Questionnaire Module Research Articles

New approaches for integrating sex/gender into environmental health research

PDS 69: Methods and statistics, Johan Friso Foyer, Floor 1, August 26, 2019, 4:30 PM - 5:30 PM Background/Aim. Up to now, the environmental health paradigm is predominantly based upon the distinction of sex-linked biological characteristics. A dichotomous category “male/female” is used for stratified analyses or merely for adjusting as confounder, assuming static differences between men and women on an individual level. However, gender refers to socially influenced behaviours, living conditions and thereby exposure opportunities. Moreover, gender-related factors and stressors (discrimination experiences, social role relations) may modify health effects of environmental exposures. Gender-theoretical concepts like embodiment and intersectionality are promising to advance integration of gender as multidimensional, dynamic category into environmental health research. The aim of the collaborative research project INGER is to develop innovative methods for gender-sensitive data collection and analyses in environmental health studies. Methods. The current state of knowledge and methodological approaches to study the impact of sex/gender on environmental health was assessed by systematic literature reviews for selected topics. Gender-theoretical concepts and proposals for operationalization of gender dimensions (e.g. gender bundle) were evaluated for their applicability. Results. Two questionnaire modules were developed for analyses of sex/gender impact to be applied in (1) KORA (Cooperative Health Research in the Augsburg Region): associations of air pollution and noise with cardiovascular health, of green space availability with self-rated health; (2) German Environmental Specimen Bank: body burden with environmental chemicals. Understandability and feasibility of KORA module was tested in a pilot study (response rate 53% among N=109), 6705 participants will be contacted in the main study. In the German Environmental Specimen Bank 600 participants are being contacted in four cities (so far in one city response rate 80%). Conclusion. The newly collected data will be used to identify methodological approaches of multivariable data analyses which are adequate to quantify sex/gender impacts on environmental exposures and health outcomes. Thus INGER will contribute to gender-sensitive prevention and environmental health protection.

394O - Health-related quality of life (HRQoL) evaluation in the REGOMA trial: A randomized, phase II clinical trial analyzing regorafenib activity in relapsed glioblastoma patients

BackgroundREGOMA trial showed that regorafenib (REG) significantly improved OS and PFS in patients (pts) with relapsed GBM with respect to lomustine (LOM). REG showed a different toxicity profile compared to LOM. Here, we report final results of the HRQoL assessment, a secondary end point. MethodsHRQoL was measured using the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (QLQ-C30) and brain module (QLQ-BN20) administered before any MRI assessments, every 8 weeks (+/- 2 weeks) until disease progression. To evaluate treatment impact on HRQoL, questionnaires at progression were excluded. Mixed-effect linear models were fitted for each of the HRQOL domain to examine the change over progression-free time within and between arms. The models included the time of questionnaire assessment, the treatment group and their interaction, as fixed effects, and a compound symmetry covariance structure for the random effects. Differences of at least 10 points were classified as a clinically meaningful change. To correct for multiple comparisons and to avoid type I error, the level of significance was set at P=0.01 (2-sided). ResultsOf 119 randomized pts, 117 participated in the HRQoL evaluation, and 114 had a baseline assessment (n=56 REG; n=58 LOM).No statistically significant differences were observed in any generic or cancer specific domain during treatment in the REG and LOM arms, or between the two arms, except for the appetite loss scale which was significantly worse in PTS treated with REG (Global mean 14.7 (SD=28.6) vs 7.6 (SD=16.0); p=0.0081). The rate of pts with a clinically meaningful worsening for appetite loss was not statistically different between the two arms (9 out of 24 and 0 out of 13 in the REG and LOM arm, respectively; p=0.02). ConclusionsIn the REGOMA trial, HRQoL did not change during regorafenib treatment. Pts treated with regorafenib and lomustine reported no significant difference in HRQoL. Legal entity responsible for the studyGiuseppe Lombardi. FundingHas not received any funding. DisclosureAll authors have declared no conflicts of interest.

