Non-validated Questionnaires Research Articles

A randomized intraindividual comparative study evaluating the effects of two ultrasound-assisted liposuction devices on the abdomen

BackgroundUltrasound-assisted liposuction (UAL) has become popular because of its favorable outcomes in terms of fat emulsification, blood loss reduction, and skin tightening. This study aimed to compare the effects of two UAL devices on the abdomen by assessing postsurgery skin biomechanical properties. MethodsThis single-blind, prospective study (2020-2022) involved 13 liposuction procedures performed on patients without chronic diseases. Each patient's abdomen was divided vertically from the xiphoid to the perineum. Vibration amplification of sound energy at resonance (VASER)-assisted liposuction (Solta Medical, Inc., Hayward, CA) was performed on one half, while the other half underwent liposuction with high-frequency ultrasound energy (HEUS)-assisted technology. Skin biomechanical measurements, including distensibility, net elasticity, biological elasticity, hydration, erythema, melanin, and skin firmness, were taken at 12 and 24 months postsurgery, focusing on the anterior abdomen, 8cm to the right and left of the umbilicus. ResultsAnalysis of the above skin biomechanical measurements revealed no significant differences between the HEUS and VASER devices, except for skin firmness, which showed a notable increase following HEUS surgery. Patient-perceived clinical differences were assessed via nonvalidated questionnaires, revealing no distinctions between devices. ConclusionBiomechanical skin results post-UAL surgery with these devices on the abdomen were not significantly different, although HEUS revealed increased skin firmness. This suggests that HEUS-assisted technology, akin to other devices, is a viable option for UAL procedures.

Scoring Abdominal Symptoms in People with Cystic Fibrosis.

(1) Background: The introduction of highly effective CFTR-modulating therapies (HEMT) has changed the course of the disease for many people with Cystic Fibrosis (pwCF). Attention previously focused on life-threatening conditions of the respiratory system has broadened, bringing the involvement of the digestive system into the clinical and scientific focus. This emphasized the need for sensitive tools to capture and quantify changes in abdominal symptoms (AS), ideally applying patient-reported outcome measures (PROMs). (2) Methods: The present review focuses on studies addressing AS assessment deriving from the multi-organic abdominal involvement in pwCF. Among 5224 publications retrieved until Nov. 2022, 88 were eligible, and 39 were finally included. (3) Results: The review reveals that for a long time, especially before HEMT availability, AS in pwCF were assessed by single questions on abdominal complaints or non-validated questionnaires. PROMs focusing on quality of life (QOL) including a few GI-related questions were applied. Likewise, PROMs developed and partially validated for other non-CF GI pathologies, such as chronic inflammatory bowel diseases, irritable bowel syndrome, gastroesophageal reflux, constipation, or pancreatitis, were implemented. (4) Conclusions: Only lately, CF-specific GI-PROMs have been developed and validated following FDA guidelines, showing high sensitivity to changes and capturing marked and statistically significant reductions in the burden of AS achieved with HEMT implementation.

Are We Adequately Measuring Patient Satisfaction with Telemedicine? A Systematic Review with a Meta-Analysis.

Introduction: Telemedicine has gained significant attention as an effective means of providing health care remotely, particularly during the COVID-19 pandemic. Patient satisfaction is a critical aspect of implementing telemedicine, but we have no comprehensive understanding of satisfaction levels and the associated factors. The aim of this systematic review and meta-analysis was to assess patient satisfaction related to telemedicine consultations and to identify key factors influencing satisfaction levels. Results: The search yielded a total of 147 cross-sectional studies, of which 107 met the criteria for inclusion in the meta-analysis. Overall, patient satisfaction with teleconsultations was found to be high, with satisfaction levels ranging from 38 to 100 on a scale of 0 to 100. Only a small percentage (2.72%) of the studies reported satisfaction levels below 75%. Surprisingly, most studies used nonvalidated satisfaction questionnaires, which highlight the need for the development of standardized measurement instruments. Conclusions: This systematic review and meta-analysis provide evidence that patients generally exhibit high levels of satisfaction with telemedicine consultations. The use of nonvalidated satisfaction questionnaires in many studies, however, suggests a need for more standardized assessment tools. Factors such as the time interval between the consultation and the assessment were found to influence satisfaction levels. Understanding these factors can help health care providers improve telemedicine services and patient-provider relationships and optimize health care delivery in the context of telemedicine. Further research is warranted to develop validated satisfaction measurement instruments and explore any additional factors that influence patient satisfaction with telemedicine.

