OBJECTIVES: Olfactory dysfunction (OD) is common and carries significant personal and societal burden. Accurate assessment is necessary for good clinical and research practice but is highly dependent on the assessment technique used. Current practice with regards to UK/international clinical assessment is unknown. We aimed to capture current clinical practice, with reference to contemporaneously available guidelines. We further aimed to compare UK to international practice. DESIGN: Anonymous online questionnaire with cross-sectional non-probability sampling. Subgroup analysis according to subspeciality training in rhinology ('rhinologists' and 'non-rhinologists') was performed, with geographical comparisons only made according to subgroup. PARTICIPANTS: ENT surgeons who assess olfaction. RESULTS: Responses were received from 465 clinicians (217 from UK and 17 countries total). Country-specific response rate varied, with the lowest rate being obtained from Japan (1.4%) and highest from Greece (72.5%). Most UK clinicians do not perform psychophysical smell testing during any of the presented clinical scenarios-though rhinologists did so more often than non-rhinologists. The most frequent barriers to testing related to service provision (e.g., time/funding limitations). Whilst there was variability in practice, in general, international respondents performed psychophysical testing more frequently than those from the UK. Approximately 3/4 of all respondents said they would like to receive training in psychophysical smell testing. Patient reported outcome measures were infrequently used in the UK/internationally. More UK respondents performed diagnostic MRI scanning than international respondents. CONCLUSIONS: To our knowledge, this is the most comprehensive UK-based, and only international survey of clinical practice in the assessment of OD. We present recommendations to improve practice, including increased education and funding for psychophysical smell testing. We hope this will promote accurate and reliable olfactory assessment, as is the accepted standard in other sensory systems.
- MeSH
- čich * fyziologie MeSH
- hodnocení výsledků péče pacientem MeSH
- lidé MeSH
- poruchy čichu * diagnóza MeSH
- průřezové studie MeSH
- průzkumy a dotazníky MeSH
- stupeň vzdělání MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Electronic patient-reported outcomes (ePROs) have been shown to enhance healthcare quality by improving patient symptom management or quality of life (QoL). However, ePROs data for urothelial cancer (UC) patients receiving systemic therapies are scarce, and the application of ePROs in this patient cohort may need specific setups. This study tested the feasibility of ePROs for UC patients receiving systemic therapies in the outpatient clinic of a tertiary care center. PATIENTS AND METHODS: From January 2022 to April 2023, 30 UC patients receiving systemic cancer therapies received ePROs based on the Common Terminology Criteria for Adverse Events (CTCAE) and European Organization for Research and Treatment of Cancer Core Quality of Life questionnaires (EORTC QLQ-30) to report their symptoms and QoL during systemic therapy, in total, 125 questions for every therapy cycle. The proportion of patients adherent to the ePROs was assessed to evaluate feasibility, with a preset threshold of 50%. At least half of all treatment cycles with a minimum of two consecutive ePROs (corresponding to two successive therapy cycles) had to be completed to be counted as adherent, and a maximum of six successive therapy cycles was followed by ePROs. Descriptive statistics were calculated for clinical and demographic patient characteristics. T-test and chi-square-test analyses were performed to study the association between ePROs adherence and clinical or demographic factors. The digital process was closely monitored for procedural impediments that could occur. RESULTS: 21 (70%) of the included 30 patients adhered to the provided ePROs, significantly higher than the predetermined threshold of 50%. Adherence remained above 70% until the end of the observation period. A significant negative effect of immigration background on ePROs compliance was observed (p = 0.006). No other variables were significantly associated with ePROs compliance. CONCLUSIONS: In this study, ePROs were a feasible method to assess symptoms and QoL during the systemic cancer therapy of UC patients at our center. The compliance of patients with immigration backgrounds was the most significant barrier to using ePROs in this setting. However, the study is limited by the exclusion of patients without email access and the lack of assessment of physician compliance with the ePROs data, which may affect the generalizability and implementation of the findings.