OS7.3 Health-related quality of life (HRQoL) evaluation in the REGOMA trial: a randomized, phase II clinical trial analyzing regorafenib activity in relapsed glioblastoma patients

Abstract BACKGROUND REGOMA trial showed that regorafenib (REG) significantly improved OS and PFS in patients (pts) with relapsed GBM with respect to lomustine (LOM). REG showed a different toxicity profile compared to LOM. Here, we report final results of the HRQoL assessment, a secondary end point. MATERIAL AND METHODS HRQoL was measured using the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (QLQ-C30) and brain module (QLQ-BN20) administered before any MRI assessments, every 8 weeks (+/- 2 weeks) until disease progression. To evaluate treatment impact on HRQoL, questionnaires at progression were excluded. Mixed-effect linear models were fitted for each of the HRQOL domain to examine the change over progression-free time within and between arms. The models included the time of questionnaire assessment, the treatment group and their interaction, as fixed effects, and a compound symmetry covariance structure for the random effects. Differences of at least 10 points were classified as a clinically meaningful change. To correct for multiple comparisons and to avoid type I error, the level of significance was set at P=0.01 (2-sided). RESULTS Of 119 randomized pts, 117 partecipated in the HRQoL evaluation, and 114 had a baseline assessment (n=56 REG; n=58 LOM). No statistically significant differences were observed in any generic or cancer specific domain during treatment in the REG and LOM arms, or between the two arms, except for the appetite loss scale which was significantly worse in PTS treated with REG (Global mean 14.7 (SD=28.6) vs 7.6 (SD=16.0); p=0.0081). The rate of pts with a clinically meaningful worsening for appetite loss was not statistically different between the two arms (9 out of 24 and 0 out of 13 in the REG and LOM arm, respectively;p=0.02). CONCLUSION In the REGOMA trial, HRQoL did not change during regorafenib treatment. Pts treated with regorafenib and lomustine reported no significant difference in HRQoL.

A study protocol of vaginal laser therapy in gynecological cancer survivors

Objectives: Sexual dysfunction and radiation cystitis are common adverse events following radiotherapy for gynecological cancer (GC). This study aims to assess the efficacy of intravaginal CO2 laser on GC survivors with dyspareunia following pelvic radiation and/or brachytherapy.Methods: This is the study protocol of a randomized double-blind placebo-controlled trial. All participants will receive five therapies (active or placebo) at monthly intervals. Outcomes will include a 10-cm visual analog scale measuring dyspareunia, vaginal dryness, and other symptom intensity, 3-day voiding diary, Day-to Day Impact of Vaginal Aging questionnaire, Female Sexual Function Index, European Organization for Research and Treatment of Cancer Quality of Life questionnaire cervical cancer module, Urogenital Distress Inventory short form, King's Health Questionnaire, International Consultation on Incontinence Questionnaire short form/female lower urinary tract symptoms, patient perception of improvement, sexual satisfaction of male partners, vaginal maturation value, and Vaginal Health Index. Differences between groups will be assessed at baseline and 1, 3, 6, 9, and 12 months following the five laser therapies.Results: As this is a study protocol, the study is ongoing with an expected end of recruitment and analysis date of 2021.Conclusion: Pelvic radiotherapy for GC increases the 5-year survival rate but with a negative impact on women’s quality of life due to sexual dysfunction and radiation cystitis onset. With this study, CO2 laser therapy will be evaluated for the first time in GC survivors treated with radiotherapy. ClinicalTrials.gov registration number: NCT03714581

Do School Social Studies Textbooks Need to Be Changed?

Expected learning outcomes have changed following the adoption of the new Federal State Educational Standards of General Education. New organizational forms, teaching methods and tools are required to achieve the new learning outcomes, which affects functionality of conventional learning aids, school textbooks in particular. New interrelation mechanisms are being developed between the textbook and the other components of learning environment, transforming the textbook from the “communicator of ready-to-consume knowledge” into a “navigator for independent learning”. Under such circumstances, it is important to evaluate teachers’ attitudes towards the textbooks used, their perception of the changing role of textbooks in the learning process, and their satisfaction with textbook content, namely the methodological apparatus and its potential for achieving the new learning outcomes.
 This article presents the results of a survey assessing school teachers’ perceptions of the system of learning tasks in some widely assigned social studies textbooks from the series edited by Leonid Bogolyubov, Anatoly Nikitin and Tatyana Nikitina, Gennady Bordovsky, and Yevgeniya Korolkova. The survey covered thirteen regions of the Russian Federation: Moscow Oblast, Voronezh, Tambov, Bryansk, Tver, Smolensk, Omsk, Krasnoyarsk, Rostov-on Don, Volgograd, Kazan, Nizhny Novgorod, and Saransk. The interview questionnaire included six themed modules: target audience profile analysis, teachers’ usage of different textbooks, the role of social studies textbooks in the learning process, textbook influence on the achievement of the new learning outcomes (formation of key 21st century competencies), teachers’ assessment of teaching guidebooks, and availability of social studies teaching packages in schools.
 The article only explores the findings obtained for one questionnaire module, which explored how the methodological apparatus of social theory textbooks affected the creation of conditions for achieving metadisciplinary learning outcomes by school students, and offers recommendations on improving this apparatus.

