Recommendations for optimising pilot and feasibility work in surgery.

BACKGROUND: Surgical trials are recognised as inherently challenging. Pilot and feasibility studies (PAFS) are increasingly acknowledged as a key method to optimise the design and conduct of randomised trials but remain limited in surgery. We used a mixed methods approach to develop recommendations for how surgical PAFS could be optimised. METHODS: The findings from a quantitative analysis of funded surgical PAFS over a 10-year period and in-depth qualitative interviews with surgeons, methodologists and funders were triangulated and synthesised with available methodological guidance on PAFS. RESULTS: The synthesis informed the development of an explanatory model describing root causes and compounding challenges that contribute to how and why surgical PAFS is not currently optimised. The four root causes identified include issues relating to (i) understanding the full scope of PAFS; (ii) design and conduct of PAFS; (iii) reporting of PAFS; and (iv) lack of appreciation of the value of PAFS by all stakeholder groups. Compounding challenges relate to both cultural issues and access to and interpretation of available methodological PAFS guidance. The study findings and explanatory model were used to inform the development of a practical guidance tool for surgeons and study teams to improve research practice. CONCLUSIONS: Optimisation of PAFS in surgery requires a cultural shift in research practice amongst funders, academic institutions, regulatory bodies and journal editors, as well as amongst surgeons. Our 'Top Tips' guidance tool offers an accessible framework for surgeons designing PAFS. Adoption and utilisation of these recommendations will optimise surgical PAFS, facilitating successful and efficient future surgical trials.

An Ergonomic Risk Assessment of Ophthalmology Residents Using the Rapid Entire Body Assessment (REBA) Scale.

BACKGROUND: The healthcare industry has one of the highest rates of work-related injuries. Ophthalmologists are at particularly high risk for developing musculoskeletal disorders (MSDs), which are often the result of repetitive movements, such as performing slit lamp examinations. Previous studies used the Rapid Entire Body Assessment (REBA) scale to determine the ergonomic risk of a particular task. Higher REBA scores correlate with increased risk of injury, which ranges from negligible risk (1) to very high risk (11+). OBJECTIVE: Given the long-term implications of repetitive examinations by ophthalmologists, this study aims to describe the average ergonomic risk posed to residents using the REBA scale. METHODS: This descriptive case study assessed four ophthalmology residents performing slit lamp examinations between September 2022 and February 2023. Photographs were taken of residents performing slit lamp examinations. Total REBA scores, Score A, Score B, and the REBA scores for each participant were calculated and compared. RESULTS: The average REBA score across all participants was 4.59 (SD±0.89). The highest score was 7.00 and the lowest was 3.00. The average Score A, representing posture for the head, leg, and trunk, was 3.54 (SD±0.74) and the average Score B, representing posture for the upper arm, lower arm, and wrist, was 3.18 (SD±1.22). CONCLUSION: Our study found that residents are at increased risk for developing MSDs. Furthermore, variation in REBA scores between residents indicates that not all residents are at equal ergonomic risk. This highlights an opportunity for ophthalmology residency programs to implement ergonomics training into their curriculum.

Prognostic and Diagnostic Utility of Serum Biomarkers in Pediatric Traumatic Brain Injury.

Traumatic brain injury (TBI) remains a major cause of morbidity and death among the pediatric population. Timely diagnosis, however, remains a complex task because of the lack of standardized methods that permit its accurate identification. The aim of this study was to determine whether serum levels of brain injury biomarkers can be used as a diagnostic and prognostic tool in this pathology. This prospective, observational study collected and analyzed the serum concentration of neuronal injury biomarkers at enrollment, 24h and 48h post-injury, in 34 children ages 0-18 with pTBI and 19 healthy controls (HC). Biomarkers included glial fibrillary acidic protein (GFAP), neurofilament protein L (NfL), ubiquitin-C-terminal hydrolase (UCH-L1), S-100B, tau and tau phosphorylated at threonine 181 (p-tau181). Subjects were stratified by admission Glasgow Coma Scale score into two categories: a combined mild/moderate (GCS 9-15) and severe (GCS 3-8). Glasgow Outcome Scale-Extended (GOS-E) Peds was dichotomized into favorable (≤4) and unfavorable (≥5) and outcomes. Data were analyzed utilizing Prism 9 and R statistical software. The findings were as follows: 15 patients were stratified as severe TBI and 19 as mild/moderate per GCS. All biomarkers measured at enrollment were elevated compared with HC. Serum levels for all biomarkers were significantly higher in the severe TBI group compared with HC at 0, 24, and 48h. The GFAP, tau S100B, and p-tau181 had the ability to differentiate TBI severity in the mild/moderate group when measured at 0h post-injury. Tau serum levels were increased in the mild/moderate group at 24h. In addition, NfL and p-tau181 showed increased serum levels at 48h in the aforementioned GCS category. Individual biomarker performance on predicting unfavorable outcomes was measured at 0, 24, and 48h across different GOS-E Peds time points, which was significant for p-tau181 at 0h at all time points, UCH-L1 at 0h at 6-9 months and 12 months, GFAP at 48h at 12 months, NfL at 0h at 12 months, tau at 0h at 12 months and S100B at 0h at 12 months. We concluded that TBI leads to increased serum neuronal injury biomarkers during the first 0-48h post-injury. A biomarker panel measuring these proteins could aid in the early diagnosis of mild to moderate pTBI and may predict neurological outcomes across the injury spectrum.

