Search

Objective: To comparatively evaluate performances of tablet-based versus paper-based Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptom (VEINES-QOL/Sym) questionnaire. Methods: We prospectively evaluated 78 consecutive patients who completed tablet-based and paper-based VEINES-QOL/Sym questionnaires and compared their scores, completion time, data entry time, and ease of use. We used Student's t-test and Wilcoxon test for quantitative variables, Bland–Altman test and kappa coefficient for agreement between questionnaires and patients, respectively. Spearman's correlation coefficient was used to assess correlations. Results: Most participants (83.3%) found it easier to use the tablet device. Less time was needed to complete the tablet-based (median, 4.75; IQR, 3–7 min) than the paper-based (median, 8.3; IQR, 6.3–11.3 min) questionnaire (p <.001). Better educated patients took less time to complete paper-based (p =.003) and tablet-based (p =.001) questionnaires and considered the latter easier to use (p =.010). Conclusions: The tablet-based VEINES-QOL/Sym proved to be an easy-to-use and time-saving tool. [ABSTRACT FROM AUTHOR]

Background: Malnutrition is associated with increased morbidity, mortality, and healthcare costs. Early detection is important for timely intervention. This paper assesses the ability of a machine learning screening tool (MUST‐Plus) implemented in registered dietitian (RD) workflow to identify malnourished patients early in the hospital stay and to improve the diagnosis and documentation rate of malnutrition. Methods: This retrospective cohort study was conducted in a large, urban health system in New York City comprising six hospitals serving a diverse patient population. The study included all patients aged ≥ 18 years, who were not admitted for COVID‐19 and had a length of stay of ≤ 30 days. Results: Of the 7736 hospitalisations that met the inclusion criteria, 1947 (25.2%) were identified as being malnourished by MUST‐Plus‐assisted RD evaluations. The lag between admission and diagnosis improved with MUST‐Plus implementation. The usability of the tool output by RDs exceeded 90%, showing good acceptance by users. When compared pre‐/post‐implementation, the rate of both diagnoses and documentation of malnutrition showed improvement. Conclusion: MUST‐Plus, a machine learning‐based screening tool, shows great promise as a malnutrition screening tool for hospitalised patients when used in conjunction with adequate RD staffing and training about the tool. It performed well across multiple measures and settings. Other health systems can use their electronic health record data to develop, test and implement similar machine learning‐based processes to improve malnutrition screening and facilitate timely intervention. Key points/Highlights: Malnutrition is prevalent among hospitalised patients and frequently goes unrecognised, with the potential for severe sequelae. Accurate diagnosis, documentation and treatment of malnutrition have the potential of having a positive impact on morbidity rate, mortality rate, length of inpatient stay, readmission rate and hospital revenue. The tool's successful application highlights its potential to optimise malnutrition screening in healthcare systems, offering potential benefits for patient outcomes and hospital finances. [ABSTRACT FROM AUTHOR]

Aim: Partnered Pharmacist Medication Charting (PPMC) in patients admitted under general medical units has been shown to reduce medication errors. The aim of this study is to evaluate the impact of the PPMC model on medication errors in patients admitted under cancer units in Victorian hospitals. Methods: A prospective cohort study comparing cohorts before and after the introduction of PPMC was conducted. This included a 2-month pre-intervention phase and 3-month intervention phase. PPMC was implemented during the intervention phase as new model of care that enabled credentialed pharmacists to chart all admission medications, including pre-admission or new medications and cancer therapies, in collaboration with the admitting medical officer. The proportion of medication charts with at least one error was the primary outcome measure. Results: Seven health services across Victoria were included in the study. The majority of health services were using paper-based prescribing systems for oncology. Of the 547 patients who received standard medical medication charting, 331 (60.5%) had at least one medication error identified compared to 18 out of 416 patients (4.3%) using the PPMC model (p < 0.001). The median (interquartile range) inpatient length of stay was 5 (2.9–10.6) days in pre-intervention and 4.9 (2.9–11) days in intervention (p = 0.88). In the intervention arm, 42 patients had cancer therapy charted by a pharmacist with no errors. Conclusions: PPMC was successfully scaled into cancer units as a collaborative medication safety strategy. The model was associated with significantly lower rates of medication errors, including cancer therapies. PPMC should be adopted more widely in cancer units in Australia. [ABSTRACT FROM AUTHOR]

Background Value-based healthcare (VBHC) is a conceptual framework to improve the value of healthcare by health, care-process and economic outcomes. Benchmarking should provide useful information to identify best practices and therefore a good instrument to improve quality across healthcare organizations. This paper aims to provide a proof-of-concept of the feasibility of an international VBHC benchmarking in breast cancer, with the ultimate aim of being used to share best practices with a data-driven approach among healthcare organizations from different health systems. Methods In the VOICE community—a European healthcare centre cluster intending to address VBHC from theory to practice—information on patient-reported, clinical-related, care-process-related and economic-related outcomes were collected. Patient archetypes were identified using clustering techniques and an indicator set following a modified Delphi was defined. Benchmarking was performed using regression models controlling for patient archetypes and socio-demographic characteristics. Results Six hundred and ninety patients from six healthcare centres were included. A set of 50 health, care-process and economic indicators was distilled for benchmarking. Statistically significant differences across sites have been found in most health outcomes, half of the care-process indicators, and all economic indicators, allowing for identifying the best and worst performers. Conclusions To the best of our knowledge, this is the first international experience providing evidence to be used with VBHC benchmarking intention. Differences in indicators across healthcare centres should be used to identify best practices and improve healthcare quality following further research. Applied methods might help to move forward with VBHC benchmarking in other medical conditions. [ABSTRACT FROM AUTHOR]

Background: Acute and late toxicities in patients treated with (chemo)radiotherapy for head and neck cancer (HNC) is common and can negatively impact quality of life and performance. Performance status instruments measure the functional ability to perform daily life activities and are important tools in the oncologic population. Aims: Since Dutch performance status scales for the HNC population are lacking, we conducted this study to translate the Performance Status Scale for Head and Neck Cancer Patients (PSS‐HN) into Dutch (D‐PSS‐HN) and to validate this version. Methods & Procedures: The D‐PSS‐HN was translated into Dutch according to the internationally described cross‐cultural adaptation process. It was administered to HNC patients and together with the Functional Oral Intake Scale completed by a speech and language pathologist at five different time points during the first 5 weeks of (chemo)radiotherapy. Patients were asked each time to complete the Functional Assessment of Cancer Therapy and the Swallowing Quality of Life Questionnaire. Pearson correlation coefficients were used to calculate convergent and discriminant validity and the evolution of D‐PSS‐HN scores was assessed by means of linear mixed models. Outcomes & Results: A total of 35 patients were recruited and > 98% of the clinician‐rated scales were completed. Convergent and discriminant validity were demonstrated, with all correlations rs between 0.467 and 0.819, and between 0.132 and 0.256, respectively. The subscales of the D‐PSS‐HN are sensitive to detect changes through time. Conclusion & Implications: The D‐PSS‐HN is a valid and reliable instrument to assess performance status in patients with HNC treated with (chemo)radiotherapy. It is a useful tool to measure HNC patients' current diet level and functional abilities to perform daily life activities. WHAT THIS PAPER ADDS: What is already known on the subject: Acute and late toxicities in patients treated with (chemo)radiotherapy for HNC are common and can negatively impact quality of life and performance. Performance status instruments measure the functional ability to perform daily life activities and are important tools in the oncologic population. However, Dutch performance status scales for the HNC population are lacking. Therefore, we translated the Performance Status Scale for Head and Neck Cancer Patients (PSS‐HN) into Dutch (D‐PSS‐HN) and validated this version. What this paper adds to existing knowledge: We translated the PSS‐HN and demonstrated its convergent and discriminant validity. The subscales of the D‐PSS‐HN are sensitive to detect changes through time. What are the potential or actual clinical implications of this work?: The D‐PSS‐HN is a useful tool to measure HNC patients' functional abilities to perform daily life activities. The tool can easily be used in clinical settings: since data collection duration is very short, this facilitates clinical (and research‐related) implementation of the scale. Patients' individual needs could be identified by using the D‐PSS‐HN, resulting in more appropriate approaches and (early) referrals if needed. Interdisciplinary communication could be facilitated. [ABSTRACT FROM AUTHOR]

