Role of simulation-based training in thoracic anaesthesia.

Simulation-based training (SBT) aims to acquire technical and non-technical skills in a simulated fashion without harming the patient. Simulation helps the anaesthesiologist acquire procedural competence and non-technical abilities. In thoracic anaesthesia, various simulators are available with varying degrees of fidelity and costs. Apart from improving bronchoscopy-related skills, other potential applications of SBT include the practice of lung isolation in normal and difficult airway scenarios, troubleshooting complications during surgeries, and certification of the proficiency of anaesthesiologists. A pragmatic approach is required for choosing the simulator based on its availability, cost, and benefits. Although the literature supports SBT to improve procedural skills, retention of the skills and their translation into improving clinical outcomes remain largely unproven. Randomised, controlled studies targeting the effect of SBT on the improvement of clinical outcomes of patients are needed to prove their worth.

Designing and validating a research questionnaire - Part 2.

Validity and reliability refer to the accuracy and consistency of a research tool. In the previous article in this series, we examined the development of a research questionnaire. In this article, we discuss the methods of determining the validity and reliability of a research questionnaire.

Rapidly derived equimolar Ca: P phasic bioactive glass infused flexible gelatin multi-functional scaffolds - A promising tissue engineering.

The study aims to design and fabricate an ultra-easier multi-functional biomedical polymeric scaffold loaded with unique equimolar Ca:P phasic bioactive glass material (BG). Gelatin (G) - 45S5 bioactive glass (BG) scaffolds were synthesized via a simple laboratory refrigerator with higher biocompatibility and cytocompatibility. The results proved that BG has enhanced bio-mineralization of the scaffolds and results support that the G: BG (1:2) ratio is the more appropriate composition. Brunauer-Emmett-Teller (BET) study confirms the higher surface area for pure Gelatin and G: BG (1:2). Scanning Electron Microscopic images display the precipitation of hydroxycarbonate apatite layer over the scaffolds on immersing it in simulated body fluid. Alkaline phosphate activity proved that G: BG (1:2) scaffold could induce mitogenesis in MG-63 osteoblast cells, thus helping in hard tissue regeneration. Sirius red collagen deposition showed that higher content bioactive glass incorporated Gelatin polymeric scaffold G: BG (1:2) could induce rapid collagen secretion of NIH 3T3 fibroblast cell line that could help in soft tissue regeneration and earlier wound healing. The scaffolds were also tested for cell viability using NIH 3T3 fibroblast cell lines and MG 63 osteoblastic cell lines through methyl thiazolyl tetrazolium (MTT) assay. Thus, the study shows a scaffold of appropriate composition G: BG (1:2) can be a multifunctional material to regenerate hard and soft tissues.

Inequities in global cancer surgery: Challenges and solutions.

The disparity in access to and quality of surgical cancer care between high and low resource settings impacts immediate and long-term oncological outcomes. With cancer incidence and mortality set to increase rapidly in the next few decades, we examine the factors leading to inequities in global cancer surgery, and look at potential solutions to overcome these challenges.

Virtual clinical trials.

Virtual clinical trials refer to clinical trials that take advantage of digital technologies, including computer and mobile device apps, web-based tools, and remote monitoring devices, for one or more of the trial processes, such as participant recruitment, counseling, informed consent, measurement of endpoints, and/or adverse event monitoring, to obviate or reduce the need for participant visits to the trial site. The advantages of such trials may include higher recruitment rates, better compliance, lower dropout rates, reduction in time for trial completion, and lower costs. The use of such trials increased manifold during the COVID-19 pandemic and is likely to continue in the future.

A single-arm, prospective study comparing translaryngeal ultrasonography with direct visualisation by flexible laryngoscopy for vocal cord assessment in patients undergoing oesophagectomy or mediastinoscopy.

