Impact of surgical approach on short-term oncological outcomes and recovery following low anterior resection for rectal cancer.

AIM: The aim was to evaluate the influence of operative approach for low anterior resection (LAR) on oncological and postoperative outcomes. Minimally invasive surgical approaches are increasingly used for the treatment of rectal cancer with mixed outcomes. METHOD: We compared patients undergoing LAR in the National Cancer Database between 2010 and 2015 by surgical approach. Multivariable regression was used to identify risk factors associated with conversion rate, prolonged length of stay (LOS) and 30-day unplanned readmission. RESULTS: During the study period, 41 282 patients underwent LAR: 6035 robotic-assisted (RLAR) (14.6%), 13 826 laparoscopic (LLAR) (33.5%) and 21 421 open (OLAR) (51.9%). In propensity score matched analysis, RLAR compared to LLAR was associated with shorter LOS (6.3 vs 6.8 days, P < 0.0001), lower risk of prolonged LOS (22.1% vs 25.6%, P < 0.0001) and lower rate of conversion to open (7.5% vs 14.95%, P < 0.0001). Compared to OLAR, RLAR had shorter LOS (6.3 vs 7.8 days, P < 0.0001) and less prolonged LOS (14.1% vs. 20.9%, P < 0.0001). In multivariable analysis, for conversion to open, the laparoscopic approach was one of the risk factors; for prolonged LOS, conversion to open and non-robotic approaches (i.e. LLAR and OLAR) were risk factors; and for unplanned 30-day readmission, conversions and prolonged LOS were risk factors. CONCLUSIONS: For patients with rectal cancer, RLAR shows recovery benefits over both open and laparoscopic LAR with reduced conversion to open compared with LLAR and less prolonged LOS compared with LLAR and OLAR. RLAR is associated with short-term oncological outcomes comparable to OLAR, supporting its use in minimally invasive surgery for rectal cancer.

Towards a single step process to create high purity gold structures by electron beam induced deposition at room temperature.

Highly pure metallic structures can be deposited by electron beam induced deposition and they have many important applications in different fields. The organo-metallic precursor is decomposed and deposited under the electron beam, and typically it is purified with post-irradiation in presence of O2. However, this approach limits the purification to the surface of the deposit. Therefore, 'in situ' purification during deposition using simultaneous flows of both O2 and precursor in parallel with two gas injector needles has been tested and verified. To simplify the practical arrangements, a special concentric nozzle has been designed allowing deposition and purification performed together in a single step. With this new device metallic structures with high purity can be obtained more easily, while there is no limit on the height of the structures within a practical time frame. In this work, we summarize the first results obtained for 'in situ' Au purification using this concentric nozzle, which is described in more detail, including flow simulations. The operational parameter space is explored in order to optimize the shape as well as the purity of the deposits, which are evaluated through scanning electron microscope and energy dispersive x-ray spectroscopy measurements, respectively. The observed variations are interpreted in relation to other variables, such as the deposition yield. The resistivity of purified lines is also measured, and the influence of additional post treatments as a last purification step is studied.

Disclosure of Leprosy by Health Care Providers in South-India: Patients' Perception and Relevance to Leprosy Control, Tamil Nadu.

Stigma, isoIation and discrimination are typically associated with diagnosis of leprosy and its disclosure. Health care providers (HCPs) find it challenging to disclose the diagnosis of leprosy to patients and their family members. A qualitative study was done in a rural community near Chennai in Tamil Nadu, from August 2011 to March 2012, covering 155 out of 648 (23.9%) purposively selected leprosy patients from 53 out of 148 panchayats, representing 264 villages in the study area; Out of these 155 patients, 59% were males; 30% were illiterates; 70% were married; 56% were living in nuclear families; half the leprosy patients were either agricultural labourers or skilled workers (50%).Thirty two percent were multibacillary (MB) cases and 68% were pauci bacillary (PB) cases; 77% were old patients and 23% were new patients; 22% had leprosy deformity 12% had disfiguration; 23% had anaesthesia and 3% were with lagophthalmous. Of the 155 patients, 31 (20%) reported that they were not informed about diagnosis of their disease by the concerned HCPs. They were informed to be having a skin disease or a skin patch. Of these 31 patients, 22 (71%) were women; all except one with PB leprosy. Seven patients (23%) had not yet started on treatment 3 patients (10%) were given treatment when they were young and neither, them nor their parents were informed about this disease. Seven (33%) of the married patients who had the disease during their child had or when they were young, were not informed of the diagnosis by the HCPs. Ten respondents (32%) were neither bothered nor concerned about non disclosure of the disease by HCPs. Now, after knowing the diagnosis of the disease 4 females (13%) mentioned that they were having some fear, worry or stigma. As non-disclosure of leprosy by HCPs may adversely affect acceptance and adherence, to treatment by the patients, appropriate communication strategies should be developed and implemented.

