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:: Table of Contents
July-September 2022
Volume 68 | Issue 3
Page Nos. 125-185
Online since Thursday, August 25, 2022
Accessed 37,971 times.
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EDITORIAL
National Ethical Guidelines for biomedical and health research: Issues to ponder over
p. 125
SB Bavdekar, S Karande
DOI
:10.4103/jpgm.jpgm_474_22
PMID
:35975346
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EDITORIAL COMMENTARIES
Under-reporting of safety data – cause for concern
p. 129
S Gajbhiye
DOI
:10.4103/jpgm.jpgm_326_22
PMID
:35975345
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Pulmonary complications of supracostal percutaneous nephrolithotomy – Must know facts for surgeons
p. 131
MV Sharma
DOI
:10.4103/jpgm.JPGM_341_21
PMID
:35259788
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ORIGINAL ARTICLES
An audit of safety reporting in randomized controlled trials over a five-year period in a high impact factor journal
p. 133
M Konwar, A Mamde, P Patankar, UM Thatte, NJ Gogtay
DOI
:10.4103/jpgm.JPGM_78_21
PMID
:34528514
Background:
Randomized controlled trials [RCTs] form the corner-stone of evidence-based medicine. RCTs published in high impact factor journals such as the New England Journal of Medicine [NEJM] are a key driver of clinical practice and policy decisions. RCTs are expected to report both efficacy and safety, however, safety reporting in many studies tends to be poor. The present audit was undertaken with the primary objective of evaluating safety reporting during a five-year period in all RCTs published in the NEJM.
Methods:
PubMed alone was searched for RCTs published in NEJM from 2013-17. Each RCT was searched for the following outcome measures –whether the trial was sponsored by pharmaceutical industry or investigator initiated, phase of trial, nature of intervention and therapeutic area in terms of reporting of safety outcomes [with '
P
values' or '95% confidence interval'].
Results:
A total of
n
=623 articles reported safety outcomes of which 275/623 (44.1%) articles reported statistics for safety outcome. There was significant difference in reporting of safety statistics between investigator initiated studies and pharmaceutical industry sponsored studies, [cOR=4.0, 95% CI 2.8- 5.5
P
< 0.001]; phase 3 and phase 4 trials, [cOR 0.67, 95% CI 0.5 - 0.9,
P
= 0.02]; trials involving drugs and surgery, [ cOR 2.07, 95% CI 1.2-3.5,
P
= 0.01] and in therapeutic areas, cardiovascular and oncology [cOR 0.26, 95% CI 0.1-0.4,
P
< 0.0001].
Conclusions:
Safety reporting in RCTs continues to take a back seat relative to efficacy reporting and is worse for pharmaceutical industry funded studies. Safety reporting should be emphasized in the CONSORT guidelines.
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Effect of COVID-19 driven lockdown on social contact pattern in Puducherry, India: A longitudinal study
p. 138
SS Kar, Y Krishnamoorthy, P Sivanantham, J Anandraj, J Gnanadhas
DOI
:10.4103/jpgm.jpgm_1085_21
PMID
:35708395
Objective:
This study was undertaken to assess the change in social contact and transmission dynamics among adults in the Puducherry district during the different phases of country-wide lockdown.
Methods:
Adults aged 18–69 years in Puducherry were assessed for frequency and duration of contacts in the following time points: prior to lockdown (March 2020), during lockdown, immediate post-lockdown (April, June 2020), and seven months post-lockdown (February 2021). Adjusted incidence rate ratios (aIRR) were obtained using a generalized estimating equation. We also assessed the exponential trajectory of the time-varying reproduction number (R
t
) during and after lockdown.
Results:
Compared to pre-lockdown phase, frequency of social contacts during 1
st
week, 4
th
week of lockdown, and immediate post-lockdown were reduced by 89% (aIRR = 0.11; 95% CI: 0.09–0.13), 40% (aIRR = 0.60; 95% CI: 0.52–0.69) and 91% (aIRR = 0.09; 95% CI: 0.07–0.10) respectively. However, the decline was not statistically significant at seven months post-lockdown. Correspondingly, we observed an initial spike in R
t
during the lockdown phase followed by a gradual decline during the immediate post-lockdown phase. However, seven months post-lockdown, R
t
has increased again.
Conclusion:
The study showed high compliance to the lockdown measures in Puducherry during the lockdown and immediate post-lockdown periods. However, as the lockdown measures were relaxed, the contact rate returned to the pre-lockdown state.
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BRIEF REPORT
Impact of COVID-19 pandemic on eating styles: A population based-survey during the first lockdown in Italy
p. 148
A Andaloro, MG Maggio, MC Stagnitti, D Marchese, RS Calabrò
DOI
:10.4103/jpgm.jpgm_919_21
PMID
:36018073
Background:
The Coronavirus disease (COVID-19) pandemic has had a strong impact on eating behavior. To maintain health and well-being, correct nutrition is essential, especially when the immune system is under pressure.