Dearomative (3+2) Cycloadditions between Indoles and Vinyldiazo Species Enabled by a Red-Shifted Chromium Photocatalyst.

A direct dearomative photocatalyzed (3+2) cycloaddition between indoles and vinyldiazo reagents is described. The transformation is enabled by the development of a novel oxidizing CrIII photocatalyst, its specific reactivity attributed to increased absorptive properties over earlier Cr analogs and greater stability than Ru counterparts. A variety of fused indoline compounds are synthesized using this method, including densely functionalized ring systems that are feasible due to base-free conditions. Experimental insights corroborate a cycloaddition initiated by nucleophilic attack at C3 of the indole radical cation by the vinyldiazo species.

Cardiac arrest: An interdisciplinary scoping review of clinical literature from 2020.

Objectives: The Interdisciplinary Cardiac Arrest Research Review (ICARE) group was formed in 2018 to conduct an annual search of peer-reviewed literature relevant to cardiac arrest. Now in its third year, the goals of the review are to highlight annual updates in the interdisciplinary world of clinical cardiac arrest research with a focus on clinically relevant and impactful clinical and population-level studies from 2020. Methods: A search of PubMed using keywords related to clinical research in cardiac arrest was conducted. Titles and abstracts were screened for relevance and sorted into 7 categories: Epidemiology & Public Health Initiatives; Prehospital Resuscitation, Technology & Care; In-Hospital Resuscitation & Post-Arrest Care; Prognostication & Outcomes; Pediatrics; Interdisciplinary Guidelines & Reviews; and a new section dedicated to the coronavirus disease 2019 (COVID-19) pandemic. Screened manuscripts underwent standardized scoring of methodological quality and impact on the respective fields by reviewer teams lead by a subject matter expert editor. Articles scoring higher than 99 percentiles by category were selected for full critique. Systematic differences between editors' and reviewers' scores were assessed using Wilcoxon signed-rank test. Results: A total of 3594 articles were identified on initial search; of these, 1026 were scored after screening for relevance and deduplication, and 51 underwent full critique. The leading category was Prehospital Resuscitation, Technology & Care representing 35% (18/51) of fully reviewed articles. Four COVID-19 related articles were included for formal review that was attributed to a relative lack of high-quality data concerning cardiac arrest and COVID-19 specifically by the end of the 2020 calendar year. No significant differences between editor and reviewer scoring were found among review articles (P = 0.697). Among original research articles, section editors scored a median 1 point (interquartile range, 0-3; P < 0.01) less than reviewers. Conclusions: Several clinically relevant studies have added to the evidence base for the management of cardiac arrest patients including methods for prognostication of neurologic outcome following arrest, airway management strategy, timing of coronary intervention, and methods to improve expeditious performance of key components of resuscitation such as chest compressions in adults and children.

Changes in Critical Bronchiolitis After COVID-19 Lockdown.