The most used questionnaires for evaluating the usability of robots and smart wearables: A scoping review.

As the field of robotics and smart wearables continues to advance rapidly, the evaluation of their usability becomes paramount. Researchers may encounter difficulty in finding a suitable questionnaire for evaluating the usability of robotics and smart wearables. Therefore, the aim of this study is to identify the most commonly utilized questionnaires for assessing the usability of robots and smart wearables. A comprehensive search of databases, including PubMed, Web of Science, and Scopus, was conducted for this scoping review. Two authors performed the selection of articles and data extraction using a 10-field data extraction form. In cases of disagreements, a third author was consulted to reach a consensus. The inclusions were English-language original research articles that utilized validated questionnaires to assess the usability of healthcare robots and smart wearables. The exclusions comprised review articles, non-English publications, studies not focused on usability, those assessing clinical outcomes, articles lacking questionnaire details, and those using non-validated or researcher-made questionnaires. Descriptive statistics methods (frequency and percentage), were employed to analyze the data. A total of 314 articles were obtained, and after eliminating irrelevant and duplicate articles, a final selection of 50 articles was included in this review. A total of 17 questionnaires were identified to evaluate the usability of robots and smart wearables, with 10 questionnaires specifically for wearables and 7 questionnaires for robots. The System Usability Scale (50%) and Post-Study System Usability Questionnaire (19.44%) were the predominant questionnaires utilized to assess the usability of smart wearables. Moreover, the most commonly used questionnaires for evaluating the usability of robots were the System Usability Scale (56.66%), User Experience Questionnaire (16.66%), and Quebec User Evaluation of Satisfaction with Assistive Technology (10%). Commonly employed questionnaires serve as valuable tools in assessing the usability of robots and smart wearables, aiding in the refinement and optimization of these technologies for enhanced user experiences. By incorporating user feedback and insights, designers can strive towards creating more intuitive and effective robotic and wearable solutions.

Psychometric Properties of the Slovenian Version of Brief Sensation Seeking Scale.

Sensation seeking (SS) is a psychobiological personality trait characterized by an individual's propensity to engage in various forms of risk-taking behavior. The Brief Sensation Seeking Scale (BSSS-8) is a widely used instrument for assessing SS that has been translated into several languages. However, only outdated and non-validated questionnaires have been used to measure SS in the Slovenian population. The aim of this study was to translate and psychometrically validate the Slovenian version of the BSSS-8. A total of 363 participants aged between 14 and 65 years completed the translated BSSS-8 and the questionnaire on drug abuse. The scale demonstrated good reliability (Cronbach's α=0.81) and a unidimensional factorial structure as revealed by confirmatory factor analysis (CFA). The multigroup CFA showed gender-specific measurement invariance. In the nomological network, SS was positively associated with drug-related variables. The Slovenian version of the BSSS-8 scale is a short and simple instrument to assess SS for research and epidemiological purposes.

Use of Questionnaire-Based Research in Hand Surgery

Introduction Questionnaire-based research is ubiquitous, and careful survey design is paramount to obtaining meaningful results. This study characterizes the use of questionnaire-based studies in the current hand surgery literature. Methods We conducted a systematic review of questionnaire-based studies published between 2010 and 2020 in 4 major American journals. We included studies in which questionnaire results represented a primary outcome. Validation status of the survey instruments was assessed, and topics of study were categorized. Nonvalidated instruments were assessed for reporting of parameters to limit bias. Results Three hundred fifty-four studies were identified, including 186 (52.5%) using validated instruments, 98 (27.7%) using nonvalidated instruments, 64 (18.1%) using a combination, and 6 (1.7%) that sought to validate an instrument. Of the studies that used validated instruments, 84.9% focused on patient-reported outcomes and 15.1% focused on other patient-centered topics. In contrast, of studies that used nonvalidated instruments, 44.9% focused on physician practice, 30.6% were patient centered, and 13.3% focused on education. Among nonvalidated questionnaires, 74.5% did not report predistribution testing, 49.0% did not publish full survey questions, and 33.3% did not report response rates. Conclusions Survey research is common in the hand surgery literature. Forty-six percent of examined studies included at least some nonvalidated elements. Techniques to limit bias in the design and reporting of studies based on nonvalidated surveys were not uniformly disclosed. Identified areas for improvement include (1) pilot testing to assess for question clarity; (2) publication of full texts to improve transparency; and (3) better reporting on sample selection, respondents, and nonrespondents.

