Medical case reports published in PubMed-indexed Indian journals in 2015: Adherence to 2013 CARE guidelines

In 2013, an independent group of researchers developed the CARE guidelines, a checklist to standardise reporting of case reports. This study assesses adherence to CARE guidelines among PubMed-indexed Indian medical journals in 2015 and the extent of endorsement of these guidelines by the journals. Case reports published in 2015 in journals indexed by PubMed, belonging to the medical stream, currently active, and that had an impact factor were included for analysis. Case series and journals that were published from India but for another country were excluded. Total adherence score and classification of adherence as “excellent”, “very good”, “good”, and “poor” as also adherence to individual components of the checklist were the outcome measures. A total of 162 journals were identified by the search strategy, of which 36 satisfied the selection criteria. In these 36 journals, 1178 case reports were published. We tested the association between the type of journal and impact factor with adherence by using the chi-squared test and generated crude odds ratios. All analyses were done at 5% significance. Based on the total percent score, no case report had excellent adherence, and 19% had good, 70.7% average, and 10% poor adherence, respectively. Among the sub-items, the best adherence was seen in the clinical findings [97.9%], followed by keywords [88.5%], and introduction [71.5%]. The items with extremely poor adherence were patient perspective [0%], informed consent [2.8%], and timeline [4.6%]. Journals with an impact factor of more than 1 had better adherence, relative to those with an impact factor lower than 1. Only one journal’s website mentioned the CARE guidelines. Greater awareness needs to be created among authors, peer reviewers, and editors about using these guidelines. As informed consent is a metric of autonomy, all stakeholders must ensure its reporting.

Impact of recent regulatory notifications on an institutional ethics committee.

The Government of India came out with a slew of notifications to streamline clinical research in the beginning of 2013 in response to the Supreme Court’s orders and a Parliamentary Standing Committee’s report. The notifications greatly influenced the structure, review process, outcomes and administration of ethics committees across India. In this study, we attempted to objectively evaluate the impact of these notifications on our institutional ethics committee’s (IEC) structure, review process, outcomes and administration. The results revealed that though the number of regulatory studies reviewed by our IEC remained the same, the number of studies actually approved decreased with an increase in the turnover time. The number of serious adverse events (SAEs) reported also fell, although the number of meetings held to discuss these SAEs increased significantly. The administrative workload rose with increased documentation. Though the annual income of the IEC fell marginally, the expenses shot up. We believe that the notifications definitely had an impact on the structure, review process, outcomes and administration of our IEC, although it remains to be seen whether they had a real impact on the research participants’ safety and well-being.

Use of computerized tests to evaluate psychomotor performance in children with specific learning disabilities in comparison to normal children.

Background & objectives: Children with specific learning disabilities (SpLD) have an unexplained difficulty in acquiring basic academic skills resulting in a significant discrepancy between their academic potential and achievements. This study was undertaken to compare the performance on a battery of six psychomotor tests of children with SpLD and those without any learning disabilities (controls) using computerized tests. Methods: In this study, 25 children with SpLD and 25 controls (matched for age, socio-economic status and medium of instruction) were given three training sessions over one week. Then children were asked to perform on the six computerized psychomotor tests. Results were compared between the two groups. Results: children with SpLD fared significantly worse on finger tapping test, choice reaction test, digit picture substitution test and card sorting test compared to the controls (p<0.05). Interpretation & conclusions: Children with SpLD have impairment of psychomotor skills like attention, sensory-motor coordination and executive functioning. Further research is needed to evaluate if the remedial education plan results in improvement in psychomotor performance of children with SpLD on these selected tests.

Establishing institutional ethics committees: challenges and solutions–a review of the literature.

This review of the literature was conducted to identify the challenges faced while establishing institutional ethics committees (IECs) as well as to suggest some solutions. The search of the literature was carried out with the help of the PubMed search engine, using “research ethics committees” (MeSH] and “India” (MeSH]) as the key words for articles published between 2004 and 2012. We found 31 articles related to the topic, and the most common challenge mentioned was inappropriate functioning of IECs (n=17), followed by inappropriate structure (n=14).

Survey of ethics committee protocol approval letters: compliance with Schedule Y / ICMR Guidelines 2006; Schedule Y requirements.

A study was carried out to determine the extent to which ECs comply with format requirements given in guidelines and regulations. ECs were sent a written communication requesting them to permit investigators to study their approval letter for compliance with the ICMR Guidelines and Schedule Y, using a predesigned proforma. Of the 60 ECs approached, only 20 agreed to participate. Legal experts and social scientists were not present at the approval meetings of most of the ECs. Only 7 ECs had a quorum according to Schedule Y. Several ECs did not state whether documents such as the clinical trial agreement and insurance policy were reviewed. Delays in sending approval letters could be shortened with efficacious operating of ECs. There is a need to train EC members and create a better awareness of regulatory requirements. There is also a need to evolve a mechanism to monitor EC functioning.