- MeSH
- emigrace a imigrace MeSH
- hodnocení výsledků péče pacientem * MeSH
- kvalita života * MeSH
- lidé středního věku MeSH
- lidé MeSH
- průzkumy a dotazníky MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- studie proveditelnosti * MeSH
- urologické nádory terapie psychologie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Vertebral fragility fractures (VFFs) commonly result from low bone mass and microarchitecture deterioration of bone tissue. spinal orthoses are common non-pharmacological options for managing vertebral fracture pain. However, the effects of spinal orthoses on pain, physical functioning, and quality of life (QoL) are still debated. OBJECTIVE: This survey aimed to investigate the patients-reported outcomes of a dynamic spinal orthosis prescribed in the routine clinical practice of VFFs management. METHODS: This multi-center national-wide prospective cohort study assessed older patients (aged > 60 years) diagnosed with acute VFFs and prescribed with a dynamic spinal orthosis (Spinfast®). A survey questionnaire was realized and included sections on patient characterization, osteoporosis characterization, spinal orthosis, clinical outcomes, pain medications, and osteoporosis medications. The questionnaire was administered at baseline and after three months. A total of 68 patients completed the questionnaire at three months. Most patients had one or two VFFs and were treated with pain medications and osteoporosis medications. Compliance and tolerability of the spinal orthosis were assessed, and clinical outcomes such as pain intensity, physical functioning, and QoL were measured. RESULTS: The results showed no significant differences in outcomes between age subgroups. Italian physical medicine and rehabilitation physicians were commonly involved in the management of VFFs patients. Sixty-six patients completed the questionnaire. The results showed that pain intensity, physical functioning and QoL improved after three months of spinal orthosis wearing (p< 0.0001). CONCLUSION: The correct management of VFFs is mandatory to improve pain and reduce disability, and our findings suggested a positive role of dynamic spinal orthosis to improve the comprehensive management of VFFs patients. However, high-quality research trials are warranted to provide clear recommendations for the correct clinical management of VFF.
- MeSH
- bolesti zad rehabilitace terapie MeSH
- fraktury páteře * rehabilitace MeSH
- hodnocení výsledků péče pacientem MeSH
- kvalita života * MeSH
- lidé středního věku MeSH
- lidé MeSH
- měření bolesti MeSH
- osteoporotické fraktury * rehabilitace MeSH
- prospektivní studie MeSH
- protetické prostředky * MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- zpráva o sobě MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
OBJECTIVE: We report patient-reported outcomes (PROs) measuring health-related quality of life (HRQoL) from the ROSEWOOD trial (NCT03332017), which demonstrated superior efficacy and a manageable safety profile with zanubrutinib plus obinutuzumab (ZO) versus obinutuzumab (O) in patients with heavily pretreated relapsed/refractory follicular lymphoma (R/R FL). METHODS: PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) and EQ-5D-5L questionnaires at baseline and subsequently every 12 weeks. All QLQ-C30 domains and EQ-5D-5L visual analog scale (VAS) scores were analyzed descriptively. At the key clinical timepoints (weeks 12 and 24), a mixed model for repeated measures (MMRM) analysis was used to evaluate the key PRO endpoints, including global health status, physical and role functioning, and symptoms of fatigue, pain, diarrhea, and nausea/vomiting. Clinically meaningful change was defined as a ≥ 5-point mean difference from baseline and between the ZO and O arms. RESULTS: Patients were randomized to ZO (n = 145) or O (n = 72). By week 48, descriptive analysis results indicated that patients in the ZO arm demonstrated improved outcomes in role functioning and fatigue and nausea/vomiting symptoms, compared with those in the O arm. Both groups experienced improvements in pain symptoms. EQ-5D-5L VAS scores showed no observable differences between treatment arms through week 48. MMRM analysis revealed that the global health status/quality of life of patients treated with ZO improved, as did fatigue, at week 12. At week 24, patients in the ZO arm experienced a clinically meaningful improvement in role functioning, pain, and fatigue. CONCLUSIONS: In patients with R/R FL, ZO was associated with improved PROs compared with O. These findings suggest that zanubrutinib contributed clinically meaningful benefits to patient HRQoL when added to obinutuzumab. TRIAL REGISTRATION: The ROSEWOOD trial is registered on ClinicalTrials.gov (BGB-3111-212; ClinicalTrials.gov identifier: NCT03332017).
