Effect of anesthetic technique on antitumor immunity in patients undergoing surgery for gall bladder cancer: A prospective randomized comparative study.

There is a paucity of literature regarding the effect of anesthetic techniques on antitumor immunity, especially in gall bladder malignancies. We designed a study to compare the effect of propofol-based total intravenous anesthesia and sevoflurane-based general anesthesia-on antitumor immunity, including tumor growth factor-ß (TGF-ß), T-helper cell profile, and inflammatory markers. A pilot prospective randomized trial was conducted in 64 patients undergoing surgery for gall bladder malignancy under general anesthesia in a tertiary specialty cancer hospital. Adult cancer patients of ASA physical status I-III fulfilling the inclusion criteria were randomized to either group S (sevoflurane-based general anesthesia) or group T (propofol-based total intravenous anesthesia). Preoperative (morning of surgery) and postoperative (24 h and 1 month after surgery) blood samples were obtained. Demographic profile and preoperative parameters were comparable between both groups. There was a statistically significant difference in the postoperative value of TGF-ß (higher in group T). There was a statistically significant difference in postoperative interleukin-17A value (indicative of TH17 cells), and it was found to be higher in group S. Propofol-based TIVA increases serum TGF-ß levels. At the same time, Sevoflurane modulates T-helper cells-based immunity to increase TH17 cells in patients with gall bladder cancer. Multiple larger studies will be required to validate the results and provide useful recommendations.

Malignant Chest Wall Tumors: Complex Defects and Their Management-A Review of 181 Cases.

BACKGROUND: Chest wall tumors are a heterogeneous group of tumors that are managed by surgeons from diverse specialties. Due to their rarity, there is no consensus on their diagnosis and management. MATERIALS: This retrospective, descriptive analysis includes patients with malignant chest wall tumors undergoing chest wall resection. Tumors were classified as primary, secondary, and metastatic tumors. The analysis includes clinicopathological characteristics, resection-reconstruction profile, and relapse patterns. RESULTS: A total of 181 patients underwent chest wall resection between 1999 and 2020. In primary tumors (69%), the majority were soft tissue tumors (59%). In secondary tumors, the majority were from the breast (45%) and lung (42%). Twenty-five percent of patients received neoadjuvant chemotherapy, and 98% of patients underwent R0 resection. Soft tissue, skeletal + soft tissue, and extended resections were performed in 45%, 70%, and 28% of patients, respectively. The majority of patients (60%) underwent rib resections, and a median of 3.5 ribs were resected. The mean defect size was 24 cm2. Soft tissue reconstruction was performed in 40% of patients, mostly with latissimus dorsi flaps. Rigid reconstruction was performed in 57% of patients, and 18% underwent mesh-bone cement sandwich technique reconstruction. Adjuvant radiotherapy and chemotherapy were given to 29% and 39% of patients, respectively. CONCLUSIONS: This is one of the largest single-institutional experiences on malignant chest wall tumors. The results highlight varied tumor spectra and multimodality approaches for optimal functional and survival outcomes. In limited resource setting, surgery, including reconstructive expertise, is very crucial.

Quality of life and symptom burden in hematological cancer patients receiving hematopoietic stem cell transplantation: an observational study at Regional Cancer Centre, India.

PURPOSE: Hematopoietic stem cell transplant (HSCT) is an intense form of treatment, resulting in major symptom burden but can prove curative. The quality of life (QOL) is a major endpoint for these patients as the survival rate in them has improved over time. The aim of the study is to assess the QOL and symptom burden of hematological malignancy patients at admission to hospital for HSCT, at 1 month and at 3 months following HSCT. METHODS: This prospective observational study was done on hematological malignancy patients who were admitted for HSCT in a regional cancer center. The study subjects were assessed by the Functional Assessment of Cancer Therapy-Bone Marrow Transplant Scale (FACT-BMT Scale), Edmonton Symptom Assessment Scale-revised (r-ESAS), and Depression, Anxiety and Stress Scale-21 Items (DASS-21) at the time of hospital admission for transplantation, on day 30 (~ 1 month) and day100 (~ 3 months) of transplantation. RESULTS: A total of 68 patients were included in this study. FACT-BMT scores have decreased from baseline (F0) to the first follow-up (F1) and then increased in the third follow-up (F2). The maximum r-ESAS mean score was for tiredness among all other symptoms at F0 as well as at F1 and at F2. The DASS 21 scores for depression, anxiety, and stress were maximum during F1 and minimum during F2. CONCLUSION: Symptom burden is maximum during the first month of BMT, which improves later and QOL becomes improved with time.

A comparative evaluation of fibreoptic bronchoscopy versus C-MAC® D-BLADE-guided videolaryngoscopy for nasotracheal intubation under general anesthesia in oropharyngeal carcinoma surgery patients.