Post-traumatic immunosuppression is reversed by anti-coagulated salvaged blood transfusion: deductions from studying immune status after knee arthroplasty.

Major trauma increases vulnerability to systemic infections due to poorly defined immunosuppressive mechanisms. It confers no evolutionary advantage. Our objective was to develop better biomarkers of post-traumatic immunosuppression (PTI) and to extend our observation that PTI was reversed by anti-coagulated salvaged blood transfusion, in the knowledge that others have shown that non-anti-coagulated (fibrinolysed) salvaged blood was immunosuppressive. A prospective non-randomized cohort study of patients undergoing primary total knee arthroplasty included 25 who received salvaged blood transfusions collected post-operatively into acid-citrate-dextrose anti-coagulant (ASBT cohort), and 18 non-transfused patients (NSBT cohort). Biomarkers of sterile trauma included haematological values, damage-associated molecular patterns (DAMPs), cytokines and chemokines. Salvaged blood was analysed within 1 and 6 h after commencing collection. Biomarkers were expressed as fold-changes over preoperative values. Certain biomarkers of sterile trauma were common to all 43 patients, including supranormal levels of: interleukin (IL)-6, IL-1-receptor-antagonist, IL-8, heat shock protein-70 and calgranulin-S100-A8/9. Other proinflammatory biomarkers which were subnormal in NSBT became supranormal in ASBT patients, including IL-1ß, IL-2, IL-17A, interferon (IFN)-γ, tumour necrosis factor (TNF)-α and annexin-A2. Furthermore, ASBT exhibited subnormal levels of anti-inflammatory biomarkers: IL-4, IL-5, IL-10 and IL-13. Salvaged blood analyses revealed sustained high levels of IL-9, IL-10 and certain DAMPs, including calgranulin-S100-A8/9, alpha-defensin and heat shock proteins 27, 60 and 70. Active synthesis during salvaged blood collection yielded increasingly elevated levels of annexin-A2, IL-1ß, Il-1-receptor-antagonist, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IFN-γ, TNF-α, transforming growth factor (TGF)-ß1, monocyte chemotactic protein-1 and macrophage inflammatory protein-1α. Elevated levels of high-mobility group-box protein-1 decreased. In conclusion, we demonstrated that anti-coagulated salvaged blood reversed PTI, and was attributed to immune stimulants generated during salvaged blood collection.

A new sequential EBID process for the creation of pure Pt structures from MeCpPtMe3.

Electron beam induced deposition (EBID) is a process used for the fabrication of three-dimensional nanostructures of a variety of materials, but direct deposition of pure metallic structures has rarely been achieved. Typically, MeCpPtMe3 as a precursor for Pt leads to a carbon rich deposit with ~15 at.% Pt, which negatively affects its application as an electrical contact. We report a new process for Pt purification: in situ annealing with electron beam post-irradiation under oxygen flux, which can completely purify a thin (<100 nm) Pt EBID structure at substrate temperatures as low as 120 °C. We have developed a sequential method in which a thin Pt EBID structure is deposited on a previously purified structure and subsequently purified. The resistivity of the contact grown by this sequential procedure is observed to be ~70 ± 8 µΩ cm-only six times higher than that of pure bulk Pt. Thus, sequential deposition and purification proves to be an effective method for fabricating pure Pt structures of desired dimensions.