Background: At the beginning of the 21st century, international adoptions of children with cleft lip and/or palate increased dramatically in Sweden. Many children arrived partially or totally unoperated, despite being at an age when palatoplasty has usually been performed. To date, the speech development of internationally adopted (IA) children has been described up to age 7–8 years, but later development remains unstudied. Aims: To investigate speech development between ages 5 and 10 years in children born with cleft lip and palate (CLP) adopted from China and to compare them with non‐adopted (NA) children with CLP. A secondary aim was to compare the frequencies of secondary palatal surgery and number of visits to a speech and language pathologist (SLP) between the groups. Methods & Procedures: In a longitudinal study, 23 IA children from China were included and matched with 23 NA children born in Sweden. Experienced SLPs blindly reassessed audio recordings from routine follow‐ups at ages 5 and 10 years. Velopharyngeal function (VPF) was assessed with the composite score for velopharyngeal competence (VPC‐Sum) for single words and rated on a three‐point scale (VPC‐Rate) in sentence repetition. Target sounds in words and sentences were phonetically transcribed. Per cent correct consonants (PCC) were calculated at word and sentence levels. For in‐depth analyses, articulation errors were divided into cleft speech characteristics (CSCs), developmental speech characteristics (DSCs) and s‐errors. Information on secondary palatal surgery and number of visits to an SLP was collected. Outcomes & Results: VPF differed significantly between the groups at both ages when assessed with VPC‐Sum, but not with VPC‐Rate. Regardless of the method for assessing VPF, a similar proportion in both groups had incompetent VPF but fewer IA than NA children had competent VPF at both ages. IA children had lower PCC at both ages at both word and sentence levels. More IA children had CSCs, DSCs and s‐errors at age 5 years, and CSCs and s‐errors at age 10. The development of PCC was significant in both groups between ages 5 and 10 years. The proportion of children receiving secondary palatal surgery did not differ significantly between the groups, nor did number of SLP visits. Conclusions & Implications: CSCs were more persistent in IA children than in NA children at age 10 years. Interventions should target both cleft and DSCs, be comprehensive and continue past the pre‐school years. WHAT THIS PAPER ADDS: What is already known on this subject: At the beginning of the 21st century, IA children with cleft lip and/or palate arrived in Sweden partially or totally unoperated, despite being at an age when palatoplasty has usually been performed. Studies up to age 7–8 years show that adopted children, compared with NA peers, have poorer articulation skills, demonstrate both cleft‐related and developmental articulation errors, and are more likely to have velopharyngeal incompetence. Several studies also report that adopted children more often require secondary palatal surgery due to fistulas, dehiscence or velopharyngeal incompetence compared with NA peers. What this paper adds to existing knowledge: This longitudinal study provides additional knowledge based on longer follow‐ups than previous studies. It shows that the proportion of children assessed to have incompetent VPF was similar among IA and NA children. It was no significant difference between the groups regarding the proportion that received secondary palatal surgery. However, fewer IA children were assessed to have a competent VPF. Developmental articulation errors have ceased in most IA and all NA children at age 10 years, but significantly more adopted children than NA children still have cleft‐related articulation errors. What are the potential or actual clinical implications of this work?: Speech and language therapy should target both cleft‐related and developmental articulation errors. When needed, treatment must be initiated early, comprehensive, and continued past the pre‐school years, not least for adopted children. [ABSTRACT FROM AUTHOR]

Background: Despite accumulated evidence that language development depends on basic cognitive processes, the balance in contributions of verbal and non‐verbal cognitive skills to language abilities is still underexplored. Little is known about which cognitive measures best predict the degree of severity in children with language disorder (LD). Aims: To examine the association between verbal and non‐verbal cognitive abilities with language abilities in typically developing and language impaired 8‐year‐old children, as well as which cognitive abilities are most effective in distinguishing LD severity levels. Methods & Procedures: Children (N = 509) from the Language‐8 Study, which oversampled probable cases of children with LD from a population‐based cohort in Norway, were assessed at 8 years. Language skills were assessed using the Norwegian Clinical Evaluation of Language Fundamentals—4 (CELF‐4). Children's verbal and non‐verbal cognitive abilities were assessed via standardized cognitive measures. An exploratory factor analysis (EFA) was first conducted to uncover the underlying factor structure of the cognitive variables. Using a hierarchical multiple regression analysis, we then examined to what extent the non‐verbal cognition factor explained language abilities above and beyond verbal cognition factors. Lastly, multinomial logistic regression was used to examine which cognitive measures best predicted the degree of severity in the children with LD. Outcomes & Results: The EFA resulted in three factors (Verbal Cognition, Processing Speed and Memory, and Non‐Verbal Cognition). The hierarchical multiple regression analysis revealed that all three cognitive factors contributed significantly to individual variation in language abilities. Non‐Verbal Cognition explained 5.4% variance in language abilities above and beyond that accounted for by Verbal Cognition and Processing Speed and Memory. Results from the multinomial logistic regression analysis indicated that cognitive subtests, including Familiar Sequences, WASI Vocabulary and WASI Similarities, not only distinguished LD from typically developing children, but were also efficient in distinguishing severity of LD symptoms. Conclusions & Implications: This study confirms concurrent links between language and non‐verbal cognitive skills above and beyond the contribution of verbal cognitive skills. The results provide further evidence that children with LD experience both language and cognitive problems in mid‐childhood. Our findings suggest implications for LD intervention and diagnosis. The findings support the importance of measuring both verbal and non‐verbal cognitive skills when making an LD diagnosis, and point to the potential of targeting underlying cognitive skills as one strategy to support language abilities. WHAT THIS PAPER ADDS: What is already known on the subject: Language development is dependent on basic cognitive processes. These include both verbal and non‐verbal cognitive abilities. Children with LD often experience both language and cognitive problems. There is evidence that performance on cognitive tests may be associated with the degree of severity of LD. What this paper adds to existing knowledge: The current results from a large population‐based cohort establish that a number of verbal and non‐verbal cognitive abilities are tightly linked to variation in language abilities and the degree of severity of LD. Our study confirms concurrent links between language and non‐verbal cognitive abilities above and beyond the contribution of verbal cognitive abilities. We also identify specific verbal and non‐verbal cognitive tests that distinguish between typical children and children with LD, as well as LD severity. What are the potential or actual clinical implications of this work?: Our findings support the importance of measuring both verbal and non‐verbal cognitive skills when making an LD diagnosis. Our findings also point to the potential of targeting underlying cognitive skills as one strategy to support language abilities. We suggest that future intervention studies focus on the impact of non‐verbal cognitive skills on language development in children with LD. [ABSTRACT FROM AUTHOR]

Background: The purpose of this paper is to provide a preliminary evaluation of treatment outcomes, retention and client satisfaction following a 12-week combined cognitive behavioural therapy (CBT) and motivational enhancement therapy (MET) group treatment for cannabis use disorder (CUD) delivered in an outpatient setting. Implementation of the program is also described. Methods: A retrospective observational cohort study was conducted using data collected from medical records and self-report assessments. Participants were treatment-seeking cannabis users at the Centre for Addiction and Mental Health, Toronto. Cannabis use, cannabis-related problems, craving, withdrawal symptoms, self-efficacy for remaining abstinent, depression and anxiety were assessed pre- and post-treatment. Treatment retention was calculated by inspecting clinic attendance records, and client satisfaction was evaluated using an anonymous feedback survey. Potential predictors of treatment outcomes and retention were investigated in exploratory analyses. Results: Cannabis use was lower and days of abstinence higher post-treatment (vs pre-treatment). Post-treatment improvements in cannabis-related problems, craving, withdrawal symptoms, self-efficacy and mood were also observed. Completion of group treatment (⩾75% of sessions attended) was 57% and moderate levels of treatment satisfaction were reported. Conclusions: This study provides preliminary evidence that a 12-week combined CBT and MET treatment for cannabis use disorder delivered in a novel group setting improves cannabis use outcomes. Potential predictors of reduced cannabis use and retention were identified. Future controlled studies are warranted, and strategies for increasing retention should be explored. [ABSTRACT FROM AUTHOR]

Simple Summary: Measurable residual disease monitoring is an important prognostic tool in haematological malignancies commonly performed by two modalities: flow cytometry and molecular methods. In this paper, we studied consecutive adult participants requiring flow cytometric measurable residual disease monitoring. This is one of the largest prospective Australian studies to date, providing a unique insight into the Australian context. We described five distinctive patterns associated with disease relapse and survival and also investigated correlation with molecular methods. Our results provide additional evidence that the correlation between molecular and flow cytometric methods is moderate in B-lymphoblastic leukaemia and poor in acute myeloid leukaemia. There was a strong association between flow cytometry results and relapse in acute myeloid leukaemia but less so for B-lymphoblastic leukaemia. Our novel data indicate that the pattern of change in measurable residual disease over time was associated with the risk of relapse, particularly in acute myeloid leukaemia and highlight the divergent ways measurable residual disease testing can be employed across different leukaemias. Measurable residual disease (MRD) detected by flow cytometry (FC) is well established in paediatric B- lymphoblastic leukaemia (B-ALL) and adult chronic lymphocytic leukaemia (CLL), but its utility in adult B-ALL and adult acute myeloid leukaemia (AML) is less clear. In this prospective MRD study, one of the largest in Australia to date, we examined consecutive bone marrow aspirates from adult participants with B-ALL (n = 47) and AML (n = 87) sent for FC-MRD testing at a quaternary referral hospital in Sydney. FC-MRD results were correlated to corresponding Mol-MRD testing where available and clinical outcomes at three-month intervals over 1 year. B-ALL showed a moderate positive correlation (rs = 0.401, p < 0.001), while there was no correlation between FC-MRD and Mol-MRD for AML (rs = 0.13, p = 0.237). Five FC-MRD patterns were identified which had significant associations with relapse (X2(4) = 31.17(4), p > 0.001) and survival (X2(4) = 13.67, p = 0.008) in AML, but not in B-ALL. The three-month MRD results were also strongly associated with survival in AML, while the association in B-ALL was less evident. There was a moderate correlation between FC-MRD and Mol-MRD in B-ALL but not AML. The association of FC-MRD with relapse and survival was stronger in AML than in B-ALL. Overall, these findings suggest divergent utilities of FC-MRD in AML and B-ALL. [ABSTRACT FROM AUTHOR]

