Aluminum Nanoparticles Affect Human Platelet Function In Vitro.

Endoprostheses are prone to tribological wear and biological processes that lead to the release of particles, including aluminum nanoparticles (Al NPs). Those particles can diffuse into circulation. However, the toxic effects of NPs on platelets have not been comprehensively analyzed. The aim of our work was to investigate the impact of Al NPs on human platelet function using a novel quartz crystal microbalance with dissipation (QCM-D) methodology. Moreover, a suite of assays, including light transmission aggregometry, flow cytometry, optical microscopy and transmission electron microscopy, were utilized. All Al NPs caused a significant increase in dissipation (D) and frequency (F), indicating platelet aggregation even at the lowest tested concentration (0.5 µg/mL), except for the largest (80 nm) Al NPs. A size-dependent effect on platelet aggregation was observed for the 5-20 nm NPs and the 30-50 nm NPs, with the larger Al NPs causing smaller increases in D and F; however, this was not observed for the 20-30 nm NPs. In conclusion, our study showed that small (5-50 nm) Al NPs caused platelet aggregation, and larger (80 nm) caused a bridging-penetrating effect in entering platelets, resulting in the formation of heterologous platelet-Al NPs structures. Therefore, physicians should consider monitoring NP serum levels and platelet activation indices in patients with orthopedic implants.

Content validity of the EORTC quality of life questionnaire QLQ-C30 for use in cancer.

AIM: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) is among the most widely used patient-reported outcome measures in cancer research and practice. It was developed prior to guidance that content should be established directly from patients to confirm it measures concepts of interest and is appropriate and comprehensive for the intended population. This study evaluated the content validity of the QLQ-C30 for use with cancer patients. METHODS: Adults undergoing cancer treatment in Europe and the USA participated in open-ended concept elicitation interviews regarding their functional health, symptoms, side-effects and impacts on health-related quality of life. Thematic analysis was conducted, and similarities across cancer types, disease stages and countries or languages were explored. RESULTS: Interviews with 113 patients with cancer (85 European, 28 USA) including breast, lung, prostate, colorectal and other cancers were conducted between 2016 and 2020. Conceptual saturation was achieved. The most frequently reported concepts were included in the QLQ-C30 conceptual framework. QLQ-C30 items were widely understood across language versions and were relevant to patients across cancer types and disease stages. While several new concepts were elicited such as difficulty climbing steps or stairs, weight loss, skin problems and numbness, many were not widely experienced and/or could be considered sub-concepts of existing concepts. CONCLUSIONS: The QLQ-C30 demonstrates good evidence of content validity for the assessment of functional health, symptom burden and health-related quality of life in patients with localised-to-advanced cancer.

Effects of Transcutaneous Electrical Nerve Stimulation on Pain and Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Systematic Review.

Transcutaneous electrical nerve stimulation (TENS) is the usage of a mild electrical current through electrodes that stimulate nerves. Patients with malignancies experience pain and chemotherapy-induced peripheral neuropathy. A systematic review was performed to find research evaluating the effect of TENS on these two common symptoms decreasing the quality of life in cancer patients. PubMed, the Cochrane Central Register of Controlled Trials and EMBASE were searched. Original studies, namely randomized controlled trials, quasi-randomized controlled trials and controlled clinical trials, published between April 2007 and May 2020, were considered. The quality of the selected studies was assessed. Seven papers were incorporated in a qualitative synthesis, with 260 patients in total. The studies varied in terms of design, populations, endpoints, quality, treatment duration, procedures and follow-up period. Based on the results, no strict recommendations concerning TENS usage in the cancer patient population could be issued. However, the existing evidence allows us to state that TENS is a safe procedure that may be self-administered by the patients with malignancy in an attempt to relieve different types of pain. There is a need for multi-center, randomized clinical trials with a good methodological design and adequate sample size.

The persistent median artery and its vascular patterns: A meta-analysis of 10,394 subjects.