Clinical trials of pneumonia management assess heterogeneous outcomes and measurement instruments

ObjectivesTo inform clinical practice guidelines, randomized controlled trials (RCTs) of the management of pneumonia need to address the outcomes that are most important to patients and health professionals using consistent instruments, to enable results to be compared, contrasted, and combined as appropriate. This systematic review describes the outcomes reported in clinical trials of pneumonia management and the instruments used to measure these outcomes. Study Design and SettingBased on a prospective protocol, we searched MEDLINE/PubMed, Cochrane CENTRAL and clinical trial registries for ongoing or completed clinical trials evaluating pneumonia management in adults in any clinical setting. We grouped reported outcomes thematically and classified them following the COMET Initiative's taxonomy. We describe instruments used for assessing each outcome. ResultsWe found 280 eligible RCTs of which 115 (41.1%) enrolled critically ill patients and 165 (58.9%) predominantly noncritically ill patients. We identified 43 distinct outcomes and 108 measurement instruments, excluding nonvalidated scores and questionnaires. Almost all trials reported clinical/physiological outcomes (97.5%). Safety (63.2%), mortality (56.4%), resource use (48.6%) and life impact (11.8%) outcomes were less frequently addressed. The most frequently reported outcomes were treatment success (60.7%), mortality (56.4%) and adverse events (41.1%). There was significant variation in the selection of measurement instruments, with approximately two-thirds used in less than 10 of the 280 RCTs. None of the patient-reported outcomes were used in 10 or more RCTs. ConclusionThis review reveals significant variation in outcomes and measurement instruments reported in clinical trials of pneumonia management. Outcomes that are important to patients and health professionals are often omitted. Our findings support the need for a rigorous core outcome set, such as that being developed by the European Respiratory Society.

Design and development of a Telemedicine Assessment Toolkit (TAT) for the assessment of audiovisual telemedicine encounters.

Although the use of audiovisual telemedicine has grown in recent years especially during recent COVID-19-related lockdowns, evidence shows there is still a lack of tools that can be used for the assessment of telemedicine encounters. The few validated questionnaires that are available for assessing telemedicine encounters are not often used. Non-validated questionnaires dominate research, leading to results that cannot be compared or extrapolated to other research or medical sites. Development of standard measures for the assessment of telemedicine encounters has been advocated by stakeholders. The objective of this study is to provide a comprehensive set of measures by developing a conceptual approach and a preliminary Telemedicine Assessment Toolkit (TAT) for the assessment of audiovisual telemedicine encounters. A two-step conceptual approach was used to identify potential domains and sub-domains by qualitative analysis of a pool of questions from studies published from 2016 to 2021. Questions were adopted from validated questionnaires or generated to represent the underlying concept of each sub-domain, resulting in a core block of comprehensive questions. A toolkit is proposed with question-measures that cover the sub-domains relevant to the assessment of telemedicine encounters. This study recommended 11 domains to be used for the assessment of telemedicine encounters: "usability," "patient satisfaction," "patient-provider interaction," "patient perspectives," "telemedicine readiness," "qualitative feedback," "comparison to standard (in-person) care," "privacy," "technology," "patient feeling," and "patient costs." Of the 11 domains, 26 underlying sub-domains were created. From the subdomains, a 30-question core block was proposed. The core-block together with a precursor block aimed to retrieve demographic/patient characteristics and, together with a customizable clinical outcomes block, complete the comprehensive toolkit. The toolkit, upon testing and validation, would enable researchers and system owners to assess patient-oriented aspects of audiovisual telemedicine encounters more accurately and accelerate the adoption of common audiovisual telemedicine assessment measures.