Introduction In response to the coronavirus disease 2019 (COVID-19) pandemic, state and local governments implemented mitigation strategies, including lockdowns, thereby averting the typical fall/winter 2020 bronchiolitis season and reducing the incidence of respiratory viruses, such as respiratory syncytial virus (RSV). Florida implemented a strict lockdown from April 1, 2020, to April 30, 2020. The removal of lockdown precautions on September 25, 2020, was followed by an atypical out-of-season surge of bronchiolitis in April 2021. Anecdotally, this surge appeared to be associated with both increased poly-viral coinfections and disease severity. Objective To determine if the bronchiolitis out-of-season surge differed from historical seasonal case patterns. Methods A single-center retrospective cohort study of admissions to the pediatric intensive care unit (PICU) with International Classification of Diseases, Tenth Revision (ICD-10) codes of bronchiolitis, from December 9, 2019, to February 29, 2020 (12 weeks, pre-lockdown group or PreLD), was compared to March 29, 2021, to June 19, 2021 (12 weeks, post-lockdown group or PostLD). Variables used for comparison were gender, ethnicity, age, viral coinfections, viruses detected, PICU length of stay, hospital length of stay, mortality, maximum respiratory support needed, mechanical ventilation days, extracorporeal life support (ECLS) days, and severity of disease measured by Pediatric Logistic Organ Dysfunction-2 (PELOD-2) and Pediatric Sequential Organ Failure Assessment (pSOFA). Categorical data were analyzed using Fisher's exact test, and a t-test was used for continuous variables. A two-sided p < 0.05 was considered significant. Results A total of 135 subjects were analyzed from the two cohorts. More patients were admitted during the PostLD phase (87 vs. 48). The PostLD group had a higher age at admission (11.2 ± 12.3 vs. 6.6 ± 7.5, p = 0.0075), but there were no differences in gender or race/ethnicity. The PostLD group also exhibited a higher proportion of RSV infections (73 vs. 16, p < 0.0001) and poly-viral infections (p < 0.0001). Higher coronavirus OC43 (9 vs. 0, p = 0.0263) and parainfluenza types 1-4 (human parainfluenza virus (HPIV)) (19 vs. 1, p = 0.0017) detections, yet fewer human metapneumovirus (HMPV) detections (0 vs. 4, p = 0.0147), were observed PostLD. No differences were found in hospital length of stay, PICU length of stay, mortality, mechanical ventilation days, ECLS days, or severity of illness scores based on PELOD-2 or pSOFA scores. Conclusion In the bronchiolitis out-of-season surge, there were an increased number of admissions to the PICU. Those patients were older, and more likely to have RSV, as well as a coinfection with coronavirus OC43 or HPIV, yet less likely to have HMPV. No difference in length of stay or disease severity was demonstrated.

Transfusion-Associated Delirium in Children: No Difference Between Short Storage Versus Standard Issue RBCs.

OBJECTIVES: Primary objective is to determine if transfusion of short storage RBCs compared with standard issue RBCs reduced risk of delirium/coma in critically ill children. Secondary objective is to assess if RBC transfusion was independently associated with delirium/coma. DESIGN: This study was performed in two stages. First, we compared patients receiving either short storage or standard RBCs in a multi-institutional prospective randomized controlled trial. Then, we compared all transfused patients in the randomized controlled trial with a single-center cohort of nontransfused patients matched for confounders of delirium/coma. SETTING: Twenty academic PICUs who participated in the Age of Transfused Blood in Critically Ill Children trial. PATIENTS: Children 3 days to 16 years old who were transfused RBCs within the first 7 days of admission. INTERVENTIONS: Subjects were randomized to either short storage RBC study arm (defined as RBCs stored for up to seven days) or standard issue RBC study arm. In addition, subjects were screened for delirium prior to transfusion and every 12 hours after transfusion for up to 3 days. MEASUREMENTS AND MAIN RESULTS: Primary outcome measure was development of delirium/coma within 3 days of initial transfusion. Additional outcome measures were dose-response relationship between volume of RBCs transfused and delirium/coma, and comparison of delirium/coma rates between transfused patients and individually matched nontransfused patients. We included 146 subjects in the stage I analysis; 69 were randomized to short storage RBCs and 77 to standard issue. There was no significant difference in delirium/coma development between study arms (79.5% vs 70.1%; p = 0.184). In the stage II analysis, adjusted odds for delirium in the transfused cohort was more than eight-fold higher than in the nontransfused matched cohort, even after controlling for hemoglobin (adjusted odds ratio, 8.9; CI, 2.8-28.4; p < 0.001). CONCLUSIONS: RBC transfusions (and not anemia) are independently associated with increased odds of subsequent delirium/coma. However, storage age of RBCs does not affect delirium risk.

Electronic collection of patient-reported outcomes following discharge after surgery: systematic review.

