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   2013| April-June  | Volume 4 | Issue 2  
    Online since May 14, 2013

 
 
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QUALITY
Fraud and misconduct in clinical research: A concern
Ashwaria Gupta
April-June 2013, 4(2):144-147
DOI:10.4103/2229-3485.111800  PMID:23833741
Fraud and misconduct in clinical research is widespread. Good clinical practice is a guideline adopted internationally as standard operating procedure for conduct of clinical research. Despite these guidelines being available, unavailability of internationally harmonized framework for managing research fraud and misconduct makes clinical research a highly vulnerable area to commit fraud. Fraud could be of various types and due to various reasons. Whatever the circumstances be, any fraud should be dealt with strictly and regulations should be in place to prevent its occurrence.
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ORIGINAL ARTICLES
An evaluation of knowledge, attitude and practices about prescribing fixed dose combinations among resident doctors
Nimit Goswami, Anuradha Gandhi, Prakruti Patel, Ramkumar Dikshit
April-June 2013, 4(2):130-135
DOI:10.4103/2229-3485.111797  PMID:23833738
Background: Fixed Dose Combinations (FDCs) improve patient compliance and decrease pill burden. However, irrational prescribing of FDCs is a major health concern. As resident doctors are primarily involved in patient management at tertiary care hospitals, knowledge about prescribing FDCs is of paramount importance. Objective: To evaluate knowledge, attitude and practice, regarding use of FDCs by resident doctors at a tertiary care teaching hospital. Materials and Methods: The study was carried out among resident doctors working at Civil Hospital, Ahmedabad, a tertiary care teaching hospital. One hundred resident doctors from the departments of medicine, obstetrics and gynaecology, surgery, paediatrics, skin and psychiatry, who gave their informed consent, were enrolled. A prevalidated questionnaire regarding knowledge, attitude and prescribing practice of fixed dose combinations was filled up. Data was analyzed with suitable statistical tests. Results: Out of the 100 residents recruited for the study, 34, 33 and 33 residents were selected from the 1 st , 2 nd and 3 rd year respectively. The resident doctors were not aware about all of the advantages and disadvantages of FDCs. On an average, only 31% of the residents (lowest 16% among 1 st year residents) had knowledge about the Essential Medicine List (EML). Knowledge about rationality of given FDCs was lacking in 81% of the residents. Only 47% could name a single banned FDC in India. Common sources of information about FDCs were medical representatives, colleagues/peers, the Monthly Index of Medical Specialities (MIMS) and Continuous Medical Education (CMEs). A majority of residents (96%) agreed that FDCs should be allowed to be marketed. The residents opined that most commonly prescribed FDCs were of antimicrobial drugs, amongst which amoxicillin + clavulanic acid was the most frequent. Conclusion: There is need to improve knowledge about rationality, EML, usage and banned FDCs in post graduate medical students to promote the rational use of drugs.