Background: The majority of children with cerebral palsy (CP) experience challenges in functional communication from a young age. A pivotal aspect of functional communication is language comprehension. A variety of classification systems and questionnaires are available to classify and describe functional communication skills in children with CP. A better understanding of the convergent validity of (subsections of) these tools, as well as their relationship with spoken language comprehension, will be valuable in both clinical practice and research. Aims: To investigate the convergent validity of (subsections of) functional communication tools and the relationship with spoken language comprehension in children with CP. Methods & Procedures: Cross‐sectional data on 138 children were subdivided into three developmental stages based on (Dutch) educational phases: ages 18 months–3;11y (n = 59), 4;0–5;11 years (n = 37) and 6;0–8;11 years (n = 42). The following functional communication tools were used to classify and describe functional communication: Communication Function Classification System (CFCS), subscales of the Caregivers Priorities and Child Health Index of Life with Disabilities—Dutch Version (CPCHILD‐DV) and the Focus on Communication Under Six‐34 (FOCUS‐34) questionnaire. Spoken language comprehension was assessed with the Computer‐Based instrument for Low motor Language Testing (C‐BiLLT). Correlations between the functional communication tools, and with the C‐BiLLT, were calculated using Pearson's and Spearman's correlation coefficients. It was hypothesized a priori that correlations of at least 0.60 suggest good convergent validity. Outcomes & Results: At all developmental stages, a significant ordered decreasing tendency of communication outcomes was found across CFCS levels; lower CFCS levels were associated with lower scores on the CPCHILD‐DV and FOCUS‐34, and with a lower level of spoken language comprehension (C‐BiLLT). Correlation coefficients of the functional communication tools exceeded 0.60 at all developmental stages. Correlations between C‐BiLLT raw scores and the functional communication tools varied between 0.351 and 0.591 at developmental stage 18 months–3;11 years, between 0.781 and 0.897 at developmental stage 4;0–5;11 years, and between 0.635 and 0.659 at developmental stage 6;0–8;11 years. Conclusions & Implications: The functional communication tools assessed in this study showed convergent validity at all developmental stages. The CFCS, currently most widely used in paediatric rehabilitation, is adequate in the classification of functional communication. However, for more detailed clinical goal setting and evaluation of change in functional communication, the additional use of FOCUS‐34 or CPCHILD‐DV is recommended. What this paper adds: What is already known on the subject: A range of functional communication tools are available that help describe and classify functional communication in children with CP. These include the CFCS, subsections of CPCHILD‐DV and FOCUS‐34. The CFCS classifies functional communication in daily life with familiar and unfamiliar partners. Specific subsections of the CPCHILD‐DV and FOCUS‐34 include items that pertain to communicative participation. The innovative C‐BiLLT provides a standardized method to assess spoken language comprehension in children with CP and significant motor impairments. What this paper adds to existing knowledge: In the present study, convergent validity was confirmed between CFCS and specific subsections of the CPCHILD‐DV and FOCUS‐34. Correlations between these functional communication tools and the C‐BiLLT were moderate to strong. What are the potential or actual clinical implications of this work?: For clinical and research purposes (for instance, accurate prescription of augmentative and alternative communication—AAC), healthcare and educational professionals together with parents need to know how functional communication tools converge and how functional communication levels relate to the comprehension of spoken language. The CFCS provides a valid classification of functional communication abilities in children with CP. However, to measure change in functional communication and to evaluate treatment outcomes, use of additional functional communication tools such as the CPCHILD‐DV and FOCUS‐34 is recommended. When discrepancies are found between communicative abilities and spoken language comprehension, it is strongly recommended that valid tools are used in a more detailed examination of the child's spoken language comprehension skills and functional communication. [ABSTRACT FROM AUTHOR]

Background: Critical incident reporting and analysis is one of the key components of patient safety in anesthesiology. The aim of this study was to determine the frequency and characteristics of critical incidents during anesthesia, main causes and factors involved, influence on patient outcomes, prevalence of incident reporting and further analysis. Methods: A multicenter prospective audit was conducted at the clinical departments of the Bogomolets National Medical University during the period from 1 to 2021 to 1 December 2021. 13 hospitals from different Ukrainian regions took part in the study. Anesthesiologists voluntarily submitted critical incident reports into a Google form as they occurred during the working shifts, reporting the details of the incident, and the incident registration routine in their hospital. The study design was approved by the Bogomolets National Medical University (NMU) ethics committee, protocol #148, 07.09.2021. Results: The incidence of critical incidents was 9.35 cases per 1000 anesthetic procedures. Most common incidents were related to the respiratory system: difficult airway (26.8%), reintubation (6.4%), oxygen desaturation (13.8%); cardiovascular system: hypotension (14.9%), tachycardia (6.4%), bradycardia (11.7%), hypertension (5.3%), collapse (3.2%); massive hemorrhage (17%). Factors associated with critical incidents were elective surgery (OR 4.8 [3.1–7.5]), age from 45 to 75 years (OR 1.67 [1.1–2.5]), ASA II (OR 38 [13–106]}, III (OR 34 [12–98]) or IV (3.7 [1.2–11]) compared to ASA I; regional anesthesia (OR 0.67 95 CI 0.5–0.9) or general anesthesia (GA) and regional anesthesia combination (OR 0.55 95 CI 0.3–0.9] decreased the risk of incidents compared to GA alone. Procedural sedation was associated with increased risk of a critical incident, compared to GA (OR 0.55 95 CI 0.3–0.9). The incidents occurred most commonly during the maintenance phase (75/113, 40%, OR compared to extubation phase 20 95 CI 8–48) or the induction phases of anesthesia (70/118, 37%, OR compared to extubation phase 18 95 CI 7–43). Among common reasons that could lead to the incident, the physicians have identified: individual patient features (47%), surgical tactics (18%), anesthesia technique (16%) and human factor (12%). The most frequent failings contributing to the incident occurrence were: insufficient preoperative assessment (44%), incorrect interpretation of the patients' state (33%), faulty manipulation technique (14%), miscommunication with a surgical team (13%) and delay in emergency care (10%). Furthermore, 48% of cases, as judged by participating physicians, were preventable and the consequences of another 18% could be minimized. The consequences of the incidents were insignificant in over a half of the cases, but in 24.5% have led to prolonged hospital stay, in 16% patients required an urgent transfer to the ICU and 3% of patients died during their hospital stay. The majority of the critical incidents (84%) were reported through the hospital reporting system, using mostly paper forms (65%), oral reports (15%) and an electronic database (4%). Conclusion: Critical incidents during anesthesia occur rather often, mainly during the induction or maintenance phases of anesthesia, and could lead to prolonged hospital stay, unplanned transfer to the ICU or death. Reporting and further analysis of the incident are crucial, so we should continue to develop the web-based reporting systems on both local and national levels. Study registration: NCT05435287, clinicaltrials.gov, 23/6/2022. [ABSTRACT FROM AUTHOR]

This paper reflects on the value of diary methods in the context of a qualitative, longitudinal narrative inquiry exploring the higher education decision-making of further education students in England. Event-based diaries were used alongside interviews and focus groups over a 14-month period to gain in-depth insights into the reasons and influences informing their decision-making trajectories. I explore the challenges, successful approaches and advantages of employing diary methods with young people in this context. Challenges consisted of maintaining participant engagement, which was overcome by combining methods and incorporating a reactive co-participatory element. Yet, a number of advantages emerged from participants' engagement with diary keeping which enhanced the richness of the data; this inspired deeper reflections on decision-making and influences and provided a private space for participants to disclose personal difficulties that could not be obtained via interviews. [ABSTRACT FROM AUTHOR]

Various models of specialized foster care have been developed, but research on them is limited. This longitudinal, exploratory study analysed data on adaptive functioning, emotional and social problems and self‐concept in a specialized foster care service in Sweden. The focus of the study was on the development of the children and young people in placement. The Adaptive Behaviour Assessment System (ABAS‐II) was used to measure adaptive functioning, and the Beck Youth Inventories of Emotional and Social Impairment (BYI) was used to measure self‐rated emotional and social problems and self‐concept. Self‐ratings showed significant improvements in disruptive behaviour, anger, anxiety and depression. Adaptive functioning as rated by foster parents improved but not enough to catch up with the non‐clinical norm group. The average adaptive functioning among the participants at baseline was considerably below the Swedish norm group. Similar to the results of a previous study of the same treatment model, children and young people rated improvement while their foster parents did not do so to the same extent. Possible explanations for this are discussed in the paper. The study is limited by the lack of a control group and by data attrition. [ABSTRACT FROM AUTHOR]

Background: The subcutaneous implantable‐defibrillator (S‐ICD) is a relatively new alternative to the transvenous ICD system to minimize intravascular lead‐related complications. This paper presents outcome of SICD implantation in patients enrolled in Iran S‐ICD registry. Methods: Between October 2015 and June 2022, this prospective multicenter national registry included 223 patients with a standard indication for an ICD, who neither required bradycardia pacing nor needed cardiac resynchronization to evaluate the early post‐implant complications and long‐term follow‐up results of the S‐ICD system. Results: The mean age of the patients was 45 ± 17 years. The majority (79.4%) were male. Ischemic cardiomyopathy (39.5%) was the most common underlying disorder among patients selected for S‐ICD implant. Most study patients (68.6%) had ICD for primary prevention of sudden cardiac death. Seven patients (3.1%) were found to have suboptimal lead positions. Six patients (2.7%) developed a pocket hematoma; all were managed medically. During a mean follow‐up of 2 years, the appropriate therapy was recorded in 13% of the patients and inappropriate ICD intervention mainly due to supraventricular tachycardia in 8.9%. Pocket infection was observed in four patients (1.8%) and five patients (2.2%) died mainly due to heart failure. Conclusion: S‐ICDs were effective at detecting and treating both induced and spontaneous ventricular arrhythmias. Major clinical complications were rare. [ABSTRACT FROM AUTHOR]