BACKGROUND: Little is known about the electronic collection and clinical feedback of patient-reported outcomes (ePROs) following surgical discharge. This systematic review summarized the evidence on the collection and uses of electronic systems to collect PROs after discharge from hospital after surgery. METHOD: Systematic searches of MEDLINE, Embase, PsycINFO, CINAHL and Cochrane Central were undertaken from database inception to July 2019 using terms for 'patient reported outcomes', 'electronic', 'surgery' and 'at home'. Primary research of all study designs was included if they used electronic systems to collect PRO data in adults after hospital discharge following surgery. Data were collected on the settings, patient groups and specialties, ePRO systems (including features and functions), PRO data collected, and integration with health records. RESULTS: Fourteen studies were included from 9474 records, including two RCTs and six orthopaedic surgery studies. Most studies (9 of 14) used commercial ePRO systems. Six reported types of electronic device were used: tablets or other portable devices (3 studies), smartphones (2), combination of smartphones, tablets, portable devices and computers (1). Systems had limited features and functions such as real-time clinical feedback (6 studies) and messaging service for patients with care teams (3). No study described ePRO system integration with electronic health records to support clinical feedback. CONCLUSION: There is limited reporting of ePRO systems in the surgical literature, and ePRO systems lack integration with hospital clinical systems. Future research should describe the ePRO system and ePRO questionnaires used, and challenges encountered during the study, to support efficient upscaling of ePRO systems using tried and tested approaches.

Menstrual Migraines: Diagnosis, Evidence, and Treatment.

"Menstrual" or "catamenial" migraine (MM) is separated into two categories in the International Classification of Headache Disorders pure menstrual migraine and menstrually-related migraine. Pure menstrual migraine is defined as a migraine occurring exclusively on day 1 ± 2 of menstruation in at least two out of three menstrual cycles and at no other time in the cycle. Menstrually-related migraine is defined as the same but may occur at other times in the menstrual cycle, not just around menstruation. The withdrawal of estrogen has been correlated with the onset of MM, providing an opportunity for specific treatment with hormone therapies. Traditionally, MM has been treated with nonspecific treatments such as abortive and prophylactic non-steroidal anti-inflammatory drugs and triptans. While this is first line, evidence suggests that nonspecific treatments can be used in combination with specific hormone treatments. The hormone treatment recommended is either continuous combined hormonal contraceptives (CHCs) with no placebo pills or using just two days of placebo pills to avoid the estrogen withdrawal trigger. Although MM with aura is uncommon, when referring to using CHCs for MM with aura, the U.S. Medical Eligibility Criteria for Contraceptive Use 2016 categorizes MM with aura as "A condition that represents an unacceptable health risk if the contraceptive method is used." Therefore, the current recommendation is not to use CHCs with a history of menstrual migraine with aura, especially when other risk factors such as smoking are present. Other treatments such as GnRH agonists, selective estrogen receptor modulators, and bilateral oophorectomy have limited evidence.

Patient-Reported Outcome Measures for Post-mastectomy Breast Reconstruction: A Systematic Review of Development and Measurement Properties.

BACKGROUND: Breast reconstruction (BR) is performed to improve outcomes for patients undergoing mastectomy. A recently developed core outcome set for BR includes six patient-reported outcomes that should be measured and reported in all future studies. It is vital that any instrument used to measure these outcomes as part of a core measurement set be robustly developed and validated so data are reliable and accurate. The aim of this systematic review is to evaluate the development and measurement properties of existing BR patient-reported outcome measures (PROMs) to inform instrument selection for future studies. METHODS: A PRISMA-compliant systematic review of development and validation studies of BR PROMs was conducted to assess their measurement properties. PROMs with adequate content validity were assessed using three steps: (1) the methodological quality of each identified study was assessed using the COSMIN Risk of Bias checklist; (2) criteria were applied for assessing good measurement properties; and (3) evidence was summarized and the quality of evidence assessed using a modified GRADE approach. RESULTS: Fourteen articles reported the development and measurement properties of six PROMs. Of these, only three (BREAST-Q, BRECON-31, and EORTC QLQ-BRECON-23) were considered to have adequate content validity and proceeded to full evaluation. This showed that all three PROMs had been robustly developed and validated and demonstrated adequate quality. CONCLUSIONS: BREAST-Q, BRECON-31, and EORTC QLQ-BRECON-23 have been well-developed and demonstrate adequate measurement properties. Work with key stakeholders is now needed to generate consensus regarding which PROM should be recommended for inclusion in a core measurement set.

