Publications by authors named "Gayatri Vishwakarma"

21 Publications

  • Page 1 of 1

Radiological changes in sagittal parameters after C1-C2 arthrodesis and their clinical correlation: Is there a difference between traumatic and non-traumatic causes?

Int J Neurosci 2021 May 12:1-10. Epub 2021 May 12.

Department of Spine Service, Indian Spinal Injuries Centre, Vasant Kunj, New Delhi, India.

: Compensatory changes in cervical sagittal alignment after C1-C2 arthrodesis have been reported in a few studies. No studies have explored the differences in these compensatory changes between traumatic and non-traumatic pathologies. Conflicting reports exist on the correlation between cervical sagittal parameters and neck pain or function.: Medical records of 81 consecutive patients [Jan 2010 - Dec 2018] who underwent Harms arthrodesis were retrospectively reviewed. 53 patients were included in the final analysis. Radiological parameters [C0-C1, C1-C2, C2-C7 angles and T1 slope] and clinical parameters [VAS (Visual analogue scale) and NDI (Neck disability index)] were compared between the two groups, Group A (traumatic) and Group B (non-traumatic).: The 53 patients [Group A ( = 24,) and Group B ( = 29)] had a mean age of 49.98 ± 21.82 years (42 males, 11 females). Mean follow up duration was 48.9 months. Δ C1-C2 angle is significantly correlated with ΔC2-C7 angle (Group A,  = 0.004; Group B,  = 0.015) but not with ΔC0-C1 angle (Group A,  = 0.315; Group B,  = 0.938). Though significant improvement in the clinical parameters (VAS/NDI) has been noted in both groups, Group A showed a greater improvement in VAS scores [Group A, ( < 0.001); Group B, ( < 0.023)]. The sub-axial sagittal profile was strongly correlated with the ΔC1-C2 angle in both groups. Group B showed greater changes in sagittal parameters after Harms fixation and Group A showed greater improvement in long-term functional outcomes. The final functional outcomes were not related to the initial or final radiological sagittal profile in both groups.
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http://dx.doi.org/10.1080/00207454.2021.1929213DOI Listing
May 2021

Effect of Meditation on Psychological and Functional Outcomes in Spinal Cord Injury Patients.

Int J Yoga 2021 Jan-Apr;14(1):36-42. Epub 2021 Feb 5.

Indian Spinal Injuries Centre, New Delhi, India.

Background: Spinal cord injury (SCI) is a debilitating disorder with dysfunction in daily activities and psychological consequences like anxiety as well as depression impacting the quality of life substantially. Existing treatments focus mainly on rehabilitation, symptom reduction, and secondary complications. However, psychological, social, and existential issues are least addressed in the prevailing models.

Aims: To study the role of meditation in addressing psychological impairment and any resultant improvement in functional outcomes in SCI patients.

Methods: Nonrandomized controlled study was conducted in a tertiary care center for SCI patients. Hospital inpatients were recruited into either experimental intervention group (add on easy with conventional rehabilitation-ER = 50) or control intervention group (conventional rehabilitation alone-CR = 50). Patients in the ER group received easy for 1 month, along with conventional rehabilitation and the CR group patients received only conventional rehabilitation. All the subjects were assessed for psychological (perceived stress scale [PSS], Hospital Anxiety and Depression Scale [HADS]) and functional impairment (spinal cord independence measure (SCIM), numeric pain rating (NPR) and WHO quality of life-BRIEF (WHOQOLBREF)] at baseline and after 1 month.

Results: After 1 month of add-on easy , there was significant decrease in the scores of HADS (F[1,88] = 272.92, < 0.001), PSS (F[1,88] = 274.41, < 0.001) and NPR (F[1,88] = 60.60, < 0.001) and significant increase in the scores of WHOQOLBREF (F[1,88] = 349.94, < 0.001) and SCIM (F[1,88] = 29.09, < 0.001) in the ER group compared to CR group in analysis of covariance.

Conclusion: One-month add-on easy improves psychological and functional outcomes (HADS, PSS, NPR, WHOQOLBREF and SCIM) in patients with SCI. Future studies with robust designs are needed to validate the results.
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http://dx.doi.org/10.4103/ijoy.IJOY_68_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8023440PMC
February 2021

New Onset Sacroiliac Joint Pain After Transforaminal Interbody Fusion: What Are the Culprits?

Global Spine J 2021 Apr 12:21925682211003852. Epub 2021 Apr 12.

Department of Spine Service, 76434Indian Spinal Injuries Center, Vasant Kunj, New Delhi, India.

Study Design: A retrospective case-control study.

Objective: Only a few studies have studied the incidence of new-onset SI joint pain following lumbar spine fusion surgery. We aimed to explore the association between new-onset SI joint pain following Transforaminal Lumbar Interbody Fusion (TLIF) for degenerative spine disorders and changes in spinopelvic parameters.

