Assessing decisional capacity for research participation in psychiatric patients and their relatives

A cross-sectional study among adult inpatients with non-organic psychiatric disorders, and among their key relatives, assessed their comprehension and recall of key information in consent forms. It also assessed their capacity to consent to participate in two hypothetical randomised controlled trials (RCTs) with different potential risks and burdens, using structured questionnaires and recorded interviews. Of the 24 participants (12 patient–key relative dyads), seven patients (58%) and three key relatives (25%) were clinically judged to lack the capacity to consent. Of the remaining 14 participants s, less than half the patients (2/5; 40%) or relatives (3/9; 33%) accurately recalled 50% of the key information on both trials. Among the eight participants (3 patients, 5 relatives) independently assessed on the MacArthur Competence Assessment Tool for Clinical Research, the proportions judged competent for each trial varied with the criteria for defining competence. No one fulfilled the stringent competence criteria for both trials. Routine assessments of the capacity of psychiatric research participants, and of relatives providing proxy consent, appear to be warranted. However, neither suboptimal understanding of consent forms, nor incompetence determined by the use of formal assessment tools, necessarily denote an incapacity to consent to research if detailed clinical assessments indicate otherwise. Research into incorporating participants’ health literacy and clinical status in formal assessments may help determine the optimal standards for defining competence.

Participation in randomised controlled trials: perspectives of psychiatric patients and key relatives

This study assessed the perspectives of adults who had acute nonorganic psychiatric disorders and were admitted in a private, not for- profit medical college hospital, and also of their key relatives, on randomised controlled trials (RCTs). Structured questionnaires and audio-recorded interviews were used for the purpose. We explored their willingness and motivation to participate in two hypothetical RCTs with different risks and burdens. The transcripts of the interviews were analysed using the principles of grounded theory and framework analysis. Of the 24 consenting participants (12 patient and key-relative dyads), the 20 who completed the interviews had largely positive attitudes towards research and RCTs. However, 50% of those interviewed declined to participate in either of the hypothetical RCTs. The refusal to participate seemed to be influenced by a lack of education; forgetfulness, which impeded the process of making informed decisions; unfavourable benefit–risk–burden ratios; practical difficulties; dependence on treating doctors and relatives for decision-making; and the wish to exercise one’s choice regarding treatment options. The factors that motivated the patients and relatives were trust in doctors and organisations, altruism, expectation of personal benefits and favourable risk–benefit ratios. These observations indicate that while the respondents in this study valued research, they were discerning about whether or not to participate in the trials; their decision-making was influenced by individualised assessments of risks and burdens and pragmatic considerations, rather than only by the benefits they would obtain.

Building Capacity of Indian Scientists to Conduct Systematic Reviews in Child Health: An ICMR Initiative.

Knowledge and training in evidence-based medicine is essential for informed clinical decision-making and treatment choices. Systematic reviews identify, appraise and synthesize research-based evidence and present it in accessible format. The Indian Council of Medical Research has promoted evidence-based medicine in India by establishing an Advanced Center for evidence based medicine that hosted the South Asian Cochrane Network and Center at the Christian Medical College, Vellore; procuring a national subscription to The Cochrane Library making it accessible to all Indian scientists; and establishing a Center for Advanced research on evidence-based child health at Post Graduate Institute of Medical Education and Research, Chandigarh. This article informs about a national level initiative by ICMR that aims to harness the translational potential of secondary research, by funding systematic reviews aligned to national health priorities selected through a national competitive process; and to provide training, mentoring, and quality assurance. A continuing scheme of funding high-quality systematic reviews on priority areas of Child Health may follow.

Finding and using evidence that you can trust.

Much of the evidence-base from research is biased. Systematically assembled, quality-appraised, and appropriately summarised reviews of the effects of interventions from all relevant intervention studies are needed, in order to use research evidence to reliably inform health decisions. The Cochrane Library is an online collection of six searchable, up-to-date, evidence-based databases that is available free to access by anyone in India, thanks to a national subscription purchased by the Indian Council of Medical Research.

Evidence-based medicine: can the evidence be trusted?.

Empirical research indicates that much of the evidence required for the practice of evidence-based medicine cannot be trusted. The research agenda has been hijacked by those with vested interests within industry and academia, determining what research is funded and how it is done and reported. Unnecessary, inappropriate, or poorly designed and reported research results in suboptimal health outcomes. Many well-reported randomized controlled trials are designed to deceive by their choice of comparators and outcomes, and manipulation of statistics to produce desired outcomes that are selectively reported. Undisclosed conflict of interest, ghostwriting, the manufacturing of disease to increase drug marketing, and the marketing of research disguised as education are common. Understanding the many ways in which research is used to deceive, rather than reliably inform health decisions, and reclaiming the research agenda, is the collective responsibility of the scientific community and civil society.

GRADE the evidence before using the results in clinical practice.

Reports of clinical trials that do not describe the methods used to minimise the risk of bias, and reports that do not present results in a comprehensible and accurate manner, are unethical as they could lead to misleading conclusions, adverse health outcomes, and the inappropriate use of healthcare resources. The Grading of Recommendations: Assessment, Development, and Evaluation (GRADE) approach to framing healthcare recommendations provides a pragmatic approach to making summary evidence profiles of outcome-specific evaluations regarding the magnitude and precision of estimates of benefit and harms, and the overall quality of evidence from comparisons of healthcare interventions.

Editorial policy and the reporting of randomized controlled trials: a survey of instructions for authors and assessment of trial reports in Indian medical journals (2004-05).