Adults with impaired gastrointestinal function show improvements in gastrointestinal symptoms and protein intake with a high-protein, peptide-based oral nutritional supplement

Provision of feeds containing hydrolysed, peptide-based proteins and medium-chain triglycerides (MCT), can help mitigate gastrointestinal (GI) intolerance in adults with impaired GI function, maldigestion and/or malabsorption. This study evaluated a high-protein, peptide-based, MCT-containing oral nutritional supplement (PEHP; 1.5kcal/ml and 7.5g protein/100ml). Adults with impaired GI function were recruited by their managing dietitian and took PEHP orally for 28-days, with GI tolerance, compliance, weight, energy and protein intake assessed via non-validated questionnaires and a 24-hour dietary recall at baseline and at intervention end. Fifteen, adults (56 years (16), 67kg (26.0), 24kg/m2 (7.6)) took part in this study. Intensity of nausea (Z= -2.070, p=0.038, n=15) and abdominal pain (Z= -2.236, p=0.025, n=15) improved significantly compared to baseline. Reductions in the intensity of diarrhoea, constipation, vomiting, flatulence, and burping were observed but were not statistically significant (p>0.05 for all). Compliance was higher with PEHP (81% (24)) than baseline feeds (63% (42)) but not significantly. Weight remained stable between baseline (67kg (26)) and at intervention end (67kg (27), p=0.414, n=15). Compared to baseline, total energy intake increased with PEHP albeit not significantly (1661 kcal/day (572) vs 1981 kcal/day (592), p=0.137, n=15). Increases in total protein intake were also observed, this time significantly (61 g/day (23) vs 78 g/day (29), p=0.042, n=15). This study in adults with impaired GI function found that PEHP improved GI tolerance and protein intake compared to feeds taken at baseline (including both polymeric and peptide-based feeds).

(047) A Systematic Review of Partner Satisfaction after Penile Prosthesis and Review of Patient Satisfaction in LGBTQ+ Men after Penile Prosthesis

Abstract Introduction Erectile dysfunction (ED), known to negatively affect both patient and partner quality-of-life (QoL), is estimated to affect more than 30 million men in the United States. Penile prosthesis (PP) implantation has been shown to be a successful surgical option for men with erectile dysfunction refractory to medical treatment. Several recent studies have demonstrated post-surgical patient satisfaction rates of >90% using validated, non-specific tools such as the International Index of Erectile Function (IIEF) and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). Objective Despite the progress in examining the satisfaction of heterosexual male patients with PP implantation, there has been no thorough review of partner satisfaction and QoL. Our objective was to summarize the current literature around partner satisfaction for heterosexual patients and patient satisfaction for LGBQT+ patients, respectively. We specifically conducted a systematic review according to the Cochrane and preferred reporting items for systematic reviews and meta-analyses (PRISMA) standards and stratified studies into three tiers by methodological rigor. Methods A PRISMA systematic literature review was performed using the PubMed database in March 2022. For the heterosexual partner review, a search was conducted to find all relevant abstracts regarding ‘penile prosthesis’, ‘partner satisfaction’, and ‘partner quality of life’. For the LGBQT+ review, ‘MSM’, ‘gay’, ‘homosexual’, ‘queer’, and ‘heterosexual’ were used as additional search terms. The research was limited to English-language articles from January 2000 to March 2022. The list of studies generated by the search was screened to identify eligible studies. Inclusion criteria included a clinical outcome study with primary outcomes related to penile prosthesis, and partner satisfaction was included as an outcome measure. Exclusion criteria included case reports, review articles, animal studies, and patient satisfaction studies that did not include partner satisfaction. Studies for the partner satisfaction review were sorted into three tiers based on the accuracy and external validity of each study’s methods. Results After an initial search of 172 articles, 30 studies met the inclusion criteria for the partner satisfaction review (Table 1). For our LGBTQ review, three studies consisting of 129 patients met the inclusion criteria from an initial search of 13 records (Table 2). For our partner satisfaction review, 10 studies were classified as Tier 1, 11 studies were classified as Tier 2, and 9 studies were classified as Tier 3. Across all the tiers, studies noted partner satisfaction rates between 50%-90% and improved satisfaction and sexual QoL metrics compared to pre-surgery rates. Overall, although partner satisfaction rates were high after PP implantation, many studies noted slightly lower partner satisfaction rates than patient satisfaction rates. Satisfaction rates among LGBTQ patients after PP implantation varied greatly between studies, ranging from 11% to 93% satisfaction. Conclusions Although the quality of evidence varies, the available literature suggests relatively high rates of partner satisfaction after PP implantation, in addition to varying rates of patient satisfaction after PP implantation in LGBTQ patients. Given the diversity of study designs and widespread use of non-validated or non-specific questionnaires in the current literature, future research should focus on prospective studies and/or data collection using validated, PP-specific questionnaires. Disclosure No