Simple Summary: Recently, nivolumab, pembrolizumab, both immune-checkpoint inhibitors (ICIs) and the combination of dabrafenib plus trametinib (D + T) were registered as adjuvant melanoma treatments, to prevent recurrence. The aim of this paper was to retrospectively review the benefits and risks of these treatments in clinical practice, by extracting data from electronic health records with a text-mining tool. In a population of 122 patients, 55 used nivolumab, 48 used pembrolizumab and 20 used D + T, and we found that the ICIs were better tolerated than D + T. However, the frequent adverse events of D + T are reversible and include pyrexia and fatigue. ICIs show immune-related chronic adverse events, and chronic thyroid-related adverse events occurred frequently. The efficacy results, including the recurrence-free survival, are promising; however, the follow-up was too short for conclusions. This study furthermore showed that the application of text-mining is a valuable method to collect data for the evaluation of adjuvant melanoma treatments. Introduction: Nivolumab (N), pembrolizumab (P), and dabrafenib plus trametinib (D + T) have been registered as adjuvant treatments for resected stage III and IV melanoma since 2018. Electronic health records (EHRs) are a real-world data source that can be used to review treatments in clinical practice. In this study, we applied EHR text-mining software to evaluate the real-world tolerability, safety, and efficacy of adjuvant melanoma treatments. Methods: Adult melanoma patients receiving adjuvant treatment between January 2019 and October 2021 at the Leiden University Medical Center, the Netherlands, were included. CTcue text-mining software (v3.1.0, CTcue B.V., Amsterdam, The Netherlands) was used to construct rule-based queries and perform context analysis for patient inclusion and data collection from structured and unstructured EHR data. Results: In total, 122 patients were included: 54 patients treated with nivolumab, 48 with pembrolizumab, and 20 with D + T. Significantly more patients discontinued treatment due to toxicity on D + T (N: 16%, P: 6%, D + T: 40%), and X2 (6, n = 122) = 14.6 and p = 0.024. Immune checkpoint inhibitors (ICIs) mainly showed immune-related treatment-limiting adverse events (AEs), and chronic thyroid-related AE occurred frequently (hyperthyroidism: N: 15%, P: 13%, hypothyroidism: N: 20%, P: 19%). Treatment-limiting toxicity from D + T was primarily a combination of reversible AEs, including pyrexia and fatigue. The 1-year recurrence-free survival was 70.3% after nivolumab, 72.4% after pembrolizumab, and 83.0% after D + T. Conclusions: Text-mining EHR is a valuable method to collect real-world data to evaluate adjuvant melanoma treatments. ICIs were better tolerated than D + T, in line with RCT results. For BRAF+ patients, physicians must weigh the higher risk of reversible treatment-limiting AEs of D + T against the risk of long-term immune-related AEs. [ABSTRACT FROM AUTHOR]

Various barriers make recruiting a difficult task for researchers, especially when recruiting people living with HIV (PLWH) or conducting longitudinal studies. Effective recruitment is crucial to the validity of studies, and in this regard, social media can come to aid, although researchers usually rely on paid advertisements. This paper describes the free social media strategies used for participant recruitment in two studies carried out with PLWH in Spain and Latin America. Study 1 was a cross‐sectional study on the validation of two stigma scales with a 1‐month retest. Study 2 was a longitudinal study exploring the mental health of newly diagnosed PLWH, with a second assessment after 6 months. Facebook posts, Twitter mentions, and discussion forums were used in both studies. Study 2 also recruited participants through a healthcare centre. In Study 1, 5‐month recruitment yielded a sample of 458 PLWH, averaging 91.6 surveys/month and a 43% retention rate. In study 2, recruitment took 16 months, yielding a final sample of 145 newly diagnosed PLWH, 92 from the healthcare centre (5.75 surveys/month) and 53 from social media (3.31 surveys/month), with 95% and 60% retention rates, respectively. Participants in Study 2 did not differ in sociodemographic characteristics by recruitment method, except for the region of origin and financial difficulty (more diverse origin and greater difficulty emerged in social media participants). Greater psychological distress and lower personal and social resources were also found in social media participants. These data indicate that free social media recruitment is a feasible and effective tool for the recruitment of Spanish‐speaking PLWH, although it is best used in combination with traditional methods for newly diagnosed PLWH and longitudinal studies. [ABSTRACT FROM AUTHOR]

Purpose To examine the nature of the interruptions during medication work. Design An exploratory descriptive design was used with 28 nurses during 15 medication rounds in the medical, surgical, and gynecology wards at a 1000‐bed tertiary teaching hospital in Saudi Arabia. Methods: Non‐participant prospective observational and follow‐up interview methods were used to collect data. A standard paper‐based tool and digital stopwatch to count the interruptions were used. Nurses' sources, the secondary tasks undertaken, and the impacts of the interruptions were considered. The data were analyzed via descriptive analysis. Results: A total of 87 medication‐related events occurred. In these, 182 interruptions accounted for 90.0% of the total. Interruptions were more frequent during medication administration and often occurred in the corridors and patients' rooms. Nurses, medical officers, and impediments were frequent sources of interruptions. The secondary tasks attended by the nurses were mostly related with impediment resolutions and patients' needs. System failures appeared to be associated with clinical and procedural errors. Conclusion: The results of this study provide information regarding the course of interruptions during medication work in a Saudi Arabian hospital. Nurses were the main source of interruptions related with the provision of patient care and resolution of impediments. Interruptions tended to be associated with clinical errors and procedural failures due to system failure. Promoting a culture of respect and workplace etiquette in global healthcare settings demands minimizing non‐life‐threatening interruptions during nursing works. Clinical relevance: Strategies used in hospital management systems that affect nursing, pharmacies, human resources, and ancillary service department collaborations should be monitored for effectiveness and to ensure patient safety. Various approaches toward medication management systems, such as the utilization of an Omnicell automatic dispensing machine and cabinets within each patient's room, as well as others, such as wearing a "no‐interruption zone" sign, could be tailored and matched to the context of the practice to reduce interruptions. [ABSTRACT FROM AUTHOR]

This paper analyses wave 4 the Tsogolo la Thanzi survey of n = 1349 Malawian women aged 16–26 to explore the prevalence and predictors of self-reported fertility impairments (difficulties conceiving and/or difficulties carrying a pregnancy to term) and help-seeking strategies. Using descriptive statistics, logistic regression models, and graphic displays, the correlates of self-reporting an impairment and patterns of help-seeking strategies are examined. Nearly 13% (n = 117) of those who had ever tried to conceive reported experiencing a fertility impairment. Age was positively associated with reporting an impairment, while there was a negative association with education and with parity. Of women who reported an impairment, 85.5% sought help. Visiting a hospital or clinic was the most common response, followed closely by going to a traditional healer. Around one-quarter employed multiple help-seeking strategies, highlighting the need for various help-seeking behaviours to be viewed in tandem rather than in isolation. [ABSTRACT FROM AUTHOR]

Background: This paper is a follow‐up study continuing the COVISTRESS network previous research regarding health‐related determinants. Objective: The aim was to identify the main consequences of COVID‐19 lockdown on Body MassIndex and Perceived Fragility, related to Physical Activity (PA), for different categories of populations, worldwide. Design: The study design included an online survey, during the first wave of COVID‐19 lockdown, across different world regions. Setting and participants: The research was carried out on 10 121 participants from 67 countries. The recruitment of participants was achieved using snowball sampling techniques via social networks, with no exclusion criteria other than social media access. Main outcome measures: Body MassIndex, Physical Activity, Perceived Fragility and risk of getting infected items were analysed. SPSS software, v20, was used. Significance was set at P <.05. Results: Body MassIndex significantly increased during lockdown. For youth and young adults (18‐35 years), PA decreased by 31.25%, for adults (36‐65 years) by 26.05% and for the elderly (over 65 years) by 30.27%. There was a high level of Perceived Fragility and risk of getting infected for female participants and the elderly. Correlations between BMI, Perceived Fragility and PA were identified. Discussion and Conclusions: The research results extend and confirm evidence that the elderly are more likely to be at risk, by experiencing weight gain, physical inactivity and enhanced Perceived Fragility. As a consequence, populations need to counteract the constraints imposed by the lockdown by being physically active. [ABSTRACT FROM AUTHOR]

Accessible summary: What is known on the subject?: Numerous studies have shown that organizational and managerial factors have significant effects on nurses' workplace well‐being.There are few studies on the effects of nurses' perceptions of their supervisors' autonomy‐supportive behaviours on their workplace well‐being. There are few studies on the determinants of nurses' workplace well‐being within a psychiatric context. What does this paper add to existing knowledge?: This study examines the psychological processes underlying the relationship between nurses' perceptions of their supervisors' autonomy‐supportive behaviours and their workplace well‐being.Mental health nurses' perceptions of their supervisors' autonomy‐supportive behaviours are indirectly and positively related to their workplace well‐being through their positive effects on psychological need satisfaction.Autonomy and competence need satisfaction has stronger effects on workplace well‐being than relatedness need satisfaction. What are the implications for practice?: When their supervisor gives nurses a meaningful rationale for tasks and acknowledges their feelings and views, they feel more autonomous, competent and related to others. It is important for nurses to feel autonomous and competent in order to experience well‐being at work.Nurses' workplace well‐being might be positively and negatively linked to quality of care and turnover intentions, respectively. Introduction: There is growing interest in the relationships between work factors and nurses' workplace well‐being. However, there has been very little research on the psychological processes underlying the relationships between nurses' perceptions of supervisors' autonomy‐supportive managerial style and their workplace well‐being. Aim/question: Drawing on self‐determination theory, we explored the mediating role of psychological need satisfaction (autonomy, competence and relatedness) in the relationships between nurses' perceptions of supervisors' autonomy‐supportive managerial style and their workplace well‐being, using a prospective design. Method: A prospective questionnaire was given to nurses in eight French psychiatric units. Data were collected from a sample of 294 French nurses who completed measures of perceived supervisors' autonomy‐supportive behaviours at Time 1 and of psychological need satisfaction, work engagement and job satisfaction at Time 2 one year later. Results: Results revealed that nurses' perceptions of supervisors' autonomy‐supportive managerial style were indirectly and positively related to their vigour, dedication, absorption and job satisfaction one year later through their positive effects on psychological need satisfaction. Discussion/implications for practice: Overall, this paper sheds light on the indirect effect of nurses' perceptions of supervisors' autonomy‐supportive behaviours on their workplace well‐being. Theoretical contributions and future directions, as well as implications for practice, are discussed. [ABSTRACT FROM AUTHOR]