Added value of the measles-rubella supplementary immunization activity in reaching unvaccinated and under-vaccinated children, a cross-sectional study in five Indian districts, 2018-20.

INTRODUCTION: Supplementary immunization activities (SIAs) aim to interrupt measles transmission by reaching susceptible children, including children who have not received the recommended two routine doses of MCV before the SIA. However, both strategies may miss the same children if vaccine doses are highly correlated. How well SIAs reach children missed by routine immunization is a key metric in assessing the added value of SIAs. METHODS: Children aged 9 months to younger than 5 years were enrolled in cross-sectional household serosurveys conducted in five districts in India following the 2017-2019 measles-rubella (MR) SIA. History of measles containing vaccine (MCV) through routine services or SIA was obtained from documents and verbal recall. Receipt of a first or second MCV dose during the SIA was categorized as "added value" of the SIA in reaching un- and under-vaccinated children. RESULTS: A total of 1,675 children were enrolled in these post-SIA surveys. The percentage of children receiving a 1st or 2nd dose through the SIA ranged from 12.8% in Thiruvananthapuram District to 48.6% in Dibrugarh District. Although the number of zero-dose children prior to the SIA was small in most sites, the proportion reached by the SIA ranged from 45.8% in Thiruvananthapuram District to 94.9% in Dibrugarh District. Fewer than 7% of children remained measles zero-dose after the MR SIA (range: 1.1-6.4%) compared to up to 28% before the SIA (range: 7.3-28.1%). DISCUSSION: We demonstrated the MR SIA provided considerable added value in terms of measles vaccination coverage, although there was variability across districts due to differences in routine and SIA coverage, and which children were reached by the SIA. Metrics evaluating the added value of an SIA can help to inform the design of vaccination strategies to better reach zero-dose or undervaccinated children.

Changes in condom use during a microbicide clinical trial in Pune, India.

Researchers have raised concerns that microbicide use during clinical trials would displace condom use. We sought to understand whether condom use changed for participants in a microbicide clinical trial in Pune, India, to understand whether condom shifts were a legitimate concern. We hypothesize that women participating in a microbicide clinical trial in Pune, India, were more likely, on average, to report condom use at follow-up. We further hypothesize that men, whose female partners participated in a microbicide clinical trial were more likely, on average, to report condom use at follow-up. The outcome measure for reported condom use was a dichotomous variable to indicate whether or not the participant had used a male or female condom with a sexual partner since 2 months before enrollment or since the last survey, depending on the visit. Data are from semi-structured interviews at baseline, 2 months, 4 months, and 6 months with HPTN 059 clinical trial participants (100 women and 57 male partners). We used generalized estimating equations with a logit link function, exchangeable correlation, and a binomial family to model condom use. The odds of condom use for clinical trial women increased from baseline to 6 months by a factor of 3.7 (95% CI: 1.84-7.63) and the change in odds of condom use for clinical trial men from baseline to 6 months increased by a factor of 2.58 (95% CI: 1.37-4.85). We found concerns about microbicide use displacing condom use were not merited in this study population. The percent of participants reporting condom use declined from 4 to 6 months, suggesting that increases in condom use may only be during active study participation. Information about clinical trial factors that enabled these men and women to enact this important HIV prevention behavior is needed to develop interventions.

Awareness, social acceptance and community views on leprosy and its relevance for leprosy control, Tamil Nadu.

As the leprosy burden has declined considerably, we need to understand the current social status of the disease and patients. A qualitative study was conducted in a rural community near Chennai in Tamil Nadu, between March and October 2011. In-depth interviews with 72 leprosy patients from 25 villages and 3 focus group discussions (FGDs) with 26 women from 3 villages were conducted using a guide. The qualitative data were grouped into different domains and analysed. Most of them did not have basic knowledge on leprosy; instead there were misconceptions on cause and spread of leprosy. Nearly one third of the patients had not disclosed about the disease to their spouse, family members, relatives or friends for fear of social rejection, discrimination and ill treatment. In all, more than half of them had self-stigma and, most of them who had deformity faced actual stigma by way of disowning, isolation and social rejection. Many patients, particularly PB cases had the behavior of "denial". FGD women reported of self and actual stigma, particularly towards deformity and disfigurement, for fear of getting infected. Stigma among patients with deformity, and denial of the disease among PB cases, were highlighted. Importance of awareness programmes to remove misconceptions related to cause and spread of the disease was stressed. Need for person-centered social treatment was suggested for increased case detection.