The presence of a persistent median artery (PMA) has been implicated in the development of compression neuropathies and surgical complications. Due to the large variability in the prevalence of the PMA and its subtypes in the literature, more awareness of its anatomy is needed. The aim of our meta-analysis was to find the pooled prevalence of the antebrachial and palmar persistent median arteries. An extensive search through the major databases was performed to identify all articles and references matching our inclusion criteria. The extracted data included methods of investigation, prevalence of the PMA, anatomical subtype (antebrachial, palmar), side, sex, laterality, and ethnicity. A total of 64 studies (n = 10,394 hands) were included in this meta-analysis. An antebrachial pattern was revealed to be more prevalent than a palmar pattern (34.0% vs. 8.6%). A palmar PMA was reported in 2.6% of patients undergoing surgery for carpal tunnel syndrome when compared to cadaveric studies of adult patients in which the prevalence was 8.6%. Both patterns of PMA are prevalent in a considerable portion of the general population. As the estimated prevalence of the PMA was found to be significantly lower in patients undergoing surgery for carpal tunnel syndrome than those reported in cadaveric studies, its etiological contribution to carpal tunnel syndrome is questionable. Surgeons operating on the forearm and carpal tunnel should understand the anatomy and surgical implications of the PMA and its anatomical patterns.

A systematic review and meta-analysis of iliocapsularis muscle: an important landmark in orthopedic surgery.

PURPOSE: Iliocapsularis (IC) is a small muscle overlying the capsule of the hip joint. Although recent attention is being given to this muscle by orthopedic surgeons who encounter it during the anterior approach to total hip arthroplasty, little is known about its anatomical features. The aim of this study was to review the anatomy of IC, and describe its' origin, insertion, blood supply, innervation, muscle fiber characteristics and size. The function, clinical relevance and comparative anatomy of IC were also appraised. METHODS: Using Evidence-Based Anatomy methodology, electronic databases were searched with the terms "iliocapsularis", "iliacus minor", "iliotrochantericus", and "ilioinfratrochantericus" to identify eligible studies. RESULTS: Six studies (n = 287 lower limbs) examining the anatomy of IC were included. The pooled prevalence (PP) of the IC was 98.7% (95% CI 96.5-100.0). It arises from the inferior facet of the anterior inferior iliac spine (AIIS) and attaches inferior to the lesser trochanter. Attached to the anteromedial capsule along its entire length, IC has the largest capsular contribution of any of the hip muscles (73.8 ± 27.3 × 16.1 ± 4.4 mm). Thus, it is an important landmark in anterior surgical approaches to the hip joint. CONCLUSION: The anatomy of IC is becoming more relevant with the increasing use of anterior approaches to hip surgery. With attachments to the AIIS, the lesser trochanter as well as the length of the capsule, this muscle is an important landmark in total hip arthroplasty. LEVEL OF EVIDENCE: Level V.

Psychometric validation of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire Sexual Health (EORTC QLQ-SH22).

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group developed a questionnaire to assess sexual health in patients with cancer and cancer survivors. This study evaluates the psychometric properties of the questionnaire. METHODS: The 22-item EORTC sexual health questionnaire (EORTC QLQ-SH22) was administered with the EORTC QLQ-C30 to 444 patients with cancer. The hypothesised scale structure, reliability and validity were evaluated through standardised psychometric procedures. RESULTS: The cross-cultural field study showed that the majority of patients (94.7%) were able to complete the QLQ-SH22 in less than 20 min; 89% of the study participants did not need any help to fill in the questionnaire. Multi-item multi-trait scaling analysis confirmed the hypothesised scale structure with two multi-item scales (sexual satisfaction, sexual pain) and 11 single items (including five conditional items and four gender-specific items). The internal consistency yielded acceptable Cronbach's alpha coefficients (.90 for the sexual satisfaction scale, .80 for the sexual pain scale). The test-retest correlations (Pearson's r) ranged from .70 to .93 except for the scale communication with professionals (.67) and male body image (.69). The QLQ-SH22 discriminates well between subgroups of patients differing in terms of their performance and treatment status. CONCLUSION: The study supports the reliability, the content and construct validity of the QLQ-SH22. The newly developed questionnaire is clinically applicable to assess sexual health of patients with cancer at different treatment stages and during survivorship for clinical trials and for clinical practice.

Clinical Anatomy of the Posterior Meniscofemoral Ligament of Wrisberg: An Original MRI Study, Meta-analysis, and Systematic Review.