Methods: A retrospective review of hospital records and imaging database of a tertiary care institute was done for patients who underwent TLIF from October 2018 to October 2019. The 354 patients who satisfied the eligibility criteria were divided into 2 groups(Group A, new-onset SI joint pain group, n = 34 and Group B, normal controls, n = 320). Symptomatic relief (>70% reduction in the VAS [Visual Analogue Scale] score) after 15 minutes of SI joint injection was considered diagnostic of SI joint pain. Clinical and radiological spinopelvic parameters were compared between the 2 groups.

Results: Patients with postoperative SI joint pain (Group A) had significantly less preoperative and postoperative lumbar lordosis (p < 0.001) compared to the other group. Most of the patients in Group A had a cephalad migration of the apex postoperatively (30/34 patients) whereas majority of patients in group B had either predominant caudal migration (44/320 patients) or no migration of the lumbar apex (272/320 patients).

Conclusions: The preoperative and postoperative lumbar lordosis are significantly less and the postoperative pelvic tilt is significantly high in patients with new-onset SI joint pain compared to the control group. The cephalad migration of the lumbar apex is significantly associated with new-onset SI joint pain.
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http://dx.doi.org/10.1177/21925682211003852DOI Listing
April 2021

To study the role of pre-treatment microRNA (micro ribonucleic acid) expression as a predictor of response to chemoradiation in locally advanced carcinoma cervix.

Cancer Rep (Hoboken) 2021 Mar 3:e1348. Epub 2021 Mar 3.

Department of Biostatistics, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.

Background: Concurrent chemoradiotherapy followed by brachytherapy is the standard of care in locally advanced carcinoma cervix. There is no prognostic factor at present to predict the outcome of disease in locally advanced carcinoma cervix.

Aim: Differential expression of microRNAs can be used as biomarkers to predict clinical response in locally advanced carcinoma cervix patients.

Methods: Thirty-two patients of locally advanced carcinoma cervix with International Federation of Gynecology and Obstetrics Stage IB-IVA were enrolled from 2017 to 2018. Expression of microRNA-9 5p, -31 3p, -100 5p, -125a 5p, -125b-5p, and -200a 5p in formalin-fixed paraffin embedded (FFPE) biopsied tissue were analyzed by real time quantitative reverse transcriptase polymerase chain reaction (RT qPCR). Pretreatment evaluation was done with clinical examination and MRI pelvis. All patients received concurrent chemoradiotherapy followed by brachytherapy. Patients were evaluated for the clinical response after 3 months of treatment, with clinical examination and MRI pelvis scan using RECIST 1.1 criteria. Patients with no residual disease were classified as Complete responders (CR) and with residual or progressive disease were classified as Nonresponders (NR). Results were statistically analyzed using Mann Whiney U test to examine significant difference between the expression of microRNA between complete responders (CR) and nonresponders (NR).

Results: microRNA-100 5p was upregulated in complete responders (CR) which showed a trend towards statistical significance (p value = 0.05).

Conclusion: microRNA-100 5p can serve as a potential molecular biomarker in predicting clinical response to chemoradiation in locally advanced Carcinoma cervix. Its role should be further investigated in a larger study population.
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http://dx.doi.org/10.1002/cnr2.1348DOI Listing
March 2021

Incidence and Risk Factors for Neurological Deterioration in Posterior Corrective Surgeries for Severe Angular Kyphotic Deformities: A 10-Year Institutional Retrospective Study.

Global Spine J 2020 Dec 30:2192568220979122. Epub 2020 Dec 30.

Department of Spine Service, Indian Spinal Injuries Center, New Delhi, India.

Study Design: Retrospective case-control study.

Objective: Neurological deficit is one of the dreaded complications of kyphotic deformity correction procedures. There is inconsistency in the reports of neurological outcomes following such procedures and only a few studies have analyzed the risk factors for neurological deficits. We aimed to analyze the factors associated with neurological deterioration in severe kyphotic deformity correction surgeries.

Methods: We performed a retrospective study of 121 consecutive surgically treated severe kyphotic deformity cases (49 males, 56 females) at a single institute (May 1st 2008 to May 31st 2018) and analyzed the risk factors for neurological deterioration. The demographic, surgical and clinical details of the patients were obtained by reviewing the medical records.

Results: 105 included patients were divided into 2 groups: Group A (without neurological deficit) with 92 patients (42 males, 50 females) and Group B (with neurological deficit) with 13 patients (7 males, 6 females) (12.4%). Statistically significant difference between the 2 groups was observed in the preoperative sagittal Cobbs angle (p < 0.0001), operative time (p = 0.003) and the presence of myelopathic signs on neurological examination (p = 0.048) and location of the apex of deformity (p = 0.010) but not in other factors.

Conclusions: Preoperative Sagittal Cobbs angle, presence of signs of myelopathy, operative time and location of apex in the distal thoracic region were significantly higher in patients with neurological deterioration as compared to those without neurological deterioration during kyphotic deformity correction surgery. Distal thoracic curve was found to have 4 times more risk of neurological deterioration compared to others.
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http://dx.doi.org/10.1177/2192568220979122DOI Listing
December 2020

Magnetic resonance imaging findings in intervertebral disc herniation: Comparison of canal compromise and canal size in patients with and without cauda equina syndrome.