- MeSH
- dospělí MeSH
- folikulární lymfom * farmakoterapie MeSH
- hodnocení výsledků péče pacientem * MeSH
- humanizované monoklonální protilátky * aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- kvalita života * MeSH
- lidé středního věku MeSH
- lidé MeSH
- protokoly antitumorózní kombinované chemoterapie terapeutické užití škodlivé účinky aplikace a dávkování MeSH
- pyrazoly * aplikace a dávkování terapeutické užití MeSH
- pyrimidiny * aplikace a dávkování terapeutické užití škodlivé účinky MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
PURPOSE: There is a paucity of long-term objective and patient-reported outcomes after definitive perineal urethrostomy for complex urethral strictures. Our objective is to determine comprehensive long-term success of perineal urethrostomy with our 15-year experience at a reconstructive referral center. MATERIALS AND METHODS: Patients who underwent perineal urethrostomy between 2009 and 2023 were identified. A comprehensive long-term follow-up was conducted, evaluating both objective outcomes (retreatment-free survival) and subjective outcomes through the use of validated questionnaires. Additionally, to provide further context for our findings, we conducted a scoping review of all studies reporting outcomes following perineal urethrostomy. RESULTS: Among 76 patients, 55% had iatrogenic strictures, with 82% previously undergoing urethral interventions. At a median follow-up of 55 months, retreatment-free survival was 84%, with 16% of patients experiencing perineal urethrostomy recurrent stenosis. Patient-reported outcomes revealed a generally satisfactory voiding function (Urethral Stricture Surgery Patient-Reported Outcome Measure Lower Urinary Tract Symptoms score) and continence (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form), with median scores of 4 (range 0-24) and 0 (range 0-21), but with bimodal distributions of sexual function scores (median International Index of Erectile Function-Erectile Function domain: 3.5; median Male Sexual Health Questionnaire-Ejaculation Scale: 21). Treatment satisfaction was very high with a median International Consultation on Incontinence Questionnaire-Satisfaction outcome score of 21 (range 0-24). The scoping review revealed varying success rates ranging from 51% to 95%, highlighting difficulties in comparison due to variable success definitions and patient case mix. CONCLUSIONS: Perineal urethrostomy provides effective treatment for complex anterior urethral strictures, with high patient satisfaction, preserved continence function, and favorable voiding outcomes. It presents a viable option for older and comorbid patients, especially after thorough counseling on expected outcomes and potential risks.
- MeSH
- časové faktory MeSH
- dospělí MeSH
- hodnocení výsledků péče pacientem * MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- perineum * chirurgie MeSH
- retrospektivní studie MeSH
- senioři MeSH
- striktura uretry * chirurgie MeSH
- uretra chirurgie MeSH
- urologické chirurgické výkony u mužů metody MeSH
- výsledek terapie MeSH
- zákroky plastické chirurgie metody MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
OBJECTIVES: To compare the treatment effectiveness of secukinumab in radiographic (r) versus non-radiographic (nr) axial spondyloarthritis (axSpA) patients treated in routine care across Europe. METHODS: Prospectively collected data on secukinumab-treated axSpA patients with known radiographic status were pooled from nine countries.Remission rates based on patient-reported outcomes (PROs; Numeric Rating Scale (0-10), for example, pain ≤2/Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≤2 and Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (ID) <1.3 after 6/12/24 months of secukinumab treatment were calculated.Remission and drug retention rates in r-axSpA versus nr-axSpA patients were compared by logistic and Cox regression models (unadjusted/adjusted for age+sex/adjusted for multiple confounders). RESULTS: Overall, 1161 secukinumab-treated patients were included (r-axSpA/nr-axSpA: 922/239). At baseline, r-axSpA patients had longer disease duration and higher C reactive protein, were more often male and HLA-B27 positive and had received fewer prior biological or targeted synthetic disease-modifying antirheumatic drugs compared with nr-axSpA patients, whereas PROs were largely similar.During follow-up, crude PRO remission rates were significantly higher in r-axSpA compared with nr-axSpA patients (6 months: pain≤2: 40%/28%, OR=1.7; BASDAI≤2: 37%/25%, OR=1.8), as were drug retention rates (24 months: 66%/58%, HR 0.73 (ref: r-axSpA)). Proportions of patients achieving ASDAS ID were low for both groups, particularly nr-axSpA (6 months: 11%/8%).However, when adjusting for age+sex, these differences diminished, and after adjusting for multiple confounders, no significant between-group differences remained for either remission or drug retention rates. CONCLUSION: Crude remission/drug retention rates in European secukinumab-treated patients were higher in r-axSpA compared with nr-axSpA patients. In adjusted analyses, secukinumab effectiveness was similar in both groups, suggesting that observed differences were related to factors other than radiographic status.