BACKGROUND: The posterior meniscofemoral ligament (pMFL) of Wrisberg attaches to the posterior horn of the lateral meniscus and the lateral intercondylar aspect of the medial femoral condyle and passes posteriorly to the posterior cruciate ligament (PCL). The pMFL plays a role in recovery after PCL injuries and offers stability to the lateral meniscus, promoting normal knee function. PURPOSE/HYPOTHESIS: The aim of the magnetic resonance imaging (MRI) arm of this study was to evaluate the prevalence of the pMFL in Polish patients. The purpose of the systematic review and meta-analysis was to evaluate the clinical relevance of the pMFL in knee surgery. It was hypothesized that extensive variability exists in reports on the prevalence, function, and clinical significance of the pMFL. STUDY DESIGN: Cross-sectional study and systematic review; Level of evidence, 3. METHODS: A retrospective MRI investigation was conducted on 100 randomly selected lower limbs of Polish patients (56 male, 44 female) performed in 2019 to determine the prevalence of the pMFL. Additionally, an extensive literature search of major online databases was performed to evaluate all reported data on the pMFL. Assessments of article eligibility and data extraction were completed independently by 2 reviewers, and all disagreements were resolved via a consensus. A quality assessment of the included articles was performed using the Anatomical Quality Assessment tool. RESULTS: In the MRI arm of this study, the pMFL was observed in 73 of the 100 limbs. In the meta-analysis, 47 studies were included, totaling 4940 lower limbs. The pooled prevalence of the pMFL was found to be 70.4% (95% CI, 63.4%-76.9%); the mean length was 27.7 mm (95% CI, 24.8-30.5 mm) and the mean widths were 4.5, 6.1, and 4.1 mm for the meniscal and femoral attachments and midportion, respectively. The mean pMFL thickness was 2.3 mm (95% CI, 1.8-2.7 mm). CONCLUSION: Despite the variability in the literature, the pMFL was found to be a prevalent and large anatomic structure in the knee joint. The shared features of this ligament with the PCL necessitate the consideration of its value in planning and performing arthroscopic procedures of the knee.

Evaluating the Thresholds for Clinical Importance of the EORTC QLQ-C15-PAL in Patients Receiving Palliative Treatment.

Background: The EORTC QLQ-C15-PAL is a shortened version of the widely used EORTC QLQ-C30. This questionnaire was developed to measure the symptoms and functional health of patients receiving palliative care. Objective: To enhance clinical interpretability of the EORTC QLQ-C15-PAL, our aim was to evaluate the sensitivity and specificity of thresholds for clinical importance developed previously for the QLQ-C30 when applied to the QLQ-C15-PAL scales. Design: Cross-sectional observational study. Setting/Subjects: Patients with cancer receiving any type of palliative treatment. Measurement: Patients completed the EORTC QLQ-C15-PAL and anchor items on limitations, worries, and need for help for each of the health domains covered by the questionnaire. The anchor items were summarized in a binary criterion for clinical importance to calculate the sensitivity and specificity of the thresholds for clinical importance. Results: In total, 225 patients participated in the study (mean age 64.5 years). Patients were recruited from Austria, Italy, the Netherlands, Poland, Spain, and the United Kingdom. The thresholds for clinical importance for the QLQ-C15-PAL scales showed a median sensitivity of 0.88 (range: 0.82 for sleep disturbances to 1.00 for dyspnea) and a median specificity of 0.74 (range: 0.54 for dyspnea to 0.89 for constipation). Conclusion: The thresholds for clinical importance showed high sensitivity and mostly high specificity in identifying clinically important symptoms and functional health impairments as assessed by the QLQ-C15-PAL. These thresholds will facilitate interpretation of EORTC QLQ-C15-PAL scores in daily clinical practice and clinical research.

Congenital Anomalies of the Tracheobronchial Tree: A Meta-Analysis and Clinical Considerations.