Surg Neurol Int 2020 27;11:171. Epub 2020 Jun 27.

Departments of Spine Service, Indian Spinal Injuries Center, New Delhi, India.

Background: Surgical decompressions are typically warranted in patients with magnetic resonance (MR) and clinical evidence of cauda equina syndromes (CESs). However, it is still unclear what MR findings best correlate with such CES. Here, we compared MR-documented canal size and level/extent of compromise in 52 patients with and 56 others without CES attributed to lumbar disc herniation.

Methods: This was a retrospective study of 52 patients with and 56 patients without CES attributed to MR- documented lumbar disc herniations (IDHs). The anteroposterior diameters of the spinal canal and the levels of maximal compression were documented and compared utilizing MR scans from both groups.

Results: The 52 patients with CES had more extensive narrowing of the canal diameters at the L4-L5 and L5- S1 levels and higher mean canal compression ratios versus 56 patients without CES. The mean percentage of compression in the CES group at L4-L5 and L5-S1 levels (70% and 67.5%, respectively) was less versus L2-L3 and L3-L4 levels (89.7% and 81.8%, respectively).

Conclusion: The 52 patients with CES due to IDH had greater canal compromise versus 56 without CES. Further, the percentage of canal compromise was less at L4-L5 and L5-S1 levels compared to other levels in patients with CES.
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http://dx.doi.org/10.25259/SNI_242_2020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7332702PMC
June 2020

Minimally invasive vs open distal metatarsal osteotomy for hallux valgus - A systematic review and meta-analysis.

J Clin Orthop Trauma 2020 May-Jun;11(3):348-356. Epub 2020 Apr 21.

Indian Spinal Injuries Centre, New Delhi, India.

Background: Numerous publications of the late 20th century have presented the radiological outcome of open technique for distal metatarsal osteotomy for mild to moderate hallux valgus and the clinical outcomes by means of well-established scoring systems which have been published and make these open techniques today's benchmark and gold standard. Minimally invasive procedures reduce surgical trauma because they are performed without large incisions, and injury to the soft tissues is limited. This has the theoretical advantages of improved recovery and decreased rehabilitation times. There is however limited literature to prove the same for minimally invasive surgery for hallux valgus.Our aim was thus to pool all available comparative literature on minimally invasive hallux valgus surgery done for mild to moderate hallux valgus versus open surgical approaches.

Methods: A PubMed, Embase and Scopus search was performed using the keywords ('hallux valgus' OR bunion) AND ('minimally invasive' OR percutaneous) AND osteotomy. A total of 473 records were identified and out of which nine studies were included in the final review.

Results: Most available studies are either randomized control trials, or prospective cohort studies providing good level of evidence. Radiological analysis showed similar correction with both MIS and open osteotomies. In functional analysis results were different with open techniques providing better results in terms of AOFAS score. (p < 0.0001). VAS score and complication rate were similar in both groups.

Discussion/conclusion: We conclude that based on available literature MIS provides equivalent radiological outcomes with respect to open surgery but functionally despite the promising results (good to excellent in most series), the outcomes in terms of function are not as good as open surgery. MIS techniques provide satisfactory outcomes for mild-to-moderate severity of hallux valgus though not as good as open surgery. There is evolving literature for this relatively new procedure. Longer duration of follow up and bigger numbers would allow for more meaningful data analysis and conclusions to be drawn as more studies come forward.
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http://dx.doi.org/10.1016/j.jcot.2020.04.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7211908PMC
April 2020

Computed tomography patterns of pulmonary and pleural involvement in lymphoma.

Med J Armed Forces India 2020 Jan 19;76(1):77-83. Epub 2018 Dec 19.

Biostatistician, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi 110085, India.

Background: Pulmonary and pleural involvement is fairly common in patients with lymphoma, especially in the setting of progressive or recurrent disease. Pleuropulmonary involvement in lymphoma may occur as a single pattern or as a combination of multiple patterns which can often mimic unrelated pathologies.

Methods: Review of our institutional database from 01 Jan 2015 to 04 Oct 2017 revealed 90 patients with pulmonary and/or pleural lesions attributable to lymphoma. These lesions were classified into various categories, and the pattern of involvement was evaluated.

Results: Pulmonary involvement was seen in 17.6% of patients with Hodgkin lymphoma (HL) and in 10.5% of patients with non-Hodgkin lymphoma (NHL), whereas pleural involvement was seen in 6.5% of patients with NHL. Almost all the patients in our study had findings belonging to multiple categories. Pulmonary involvement in patients with HL was seen in the form of nodules (51.6%), masses (51.6%), and direct extension from a mediastinal/hilar mass (45.2%). Patients with NHL had pulmonary involvement in the form of nodules (42.4%), direct extension from a mediastinal/hilar mass (25.4%), pulmonary masses (18.6%), and interstitial pattern (2.4%). Pleural thickening (61.5%), masses (30.8%), and effusion (15.4%) were the three patterns of pleural involvement.

