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The winter months are an important part of the year for raptors as survival throughout this period is critical for the succeeding year's population recruitment. We reveal novel insights into the wintering of kites (Milvus spp.) on the Mediterranean island of Crete, Greece. We use a combination of 1) direct field observations, 2) online photograph searches and 3) analysis of satellite telemetry data from a tagged hybrid Red Kite × Black Kite (Milvus milvus × M. migrans migrans). The number of observations of wintering kites has increased since 1998. The wintering of numerous Black Kites with morphological features of both subspecies (M. migrans migrans and M. migrans lineatus) and a hybrid Red Kite × Black Kite is a new phenomenon on Crete. [ABSTRACT FROM AUTHOR]

Background: Short bowel syndrome (SBS) is a malabsorptive condition that can result in intestinal failure (SBS‐IF). Many patients with SBS‐IF require home parenteral nutrition (PN) for survival. However, PN has profound effects on patients and their family members. The present study aimed to understand the lived experience of SBS‐IF for patients and their families. Methods: In‐depth semi‐structured qualitative interviews were conducted with 15 patients with SBS‐IF and five adult family members living with someone with SBS‐IF. A patient‐centric approach was taken, with a patient steering group providing input and guidance to develop the interview guide. Key concepts were identified using thematic analysis of interview transcripts. Results: Patients' lives were dominated by having SBS‐IF. They described physical impacts that included patient‐reported signs and symptoms and physical restrictions comprising of restrictions on daily life, actives of daily living and physical functioning. In addition, they encountered emotional impacts with a plethora of negative feelings and social impacts, such as difficulties socialising and maintaining relationships. Patients coped by adapting their life around SBS‐IF, having support and adopting an attitude of gratitude and acceptance. Family members were also affected and, along with patients, appreciated the respite of a night off from infusions. Conclusions: Patients and families face many difficulties with SBS‐IF. Healthcare professionals can support patients by facilitating them explore what others have found beneficial; adapting their life around PN, viewing PN with acceptance and trying to cultivate gratitude. Further research into the support required for families may be beneficial. [ABSTRACT FROM AUTHOR]

The paper presents results of a laboratory investigation of the microbiological environment assisted stress corrosion cracking of carbon steel in chloride solutions. Carbon steel specimens were subjected to slow strain rate testing (SSRT) in an aqueous solution of 3·5% sodium chloride, with and without a microbiological culture. Specimens tested in the biotic (microbiological) conditions showed a considerable loss of ductility, as compared to those tested in abiotic conditions. Fractography of the specimens tested in abiotic solutions suggested features of only ductile failure (dimples), whereas those tested in biotic conditions also had features of brittle cracking. Results of SSRT tests of the specimens pre-subjected to the electrochemical conditions for hydrogen charging have indicated susceptibility of the steel to hydrogen assisted cracking, and therefore suggesting a role of microbial environment in promoting hydrogen assisted cracking. [ABSTRACT FROM AUTHOR]

The mosquito fungal pathogen Culicinomyces clavisporus was found to be sensitive to the antibiotics hygromycin B and phleomycin but resistant to kanamycin and geneticin. Protoplasts were genetically transformed to give strains resistant to phleomycin and hygromycin B. The results show that multiple integrations of transforming DNA can occur and that heterologous fungal gene expression signals are functional in C. clavisporus. [ABSTRACT FROM AUTHOR]

