The Potentially Protective Effects of Anti-Lipid, Hypoglycemic, and Anti-Hypertensive Agents for Perioperative Mortality in Geriatric Group

Background Great efforts were made to collect information and identify risk factors in predicting post-anesthetic mortality. In this study, we use national health insurance data base, including medications, underlying comorbidities and surgical factors to assess the relationship between these factors and mortality after surgery. Methods This is a retrospective, population based study. The study population who underwent general anesthesia (GA) were retrieved from the National Health Insurance Research Database in Taiwan between January 1, 2005 and December 31, 2013. We classified the study patients into 4 major comparison groups by surgical procedures, including major organ transplantation (heart, liver, lung, kidney, or pancreas), CV surgery, major neurosurgery, and others according to the diagnostic codes of the international classification of diseases, ninth revision, clinical modification (ICD-9-CM) codes. We proposed a logistic regression model with valuable variables which can significantly predicts the post-anesthesia mortality. We also designed different models for 4 subgroups according the results. Results A total of 833,685 subjects were included in this study, and the most common comorbidity was hypertension. Age was an important determinant associated with post-operation mortality among different surgical types. Perioperative prescription could reduce risks of operation. The prediction model based on the preliminary training group also performed well in the validation group (AUROC=0.8753 for in-hospital mortality; AUROC= 0.8767 for 30-days mortality). A reliable predicting model can help anesthesiologists to decide the anesthesia method or monitors, as well as helping physicians to take care of their patients after operation. Conclusions While GA is commonly used for the majority of the patients undergoing operations, the prediction model that we proposed from this nationwide study could identify the predictors for post-operation mortality. The potentially protective effects of anti-lipid, hypoglycemic, and anti-hypertensive agents were encouraging in geriatric preoperative group. It is expected that applying this prediction model and prescription into clinical practice could improve surgical risk stratification and further improve patient outcomes. Trial registration The protocol of this study was approved by the National Taiwan University Hospital Research Ethics Committee (Trial Registration 201411078RINC). Informed consent was waived by the National Taiwan University Hospital Research Ethics Committee due to the retrospective and anonymous nature of the claims data.

Seeking Approval from Universities to Research the Views of Their Staff. Do Gatekeepers Provide a Barrier to Ethical Research?

A “gatekeeper” controls access to an organization; “gatekeeper approval” is often needed before external research can take place within an organization. We explore the need for gatekeeper approval for research with university staff employing, as a case study, a project which collected data in Australia. This case study addresses known issues, seemingly rarely addressed in the literature. The Human Research Ethics Committee (HREC)'s requirement for approval from individual universities to approach their staff brought significant consequences, exacerbated by the lack of university procedures for such approvals. Simultaneously, since invitations could legitimately be distributed via other avenues, such approval was superfluous. We recommend the HREC's blanket requirement for institutional approval instead be considered on a case-by-case basis depending on the risk of the research, and perhaps waived for low-risk research where participants are able to provide informed consent, and that universities establish processes to deal with requests from external researchers.

Efficacy and safety of first-line osimertinib treatment and postprogression patterns of care in patients with epidermal growth factor receptor activating mutation-positive advanced non-small cell lung cancer (Reiwa study): study protocol of a multicentre, real-world observational study

IntroductionOsimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), is widely used as the first-line treatment for EGFR mutation-positive non-small cell lung cancer (NSCLC). Nevertheless, most cases ultimately acquire resistance to osimertinib, and no effective treatment has been currently established for cases having progressive disease (PD) with osimertinib. In clinical practice, EGFR-TKI therapy could be continued beyond response evaluation criteria in solid tumours (RECIST)-defined PD cases when they are clinically stable. Currently, the progression pattern of osimertinib and criteria for identifying patients who might benefit from osimertinib beyond PD are unknown. In addition, the efficacy and safety of osimertinib as the first-line treatment in real-world clinical practice remain unclear in Japan. This multicentre study was designed to evaluate the real-world data on first-line osimertinib and its post-treatment.Methods and analysisThe study enrols patients with EGFR mutation-positive, advanced or recurrent NSCLC who received EGFR-TKI as the first-line therapy after 1 September 2018, from October 2019 to August 2020, and those started on osimertinib will be followed up until August 2022. We will evaluate the efficacy and safety of the first-line osimertinib treatment, adherence to it, progression patterns on RECIST PD and subsequent treatment.Ethics and disseminationAll participating patients will provide written informed consent before entering the study. The protocol, amendments and patients’ informed consent forms will be approved before study commencement by the institutional review board or independent ethics committee at each participation site (Lead Ethics Committee; Japan Red Cross Medical Center (26 April 2019, order number 976)). Patients will be anonymised before registration into the study and their anonymised data will be collected from the case report form. The results of this study will be presented at the national and international conferences and submitted for publication.Trial registration numberUMIN000038683.