BACKGROUND: The aim of this study was to determine the prevalence and anatomic features of major tracheobronchial anomalies. METHODS: Major electronic databases were systematically searched to identify eligible studies. Data were extracted and pooled into a meta-analysis. The primary outcome was the prevalence of major tracheobronchial anomalies, specifically tracheal bronchus (TB) and accessory cardiac bronchus (ACB). Secondary outcomes included the origin and types of TB and ACB. RESULTS: A total of 27 studies (n = 119,695 patients) were included. A TB was present in 0.99% (95% confidence interval, 0.67 to 1.37) of patients, and an ACB was present in 0.14% (95% confidence interval, 0.09 to 0.20). The overall prevalence of TB was higher in imaging than in operative studies (1.81% vs 0.82%). It was also higher in pediatric (2.55%) than in adult studies (0.50%). Patients with other congenital anomalies were 15 times more likely to have a TB (odds ratio 14.89; 95% confidence interval, 7.09 to 31.22). The most common origin of TBs was from the trachea (81.42%), primarily from the right side (96.43%). The most common origin of ACBs was from the intermediate bronchus (74.32%). The ACBs terminated as blind-ending diverticulum in two thirds of cases. CONCLUSIONS: Major tracheobronchial anomalies are present in approximately 1% of the population, although the prevalence is higher among pediatric patients and patients with accompanying congenital anomalies. Although rare, major tracheobronchial anomalies can be associated with significant respiratory morbidities and present challenges during airway management in surgical and critical care patients. Establishing a preoperative diagnosis of these variations is essential for planning and implementing an appropriate airway management strategy to minimize attendant complications.

Evidence-Based Clinical Anatomy of the Popliteofibular Ligament and Its Importance in Orthopaedic Surgery: Cadaveric Versus Magnetic Resonance Imaging Meta-analysis and Radiological Study.

BACKGROUND: The popliteofibular ligament (PFL) is a static stabilizer of the posterolateral corner of the knee, preventing varus angulation, tibial rotation, and posterior translation. The PFL is anatomically variable, and there is no current review that outlines its prevalence rate and morphological variations. PURPOSE: To investigate the anatomic prevalence and morphological qualities of the PFL in various global patient populations via a meta-analysis of relevant literature involving both cadaveric dissections and patient-based research using magnetic resonance imaging (MRI) scans. STUDY DESIGN: Meta-analysis. METHODS: We pooled literature data detailing PFL prevalence rates and performed a retrospective MRI study of 100 knees to determine the overall PFL prevalence. Data searches and analyses were performed according to Anatomical Quality Assurance and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. RESULTS: There were 30 cadaveric studies and 11 MRI studies (including our radiological investigation), representing a total of 1595 lower limbs. The meta-analysis of cadaveric studies showed a higher prevalence of the PFL than the meta-analysis of MRI studies, with 98.4% (95% CI, 97.5%-99.2%) and 89.0% (95% CI, 73.9%-98.6%), respectively. Our MRI investigation reported a PFL prevalence of 92.0%. CONCLUSION: The PFL was found to be a constant or rarely absent anatomic structure of the human knee according to the analysis of cadaveric dissection studies, and it was identified notably less on MRI, albeit not significantly. Increasing PFL anatomic knowledge, including awareness of its prevalence and morphological diversity, will improve injury diagnoses, treatment methods, and prognoses.

Psychometric properties of the updated EORTC module for assessing quality of life in patients with lung cancer (QLQ-LC29): an international, observational field study.

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) assesses quality of life (QOL) in patients with lung cancer and was the first EORTC module developed for use in international clinical trials. Since its publication in 1994, major treatment advances with possible effects on QOL have occurred. These changes called for an update of the module and its international psychometric validation. We aimed to investigate the scale structure and psychometric properties of the updated lung cancer module, QLQ-LC29, in patients with lung cancer. METHODS: This international, observational field study was done in 19 hospitals across 12 countries. Patients aged older than 18 years with a confirmed diagnosis of lung cancer and no other previous primary tumour, and who were mentally fit with sufficient language skills to understand and complete the questionnaire were included. Patients were asked during a hospital visit to fill in the paper versions of the core questionnaire EORTC QLQ-C30 plus QLQ-LC29, and investigators selected half of these patients to complete the questionnaire again 2-4 weeks later. Our primary aim was to assess the scale structure and psychometric properties of EORTC QLQ-LC29. We analysed scale structure using confirmatory factor analysis; reliability using Cronbach's α value (internal consistency) and intra-class coefficient (test-retest reliability); sensitivity using independent t tests stratified by Karnofsky performance status; and responsiveness to change over time by ANOVA. This study is registered with ClinicalTrials.gov, NCT02745691. FINDINGS: Between April 12, 2016, and Sept 26, 2018, 523 patients with a confirmed diagnosis of either non-small-cell lung cancer (n=442) or small-cell lung cancer (n=81) were recruited. Confirmatory factor analysis provided a solution composed of five multi-item scales (coughing, shortness of breath, fear of progression, hair problems, and surgery-related symptoms) plus 15 single symptom or side-effect items: χ2=370·233, root mean square error of approximation=0·075, and comparative-fit index=0·901. Cronbach's α for internal consistencies of all multi-item scales were above the threshold of 0·70. Intra-class coefficients for test-retest reliabilities ranged between 0·82 and 0·97. Three (shortness of breath, fear of progression, and hair problems) of the five multi-item scales showed responsiveness to change over time (p values <0·05), as did nine of 15 single symptom items. Four (coughing, shortness of breath, fear of progression, and surgery-related symptoms) of the five multi-item scales and ten of the 15 single symptom items were sensitive to known group differences (ie, lower vs higher Karnofsky performance status). INTERPRETATION: Results determined the psychometric properties of the updated lung cancer module, which is ready for use in international clinical studies. FUNDING: EORTC Quality of Life Group.