Introduction: Canine osteoarthritis (OA) causes pain and mobility impairment. This can reduce dog quality of life (QoL), owner QoL and owners' satisfaction with, and adherence to, treatments. No existing canine OA-specific instrument assesses all three impacts. This study aimed to develop and psychometrically evaluate an owner-completed canine OA-specific measure of dog QoL, owner QoL and owner treatment satisfaction; the "Canine OA Quality of Life and Treatment Satisfaction Questionnaire" (CaOA-QoL-TS)., Methods: The CaOA-QoL-TS was developed using a conceptual model derived from a meta-synthesis of published literature followed by cognitive interviews with ten owners of dogs with OA, to evaluate content validity., Results: Based on interview findings, ten items were reworded, four removed, and two added; resulting in 26 items that all owners understood and considered relevant. The recall period and response options were well understood and appropriate to almost all owners. To evaluate its psychometric properties, the CaOA-QoL-TS (draft 26-item version) was administered, across six timepoints in a phase 4 field study, to owners of OA treated dogs, recruited from veterinary practices ( N  = 93). Inter-item correlations suggested items clustered into three distinct domains: Dog QoL, Owner QoL and Treatment Satisfaction, as hypothesized. Confirmatory factor analysis supported deletion of two items and calculation of the three domain scores, with acceptable model fit. The resulting 24-item CaOA-QoL-TS instrument demonstrated strong internal consistency and good to excellent test-retest reliability. Convergent validity was supported by moderate to strong correlations with concurrent measures. Known groups validity was supported by statistically significant differences between groups categorized by owner global impression of QoL. Ability to detect change was demonstrated through statistically significant improvements over time in Owner and Dog QoL, with larger within-group effect sizes reported for the mean of 'improved' dogs compared to the mean of 'stable' dogs. Only a small sample of dogs worsened throughout the study. Anchor-based analyses supported-0.9 and-1.0-point within-group responder definitions for dog and owner QoL domains, respectively., Discussion: Findings support the content validity of the CaOA-QoL-TS in canine OA. The 24-item CaOA-QoL-TS is a reliable and valid instrument to measure owner and canine QoL and TS and is sensitive to improvements following OA treatment., Competing Interests: EG and JT were employed by Zoetis International. KF, GS, SL, NW and CP were employed by Adelphi Values. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision. The authors declare that this study received funding from Zoetis Inc. The funder had the following involvement in the study: study design, data collection, preparation of the manuscript for publication, funding the journal’s service fees., (Copyright © 2024 Gildea, Scales-Theobald, Thompson, Cook, Forde, Skingley, Lawrie, Williamson and Panter.)

Introduction: Amblyopia is a reduction in vision in one or both eyes due to impaired development of the visual pathway. This study explored the experience of amblyopia and treatment from the patient, caregiver, and clinician perspectives., Methods: A targeted literature review, including a review of social media listening (SML) studies, was conducted. Next, qualitative interviews were conducted with amblyopia patients, caregivers of children with amblyopia, and ophthalmologists with experience treating patients with amblyopia. The findings informed the development of a disease model. Amblyopia clinical experts provided input at key stages., Results: Twelve data sources were reviewed, including qualitative studies in the literature and SML studies. Overall, 133 patients/caregivers were interviewed (23 adults, 16 adolescents, 47 child-caregiver dyads), plus 10 ophthalmologists from the United States, France, and Germany. Reduced visual acuity, impaired depth perception, impaired peripheral vision, and double vision were the most frequently reported symptoms. Amblyopia impacted daily activities (reading, using digital devices), the ability to move around, school/work (productivity, seeing the board in class), emotional well-being (frustration, sadness), and social functioning (difficulty socializing). Treatments, including patching and corrective lens, also impacted daily activities (using digital devices, sports/leisure), mobility (bumping into things), and work/school (tasks taking longer) as well as emotional well-being (embarrassment), and social functioning (bullying/stigma)., Conclusion: The findings contribute valuable insights into the adult and pediatric experience of amblyopia from a multi-stakeholder perspective. The findings were used to critically assess existing clinical outcome assessments and supported the development of patient- and observer-reported outcome measures for use in amblyopia clinical trials., (© 2023. The Author(s).)

Introduction: Lichen planus (LP) is an inflammatory skin disorder that can present in various forms across the body, including lesions on the skin (cutaneous LP [CLP]), scalp (lichen planopilaris [LPP]), and mucosal regions (mucosal LP [MLP]). Qualitative exploration of the patient experience of LP, notably symptoms and impacts on health-related quality of life (HRQoL), is limited. A scarcity of research was also identified relating to emotional wellbeing impacts of CLP patients. Two qualitative studies were conducted with LP patients to address these gaps., Methods: Study 1 consisted of exit interviews conducted with a subset of adult patients with MLP (n = 5), CLP (n = 4), and LPP (n = 4) enrolled in an LP clinical study in the United States (US) to explore the patient experience. Study 2 consisted of independent qualitative interviews conducted with adult CLP patients (n = 13) from the US and Germany to further explore impacts on emotional wellbeing., Results: Exit interviews found that itch , pain, and skin lesions were most frequently reported as signs/symptoms of LP. Itch and skin lesions were experienced across all LP subtypes, while pain was only reported by CLP and MLP patients. These signs/symptoms impacted HRQoL including emotional wellbeing (frustration, embarrassment), daily activities (oral hygiene, clothing options), social functioning (intimacy, social activities), and physical functioning (chewing/swallowing, opening/moving mouth). Impacts on activities of daily living (ADL) and physical functioning were mostly experienced by MLP patients. Independent qualitative interviews, which further explored impacts of CLP on patients' emotional wellbeing, identified frustration, worry, sadness, embarrassment, and depression as the most frequently experienced., Conclusion: The findings contribute to the literature by providing qualitative insights into signs/symptoms and HRQoL impacts of LP, from the adult patient perspective. The findings also highlight the importance of considering assessment of HRQoL impacts in future clinical LP research, particularly impacts on emotional wellbeing when selecting instruments for assessment of HRQoL in the CLP population., Trial Registration: NCT04300296., (© 2023. The Author(s).)