Objectives: Despite the obstacles of limited education and employment opportunities—and the stress associated with immigration and pregnancy—Mexican immigrant women have low rates of preterm birth (PTB) compared to the US national average for all races and ethnicities. Stressors during pregnancy, and stressors associated with acculturation, may accelerate cellular aging manifested by shortened telomere length (TL) in pregnant women. Our objectives were to: (1) determine whether women with PTBs had shorter telomere lengths compared to women who had full term births; (2) assess the association of acculturation with TL and PTB. Methods: This prospective pilot study collected data from 100 self-identified Mexican-origin pregnant women. Survey data included self-administered sociodemographic and acculturation measures and was collected from participants via paper and pen, while biologic data was collected via a single blood draw during a regularly scheduled prenatal visit between 26 and 36 weeks gestation. PTB data was collected from the participant's medical record after delivery. Results: TL was significantly associated with PTB; the median TL of the women with PTB was less than the median TL for the full sample (p = 0.02). Based on regression analysis for PTB vs acculturation, we found no significant associations between acculturation and PTB or TL. Conclusions for Practice: This study provides important evidence of the association between shortened maternal TL and adverse birth outcomes. By linking social, clinical and biologic data, we can enhance our understanding of social determinants that may affect racial and ethnic disparities in preterm birth. [ABSTRACT FROM AUTHOR]

Background: Cardiotoxicity is a well‐known side effect after anthracyclines and chest radiotherapy in childhood cancer survivors (CCS). The DCCSS LATER 2 CARD (cardiology) study includes evaluation of echocardiographic measurements for early identification of CCS at highest risk of developing heart failure. This paper describes the design, feasibility, and reproducibility of the echocardiography protocol. Methods: Echocardiograms from CCS and sibling controls were prospectively obtained at the participating centers and centrally analyzed. We describe the image acquisition, measurement protocol, and software‐specific considerations for myocardial strain analyses. We report the feasibility of the primary outcomes of systolic and diastolic function, as well as reproducibility analyses in 30 subjects. Results: We obtained 1,679 echocardiograms. Biplane ejection fraction (LVEF) measurement was feasible in 91% and 96% of CCS and siblings, respectively, global longitudinal strain (GLS) in 80% and 91%, global circumferential strain (GCS) in 86% and 89%, and ≥2 diastolic function parameters in 99% and 100%, right ventricle free wall strain (RVFWS) in 57% and 65%, and left atrial reservoir strain (LASr) in 72% and 79%. Intra‐class correlation coefficients for inter‐observer variability were 0.85 for LVEF, 0.76 for GLS, 0.70 for GCS, 0.89 for RVFWS and 0.89 for LASr. Intra‐class correlation coefficients for intra‐observer variability were 0.87 for LVEF, 0.82 for GLS, 0.82 for GCS, 0.85 for RVFWS and 0.79 for LASr. Conclusion: The DCCSS LATER 2 CARD study includes a protocolized echocardiogram, with feasible and reproducible primary outcome measurements. This ensures high‐quality outcome data for prevalence estimates and for reliable comparison of cardiac function parameters. [ABSTRACT FROM AUTHOR]

Background: Considering the excellent safety profile and the high efficacy rates, great benefits were expected with the availability of the new direct-acting antivirals (DAAs) in treating hepatitis C virus (HCV) infection. Following the publication of two articles in 2016 on the high incidence rates of HCC following DAAs, several papers revealed contradictory results, thereby casting shadows on the role of DAAs in hepatocarcinogenesis. Objectives: The present study aimed to assess the incidence and risk factors of HCC in patients with HCV genotype 1b infection and compensated cirrhosis with the sustained virological response (SVR) following DAAs. Methods: This multicentric prospective study encompassed 479 patients with HCV genotype 1b compensated cirrhosis treated with paritaprevir/ritonavir/ombitasvir and dasabuvir (PrOD) +/- ribavirin (RBV) for 12 weeks in two tertiary centers in Northeastern Romania. The patients were prospectively followed up in the Institute of Gastroenterology Iasi, Romania, from November 2015 to December 2020. Results: During the follow-up period (mean 60.11-3.87 months), 23 patients (4.8%) developed HCC. The 1-, 3-, and 5-year cumulative incidence rates of HCC were 1.1, 1.9, and 2.6%, respectively. At the time of the diagnosis, 15 patients (65%)had a single tumor, 12 patients (52.2%)were within the Milan criteria, and nine persons (39%) had Barcelona liver cancer stage 0-A. In this regard, the mean AFP level was 35.3-93.1 ng/mL. A multivariate analysis, age above 65 years, and a cutoff point of AFP≥ 10 ng/mL at the end of treatment were independent factors associated with HCC. A majority of the patients (n = 11, 47.8%) received curative treatment by surgical resection. In this study, histopathological examination identified a moderately differentiated tumor (G2) in 5 patients, five patients had a poorly differentiated tumor (G3), and only one patient had a well-differentiated tumor (G1). Conclusions: Our study revealed no evidence of the high incidence rate of HCC after the long-term follow-up of patients with HCV-related liver cirrhosis and SVR following DAA treatment. However, the cumulative 5-year risk remained above the cutoff point, and this makes the HCC screening cost-effective. The HCC occurrence appears to be associated with aging and a moderately increased AFP level at EOT (≥ 10 ng/mL). [ABSTRACT FROM AUTHOR]

Aim: To develop a prediction model to estimate the chances of live birth over multiple cycles of in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) treatment. Methods: A retrospective cohort study was launched in three reproductive centers including 10 824 couples who received 14 106 treatment cycles with known pregnancy outcomes by the end of 2016. Discrete time logistic regression was used to establish the model and a nomogram was developed to predict the chance of live birth on plain paper‐based final predictors. Results: Among 10 824 couples, 5809 (53.7%) ended up with a live birth with several successive transplant cycles. What's more, we found that younger female age (p < 0.001), smaller cycle number (p < 0.001), female body mass index (p < 0.001), male factor (p < 0.001), ovulation disorder (p = 0.006), and higher endometrial thickness (p < 0.001) were significantly associated with increased live birth rate. Discrimination of the model expressed by area under the curve (AUC) was 0.66. Conclusion: Our study will help shape couples' expectations of their ART outcome, allowing them to plan their treatments more efficiently and prepare emotionally and financially. [ABSTRACT FROM AUTHOR]

This paper presents the results of a longitudinal spelling study conducted among 496 school children, from sixth grade (the first year of middle school in France) to ninth grade (the fourth and final year of middle school in France). Its first objective is to examine the evolution of both lexical and grammatical spelling skills in a deep orthography and to present new findings on the advanced mastery of spelling skills. Its second aim is to provide insight into pupils' orthographic knowledge and remaining difficulties at the end of French compulsory schooling. Pupils were assessed using the same text dictation when they were sixth graders and when they were ninth graders. The data show that both lexical and grammatical performance increased from the sixth to ninth grade and that these interact with each other. The qualitative analysis of errors allows points of resistance in the acquisition of French orthography to be highlighted. [ABSTRACT FROM AUTHOR]

Background: Treatment retention is a major factor contributing to favourable outcome in the treatment of substance misuse, but the literature remains very limited. Despite evidence of the association of personality with drug use experimentation and relapse, surprisingly little is known about its role in the treatment process. Clients' personality functioning as measured by malleable and context sensitive characteristic adaptations in treatment are of concern. Aims: This study examines whether, and to what extent, personality functioning contributes to or hinders treatment completion. This paper examined the extent to which service users' characteristic adaptations may be potential determinants of treatment completion. Methodology: A longitudinal multi-site design was utilised, examining the therapy process in a naturalistic setting in five inpatient treatment units. The study examined whether service users' characteristic adaptations (SIPP-118) predict completion, while controlling psychosocial, motivational and treatment engagement indicators involving n = 340 participants from 5 inpatient centres. Multivariate regression analyses were applied to examine the predictive role of characteristic adaptations on treatment completion. Results: Findings indicated that certain dysfunctional characteristic adaptations emerged as strong predictors of treatment completion. Dysfunctional levels on Self-control and Social concordance were significant predictors of drop out from treatment. Individuals with low capacity to tolerate, use and control one's own emotions and impulses were almost three times more likely to drop-out compared to those without [OR] = 2.73, Wald = 6.09, P =.014, 95% CI [1.2, 6.0]. Individuals with dysfunctional levels on the ability to value someone's identity, withhold aggressive impulses towards others and work together with others were 2.21 more times more likely to complete treatment [OR] = 2.21, Wald = 4.12, P =.042, 95% CI [1.0, 4.7]. The analysis at the facet level provided additional insight. Individuals with higher adaptive levels on Effortful Control were 46% more times likely to complete treatment than the group [OR] = 4.67, Wald = 10.231, P =.001, 95% CI [1.81, 12.04], 47% more likely on Aggression regulation [OR] = 4.76, Wald = 16.68, P <.001, 95% CI [2.1, 10.3], and 26% more likely on Stable self-image [OR] = 2.62, Wald = 6.75, P <.009, 95% CI [0.9, 3.0]. Conclusions: These findings extend our knowledge of the predictive role of characteristic adaptations in treatment completion and highlight the clinical utility of capturing these individual differences early on. Delineating the role of characteristic adaptations in treatment may provide the basis for enhancing treatment effectiveness through individualized interventions that are scientifically driven and may open new avenues for the scientific enquiry of personality and treatment. [ABSTRACT FROM AUTHOR]

