up were included. Demographic information, diagnoses, medications, patient-reported outcomes measures (PROMs), and complications data at preoperative, three months, six months, 1 year, and two years postoperative were collected. Statistical analysis was performed using Student's t-tests, χ2, binomial correlation, odds ratios, logistic regression, and mean clinically important difference. A total of 156 patients were included (60 males, 96 females) with mean age 62.6±11.1years at surgery. Thirty-nine (25%) had depression and/or anxiety (DA). Baseline Oswestry Disability Index (ODI) and EuroQol Group 5D questionnaire (EQ5D) scores were significantly worse in the DA cohort compared to controls (ODI 51.1±18.3 vs. 42.9±15.8; P= 0.010, EQ5D 0.46±0.21 vs. 0.57±0.21; P= 0.005). Both cohorts experienced similar relative improvement at two years (delta ODI-18.2±27.9 vs.-17.8±22.1; P= 0.924, EQ5D 6.8±33.8 vs. 8.1±32.9; P= 0.830). Absolute outcome scores were worse in the DA cohort at all intervals. DA were not independently predictive of changes in PROMs (delta ODI mean difference 4.49, r2=0.36, P= 0.924). The present study showed similar improvement in PROMs following lumbar fusion for patients with anxiety and depression compared to healthy controls. These data suggest these patients are no less likely to benefit from appropriately planned lumbar fusion.

The minimal important difference and smallest detectable change of the Oxford elbow score, Quick disabilities of the arm shoulder and hand and single assessment numeric evaluation used for elbow trauma

BackgroundThe Minimal Important Difference (MID) and Smallest Detectable Change (SDC) are methods used to identify the smallest changes in Patient-Reported Outcome Measures (PROMs) that are of relevance to the patients. Data on these parameters is, however, limited for elbow conditions including traumatic injuries. The aim of this study was therefore to estimate the MID and SDC for three commonly used PROMs after elbow trauma; the Oxford Elbow Score (OES), Quick Disabilities of the Arm Shoulder and Hand (QuickDASH) and Single Assessment Numeric Evaluation (SANE). Material and methodsOne hundred patients, 67 females, aged ≥18 years (mean age 52.4 years (SD, 18.2)), who had sustained a fracture, tendon rupture or dislocation affecting the elbow, completed the OES, QuickDASH, and SANE 3-5 months after injury (T1) and again after a minimum of 3 weeks (T2). A transition item with a 7-level scale, enquiring about the situation with the elbow, was also completed at T1 and T2. The difference in scores between T1 and T2 was calculated (change scores). The MID was assessed using the mean change method; a response of “slightly better” or “slightly worse” was defined as being a clinically significant change. The SDC was estimated by calculating the standard error of measurement (SEM) based on 2 administrations (1- to 3-week interval) of PROMs in a separate group of patients who had sustained an elbow injury 1 to 2 years previously. ResultsThe most common diagnosis was fracture of the proximal radius (n = 33). Eighteen patients responded slightly better and 5 slightly worse on the transition item and had mean change scores of 7.9 (9.3) for the OES and -7.4 (11.4) for the QuickDASH. Assessment of SDC was based on 56 patients having sustained an elbow injury between September 2019 and October 2020. The SDC was: 12.1 for the OES, 11.4 for the QuickDASH and 1.94 for the SANE. ConclusionChange scores need to exceed 12.1 points for the OES, 11.4 points for the QuickDASH and 1.94 points for the SANE in order to measure change with clinical relevance and not due to measurement errors.