Conclusion: Nodules and masses were the two commonest patterns of pulmonary involvement in patients with HL, whereas nodules were the commonest pattern noted in patients with NHL. Pulmonary masses were seen more commonly in patients with HL than in those with NHL. Pleural involvement was seen exclusively in patients with NHL.
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http://dx.doi.org/10.1016/j.mjafi.2018.09.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6994760PMC
January 2020

T-ALL Minimal Residual Disease Using a Simplified Gating Strategy and Its Clinico-hematologic Correlation: A Single Center Experience from North India.

Indian J Hematol Blood Transfus 2019 Oct 5;35(4):707-710. Epub 2019 Mar 5.

1Department of Pathology and Lab Services, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India.

The presence of minimal residual disease (MRD) is one of the strong predictors of disease outcome in various hematological malignancies including B-ALL and T-ALL, independent of pre-therapeutic risk factors. There is scant Indian data on MRD by flowcytometry in T-ALL including gating strategies, clinical correlation etc. The primary aim of this retrospective observational study was to define the clinico-hematologic characteristics and prognostic significance of patients with ETP/near-ETP versus non-ETP immunophenotype, especially in terms of minimal residual disease at different time points as well as event-free survival (1 year). Baseline hematologic characteristics along with post-induction (Day-35) and post-consolidation (Day-78) MRD in bone marrow samples from newly diagnosed T-ALL patients were studied. 14.3% patients had ETP-ALL immunophenotype, 11.4% were near-ETP ALL patients and the remaining 74.5% were of non-ETP subtype. The ETP/near ETP patients was significantly associated with higher risk of MRD positivity ( > 0.01%) at the end of induction in comparison to the non-ETP patients ( = 0.033). Also, these patients showed a trend towards proclivity to anemia ( = 0.06) and higher rates of induction failure ( = 0.07) However, no difference was observed between the two subgroups in terms of age, high TLC, thrombocytopenia, adverse cytogenetics, steroid responsiveness on Day + 8 of induction, MRD-positivity > 0.01% at the end of consolidation and EFS-1 year. Through this preliminary study, it can be stated clearly that ETP status is associated with MRD > 0.01% post-induction but has no significant impact on long-term survival of these patients.
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http://dx.doi.org/10.1007/s12288-019-01106-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6825102PMC
October 2019

Diagnostic ability of real-time quantitative polymerase chain reaction versus immunohistochemistry for Ki-67 assessment in breast cancer: An Indian perspective.

Indian J Med Res 2019 09;150(3):254-260

Department of Laboratory & Transfusion Services, Rajiv Gandhi Cancer Institute & Research Centre, Delhi, India.

Background & Objectives: Breast cancer is the most common cancer of women. Inferior prognosis in some patients has been attributed to the higher proliferative capability of the tumour. Immunohistochemistry (IHC) for Ki-67, despite being a simple and cost-effective method, has not become a valid tool to evaluate this biomarker. This is ascribed to variation in pre-analytical and analytical techniques, variable expression, hotspot distribution and inter-and intra-observer inconsistency. This study was aimed at defining the analytical and clinical validity of real-time quantitative polymerase chain reaction (RT-qPCR) as an alternative to IHC evaluation.

Methods: This study included a total of 109 patients with invasive breast cancers. Ki-67 IHC visual assessment was compared with the mRNA value determined by RT-qPCR. Concordance between both the methods was assessed. Receiver operating characteristic (ROC) curve analysis and Cohen's kappa value with intraclass correlation were performed.

Results: The threshold value for Ki-67 by RT-qPCR obtained by ROC curve was 22.23 per cent, which was used to divide breast cancer cases into high proliferative and low proliferative groups. A significant correlation was observed between both the breast cancer groups formed using RT-qPCR threshold as well as median laboratory value of Ki-67 labelling index by IHC.

Interpretation & Conclusions: The study results showed a significant correlation between the two methods. While IHC is subject to technical and interpretative variability, RT-qPCR may offer a more objective alternative.
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http://dx.doi.org/10.4103/ijmr.IJMR_644_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6886141PMC
September 2019

Quantitation of in vivo brain glutathione conformers in cingulate cortex among age-matched control, MCI, and AD patients using MEGA-PRESS.

Hum Brain Mapp 2020 01 4;41(1):194-217. Epub 2019 Oct 4.

Neuroimaging and Neurospectroscopy (NINS) Laboratory, National Brain Research Centre, Gurgaon, India.