Background and Aims: Translaryngeal ultrasonography (TLUSG) for diagnosis of vocal cord palsy, a relatively new, safe and noninvasive bedside technique with minimal risk of respiratory infection transmission, has been effective in patients with thyroid disease. We studied its use as an alternative method to visual inspection by flexible laryngoscopy (FL) for vocal cord assessment in patients undergoing thoracic surgeries. Methods: After Institutional Ethics Committee approval and trial registration, in this single-arm, prospective study, the vocal cord function of 110 patients who underwent either total oesophagectomy or mediastinoscopy was assessed immediately after extubation by both FL and TLUSG. A follow-up assessment was done by laryngoscopy using Hopkin's endoscope (HL) and a repeat TLUSG. The primary outcome was the concordance between direct visualisation (FL or HL) and TLUSG. Results: Vocal cords were successfully visualised by TLUSG in 90% of male and all female patients. Findings of FL and TLUSG done at the first assessment matched in 89 (86.4%) out of 103 patients, and the degree of concordance was 0.69 (95% confidence interval [CI] =0.52-0.83). At the second assessment, HL and TLUSG findings matched in 83 (94.3%) out of 88 patients, and the degree of concordance was 0.89 (95% CI = 0.77-0.98). Conclusion: TLUSG is an effective noninvasive alternative to direct visualisation for vocal cord assessment in both male and female patients undergoing thoracic surgery.

Clinical studies with Cannabis in India - A need for guidelines for the investigators and ethics committees.

Cannabis is one of the world's oldest cultivated plants and the most commonly used recreational drug worldwide. The plant relevant for medicinal use is Cannabis sativa that has two pharmacologically active ingredients - delta-9-tetrahydrocannabinol that is psychoactive and cannabidiol that does not have psychotropic activity. The policy tapestry of Cannabis has undergone a significant change in the past few decades worldwide. Different countries have diverse policies, ranging from classifying use of Cannabis as illicit, to legalization of its use, both for medicinal and recreational purposes. Cannabis products are approved for use, for instance, in multiple sclerosis and Dravet syndrome (US Food Drug and Administration). Against this backdrop, we find that the knowledge foundations for use of Cannabis in clinical trials in India are still evolving. Conducting ethical research within a clinical trials framework is essential to understand dosing, formulation, shelf life, drug-drug interaction, tolerability, and safety before establishing its utility for various indications. In the absence of guidelines or a regulatory framework for conduct of these studies, the various Institutional Ethics Committees (IECs), which are responsible for reviewing projects related to Cannabis, face unique challenges with respect to the basic requirements. The principal investigators (PIs) are equally strained to find local guidance, recommendations, and literature in support of their application to the respective IEC, thus leading to an impasse and delay in initiating the proposed clinical studies with Cannabis. The present article addresses considerations, questions, and issues that affect the conduct of these clinical studies and recommends mandatory documents and some suggested guidelines for use by both PIs and IECs to take studies with Cannabis forward until such time that an interdisciplinary regulatory framework is firmed up by regulatory authority.

Designing and validating a research questionnaire - Part 1.

Questionnaires are often used as part of research studies to collect data from participants. However, the information obtained through a questionnaire is dependent on how it has been designed, used, and validated. In this article, we look at the types of research questionnaires, their applications and limitations, and how a new questionnaire is developed.

A single-arm prospective interventional study to assess the efficacy of continuous bronchial cuff pressure monitoring to detect the displacement of lung isolation devices in elective thoracic surgeries.

Background and Aims: During proximal or distal migration of lung isolation device (LID), the bronchial cuff would move into a wider or narrower portion of the bronchus, leading to a decrease or increase in the cuff pressure, respectively. To test this hypothesis, we conducted a study to find out the efficacy of continuous bronchial cuff pressure (BCP) monitoring for detecting the displacement of LID. Methods: A single-arm interventional study was conducted including hundred adult patients undergoing elective thoracic surgeries using a left-sided LID. BCP was monitored in a continuous manner using a pressure transducer connected to the bronchial cuff of the LID. The position of the LID was assessed using a paediatric bronchoscope. Changes in the BCP were noted when the LID was moved intentionally in the left main bronchus (part 1) and during the surgery (part 2). Bronchoscopic confirmation was performed at the end of the surgery to note any uncaptured movement of the LID (part 3). Results: During part 1 of the study, BCP consistently decreased on the proximal movement and increased on the distal movement of the LID, although the magnitude of change was not constant. During part 2 of the study, sensitivity, specificity, positive predictive value, negative predictive value and accuracy of continuous BCP monitoring to detect the dislodgement of LIDs (n = 41) during the surgery were 97.6%, 40%, 76.9%, 88.9% and 78.7%, respectively. Conclusion: Continuous BCP monitoring is a useful and sensitive method for monitoring the position of left-sided LIDs in limited-resource settings.