PURPOSE: Nasotracheal intubation (NTI) is required for surgery in oropharyngeal (OP) carcinoma patients, but it may be challenging because of distorted anatomy, mucosal congestion, and increased risk of bleeding. Flexible bronchoscopy (FB)-guided NTI is preferred in these cases but has limitations. In this randomized controlled study, we sought to compare C-MAC® D-BLADE-guided videolaryngoscopy (VL) (Karl Storz SE & Co. KG, Tuttlingen, Germany) with FB for NTI under general anesthesia in patients with OP carcinomas. METHODS: We randomized a total of 100 patients with OP carcinoma and El-Ganzouri's risk index (EGRI) < 7 to undergo NTI under general anesthesia with FB (n = 50) or C-MAC D-BLADE-guided VL (n = 50). The primary outcome was the total intubation time. We also recorded the time to glottis view, nasal intubation difficulty scale (NIDS) score, best percentage of glottis opening score, and complications. RESULTS: The median [interquartile range (IQR)] total intubation time was shorter with VL than with FB (total intubation time, 38 [26-43] sec vs 60 [52-65] sec; difference, -20 sec [95% confidence interval (CI), -27 to -11]; P < 0.001). Similarly, the median [IQR] time to glottis view was shorter with VL compared to FB (8 [6-9] sec vs 22 [14-25] sec; difference, -13 sec [95% CI, -17 to -10]; P < 0.001). The median NIDS score was higher with VL (difference, 2 [95% CI, 2 to 3]; P < 0.001). The incidences of airway trauma (two cases with FB vs seven with VL; P = 0.30) and postoperative sore throat (ten cases in both groups; P = 0.56) were similar. CONCLUSION: Compared to FB, C-MAC D-BLADE-based VL reduced the total time for nasal intubation oropharyngeal carcinoma patients, potentially representing an acceptable alternative in selected cases. TRIAL REGISTRATION: CTRI.nic.in (2018/11/0162830); first submitted 8 November 2018.

RéSUMé: OBJECTIF: L'intubation nasotrachéale est nécessaire pour la chirurgie chez la patientèle atteinte de carcinome oropharyngé, mais elle peut être difficile en raison d'une anatomie déformée, d'une congestion des muqueuses et d'un risque accru de saignement. Dans ces cas, il est préférable d'utiliser une intubation nasotrachéale guidée par bronchoscopie flexible (BF), mais cette modalité a ses limites. Dans cette étude randomisée contrôlée, nous avons cherché à comparer la vidéolaryngoscopie guidée par lame D-BLADE C-MAC® (VL) (Karl Storz SE & Co. KG, Tuttlingen, Allemagne) à la BF pour réaliser l'intubation nasotrachéale sous anesthésie générale chez les patient·es ayant un carcinome oropharyngé. MéTHODE: Au total, nous avons randomisé 100 personnes atteintes d'un carcinome oropharyngé et présentant un indice de risque d'El-Ganzouri (EGRI) < 7 à bénéficier d'une intubation nasotrachéale sous anesthésie générale par BF (n = 50) ou par VL guidée par lame D-BLADE C-MAC (n = 50). Le critère d'évaluation principal était le temps d'intubation total. Nous avons également enregistré le temps écoulé jusqu'à la visualisation de la glotte, le score sur l'échelle de difficulté de l'intubation nasale (NIDS), le meilleur pourcentage de score d'ouverture de la glotte et les complications. RéSULTATS: La durée totale d'intubation médiane [écart interquartile (ÉIQ)] était plus courte avec la VL qu'avec la BF (durée totale d'intubation, 38 [26­43] sec vs 60 [52 à 65] secondes; différence, −20 sec [intervalle de confiance (IC) à 95 %, −27 à −11]; P < 0,001). De même, le temps médian [ÉIQ] jusqu'à la visualisation de la glotte était plus court avec la VL qu'avec la BF (8 [6­9] sec vs 22 [14 à 25] secondes; différence, −13 sec [IC 95 %, −17 à −10]; P < 0,001). Le score médian sur l'échelle NIDS était plus élevé avec la VL (différence, 2 [IC 95 %, 2 à 3]; P < 0,001). L'incidence des traumatismes des voies aériennes (deux cas avec la BF vs sept avec la VL; P = 0,30) et le mal de gorge postopératoire (dix cas dans les deux groupes; P = 0,56) étaient similaires. CONCLUSION: Par rapport à la BF, la VL guidée par lame D-BLADE C-MAC a réduit le temps total d'intubation nasale pour les personnes atteintes d'un carcinome oropharyngé, ce qui représente potentiellement une alternative acceptable dans certains cas. ENREGISTREMENT DE L'éTUDE: CTRI.nic.in (2018/11/0162830); première soumission le 8 novembre 2018.