Mid-term survival of the Optimys short stem: A prospective case series of 500 patients

BACKGROUND In recent years, there has been an increase in the number of total hip arthroplasty procedures in the younger patient population. This active group has higher expectations of their prosthesis in comparison to the older population, and there is a greater physical demand for the prosthesis. Short femoral stems were introduced to retain proximal bone stock and joint biomechanics and became more common to implant in this specific population. Currently, the long-term survival and functional outcomes of various short stems are still being investigated in different clinics. AIM To determine the 5-year survival of the Optimys hip stem. METHODS This was a prospective multicenter cohort study of 500 patients conducted in two hospitals in the Netherlands. All patients received the Optimys short stem (Mathys Ltd, Bettlach, Switzerland). The primary outcome measure was survival of the hip stem, with revision as the endpoint. The secondary outcome measurements included patient-reported outcome measures (PROMs). Kaplan-Meier analysis was used to calculate the 5-year survival rate. Log-minus-log transformation was performed to calculate the 95% confidence interval (95%CI). Mixed model analyses were performed to assess the course of the PROMs during the 1st 2 years after surgery. Analyses were modeled separately for the 1st and 2nd years to calculate the yearly change in PROMs during both follow-up periods with accompanying 95%CIs. RESULTS The mean age of the total 500 patients was 62.3 years (standard deviation: 10.6) and 202 were male (40%). At a median follow-up of 5.5 years (interquartile range: 4.5-6.7), 7 patients were deceased and 6 revisions were registered, for infection (n = 3), subsidence (n = 2) and malposition (n = 1). This resulted in an overall 5-year survival of 98.8% (95%CI: 97.3-99.5). If infection was left out as reason for revision, a stem survival of 99.4% (95%CI: 98.1-99.8) was seen. Baseline questionnaires were completed by 471 patients (94%), 317 patients (63%) completed the 1-year follow-up questionnaires and 233 patients (47%) completed the 2-year follow-up. Both outcome measures significantly improved across all domains in the 1st year after the operation (P &lt; 0.03 for all domains). In the 2nd year after surgery, no significant changes were observed in any domain in comparison to the 1-year follow-up. CONCLUSION The Optimys stem has a 5-year survival of 98.8%. Patient-reported outcome measures increased significantly in the 1st postoperative year with stabilization at the 2-year follow-up.

UK Medical Cannabis Registry: a case series analyzing clinical outcomes of medical cannabis therapy for generalized anxiety disorder patients.

This study aims to analyze changes in health-related quality of life (HRQoL) and safety in patients with generalized anxiety disorder (GAD) prescribed a homogenous selection of cannabis-based medicinal products (CBMPs). Patients prescribed Adven CBMPs (Curaleaf International, UK) for GAD were identified from the UK Medical Cannabis Registry. Primary outcomes were changes in patient-reported outcome measures (PROMs) from baseline up to 12 months, including GAD-7, Single-Item Sleep Quality Scale (SQS), and EQ-5D-5L. Adverse events were recorded using CTCAE version 4.0. A total of 120 patients were identified for inclusion, of which 38 (31.67%), 52 (43.33%), and 30 (25.00%) were prescribed oils, dried flower, and both formulations of CBMP. Associated improvements in GAD-7, SQS, and EQ-5D-5L at 1, 3, 6, and 12 months were observed compared to baseline (P < 0.010). There were 24 (20.00%) patients who reported 442 (368.33%) adverse events, most of which were mild (n = 184, 41.63%) and moderate (n = 197, 44.57%). This study reports an association between initiation of a homogeneous CBMP therapy and improvements in anxiety severity and HRQoL in individuals with GAD. Moreover, therapy was well-tolerated at 12 months follow-up. Further investigation through randomized controlled trials will ultimately be required to determine causation.

Association of patient-reported outcome measures with lung function and mortality in fibrotic interstitial lung disease: a prospective cohort study.