Investigating stigma during the COVID-19 pandemic: Living conditions, social determinants and experiences of infection among employees at a tertiary referral cancer centre.

AIM: Healthcare workers (HCWs) have reported negative social experiences during the COVID-19 pandemic; however, this data is largely from medical personnel. We examined living conditions, social determinants, and experiences during the COVID-19 pandemic among all cadres of employees who had recovered from COVID-19 at a tertiary referral cancer hospital in India. METHODS: We conducted a mixed methods study combining a questionnaire-based survey followed by semi-structured interviews with open-ended questions, among hospital staff who recovered from COVID-19 between April and November 2020. We initially administered a 79-point survey to all participants; based on their responses, we used purposive sampling to identify 60 interview participants. The primary aim of the study was to examine the impact of socio-economic factors on experiences and potential stigma faced by staff during the COVID-19 pandemic. RESULTS: We surveyed 376 participants including doctors (10 %), nurses (20 %), support staff (29 %), administrators (18 %) and scientists/technicians (22 %). Of these, 126 (34 %) participants reported negative social experiences. Stigmatisation was lower among doctors compared to other professions, decreased in the second half of the study period, and was more among those living in less affluent surroundings. Interviews revealed 3 types of negative social experiences: neighbourhood tensions around restrictions of mobility, social distancing, and harassment. CONCLUSIONS: The first phase of the COVID-19 pandemic in India led to considerable negative social experiences among hospital employees, especially those lower in the socio-economic hierarchy, which was fuelled by restrictions imposed by the government and pressure on local neighbourhoods. POLICY SUMMARY: It is important to not just document and count stigma experiences during global pandemics, but also to examine sociologically the conditions under which and the processes through which stigma happens.

Outcomes of elective cancer surgery in COVID-19 survivors: An observational study.

BACKGROUND AND OBJECTIVES: Guidelines recommend deferral of elective surgery after COVID-19. Delays in cancer surgeries may affect outcomes. We examined perioperative outcomes of elective cancer surgery in COVID-19 survivors. The primary objective was 30-day all-cause postoperative mortality. The secondary objectives were 30-day morbidity, and its association with COVID-19 severity, and duration between COVID-19 and surgery. METHODS: We collected data on age, gender, comorbidities, COVID-19 severity, preoperative investigations, surgery performed, and intra and postoperative outcomes in COVID-19 survivors who underwent elective cancer surgery at a tertiary-referral cancer center. RESULTS: Three hundred and forty-eight COVID-19 survivors presented for elective cancer surgery. Of these, 332/348 (95%) patients had mild COVID-19 and 311 (89%) patients underwent surgery. Among patients with repeat investigations, computerized tomography scan of the thorax showed the maximum new abnormalities (30/157, 19%). The 30-day all-cause mortality was 0.03% (1/311) and 30-day morbidity was 17% (54/311). On multivariable analysis, moderate versus mild COVID-19 (odds ratio [OR]: 1.95; 95% confidence interval  [CI]: 0.52-7.30; p = 0.32) and surgery within 7 weeks of COVID-19 (OR: 0.61; 95% CI: 0.33-1.11; p = 0.10) were not associated with postoperative morbidity. CONCLUSIONS: In patients who recover from mild to moderate COVID-19, elective cancer surgery can proceed safely even within 7 weeks. Additional preoperative tests may not be indicated in these patients.

The "Weekday Effect"-Does It Impact Esophageal Cancer Surgery Outcomes?