Indian Society of Critical Care Medicine and Indian Association of Palliative Care Expert Consensus and Position Statements for End-of-life and Palliative Care in the Intensive Care Unit.

End-of-life care (EOLC) exemplifies the joint mission of intensive and palliative care (PC) in their human-centeredness. The explosion of technological advances in medicine must be balanced with the culture of holistic care. Inevitably, it brings together the science and the art of medicine in their full expression. High-quality EOLC in the ICU is grounded in evidence, ethical principles, and professionalism within the framework of the Law. Expert professional statements over the last two decades in India were developed while the law was evolving. Recent landmark Supreme Court judgments have necessitated a review of the clinical pathway for EOLC outlined in the previous statements. Much empirical and interventional evidence has accumulated since the position statement in 2014. This iteration of the joint Indian Society of Critical Care Medicine-Indian Association of Palliative Care (ISCCM-IAPC) Position Statement for EOLC combines contemporary evidence, ethics, and law for decision support by the bedside in Indian ICUs. How to cite this article: Mani RK, Bhatnagar S, Butola S, Gursahani R, Mehta D, Simha S, et al. Indian Society of Critical Care Medicine and Indian Association of Palliative Care Expert Consensus and Position Statements for End-of-life and Palliative Care in the Intensive Care Unit. Indian J Crit Care Med 2024;28(3):200-250.

A phase II study of gemcitabine and docetaxel combination in relapsed metastatic or unresectable locally advanced synovial sarcoma.

Synovial sarcoma (SS) is one of the commonest non-rhabdomyosarcoma soft tissue sarcoma with limited treatment options in the relapsed and advanced settings. The combination of gemcitabine and docetaxel has demonstrated its role predominantly in leiomyosarcoma and pleomorphic sarcomas but has not been prospectively studied in SS. This trial assesses the efficacy, tolerability and quality of life (QoL) with this regimen in metastatic/unresectable locally advanced relapsed SS.Patients and methods This was a single-arm, two-stage, phase II, investigator-initiated interventional study among patients with metastatic or unresectable locally advanced SS who had progressed after at least one line of chemotherapy. Gemcitabine 900 mg/m2 on days 1 and 8 and docetaxel 75 mg/m2 on day 8 were administered intravenously every 21 days. The primary endpoint was 3-month progression-free rate (PFR); overall survival (OS), progression-free survival (PFS), overall response rate (ORR), safety and quality of life (QoL) constituted the secondary endpoints.Results Twenty-two patients were enrolled between March 2020 and September 2021 and the study had to be closed early due to slow accrual. The study population comprised of 18 (81.8%) patients with metastatic disease and 4 (18.2%) patients with locally advanced, unresectable disease. The most common primary sites of disease were extremity in 15 (68%) and the median number of lines of prior therapies received was 1 (range 1-4). 3-month PFR was 45.4% (95% CI 24.8-66.1) and ORR was 4.5%. Median progression-free survival (PFS) was 3 months (95% CI 2.3-3.6) and median OS was 14 months (95% CI 8.9-19.0). 7 (31.8%) patients experienced grade 3 or worse toxicities, including anemia (18%), neutropenia (9%) and mucositis (9%). QoL analysis demonstrated significant decline in certain functional and symptom scales, while financial and global health scales remained stable.Conclusion This is the first prospective study on the combination of gemcitabine and docetaxel performed specifically in patients with advanced, relapsed SS. Although the accrual of patients could not be completed as planned, the therapy did produce clinically meaningful outcomes and met its primary endpoint of 3-month PFR. This result, along with the manageable toxicity profile and stable global health status on QoL analysis, should encourage further studies.Trial registration This trial was prospectively registered under the Clinical Trials Registry of India on 26/02/2020 (Registration number: CTRI/2020/02/023612).

A prospective study evaluating perioperative quality metrics of cancer surgery: Experience from a tertiary care cancer centre in India.