Efficacy of single-dose chemotherapy (rifampicin, ofloxacin and minocycline-ROM) in PB leprosy patients with 2 to 5 skin lesions, India: randomised double-blind trial.

UNLABELLED: We conducted randomized double-blind trial for single-dose of Rifampicin, Ofloxacin and Minocycline (ROM) compared to WHO-PB-MDT among paucibacillary (PB) leprosy patients with 2-5 skin lesions. We enrolled 1526 patients from five centres (ROM=762; WHO-PB-MDT=764) and followed them for 36 months posttreatment during 1998-2003. We generated information on clearance of skin lesions and relapse rates per 100 person-years (PY) for all the five centres. At base-line, the patients in the two arms were comparable. Complete clearance of skin lesions was similar (72% vs. 72.1%; p=0.95) in both the arms. Clinical scores declined steadily and equally. Difference in relapse rates was statistically highly significant (ROM=1.13 and WHO-PB-MDT=0.35 per 100 PY; mid-p exact=0.001016). Twenty eight of 38 of these relapses occurred within 18 months. In all, 10 suspected adverse drug reactions were.observed (ROM=2; WHO-PB-MDT=8). We extended the follow-up to 48 months for 1082 of 1526 patients from two programme-based centres. No further relapses occurred. Decline in clinical score was not dependent on age, gender, number of lesions or affected body parts. Single dose ROM, though less effective than the standard WHO-PB-MDT regimen conceptually offers an alternative treatment regimen for PB leprosy patients with 2-5 lesions only when careful follow-up for relapse is possible. Registered at the Clinical Trials Registry of India; REGISTRATION NUMBER: CTRI/2012/05/002645

Cost effectiveness of targeted HIV prevention interventions for female sex workers in India.

OBJECTIVE: To ascertain the cost effectiveness of targeted interventions for female sex workers (FSW) under the National AIDS Control Programme in India. METHODS: A compartmental mathematical Markov state model was used over a 20-year time horizon (1995-2015) to estimate the cost effectiveness of FSW targeted interventions, with a health system perspective. The incremental costs and effects of FSW targeted interventions were compared against a baseline scenario of mass media for the general population alone. The incremental cost-effectiveness ratio was computed at a 3% discount rate using HIV infections averted and disability-adjusted life-years (DALY) as benefit measures. It was assumed that the transmission of the HIV virus moves from a high-risk group (FSW) to the client population and finally to the general population (partners of clients). RESULT: Targeted interventions for FSW result in a reduction of 47% (1.6 million) prevalent and 36% (2.7 million) cumulative HIV cases, respectively, in 2015. Adult HIV prevalence in India, with and without (mass media only) FSW interventions, would be 0.25% and 0.48% in 2015. Indian government and development partners spend an average US $104 (INR4680) per HIV infection averted and US $10.7 (INR483) per DALY averted. Discounting at 3%, FSW targeted interventions cost US $105.5 (INR4748) and US $10.9 (INR490) per HIV case and DALY averted, respectively. CONCLUSION: At the current gross domestic product in India, targeted intervention is a cost-effective strategy for HIV prevention in India.

Ordered surface alloy of bulk-immiscible components stabilized by magnetism.

Using scanning tunneling microscopy and a diffraction experiment, we have discovered a new ordered surface alloy made out of two bulk-immiscible components, Fe and Au, deposited on a Ru(0001) substrate. In such a system, substrate-mediated strain interactions are believed to provide the main driving force for mixing. However, spin-polarized ab initio calculations show that the most stable structures are always the ones with the highest magnetic moment per Fe atom and not the ones minimizing the surface stress, in remarkable agreement with the observations. This opens up novel possibilities for creating materials with unique properties of relevance to device applications.