Objective:
The aim of this study was to evaluate the correlation between emotional aspects and the eating behavior of a group of people living in Sicily during the lockdown due to COVID-19.
Methodology:
We used a cross-sectional survey design with an anonymous online questionnaire, administered through technological means.
Results:
During the COVID-19 pandemic, 91 participants experienced high stress (PSS = 18.14 ± 4.1), and eating was associated with emotional behaviors (DEBQ EM = 41.74 ± 10.9). Stress correlated positively with the emotional and external aspects of eating behaviors.
Conclusion:
The present study showed that the COVID-19 lockdown caused high stress with a worsening in eating behaviors. The study participants had difficulty in adequately coping with some emotions and feelings, developing an 'addiction' to food.
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ETHICS FORUM
The truth, the whole truth, and nothing but the truth: Therapeutic privilege
p. 152
M Shalak, MA Shariff, V Doddapaneni, N Suleman
DOI
:10.4103/jpgm.jpgm_1146_21
PMID
:35975340
The term therapeutic privilege is unfamiliar in the medical field and often sparks questions and discomfort about its ethical implications. Therapeutic privilege refers to the act of withholding information by a clinician, with the underlying notion that the disclosure of this information would inflict harm or suffering upon the patient. This is a case of a 56-year-old woman who presented to our facility under critical conditions. She developed sepsis with acute respiratory failure, requiring intubation and mechanical ventilation. Prior to her admission, her husband had been admitted at our facility's intensive care unit. On the same day when our patient was extubated, her husband had died. The palliative care team was consulted to assist with disclosing this information to the patient in light of her emotional fragility, her anxiety, and concerns for her ability to receive such news given her own active illnesses.
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EDUCATION FORUM
Anatomage - the virtual dissection tool and its uses: A narrative review
p. 156
BS Raja, A Chandra, MQ Azam, S Das, A Agarwal
DOI
:10.4103/jpgm.jpgm_1210_21
PMID
:36018074
Advancement in technology has given students and institutes an educational, interactive, and diagnostic aid with virtual reality functionality known as the Anatomage table. This review analyses the various spheres of the medical field where the 3D virtual tool is being used and assesses its acceptability, convenience, and practical application. A search for relevant studies in various databases namely Pubmed, Embase, Wiley Library, and Google Scholar was performed, and the data was compiled to understand the use of the Anatomage table. The search yielded a total of 24 studies that focused on the use of the Anatomage table. Eleven articles focused on using Anatomage as a learning tool and 13 described the perception of the Table. Anatomage table offers an excellent tool for learning anatomy by virtual dissection. The tool is not only used as a teaching aid, but also as a diagnostic and planning tool in residency programs. Adding the tool as an educational aid boosts the existing curriculum and helps to counter the challenges with cadaveric dissection. The equipment cost and its maintenance charges may be a deciding factor for the underutilization of the tool in developing countries.
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CLINICO-PATHOLOGICAL CASE
Lane-Hamilton syndrome – Is it really a needle in a haystack?
p. 162
SA Mondkar, MS Tullu, P Sathe, M Agrawal
DOI
:10.4103/jpgm.JPGM_1163_20
PMID
:34708697
Introduction:
The association of pulmonary hemosiderosis with celiac disease (Lane–Hamilton syndrome) is extremely rare.
Case Details:
A five-year-old female child presented with fever, cough, breathlessness, and pallor for 20 days, without any previous history of recurrent lower respiratory tract infections, tuberculosis, or cardiac disease. There was no history of pica, chronic diarrhea, bleeding, or personal or family history of repeated blood transfusions. She had tachycardia, tachypnea, severe pallor, stunting, rickets, and bilateral fine lung crepitations. Peripheral smear and blood indices revealed dimorphic anemia. Anti-tissue transglutaminase IgA antibody levels were high (>200 U/mL) and the upper gastrointestinal endoscopy with duodenal biopsy confirmed the diagnosis of celiac disease. The child was discharged on a gluten-free diet (GFD) and oral hematinic, but her dietary compliance was poor. Interestingly, the child had persistent bilateral pulmonary infiltrates, which was initially attributed to congestive cardiac failure (CCF), which persisted even despite treatment. HRCT chest revealed interstitial thickening and bilateral alveolar shadows and bronchoalveolar lavage showed a few inflammatory cells. The child was readmitted four times with similar complaints and was given packed red cell transfusions. In the fourth admission, a lung biopsy was done, which revealed extensive pulmonary hemosiderosis. The patient was given a course of oral steroids for 6 weeks, with a gluten-free diet, following which both the anemia and the pulmonary infiltrates resolved.
Conclusion:
Pulmonary hemosiderosis is an important cause of anemia in cases of celiac disease and may be misdiagnosed as CCF due to severe anemia. A strict GFD, with or without corticosteroids, can reverse the clinical and radiological picture.