Background: Dengue is the most prevalent arboviral infection causing an estimated 50-60 million cases of febrile illness globally per year, exacting considerable disease burden. Few instruments exist to assess the patient illness experience, with most based on healthcare provider assessment, lacking standardization in timepoints and symptom assessment. This study aimed to evaluate the content validity of the novel 'Dengue Virus Daily Diary (DENV-DD)', designed to measure symptom intensity and disease burden within outpatient infant to adult populations., Methods: The Dengue Illness Index Report Card was used as a foundation to create the DENV-DD, consisting of patient- and observer-reported outcome (PRO/ObsRO) instruments. In two South American dengue-endemic communities, qualitative combined concept elicitation and cognitive debriefing interviews were conducted among individuals and caregivers of children with symptomatic laboratory-confirmed dengue. Interviews were conducted across two rounds allowing DENV-DD modifications. A small-scale quantitative assessment of the DENV-DD was also conducted with data from an independent Dengue Human Infection Model (DHIM) to generate early evidence of feasibility of DENV-DD completion, instrument performance and insight into the sign/symptom trajectory over the course of illness., Results: Forty-eight participants were interviewed (20 adults, 20 older children/adolescents with their caregivers, 8 caregivers of younger children). A wide spectrum of signs/symptoms lasting 3-15 days were reported with fever, headache, body ache/pain, loss of appetite, and body weakness each reported by > 70% participants. DENV-DD instructions, items and response scales were understood, and items were considered relevant across ages. DHIM data supported feasibility of DENV-DD completion., Conclusions: Findings demonstrate content validity of the DENV-DD (PRO/ObsRO instruments) in dengue-endemic populations. Psychometric and cultural validity studies are ongoing to support use of the DENV-DD in clinical studies., (© 2023. International Society for Quality of Life Research (ISOQOL).)

Introduction: Amblyopia is a neurodevelopmental vision disorder, characterized by poor vision in one or both eyes. Given the lack of existing clinical outcome assessments (COA) considered fit-for-purpose for amblyopia clinical trials, this study developed new COAs to assess amblyopia symptoms and health-related quality of life (HRQoL) impacts in adult and pediatric amblyopia populations that conform with best practice standards and regulatory guidelines., Methods: Findings from a targeted qualitative literature review informed the development of three versions of the new Amblyopia Quality of Life Questionnaire (AmbQoL): a patient-reported outcome measure (PRO) for individuals aged 13 years and older, a PRO for children aged 9-12 years, and an observer-reported outcome measure (ObsRO) for caregivers of children aged 4-8 years. Qualitative interviews were conducted with the target populations, and with ophthalmologists experienced in treating amblyopia patients to evaluate the content validity for further development of the AmbQoL. A translatability assessment was conducted to ensure cultural appropriateness and usability across multiple languages. Feedback from Food and Drug Administration (FDA) was also sought on the instruments, and clinical experts provided input at key stages., Results: Interviews were conducted with 112 patients/caregivers and ten ophthalmologists from the USA, France, and Germany. The instructions, items, and response options were well understood across all AmbQoL versions. Feedback from the patients, caregivers, ophthalmologists, the translatability assessment, the FDA, and the expert clinicians informed minor wording modifications to enhance clarity and translatability. Some items were removed due to low relevance. The study resulted in a 23-item adult/adolescent PRO, 24-item child PRO, and 12-item ObsRO, each employing a 7-day recall period., Conclusion: Each AmbQoL version has documented support for its face and content validity for use in amblyopia populations aged ≥ 4 years. Further research is necessary to evaluate the psychometric measurement properties of the AmbQoL instruments to enable their use in amblyopia treatment trials., (© 2023. The Author(s).)

Introduction: Treatment decisions in older adults with acute myeloid leukemia (AML) are challenging, particularly for those who are not candidates for intensive chemotherapy (IC), and the trade-offs patients, their families and physicians consider when choosing a treatment option are not well understood. This qualitative research explored the value of extending survival and the treatment decision-making process from a multi-stakeholder perspective., Methods: Overall, 28 patients with AML (≥ 65 years old, unsuitable for IC), 25 of their relatives and 10 independent physicians from the US, UK and Canada took part in one-on-one, 60-minute qualitative interviews., Results: Across all stakeholders, improved health-related quality of life (HRQoL), extended survival and relief of AML symptoms were recognized as most important in AML treatment decision-making. However, extending survival in 'good health' was more important than extending survival alone, particularly because of the extra time it gives patients and their relatives together, and allows patients to achieve important goals. Patients' limited understanding of available treatment options, paired with incorrect perceptions of treatment side effects, impacted their involvement in the treatment decision-making process. Patients and physicians perceived physicians to have the most influence in the decision-making process despite their priorities not always aligning., Conclusion: These findings illustrate the importance of having structured discussions which explicitly assess patients' goals and their understanding and expectations of treatments and also the need for patient friendly resources about the lived experience of AML and available treatment options. These measures will help to ensure that patients are fully involved in the shared decision-making process., (© 2022. The Author(s).)