- MeSH
- antirevmatika terapeutické užití MeSH
- axiální spondyloartritida * farmakoterapie etiologie MeSH
- dospělí MeSH
- hodnocení výsledků péče pacientem MeSH
- humanizované monoklonální protilátky * terapeutické užití MeSH
- indukce remise MeSH
- lidé středního věku MeSH
- lidé MeSH
- prospektivní studie MeSH
- rentgendiagnostika MeSH
- stupeň závažnosti nemoci MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- Geografické názvy
- Evropa MeSH
BACKGROUND: Breast augmentation ranks among the most popular plastic surgery procedures. Yet, reports on post-operative patient-reported quality of life (QoL) and satisfaction remain conflicting. METHODS: A systematic review was conducted following the PRISMA guidelines. Three databases were searched for eligible studies that reported pre-and/or post-operative Breast-QTM augmentation scores for patient QoL (psychosocial, sexual, and physical well-being) and/or satisfaction. RESULTS: A total of 39 studies (53 patient cohorts and 18,322 patients) were included in the quantitative synthesis. The pairwise meta-analysis revealed significant improvements in patient-reported psychosocial (MD: +38.10) and sexual well-being (MD: +40.20) as well as satisfaction with breast (MD: +47.88) (all p < 0.00001). Physical well-being improved slightly after breast augmentation (MD: +6.97; p = 0.42). The single-arm meta-analysis yielded comparable results, with Breast-QTM scores in psychosocial and sexual well-being as well as satisfaction with breast increasing from 37.2, 31.1, and 26.3 to 75.0, 70.6, and 72.7, respectively (all p < 0.00001). Physical well-being improved by 8.1 (75.8 pre-operatively to 83.9 post-operatively; p = 0.17). Subgroup analyses highlighted higher QoL and satisfaction following breast augmentation for purely esthetic purposes and alloplastic mammaplasty. Although patient-reported physical and sexual well-being increased in the long term, psychosocial well-being was the highest in the short term. CONCLUSION: Patient satisfaction with breast, psychosocial, and sexual well-being increased significantly after breast augmentation. In contrast, patient-reported physical well-being yielded ambivalent results, varying by mammaplasty technique and post-operative follow-up time. Plastic surgeons should be sensitized about our findings to refine eligibility criteria and gain a deeper understanding of the patients' perceived surgical experience. PROSPERO TRIAL REGISTRATION NO: CRD42023409605.
OBJECTIVE: To investigate long-term and patient-reported outcomes, including sexual function, in women undergoing urogenital fistula (UGF) repair, addressing the lack of such data in Western countries, where fistulas often result from iatrogenic causes. PATIENTS AND METHODS: We conducted a retrospective analysis at a tertiary referral centre (2010-2023), classifying fistulas based on World Health Organisation criteria and evaluating surgical approaches, aetiology, and characteristics. Both objective (fistula closure, reintervention rates) and subjective outcomes (validated questionnaires) were assessed. A scoping review of patient-reported outcome measures in UGF repair was also performed. RESULTS: The study included 50 patients: 17 (34%) underwent transvaginal and 33 (66%) transabdominal surgery. History of hysterectomy was present in 36 patients (72%). The median (interquartile range [IQR]) operating time was 130 (88-148) min. Fistula closure was achieved in 94% of cases at a median (IQR) follow-up of 50 (16-91) months and reached 100% after three redo fistula repairs. Seven patients (14%) underwent reinterventions for stress urinary incontinence after transvaginal repair (autologous fascial slings). Patient-reported outcomes showed median (IQR) scores on the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) of 5 (3-7) for filling symptoms, 1 (0-2) for voiding symptoms and 4.5 (1-9) for incontinence symptoms. The median (IQR) score on the ICIQ Female Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ-FLUTSsex) was 3 (1-5). The median (IQR) ICIQ Satisfaction (ICIQ-S) outcome score and overall satisfaction with surgery item score was 22 (18.5-23.5) and 10 (8.5-10), respectively. Higher scores indicate higher symptom burden and treatment satisfaction, respectively. Our scoping review included 1784 women, revealing mixed aetiology and methodological and aetiological heterogeneity, thus complicating cross-study comparisons. CONCLUSIONS: Urogenital fistula repair at a specialised centre leads to excellent outcomes and high satisfaction. Patients with urethrovaginal fistulas are at increased risk of stress urinary incontinence, possibly due to the original trauma site of the fistula.