Patient experiences of an electronic PRO tailored feedback system for symptom management following upper gastrointestinal cancer surgery.

PURPOSE: Complications following upper gastrointestinal (UGI) surgery are common. Symptom-monitoring following discharge is not standardized. An electronic patient-reported outcome (ePRO) system providing feedback to patients and clinicians could support patients and improve outcomes. Little is known about patients' experiences of using such systems. This qualitative sub-study explored patients' perspectives of the benefits of using a novel ePRO system, developed as part of the mixed methods eRAPID pilot study, to support recovery following discharge after UGI surgery. METHODS: Patients completed the online ePRO symptom-report system post-discharge. Weekly interviews explored patients' experiences of using ePRO, the acceptability of feedback generated and its value for supporting their recovery. Interviews were audio-recorded and targeted transcriptions were thematically analysed. RESULTS: Thirty-five interviews with 16 participants (11 men, mean age 63 years) were analysed. Two main themes were identified: (1) reassurance and (2) empowerment. Feelings of isolation were common; many patients felt uninformed regarding their expectations of recovery and whether their symptoms warranted clinical investigation. Participants were reassured by tailored feedback advising them to contact their care team, alleviating their anxiety. Patients reported feeling empowered by the ePRO system and in control of their symptoms and recovery. CONCLUSION: Patients recovering at home following major cancer surgery regarded electronic symptom-monitoring and feedback as acceptable and beneficial. Patients perceived that the system enhanced information provision and provided a direct link to their care team. Patients felt that the system provided reassurance at a time of uncertainty and isolation, enabling them to feel in control of their symptoms and recovery.

Outcome selection, measurement and reporting for new surgical procedures and devices: a systematic review of IDEAL/IDEAL-D studies to inform development of a core outcome set.

BACKGROUND: Outcome selection, measurement and reporting for the evaluation of new surgical procedures and devices is inconsistent and lacks standardization. A core outcome set may promote the safe and transparent evaluation of surgical innovations. This systematic review examined outcome selection, measurement and reporting in studies conducted within the IDEAL (Idea, Development, Exploration, Assessment and Long-term monitoring) framework to examine current practice and inform the development of a core outcome set for early-phase studies of surgical procedures/devices. METHODS: Web of Science and Scopus citation searches were performed to identify author-reported IDEAL/IDEAL-D studies for any surgical procedure/device. Outcomes were extracted verbatim, including contextual information regarding outcome selection and measurement. Outcomes were categorized to inform a conceptual framework of outcome domains relevant to evaluating innovation. RESULTS: Some 48 studies were identified. Outcome selection, measurement and reporting varied widely across studies in different IDEAL stages. From 1737 outcomes extracted, 22 domains specific to evaluating innovation were conceptualized under seven broad categories: procedure completion success/failure; modifications; unanticipated events; surgeons' experiences; patients' experiences; resource use specific to the innovative procedure/device; and other innovation-specific outcomes. Most innovation-specific outcomes were measured and reported in only a small number of studies. CONCLUSION: This review highlighted the need for guidance and standardization in outcome selection and reporting in the evaluation of new surgical procedures/devices. Novel outcome domains specific to innovation have been identified to establish a core outcome set for future evaluations of surgical innovations.