Beam quality degradation of a higher order transverse mode beam due to spherical aberration of a lens.

An analysis of the increase in the beam-propagation factor, M2, of a higher order transverse mode beam caused by quartic phase aberration after transmission through a spherically aberrated lens is reported. The analysis shows that for a given beam size, the increase in the M2 parameter is less for a higher order transverse mode beam as compared to that for a diffraction limited beam. Experimental results using a multimode laser diode beam show good agreement with the theoretical results.

Opportunistic parasitic infections in HIV/AIDS patients presenting with diarrhoea by the level of immunesuppression.

BACKGROUND & OBJECTIVE: Enteric parasites are major cause of diarrhoea in HIV infected individuals. The present study was undertaken to detect enteric parasites in HIV infected patients with diarrhoea at different levels of immunity. METHODS: The study was carried out at National AIDS Research Institute, Pune, India, between March 2002 and March 2007 among consecutively enrolled 137 HIV infected patients presenting with diarrhoea. Stool samples were collected and examined for enteric parasites by microscopy and special staining methods. CD4 cell counts were estimated using the FACS count system. RESULTS: Intestinal parasitic pathogens were detected in 35 per cent patients, and the major pathogens included Cryptosporidium parvum (12%) the most common followed by Isospora belli (8%), Entamoeba histolytica/Enatmoeba dispar (7%), Microsporidia (1%) and Cyclospora (0.7%). In HIV infected patients with CD4 count < 200 cells/microl, C. parvum was the most commonly observed (54%) pathogen. Proportion of opportunistic pathogens in patients with CD4 count <200 cells/microl was significantly higher as compared with other two groups of patients with CD4 count >200-499 and >or= 500 cells/microl (P=0.001, P=0.016) respectively. INTERPRETATION & CONCLUSION: Parasitic infections were detected in 35 per cent HIV infected patients and low CD4 count was significantly associated with opportunistic infection. Detection of aetiologic pathogens might help clinicians decide appropriate management strategies.

Expanded safety study of Praneem polyherbal vaginal tablet among HIV-uninfected women in Pune, India: a phase II clinical trial report.

BACKGROUND: Praneem, a candidate vaginal microbicide with reported anti-HIV and contraceptive properties was evaluated for its long-term safety through a double-blind, placebo-controlled, randomised phase II trial. METHODOLOGY: 142 women were screened and 100 HIV-uninfected, eligible women were enrolled, after obtaining written informed consents. Of these, 50 were randomly assigned to the study product arm and 50 to the placebo arm. Participants were requested to use the study product at least half an hour before each sexual act for 6 months. RESULTS: Participants in both treatment groups contributed 601 person-months of follow-up and 95% of the participants completed the last follow-up. Although transient genital discomfort was the main reported adverse experience, none of the study participants discontinued product use. Most of the adverse events were mild and there were no serious adverse events related to study product use and no HIV seroconversions. DISCUSSION: Praneem polyherbal tablet was safe for vaginal use up to 6 months with each act of sex among low-risk women. In light of the failure of Nonoxynol-9, cellulose sulphate and Carraguard in preventing HIV infections among women, additional preclinical evaluations should be undertaken urgently before moving into effectiveness studies.

Acceptability of Praneem polyherbal vaginal tablet among HIV uninfected women & their male partners in Pune, India--Phase I study.

BACKGROUND & OBJECTIVE: The number of HIV infected women is steadily increasing worldwide and women controlled methods to prevent HIV are urgently needed. Vaginal microbicides are products for vaginal administration that can be used to prevent HIV infection and other sexually transmitted diseases (STDs). We conducted a Phase I safety and acceptability study of Praneem polyherbal tablet, a candidate microbicide, among HIV uninfected women in Pune, India. METHODS: Twenty eligible women were requested to use the product intravaginally once daily for 14 consecutive days between menses. Safety was assessed by clinical examination, laboratory monitoring and colposcopy. Acceptability was assessed after 14 days of product use through structured questionnaires, focus group discussions among participating women, and in-depth interviews with a subset of 5 randomly selected male partners. RESULTS: Praneem polyherbal tablet was found acceptable by the study participants with 90 per cent of the participants showing 80 per cent and more acceptability score. Discharge of the product residue was reported as a concern by 6 (30%) of participants. Nineteen (95%) female participants liked the smell and the same number reported that the product was easy to use and did not affect the usual sexual pleasure. However, men reported lack of sexual satisfaction. INTERPRETATION & CONCLUSION: Product characteristics received good acceptability score in women. However, studies of long-term safety and acceptability among at-risk population would provide more detailed information about its long term acceptability.