A review of questionnaires used for the assessment of telemedicine

Introduction Telemedicine is the exchange of medical information from one site to another via electronic communications with the goal of improving a patient's clinical health status. Prior studies have identified the absence of a standardized assessment tool for evaluating telemedicine encounters. This study aims to collect and to analyze questionnaires used for the assessment of audiovisual telemedicine encounters from a patient perspective and aims to identify reasons driving the use of self-developed questionnaires. Methods We conducted a systematic search in PubMed for studies that used survey questionnaires to assess synchronous audiovisual telemedicine encounters from 2016 to 2021. We categorized questionnaires used into validated and non-validated types, and for each of them, collected questions, response format, author, year, specialty, and country of publication. Results and Discussion We analyzed a total of 71 articles. We found that only 16 studies used three validated questionnaires. The remaining 55 studies used non-validated questionnaires. Non-validated questionnaires had a high variability in length and used Likert scales, binary responses, multiple choice, and open-ended answers. We found only eight studies in which the authors gave a reason for resorting to designing their own questionnaires. This review reveals insufficient standardized survey questionnaires to be used for the assessment of audiovisual telemedicine encounters. Future research initiatives should focus on developing a standardized and validated instrument well accepted by researchers.

Patient-reported outcome measurements (PROMs): Use during the physical therapy practice and associated factors

ObjectiveTo assess the current level of routine use of psychosocial-related patient-reported outcome measurements (PROMs) in physical therapy practice and which physical therapist-level factors are associated with the use of these measurement instruments. MethodsWe conducted an online survey study among Spanish physical therapists involved in the treatment of LBP patients in Public Health Service, Mutual Insurance Companies, and private practice during 2020. Descriptive analyses were conducted for reporting the number and instruments utilized. Thus, sociodemographic and professional features differences between PTs using and not using PROM were analyzed. ResultsFrom 485 physiotherapists completing the questionnaire nationwide, 484 were included. A minority of therapists routinely used psychosocial-related PROMs (13.8%) in LBP patients and only 6.8% did so through standardized measurements instruments. The Tampa Scale for Kinesiophobia (28.8%) and the Pain Catastrophizing Scale (15.1%) were used most frequently. Physiotherapists working in Andalucía and País Vasco regions, in private practice environments, educated in psychosocial factors evaluation and management, considering psychosocial factors during the clinical practice and expecting patients’ collaborative attitudes demonstrated significantly greater use of PROMS (p < 0.05). ConclusionsThis study showed that the majority of physiotherapists in Spain do not use PROMs for evaluating LBP (86.2%). From those physiotherapists using PROMs, approximately the half use validated instruments such as the Tampa Scale for Kinesiophobia or the Pain Catastrophizing Scale while the other half limit their evaluation to anamnesis and non-validated questionnaires. Therefore, developing effective strategies to implement and facilitate the use of psychosocial-related PROMs would enhance the evaluation during the clinical practice.

Association between overweight, obesity, and quality of life of patients receiving an anticancer treatment for prostate cancer: a systematic literature review

BackgroundProstate cancer (PCa) and obesity are two ever-increasing public health issues that can independently impair the quality of life (QOL) of affected patients. Our objective was to evaluate the impact of overweight and obesity on the QOL of patients with PCa receiving an anticancer treatment.MethodsWe performed a systematic review of the literature using PubMed, Embase, Cochrane Library and Web of Science databases according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. The search equation targeted studies that included PCa patients who had a body mass index (BMI) greater than 25 kg/m2, who were receiving anticancer therapy, and whose QOL was analyzed according to validated or non-validated scores.ResultsOf 759 identified articles, we selected 20 studies published between 2000 and 2019 of 12,529 patients treated for PCa, including 5549 overweight or obese patients. QOL assessment was performed using nine validated scales and two non-validated questionnaires. Of seven studies on radiotherapy, six found obesity to have a negative impact on patients' QOL (especially urinary, sexual, and bowel-related QOL). Thirteen studies assessed the QOL of patients who underwent radical prostatectomy, with a BMI > 25 kg/m2 having no observed impact. In obese patients under 65 years of age and without comorbidities, nerve-sparing surgery appeared to limit the deterioration of QOL. Four studies on brachytherapy found discordant results. One study showed greater QOL impairment in obese patients receiving first-generation hormone therapy than in those with normal or decreased BMI. No study evaluated the QOL of overweight or obese patients receiving other types of systemic treatment.ConclusionBased on the published data, the level of evidence for an association between QOL and overweight or obesity in patients treated for PCa is not high. Prospective cohort studies including this type of patient population are warranted to answer this topical public health issue.