ANTECEDENTES: La selección de resultados, mediciones y redacción de los informes para la evaluación de nuevos procedimientos y dispositivos quirúrgicos es inconsistente y carece de estandarización. Determinar un conjunto de resultados básicos (core outcome set, COS) podría contribuir a la transparencia y seguridad de las evaluaciones de las innovaciones quirúrgicas. Esta revisión sistemática analizó la selección de resultados, medición de los mismos e informes de estudios efectuados en el marco metodológico IDEAL, a fin de valorar la práctica actual y presentar el desarrollo de un COS para estudios en fase inicial de procedimientos/dispositivos quirúrgicos. MÉTODOS: Se realizaron búsquedas en las bases de datos Web of Science y Scopus para identificar estudios efectuados por los autores en el marco IDEAL/IDEAL-D referentes a cualquier procedimiento/dispositivo quirúrgico. Los resultados se extrajeron literalmente, incluida la información contextualizada referente a la selección y medición de los resultados. Los resultados se categorizaron para presentar información en un marco conceptual de dominios de resultados que fueran relevantes para poder evaluar la innovación. RESULTADOS: Se identificaron 48 estudios. Los estudios mostraban una amplia variedad en la selección de resultados, mediciones e información correspondientes a diferentes estadios IDEAL. A partir de 1.737 resultados extraídos, se conceptualizaron 22 dominios específicos para evaluar la innovación agrupados en 7 amplias categorías: éxito/fracaso para completar el procedimiento; modificaciones; eventos imprevistos; experiencias de los cirujanos; experiencias de los pacientes; uso de recursos específicos del procedimiento/dispositivo innovador y otros resultados específicos de la innovación. La mayoría de los resultados específicos de la innovación se midieron y notificaron solo en un pequeño número de estudios. CONCLUSIÓN: Esta revisión ha puesto de manifiesto la necesidad de orientación y estandarización en la selección de resultados y la notificación en la evaluación de nuevos procedimientos/dispositivos quirúrgicos. Se han identificado nuevos dominios de resultados específicos de innovación para establecer un COS para futuras evaluaciones de innovaciones quirúrgicas.

A systematic review and in-depth analysis of outcome reporting in early phase studies of colorectal cancer surgical innovation.

AIM: Early phase studies are essential to evaluate new technologies prior to randomized evaluation. Evaluation is limited, however, by inconsistent measurement and reporting of outcomes. This study examines outcome reporting in studies of innovative colorectal cancer surgery. METHODS: Systematic searches identified studies of invasive procedures treating primary colorectal adenocarcinoma. Included were a random sample of studies which authors reported as 'new' or 'modified'. Outcomes were extracted verbatim and categorized using an existing framework of 32 domains relevant to early phase studies. Outcomes were classified as 'measured' (where there was an explicit statement to that effect or evidence that data collection had occurred) or 'mentioned but not measured' (where outcomes were discussed but data collection was not evident). Patterns of identified outcomes are described. RESULTS: Of 8373 records, 816 were potentially eligible. Full-text review of a random sample of 218 studies identified 51 for inclusion of which 34 (66%) were 'new' and 17 (33%) were 'modified'. Some 2073 outcomes were identified, and all mapped to domains. 'Anticipated disadvantages' were most frequently identified [660 (32%) outcomes identified across 50 (98%) studies]. No domain was represented in all studies. Under half (944, 46%) of outcomes were 'measured'. 'Surgeon's/operator's experience of the innovation' was more frequently 'mentioned but not measured' [207 (18%) outcomes across 46 (90%) studies] than 'measured' [17 (2%) outcomes, 11 (22%) studies]. CONCLUSION: There is outcome reporting heterogeneity in studies of early phase colorectal cancer surgery. The adoption of core outcome sets may help to resolve these inconsistencies and enable efficient evaluation of surgical innovations.

Associations of physical fitness and physical activity with sleep among middle-aged women.

BACKGROUND: Sleep is an important component of health. Sleep disturbances increase in women as they enter menopause. Physical activity has been associated with improved sleep among older populations. The purpose of this study was to determine if physical activity and/or physical fitness are associated with sleep quantity and quality in middle-aged women. METHODS: This study recruited 114 healthy women, aged 30-55 (43±8 y) from Saskatoon, Saskatchewan, from 2015-2019. Sleep quantity and quality were evaluated. Participants were classified on their aerobic fitness, based on estimated peak aerobic capacity, as high or low grip strength and, as active or inactive. RESULTS: The high aerobic fitness group had a greater mean sleep duration of 7.04±1.02 h compared to the low fit group 6.61±1.00 h after adjusting for age, Body Mass Index, waist circumference and menstrual status (P=0.01). The percentage of high aerobic fitness women who felt rested was greater than low aerobic fitness women (67±6% vs. 45±7%, P=0.03), after adjusting for age, Body Mass Index, waist circumference and menstrual status. Our study found a significant difference between women with higher aerobic fitness levels getting more sleep each night and feeling more rested. CONCLUSIONS: The continued examination of physical fitness and its relationship to sleep holds importance for women's health.

A real-time electronic symptom monitoring system for patients after discharge following surgery: a pilot study in cancer-related surgery.