The ECG Belt for CRT response trial is designed to test the hypothesis that in patients traditionally less likely to respond to cardiac resynchronization therapy (CRT), an individualized approach utilizing the electrocardiogram (ECG) Belt to guide lead placement, vector selection, and device programming is superior to current standard of care. The ECG Belt is a noninvasive mapping technology designed to measure beat by beat electrical activation of the left ventricle by utilizing unipolar measurements from multiple ECG electrodes on the body surface. The ECG Belt for CRT response trial is a multicenter, prospective, randomized, investigational pre‐market research study conducted at 48 centers in the United States, Canada, and Europe and will randomize approximately 400 subjects. The trial has three arms (enrollment will be 2:1:1, respectively): utilization of the Belt to guide implant as well as postimplant programming, utilizing the Belt to guide postimplant programming alone, and a non‐Belt control arm. AdaptivCRT will be an option in the treatment arm but not the control arms. The primary endpoint is change in left ventricular end‐systolic volume between preimplant and at 6 months. This paper describes the design and analytic plan for the trial. [ABSTRACT FROM AUTHOR]

Background: Currently, limited information is available regarding selection of the most successful strategies for recruitment of older adult kidney transplant recipients as research participants. Objective: The aim of this study was to explore multiple modes of recruitment strategies to enroll older kidney transplant recipients in a 1-year longitudinal study. Methods: We used a feasibility design to explore the following recruitment methods: face-to-face contact in the transplant clinic, paper flyers placed in the transplant clinic, Facebook, an online transplant newsletter, and a university website listing of research studies. Results: Enrollment was open for 9 months, during which time websites and the Facebook portal were active, 142 newsletters were e-mailed, and 424 patients were approached in the transplant clinic. Among patients approached in the clinic, 12 did not own a smartphone required for the study. The sample consisted of 60 participants (39 men, 21 women), with a mean age of 64.5 ± 4.7 years. Of the participants who enrolled in the study, the largest number (75%, n = 45) was recruited using the face-to-face method in the transplant clinic. The online transplant newsletter was the second-best recruitment source (18%, n = 11). Discussion: Recruitment strategies using face-to-face contact and the online newsletter associated with the transplant clinic organization appeared to be more effective than strategies not associated with the transplant clinic (Facebook and university website). Findings suggest that using a familiar organization communication method to recruit older chronic disease population may be the most beneficial. [ABSTRACT FROM AUTHOR]

Many Australians living with a disability find themselves recipients of Newstart Allowance when applying for the Disability Support Pension (DSP). Newstart Allowance is designed as a short-term payment for people looking for work, with a lower fortnightly payment and limited medical and transport subsidies compared to the DSP. This paper describes the financial challenges of living with a disability while on Newstart Allowance. With a focus on the experiences of Aboriginal and Torres Strait Islander (Indigenous) Australians from two regional towns, qualitative semistructured interviews and focus groups documented experiences of 39 community members and 21 medical and nonmedical service providers supporting clients living with a disability on Newstart Allowance. Four themes were identified: (i) living with severe financial hardship, (ii) challenges complying with the DSP application, (iii) being financially penalised for not complying with Newstart Allowance conditions, and (iv) supporting community members to manage severe financial stress. Although people living with a disability on Newstart were experiencing severe hardship and poverty, there was limited participation of Centrelink-employed social workers within their described experiences with Centrelink. We argue that social workers can work to humanise human service settings and potentially help to mitigate these financial challenges. IMPLICATIONS Indigenous Australians living with a disability experience severe disadvantage and poverty while living on Newstart Allowance. Social workers must be easily accessible at Centrelink customer service centres and to Newstart Allowance recipients to help coordinate service engagement. Newstart Allowance should be increased to ensure recipients can respond to cost of living pressures. [ABSTRACT FROM AUTHOR]

Chronic insomnia is a disease which brings intense mental pain and disturbing complications to patients worldwide. The oral microbiome exhibits a mechanistic influence on human health. Therefore, it is crucial to understand the oral microbial diversity in insomnia. Tongue diagnosis has been considered a critical basic procedure in insomnia therapeutic decision-making in Traditional Chinese Medicine (TCM). Hence, it is significant to elucidate the various oral microbiome differences in chronic insomnia patients with different tongue features. In this paper, we used 16S rRNA gene sequencing and bioinformatics analysis to investigate dynamic changes in oral bacterial profile and correlations between chronic insomnia patients and healthy individuals, as well as in patients with different tongue coatings. Moreover, the relationship between the severity of insomnia and oral microbiota was explored. Our findings showed that chronic insomnia patients harbored a significantly higher diversity of oral bacteria when compared to healthy controls. More importantly, the results revealed that the diversity and relative abundance of the bacterial community was significantly altered among different tongue coatings in patients but not in healthy individuals. Oral bacteria with a relative abundance > 1% and P < 0. 0 5 among different tongue groups were considered remarkable bacteria, which included three phyla Proteobacteria, Bacteroidetes, Gracilibacteria, and four genera, Streptococcus, Prevotella_7, Rothia, and Neisseria. Our findings indicate that changes in oral microbiome correlate with tongue coatings in patients with chronic insomnia. Thus, the remarkable microbiome may provide inspiration for further studies on the correlation between tongue diagnosis and oral microbiome in chronic insomnia patients. [ABSTRACT FROM AUTHOR]

Purpose: A screening instrument (0–100 points) to predict return-to-work (RTW) problems was developed. We tested the predictive validity in patients with mental diseases (MD) and musculoskeletal diseases (MSD). Materials and methods: A prospective multicenter study with questionnaires at admission and 3 months after rehabilitation was conducted. Patients with MD and MSD were included. The outcome was occurrence of RTW problems during the follow-up. Receiver operating characteristic analyses were performed. Sensitivity, specificity, and predictive values were calculated for each disease group using the threshold of 27 points. Results: There were 401 patients with MD (n = 250) and MSD (n = 151) included in the study, and 31.8% and 46.4% reported RTW problems during the follow-up, respectively. The area under curve was 0.885 (0.838–0.920) and 0.899 (0.841–0.943). The sensitivity rates were 87.1% and 87.5% and the specificity rates were 79.9% and 88.4% for MD and MSD, respectively. The post-test probability of experiencing RTW problems was 78.9% for MD and 77.8% for MSD. Analyses including only employed patients showed similar results. Conclusions: The screening predicts short-term RTW problems after rehabilitation in patients with mental or MSD regardless of employment. The threshold of 27 points was confirmed as reasonable, but alternatives in the range of 20–30 points can also be recommended. The SIMBO is a short and economic screening predicting future problems during the return to work (RTW) in patients with mental or musculoskeletal diseases. The SIMBO can be recommended to detect the initial RTW chance at the beginning of the rehabilitation process. This paper implied that there are mainly generic factors predicting the success of an RTW. Based on this it is possible to use one screening for different disease groups. [ABSTRACT FROM AUTHOR]

Summary: What is known and objective: Myocardial infarction (MI) in young adults accounts for up to 10% of all cases. Regarding life expectancy and professional activity, it is extremely important to restore and maintain young patients' full performance. Therefore, secondary prevention is especially vital in this group of patients. The paper focuses on the analysis of pharmacotherapy in young MI patients in Poland, assessing disparities between the European Society of Cardiology guidelines and clinical practice, and regional differences among the provinces. Methods: The analysis was conducted using the data from a nationwide, observational, multicentre, prospective study—the Polish Registry of Acute Coronary Syndromes (PL‐ACS). The data were collected from patients ≤45 years old with MI who were hospitalized in the period 2010‐2014. Results and discussion: A retrospective study included 6367 MI patients. They constituted 3.9% of all the patients with MI in Poland. Despite the fact that during hospitalization regional differences were observed in case of acetylsalicylic acid (range 70.3%‐93.8%), β‐blockers (range 50.0%‐79.6%), statins (range 53.4%‐85.7%) and angiotensin‐converting enzyme inhibitors (range 46.9%‐75.0%), the majority of patients received the drugs according to the guidelines. Regional differences found at discharge also regarded those medications, but the range of observed variations was smaller. On average, three‐quarter of patients received guideline‐recommended medications. Still, in some provinces, almost a quarter of patients were administered those medications only at discharge. What is new and conclusion: In the study population, there were significant differences between the provinces regarding pharmacotherapy during hospitalization, which concerned major groups of medications. However, pharmacotherapy indicated at discharge revealed fewer regional differences and adhered to guideline recommendations to a greater extent. Nevertheless, there is still some room for improvement, especially with regard to pharmacotherapy during hospitalization. [ABSTRACT FROM AUTHOR]

Background: Longitudinal cohort studies gather large amounts of data over time, often without direct benefit to participants. A positive experience may encourage retention in the study, and participants may benefit in unanticipated ways. Objective: To explore first‐time mothers' experiences of taking part in a longitudinal cohort study and completing self‐administered surveys during pregnancy and at 3, 6, 9 and 12 months' postpartum. Design: Content analysis of comments written by participants in the Maternal health And Maternal Morbidity in Ireland study's five self‐completion surveys, a multisite cohort study exploring women's health and health problems during and after pregnancy. This paper focuses on what women wrote about taking part in the research. Ethical approval was granted by the site hospitals and university. Setting and participants: A total of 2174 women were recruited from two maternity hospitals in Ireland between 2012 and 2015. Findings: A total of 1000 comments were made in the five surveys. Antenatally, barriers related to surveys being long and questions being intimate. Postpartum, barriers related to being busy with life as first‐time mothers. Benefits gained included gaining access to information, taking time to reflect, stopping to think and being prompted to seek help. Survey questions alone were described as valuable sources of information. Discussion and conclusions: Findings suggest that survey research can "give back" to women by being a source of information and a trigger to seek professional help, even while asking sensitive questions. Understanding this can help researchers construct surveys to maximize benefits, real and potential, for participants. [ABSTRACT FROM AUTHOR]