BACKGROUND: Well-defined quality metrics were studied at this high-volume tertiary care academic oncology centre to evaluate surgical quality and outcomes. METHODS: A prospective cohort of 691 patients undergoing major surgeries for all cancers was observed between 1 September 2018 and 30 August 2019 and predefined quality indicators in three categories: namely, optimal hospital resource utilisation, quality of surgery and perioperative outcomes were recorded during their admission period. Surgical procedures were divided into group I versus group II involving simple/moderate complexity versus high complexity procedures for analysis done using appropriate tests in STATA v14.0. FINDINGS: There were 373 versus 318 patients in group I versus group II with a mean of 48 years of age and 459 (66.43%) being females. Mean BMI was 24.58 kg/m2 , haemoglobin 12.12 g/dL and mean serum albumin of 4.25 g (SD ± 0.6). A total of 667(96.53%) patients had an Eastern Co-Operative Oncology Group performance score of 1 with 271 (39.22%) having comorbidities and 195 (28.22%) having tobacco/alcohol addictions. A total of 393 (56.87%) patients underwent prehabilitation. 83% of patients belonged to lower-middle socioeconomic status and 32% of patients had some prior surgical intervention. Neoadjuvant therapy was administered in 44.5% versus 37.42%, mean preoperative hospital stay was 3.65 versus 6.16 days whereas postoperative was 2.6 versus 6.09 days with total stay being 6.27 versus 12.21 days, mean surgical duration was 132 versus 268 min with mean blood loss of 100 versus 245 mL (group I vs. group II, respectively). Intraoperative events, namely, unexpected bleeding and hypotension occurred in 144 (20.84%) patients while packed red blood cells and/or fresh frozen plasma transfusion was required in 56 (8.1%) patients. 40% of patients needed intensive care unit care postoperatively with 45 (6.51%) patients having some event (hypotension, sepsis, acute kidney injury, etc.). A total of 29 (<4%) patients had ≥grade 3 surgical complications while ≥grade 2 medical complications occurred in 6.43% versus 12.58% of patients (group I vs. group II). A total of 90 (13.02%) patients were readmitted, 15 (2.17%) re-explored and 5 (0.72%) patients died. CONCLUSION: Optimal surgical outcomes in this study compared to international standards underpin the need for well-defined multidisciplinary perioperative pathways to be followed for each organ system and this framework can be adopted by other cancer centres in LMIC to achieve good surgical outcomes.

DFV890: a new oral NLRP3 inhibitor-tested in an early phase 2a randomised clinical trial in patients with COVID-19 pneumonia and impaired respiratory function.

BACKGROUND: Coronavirus-associated acute respiratory distress syndrome (CARDS) has limited effective therapy to date. NLRP3 inflammasome activation induced by SARS-CoV-2 in COVID-19 contributes to cytokine storm. METHODS: This randomised, multinational study enrolled hospitalised patients (18-80 years) with COVID-19-associated pneumonia and impaired respiratory function. Eligible patients were randomised (1:1) via Interactive Response Technology to DFV890 + standard-of-care (SoC) or SoC alone for 14 days. Primary endpoint was APACHE II score at Day 14 or on day-of-discharge (whichever-came-first) with worst-case imputation for death. Other key assessments included clinical status, CRP levels, SARS-CoV-2 detection, other inflammatory markers, in-hospital outcomes, and safety. FINDINGS: Between May 27, 2020 and December 24, 2020, 143 patients (31 clinical sites, 12 countries) were randomly assigned to DFV890 + SoC (n = 71) or SoC alone (n = 72). Primary endpoint to establish clinical efficacy of DFV890 vs. SoC, based on combined APACHE II score, was not met; LSM (SE), 8·7 (1.06) vs. 8·6 (1.05); p = 0.467. More patients treated with DFV890 vs. SoC showed ≥ 1-level improvement in clinical status (84.3% vs. 73.6% at Day 14), earlier clearance of SARS-CoV-2 (76.4% vs. 57.4% at Day 7), and mechanical ventilation-free survival (85.7% vs. 80.6% through Day 28), and there were fewer fatal events in DFV890 group (8.6% vs. 11.1% through Day 28). DFV890 was well tolerated with no unexpected safety signals. INTERPRETATION: DFV890 did not meet statistical significance for superiority vs. SoC in primary endpoint of combined APACHE II score at Day 14. However, early SARS-CoV-2 clearance, improved clinical status and in-hospital outcomes, and fewer fatal events occurred with DFV890 vs. SoC, and it may be considered as a protective therapy for CARDS. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04382053.

A comparison of two techniques of postoperative analgesia: lignocaine-fentanyl intravenous infusion and ropivacaine-fentanyl epidural infusion in patients undergoing cytoreductive cancer surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC)-prospective randomized control study.