Rate of hospitalization and inpatient care costs for HIV-1-infected patients in Pune, India.

BACKGROUND: The transition of human immunodeficiency virus (HIV) infection to acquired immune deficiency syndrome (AIDS) has begun in India, and an increase in AIDS-related hospitalizations and deaths is an anticipated challenge. We estimated the rates of hospitalization and inpatient care costs for HIV-1-infected patients. METHODS: Data were analysed on 381 HIV-1-infected persons enrolled in a HIV-1 discordant couples' cohort between September 2002 and March 2004. Inpatient care costs were extracted from select hospitals where the study patients were hospitalized and the average cost per hospitalization was calculated. RESULTS: A majority of the patients were in an advanced state of HIV-1 disease with the median CD4 counts being 207 cells/cmm (range: 4-1131 cells/cmm). In all, 63 participants who did not receive antiretroviral therapy required hospitalization, 53 due to HIV-1-related illnesses and the remaining 10 due to worsening of pre-existing conditions. The overall HIV-1-related hospitalization rate was 34.2 per 100 person-years (95% CI: 26.94-42.93). The median duration of HIV-1-related hospitalization was 10 days (range 2-48 days) and the median cost was Rs 17,464 (range: Rs 400-63,891). CONCLUSION: It is necessary to strengthen the inpatient care infrastructure and supporting diagnostic set-up, and work out economically optimized treatment algorithms for HIV-1-infected patients. Although this analysis does not cover all costs and may not be generalizable, these baseline data might be a useful reference while planning related studies accompanying the government-sponsored programme to roll out antiretroviral therapy to AIDS patients.

Modification of medical outcome study (MOS) instrument for quality of life assessment & its validation in HIV infected individuals in India.

BACKGROUND & OBJECTIVE: Several instruments have been developed specifically to assess the quality of life (QOL) in HIV infected individuals. No information is available in this aspect from India. The present study was thus carried out to assess the QOL among HIV infected persons, to study their relationship with socio-demographic characteristics and stages of disease progression, and to examine change in QOL over time. METHODS: One time assessment of QOL on 100 and repeat evaluation on 20 HIV infected persons enrolled in an ongoing longitudinal prospective study of clinical progression was done. Medical Outcome Study (MOS-QOL) core instrument was modified to suit the Indian cultural settings and interview-administered. RESULTS: The overall scale had Cronbach alpha 0.75. Instrument showed significant positive inter-domain correlations and linear association between QOL scores and CD4 counts. QOL was markedly affected in the domains of physical health, work and earnings, routine activities, and appetite and food intake. Women had significantly lower QOL scores despite having less advanced disease. The QOL scores decreased with drop in CD4 counts mainly in the physical health domains. Generally, the QOL scores were high in the follow up visit compared to baseline. INTERPRETATION & CONCLUSION: The modified MOS scale with Cronbach alpha of more than 0.7 and linear relationship between CD4 counts and the QOL scores indicated that the instrument was reliable and valid for evaluation of QOL in HIV infected persons in India. Comparative lower scores in the domains of physical health indicate medical intervention to greatly benefit the HIV infected persons. Longitudinal studies need to be undertaken to assess the impact of introduction of anti retroviral therapy (ART) through the national programme on disease progression and changes in QOL.

Prevalence of HIV infection in pregnant women in remote rural areas of Maharastra State, India.

In a study of 304 pregnant women, the prevalence of HIV infection in remote rural areas of western India was 0.7% (confidence interval 0.08-2.3%). It is nearly 2(1/2) times higher than the presumed prevalence for this part of the country.