Oxidative stress (OS) plays an important role in Alzheimer's disease (AD) and glutathione (GSH) mitigates this effect by maintaining redox-imbalance and free-radical neutralization. Quantified brain GSH concentration provides distinct information about OS among age-matched normal control (NC), mild cognitive impairment (MCI) and AD patients. We report alterations of in vivo GSH conformers, along with the choline, creatine, and N-acetylaspartate levels in the cingulate cortex (CC) containing anterior (ACC) and posterior (PCC) regions of 64 (27 NC, 19 MCI, and 18 AD) participants using MEscher-GArwood-Point-RESolved spectroscopy sequence. Result indicated, tissue corrected GSH depletion in PCC among MCI (p = .001) and AD (p = .028) and in ACC among MCI (p = .194) and AD (p = .025) as compared to NC. Effects of the group, region, and group × region on GSH with age and gender as covariates were analyzed using a generalized linear model with Bonferroni correction for multiple comparisons. A significant effect of group with GSH depletion in AD and MCI was observed as compared to NC. Receiver operator characteristic (ROC) analysis of GSH level in CC differentiated between MCI and NC groups with an accuracy of 82.8% and 73.5% between AD and NC groups. Multivariate ROC analysis for the combined effect of the GSH alteration in both ACC and PCC regions provided improved diagnostic accuracy of 86.6% for NC to MCI conversion and 76.4% for NC to AD conversion. We conclude that only closed GSH conformer depletion in the ACC and PCC regions is critical and constitute a potential biomarker for AD.
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http://dx.doi.org/10.1002/hbm.24799DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7268069PMC
January 2020

Goat lung surfactant for treatment of respiratory distress syndrome among preterm neonates: a multi-site randomized non-inferiority trial.

J Perinatol 2019 09;39(Suppl 1):3-12

St. John's Medical College, Bangalore, India.

Objective: To investigate the safety and efficacy of goat lung surfactant extract (GLSE) compared with bovine surfactant extract (beractant; Survanta®, AbbVie, USA) for the treatment of neonatal respiratory distress syndrome (RDS).

Study Design: We conducted a double-blind, non-inferiority, randomized trial in seven Indian centers between June 22, 2016 and January 11, 2018. Preterm neonates of 26 to 32 weeks gestation with clinical diagnosis of RDS were randomized to receive either GLSE or beractant. Repeat dose, if required, was open-label beractant in both the groups. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age (PMA). Interim analyses were done by an independent data and safety monitoring board (DSMB).

Result: After the first interim analyses on 5% enrolment, the "need for repeat dose(s) of surfactant" was added as an additional primary outcome and enrolment restricted to intramural births at five of the seven participating centers. Following second interim analysis after 98 (10% of 900 planned) neonates were enroled, DSMB recommended closure of study in view of inferior efficacy of GLSE in comparison to beractant. There was no significant difference in the primary outcome of death or BPD between GLSE group (n = 52) and beractant group (n = 46) (50.0 vs. 39.1%; OR 1.5; 95% CI 0.7-3.5; p = 0.28). The need for repeat dose of surfactant was significantly higher in GLSE group (65.4 vs. 17.4%; OR 9.0; 95% CI 3.5-23.3; p < 0.001).

Conclusions: Goat lung surfactant was less efficacious than beractant (Survanta®) for treatment of RDS in preterm infants. Reasons to ascertain inferior efficacy of goat lung surfactant requires investigation and possible mitigating strategies in order to develop a low-cost and effective surfactant.
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http://dx.doi.org/10.1038/s41372-019-0472-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8075884PMC
September 2019

Management and prognosis of acute traumatic cervical central cord syndrome: systematic review and Spinal Cord Society-Spine Trauma Study Group position statement.

Eur Spine J 2019 Oct 31;28(10):2390-2407. Epub 2019 Jul 31.

Department of Orthopedics, University of Pretoria, Pretoria, South Africa.

Purpose: Spinal Cord Society (SCS) and Spine Trauma Study Group (STSG) established a panel tasked with reviewing management and prognosis of acute traumatic cervical central cord syndrome (ATCCS) and recommend a consensus statement for its management.

Methods: A systematic review was performed according to the PRISMA 2009 guidelines. Delphi method was used to identify key research questions and achieve consensus. PubMed, Scopus and Google Scholar were searched for corresponding keywords. The initial search retrieved 770 articles of which 37 articles dealing with management, timing of surgery, complications or prognosis of ATCCS were identified. The literature review and draft position statements were compiled and circulated to panel members. The draft was modified incorporating relevant suggestions to reach consensus.

Results: Out of 37 studies, 15 were regarding management strategy, ten regarding timing of surgery and 12 regarding prognosis of ATCCS.

Conclusion: There is reasonable evidence that patients with ATCCS secondary to vertebral fracture, dislocation, traumatic disc herniation or instability have better outcomes with early surgery (< 24 h). In patients of ATCCS secondary to extension injury in stenotic cervical canal without fracture/fracture dislocation/traumatic disc herniation/instability, there is requirement of high-quality prospective randomized controlled trials to resolve controversy regarding early surgery versus conservative management and delayed surgery if recovery plateaus or if there is a neurological deterioration. Until such time decision on surgery and its timing should be left to the judgment of physician, deliberating on pros and cons relevant to the particular patient and involving the well-informed patient and relatives in decision making. These slides can be retrieved under Electronic Supplementary Material.
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http://dx.doi.org/10.1007/s00586-019-06085-zDOI Listing
October 2019

Light chain myeloma: A brief report from India.