BACKGROUND: Advances in peri-operative care of surgical oncology patients result in shorter hospital stays. Earlier discharge may bring benefits, but complications can occur while patients are recovering at home. Electronic patient-reported outcome (ePRO) systems may enhance remote, real-time symptom monitoring and detection of complications after hospital discharge, thereby improving patient safety and outcomes. Evidence of the effectiveness of ePRO systems in surgical oncology is lacking. This pilot study evaluated the feasibility of a real-time electronic symptom monitoring system for patients after discharge following cancer-related upper gastrointestinal surgery. METHODS: A pilot study in two UK hospitals included patients who had undergone cancer-related upper gastrointestinal surgery. Participants completed the ePRO symptom-report at discharge, twice in the first week and weekly post-discharge. Symptom-report completeness, system actions, barriers to using the ePRO system and technical performance were examined. The ePRO surgery system is an online symptom-report that allows clinicians to view patient symptom-reports within hospital electronic health records and was developed as part of the eRAPID project. Clinically derived algorithms provide patients with tailored self-management advice, prompts to contact a clinician or automated clinician alerts depending on symptom severity. Interviews with participants and clinicians determined the acceptability of the ePRO system to support patients and their clinical management during recovery. RESULTS: Ninety-one patients were approached, of which 40 consented to participate (27 male, mean age 64 years). Symptom-report response rates were high (range 63-100%). Of 197 ePRO completions analysed, 76 (39%) triggered self-management advice, 72 (36%) trigged advice to contact a clinician, 9 (5%) triggered a clinician alert and 40 (20%) did not require advice. Participants found the ePRO system reassuring, providing timely information and advice relevant to supporting their recovery. Clinicians regarded the system as a useful adjunct to usual care, by signposting patients to seek appropriate help and enhancing their understanding of patients' experiences during recovery. CONCLUSION: Use of the ePRO system for the real-time, remote monitoring of symptoms in patients recovering from cancer-related upper gastrointestinal surgery is feasible and acceptable. A definitive randomised controlled trial is needed to evaluate the impact of the system on patients' wellbeing after hospital discharge.

Cardiac arrest: An interdisciplinary review of the literature from 2018.

OBJECTIVES: The Interdisciplinary Cardiac Arrest Research Review (ICARE) group was formed in 2018 to conduct a systematic annual search of peer-reviewed literature relevant to cardiac arrest (CA). The goals of the review are to illustrate best practices and help reduce knowledge silos by disseminating clinically relevant advances in the field of CA across disciplines. METHODS: An electronic search of PubMed using keywords related to CA was conducted. Title and abstracts retrieved by these searches were screened for relevancy, separated by article type (original research or review), and sorted into 7 categories. Screened manuscripts underwent standardized scoring of overall methodological quality and importance. Articles scoring higher than 99 percentiles by category-type were selected for full critique. Systematic differences between editors and reviewer scores were assessed using Wilcoxon signed-rank test. RESULTS: A total of 9119 articles were identified on initial search; of these, 1214 were scored after screening for relevance and deduplication, and 80 underwent full critique. Prognostication & Outcomes category comprised 25% and Epidemiology & Public Health 17.5% of fully reviewed articles. There were no differences between editor and reviewer scoring. CONCLUSIONS: The total number of articles demonstrates the need for an accessible source summarizing high-quality research findings to serve as a high-yield reference for clinicians and scientists seeking to absorb the ever-growing body of CA-related literature. This may promote further development of the unique and interdisciplinary field of CA medicine.

Cardiac arrest: An interdisciplinary scoping review of the literature from 2019.

OBJECTIVES: The Interdisciplinary Cardiac Arrest Research Review (ICARE) group was formed in 2018 to conduct a systematic annual search of peer-reviewed literature relevant to cardiac arrest. Now in its second year, the goals of the review are to illustrate best practices in research and help reduce compartmentalization of knowledge by disseminating clinically relevant advances in the field of cardiac arrest across disciplines. METHODS: An electronic search of PubMed using keywords related to cardiac arrest was conducted. Title and abstracts retrieved by these searches were screened for relevance, classified by article type (original research or review), and sorted into 7 categories. Screened manuscripts underwent standardized scoring of overall methodological quality and impact on the categorized fields of study by reviewer teams lead by a subject-matter expert editor. Articles scoring higher than 99 percentiles by category-type were selected for full critique. Systematic differences between editors' and reviewers' scores were assessed using Wilcoxon signed-rank test. RESULTS: A total of 3348 articles were identified on initial search; of these, 1364 were scored after screening for relevance and deduplication, and forty-five underwent full critique. Epidemiology & Public Health represented 24% of fully reviewed articles with Prehospital Resuscitation, Technology & Care, and In-Hospital Resuscitation & Post-Arrest Care Categories both representing 20% of fully reviewed articles. There were no significant differences between editor and reviewer scoring. CONCLUSIONS: The sheer number of articles screened is a testament to the need for an accessible source calling attention to high-quality and impactful research and serving as a high-yield reference for clinicians and scientists seeking to follow the ever-growing body of cardiac arrest-related literature. This will promote further development of the unique and interdisciplinary field of cardiac arrest medicine.