Patient-reported outcome measures (PROMs) may provide clinicians and researchers with direct insights into disease impact and patient well-being. We assessed whether selected PROMs and their domains are associated with baseline and longitudinal changes in lung function and can predict mortality in patients with fibrotic interstitial lung disease (f-ILD). A single-centre prospective study of adult patients with f-ILD enrolled over 3 years was conducted assessing baseline and short-term changes in PROMs. Three questionnaires, the modified Medical Research Council dyspnoea scale (mMRC), Chronic Respiratory Questionnaire (CRQ) and Self-Management Ability Scale (SMAS-30) were administered at planned intervals and assessed for their association with baseline clinical findings, change in lung function (% predicted forced vital capacity (FVC%) and diffusion capacity of the lung for carbon monoxide (DLCO%)) and all-cause mortality. 199 patients were enrolled with a mean PROM follow-up of 9.6 months. When stratified by FVC% quartiles at presentation, lower mMRC (less dyspnoea), higher CRQ Physical and Emotional domain (better health-related quality of life) and higher total SMAS-30 scores (better self-management ability) were associated with higher FVC%. Short-term changes in all three PROMs appeared to be associated with changes in FVC% and DLCO%. Adjusted and unadjusted baseline and serial PROM changes were also predictive of mortality. Baseline and serial assessments of PROMs were associated with changes in lung function and predicted death in patients with f-ILD. PROMs may strengthen comprehensive assessments of disease impact in clinical practice as well as support patient-centred outcomes in research.

Clinical utility of elective paediatric flexible bronchoscopy and impact on the quality of life: protocol for a single-centre, single-blind, randomised controlled trial

IntroductionElective flexible bronchoscopy (FB) is now widely available and standard practice for a variety of indications in children with respiratory conditions. However, there are no randomised controlled trials (RCTs) that...

Relationships between Patient-Reported Outcome Measures and Clinical Measures in Naïve Neovascular Age-Related Macular Degeneration Patients Treated with Intravitreal Ranibizumab.

Our objective was to evaluate changes in patient-reported outcome measures using the NEI-VFQ 25 questionnaire during a treat and extend regimen in naive neovascular Age-Related Macular Degeneration patients, and its correlation with anatomical and functional data. We conducted a prospective observational study. Patients underwent a treat and extend regimen with intravitreal ranibizumab for neovascular Age-Related Macular Degeneration. Initial response was evaluated at 4th month, and subsequently in every follow-up visit. If a clinical response was achieved, the injection interval was extended in two-week increments, up to a maximum of 12 weeks. Quality of life was assessed using the NEI-VFQ 25 questionnaire at baseline, 4th months, and 12th months. Patients were categorized as good or poor responders based on Best corrected visual acuity, central foveal thickness, intraretinal fluid, or subretinal fluid. Treatment with ranibizumab led to a significant improvement in quality of life, with a mean increase in NEI-VFQ 25 score of 4.27 points in the 12th month. No significant differences in improvement were observed between good and poor responders. Quality of life scores in neovascular Age-Related Macular Degeneration patients improved with intravitreal treatment regardless of the clinical response. The early response following the loading phase could indicate better quality of life after one year of treatment, with Best corrected visual acuity being the clinical parameter with the greatest influence on quality of life.

Impact of Wiberg Patellar Type on Outcomes and Survival Following Cell-Based Cartilage Repair for Patellar Chondral Lesions at Midterm Follow-up.

Cell-based cartilage repair procedures of the patellofemoral joint have less reliable outcomes than those of the tibiofemoral joint. No previous studies have evaluated the influence of patellar shape on cell-based cartilage repair outcomes. Patellar dysplasia may predispose patients to worse outcomes after cell-based cartilage repair. The purpose of this study was to evaluate the relationship between Wiberg patellar type and outcomes after cell-based cartilage repair (autologous chondrocyte implantation or particulated juvenile allograft cartilage transplantation) for the treatment of patellar chondral lesions at a minimum 2-year follow-up. It was hypothesized that Wiberg classification of patellar shape would have no effect on patient-reported outcome measures (PROMs) or graft survival. Cohort study; Level of evidence, 3. Patients undergoing autologous chondrocyte implantation or particulated juvenile allograft cartilage transplantation for full-thickness patellar chondral defects between 2016 and 2020 were retrospectively reviewed after institutional review board approval. The change in PROMs, including International Knee Documentation Committee (IKDC), Kujala, and Veterans RAND 12-item Health Survey Mental and Physical scores, from pre- to postoperatively and the percentage of patients who achieved the minimal clinically important difference (MCID) for IKDC and Kujala scores were compared for the Wiberg type A versus Wiberg type B versus Wiberg type C groups. The log-rank test was used to evaluate for differences in survival between subgroups. A total of 59 patients (63 knees) were included, with a mean age of 33.3 ± 8.6 years, median body mass index of 26.0 (IQR, 21.8-30.2), and median follow-up time of 3.5 years (IQR, 2.6-4.2 years). In total, 26 (41%) patellae were Wiberg type A, 29 (46%) were Wiberg type B, and 8 (13%) were Wiberg type C. There were no differences between Wiberg type A versus Wiberg type B versus Wiberg type C groups with respect to change in PROMs from pre- to postoperatively or the percentage of patients who achieved the MCID for IKDC or Kujala scores (P > .05 for all). There were no differences in survival between groups (P = .45). Wiberg patellar type has no effect on patient-reported outcomes or graft survival at midterm follow-up. Patellar dysplasia should not be seen as a contraindication for cell-based cartilage repair procedures.