Anatomic Study of Accessory Infraorbital Nerves and Foramina: Application for a Better Understanding of Complications of Le Fort Fractures and Osteotomy.

PURPOSE: Neurosensory disturbance of the infraorbital nerve is one of the many complications of the Le Fort osteotomy. An accessory infraorbital foramen (AIOF) can be one reason for such complications. Therefore, the purpose of the present study was to elucidate the distribution of the accessory infraorbital nerve (AION) arising from the AIOF. MATERIALS AND METHODS: We dissected 60 sides from 30 fresh-frozen cadaveric heads. RESULTS: An AIOF was found in 36.7% of the heads examined. When an AIOF was detected, the nerve was traced distally and proximally. The mean horizontal and vertical diameters of the AIOF were 1.64 ± 0.88 and 1.75 ± 0.87 mm, respectively. The largest AIOF was 3.42 × 3.79 mm. All AIOFs were located medial to the infraorbital foramen. Most of the AIONs (87.5%) had branches to the external nose. CONCLUSIONS: The AION should always be remembered by surgeons to allow for improved outcomes and better understanding of the complications such as those occurring after Le Fort osteotomy.

International validation of the EORTC CAT Core: a new adaptive instrument for measuring core quality of life domains in cancer.

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has developed computerised adaptive tests (CATs) for the 14 functional and symptom domains of the EORTC QLQ-C30 quality of life questionnaire. This is expected to optimise measurement precision, relevance to patients and flexibility. Here, we present the first international validation of the EORTC CAT Core. METHODS: A heterogeneous sample of 699 cancer patients scheduled for chemotherapy and/or radiotherapy was recruited across seven European countries. The EORTC CAT Core and all QLQ-C30 items were administered to participants before and after initiating treatment. Correlations between CAT and QLQ-C30 scores and floor/ceiling effects were calculated. Using several grouping variables, relative validity (cross-sectional known groups difference), responsiveness (changes over time) and relative sample size requirements of the CAT compared to the QLQ-C30 were estimated. RESULTS: Correlations of the CAT and QLQ-C30 ranged from 0.81 to 0.93 across domains. The mean relative reduction in floor and ceiling effects using the CAT was 42% (range 3-99%). Analyses of known groups validity and responsiveness indicated that, across domains, mean sample size requirements for the CAT were 72% and 70%, respectively, of those using the QLQ-C30. CONCLUSIONS: The EORTC CAT Core measures the same domains as the QLQ-C30 with reduced floor/ceiling effects. The CAT generally facilitated the use of smaller samples (about 30% smaller on average) without loss of power compared to the QLQ-C30. Based on this study, the EORTC QLG will release the EORTC CAT Core for general use.

The gastrocnemiofibular ligament: A new, more anatomically accurate name for the fabellofibular ligament-An original magnetic resonance imaging study and meta-analysis.