Prospective evaluation of the quality of life of patients undergoing surgery for colorectal cancer depending on the surgical technique

PurposeMonitoring of the quality of life of patients in addition to satisfactory survival indexes in order to choose an optimal treatment method is a trend in contemporary oncological surgery. The goal of the study was to prospectively evaluate the quality of life of patients treated for colorectal cancer depending on the type of surgical technique (open surgery (OS) vs. laparoscopic surgery (LS)).MethodsThe quality of life was evaluated thrice in the study groups (on the day of admission to the ward (I), 6 months (II), and 18 months after the procedure (III)). The following questionnaires were used in this evaluation: QLQ-C30 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, QLQ-CR29 Quality of Life Questionnaire (module—colorectal cancer), and Acceptance of Illness Scale (AIS).ResultsSixty-seven patients completed this prospective clinical cohort study (LS-32; OS-35). The QLQ-C30 questionnaire demonstrated improvement in functional scales among patients treated with LS technique (p < 0.05) as well as with regard to overall quality of life 6 months after surgery (p < 0,001), while at 18 months postsurgery, statistically significant differences were noted for physical function (p = 0.001) and overall quality of life (p < 0.0001). AIS scale analysis demonstrated that patients treated with laparoscopy were characterized by better acceptance of illness (p < 0.05). Statistically significant differences between OS and LS groups were noted based on the QLQ-CR29 questionnaire with regard to the following scales: body image (p = 0.041) and body mass problem (p = 0.024)—patients treated with LS technique had better scores.ConclusionsLaparoscopic surgery gives patients a chance for better quality of life.

Impact of volume of irradiation on survival and quality of life in glioblastoma: a prospective, phase 2, randomized comparison of RTOG and MDACC protocols.

Though conformal partial-brain irradiation is the standard adjuvant treatment for glioblastoma, there is no consensus regarding the optimal volume that needs to be irradiated. European Organisation for Research and Treatment of Cancer (EORTC) and The University of Texas MD Anderson Cancer Center (MDACC) guidelines differ from the Radiation Therapy Oncology Group (RTOG) in their approach toward peritumoral edema, whereas RTOG and MDACC guidelines differ from EORTC in the concept of boost phase. A scarcity of randomized comparisons has resulted in remarkable variance in practice among institutions. Fifty glioblastoma patients were randomized to receive adjuvant radiotherapy using RTOG or MDACC protocols. Apart from dosimetric and volumetric analysis, acute toxicities, recurrence patterns, progression-free survival (PFS), overall survival (OS), and quality of life (QoL) were compared using appropriate statistical tests. Both groups were comparable with respect to demographic characteristics. Dosimetric analysis revealed significantly lower boost-phase planning treatment volumes and V60 Gy in the MDACC arm (chi-squared, P = .001 and .013, respectively). No significant differences were observed in doses with respect to organs at risk, acute toxicity, or recurrence patterns (chi-squared, P > .05). On the log-rank test, median PFS (8.8 months vs 6.1 months, P = .043) and OS (17 months vs 12 months, P = .015) were statistically superior in the MDACC group.Age, extent of resection, and proportion of whole brain receiving prescription dose were associated with improved PFS and OS on regression analysis. QoL of patients was significantly better in the MDACC group in all domains except cognitive, as assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) and Brain Cancer Module (QLQ-BN20) (general linear model, P < .05). Use of limited-margin MDACC protocol can potentially improve survival outcomes apart from QoL of glioblastoma patients, as compared with the RTOG protocol.