BACKGROUND: Extensive surgical dissection, hemodynamic alterations associated with cytoreductive surgery (CRS), and hyperthermic intraperitoneal chemotherapy (HIPEC) make pain management challenging. We hypothesized that infusions of intravenous lignocaine and fentanyl provide comparable analgesia to epidural ropivacaine and fentanyl in these patients. METHODS: Fifty patients scheduled to undergo CRS and HIPEC were enrolled in the study. The patients in group IV (Intravenous) received a bolus dose of 1.5 mg/kg lignocaine over 15 min, starting approximately 15 min before the surgical incision and fentanyl 0.5 mcg/kg, about 2 min before the surgical incision, following which patient received lignocaine infusion at 1 mg/kg/hr and fentanyl infusion at 0.5 mcg/kg/hr intraoperatively. Patients in group EPI (Epidural) received 6 mL of Ropivacaine 0.2% and fentanyl (2mcg/mL) approximately 15 min before surgical incision, followed by continuous infusion at the rate of 5 mL/hr. The procedure for induction and maintenance of anesthesia was standardized for both groups. In the postoperative period, the infusion of analgesics was reduced to half the intraoperative rates and continued for 24 h. RESULTS: Demographic profile and clinical parameters were comparable between both groups (p > 0.05). There was no difference between the number of fentanyl doses given in the IV group [Langenbecks Arch Chir 373(3):189-196, 4, IQR (2-11)] and the EPI group [Reg Anesth Pain Med 35(4):370-376, 12, IQR (5-21)] in the postoperative period (p = 0.229). The need for intraoperative rescue analgesia was comparable among the groups (p = 0.882). CONCLUSION: The two techniques, epidural (ropivacaine and fentanyl) and IV (lignocaine and fentanyl) infusions, provide comparable analgesia in patients undergoing CRS and HIPEC. TRIAL REGISTRATION NUMBER: CTRI/2020/08/027052 dated 09/08/2020.

Comprehensive coordinated community based palliative care (C3PaC) model for cancer patients in North India: a mixed-method implementation research study protocol.

BACKGROUND: Cancer remains an escalating and challenging public health issue. The management, especially palliative care (PC), is disintegrated and out of reach of in need patients. The overall aim of the project is to develop a feasible and scalable Comprehensive Coordinated Community based PC model for Cancer Patients (C3PaC); congruent with socio-cultural, context and unmet needs in north India. METHODS: A mixed method approach will be used for three-phased pre- and post-intervention study in one of the districts of North India, having a high incidence of cancer. During phase I, validated tools will be used for quantitative assessment of palliative needs among cancer patients and their caregivers. Barriers and challenges for provision of palliative care will be explored using in-depth interviews and focus group discussions among participants and health care workers. The findings of phase I along with inputs from national experts and literature review will provide inputs for the development of the C3PAC model in phase II. During phase III C3PAC model will be deployed over a period of 12 months and its impact assessed. Categorical and continuous variables will be depicted as frequency (percentages) and mean ± SD/median (IQR) respectively. Chi-square test/Fischer test, independent samples Student t-tests and Mann-Whitney U tests will be used for categorical, normally and non-normally distributed continuous variables, respectively. Qualitative data will be analyzed using thematic analysis using Atlas.ti 8 software. DISCUSSION: The proposed model is designed to address the unmet palliative care needs, to empower community-based healthcare providers in comprehensive home-based PC and to improve the quality of life of cancer patients and caregivers. This model will provide pragmatic scalable solutions in comparable health systems particularly in low- and lower-middle Income countries. TRIAL REGISTRATION: The study has been registered with the Clinical Trial Registry-India (CTRI/2023/04/051357).

Facilitators of palliative care quality improvement team cohesion: Lessons from a seven-site implementation project in India.

BACKGROUND: The Palliative Care: Promoting Access and Improvement of the Cancer Experience (PC-PAICE) initiative is a team-based, palliative care (PC) quality improvement (QI) project working to promote high-quality PC in India. As a PC QI initiative, PC-PAICE implementation relied upon building interdisciplinary teams, providing the ideal context for understanding facilitators of team cohesion that compelled clinical, organizational, and administrative team members to work together. There is an opportunity to leverage the intersection between QI implementation and organizational theory to inform and improve implementation science. PURPOSE: As a subaim of a larger implementation evaluation, we aimed to identify facilitators of team cohesion within QI implementation context. METHODOLOGY: A quota sampling approach captured the perspectives of 44 stakeholders across three strata (organizational leaders, clinical leaders, and clinical team members) from all seven sites through a semistructured interview guide informed by the Consolidated Framework for Implementation Research (CFIR). We used a combination of inductive and deductive approaches informed by organizational theory to identify facilitators. RESULT: We identified three facilitators of PC team cohesion: (a) balancing formalization and flexibility around team roles, (b) establishing widespread awareness of the QI project, and (c) prioritizing a nonhierarchical organizational culture. PRACTICE IMPLICATIONS: Leveraging CFIR to analyze PC-PAICE stakeholder interviews created a data set conducive to understanding complex multisite implementation. Layering role and team theory to our implementation analysis helped us identify facilitators of team cohesion across levels within the team (bounded team), beyond the team (teaming), and surrounding the team (culture). These insights demonstrate the value of team and role theories in implementation evaluation efforts.

Homeopathy as an Adjuvant to Standard Care in Moderate and Severe Cases of COVID-19: A Single-Blind, Randomized, Placebo-Controlled Study.