INTRODUCTION: The fabellofibular ligament (FFL) is a component of the posterolateral corner (PLC) of the knee and is an anatomically variable static stabilizer. Several investigations have reported prevalence rates for the FFL among their subjects, but no overall prevalence rate has been reported. MATERIALS AND METHODS: We conducted a meta-analysis of all relevant studies reporting prevalence rates of the FFL according to PRISMA and AQUA guidelines and pooled prevalence data using MetaXL 5.3. We also conducted a retroactive magnetic resonance imaging (MRI) study of 100 knees to assess FFL and fabella prevalence. RESULTS: Twenty-one studies (from 18 articles) and our MRI data were used in this meta-analysis (n = 1,176 knees). The pooled prevalence estimate (PPE) for FFL absence was 37.4% (95% confidence interval [CI], 24.5-51.3%). When divided by continent, PPEs of FFL absence were 31.5% (95% CI, 1.4-72.7%), 58.2% (95% CI, 44.1-71.6%), and 29.0% (95% CI, 14.7-45.7%) for North American, European, and Asian subjects, respectively. Cadaveric and MRI studies showed PPEs of FFL absence of 31.5% and 49.7%, respectively. Our MRI results showed PPEs of FFL and fabella absences of 42.0 and 80.0%, respectively. CONCLUSIONS: Understanding prevalence rates and anatomical geometry of the FFL will assist surgeons in repairing PLC injuries. Our MRI data and previous studies suggest the FFL is frequently present in knees lacking a fabella. Based on the observations of this study, we propose the ligament be renamed the gastrocnemiofibular ligament.

The Accessory Parotid Gland and its Clinical Significance.

PURPOSE: The accessory parotid gland is a collection of salivary tissue separate from the main parotid gland. When present, it may complicate parotidectomies, promote parotitis, and serve as a potential site for benign and malignant lesions to arise. The aim of this study was to provide a comprehensive and current overview of the anatomy of the accessory parotid gland, as there is a wide discrepancy in the literature regarding its prevalence. MATERIALS AND METHODS: The authors conducted a search in PubMed, Embase, ScienceDirect, Web of Science, SciELO, BIOSIS, Current Content Connect, Korean Journal Database, and Russian Citation Index to identify all studies which reported relevant data on the accessory, with no date or language restrictions applied. Data on prevalence, side of occurrence, and sex dimorphism of the accessory parotid gland were extracted and pooled into a meta-analysis. RESULTS: A total of 13 articles (n = 3115 subjects) were included in the study. The results revealed that the overall pooled prevalence of an accessory parotid gland was 32.1% (95% confidence interval: 21.2-44.0). It was more prevalent in cadaveric studies (35.8%) than in computed tomography studies (21.5%), had a higher prevalence in Asia (33.8%) as compared to North America (23.5%), and when present, it was most often found as an unilateral structure (77.8%). CONCLUSIONS: With respect to the findings presented, the accessory parotid gland may be considered an anatomical variation likely to encounter in the population. More anatomical studies on the structure and its prevalence are needed, in all regions of the world, to provide a representative global overview.

Thresholds for clinical importance were established to improve interpretation of the EORTC QLQ-C30 in clinical practice and research.

OBJECTIVE: The objective of this study was to establish thresholds for clinical importance (TCIs) for the five functioning and nine symptom scales of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). STUDY DESIGN AND SETTING: In this diagnostic study, cancer patients with mixed diagnoses and treatments completed the EORTC QLQ-C30 and anchored the questions in each domain in terms of their clinical importance. The anchor questions, concerned limitations in daily life, need for help/care, and the worries of the patient and his/her partner/family. These questions allowed categorizing patients into whether they exhibited a clinically important symptom/functional impairment for each scale and performing a receiver operating characteristic curve analysis to establish TCIs. RESULTS: Data from 498 patients from six European countries (mean age 60.4 years, 55.2% women) were analyzed. For the TCIs generated using the patient questionnaire data, the EORTC QLQ-C30 scales showed sensitivity values between 0.71 and 0.97 and specificity values between 0.62 and 0.92 (area under the curve above 0.80 for all scales). CONCLUSION: This EORTC Quality of Life Group study provides TCIs for the functioning and symptom scales of the EORTC QLQ-C30. These TCIs can increase the interpretability of the questionnaire results and foster its use in daily clinical practice and in clinical research.

Thresholds for clinical importance were defined for the European Organisation for Research and Treatment of Cancer Computer Adaptive Testing Core-an adaptive measure of core quality of life domains in oncology clinical practice and research.