BACKGROUND: Increased 30-day mortality rates have been reported in patients undergoing elective surgery later compared with earlier in the week. However, these reports have been conflicting for esophageal surgery. We conducted a study to assess the differences in outcomes of patients undergoing surgery for esophageal cancer earlier in the week (Tuesday) versus later (Friday). METHODS: This retrospective analysis of a prospectively maintained database included patients with esophageal cancer who underwent esophageal resection in a tertiary cancer center between 1 January 2005 and 31 December 2017. We compared patients operated on Tuesdays versus Fridays. The primary outcome was a composite of major morbidity (defined as Clavien-Dindo grade 3 or more) and/or mortality. Secondary outcomes included duration of post-operative ventilation, and length of ICU and hospital stay. RESULTS: Among 1300 patients included, 733 were operated on a Tuesday and 567 on a Friday. Patient and surgery characteristics were similar in the two groups. The primary outcome (composite of major morbidity and mortality) was 23.6% in the Tuesday group versus 26.3% in the Friday group. Mortality was similar in the two groups (6.0%). Multivariable logistic regression analysis showed that the day of surgery was not a predictor of major morbidity or mortality. CONCLUSIONS: In patients undergoing esophagectomy at tertiary care high volume cancer center, there was no difference in major morbidity and mortality whether the surgery was performed early in the week (Tuesday) or closer to the weekend (Friday).

Use of the McGRATH™ MAC videolaryngoscope to evaluate the ability of anesthetists to give effective cricoid pressure: An interventional study.

Background and Aims: The application of cricoid pressure (CP) for rapid sequence induction is questioned on two grounds: its effectiveness in clinical settings and its impact on the laryngeal view. The main reason cited for its ineffectiveness is the lack of knowledge and training in its correct application. This study assessed, the performance of anesthetists in applying effective CP in a clinical setting. Material and Methods: Eighty-five ASA I/II adult patients posted for elective surgery requiring oral endotracheal intubation with nasogastric tube (NGT) placement participated in the study. Eighty-five anesthetists divided into five groups based on their level of experience were randomly chosen to apply CP after induction of anesthesia. An experienced anesthetist performed videolaryngoscopy and attempted NGT insertion. The primary outcome was effectiveness of CP defined as the inability to pass the NGT into the esophageal opening. We also noted that the glottic view with and without CP and the effectiveness of CP across different levels of experience of anesthetists. Results: Of the 85 anesthetists, 61 (71.8%) applied effective CP. The effectiveness improved with experience (first-year residents-11/17 [64.7%], second-year residents-11/17 [64.7%], third-year residents-10/17 [58.8%], senior residents-13/17 [76.5%], and consultants-16/17 [94.1%]) (P = 0.157). Post hoc analysis showed higher effectiveness among anesthetists with >3 years of experience (85.3%) compared with <3 years of experience (62.7%) (P = 0.024). CP did not always impede the laryngeal view, rather it has no effect or actually improves the glottic view in many instances (81%). Conclusion: CP is effective in occluding the esophageal lumen without hampering glottic view in the majority of the cases, and its effectiveness improves with experience.

Informal Providers-Ground Realities in South Asian Association for Regional Cooperation Nations: Toward Better Cancer Primary Care: A Narrative Review.

PURPOSE: South Asian Association for Regional Cooperation (SAARC) nations are a group of eight countries with low to medium Human Development Index values. They lack trained human resources in primary health care to achieve the WHO-stated goal of Universal Health Coverage. An unregulated service sector of informal health care providers (IPs) has been serving these underserved communities. The aim is to summarize the role of IPs in primary cancer care, compare quality with formal providers, quantify distribution in urban and rural settings, and present the socioeconomic milieu that sustains their existence. METHODS: A narrative review of the published literature in English from January 2000 to December 2021 was performed using MeSH Terms Informal Health Care Provider/Informal Provider and Primary Health Care across databases such as Medline (PubMed), Google Scholar, and Cochrane database of systematic reviews, as well as World Bank, Center for Global Development, American Economic Review, Journal Storage, and Web of Science. In addition, citation lists from the primary articles, gray literature in English, and policy blogs were included. We present a descriptive overview of our findings as applicable to SAARC. RESULTS: IPs across the rural landscape often comprise more than 75% of primary caregivers. They provide accessible and affordable, but often substandard quality of care. However, their network would be suitable for prompt cancer referrals. Care delivery and accountability correlate with prevalent standards of formal health care. CONCLUSION: Acknowledgment and upskilling of IPs could be a cost-effective bridge toward universal health coverage and early cancer diagnosis in SAARC nations, whereas state capacity for training formal health care providers is ramped up simultaneously. This must be achieved without compromising investment in the critical resource of qualified doctors and allied health professionals who form the core of the rural public primary health care system.