  3,939 535 5
Adverse drug reactions to antiretroviral therapy: Results from spontaneous reporting system in Nigeria
Kenneth A Agu, Azuka C Oparah
April-June 2013, 4(2):117-124
DOI:10.4103/2229-3485.111784  PMID:23833736
Aim: This study evaluated the suspected adverse drug reactions (ADR) reported from a spontaneous reporting program in Human Immunodeficiency Virus (HIV) positive patients receiving antiretroviral therapy (ART) in Nigeria Materials and Methods: This descriptive study analyzed individual case safety reports (ICSRs) in HIV-positive patients receiving ART between January 2011 and December 2011 in 38 secondary hospitals. All ICSRs during this period were included. Chi-square was used to test the association between variables at 95% confidence interval. Results: From 1237 ICSRs collated, only 1119 (90.5%) were valid for analysis. Mean age of patients was 35.3 (95%CI, 35.1-35.5) years; and 67.1% were females. A total of 1679 ADR cases were reported, a mean (± Standard Deviation, SD) of 1.5 (± 0.8) ADR cases per patient. Of reported ADRs, 63.2%, 8.2% and 19.3% occurred in patients on Zidovudine-based, Stavudine-based and Tenofovir-based regimens, respectively. The commonest ADRs included (12.0%) peripheral neuropathy, (11.4%) skin rash, (10.1%) pruritus and (6.5%) dizziness. ADR occurrence was associated with ART regimens, concomitant medicines and age (P < 0.05) unlike gender. Anaemia was associated with Zidovudine (AZT)/ Lamivudine (3TC) /Nevirapine (NEV) regimen [Odds ratio, OR = 6.4 (3.0-13.8); P < 0.0001], and peripheral neuropathy with Stavudine (d4T)/3TC/NEV regimen [OR = 8.7 (5.8-30.0), P < 0.0001] and Tenofovir (TDF)/Emtricitabine (FTC)/Efavirenz (EFV) regimen [OR = 2.1 (1.0-4.1), P = 0.0446]. Skin rash and peripheral neuropathy were associated with patients aged < 15years [OR = 3.0 (1.3-6.6), P = 0.0056] and 45-59years [OR = 1.9 (1.3-2.7), P = 0.0006] respectively. Palpitation and polyuria were associated with Salbutamol [OR = 55.7 (4.9-349.6), P = 0.0000] and Nonsteroidal anti-inflammatory drugs (NSAIDS) [OR = 50.2 (0.9-562.1), P = 0.0040] respectively. Conclusion: ADRs were less likely to occur in patients on stavudine-based and tenofovir-based regimens compared to zidovudine-based regimens. Peripheral neuropathy was also found to be associated with tenofovir-based regimen. This may require further studies and evaluation.
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The effects of indomethacin, diclofenac, and acetaminophen suppository on pain and opioids consumption after cesarean section
Godrat Akhavanakbari, Masood Entezariasl, Khatereh Isazadehfar, Fariba Kahnamoyiagdam
April-June 2013, 4(2):136-141
DOI:10.4103/2229-3485.111798  PMID:23833739
Background: Cesarean section is one of the common surgeries of women. Acute post-operative pain is one of the recognized post-operative complications. Aims: This study was planned to compare the effects of suppositories, indomethacin, diclofenac and acetaminophen, on post-operative pain and opioid usage after cesarean section. Materials and Methods: In this double-blind clinical trial study, 120 candidates of cesarean with spinal anesthesia and American Society of Anesthesiologists (ASA) I-II were randomly divided into four groups. Acetaminophen, indomethacin, diclofenac, and placebo suppositories were used in groups, respectively, after operation and the dosage was repeated every 6 h and pain score and opioid usage were compared 24 h after the surgery. The severity of pain was recorded on the basis of Visual Analog Scale (VAS) and if severe pain (VAS > 5) was observed, 0.5 mg/kg intramuscular pethidine had been used. Statistical Analysis Used: The data were analyzed in SPSS software version 15 and analytical statistics such as ANOVA, Chi-square, and Tukey's honestly significant difference (HSD) post-hoc. Results : Pain score was significantly higher in control group than other groups, and also pain score in acetaminophen group was higher than indomethacin and diclofenac. The three intervention groups received the first dose of pethidine far more than control group and the distance for diclofenac and indomethacin were significantly longer (P < 0.001). The use of indomethacin, diclofenac, and acetaminophen significantly reduces the amount of pethidine usage in 24 h after the surgery relation to control group. Conclusions : Considering the significant decreasing pain score and opioid usage especially in indomethacin and diclofenac groups rather than control group, it is suggested using of indomethacin and diclofenac suppositories for post-cesarean section analgesia.