Clinical and psychometric validation of the BreSAS questionnaire module for symptom assessment among breast cancer survivors

The large number of women surviving many years post breast cancer (BC) diagnosis has heightened interest in studying long-term effects of cancer on quality of life (QoL). Several cancer-specific health-related measures have been developed, but these may not be appropriate for long survivors. This study evaluates the reliability and clinical and psychometric validity of the BreSAS questionnaire (BQ) among BC survivors. The BQ is a quick, simple ten-item module for the assessment of long-term physical, psychological, sexual, and cognitive effects that may influence QoL. The total BreSAS score ranks from 0 to 100, with a low score indicating a better QoL. Patients complete the BQ, the FACT-ES questionnaire, and case report forms for clinical and socio-demographic data during follow-up visits. Reliability and clinical and psychometric validity of the questionnaires are assessed by correlation analyses and exploration of known group comparisons. From September 2015 to February 2016, 149 patients from three Italian oncology units were enrolled. Baseline questionnaires were returned from all, and 134 patients (89%) completed the BQ and FACT-ES in less than 15min. For reliability, Cronbach's alpha coefficients for each scale were greater than 0.70 in all analyzed symptoms. Convergent validity of BQ showed by Pearson's r demonstrated a high correlation between intensity of symptoms and QoL, especially for pain and depression. No data were provided about reproducibility with test-retest study. The BQ demonstrates sufficient validity and reliability to support its use to assess patient-reported symptoms during planned follow-up clinical visits among BC survivors. Further full validation studies are needed.

Health-related quality of life (HRQoL) evaluation in the REGOMA trial: A randomized, phase II clinical trial analyzing regorafenib activity in relapsed glioblastoma patients.

2045 Background: REGOMA trial showed that regorafenib (REG) significantly improved OS and PFS in relapsed glioblastoma (GBM) patients (pts) with respect to lomustine (LOM). REG showed a different toxicity profile compared to LOM. Here, we report final results of the HRQoL assessment, a secondary end point. Methods: HRQoL was measured using the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (QLQ-C30) and brain module (QLQ-BN20) administered before any MRI assessments, every 8 weeks (+/- 2 weeks) until disease progression. To evaluate treatment impact on HRQoL, questionnaires at progression were excluded. Mixed-effect linear models were fitted for each of the HRQOL domain to examine the change over progression-free time within and between arms. The models included the time of questionnaire assessment, the treatment group and their interaction, as fixed effects, and a compound symmetry covariance structure for the random effects. Differences of at least 10 points were classified as a clinically meaningful change. To correct for multiple comparisons and to avoid type I error, the level of significance was set at P = 0.01 (2-sided). Results: Of 119 randomized pts, 117 participated in the HRQoL evaluation, and 114 had a baseline assessment (n = 56 REG; n = 58 LOM). No statistically significant differences were observed in any generic or cancer specific domain during treatment in the REG and LOM arms, or between the two arms, except for the appetite loss scale which was significantly worse in PTS treated with REG (Global mean 14.7 (SD = 28.6) vs 7.6 (SD = 16.0); p = 0.0081). The proportion of pts with a clinically meaningful worsening for appetite loss was not statistically different between the two arms (9 out of 24 and 0 out of 13 in the REG and LOM arm, respectively; p = 0.0146). Conclusions: In the REGOMA trial, HRQoL did not change during REG treatment. Pts treated with REG and LOM reported no significant difference in HRQoL. Clinical trial information: NCT02926222. [Table: see text]

Health-related quality of life (HRQL) in VERTU: A randomized phase II trial of veliparib (V), radiotherapy (RT), and temozolomide (TMZ) for newly diagnosed MGMT unmethylated (uMGMT) glioblastoma (GBM).