IMPACT OF ACNE VULGARIS ON A PERSON’S QUALITY OF LIFE AND IT’S CORRELATION WITH THE CLINICAL SEVERITY PRE AND POST-DRUG THERAPY

Objective: The aim of the study is to assess the therapeutic efficacy of drugs used in acne vulgaris by measuring the severity of acne using the Global Acne Grading System score (GAGS) and Cardiff Acne Disability Index (CADI) questionnaire score pre and post-drug therapy. Methods: The present study was conducted in the Department of Dermatology after getting approval from the Institutional Ethics Committee (No MC/190/2007/Pt1/MAR-2019/PG/123) dated 10/04/2019. It was an observational study for a period of 1 y. 172 patients were enrolled in the study. Patients were divided into 4 grades depending on their clinical manifestation. The severity of acne vulgaris and the quality of life were measured using the GAGS scale and the CADI questionnaire, respectively at the first visit and at the follow-up visit in all the grades of acne vulgaris. A correlation was done between the GAGS and the CADI score at the follow-up visit in all grades of acne. Results: It was observed that the GAGS score and the CADI score was significantly improved at the F/U visit (p<0.05) as compared to baseline in all the 4 grades of acne. A correlation between GAGS score and QoL using CADI scale was done using Pearson Parametric Correlation Test. In none of the groups, the correlation was significant (p>0.05). Conclusion: We can conclude from our study that following treatment with drugs, the clinical severity of acne decreased and there was also a significant improvement in the quality of life of patients.

Exploratory randomised trial of face-to-face and mobile phone counselling against usual care for tobacco cessation in Indian primary care: a randomised controlled trial protocol for project CERTAIN

IntroductionDespite widespread use of smokeless tobacco products by people within the Indian subcontinent, there is little awareness among Indians of its health hazards when compared with smoked tobacco. We hypothesise that mobile phone counselling will be feasible and effective for smokeless tobacco cessation intervention in India. This paper presents the protocol of the development and conduct of an exploratory trial before progression to a full randomised controlled trial.Methods and analysisAn exploratory randomised controlled trial will be conducted in urban primary health centres in the state of Odisha, India. A total of 250 smokeless tobacco users will be recruited to the study (125 in each arm). Participants in the intervention arm will receive routine care together with a face-to-face counselling intervention followed by advice and reminder mobile messages. The control arm will receive routine care, delivered by a primary care physician based on ‘Ask’ and ‘Advice’. All participants will be followed up for 3 months from the first counselling session. The primary outcome of this trial is to assess the feasibility to carry out a full randomised controlled trial.Ethics and disseminationEthical approvals were obtained from the Institutional Ethics Committee of Public Health Foundation of India, Health Ministry’s Screening Committee, Odisha State Ethics Board and also from University College London Research Ethics Committee, UK. The study findings will be published in a peer-reviewed scientific journal.Trial registration numberCTRI/2019/05/019484.

Early detection of Australian Aboriginal and Torres Strait Islander infants at high risk of adverse neurodevelopmental outcomes at 12 months corrected age: LEAP-CP prospective cohort study protocol

IntroductionNeurodevelopmental disorders (NDD), including cerebral palsy (CP), autism spectrum disorder (ASD) and foetal alcohol spectrum disorder (FASD), are characterised by impaired development of the early central nervous system, impacting cognitive and/or physical function. Early detection of NDD enables infants to be fast-tracked to early intervention services, optimising outcomes. Aboriginal and Torres Strait Islander infants may experience early life factors increasing their risk of neurodevelopmental vulnerability, which persist into later childhood, further compounding the health inequities experienced by First Nations peoples in Australia. The LEAP-CP prospective cohort study will investigate the efficacy of early screening programmes, implemented in Queensland, Australia to earlier identify Aboriginal and Torres Strait Islander infants who are ‘at risk’ of adverse neurodevelopmental outcomes (NDO) or NDD. Diagnostic accuracy and feasibility of early detection tools for identifying infants ‘at risk’ of a later diagnosis of adverse NDO or NDD will be determined.Methods and analysisAboriginal and/or Torres Strait Islander infants born in Queensland, Australia (birth years 2020–2022) will be invited to participate. Infants aged <9 months corrected age (CA) will undergo screening using the (1) General Movements Assessment (GMA); (2) Hammersmith Infant Neurological Examination (HINE); (3) Rapid Neurodevelopmental Assessment (RNDA) and (4) Ages and Stages Questionnaire-Aboriginal adaptation (ASQ-TRAK). Developmental outcomes at 12 months CA will be determined for: (1) neurological (HINE); (2) motor (Peabody Developmental Motor Scales 2); (3) cognitive and communication (Bayley Scales of Infant Development III); (4) functional capabilities (Paediatric Evaluation of Disability Inventory-Computer Adaptive Test) and (5) behaviour (Infant Toddler Social and Emotional Assessment). Infants will be classified as typically developing or ‘at risk’ of an adverse NDO and/or specific NDD based on symptomology using developmental and diagnostic outcomes for (1) CP (2) ASD and (3) FASD. The effects of perinatal, social and environmental factors, caregiver mental health and clinical neuroimaging on NDOs will be investigated.Ethics and disseminationEthics approval has been granted by appropriate Queensland ethics committees; Far North Queensland Health Research Ethics Committee (HREC/2019/QCH/50533 (Sep ver 2)-1370), the Townsville HHS Human Research Ethics Committee (HREC/QTHS/56008), the University of Queensland Medical Research Ethics Committee (2020000185/HREC/2019/QCH/50533) and the Children’s Health Queensland HHS Human Research Ethics Committee (HREC/20/QCHQ/63906) with governance and support from local First Nations communities. Findings from this study will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberACTRN12619000969167.