Aim: To investigate use of the 'Managing Advanced Cancer Pain Together' conversation tool between individuals with advanced cancer and healthcare professionals (HCPs) during routine consultations. Methods: Twenty-one patients and six HCPs completed questionnaires before and after use of the tool (at their routine consultation 1 and consecutive consultation 2, respectively). Results: Patients and HCPs were satisfied with communication during both consultations. When using the tool, patients most frequently selected physical pain descriptors (95.2%), followed by emotional (81.0%), social (28.6%) and spiritual (28.6%) descriptors. Patients found the tool useful, stating that it helped them describe their pain. HCPs considered the tool difficult to incorporate into consultations. Conclusion: The study highlighted the need to consider the various aspects of cancer pain.

Purpose: Endometriosis is a chronic disorder of the female reproductive system characterized by debilitating symptoms, particularly endometriosis-related pain (ERP). Patient-reported outcome (PRO) measures of symptoms and impacts are required to assess disease severity in ERP clinical studies and clinical practice. A content-valid instrument was developed by modifying the Dysmenorrhea Daily Diary (DysDD) to form the Endometriosis Daily Diary (EDD), an electronic PRO administered via handheld device., Methods: Qualitative research with US females with ERP was conducted in three stages: (1) Development of an endometriosis conceptual model based on qualitative literature and conduct of concept elicitation (CE) interviews (N = 30). (2) Cognitive debriefing (CD) interviews (N = 30) conducted across two rounds to assess relevance and understanding of the EDD, with modifications between interview rounds. (3) Pilot testing to assess usability/feasibility of administrating the EDD daily on an electronic handheld device (N = 15). Clinical experts provided guidance throughout the study., Results: The conceptual model provided a comprehensive summary of endometriosis to inform modifications to the DysDD, forming the EDD. CD results demonstrated that EDD items were relevant for most participants. Instructions, items, response scales, and recall period were well-understood. The resulting daily diary assesses severity of cyclic and non-cyclic pelvic pain, dyspareunia, impact of ERP on functioning and daily life, symptoms associated with ERP, and bowel symptoms. Participants were able to complete the diary daily and found the device easy to use., Conclusion: The EDD demonstrated good content validity in females experiencing ERP. The next step is to perform psychometric validation in an ERP sample., (© 2022. The Author(s).)

Background: Disease-specific patient-reported outcome measures (PROMs) are fundamental to understanding the impact on, and expectations of, patients with genetic disorders, and can facilitate constructive and educated conversations about treatments and outcomes. However, generic PROMs may fail to capture disease-specific concerns. Here we report the development and validation of a Gaucher disease (GD)-specific PROM for patients with type 1 Gaucher disease (GD1) a lysosomal storage disorder characterized by hepatosplenomegaly, thrombocytopenia, anemia, bruising, bone disease, and fatigue., Results and Discussion: The questionnaire was initially developed with input from 85 patients or parents of patients with GD1 or GD3 in Israel. Owing to few participating patients with GD3, content validity was assessed for patients with GD1 only. Content validity of the revised questionnaire was assessed in 33 patients in the US, France, and Israel according to US Food and Drug Administration standards, with input from a panel of six GD experts and one patient advocate representative. Concept elicitation interviews explored patient experience of symptoms and treatments, and a cognitive debriefing exercise explored patients' understanding and relevance of instructions, items, response scales, and recall period. Two versions of the questionnaire were subsequently developed: a 24-item version for routine monitoring in clinical practice (rmGD1-PROM), and a 17-item version for use in clinical trials (ctGD1-PROM). Psychometric validation of the ctGD1-PROM was assessed in 46 adult patients with GD1 and re-administered two weeks later to examine test-retest reliability. Findings from the psychometric validation study revealed excellent internal consistency and strong evidence of convergent validity of the ctGD1-PROM based on correlations with the 36-item Short Form Health Survey. Most items were found to show moderate, good, or excellent test-retest reliability., Conclusions: Development of the ctGD1-PROM represents an important step forward for researchers measuring the impact of GD and its respective treatment., (© 2022. The Author(s).)