2042 Background: The VERTU trial (ANZCTR #ACTRN12615000407594) compared Arm A (standard of care) = RT (60Gy/30 fractions) + TMZ (75mg/m2 daily) followed by TMZ (150–200mg/m2 D1–5) every 28 days for 6 cycles vs Arm B (experimental arm) = RT (60Gy/30 fractions) + V (200mg PO BID) followed by TMZ (150–200mg/m2 D1–5) + V (40mg PO BID, D1–7) every 28 days for 6 cycles in pts with newly diagnosed centrally determined uMGMT GBM. To ensure that veliparib was not associated with clinical detriment, serial HRQL assessments were performed for comparison as a secondary objective. Methods: Pts completed the EORTC quality of life core questionnaire (QLQ-C30) and brain cancer module (BN20) every 4 weeks (w) (baseline: w0; concurrent: w4,8; adjuvant: w10,14,18,22,26,30). Based on relevance to GBM patients, 5 HRQL scales (global health [GH], physical functioning [PF], social functioning [SF], motor dysfunction [MD] and communication deficit [CD]) were pre-selected for primary analysis. Maximum change from baseline score (clinically relevant deterioration/improvement defined as ≥10-point change) during the progression-free period, and deterioration-free survival (time to deterioration/progression/death) were evaluated. Results: Patient characteristics were well-matched (Arm A: N = 41, median age = 62, male = 68%, ECOG 0 = 66%, macroscopic resection = 88%; Arm B: N = 84, median age = 60, male = 70%, ECOG 0 = 65%, macroscopic resection = 86%). Almost all completed at least one HRQL assessment (98%). HRQL assessments during the progression-free period were completed in 87% (Arm A) and 90% (Arm B) of cases. For Arm A vs B, the proportion of patients who experienced a deterioration in GH (59% vs 64%, p = 0.69), PF (53% vs 53%, p &gt; 0.99), SF (46% vs 53%, p = 0.56), MD (63% vs 58%, p = 0.70) and CD (45% vs 46%, p &gt; 0.99) were similar. Deterioration-free survival was not statistically different for any HRQL item. Conclusions: The addition of veliparib to standard of care for newly diagnosed uMGMT GBM does not appear to compromise HRQL. This would support the primary efficacy analysis of the VERTU trial. Clinical trial information: ACTRN12615000407594.

Effectiveness of a self-instructional module on knowledge, attitude, and practice regarding pharmacovigilance among staff nurses

IntroductionDrugs with beneficial effects do come with adverse effects called adverse drug reactions (ADRs) which may even lead to fatal reactions. Hence, awareness about ADRs among healthcare professionals is an essential component for a healthy healthcare system. ObjectiveThis study was carried out to assess the effectiveness of a self-instructional module on existing knowledge, attitude, and practice (KAP) regarding pharmacovigilance. Materials and methodsA quasi-experimental approach with a repeated-measure design was used to compare the pretest and posttest assessment. Based on the reviews of previous research articles and literature on pharmacovigilance, the KAP questionnaire and self-instructional module were developed. A total of 60 nurses were included in the study. Assessment was conducted using a validated and modified structured KAP questionnaire which included 35 items, 20 items to test knowledge, eight to test attitude, and seven to test practice. Thirty minutes was allotted to fill up the questionnaire. Filled-up questionnaires were collected after the pretest assessment, and the self-instructional module was given to the participants after the test. The participants were instructed to study the module properly for the next seven days. After the completion of seven days, the KAP questionnaire was readministered to them for posttest assessment. ResultsPosttest performance significantly improved compared with the pretest performance, indicating the effectiveness of the educational self-instructional module on pharmacovigilance. ConclusionThe self-instructional module on pharmacovigilance should be given priority and become a regular mandatory learning component of the nursing staffs.

The role of religious coping and social support on medication adherence and quality of life among the elderly with type 2 diabetes.

Type 2 diabetes is a major public health issue particularly in the elderly. Religion may affect the Health Related Quality of Life (HRQoL) in such patients, mediated by factors such as religious coping and social support. This study aimed to investigate the impact of religiosity on medication adherence and HRQoL. 793 adults (> 65years old, 45% females) were recruited from 4 diabetes care centers and followed for 1 year. Duke University Religion Index, Spiritual Coping Strategies, Multidimensional Perceived Social Support, Medication Adherence Report Scale, WHOQOL-BREF and Diabetes-specific Quality of Life Questionnaire Module were used for assessment, as well as HbA1c and fasting blood glucose level. Using structural equation modeling, the potential paths were tested between religiosity, medication adherence and HRQoL; social support, religious coping and medication adherence served as the mediators. Religious coping and social support were recognized as the significant mediators between religiosity and medication adherence (CFI = 0.983, TLI = 0.985, and RMSEA = 0.021). The relationships between religiosity and HRQoL were considerably mediated by social support, religious coping and medication adherence and these variables explained 12% and 33% of variances of generic and specific HRQoL, respectively. There was no significant direct effect of religiosity on HRQoL. HbA1c and fasting blood glucose level were successfully loaded on the latent construct of medication adherence (factor loading = 0.51 and 0.44, respectively). The impact of religiosity on medication adherence and HRQoL occurs through the mediators such as religious coping and social support. Therefore, to improve the adherence to treatment and quality of life, interventions may be designed based on these mediators.