BACKGROUND: Many international journals require authors of randomized controlled trials to adhere to standards of reporting described in the statement of the Consolidated Standards of Reporting Trials (CONSORT) and the requirements issued by the International Committee of Medical Journal Editors (ICMJE). We examined the extent to which these international standards have been adopted by Indian medical journals. METHODS: To identify Indian medical journals that publish randomized controlled trials, we did electronic searches of the websites of the National Informatics Centre (Indian Medlars Centre), Database of Open Access Journals, National Library of Medicine, WHO's Index Medicus for the South-East Asian region and Google. We analysed their instructions to authors for endorsement of the CONSORT statement and the ICMJE requirements for reporting of randomized controlled trials. We then identified all randomized controlled trials published in these journals during 2004 and 2005 and assessed them against selected CONSORT items and ICMJE requirements, and scored them on the Jadad scale. RESULTS: Of the 65 journals selected, 38 (58.5%) mentioned the ICMJE requirements in their instructions for authors but only 20 (31%) specifically required authors to submit manuscripts in accordance with the CONSORT statement. Of 151 randomized controlled trials published during 2004-05, only 4 of 13 (30.8%) selected CONSORT items were reported in > 50% of trial reports. Items reflecting internal validity were poorly reported. Jadad scores were significantly higher for general medical journals compared with specialty journals (mean difference 0.46; 95% CI: 0.15-0.78; p = 0.005) and in trials published in 2005 over those published in 2004 (mean difference 0.48; 95% CI: 0.18-0.79; p = 0.002). Ethical issues were poorly reported in one-third of reports, and sources of funding and conflicts of interest were not declared in over three-fourths. Adequacy of reporting was not related to endorsing either the CONSORT statement or the ICMJE requirements. CONCLUSION: Medical journals published in India should adopt internationally recognized norms for reporting clinical trials and work with authors, reviewers and institutional review boards to improve the standards of conduct, reporting and validity of inferences of trials.

Registering clinical trials in India: a scientific and ethical imperative.

The Clinical Trials Registery-India is an online, primary register of the WHO's International Clinical Trials Registry Platform. It was launched on 20 July 2007, and is now open to the prospective registration of clinical trials of any intervention conducted in India involving human participants. Registration is voluntary and free, and the register is searchable free of charge. Public disclosure of all 20 items in the WHO Trial Registration Data Set is mandatory for a valid registration number to be allocated. This number is required if the results are to be published in journals that endorse the International Committee of Medical Journal Editors' position on prospective trials registration. Trials in the Clinical Trials Registery-India will be included in the central repository of the WHO's International Clinical Trials Registry Platform search portal. In addition to the 20 items, the Clinical Trials Registery-India also requires mandatory disclosure of details of ethics committee and regulatory clearances. Further items pertaining to the methods that improve the internal validity of the trial are optional and serve as a template to improve trial design and the reliability of results. The success of this endeavour depends on the cooperation of the pharmaceutical industry, academic institutions, medical associations, ethics committees and medical journal editors in India. In the absence of legislation, ethics committees and medical journal editors have an important role in ensuring prospective registration of trials.

Ethics committees and clinical trials registration in India: opportunities, obligations, challenges and solutions.

Registering clinical trials is considered an ethical and moral imperative. The launch of the Clinical Trials Registry-India provides opportunities to all in India to fulfil this imperative. The CTRI requires prospective registration, disclosure of all 20 items in the WHO Trial Registration Data Set and proof of ethics and regulatory clearances. Registration in the CTRI is voluntary. However, institutional research ethics committees have obligations. This article reviews these obligations and provides an example of how this can be achieved.

International activity in the Cochrane Collaboration with particular reference to India.

The Cochrane Collaboration is the world's largest organization dedicated to preparing, maintaining and promoting the accessibility of systematic reviews of the effects of healthcare interventions. It is an international organization with participants in more than 100 countries. Since the year 2000, a periodic audit has been done to count the number of active members in Cochrane Review Groups, categorized by the countries in which these people are based. At the beginning of 2007, there were more than 15 800 people involved, an increase from about 5500 in 2000. The South Asian Cochrane Network was formed in 2005 to raise awareness about the Cochrane Collaboration and evidence-based practice in South Asia, support review authors and contributors from countries within the region, promote access to The Cochrane Library and advocate high quality research in South Asia. The growth of activity in India has been dramatic, particularly authors of Cochrane reviews and protocols--from just 19 (with 11 authors) in 2000 to 126 (with 78 authors) in 2007. Increasing the uptake of relevant and reliable evidence in healthcare decisions in India and the South Asian region forms the core of the network's strategic plan. The continued growth of contributors from India and South Asia will help ensure that decisions regarding healthcare in the region are informed by reliable and relevant evidence.

Systematic reviews and meta-analyses: an illustrated, step-by-step guide.

Systematic reviews and meta-analyses synthesize data from existing primary research, and well-conducted reviews offer clinicians a practical solution to the problem of staying current in their fields of interest. A whole generation of secondary journals, pre-appraised evidence libraries and periodically updated electronic texts are now available to clinicians. However, not all systematic reviews are of high quality, and it is important to be able to critically assess their validity and applicability. This article is an illustrated guide for conducting systematic reviews. A clear understanding of the process will provide clinicians with the tools to judiciously appraise reviews and interpret them. We hope that it will enable clinicians to conduct systematic reviews, generate high-quality evidence, and contribute to the evidence-based medicine movement.