Quality of life in neurogenic patients based on different bladder management methods: A review.

To determine the overall quality of life and patient satisfaction associated with different bladder management strategies in neuro-urological patients. The second objective was to identify other associated factors that may further influence the patient's quality of life. Systematic Review. Studies from Pubmed, Cochrane, and Google Scholar databases were extracted using terms relating to 'quality of life', 'satisfaction', in 'neurogenic bladder' combined with 'bladder management methods' that included 'continent and non-continent urine diversion', 'intermittent-catheterization', 'indwelling catheter' and 'condom-catheter'. Only studies with a minimal proportion of 80% of neurogenic bladder patients were included. Search was conducted, and article titles and abstracts were rated. 136 papers were screened and assessed for eligibility. 25 studies were included in the final analysis and consisted of ten retrospective, nine prospective, five cross-sectional and a single randomized controlled trial. In total, 3002 patients were included, with a majority of male (55%) and spinal cord injury (88%) patients. 167 patients had incontinent urinary diversions, 464 had continent urinary diversions (bladder augmentation with or without cutaneous catheterizable channel), 1698 used intermittent catheterization (self or by an attendant), 550 had an indwelling catheter (urethral or suprapubic), and 123 had condom catheters. Quality of life was assessed using a wide variety of validated and non-validated questionnaires. Overall, patients with continent and incontinent diversion tended to have better scores. Use of catheters tended to have more unsatisfactory scores, with indwelling and attendant-intermittent catheterization often scoring worse. On the other hand, patients using self-intermittent catheterization tended to fair well. Normal micturition followed by self-catheterization yielded an overall higher quality of life. Data were too divergent to rank the other bladder management methods. However, by improving continence, each method aims to enhance quality of life.

ICON 2020-International Scientific Tendinopathy Symposium Consensus: A Scoping Review of Psychological and Psychosocial Constructs and Outcome Measures Reported in Tendinopathy Clinical Trials.

To identify and describe the psychological and psychosocial constructs and outcome measures used in tendinopathy research. Scoping review. We searched the PubMed, EMBASE, Scopus, Web of Science, PEDro, CINAHL, and APA PsychNet databases on July 10, 2021, for all published studies of tendinopathy populations measuring psychological and psychosocial factors. Studies using a clinical diagnosis of tendinopathy or synonyms (eg, jumper's knee or subacromial impingement) with or without imaging confirmation. We described the volume, nature, distribution, and characteristics of psychological and psychosocial outcomes reported in the tendinopathy field. Twenty-nine constructs were identified, including 16 psychological and 13 psychosocial constructs. The most frequently-reported constructs were work-related outcomes (32%), quality of life (31%), depression (30%), anxiety (18%), and fear (14%). Outcome measures consisted of validated and nonvalidated questionnaires and 1-item custom questions (including demographics). The number of different outcome measures used to assess an individual construct ranged between 1 (emotional distress) and 11 (quality of life) per construct. There was a large variability in constructs and outcome measures reported in tendinopathy research, which limits conclusions about the relationship between psychological and psychosocial constructs, outcome measures, and tendinopathies. Given the wide range of psychological and psychosocial constructs reported, there is an urgent need to develop a core outcome set in tendinopathy. J Orthop Sports Phys Ther 2022;52(6):375-388. doi:10.2519/jospt.2022.11005.