Quaternary ammonium compounds have been used as antibacterial materials. However, as they are hydrophilic and produce a positively charged surface, it is challenging to develop a durable antimicrobial coating of such compounds. The objective of this study is to investigate a two-step silane coating incorporated with quaternary ammonium silane for mitigation of microbiologically influenced corrosion (MIC) of mild steel in biotic solution (a marine environment with bacteria). The corrosion resistance was characterized by electrochemical impedance spectroscopy and potentiodynamic polarization tests. The intact silane coating and that pre-exposed to the biotic solution were characterized by attenuated total reflectance-Fourier transform infrared spectroscopy (ATR-FTIR). The most probable method (MPN) was used to quantify the active microorganisms attached to the uncoated and silane-coated surfaces. Electrochemical results reveal that the coating thus developed improved the corrosion resistance of steel in the biotic solution. The MPN, FTIR, and scanning electron microscopy suggest a significant decrease in the number of active cells that get attached to the coated surface., Competing Interests: The authors declare no competing financial interest., (© 2021 The Authors. Published by American Chemical Society.)

Background: Many patients with hand osteoarthritis (HOA) experience reduced health-related quality of life. This study sought to better understand the disease and treatment experience of individuals with HOA, explore any differences in experiences between erosive and non-erosive HOA sub-types, and evaluate content validity of the Michigan Hand Outcomes Questionnaire (MHQ) in HOA., Methods: Thirty subjects from the United States (n = 15 erosive HOA; n = 15 non-erosive HOA) participated in semi-structured interviews: concept elicitation explored symptoms/impacts important to patients; cognitive interviews assessed understanding and relevance of the MHQ. A sub-sample participated in real-time data capture (RTDC) activities via a smartphone/tablet app over 7 days. Verbatim transcripts were coded using Atlas.ti software and thematically analyzed. Concept saturation and MHQ content validity were evaluated., Results: Most participants reported experiencing pain, swelling and stiffness, symptoms that most commonly had a direct impact on physical functioning. Substantial impacts on activities of daily living, emotional functioning, sleep and work were also reported. RTDC findings corroborated concept elicitation findings. There were no notable differences between erosive and non-erosive HOA, except nodules were reported more frequently in erosive disease. Most participants used analgesic treatments, but effects were short-lived. Pain was the symptom most frequently reported as most bothersome and important to treat. Concept saturation was achieved. MHQ items and instructions were well understood and relevant to most participants; stiffness and swelling were reported as important symptoms not included in the MHQ., Conclusions: This study characterizes key symptoms of HOA which are burdensome for patients and not well controlled by current therapies, highlighting an unmet treatment need. Although the study is limited by a small sample size that may not be representative of the broader erosive and non-erosive HOA population, concept saturation was achieved, and our findings suggest that disease experience is similar for patients with erosive and non-erosive HOA. Evaluation of stiffness and swelling items in conjunction with the MHQ may enhance relevance and improve measurement precision to assess important domains of HQRoL in an HOA population.

Background: The lower-risk (low and intermediate-1 risk based on IPSS) myelodysplastic syndrome (MDS) has a negative impact on patients' health-related quality of life (HRQoL). Patient Reported Outcomes (PROs) instruments, which are used to collect patients' HRQoL data, should have established content validity in the target population to ensure that the instrument is comprehensive and comprehensible. The present study was conducted to evaluate the content validity of the Quality of Life in Myelodysplasia Scale (QUALMS) and the Functional Assessment of Cancer Therapy-Anemia (FACT-An) PRO instruments in patients with lower-risk MDS., Methods: In this cross-sectional, qualitative study, 16 patients aged ≥18 years with lower-risk MDS, who were RBC transfusion dependent, literate and fluent in US-English were interviewed. Interviews were semi-structured comprising of two parts: concept elicitation (CE) explored symptoms and impacts important to patients, and cognitive debriefing (CD) assessed understanding and relevance of the QUALMS and FACT-An. A conceptual model was developed, which was used to map the concepts that emerged during CE onto the QUALMS and FACT-An to assess concept coverage and suitability of the instruments., Results: The median age of participants was 67.5 years (range: 51-91), with half being female (n = 8). Nine (56.2%) participants had intermediate-1-risk MDS and 10 (62.5%) were relapsed or refractory to erythropoiesis-stimulating agent treatment. Fatigue/tiredness (100.0%), shortness of breath (87.5%), weakness (81.2%), and low energy (75.0%) were reported most commonly and were the most bothersome symptoms as well. Of seven high-level HRQoL domains identified, activities of daily living (n = 16, 100.0%), physical functioning (n = 15, 93.8%), emotional wellbeing (n = 13, 81.3%), social functioning (n = 12, 75.0%), sleep disturbance (n = 9, 56.3%), and impact on work (n = 9, 56.3%) were the most commonly reported. For CD, the QUALMS and FACT-An were found to be mostly relevant and very well understood; response options were easy to use, and recall period was appropriate., Conclusion: Both QUALMS and FACT-An demonstrated a strong face and content validity in patients with lower-risk MDS, suggesting that these instruments are appropriate for assessing HRQoL in this population.