Research studies on screening tests.

Screening tests are done to diagnose asymptomatic disease in apparently healthy people with the aim to reduce mortality and morbidity from the disease. Certain criteria need to be fulfilled before we adopt population-level screening for any disease. Several biases exist in evaluating screening studies, and the ideal study design would be a randomized trial with hard endpoints such as mortality and morbidity.

Ultrasound-guided estimation of gastric residual volume using Perlas's formula: A validation study in patients.

Background and Aims: Bedside ultrasound (US) is used to evaluate gastric residual volume (GRV) and assess aspiration risk. We examined the accuracy of US-guided measurement of GRV using Perlas's formula, by two trained anaesthesiologists, in patients who had consumed different types and volumes of fluids. Methods: Patients with no risk factors for delayed gastric emptying were included. Each assessor independently determined the baseline US-guided GRV. The patients were randomly allocated to receive no drink or 100 or 200 mL of water or milk. US-guided GRV was re-assessed within 5 min after the intervention. Investigators were blinded to the measurements performed by each other and to the randomisation arm. The primary outcome was the agreement between actual volumes consumed and estimated change in GRV. Results: Agreement between actual volume consumed and estimated change in GRV was poor [Intra-class correlation coefficient (ICC) 0.46, 95% confidence interval (CI) 0.09 to 0.72; P = 0.09 for assessor 1 and ICC 0.37; 95% CI 0.02 to 0.66; P = 0.03 for assessor 2]. Conclusion: US-guided GRV measurements using Perlas's formula, performed by trained anaesthesiologists may not be a reliable measure of GRV.

Equivalence trials.

In an equivalence trial, researchers aim to show that a new intervention is more or less similar to an existing standard of care, i.e., the two are "equivalent". In this article, we discuss some aspects of the design, analysis, interpretation and reporting of equivalence trials.

Priorities for cancer research in low- and middle-income countries: a global perspective.

Cancer research currently is heavily skewed toward high-income countries (HICs), with little research conducted in, and relevant to, the problems of low- and middle-income countries (LMICs). This regional discordance in cancer knowledge generation and application needs to be rebalanced. Several gaps in the research enterprise of LMICs need to be addressed to promote regionally relevant research, and radical rethinking is needed to address the burning issues in cancer care in these regions. We identified five top priorities in cancer research in LMICs based on current and projected needs: reducing the burden of patients with advanced disease; improving access and affordability, and outcomes of cancer treatment; value-based care and health economics; quality improvement and implementation research; and leveraging technology to improve cancer control. LMICs have an excellent opportunity to address important questions in cancer research that could impact cancer control globally. Success will require collaboration and commitment from governments, policy makers, funding agencies, health care organizations and leaders, researchers and the public.

Outcomes of COVID-19 and risk factors in patients with cancer.

Patients with cancer are at higher risk for adverse coronavirus disease 2019 (COVID-19) outcomes. Here, we studied 1,253 patients with cancer, who were diagnosed with severe acute respiratory syndrome coronavirus 2 at a tertiary referral cancer center in India. Most patients had mild disease; in our settings, recent cancer therapies did not impact COVID-19 outcomes. Advancing age, smoking history, concurrent comorbidities and palliative intent of treatment were independently associated with severe COVID-19 or death. Thus, our study provides useful insights into cancer management during the COVID-19 pandemic.