Artificial intelligence (AI) to enhance breast cancer screening: protocol for population-based cohort study of cancer detection

IntroductionArtificial intelligence (AI) algorithms for interpreting mammograms have the potential to improve the effectiveness of population breast cancer screening programmes if they can detect cancers, including interval cancers, without contributing substantially to overdiagnosis. Studies suggesting that AI has comparable or greater accuracy than radiologists commonly employ ‘enriched’ datasets in which cancer prevalence is higher than in population screening. Routine screening outcome metrics (cancer detection and recall rates) cannot be estimated from these datasets, and accuracy estimates may be subject to spectrum bias which limits generalisabilty to real-world screening. We aim to address these limitations by comparing the accuracy of AI and radiologists in a cohort of consecutive of women attending a real-world population breast cancer screening programme.Methods and analysisA retrospective, consecutive cohort of digital mammography screens from 109 000 distinct women was assembled from BreastScreen WA (BSWA), Western Australia’s biennial population screening programme, from November 2016 to December 2017. The cohort includes 761 screen-detected and 235 interval cancers. Descriptive characteristics and results of radiologist double-reading will be extracted from BSWA outcomes data collection. Mammograms will be reinterpreted by a commercial AI algorithm (DeepHealth). AI accuracy will be compared with that of radiologist single-reading based on the difference in the area under the receiver operating characteristic curve. Cancer detection and recall rates for combined AI–radiologist reading will be estimated by pairing the first radiologist read per screen with the AI algorithm, and compared with estimates for radiologist double-reading.Ethics and disseminationThis study has ethical approval from the Women and Newborn Health Service Ethics Committee (EC00350) and the Curtin University Human Research Ethics Committee (HRE2020-0316). Findings will be published in peer-reviewed journals and presented at national and international conferences. Results will also be disseminated to stakeholders in Australian breast cancer screening programmes and policy makers in population screening.

Association between long-term oxygen therapy provided outside the guidelines and mortality in patients with COPD

IntroductionHypoxaemia is a frequent complication of chronic obstructive pulmonary disease (COPD). To prevent its consequences, supplemental oxygen therapy is recommended by international respiratory societies. However, despite clear recommendations, some patients receive long-term oxygen therapy (LTOT), while they do not meet prescription criteria. While evidence suggests that acute oxygen supply at high oxygenation targets increases COPD mortality, its chronic effects on COPD mortality remain unclear. Thus, the study will aim to evaluate through a systematic review and individual patient data meta-analysis (IPD-MA), the association of LTOT prescription outside the guidelines on survival over time in COPD.MethodsSystematic review and IPD-MA will be conducted according to Preferred Reporting Items for a Systematic Review and Meta-Analyses IPD guidelines. Electronic databases (PubMed, Web of Science, EMBASE, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, OpenGrey and BioRxiv/MedRxix) will be scanned to identify relevant studies (cohort of stable COPD with arterial oxygen tension data available, with indication of LTOT filled out at the moment of the study and with a survival follow-up). The anticipated search dates are January–February 2022. The main outcome will be the association between LTOT and time to all-cause mortality according to hypoxaemia severity, after controlling for potential covariates and all available clinical characteristics. Quantitative data at the level of the individual patient will be used in a one-step approach to develop and validate a prognostic model with a Cox regression analysis. The one-step IPD-MA will be conducted to study the association and the moderators of association between supplemental oxygen therapy and mortality. Multilevel survival analyses using Cox-mixed effects models will be performed.Ethics and disseminationAs a protocol for a systematic review, a formal ethics committee review is not required. Only studies with institutional approval from an ethics committee and anonymised IPD will be included. Results will be disseminated through peer-reviewed publications and presentations in conferences.PROSPERO registration numberCRD42020209823.