For patients with non-obstructive azoospermia, the outcome of testicular sperm extraction correlates with self-esteem, sexual health and the quality of the couple\u2019s relationship

BackgroundA very small number of studies have indicated that azoospermia or negative testicular sperm extraction (TESE) outcomes are linked to depression or erectile dysfunction. However, the data are often weak, conflicting and gathered with non-validated questionnaires. Hence, we performed a cross-sectional study of 44 men with non-obstructive azoospermia. Levels of self-esteem and the quality of the couple’s sex life and overall relationship were assessed with validated questionnaires before and after the TESE procedure as a function of the TESE outcome.ResultsA positive TESE outcome (n = 24) was associated with a statistically significant increase in self-esteem (particularly with regard to family aspects), sexual health and couples’ adjustment quality. In contrast, a negative TESE outcome (n = 20) was associated with statistically significant decreases in self-esteem, erectile function, intercourse satisfaction, orgasmic function, couples’ adjustment quality and all aspects of the couple’s relationship (consensus, cohesion, satisfaction and affection).ConclusionFor men with non-obstructive azoospermia (NOA), negative TESE outcomes may have a negative impact on self-esteem and the quality of the couple’s sex life and overall relationship. This should be borne in mind when counselling men with NOA and their partners to (ideally) help them to cope with and decrease the harmful impacts of azoospermia and negative TESE.

Mapping the prevalence and use of questionnaires to detect the neglected sexual side effects after prostate cancer treatment: a scoping review

BackgroundEarly prostate cancer (PCa) treatment interventions may leave men with debilitating sexual side effects, especially when not diagnosed or present at initial follow-up treatment. Men are often embarrassed to disclose their sexual dysfunction. This may lead to sexual side effects related to PCa treatment remaining untreated, adding to their burden of disability. This study was conducted to map the evidence on the prevalence of neglected sexual side effects (NSSE) after radical prostatectomy (RP) surgery or radiation treatment (RT) for PCa treatment and the reported use of questionnaires to identify such side effects.MethodsThis systematic scoping review’s search strategy involved searching MEDLINE/PubMed, Science Direct and Google Scholar databases. Guided by eligibility criteria, two independent reviewers conducted title, abstract and full-text screening. Data from the included studies were extracted. The review team explored the implications of the findings in relation to the research question and aims of the study. The Mixed Method Appraisal Tool was used to appraise the quality of the included studies. This review is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines.ResultsSearches of the databases identified 1369 articles, with 23 eventually included for review. The prevalence of NSSE ranged between 0 and 78% in studies reporting on early PCa treatment of RP and RT patients. Orgasmic dysfunction (5–78%), penile curvature changes (10–15.9%) and penile length shortening (0–55%) similarly showed a low to moderate prevalence. Climacturia had low prevalence (4–5.2%) after RT and moderate prevalence (21–38%) after RP, whilst anejaculation had low to high prevalence (11–72%) after RT. No validated questionnaire was used to detect any NSSE after early PCa treatment. Studies mainly modified other questionnaires, and two studies used non-validated questionnaires to identify some NSSE. Participants in the included studies reported being inadequately informed about the possible sexual side effects of their treatment.ConclusionThis study showed a low to a high prevalence of NSSE in men after RP and RT for early PCa treatment. Questionnaires helped detect individual NSSEs after PCa treatment but there is currently no evidence of a valid, reliable and comprehensive questionnaire to detect the NSSE collectively.Scoping review registrationN/A

Health-Related Quality of Life in Locally Advanced Gastric Cancer: A Systematic Review.

Simple SummaryEvaluating health-related quality of life (HRQOL) is important because it reflects the impact of treatment from the patient’s perspective. This holds especially true when prognosis is poor, as is the case for gastric cancer patients. This systematic review was performed to evaluate the short- and long-term impacts of current treatments on HRQOL in patients with locally advanced gastric cancer. The results of this review show that surgery and chemoradiotherapy have a significant impact on short-term HRQOL, although this recovers after 6–12 months. More focus on HRQOL in current clinical practice might improve patient counselling and monitoring before, during, and after treatment in locally advanced gastric cancer patients.Background: Current treatment strategies have been designed to improve survival in locally advanced gastric cancer patients. Besides its impact on survival, treatment also affects health-related quality of life (HRQOL), but an overview of reported studies is currently lacking. The aim of this systematic review was therefore to determine the short- and long-term impact of chemotherapy, surgery, and (chemo)radiotherapy on HRQOL in locally advanced, non-metastatic gastric cancer patients. Methods: A systematic review was performed including studies published between January 2000 and February 2021. We extracted studies published in Medline, Embase, and Scopus databases that assessed HRQOL in patients with locally advanced, non-metastatic gastric cancer treated with curative intent. Studies using non-validated HRQOL questionnaires were excluded. Short-term and long-term HRQOL were defined as HRQOL scores within and beyond 6 months after treatment, respectively. Results: Initially, we identified 8705 articles (4037 of which were duplicates, i.e., 46%) and ultimately included 10 articles. Most studies reported that short-term HRQOL worsened in the follow-up period from 6 weeks to 3 months after surgery. However, recovery of HRQOL to preoperative levels occurred after 6 months. After completion of chemoradiotherapy, the same pattern was seen with worse HRQOL after treatment and a recovery of HRQOL after 6–12 months. Conclusions: In patients with locally advanced, non-metastatic gastric cancer, HRQOL deteriorated during the first 3 months after surgery and chemoradiotherapy. However, the long-term data showed a recovery of HRQOL after 6–12 months. To implement HRQOL in clinical decision making in current clinical practice, more research is needed.