Timing of Surgery and Outcomes in Chronic Rhinosinusitis: A Narrative Review and Meta-Analysis.

Surgery is often indicated in the treatment of medically recalcitrant chronic rhinosinusitis (CRS). There is conflicting evidence on the impact of timeliness of sinus surgery on the degree of perceived symptom improvement in CRS. The goal of this study was to systematically evaluate the available literature on the relationship between patient wait times for endoscopic sinus surgery (ESS) and postoperative changes in patient-reported outcome measures. Ovid, MEDLINE, CINAHL, and Cochrane Library of Systematic Reviews between January 2000 and September 1, 2023, were searched. A total of 931 studies were independently screened by 2 reviewers. Two studies were included in the meta-analysis, while 4 others were included in a narrative review. Two studies consisting of 1606 patients were included in the meta-analysis. A mean difference in 22-Item Sino-Nasal Outcome Test (SNOT-22) of -0.3 (95% CI = -3.9 to 3.3, I2 = 89%, P < .01 was observed between "long" and "short" groups, while a mean difference in SNOT-22 of -0.1 (95% CI = -2.5 to 2.3, I2 = 80%, P = .03) was observed between "long" and "mid" groups. Patients who receive surgery earlier on their disease process (ie, earlier from the time of diagnosis to eventual surgery) appear to require less access to healthcare resources including prescription medications, thus suggesting better disease control. There is conflicting evidence to conclude whether timing of ESS affects disease-specific measures in patients with CRS. Patients who receive surgery earlier appear to have lower demands on healthcare utilization including visits and prescription use. Our study suggests there is a need for increased access to surgical specialists who manage patients with CRS, and better understanding by primary care specialists in how to manage CRS when specialist access is not available.

A cohort study comparing the effects of medical cannabis for anxiety patients with and without comorbid sleep disturbance.

Research on cannabis-based medicinal products (CBMPs) in anxiety remains inconclusive due to a paucity of high-quality evidence. Studies indicate a bidirectional relationship between generalized anxiety disorder (GAD) and sleep disruption, but it is unclear how this affects CBMP treatment outcomes. This study aims to compare the patient-reported outcome measures (PROMs) of patients prescribed CBMPs for GAD, with and without impaired sleep. Changes in PROMs were recorded from baseline to 1, 3, 6, and 12 months between those with impaired or unimpaired sleep. Multivariate logistic regression was applied to compare factors associated with a clinically significant improvement in GAD-7 at 12 months. Secondary outcomes included adverse event incidence and frequency. Of the 302 patients that fit the inclusion criteria, mean GAD-7, single-item sleep quality, and EQ-5D-5L index values improved at all time points (p < 0.001). A relationship between sleep impairment and clinically significant changes in GAD-7 at 1 and 3 months was identified (p ≤ 0.01). On multivariate regression, only baseline GAD severity was associated with an increased likelihood of observing a clinically significant improvement in anxiety (p < 0.001). Seven hundred and seven (234%) adverse events were reported by 55 (18.21%) participants. This study observed an association between CBMP treatment and improvements in anxiety in patients with GAD. While patients with comorbid sleep disruption had greater improvements in anxiety, the differences were not maintained in a multivariate analysis. Baseline anxiety severity may be a predictor for CBMP treatment outcomes.