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ADR REPORT
Levetiracetam-induced gingival hyperplasia
p. 168
J James, J Jose, VA Gafoor
DOI
:10.4103/jpgm.jpgm_1059_21
PMID
:35848684
Levetiracetam is a new generation antiseizure medication which binds to synaptic vesicle protein SV2A and inhibits the release of neurotransmitters. Gingival hyperplasia is a common side effect of conventional antiseizure medications like phenytoin, but very rare with the newer ones. A 14-year-old boy was started on levetiracetam 250 mg twice daily after a generalized seizure. Five days later he presented with gingival swelling and painful oral aphthae, without lymphadenopathy or systemic symptoms. Blood investigations were normal. After one-month of stopping the drug, the lesions cleared. This case highlights the importance of maintaining good oral hygiene and periodic dental review in patients on antiseizure medications.
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CASE SERIES
Hypercalcemia with methotrexate pneumonitis: A rare, important and intriguing adverse event
p. 170
R Samant, S Yadav, A Khune, R Shah
DOI
:10.4103/jpgm.jpgm_1180_21
PMID
:35975343
Methotrexate leading to hypercalcaemia is a rarely reported adverse event. We present three elderly patients with inflammatory arthritis who developed hypercalcemia probably due to methotrexate-induced granulomatous pneumonitis. All patients presented with worsening non-productive cough with dyspnea, nausea, loss of appetite, and confusion. Their clinical and radiologic features were consistent with methotrexate-induced pneumonitis. On evaluation, all patients concurrently had hypercalcemia with normal 25OH D3, and low PTH with markedly elevated levels of 1,25OH D3 seen in two patients. In all three patients, hypercalcemia and pneumonia responded to hydration, corticosteroids, and methotrexate withdrawal. There was no relapse of symptoms on long term follow-up. In these three patients with inflammatory arthritis, methotrexate-induced pneumonitis led to symptomatic hypercalcemia. Unless hypercalcemia is looked for and treated in this setting, the morbidity can be high.
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CASE REPORTS
Unilateral diaphragmatic paresis following supracostal post-percutaneous nephrolithotomy
p. 176
A Bhat, JE Katz, NA Smith, HN Shah
DOI
:10.4103/jpgm.JPGM_13_21
PMID
:34708699
Unilateral acquired diaphragmatic paresis is a known complication of thoracic surgeries. Direct mechanical injury to the phrenic nerve during surgery results in this complication. However its occurrence post-percutaneous nephrolithotomy (PCNL) has not been described. We report a 43-year-old man who underwent prone PCNL for endourological management of left complete staghorn calculus. Access via the 10
th
left intercostal space, under fluoroscopy, was carried out to remove the calculus. Post-operative, the routine chest radiograph revealed left hemidiaphragmatic blunting. Computerized tomography of the chest confirmed left hemidiaphragmatic elevation, suggesting unilateral diaphragmatic paresis. He did not have any respiratory symptoms, was managed conservatively with chest physiotherapy and incentive spirometry and responded extremely well. The absence of reported cases of diaphragmatic paresis post PCNL lends to a dearth in knowledge regarding recognition and management. This case report aims to acquaint urologists with this rare complication associated with supracostal PCNL and provide a rational management plan.
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Longitudinally extensive transverse myelitis following ChAdOx1 nCoV-19 vaccine
p. 179
AJ Shetty, A Rastogi, V Jha, A Sudhayakumar
DOI
:10.4103/jpgm.jpgm_1047_21
PMID
:35975341
Transverse myelitis (TM) has been reported in association with various vaccinations. Herein we describe a case of longitudinally extensive transverse myelitis (LETM) associated with vaccination with ChAdOx1 nCoV-19 (COVISHIELD) vaccine. A 59-year-old woman with no prior co-morbidities presented with lower extremity numbness, weakness, acute urinary retention, and constipation. Numbness gradually extended up to the lower costal margin with band like sensation. She had received the vaccine 5 days prior to the onset of the symptoms. Extensive diagnostic evaluation effectively ruled out causes other than vaccination-associated transverse myelitis. Following treatment with intravenous methylprednisolone, the patient made a significant recovery. TM may be associated with vaccination against the novel ChAdOx1 nCoV-19 vaccine and we believe this to be the first report from India of LETM associated with this vaccine.
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CASE SNIPPETS
Peripheral gangrene secondary to vasculitis: A rare extra-articular manifestation of rheumatoid arthritis
p. 182
MB Indu, DS Meena, P Jain, B Sharma
DOI
:10.4103/jpgm.jpgm_1126_21
PMID
:35975342
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Cutaneous nodular exophytic angiosarcoma with involvement of tibia
p. 184
K Manoharan, S Sivaramakrishnan, D Manoharan, DI Reddy
DOI
:10.4103/jpgm.jpgm_1092_21
PMID
:36018075
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© 2004 - Journal of Postgraduate Medicine
Official Publication of the Staff Society of the Seth GS Medical College and KEM Hospital, Mumbai, India
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