OBJECTIVES: This study aimed to evaluate whether individualized homeopathic medicines have a greater adjunctive effect than adjunctive placebos in the treatment of moderate and severe cases of coronavirus disease 2019 (COVID-19). METHODS: The study was a randomized, single-blind, prospective, placebo-controlled clinical trial set in the clinical context of standard care. INTERVENTION: Patients of either sex, admitted in a tertiary care hospital, suffering from moderate or severe COVID-19 and above 18 years of age were included. In total, 150 patients were recruited and then randomly divided into two groups to receive either individualized homeopathic medicines or placebos, in addition to the standard treatment of COVID-19. OUTCOME MEASURES: The primary outcome was time taken to achieve RT-PCR-confirmed virus clearance for COVID-19. Secondary outcomes were changes in the Clinical Ordinal Outcomes Scale (COOS) of the World Health Organization, the patient-reported MYMOP2 scale, and several biochemical parameters. Parametric data were analyzed using unpaired t-test. Non-parametric data were analyzed using the Wilcoxon signed rank test. Categorical data were analyzed using Chi-square test. RESULTS: In total, 72 participants of the add-on homeopathy (AoH) group showed conversion of RT-PCR status to negative, in an average time of 7.53 ± 4.76 days (mean ± SD), as compared with 11.65 ± 9.54 days in the add-on placebo (AoP) group (p = 0.001). The mean COOS score decreased from 4.26 ± 0.44 to 3.64 ± 1.50 and from 4.3 ± 0.46 to 4.07 ± 1.8 in the AoH and AoP groups respectively (p = 0.130). The mortality rate for the AoH group was 9.7% compared with 17.3% in the AoP group. The MYMOP2 scores between the two groups differed significantly (p = 0.001), in favor of AoH. Inter-group differences in the pre- and post- mean values of C-reactive protein, fibrinogen, total leukocyte count, platelet count and alkaline phosphatase were each found to be statistically significant (p <0.05), favoring AoH; six other biochemical parameters showed no statistically significant differences. CONCLUSION: The study suggests homeopathy may be an effective adjunct to standard care for treating moderate and severe COVID-19 patients. More rigorous, including double-blinded, studies should be performed to confirm or refute these initial findings.

Development of Mobile Application-Based System for Improving Medication Adherence Among Cancer Patients Receiving Palliative Therapy.

Objectives: Cancer patients seeking palliative care faces distressing symptoms which affect their quality of life adversely. Patients' lack of adherence to analgesics is one of the major factors contributing to the undertreatment of cancer pain. The objective of this paper is to outline the development of a mobile application-based system to develop a physician-patient relationship and to improve adherence to medications prescribed for cancer pain management. Material and Methods: The mobile application-based system is developed using alarm and cloud based data sysncronisation for improving medication adherence and self-recording symptoms among cancer patients receiving palliative therapy at a palliative care clinic. Results: Ten palliative medicine physicians tested the project website and the mobile application thoroughly instead of patients. The physician recoded the prescription and other details on the project website. The data transferred from website to mobile application. The mobile application reminded scheduled medication by alarm, collected medical adherence details, daily symptom observation, and their severity and SOS medication details. The data from the mobile application was transferred back to project website successfully. Conclusion: The developed system can directly improve the physician-patient relationship, and improve better communication and sharing of information between physician and patient. This will impact the quality of life of the patient, improve the awareness of the patient about the disease, and may reduce rate of hospitalisation. This will also help physicians to treat patients efficiently. The developed system is being tested under a randomised control trial study. The findings of the study can be generalised to all patients suffering from chronic illnesses and on long-term medications.

Non-Invasive Objective Markers to Measure Pain: A Direction to Develop a Pain Device - A Narrative Review.

Objective: To review the literature regarding non-invasive objective measurements of pain. Measuring pain is of uttermost importance, but it can be an inconvenient task, especially in terms of the interpretation of patient's information. Reiterating, there is no "standard" that provides the physician with a method to objectively quantify this problem of patient's pain. For assessing the pain, physician relies solely on unidimensional assessment tools or questionnaire-based pain assessment. Although pain is a subjective experience of the patient, but there is a need to measure pain sometimes in the individuals who cannot communicate their quality and severity of pain. Material and Methods: The articles from PubMed and Google Scholar without any year and age limit were searched in the current narrative review. A total of 16 markers were searched and their relation to pain was studied. Results: Studies have shown that these markers change in relation to pain and it can be considered a valuable tool for pain measurement but there are multiple factors like psychological and emotional factors which affect these markers. Conclusion: There is lack of evidence to show which marker can be used for measuring pain accurately. This narrative review is an attempt to look into the various pain-related markers that can be used and it calls for further studies including clinical trials with different diseases and taking into accounts different factors affecting pain to give an accurate measurement of pain.