Background: The International Classification of Functioning, Disability and Health (ICF) aims to comprehensively describe the ways in which a person's health condition affects their life. This study aimed to contribute to the development of an ICF core set for gout through patient opinion derived from focus groups and interviews., Methods: We conducted a secondary qualitative analysis of data from three studies investigating the patient experience of gout. In total there were 30 individual interviews and 2 focus groups ( N  = 17) comprising 47 participants. We conducted thematic analysis of the textual data to extract meaning units, which were then linked to the ICF., Results: A large number of ICF categories were relevant to patients with gout. Participants mentioned 93 third level categories, 17 of which were mentioned by more than 50% of patients. The most references for a single category was for b280, Sensation of pain , followed by personal factors (not yet categorised by the ICF). The most participants mentioned the environmental factor e355, Health professional support , followed by b280, Sensation of pain ., Conclusion: The categories identified in this study as relevant to patients with gout highlight the severe pain associated with this disease, the impact on mobility and corresponding life areas. The roles of health professional support, medication, and personal attitudes to disease management are also reflected in the data. These results will contribute to the development of the ICF core set for gout., Competing Interests: Competing interestsND has received consulting fees, speaker fees or grants from Takeda, Ardea, AstraZeneca, Cymabay, Abbvie, and Crealta, outside the submitted work. WT has received consulting fees from Pfizer (NZ) and Janssen-Cilag Pty Ltd., outside the submitted work. CDT has received consulting fees, speaker fees or grants from AstraZeneca and Grünenthal. BRT declares no conflicts of interest. RA, ST and CP are employees of Adelphi Values and as such were contracted by Pfizer to conduct the research; they perform research for many other pharmaceutical companies for payment., (© The Author(s) 2020.)

Background: Little is known about the humanistic burden of small cell lung cancer (SCLC), specifically the impact on health-related quality of life (HRQoL). The aim of this systematic literature review was to explore the impact of SCLC on HRQoL and the patient reported outcomes (PROs) used to capture this impact. Methods: We conducted a systematic search of Medline®, Embase, and PsycINFO, oncology organization websites and conference proceedings within the past 10 years. Articles reporting HRQoL outcomes of SCLC patients were selected. Results: Twenty-seven eligible publications were identified. Global or overall impact on HRQoL ( n = 21) was reported most often, with considerably fewer reporting individual domains that comprise HRQoL. Results indicated that HRQoL was negatively impacted in SCLC patients in comparison to the normal population in most domains. Overall, the domains measuring physical functioning and activities of daily living were most impacted. However, results on cognitive and emotional functioning were inconclusive. The impact on HRQoL may be least in both limited disease and extensive disease (ED) SCLC patients who have responded to treatment, and greatest in ED patients who were treatment naïve. The most frequently used PROs were the EORTC QLQ-C30 core cancer instruments, the lung cancer specific module the EORTC QLQ-LC13, LCSS, and EQ-5D. Conclusion: There exists a paucity of reporting on SCLC HRQoL outcomes. This extends to the reporting of domain level scores and by patient sub-group. Greater reporting at a granular level is recommended to allow for more robust conclusions to be made.

Background: The use of angiotensin-converting enzyme inhibitors (ACEI) has been associated with the development of bradykinin-mediated angioedema. With ever-widening indications for ACEI in diseases including hypertension, congestive heart failure and diabetic nephropathy, a concomitant increase in ACEI-Angioedema (ACEI-A) has been reported. At present there is no validated severity scoring or discharge criteria for ACEI-A. We sought to develop and validate an investigator rating scale with corresponding discharge criteria using clinicians experienced in treating ACEI-A., Methods: In-depth, 60-min qualitative telephone interviews were conducted with 12 US-based emergency physicians. Beforehand, clinicians were sent four case studies describing patients experiencing different severities of angioedema attacks. Clinicians were initially asked open-ended questions about their experience of patients' symptoms, treatment and discharge decisions. Clinicians then rated each patient case study and discussed patient diagnoses, ratings of symptom severity and discharge evaluation. The ratings were used to assess inter-rater reliability of the scale using the intra-class correlation coefficient (ICC) using IBM SPSS analysis Version 19 software., Results: The findings provide support focusing on four key symptoms of airway compromise scored on a 0-4 scale: 1) Difficulty Breathing, 2) Difficulty Swallowing, 3) Voice Changes and 4) Tongue Swelling and the corresponding discharge criteria of a score of 0 or 'No symptoms' for Difficulty Breathing and Difficulty Swallowing and a score of 0 or 1 indicating mild or absence of symptoms for Voice Change and Tongue Swelling. Eleven clinicians agreed the absence of standardized discharge criteria supported the use of this scale. All physicians concurred with the recommended discharge criteria. The clinician ratings provided evidence of strong inter-rater reliability for the rating scale (ICC > 0.80)., Conclusion: The investigator rating scale and discharge criteria are clinically valid, relevant and reliable. Moreover, both address the current unmet need for standardized ED discharge criteria.