Factors affecting quality of life of cervical cancer patients: A multivariate analysis.

The aim of good management for cancer survivors should not be limited to only clinical care, but rather it should also include best quality of life (QOL). The objective of this study was to find out various factors affecting QOL in cervical cancer patients so that by modifying these factors, the best QOL can be provided to them. This was a prospective cohort study conducted in the Department of Obstetrics and Gynaecology and Department of Radiotherapy, King George's Medical University (KGMU), Lucknow, from May 2015 to July 2016. The cases were selected from patients visiting the outpatient department or who were admitted to the Department of Obstetrics and Gynaecology and Department of Radiotherapy, KGMU. The data information was collected in the form of face-to-face interview using European Organization for Research and Treatment of Cancer general cancer QOL Score 30 (EORTC QLQ C-30) and EORTC QOL questionnaire cervical cancer module (QLQ CX-24) questionnaire. QOL was assessed in 85 patients. Health-related QOL was separately studied in terms of overall general QOL and cancer cervix-specific QOL, and various factors affecting QOL were studied by multivariate analysis. Education, tobacco use, degree of differentiation of tumor, and size of tumor were the independent factors found to have statistically significant effect on QOL of cervical cancer survivors.

Health-related quality of life assessment for head-and-neck cancer patients during and at 3 months after radiotherapy - A prospective, analytical questionnaire-based study.

Introduction:Health-related quality of life (HRQoL) is a more specific area of QoL that deals with the evaluation and assessment of the impact of the disease and its treatment-related morbidities on a patient's physical, psychological, and social aspects. The aim of the present study was to assess the HRQoL of patients with head-and-neck cancer (HNCs) during and at 3 months after completion of radiotherapy (RT) by intensity-modulated RT.Materials and Methods:This study was a prospective, longitudinal, observational, and self-completed questionnaire-based study that included 120 patients with HNC who underwent intensity-modulated RT. The questionnaire had adequate internal consistency. The questionnaires were given to each patient at the beginning of treatment (pretreatment), weekly visits during the course of RT (at the end of 1st, 2nd, 3rd, 4th, 5th, and 6th week), on the day of completion of RT, and then finally at 3 months after completion of RT. Thus, a total of successive nine time points were assessed.Results and Conclusions:One hundred and eleven patients completed the questionnaires at all nine time points. HRQoL usually decreases during treatment and then increases to pretreatment levels by 3 months after treatment. The Quality of Life Questionnaire, Core Module and Quality of Life Questionnaire, Head and Neck Module were found to be both valid and reliable. There was a significant QoL reduction for the patients throughout treatment in relation to functions and symptoms in the treatment of HNC. However, all the functions and most of the symptoms returned to baseline at the 3-month follow-up.

International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26

BackgroundGiven the high cure-rate for testicular cancer (TC) and the patients’ young age, comprehensive evaluation of health-related quality of life (HRQOL) is an important consideration in this patient population. The EORTC QLQ-TC26 questionnaire module has been developed to supplement the EORTC QLQ-C30 in assessing TC-specific HRQOL in clinical trials and routine clinical practice. This international, multicentre phase IV validation study evaluated the psychometric properties of the new module.MethodsThis international, multicentre phase IV validation study enrolled testicular cancer patients from seven European countries. Patients completed the EORTC quality of life core questionnaire EORTC QLQ-C30 and the QLQ-TC26 at two consecutive time points and a debriefing questionnaire regarding the QLQ-TC26 after baseline assessment. Psychometric evaluation included examination of the hypothesized module scale structure, internal consistency and test-retest reliability, known-groups validity, responsiveness to change over time and cross-cultural acceptability.ResultsData from 313 patients (mean age 38.6, SD 9.5) were analysed. All items exhibited a high completion rate with less than 2.4% missing values except for the sexuality items (up to 8.8%). The confirmatory factor analysis supported the hypothesised scale structure of the QLQ-TC26. Test-retest reliability was good for 8 of 12 scales (intraclass correlation: R t1|t2 ranged from 0.71–0.91) and four scales did not meet the acceptable criteria. Internal consistency was good for all twelve scales (Cronbach alpha = 0.79–0.90), except Communication (alpha = 0.67) and Sexual Functioning (alpha = 0.62). The module was able to distinguish clearly between patients with differing clinical status. Responsiveness to change over time was acceptable.ConclusionThe EORTC QLQ-TC26 is a valid, reliable and well-accepted condition-specific questionnaire, supplementing the EORTC QLQ-C30, for the assessment of testicular cancer patients’ HRQOL in clinical trials.