OBJECTIVES: The aim of this article was to establish thresholds for clinical importance (TCIs) for the European Organisation for Research and Treatment of Cancer (EORTC) Computer Adaptive Testing (CAT) Core measure, the new adaptive version of the EORTC QLQ-C30. STUDY DESIGN AND SETTING: For our diagnostic study, we recruited cancer patients with mixed diagnoses and treatments from six European countries. Patients completed the EORTC CAT Core and a questionnaire with anchor items assessing criteria for clinical importance (limitations in everyday life, need for help/care, and worries by the patient/family/partner) for each EORTC CAT Core domain. We used a binary variable summarizing the anchor items for determining TCIs and for calculating the area under the curve (AUC) in receiving operator characteristic analysis as a measure of diagnostic accuracy. RESULTS: Using data from 498 cancer patients (mean age 60.4 years, 55.2% women), we established TCIs for the 14 domains of the EORTC CAT Core. Median AUC across domains was 0.93 (range 0.84-0.94). Median sensitivity and specificity of the TCIs were 0.91 (range 0.80-0.96) and 0.77 (range 0.66-0.84), respectively. TCIs and AUCs were largely consistent across patient groups. CONCLUSION: We have generated TCIs for the 14 functional health and symptom domains of the EORTC CAT Core. The EORTC CAT Core showed high diagnostic accuracy in identifying clinically important symptoms and functional impairments.

Current state of quality of life and patient-reported outcomes research.

The 5th EORTC Quality of Life in Cancer Clinical Trials Conference presented the current state of quality of life and other patient-reported outcomes (PROs) research from the perspectives of researchers, regulators, industry representatives, patients and patient advocates and health care professionals. A major theme was the assessment of the burden of cancer treatments, and this was discussed in terms of regulatory challenges in using PRO assessments in clinical trials, patients' experiences in cancer clinical trials, innovative methods and standardisation in cancer research, innovative methods across the disease sites or populations and cancer survivorship. Conferees demonstrated that PROs are becoming more accepted and major efforts are ongoing internationally to standardise PROs measurement, analysis and reporting in trials. Regulators are keen to collaborate with all stakeholders to ensure that the right questions are asked and the right answers are communicated. Improved technology and increased flexibility of measurement instruments are making PROs data more robust. Patients are being encouraged to be patient partners. International collaborations are essential, because this work cannot be accomplished on a national level.

Sensitivity to change of the EORTC quality of life module measuring cancer-related fatigue (EORTC QlQ-Fa12): Results from the international psychometric validation.

OBJECTIVE: The European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG) has developed a multidimensional instrument measuring cancer-related fatigue, the EORTC QLQ-FA12. The analysis of sensitivity to change is an essential part of psychometric validation. With this study, we investigated the EORTC QLQ-FA12's sensitivity to change. METHODS: The methodology follows the EORTC guidelines of EORTC QLG for phase IV validation of modules. We included cancer patients undergoing curative and palliative treatment at t1 and followed them up prospectively over the course of their treatment (t2) and 4 weeks after completion of treatment (t3). Data were collected prospectively at 17 sites in 11 countries. Sensitivity to change was investigated using analysis of variance. RESULTS: A total sample of 533 patients was enrolled with various tumour types, different stages of cancer, and receiving either curative treatment (n=311) or palliative treatment (n=222). Over time all fatigue scores were significantly higher in the palliative treatment group compared with the curative group (p < .001). Physical fatigue increased with medium effect size over the course of treatment in the curative group (standardized response mean [SRM] (t1,t2) = 0.44]. After treatment physical [SRM (t2,t3) = 0.39], emotional [SRM (t2,t3)= 0.28] and cognitive fatigue (SRM [t2,t3] = 0.22) declined significantly in the curative group. In the palliative group, emotional (SRM [t2,t3] = 0.18) as well as cognitive [SRM [t2,t3] = 0.26) fatigue increases significantly. CONCLUSIONS: The EORTC-QLQ-FA12 proved to identify clinically significant changes in fatigue in the course of curative and palliative cancer treatment.

Clinical anatomy of the maxillary sinus: application to sinus floor augmentation.

The anatomy of the maxillary sinus, especially its vascular anatomy, and its relationships with the teeth and alveolar processes have been well documented. The development of cone-beam computed tomography has resulted in dentists being more familiar with maxillary sinus floor augmentation procedures. This paper aims to revisit the classic anatomy of the maxillary sinus and review the newly published literature in order to help dentists diagnose in more detail and perform safer surgery of the maxillary sinus.