Indian J Pathol Microbiol 2019 Jul-Sep;62(3):441-444

Department of Hemato-Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India.

Light chain myeloma (LCM) has a reported worldwide incidence of approximately 15%-20% among all multiple myeloma (MM) patients. Few western studies have shown strong correlation of LCM with anemia, higher International Staging System scores, proclivity to renal failure, elevated lactate dehydrogenase levels, raised serum-free light chain ratio, higher frequency of extramedullary plasmacytomas, and poorer overall survival, attributable probably to lack of differentiation and skeletal destruction. The primary aim of this retrospective observational study was to define the clinical and hematological characteristics as well as prognostic outcome of Indian LCM patients in comparison with the IgG and IgA subtypes. Patients were defined according to the International Myeloma Working Group diagnostic criteria 2016 and staged as per the International Staging System. Out of 104 patients of newly diagnosed MM in which results of serum immunofixation (IFE) were available, 65 were of IgG isotype (62.5%), 15 had IgA (14.4%), and 24 had light chain myelomas (LCMs) (23.1%). It was observed that LCM patients significantly correlated with hypercalcemia and higher serum-free light chain ratios, whereas IgA patients were strongly associated with anemia and lower serum albumin levels. However, no difference was found among the three subgroups in terms of serum lactate dehydrogenase levels, proclivity to renal failure, presence of lytic bone lesions, prognostic scoring, pretransplant chemosensitivity, and progession-free survival (1 year). Thus, it may be concluded that Indian LCM patients have significantly different clinico-hematological profile in comparison with other published studies worldwide. Also, their prognostic outcomes are not worse when compared with patients of other protein isotypes, probably due to standardized treatment regimens applied.
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http://dx.doi.org/10.4103/IJPM.IJPM_385_18DOI Listing
December 2019

Reproductive factors and breast cancer risk: A meta-analysis of case-control studies in Indian women.

South Asian J Cancer 2019 Apr-Jun;8(2):80-84

The University of Texas Health Science Center at Tyler, Texas, USA.

Background/objective: India is the world's most biodiverse region and is undergoing a period of dramatic social and economic change. Due to population's explosion, climate change and lax implementation of environmental policies, the incidence of breast cancer is increasing. From population-based cancer registry data, breast cancer is the most common cancer in women in urban registries where it constitutes more than 30% of all cancers in females. We conducted a meta-analysis of all breast cancer case-control studies conducted in India during 1991-2018 to find pooled estimates of odds ratio (OR).

Materials And Methods: Eligible studies were identified through a comprehensive literature search of PubMed, EMBASE, and HINARI databases from 1991 to January 2018. This analysis included 24 observational studies out of 34 that reported the case-control distribution of reproductive factors, body mass index (BMI) and type of residence. The analysis was performed using RevMan 5.3 (Review Manager, 2017) applying the random-effects model.

Results: A total of 21,511 patients (9889 cases and 11,622 controls) were analyzed, resulting in statistically significant association between breast cancer and the following reproductive factors: never breastfeed (OR: 3.69; 95% confidence interval [CI]: 1.70, 8.01), menopausal age >50 years (OR: 2.88; 95% CI: 1.85, 3.85), menarche age <13 years (OR: 1.83; 95% CI: 1.34, 2.51), null parity (OR: 1.58; 95% CI: 1.21, 2.06), postmenopause (OR: 1.35; 95% CI: 1.13, 1.62), and age at the 1 pregnancy >25 years (OR: 1.57; 95% CI: 1.37, 1.80). Family history (FH) of breast cancer (OR: 5.33; 95% CI: 2.89, 9.82), obesity (OR: 1.19; 95% CI: 1.00, 1.42), and urban residence (OR: 1.22; 95% CI: 1.03, 1.44) were also found to be significant risk factors.

Conclusion: The results of this meta-analysis are indicative of significant associations between reproductive factors and breast cancer risk, profoundly so among women experiencing menopause after the age of 50, women who never breastfeed and FH of breast cancer.
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http://dx.doi.org/10.4103/sajc.sajc_317_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6498720PMC
May 2019

A randomized, open-label non-inferiority study to compare palonosetron and ondansetron for prevention of acute chemotherapy-induced vomiting in children with cancer receiving moderate or high emetogenic chemotherapy.

Support Care Cancer 2018 Sep 22;26(9):3091-3097. Epub 2018 Mar 22.

Research Department, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.

Background: Chemotherapy-induced vomiting is a common adverse effect of cancer treatment. We assessed the non-inferiority of palonosetron versus ondansetron in prevention of acute chemotherapy-induced vomiting in children with cancer in 2-18 years of age.