  3,613 450 2
Relationship of admission mean platelet volume, platelet distribution width and white blood cells with ST resolution in patients with acute ST segment elevation myocardial infarction treated with streptokinase without history of previous cardiovascular surgery
HR Varasteh-ravan, S Ali-Hassan-Sayegh, Shohre Shokraneh, Mohammad R Mozayan, Ali Akbar Karimi-bondarabadi
April-June 2013, 4(2):125-129
DOI:10.4103/2229-3485.111792  PMID:23833737
Background: Mean platelet volume (MPV) and platelet distribution width (PDW), markers of platelet reactivity, and white blood cell count (WBC-C), a marker of inflammation, have been shown to be predictive of unfavorable outcomes among survivors of ST elevation myocardial infarction (STEMI).we aimed to evaluate the value of admission of MPV, PDW and WBC-C for the prediction of ST segment resolution, in patient with acute STEMI treated with Streptokinase. Materials and Methods: This cross sectional study conducted on 280 patients with STEMI treated with streptokinase, from August 2009 until August 2011, in Afshar cardiovascular center, Yazd, Iran. Blood samples were obtained on admission in 280 patients with STEMI. According to sum of ST segment resolution and Schroder's method, patients divided two groups ((patients with ST resolution≥ 70% versus group with ST resolution < 70%)).The best cut off value of MPV, PDW and WBC-C for prediction of ST resolution (STR) were identified by using the receiver operating characteristic curve. The optimum cut off level was determined by selecting points of test value that provided the greatest sum of sensitivity and specificity. Results: Of 280 patients enrolled this study, 39.3% of the patients with STR≥70% and in 60.7% with STR<70% were found. Patients in the STR < 70% group had higher admission MPV (10.6 ± 0.8 vs. .9.5 ± 0.8, P = 0.00) and higher PDW (13.8 ± 1.8 vs. 11.8 ± 1.7, P = 0.00)and higher WBC-C (12.1 ± 3.1 vs. 10.5 ± 2.5, P = 0.00) compare with patients with ST resolution ≥ 70%.The best cut off value of MPV for predicting STR < 70%was 10/05 fl (sensitivity 71/8 and specificity 80.9%) and for PDW was 12.85 fl (sensitivity 71.2% and specificity 83.6%) and for WBC-C was 12.65 × 1000 (sensitivity 42.9% and specificity 82.7%). The greatest area under the receiver operating characteristic (ROC) curve and greatest predicting value for ST resolution lower 70% was due to PDW (area = o.812, P = 0/00). Conclusion: MPV, PDW and WBC-C at admission might be valuable in the prediction of impaired STR and in planning the need for adjunctive therapy to improve outcomes with STEMI treated with Streptokinase .We can speculate that acute STEMI patients having MPV-PDW and WBC-C values above their's cut off patients should be considered for stronger antiplatelet and helps anti inflammation treatment to be able to attain a favorable ST resolution and better clinical outcome.
  2,879 588 8
CONFERENCE SYMPOSIUM
Pharmacovigilance Symposium ISCR Annual Conference Jan 5, 2013: Safety aspects of hard endpoint or outcome trials
Viraj Suvarna, Indu Nambiar, Shoibal Mukherjee, Mohandas K Mallath
April-June 2013, 4(2):148-152
DOI:10.4103/2229-3485.111801  PMID:23833742
The articles describes some highlights of the Pharmacovigilance Symposium held during Annual conference.
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EDITORIAL
Clinical data interchange standards consortium: A bridge to overcome data standardisation
Deven Kishor Babre
April-June 2013, 4(2):115-116
DOI:10.4103/2229-3485.111779  PMID:23833735
  1,593 333 1
SITE
Journey from clinical practice to clinical research
Mahesh Fulwani, Raviraj Pardeshi
April-June 2013, 4(2):142-143
DOI:10.4103/2229-3485.111799  PMID:23833740
  1,259 256 -
LETTERS TO EDITOR
Role of pharmacologists in clinical research: The onus is on us
Jagjit Singh
April-June 2013, 4(2):154-154
DOI:10.4103/2229-3485.111804  PMID:23833744
  1,066 220 -
Discouraging adverse drug reactions reporting culture: Just a tip of the 'Gullible Prescribing'
Imran Mohammed
April-June 2013, 4(2):153-154
DOI:10.4103/2229-3485.111803  PMID:23833743
  1,006 196 -
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