Value of surgical pilot and feasibility study protocols.

BACKGROUND: RCTs in surgery are challenging owing to well established methodological issues. Well designed pilot and feasibility studies (PFS) may help overcome such issues to inform successful main trial design and conduct. This study aimed to analyse protocols of UK-funded studies to explore current use of PFS in surgery and identify areas for practice improvement. METHODS: PFS of surgical interventions funded by UK National Institute for Health Research programmes from 2005 to 2015 were identified, and original study protocols and associated publications sourced. Data extracted included study design characteristics, reasons for performing the work including perceived uncertainties around conducting a definitive main trial, and whether the studies had been published. RESULTS: Thirty-five surgical studies were identified, of which 29 were randomized, and over half (15 of 29) included additional methodological components (such as qualitative work examining recruitment, and participant surveys studying current interventions). Most studies focused on uncertainties around recruitment (32 of 35), with far fewer tackling uncertainties specific to surgery, such as intervention stability, implementation or delivery (10 of 35). Only half (19 of 35) had made their results available publicly, to date. CONCLUSION: The full potential of pretrial work to inform and optimize definitive surgical studies is not being realized.

What surgeons tell patients and what patients want to know before major cancer surgery: a qualitative study.

BACKGROUND: The information surgeons impart to patients and information patients want about surgery for cancer is important but rarely examined. This study explored information provided by surgeons and patient preferences for information in consultations in which surgery for oesophageal cancer surgery was discussed. METHODS: Pre-operation consultations in which oesophagectomy was discussed were studied in three United Kingdom hospitals and patients were subsequently interviewed. Consultations and interviews were audio-recorded, transcribed in full and anonymized. Interviews elicited views about the information provided by surgeons and patients' preferences for information. Thematic analysis of consultation-interview pairs was used to investigate similarities and differences in the information provided by surgeons and desired by patients. RESULTS: Fifty two audio-recordings from 31 patients and 7 surgeons were obtained (25 consultations and 27 patient interviews). Six consultations were not recorded because of equipment failure and four patients declined an interview. Surgeons all provided consistent, extensive information on technical operative details and in-hospital surgical risks. Consultations rarely included discussion of the longer-term outcomes of surgery. Whilst patients accepted that information about surgery and risks was necessary, they really wanted details about long-term issues including recovery, impact on quality of life and survival. CONCLUSIONS: This study demonstrated a need for surgeons to provide information of importance to patients concerning the longer term outcomes of surgery. It is proposed that "core information sets" are developed, based on surgeons' and patients' views, to use as a minimum in consultations to initiate discussion and meet information needs prior to cancer surgery.

Assessing the quality of written information provision for surgical procedures: a case study in oesophagectomy.

OBJECTIVE: To examine the content and quality of written information provided by surgical centres for patients undergoing oesophagectomy for cancer. DESIGN: Cross-sectional study of the content of National Health Service (NHS) patient information leaflets (PILs) about oesophageal cancer surgery, using a modified framework approach. DATA SOURCES: Written information leaflets from 41 of 43 cancer centres undertaking surgery for oesophageal cancer in England and Wales (response rate 95.3%). ELIGIBILITY CRITERIA: All English language versions of PILs about oesophagectomy. RESULTS: 32 different PILs were identified, of which 2 were generic tools (Macmillan 'understanding cancer of the gullet' and EIDO 'oesophagectomy'). Although most PILs focused on describing in-hospital adverse events, information varied widely and was often misleading. Just 1 leaflet described survival benefits of surgery and 2 mentioned the possibility of disease recurrence. CONCLUSIONS: Written information provided for patients by NHS cancer centres undertaking oesophagectomy is inconsistent and incomplete. It is recommended that surgeons work together with patients to agree on standards of information provision of relevance to all stakeholders' needs.