Methods: In this single-center, open-label, randomized study, children receiving moderate and high emetogenic chemotherapy were assigned to get either ondansetron or palonosetron in addition to other antiemetic prophylaxis. The primary efficacy endpoint was the proportion of children with complete response during the acute phase of the first on-study chemotherapy cycle. Non-inferiority was assessed by demonstration of lower limit of the 97.5% confidence interval for differences in complete response rates in palonosetron arm to be superior by - 15%. Risk factors for suboptimal response and the cost of administration of two drugs were also analyzed.

Results: A total of 108 children were analyzed and various factors likely to influence response were equally distributed in two arms. These 108 patients received 412 blocks of chemotherapy. During the acute phase, complete responses were recorded in 72.2% (39/54) and 83.3% (45/54) receiving ondansetron and palonosetron, respectively (ΔCR + 11.1%). The lower limit of 97.5% confidence interval (- 6.95-28.39) for this difference was greater than - 15% in palonosetron arm. Only statistically significant risk factor that predisposed response was use of dexamethasone (p value < 0.01). The cost associated with ondansetron administration was significantly higher compared to palonosetron.

Conclusion: Palonosetron is non-inferior and cost-effective compared to ondansetron for prevention of acute chemotherapy-induced vomiting (CIV) in children receiving moderate and high emetogenic chemotherapy.
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http://dx.doi.org/10.1007/s00520-018-4158-5DOI Listing
September 2018

Clinical utility of RT-PCR in assessing HER 2 gene expression versus traditional IHC and FISH in breast cancer patients.

Breast Cancer 2018 Jul 9;25(4):416-430. Epub 2018 Feb 9.

Amity Institute of Molecular Medicine and Stem Cell Research (AIMMSCR) Amity University, Uttar Pradesh Campus, Sector-125, Noida, 201313, India.

Background: IHC and FISH are used for categorizing HER 2 status in breast cancer at the protein and DNA level, respectively. HER 2 expression at the RNA level is quantitative, cheaper, easier to standardize and free from interobserver variation.

Methods: 115 consecutive patients were tested by IHC, FISH and RT-PCR (test cohort). Assuming FISH result to be the response variable, ROC curves for RT-PCR ratio were analyzed to label HER 2 negative, equivocal and positive cases as RT-PCR score 1, 2 and 3, respectively. Inter-relationships between RT-PCR, IHC and FISH were defined. 'Clinical benefit' of a test was defined as proportion of patients labeled unequivocally as HER 2 positive or negative. Population for 1 year was simulated constraint to previous reports of HER 2 positivity and IHC category distribution by a meta-analysis of previous studies that evaluated concordance between IHC and FISH to determine HER 2 status (simulation cohort). Four diagnostic pathways in the simulation cohort were defined-(1) initial IHC, followed by FISH (conventional pathway); (2) initial RT-PCR, followed by FISH; (3) initial IHC, followed by RT-PCR and then by FISH; (4) initial RT-PCR, followed by IHC and then by FISH. The clinical benefit of IHC and RT-PCR in the four pathways was analyzed and sensitivity analysis for incremental cost-effectiveness ratio and cost-benefit comapring RT-PCR against IHC, both as first-line tests and among those with IHC score 2 as a reflex second-line test was performed by the Monte Carlo technique.

Findings: 115 patients comprised the study population. While none with IHC score of 0 or 1 was FISH positive for HER 2, all cases with IHC score of 3 were FISH positive. 43 cases were assigned IHC score of 2. Thus, 72 patients benefited from the initial IHC testing [clinical benefit 62.6%], with the overall concordance between IHC and FISH being 100% for those with IHC score of 0, 1 and 3 (conclusive IHC categories). For RT-PCR with 100% concordance, 15.7% (115-97 = 18) patients would have benefited from RT-PCR testing if it was used as a first-line test. If RT-PCR would have been used as a second-line test among those with IHC score 2 (n = 43), then only 6 patients would have been assigned a conclusive RT-PCR category (category 1 or 3) translating to a clinical benefit of 14% (6/43) as a second-line test. As a second-line test it had 51% probability to prove more cost-effective than the conventional pathway, provided the cost of RT-PCR was 0.4 times the cost of IHC. Also in a three-step pathway, RT-PCR upfront would have 56% probability of higher cost-benefit provided the cost of RT-PCR was 0.1 times the cost of IHC.

Conclusion: RT-PCR results were found to be suboptimal to IHC in terms of discriminative ability and clinical benefit; thus, it is unlikely to replace IHC as a first-line test in the near future.
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http://dx.doi.org/10.1007/s12282-018-0840-1DOI Listing
July 2018

Lower Serum Vitamin D Metabolite Levels in Relation to Circulating Cytokines/Chemokines and Metabolic Hormones in Pregnant Women with Hypertensive Disorders.

Front Immunol 2017 13;8:273. Epub 2017 Mar 13.

Drug Discovery Research Center, Translational Health Science and Technology Institute (THSTI) , Faridabad, Haryana , India.