Abstract Background: Tape blisters are common complications in the peri-lesional area of the surgical incision, forming below the layer of dressing adhesive applied and causing numerous complications for patients. Objectives: The purpose of this study was to investigate the incidence of the phenomenon, and to identify and quantify the main prognostic factors associated. Design: Multicentric, prognostic prospective cohort study. Setting: Shoulder Orthopaedic surgery, General surgery, Advanced Oncology therapies, Gastro-entero mininvasive surgery and Endocrine surgery. Participants: One thousand and two patients who underwent chest, abdominal, upper limb and joint laparotomic surgery consecutively admitted to the surgical units involved, were included. Methods: Data regarding individual and patient care variables, such as intrinsic (e.g. age and gender) and extrinsic (e.g. surgery type and time) data were collected. A multivariate logistic regression model was used to identify the variables which independently influenced the onset of the tape blister. Results: In the multivariate analysis, patients who underwent chest (Odds Ratio = 8.99, 95% CI 5.33–15.13), and upper limb and joint surgery (Odds Ratio = 2.09, 95% CI 1.22–3.58) were more likely to develop tape blisters in the postoperative period, At the same time, having drainage (Odds Ratio = 1.98, 95% CI 1.11–3.53), being female (Odds Ratio = 1.56, 95% CI 1.01–2.44) and having a high Body Mass Index (BMI) score (Odds Ratio: 1.06, 95% CI 1.02–1.11) were also predictors of tape blister formation. Conclusions: A higher BMI score, chest, upper limb and joint surgery, female gender and the presence of drainage were predictive factors of the tape blister event while, in contrast with the literature, the type of dressing used in this study was not significantly associated with the event. [ABSTRACT FROM AUTHOR]

Aims and objectives: To present findings from a study that explored nursing students' experiences of bullying in clinical and academic settings, the strategies used to negotiate bullying and recommendations for empowering future students. Background: Nursing students are identified as a group who are at particular risk of bullying. Numerous studies have examined students' experiences of bullying in clinical contexts by qualified nurses; however, there has been far less attention to the bullying that occurs in academic settings where the perpetrators are university staff and other students. Design: The qualitative findings presented in this paper form one component of a mixed‐methods, multisite study that examined the nature and extent of bullying in one cohort of nursing students. Methods: A convenience sample of 29 first‐, second‐ and third‐year undergraduate nursing students from one semimetropolitan Australian university was recruited for semistructured interviews in 2014. Interview data were analysed using NVivo. Findings: Participants described multiple examples of bullying occurring in both clinical and academic settings. Perpetrators included clinicians, facilitators, academics and fellow students. Bullying ranged from incivility to physical attacks. The impact of the bullying was profound; it caused many of the participants to feel anxious and distressed, it undermined their confidence and perception of competence, and it often led them to question their career choice. Strategies described by participants to cope with or manage the bullying included avoidance, trying to “just survive” and seeking support from trusted academic staff, family and friends. No episodes of bullying were formally reported. Conclusion: Bullying remains a pervasive phenomenon occurring in both clinical and academic settings. Students are, in many respects, a vulnerable and disempowered population who often fear the consequences of making a formal complaint. Thus, reporting structures and support strategies need to be re‐examined, and resilience training is imperative. Relevance to clinical practice: Bullying remains a continuing concern in undergraduate nursing degrees. Efforts must be made in clinical and academic settings to heed the advice of undergraduates using broader strategies to address the issues. [ABSTRACT FROM AUTHOR]

Aims and objectives To determine presence of clinical complications related to dysphagia and to explore their operational outcomes. Background Dysphagia is a common complication of stroke. The management of poststroke dysphagia is multidisciplinary with nurses playing a key role in screening for dysphagia risk, monitoring tolerance of food and fluids and checking for the development of complications such as fever, dehydration and change in medical status. Dysphagia often results in further complications including aspiration pneumonia and the need for nasogastric feeding. Dysphagia-related complications have been shown to have a significant impact on morbidity and mortality, length of stay and cost of admission. Design Retrospective cohort study. Methods A total of 110 patients presenting with an ischaemic stroke were chart-audited. Results Aspiration pneumonia poststroke was found to be significantly associated with increased overall length of stay, poorer functional outcomes poststroke as well as being associated with a high risk of mortality. The presence of a nasogastric tube was also associated with reduced functional outcomes poststroke and increased risk of death. Conclusion High prevalence and cost of complications associated with stroke highlight the complexity of providing nursing and allied health care to this patient population. This provides a snapshot of dysphagia-related complications experienced by stroke patients. Relevance to clinical practice This paper highlights that poststroke complications can significantly impact on patient outcomes and operational factors such as cost of admission; therefore, poststroke care requires a multidisciplinary approach to management. Furthermore, preventing and managing complications poststroke is a key element of nursing care and has the potential to significantly reduce incidence of mortality, length of stay and cost of hospital admission. [ABSTRACT FROM AUTHOR]

Aims and objectives To investigate whether the type of dressing used (occlusive vs. semi-occlusive) impacts on exit-site infection. Background The exit-site infections are a major predisposing factor for peritoneal dialysis-related peritonitis, the main cause of technique failure and an important cause of mortality. The care taken in exit-site dressing is considered an important procedure for the prevention of trauma and contamination of this area. Nevertheless, to our knowledge, no study has yet analysed the impact of different dressing types on early exit-site infection (up to two months after catheter insertion). Design A prospective observational study involving the BRAZPD II (Brazilian Peritoneal Dialysis Multicenter Study) cohort. Methods All incident patients with data available for dressing type applied following peritoneal dialysis catheter insertion were included in the study. A multilevel logistic regression model was used to compare the log-odds of exit-site infections between groups. Results A total of 2460 incident patients were included. Occlusive and semi-occlusive dressings were applied in 82·6% (n = 2031) and 17·4% (n = 427) of patients, respectively. Exit-site infection incidence was not affected by the type of dressing used, with a logit for occlusive dressing of 2·15 (95% CI 0·81-5·70). The combined outcome of exit-site infection and tunnel infection also showed no significance between the groups (logit 1·46, 95% CI 0·72-2·97). Conclusion Our results indicate that the type of exit-site dressing used during the healing phase following peritoneal dialysis catheter insertion has no impact on early exit-site infection rates. Relevance to clinical practice Provides evidence to support the similarity between occlusive and semi-occlusive dressing regarding infection rates in exit site of peritoneal dialysis catheter, therefore allowing the choice to be made accordingly to routine or availability. [ABSTRACT FROM AUTHOR]

This paper provides an overview of the design and cohort characteristics of the Social Spectrum Study: a clinical cohort study that used a two-phase sampling design to identify children at risk for ASD. After screening 1281 children aged 2.5-10 years who had been consecutively referred to one of six mental health services in the Netherlands, children who screened positive for ASD (n = 428) and a random selection of screen negatives (n = 240) were invited to participate in diagnostic assessments and questionnaires regarding the child, family and society. A 1-year follow-up was also conducted. Results from this study may contribute to knowledge of the identification and characterization of children with ASD, family processes, and the impact of ASD on the family and society. [ABSTRACT FROM AUTHOR]

Nurses experience high levels of work related stress and burnout as well as low job satisfaction and poor general health owing to the nature of their work. This paper seeks to provide a better understanding of the nature of relationships between work related stress, burnout, job satisfaction and general health of nurses over one year. This study involved a longitudinal design. Two hundred and seventy seven nurses from four hospitals completed a follow up survey consisting of five questionnaires. Data were collected between 2013 and 2014. The data were analysed using generalized estimation equation analysis. Lack of support was associated with burnout, patient care was associated with job satisfaction and staff issues were associated with general health of nurses. Burnout is more strongly related to job satisfaction than general health. The findings of this study could inform evidence based policy and practice through interventions aimed at improving job satisfaction and reducing the impact of burnout on general health of nurses. [ABSTRACT FROM AUTHOR]

Objective In Western Australia the cancer nurse coordinator (CNC) role is unique, state wide and situated in nursing. It requires the domains of clinical expert, resource consultant, educator, change agent, researcher and advocate to facilitate seamless coordination of care for patients across metropolitan, rural and remote geographical areas of Western Australia. This study examined the role, function and impact of CNCs from the perspective of coordinators themselves. Design Prospective two-phase mixed method study. This paper reports data from the Self Report Activity Questionnaire in Phase one. Setting The state-wide Western Australian Cancer Nurse Coordinator Service. Subjects Metropolitan and rural CNCs (n=18) who had worked in the role for at least six months. Results Overall, CNCs spent 70% of time in clinical consultation and 41% of CNCs reported having an educational role. Most CNCs (71%) noted that at least half of their patients had complex psychosocial needs at referral. Key role-related activities related to direct nursing care and patient education were performed most frequently on a daily basis. Tasks related to care management planning, patient advocacy and multidisciplinary clinical care were performed weekly. Strategic, team communication and professional development activities were performed less frequently. Conclusion Diversity of the CNC role was demonstrated with findings showing that CNCs fulfilled the core components of the specialist cancer nurse. Given the clear need to provide consistent support to cancer patients in an increasingly individualised and integrated manner, we consider the CNC role a fundamental element of quality cancer care. [ABSTRACT FROM AUTHOR]