ASSESSMENT OF RESIDENT KNOWLEDGE REGARDING ANAPHYLAXIS USING AN ELECTRONIC EDUCATIONAL MODULE AND PRE/POST QUESTIONNAIRE

Introduction Anaphylaxis is an acute, life-threatening systemic hypersensitivity reaction that is frequently underdiagnosed, underreported, and undertreated by medical professionals. There is limited graduate medical education (GME) curriculum dedicated to allergy/immunology (A/I) topics, including anaphylaxis. We hypothesized that providing an electronic educational learning module would improve resident knowledge regarding anaphylaxis diagnosis and treatment. Methods Participants included pediatric, internal medicine, family medicine, and emergency medicine residents of all training levels. Participants watched a pre-recorded 15-minute video module reviewing high yield topics regarding the diagnosis and management of anaphylaxis. General knowledge regarding the diagnosis and management of anaphylaxis was evaluated by a 10-point questionnaire before and 5 weeks following completion of the module. Results The pre-test questionnaire and educational module was completed by 78 residents, whose training level was either PGY-1, PGY-2, PGY-3 or higher. Over half of the participants (60%) had prior clinical experience diagnosing and treating anaphylaxis, yet only 15% had completed a rotation in A/I. Overall, the number of questions answered correctly in the post-test questionnaire (88%) was higher than the pre-test questionnaire (80%) (p-value Conclusions Residents from various levels of training and specialties improved their knowledge in diagnosis and treatment of anaphylaxis after participation in an electronic educational module.

Long-term quality of life after comprehensive surgical staging of high-risk endometrial cancer – results from the RASHEC trial

Purpose: The health-related quality of life (HRQoL) outcomes after comprehensive surgical staging including infrarenal paraaortic lymphadenectomy in women with high-risk endometrial cancer (EC) are unknown. Our aim was to investigate the long-term HRQoL between robot-assisted laparoscopic surgery (RALS) and laparotomy (LT).Patients and Methods: A total of 120 women with high-risk stage I-II EC were randomised to RALS or LT for hysterectomy, bilateral salpingoophorectomy, pelvic and infrarenal paraaortic lymphadenectomy in the previously reported Robot-Assisted Surgery for High-Risk Endometrial Cancer trial. The HRQoL was measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-30) and its supplementary questionnaire module for endometrial cancer (QLQ-EN24) questionnaire. Women were assessed before and 12 months after surgery. In addition, the EuroQol Eq5D non-disease specific questionnaire was used for descriptive analysis.Results: There was no difference in the functional scales (including global health status) in the intention to treat analysis, though LT conferred a small clinically important difference (CID) over RALS in ‘cognitive functioning’ albeit not statistically significant −6 (95% CI−14 to 0, p = .06). LT conferred a significantly better outcome for the ‘nausea and vomiting’ item though it did not reach a CID, 4 (95% CI 1 to 7, p = .01). In the EORTC-QLQ/QLQ-EN24, no significant differences were observed. Eq5D-3L questionnaire demonstrated a higher proportion of women reporting any extent of mobility impairment 12 months after surgery in the LT arm (p = .03).Conclusion: Overall, laparotomy and robot-assisted surgery conferred similar HRQoL 12 months after comprehensive staging for high-risk EC.

Innovation as a vehicle for improving socially vulnerable groups’ access to basic provisions: A research note on the development of a questionnaire module

Reducing inequality and social exclusion is a challenging task that will require a joint effort by all societal stakeholders, including not-for-profit and for-profit organizations. In order to develop and evaluate policy actions in this area, monitoring the contribution of these for-profit and not-for-profit organizations to a more inclusive society becomes crucial. This research note describes the development, cognitive pretesting, and large-scale empirical testing of a module that can be included in (inter)national innovation surveys. The module measures whether not-for-profits’ and for-profits’ innovation activities improve vulnerable groups’ access to basic provisions. It also provides insights in the main drivers for improving beneficiaries’ access to basic provisions through innovation and in the types and numbers of beneficiaries reached. The module was tested in the context of the Community Innovation Survey in Flanders, Belgium.