The aim of this study was to investigate whether lower serum vitamin D metabolite levels were associated with altered cytokine/chemokine and metabolic hormone levels in three different hypertensive disorders in pregnancy (HDP). Healthy pregnancy ( = 30) and hypertensive disorders in pregnancy (HDP) ( = 30), i.e., gestational hypertension (GH), preeclampsia (PE), and eclampsia (EC) subjects were enrolled. Vitamin D metabolites were measured by UPLC/APCI/HRMS method. Circulatory 27 cytokines/chemokines and 10 metabolic hormones were measured. Significantly decreased 25(OH)D and 1,25(OH)D levels were observed in HDP. The levels of 25(OH)D were significantly lower in PE and EC, whereas the serum levels of 1,25(OH)D significantly decreased only in EC subjects. Serum 25(OH)D and 1,25(OH)D levels were negatively correlated with systolic- and diastolic blood pressure, creatinine, and uric acid levels. Serum interleukin (IL)-6 and IL-13 decreased, and GIP levels were increased in gestational hypertensive subjects. Platelet-derived growth factor-BB and IL-8 levels were increased and macrophage inflammatory protein-1beta levels were decreased in EC subjects. IL-8 and IL-10 increased, and rantes and GIP levels decreased in the EC group as compared with the GH group. Multivariate logistic regression analysis showed that eotaxin, monocyte chemotactic protein-1, 25(OH)D, and 1,25(OH)D were predictors of HDP. Our analyses suggest that lower vitamin D metabolites are associated with altered cytokines/chemokines and metabolic hormones in HDP.
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http://dx.doi.org/10.3389/fimmu.2017.00273DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5346572PMC
March 2017

Lower Vitamin D Metabolites Levels Were Associated With Increased Coronary Artery Diseases in Type 2 Diabetes Patients in India.

Sci Rep 2016 11 24;6:37593. Epub 2016 Nov 24.

Drug Discovery Research Center, Translational Health Science and Technology Institute (THSTI), Faridabad, HR-121001 (RA, SKB), India.

The purpose of the present study was to measure six vitamin D metabolites and to find the association between vitamin D deficiency and coronary artery diseases in diabetes (T2DM_CAD). Four groups [control (n = 50), type 2 diabetes (T2DM, n = 71), coronary artery diseases (CAD, n = 28), T2DM_CAD (n = 38)] of total 187 subjects were included in the study. Six vitamin D metabolites (D, D, 25(OH)D, 25(OH)D, 1,25(OH)D, 1,25(OH)D), total 25(OH)D and total 1,25(OH)D were measured by UPLC/APCI/HRMS method in these subjects. Although all the vitamin D metabolites were significantly decreased in T2DM_CAD as compared to both control and T2DM subjects (p < 0.05), only two metabolites i.e., 25(OH)D and total 25(OH)D were significantly (p < 0.05) decreased in the T2DM subjects as compared with the control subjects (p < 0.05). Vitamin D, 1,25(OH)D, 25(OH)D, and 1,25(OH)D levels were significantly decreased in T2DM_CAD subjects as compared with CAD subjects (p < 0.05). Further, multiple logistic regression analysis revealed that total 25(OH)D and total 1,25(OH)D can be used to predict T2DM (OR 0.82.95% CI 0.68-0.99; p = 0.0208) and T2DM with CAD (OR 0.460, 95% CI 0.242-0.874; p = 0.0177), respectively. Our data concludes that lower concentration of 1,25(OH)D is associated with type 2 diabetes coexisting with coronary artery diseases in South Indian subjects.
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http://dx.doi.org/10.1038/srep37593DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5121614PMC
November 2016

Elevated levels of GDF-15 is associated with increased angiotensin II in hypertensive patients with Type 2 diabetes.

Per Med 2016 Jul 28;13(4):325-336. Epub 2016 Jun 28.

Drug Discovery Research Center, Translational Health Science & Technology Institute (THSTI), Faridabad, HR-122016, India.

Aim: Circulatory GDF-15, angiotensin II (Ang-II) and GDF-15 mRNA expression levels were examined in three groups, in other words, control (n = 25), Type 2 diabetes (T2DM; n = 25) and Type 2 diabetes with hypertension (T2DM_HTN; n = 36).

Results: T2DM and T2DM_HTN subjects had significantly (p < 0.05) higher GDF-15 and Ang-II levels compared with control subjects. Significant positive correlation was found between Ang-II and GDF-15 levels. GDF-15 mRNA expression from blood cells was significantly elevated in T2DM_HTN (p < 0.05) but not in T2DM subjects. GDF-15 mRNA expression was significantly elevated in Ang-II-treated (50 nM) THP-1 (p < 0.001) and H9C2 (p < 0.05) cells but not altered after high glucose treatment.

Conclusion: Collectively, our data suggest that higher levels of GDF-15 is associated with increased Ang-II levels in diabetic patients with concurrent hypertension.
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http://dx.doi.org/10.2217/pme-2016-0030DOI Listing
July 2016