Development and Validation of Total Pain Scale for Evaluation of Total Pain in Cancer Patients.

Objectives: Cancer pain has all the components of total pain such as physical, social, psychological, and spiritual. These components contribute to the overall pain experience in cancer patients. Many instruments have been developed till date to assess the effect of pain in cancer patients but none of the instruments include all components of total pain. In this article, we describe the development and validation of the total pain scale (TPS) for the evaluation of total pain in cancer patients with pain. This study aimed to develop and validate a questionnaire for the evaluation of total pain in cancer patients with pain. Material and Methods: This study included a review of existing pain questionnaires for cancer pain for item pool generation. Items were generated in the Hindi language by six stakeholders to create 23 items to develop TPS. TPS was applied to 300 Hindi-speaking cancer patients. Bivariate correlation was used to reduce the number of items as well as construction of the domain followed by factor analysis to finalise TPS. Confirmatory factor analysis (CFA) was performed for testing the validity and reliability of TPS. Results: TPS is an 18-item scale composed of four domains (physical, social, spiritual and psychological domain). The internal consistency of TPS and its subscales was found to be very good (a = 0.84-0.88). CFA and structural equation modeling Goodness of fit has confirmed that model 4 is the best fit as it yielded a lesser root-mean-squared error of approximation value of 0.062 and a greater comparative fit index, Tucker-Lewis index value of 0.944. The convergent and divergent validity of TPS and its domain was good. Conclusion: This study reports TPS to be a brief (18-item), valid, and reliable questionnaire in the Hindi language for assessment of all components of total pain in cancer patients with pain.

COVID-19 disease in hospitalized young adults in India and China: Evaluation of risk factors predicting progression across two major ethnic groups.

Data pertaining to risk factor analysis in coronavirus disease 2019 (COVID-19) is confounded by the lack of data from an ethnically diverse population. In addition, there is a lack of data for young adults. This study was conducted to assess risk factors predicting COVID-19 severity and mortality in hospitalized young adults. A retrospective observational study was conducted at two centers from China and India on COVID-19 patients aged 20-50 years. Regression analysis to predict adverse outcomes was performed using parameters including age, sex, country of origin, hospitalization duration, comorbidities, lymphocyte count, and National Early Warning Score 2 (NEWS2) score at admission. A total of 420 patients (172 East Asians and 248 South Asians) were included. The predictive model for intensive care unit (ICU) admission with variables NEWS2 Category II and higher, diabetes mellitus, liver dysfunction, and low lymphocyte counts had an area under the curve (AUC) value of 0.930 with a sensitivity of 0.931 and a specificity of 0.784. The predictive model for mortality with NEWS2 Category III, cancer, and decreasing lymphocyte count had an AUC value of 0.883 with a sensitivity of 0.903 and a specificity of 0.701. A combined predictive model with bronchial asthma and low lymphocyte count, in contrast, had an AUC value of 0.768 with a sensitivity of 0.828 and a specificity of 0.719 for NEWS2 score (5 or above) at presentation. NEWS2 supplemented with comorbidity profile and lymphocyte count could help identify hospitalized young adults at risk of adverse COVID-19 outcomes.

Statin and aspirin as adjuvant therapy in hospitalised patients with SARS-CoV-2 infection: a randomised clinical trial (RESIST trial).

BACKGROUND: Statins and aspirin have been proposed for treatment of COVID-19 because of their anti-inflammatory and anti-thrombotic properties. Several observational studies have shown favourable results. There is a need for a randomised controlled trial. METHODS: In this single-center, open-label, randomised controlled trial, 900 RT-PCR positive COVID-19 patients requiring hospitalisation, were randomly assigned to receive either atorvastatin 40 mg (Group A, n = 224), aspirin 75 mg (Group B, n = 225), or both (Group C, n = 225) in addition to standard of care for 10 days or until discharge whichever was earlier or only standard of care (Group D, n = 226). The primary outcome variable was clinical deterioration to WHO Ordinal Scale for Clinical Improvement ≥ 6. The secondary outcome was change in serum C-reactive protein, interleukin-6, and troponin I. RESULTS: The primary outcome occurred in 25 (2.8%) patients: 7 (3.2%) in Group A, 3 (1.4%) in Group B, 8 (3.6%) in Group C, and 7 (3.2%) in Group D. There was no difference in primary outcome across the study groups (P = 0.463). Comparison of all patients who received atorvastatin or aspirin with the control group (Group D) also did not show any benefit [Atorvastatin: HR 1.0 (95% CI 0.41-2.46) P = 0.99; Aspirin: HR 0.7 (95% CI 0.27-1.81) P = 0.46]. The secondary outcomes revealed lower serum interleukin-6 levels among patients in Groups B and C. There was no excess of adverse events. CONCLUSIONS: Among patients admitted with mild to moderate COVID-19 infection, additional treatment with aspirin, atorvastatin, or a combination of the two does not prevent clinical deterioration. Trial Registry Number CTRI/2020/07/026791 ( http://ctri.nic.in ; registered on 25/07/2020).