- MeSH
- dospělí MeSH
- hodnocení výsledků péče pacientem * MeSH
- lidé středního věku MeSH
- lidé MeSH
- retrospektivní studie MeSH
- vezikovaginální píštěl * chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- pozorovací studie MeSH
INTRODUCTION AND HYPOTHESIS: It is reported that up to 60% of women would prefer to spare their uterus during pelvic organ prolapse (POP) repair surgery. A reliable hysteropexy technique is therefore crucial. We aimed to describe the safety profile and initial core patient-reported and clinical outcomes of the Pilsner modification of laparoscopic mesh sacrohysterocolpopexy (PiMMS) in comparison with the laparoscopic sacrohysterocolpopexy technique (standard laparoscopic sacrohysterocolpopexy [sLSH]) previously used in our unit. METHODS: This was a retrospective cohort study conducted in a single tertiary referral urogynecological center. All patients who underwent laparoscopic mesh sacrohysterocolpopexy between 1 January 2015, and 31 January 2022 were included in the study. Follow-up clinical, patient-reported, and imaging outcomes at the 12-month follow-up time point are presented. RESULTS: A total of 87 patients were included. Of these, 49 (56.3%) and 38 (43.7%) underwent sLSH and PiMMS respectively. Low numbers of perioperative complications were found in both groups with no mesh-related complications reported following PiMMS up to 12 months postoperatively. There were no apical compartment failures in either group. There were 8 (17.0%) vs 1 (2.7%) anterior compartment failures (Ba ≤ -1) in the sLSH and PiMMS groups respectively (p = 0.07) at 12 months. At the 1-year follow-up, 42 (89.4%) patients reported a Patient Global Impression of Improvement score of ≤ 2 in the sLSH groups compared with 35 (94.6%) patients following PiMMS. CONCLUSIONS: The PiMMS technique seems to have comparable safety profile and patient-reported outcomes with the sLSH technique. However, there is a trend toward reduced anterior compartment failures with this modification. The findings of this preliminary report need to be re-evaluated in a well-powered prospective study.
- MeSH
- chirurgické síťky * škodlivé účinky MeSH
- gynekologické chirurgické výkony * metody MeSH
- hodnocení výsledků péče pacientem MeSH
- laparoskopie metody škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- pooperační komplikace etiologie epidemiologie MeSH
- prolaps pánevních orgánů * chirurgie MeSH
- retrospektivní studie MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
BACKGROUND: The Near Visual Acuity Questionnaire Presbyopia (NAVQ-P) is a patient-reported outcome (PRO) measure that was developed in a phakic presbyopia population to assess near vision function impacts. The study refined and explored the psychometric properties and score interpretability of the NAVQ-P and additional PRO items assessing near vision correction independence (NVCI), near vision satisfaction (NVS), and near vision correction preference (NVCP). METHODS: This was a psychometric validation study conducted using PRO data collected as part of a Phase IIb clinical trial (CUN8R44 A2202) consisting of 235 randomized adults with presbyopia from the US, Japan, Australia, and Canada. Data collected at baseline, week 2, and months 1, 2, and 3 during the 3-month trial treatment period were included in the analyses to assess item (question) properties, NAVQ-P dimensionality and scoring, reliability, validity, and score interpretation. RESULTS: Item responses were distributed across the full response scale for most NAVQ-P and additional PRO items. Confirmatory factor analysis supported the pre-defined unidimensional structure and calculation of a NAVQ-P total score as a measure of near vision function. Item deletion informed by item response distributions, dimensionality analyses, item response theory, and previous qualitative findings, including clinical input, supported retention of 14 NAVQ-P items. The 14-item NAVQ-P total score had excellent internal consistency (α = 0.979) and high test-retest reliability (Intraclass Correlation Coefficients > = 0.898). There was good evidence of construct-related validity for all PROs supported by strong correlations with concurrent measures. Excellent results for known-groups validity and ability to detect change analyses were also demonstrated. Anchor-based and distribution-based methods supported interpretation of scores through generation of group-level and within-individual estimates of meaningful change thresholds. A meaningful within-patient change in the range of 8-15-point improvement on the NAVQ-P total score (score range 0-42) was recommended, including a more specific responder definition of 10-point improvement. CONCLUSIONS: The NAVQ-P, NVCI, and NVS are valid and reliable instruments which have the ability to detect change over time. Findings strongly support the use of these measures as outcome assessments in clinical/research studies and in clinical practice in the presbyopia population.
- MeSH
- dospělí MeSH
- hodnocení výsledků péče pacientem MeSH
- lidé MeSH
- myopie * MeSH
- presbyopie * diagnóza MeSH
- psychometrie MeSH
- reprodukovatelnost výsledků MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Austrálie MeSH