Cross-Sectional Patient-Reported Outcome Measuring of Health-Related Quality of Life With Establishment of Cancer- and Treatment-Specific Functional and Symptom Scales in Patients With Penile Cancer.

In the field of uro-oncology, the assessment of quality of life (QoL) is considered an integral part of clinical research. Because of the rarity of penile cancer, there is currently no cancer-specific questionnaire module available to assess the tumor-specific loss of function and symptoms in terms of influencing QoL. The aim of the study was to apply a validated questionnaire (European Organization for Research and Treatment of Cancer [EORTC] QLQ-C30) in a population of patients diagnosed with penile cancer and to compare these results to reference data of the general population. We also developed a new unvalidated questionnaire (Quality of Life Questionnaire-Penile Cancer-Rostock, HRO-PE29) in this population to promote QoL research in the field of uro-oncology. Cross-sectional evaluation of patients with penile cancer after local surgical treatment (n= 76) was performed using EORTC QLQ-C30 and HRO-PE29. The QLQ-C30 provides information on QoL, functional scales, symptom scales, and 6 individual items (inappetence, insomnia, dyspnea, constipation, diarrhea, financial difficulties). Cancer-specific functional and symptom scales (HRO-PE29) were then established for use in different disease states and forms of treatment. These provide information on QoL as well as on cancer-specific function and symptom scores. The global QoL score was 54, which corresponds to an average QoL (score 0-100) and was well below the age-standardized average for German patients. For the general function scores, the following mean values were determined: physical (x¯= 73), social (x¯= 61), emotional (x¯= 60), cognitive functioning (x¯= 69), and role function (x¯= 63). With regard to the general symptom scores and the individual items, the following values were found: fatigue (x¯= 35), nausea (x¯= 6), pain (x¯= 27), dyspnea (x¯= 23), insomnia (x¯= 41), loss of appetite (x¯= 25), constipation (x¯= 19), diarrhea (x¯= 10), and financial difficulties (x¯= 25). The following mean values were found for the cancer-specific functional scores: voiding (x¯= 77), sexuality (x¯= 69, function and pleasure), body image (x¯= 64), lymphedema (x¯= 75), future prospects (x¯= 72), and adverse effects of systemic treatment (x¯= 73). Defects of the external genitalia have implications for identity, personality, and interpersonal relationships. The mental stress of these patients results from the diagnosis of cancer as well as the partly mutilating treatment. Reconstructive surgery in penile cancer patients promises to maintain sexual and micturition function and thus improve QoL. Cancer-specific functional losses can be sufficiently named and their influence on QoL determined.

Health-Related Quality of Life Changes in Prostate Cancer Patients after Radical Prostatectomy: A Longitudinal Cohort Study.

PurposeHealth-related quality of life (HRQOL) information related to radical prostatectomy (RP) is valuable for prostate cancer (PC) patients needing to make treatment decisions. We aimed to investigate HRQOL change in PC patients who underwent three types of RP (open, laparoscopic, or robotic) and compared their HRQOL with that of general population.Materials and MethodsPatients were prospectively recruited between October 2014 and December 2015. European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) and PC-specific module (PR25) were administered before surgery (baseline) and at postoperative 3 and 12 months. At each time point, HRQOL was compared, and a difference of 10 out of 0-100 scale was considered clinically significant.ResultsAmong 258 screened patients, 209 (41 open, 63 laparoscopic, and 105 robotic surgeries) were included. Compared to baseline, physical, emotional, and cognitive functioning improved at 12 months. Role functioning worsened at 3 months, but recovered to baseline at 12 months. Pain, insomnia, diarrhea, and financial difficulties also significantly improved at 12 months. Most PR25 scales excluding bowel symptoms deteriorated at 3 months. Urinary symptoms and incontinence aid recovered at 12 months, whereas sexual activity and sexual function remained poor at 12 months. Clinically meaningful differences in HRQOL were not observed according to RP modalities. Compared to the general population, physical and role functioning were significantly lower at 3 months, but recovered by 12 months. Social functioning did not recover.ConclusionMost HRQOL domains showed recovery within 12 months after RP, excluding sexual functioning and social functioning. Our findings may guide patients considering surgical treatment for PC.