Background: Patient-reported outcome (PRO) instruments are important tools for monitoring disease activity and response to treatment in clinical trials and clinical practice. In recent years, there have been movements away from traditional pen-and-paper PROs towards electronic administration. When using electronic PROs (ePROs), evidence that respondents complete ePROs in a similar way to their paper counterparts provides assurance that the two modes of administration are comparable or equivalent. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 item (EORTC QLQ-C30) and associated disease-specific modules are among the most widely used PROs in oncology. Although studies have evaluated the comparability and equivalence of electronic and original paper versions of the EORTC QLQ-C30, no such studies have been conducted to date for the head and neck cancer specific module (EORTC QLQ-H&N35)., Objective: This study aimed to qualitatively assess the comparability of paper and electronic versions of the EORTC QLQ-H&N35., Methods: Ten head and neck cancer patients in the United States underwent structured cognitive debriefing and usability interviews. An open randomized crossover design was used in which participants completed the two modes of administration allocated in a randomized order. Using a "think-aloud" process, participants were asked to speak their thoughts aloud while completing the EORTC QLQ-H&N35. They were thoroughly debriefed on their responses to determine consistency in interpretation and cognitive process when completing the instrument in both paper and electronic format., Results: Participants reported that the EORTC QLQ-H&N35 demonstrated excellent qualitative comparability between modes of administration. The proportion of noncomparable responses (ie, where the thought process used by participants for selecting responses appeared to be different) observed in the study was low (11/350 response pairs [35 items x 10 participants]; 3.1%). Evidence of noncomparability was observed for 9 of the 35 items of the EORTC QLQ-H&N35 and in no more than 2 participants per item. In addition, there were no apparent differences in level of comparability between individual participants or between modes of administration., Conclusions: Mode of administration does not affect participants' response to, or interpretation of, items in the EORTC QLQ-H&N35. The findings from this study add to the existing evidence supporting the use of electronic versions of the EORTC instruments when migrated to electronic platforms according to best practice guidelines., (©Josephine Norquist, Diana Chirovsky, Teja Munshi, Chloe Tolley, Charlotte Panter, Adam Gater. Originally published in JMIR Cancer (http://cancer.jmir.org), 12.05.2017.)

Background and Objectives: Characterized by sudden onset of severe joint pain, swelling, redness, and tenderness to touch, gout 'flare ups' have a substantial impact on quality of life (QoL). This research employed a patient-centered approach to explore the symptoms and impacts of gout, and assess the content validity of existing patient-reported outcomes (PROs)., Methods: Qualitative interviews were conducted with 30 US gout patients (non-tophaceous: n = 20, tophaceous: n = 10) and five expert rheumatologists. Each interview included both concept elicitation (CE) questioning to learn about the patient experience and cognitive debriefing to assess the content validity of three PRO instruments (HAQ-DI, GAQ, and TIQ-20). Nine of the patients provided further real-time qualitative data through a smart phone application. All qualitative data were subject to thematic analysis using Atlas.ti. Two patient advisors and three expert clinicians were engaged as advisors at key stages throughout the research., Results: Interview and real-time data identified the same core symptoms and proximal impact concepts. Severe pain (typically in joints of extremities) was described as the cardinal symptom, often accompanied by swelling, redness, heat, sensitivity to touch, and stiffness. Domains of QoL impacted included physical functioning, sleep, daily activities, and work. The PRO instruments were generally well-understood by patients, but each included items with questionable relevance to at least some of the sample, dependent on the specific joints affected., Conclusions: Gout patients experience severe pain in affected joints, resulting in substantial limitations in physical functioning. Both the HAQ-DI and the TIQ-20 are useful for specific research purposes in the gout population, although modifications are recommended., Competing Interests: Compliance with Ethical Standards This study was sponsored by Pfizer. Katja Rudell and Tara Symonds were employees of Pfizer Ltd when the research was conducted and were shareholders of Pfizer. Sophi Tatlock, Charlotte Panter, and Rob Arbuckle are employees of Adelphi Values who were paid consultants to Pfizer in connection with the development of this manuscript. Leslie Harold and Will Taylor were financially compensated by Pfizer for their participation in the clinicians interviews; however, they were not financially compensated for their involvement in the study or their development of this manuscript. The study was approved and overseen by an Independent Review Board in the US (approval codes: ADE1-14-472, ADE2-14-168) and was performed in accordance with the ethical standards of the Declaration of Helsinki. Written informed consent was obtained prior to the collection of any data.