Factors influencing the 8-item contact lens dry eye questionnaire score and comparison of translations in Japanese soft contact lens wearers

PurposeTo determine (1) the factors associated with a high degree of self-reported symptoms with Japanese translations of the 8-Item Contact Lens Dry Eye Questionnaire (J-CLDEQ-8) in a cross-section of soft contact lens (SCL) wearers in Japan and (2) whether the difference in translation of the CLDEQ-8 affects the scores between validated and non-validated versions of the Japanese translation. MethodsHabitual SCL wearers completed the validated J-CLDEQ-8 and a previous non-validated version. Demographics and SCL history questions were queried when they presented for routine eye care in nine geographically distinct clinics across Japan. The following risk factors for high J-CLDEQ-8 scores (≥11) were tested: sex, age, SCL replacement (daily disposable vs. bi-weekly and monthly reusable), years of SCL wear, and self-reported use of rewetting drops. The scores of the validated and non-validated questionnaires were compared. ResultsSignificant patient-related risk factors for high J-CLDEQ-8 scores were female sex, use of reusable SCLs, longer years of SCL wear, and use of rewetting drops. Scores for six out of eight questions in the validated J-CLDEQ-8 were significantly higher than those of the non-validated version, resulting in a significant difference in the average total score between the two questionnaires (validated J-CLDEQ-8: 10.5 ± 5.9 vs non-validated J-CLDEQ-8: 9.5 ± 5.8, P < 0.001). ConclusionsFemale sex, use of reusable SCLs, longer years of SCL wear, and use of rewetting drops were significant risk factors for high J-CLDEQ-8 scores in a cross-sectional clinical population of Japanese SCL wearers. Symptoms with SCL are not predicted by age and must therefore be queried at follow-up visits for all SCL wearers. Differences in the two translations affected the ability of the questionnaire to identify individuals with high symptoms associated with SCL wear.

REGISTRIES AND CARE OF NMD: EP.344 The international GNE myopathy patient registry

The GNE myopathy registry is an international, patient reported, disease specific database which provides the neuromuscular community with a valuable, flexible and sustainable resource of disease specific information. The registry can be used to support planning and recruitment for clinical trials, and to capture real-world patient data (including data that may contribute to post marketing surveillance and standards of care). The GNE registry is managed by the John Walton muscular dystrophy research centre (JWMDRC, Newcastle University, UK) and supervised by an international steering committee. The GNE myopathy registry helps to facilitate translational research. The registry is available in 7 languages, collecting data since March 2014 with over 350 participants from 48 countries worldwide. To contribute to the disease understanding by collecting reliable clinical information; facilitating clinical trial readiness and translational research by helping the recruitment of patients into clinical trials; helping to overcome the scarcity of resources and the geographic isolation of patients; informing patients and the GNE myopathy community of latest developments in scientific research and disease management via newsletters. Patient reported data gathered through disease specific questionnaires, GNEM-FAS, quality of life (SF12) and other non-validated questionnaires. The registry has allowed a genotype-phenotype study to be conducted (NCT01417533). Ten newsletters have been produced in 7 languages and distributed to the registry participants and to the neuromuscular community via the TREAT-NMD network. The registry helped to facilitate recruitment for patient advocacy meetings, clinical trials (NCT02736188, NCT02377921) and a natural history study (NCT01784679). The registry has also participated in EURORDIS and MDUK research, namely The Voice of rare disease patients and GNE patient's day. The international GNE myopathy patient registry is a valuable research and communication tool for this ultra-rare disease.