The COVID-19 pandemic: a new epoch and fresh challenges for cancer patients and caregivers-a descriptive cross-sectional study.

PURPOSE: Cancer patients and their caregivers are overwhelmed with features of uncertainty, fear, shock, worry, anxiety, sadness, and grief. To add on to their misery, the COVID-19 pandemic has severely afflicted the cancer care delivery. The study was conducted to observe the challenges faced by cancer patients and their caregivers and to formulate strategies for oncological setups to overcome those challenges. METHODS: After obtaining institutional ethical clearance, a descriptive cross-sectional study was conducted to observe the challenges faced by patients and their caregivers at the level of various domains (physical, logistic, psychological, socioeconomic, and spiritual) who visited the outpatient and inpatient department of cancer pain and palliative care unit. The results were expressed in absolute numbers. RESULTS: Major challenges encountered were suffering from physical symptoms like pain, nausea, vomiting, dyspnea (90%), postponement of cancer treatment (80%), fear of contracting COVID infection due to hospital visit (93.5%), lack of accommodation (70%), and lack of spiritual clarity and hope (50%). CONCLUSIONS: Major challenges faced by patients were in physical and psychological domains, and those by caregivers were in socioeconomic domains and handling physical symptoms of their patients. It is imperative to recognize and be cognizant of the challenges faced by cancer patients and their caregivers. Health care setups should formulate strategies to alleviate these challenges and provide holistic care to cancer patients. These strategies will hold in good stead for future pandemics also.

Institutional end-of-life care policy for inpatients at a tertiary care centre in India: A way forward to provide a system for a dignified death.

India has a high share in the global burden of chronic terminal illnesses. However, there is a lack of a uniform system in providing better end-of-life care (EOLC) for large patients in their terminal stage of life. Institutional policies can be a good alternative as there is no national level policy for EOLC. This article describes the important aspects of the EOLC policy at one of the tertiary care institutes of India. A 15 member institutional committee including representatives from various departments was formed to develop this institutional policy. This policy document is aimed at helping to recognize the potentially non-beneficial or harmful treatments and provide transparency and accountability of the process of limitation of treatment through proper documentation that closely reflects the Indian legal viewpoint on this matter. Four steps are proposed in this direction: (i) recognition of a potentially non-beneficial or harmful treatment by the physicians, (ii) consensus among all the caregivers on a potentially non-beneficial or harmful treatment and initiation of the best supportive care pathway, (iii) initiation of EOLC pathways, and (iv) symptom management and ongoing supportive care till death. The article also focuses on the step-by-step process of formulation of this institutional policy, so that it can work as a blueprint for other institutions of our country to identify the infrastructural needs and resources and to formulate their own policies.

Characteristics & outcomes of cancer patients with COVID-19: A multicentre retrospective study from India.

Background & objectives: High mortality has been observed in the cancer population affected with COVID-19 during this pandemic. We undertook this study to determine the characteristics and outcomes of cancer patients with COVID-19 and assessed the factors predicting outcome. Methods: Patients of all age groups with a proven history of malignancy and a recent diagnosis of SARS-CoV-2 infection based on nasal/nasopharyngeal reverse transcriptase (RT)-PCR tests were included. Demographic, clinical and laboratory variables were compared between survivors and non-survivors groups, with respect to observed mortality. Results: Between May 11 and August 10, 2020, 134 patients were included from the three centres and observed mortality was 17.1 per cent. The median age was 53 yr (interquartile range 39-61 yr) and thirty four patients (25%) were asymptomatic. Solid tumours accounted for 69.1 per cent and breast cancer was the most common tumour type (20%). One hundred and five patients (70.5%) had received chemotherapy within the past four weeks and 25 patients (19.3%) had neutropenia at presentation. On multivariate analysis, age [odds ratio (OR) 7.99 (95% confidence interval [CI] 1.18-54.00); P=0.033], haemoglobin [OR 6.28 (95% CI 1.07-37.04); P=0.042] neutrophil-lymphocyte ratio [OR 12.02 (95% CI 2.08-69.51); P=0.005] and baseline serum albumin [OR 18.52 (95% CI 2.80-122.27); P=0.002], were associated with higher mortality. Recent chemotherapy, haematological tumours type and baseline neutropenia did not affect the outcome. Interpretation & conclusions: Higher mortality in moderate and severe infections was associated with baseline organ dysfunction and elderly age. Significant proportion of patients were asymptomatic and might remain undetected.