Background: Asthma-chronic obstructive pulmonary disease overlap (ACO) differs from asthma and chronic obstructive pulmonary disease (COPD) in demographics, phenotypic characteristics and outcomes, yet the patient experience of ACO is poorly characterized. We aimed to understand and compare the patient experience of symptoms and domains of impact in ACO relative to COPD, and assess the content validity of existing patient-reported outcome (PRO) instruments in ACO., Methods: This US qualitative, interview study included patients who met American Thoracic Society/European Respiratory Society spirometric criteria for COPD. Additionally, patients with ACO demonstrated reversibility (forced expiratory volume in 1 s [FEV 1 ] increase ≥ 12% and ≥ 200 mL) to albuterol/salbutamol and an FEV 1 /forced vital capacity ratio < 0.7. Patients took part in concept elicitation (CE) to explore symptoms and impacts of obstructive lung disease. The Exacerbations of Chronic Pulmonary Disease Tool (EXACT), St George's Respiratory Questionnaire (SGRQ) and a daily wheeze assessment were cognitively debriefed to assess relevance and comprehensiveness. Interviews were analyzed using Atlas.Ti. Concept saturation was evaluated at the symptom level., Results: Twenty patients with ACO and 10 patients with COPD were recruited. Patients from both groups indicated that shortness of breath was their most frequent and bothersome symptom. The most frequently reported symptoms in both groups were shortness of breath, cough, wheezing, difficulty breathing, mucus/phlegm, chest tightness, and tiredness, weakness or fatigue. The onset, severity, frequency and duration of symptoms were consistently described across both groups, although a higher proportion of patients with ACO experienced exacerbations versus those with COPD. Impacts on daily living, physical impacts and emotional impacts were commonly described (ACO: 90-100%, COPD: 80-100%). Concept saturation was achieved in both groups. Overall, the EXACT, SGRQ and daily wheeze assessment were well understood and relevant to most patients with ACO or COPD (50-100%) and patients generally found the assessments easy to complete. The PRO instruments adequately captured symptoms described during CE, demonstrating high content validity in ACO and COPD., Conclusions: Patients with ACO and COPD experienced similar symptoms and impacts. The EXACT, SGRQ and assessment of wheeze were well understood and captured concepts relevant to patients with ACO., Competing Interests: Not applicable.This trial was approved by an independent ethical review board in the US (IRB number: ADE2–15-022) and was conducted in accordance with FDA PRO guidelines. All patients provided written informed consent.Not applicable.The authors met the criteria for authorship as recommended by the International Committee of Medical Journal Editors. LN, LL and SP are employees of GSK and hold stocks. AG, CP and CT are employees of Adelphi Values and conducted the study through sponsorship from GSK; they were not paid for manuscript development.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Background: Gold mineworkers in South Africa are exposed to high levels of silica dust as a result of which they are at risk of developing silicosis, which is a compensable disease. The incidence of tuberculosis is also high., Methods: To determine the prevalence of occupational lung disease and the previous compensation history in former migrant mineworkers, a study was undertaken in a random sample of men living in Libode, a rural district of Eastern Cape Province, South Africa. Two hundred thirty-eight ex-mineworkers were examined according to a protocol that included chest radiography and spirometry. Chest radiographs were read into the International Labour Organisation (ILO) classification for pneumoconioses by two readers., Results: The mean age was 52.8 years, and the mean length of service was 12.15 years. The prevalence of pneumoconiosis (> or = ILO 1/0) was 22% and 36% (variation by reader). For both readers, a significant association between length of service and pneumoconiosis and between pneumoconiosis and reduction in FVC and FEV was found. Twenty-four percent of study subjects were eligible for compensation., Conclusion: There is a high prevalence of previously undiagnosed, uncompensated pneumoconiosis in the study group. As a result of the failure to diagnose and compensate occupational lung disease, the social and economic burden of such disease is being borne by individuals, households, and the migrant labor-sending communities as a whole.