Background Alcohol-related blackouts are periods of amnesia that reflect the failure of the brain to record memories of what transpires while drinking. This paper examined the incidence, predictors, and behavioral correlates of blackouts among emerging adults and examined whether questions about blackouts could serve as better markers of risk for other alcohol related harms than questions about levels of consumption. Methods In 2012 to 2013, 1,463 (68%) of 2,140 respondents 1-year past high school reported having consumed alcohol. They were asked whether, in the past 6 months because of drinking, they forgot where they were or what they did. The survey also explored demographics, substance use behaviors, and other alcohol-related problems in the past 6 months. Chi-square and logistic regression analyses explored bivariate and multivariate predictors of blackouts and other alcohol-related problems. Results Twenty percent of respondents who ever drank alcohol reported a blackout in the past 6 months. Blackouts were more prevalent among females and those who, in the past 30 days, used multiple drugs, more frequently binged, were drunk, smoked, had lower body weight, and lived in college dorms. After controlling for drinking levels, having a blackout was the strongest independent predictor of most other alcohol problems examined, including in the past 6 months because of drinking, missing class or work, getting behind in work or school, doing something respondents later regretted, arguing with friends, experiencing an overdose, and total number of alcohol problems reported. It was also an independent predictor of hangovers, damaging property, getting hurt, and trouble with police. Conclusions Because blackouts indicate drinking at levels that result in significant cognitive and behavioral impairment, questions about blackouts could serve as important, simple screeners for the risk of experiencing other alcohol related harms. Additional work on this subject is warranted. [ABSTRACT FROM AUTHOR]

Background: Mastitis is an acute, debilitating condition that occurs in approximately 20 % of breastfeeding women who experience a red, painful breast with fever. This paper describes the factors correlated with mastitis and investigates the presence of Staphylococcus aureus in women who participated in the CASTLE (Candida and Staphylococcus Transmission: Longitudinal Evaluation) study. The CASTLE study was a prospective cohort study which recruited nulliparous women in late pregnancy in two maternity hospitals in Melbourne, Australia in 2009-2011. Methods: Women completed questionnaires at recruitment and six time-points in the first eight weeks postpartum. Postpartum questionnaires asked about incidences of mastitis, nipple damage, milk supply, expressing practices and breastfeeding problems. Nasal and nipple swabs were collected from mothers and babies, as well as breast milk samples. All samples were cultured for S. aureus. "Time at risk" of mastitis was defined as days between birth and first occurrence of mastitis (for women who developed mastitis) and days between birth and the last study time-point (for women who did not develop mastitis). Risk factors for incidence of mastitis occurring during the time at risk (Incident Rate Ratios [IRR]) were investigated using a discrete version of the multivariable proportional hazards regression model. Results: Twenty percent (70/346) of participants developed mastitis. Women had an increased risk of developing mastitis if they reported nipple damage (IRR 2.17, 95 % CI 1.21, 3.91), over-supply of breast milk (IRR 2.60, 95 % CI 1.58, 4.29), nipple shield use (IRR 2.93, 95 % CI 1.72, 5.01) or expressing several times a day (IRR 1.64, 95 % CI 1.01, 2.68). The presence of S. aureus on the nipple (IRR 1.72, 95 % CI 1.04, 2.85) or in milk (IRR 1.78, 95 % CI 1.08, 2.92) also increased the risk of developing mastitis. Conclusions: Nipple damage, over-supply of breast milk, use of nipple shields and the presence of S. aureus on the nipple or in breast milk increased the mastitis risk in our prospective cohort study sample. Reducing nipple damage may help reduce maternal breast infections. [ABSTRACT FROM AUTHOR]

Ethnopharmacological relevance Being one of the most common types of life threatening diseases in Southern Assam, India, the digestive system disorders (DSD) have gained much attention in recent decades. Traditional beliefs and inadequate income of mass population result in the use of alternative phytotherapies to treat the diseases. Aim of the study The present paper documents the medicinal knowledge and utilization of plants for treatment of digestive system disorders in Southern Assam, India by Disease Consensus Index (DCI). It also determines the most suitable plant species used to treat digestive system disorders in the study area. Materials and methods The study was based on ethnomedicinal field survey covering a period of 1 year from 2014–2015. The ethnomedicinal information was collected by using semi-structured questionnaires from different traditional Bengali people having knowledge on medicinal plants. Collected data were analyzed by calculating DCI. Results During the survey, 29 informants were interviewed and a total of 49 plants under 46 genera belonging to 33 families were listed. Data analysis revealed that Litsea glutinosa , Momordica charantia , Andrographis paniculata , Lawsonia inermis , Cleome viscosa , Psidium guajava , Ageratum conyzoides , Cuscuta reflexa , Cynodon dactylon and Carica papaya are the most prominent plants among the people of Southern Assam for treating DSD. Conclusion This explorative survey emphasizes the need to preserve and document the traditional healing practices for managing DSD inviting for more imminent scientific research on the plants to determine their efficacy as well as safety. With the help of statistical analysis (DCI), we propose 10 priority plants for DSD in present work. Systematic pharmacological study with these plants may contribute significant result. [ABSTRACT FROM AUTHOR]

The article reports on a 2015 study of health care provider (HCP) and patient perceptions on oral anticancer medications (OACM) adherence, toxicity reporting, and patient educational needs. Results show that only 40% of HCPs believe their patients were adherent, that 61% of patients reported toxicities sometimes or often, and that both groups favored paper-based educational materials. The article notes the differences in patient and HCP perceptions on OACM adherence and toxicity reporting.

Background: It is important when conducting epidemiologic studies to closely monitor lost to follow up (LTFU) rates. A high LTFU rate may lead to incomplete study results which in turn can introduce bias to the trial or study, threatening the validity of the findings. There is scarce information on LTFU in prospective community-based perinatal epidemiological studies. This paper reports the rates of LTFU, describes socio-demographic characteristics, and pregnancy/delivery outcomes of mothers LTFU in a large community-based pregnancy registry study. Methods: Data were from a prospective, population-based observational study of the Global Network for Women's and Children's Health Research Maternal Newborn Health Registry (MNHR). This is a multi-centre, international study in which pregnant women were enrolled in mid-pregnancy, followed through parturition and 42 days postdelivery. Risk for LTFU was calculated within a 95%CI. Results: A total of 282,626 subjects were enrolled in this study, of which 4,893 were lost to follow-up. Overall, there was a 1.7% LTFU to follow up rate. Factors associated with a higher LTFU included mothers who did not know their last menstrual period (RR 2.2, 95% CI 1.1, 4.4), maternal age of < 20 years (RR 1.2, 95% CI 1.1, 1.3), women with no formal education (RR 1.2, 95% CI 1.1, 1.4), and attending a government clinic for antenatal care (RR 2.0, 95% CI 1.4, 2.8). Post-natal factors associated with a higher LTFU rate included a newborn with feeding problems (RR 1.6, 94% CI 1.2, 2.2). Conclusions: The LTFU rate in this community-based registry was low (1.7%). Maternal age, maternal level of education, pregnancy status at enrollment and using a government facility for ANC are factors associated with being LTFU. Strategies to ensure representation and high retention in community studies are important to informing progress toward public health goals. [ABSTRACT FROM AUTHOR]

Simple Summary: Afatinib is used to treat non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation as a second-generation EGFR-tyrosine kinase inhibitor (TKI). We examined the relationship between the trough plasma concentrations of afatinib and adverse effects, including diarrhea, rash, stomatitis and mucositis. The dose reduction of afatinib was associated with the trough plasma concentration of afatinib in this paper. As a result, we clarified that a higher trough plasma concentration induced adverse events, and there was a threshold to reduce the dosage or not. Monitoring plasma concentrations of afatinib is useful to predict the adverse effects of afatinib and to support quality of life in patients with EGFR-mutated advanced NSCLC. Afatinib is used to treat non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation as a second-generation EGFR-tyrosine kinase inhibitor (TKI). Early prediction of adverse effects based on the pharmacokinetics of afatinib enables support for quality of life (QOL) in patients with no change in efficacy. We examined the pharmacokinetic relationship between trough plasma concentration and adverse effects and evaluated the utility of measuring the trough plasma concentration of afatinib as the first EGFR-TKI treatment for NSCLC in a prospective multicenter study. Twenty-four patients treated with afatinib were enrolled in this study. All blood samples were collected at the trough point, and plasma concentrations were measured using high-performance liquid chromatography–tandem mass spectrometry. Logistic regression analysis for the dose reduction of afatinib was performed, and the receiver operating characteristic (ROC) curve was plotted. Although all patients started afatinib at 40 mg/day, plasma concentrations were variable, and mean and median trough plasma concentrations were 32.9 ng/mL and 32.5 ng/mL in this study, respectively. Minimum and maximum trough plasma concentrations were 10.4 ng/mL and 72.7 ng/mL, respectively. This variability was speculated to involve personal parameters such as laboratory data. However, no patient characteristics or laboratory data examined correlated with the trough plasma concentration of afatinib, except albumin. Albumin showed a weak correlation with plasma concentration (r = 0.60, p = 0.009). The trough plasma concentration of afatinib was significantly associated with the dose reduction of afatinib (p = 0.047). The area under the ROC curve (AUC) for the trough plasma concentration of afatinib was 0.81. The cut-off value was 21.4 ng/mL. The sensitivity and specificity of the cut-off as a risk factor were 0.80 and 0.75. In summary, the trough plasma concentration of afatinib was associated with continued or reduced dosage because of the onset of several adverse effects, and a threshold was seen. Adverse effects not only lower QOL but also hinder continued treatment. Measuring plasma concentrations of afatinib appears valuable to predict adverse effects and continue effective therapy. [ABSTRACT FROM AUTHOR]