How to design and set up a clinical trial part 2 : protocols and approvals

Data from clinical trials involving human participants are essential in establishing an evidence base about the safety and effectiveness of our treatments. This second article describes the steps involved in designing and setting up a clinical trial, from writing a protocol to gaining the necessary approvals. Acquiring some knowledge about how to set up a clinical trial will allow the conscientious clinician to use the most relevant information to provide the highest possible standards of clinical care for his/her patients

Preferred reporting items for studies mapping onto preference-based outcome measures: The MAPS statement

'Mapping' onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a new checklist, which aims to promote complete and transparent reporting of mapping studies. The primary audiences for the MAPS statement are researchers reporting mapping studies, the funders of the research, and peer reviewers and editors involved in assessing mapping studies for publication. A de novo list of 29 candidate reporting items and accompanying explanations was created by a working group comprised of six health economists and one Delphi methodologist. Following a two-round, modified Delphi survey with representatives from academia, consultancy, health technology assessment agencies and the biomedical journal editorial community, a final set of 23 items deemed essential for transparent reporting, and accompanying explanations, was developed. The items are contained in a user friendly 23 item checklist. They are presented numerically and categorised within six sections, namely: (i) title and abstract; (ii) introduction; (iii) methods; (iv) results; (v) discussion; and (vi) other. The MAPS statement is best applied in conjunction with the accompanying MAPS explanation and elaboration document. It is anticipated that the MAPS statement will improve the clarity, transparency and completeness of reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by eight health economics and quality of life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in five years' time. This statement was published jointly in Applied Health Economics and Health Policy, Health and Quality of Life Outcomes, International Journal of Technology Assessment in Health Care, Journal of Medical Economics, Medical Decision Making, PharmacoEconomics, and Quality of Life Research

Systems validation: application to statistical programs

BACKGROUND: In 2003, the United States Food and Drug Administration (FDA) released a guidance document on the scope of "Part 11" enforcement. In this guidance document, the FDA indicates an expectation of a risk-based approach to determining which systems should undergo validation. Since statistical programs manage and manipulate raw data, their implementation should be critically reviewed to determine whether or not they should undergo validation. However, the concepts of validation are not often discussed in biostatistics curriculum. DISCUSSION: This paper summarizes a "Plan, Do, Say" approach to validation that can be incorporated into statistical training so that biostatisticians can understand and implement validation principles in their research. SUMMARY: Validation is a process that requires dedicated attention. The process of validation can be easily understood in the context of the scientific method

Assessing the quality of reports of systematic reviews in pediatric complementary and alternative medicine

OBJECTIVE: To examine the quality of reports of complementary and alternative medicine (CAM) systematic reviews in the pediatric population. We also examined whether there were differences in the quality of reports of a subset of CAM reviews compared to reviews using conventional interventions. METHODS: We assessed the quality of reports of 47 CAM systematic reviews and 19 reviews evaluating a conventional intervention. The quality of each report was assessed using a validated 10-point scale. RESULTS: Authors were particularly good at reporting: eligibility criteria for including primary studies, combining the primary studies for quantitative analysis appropriately, and basing their conclusions on the data included in the review. Reviewers were weak in reporting: how they avoided bias in the selection of primary studies, and how they evaluated the validity of the primary studies. Overall the reports achieved 43% (median = 3) of their maximum possible total score. The overall quality of reporting was similar for CAM reviews and conventional therapy ones. CONCLUSIONS: Evidence based health care continues to make important contributions to the well being of children. To ensure the pediatric community can maximize the potential use of these interventions, it is important to ensure that systematic reviews are conducted and reported at the highest possible quality. Such reviews will be of benefit to a broad spectrum of interested stakeholders

Effective communication in eliciting and responding to suicidal thoughts: a systematic review protocol

Background In the UK, over 6500 people die by suicide each year. In England alone, this is one person every 2 h. Professionals assess risk of suicide in face-to-face contacts with people potentially at risk. The National Confidential Inquiry into Suicide found that most people who took their life were classified as ‘low risk’ in their final contact with mental health services. Training for front-line staff in reducing suicide is a NHS priority. While there is considerable evidence on what to assess when exploring suicidal ideation, there is little evidence on how to ask sensitive questions to effectively identify suicide risk and how to respond in the treatment encounter to reduce patient distress and suicidal ideation. This is critical for identifying risk and putting appropriate care in place. Methods An electronic search will be conducted using MEDLINE, CINAHL, Cochrane Library, EMBASE and PsycINFO databases. Controlled studies of effectiveness will be identified using a predefined search strategy. The focus will be on suicidal thoughts/feelings rather than self-harm without intent to die. Two authors will independently screen articles using predefined inclusion and exclusion criteria and relevant data will be extracted using the Cochrane Collaboration data extraction form for randomised controlled trials (RCTs). Discrepancies between the two authors will be resolved by consensus or by consulting a third author at all levels of screening. We will assess the quality of evidence as well as risk of bias. A meta-analysis will be conducted if participants, interventions and comparisons are sufficiently similar, and we will perform the meta-analysis using Stata data analysis and statistical software. Discussion The results of this systematic review will be used to guide training and practice for health care professionals

Assessing the quality of reports of randomized trials in pediatric complementary and alternative medicine

OBJECTIVE: To evaluate the quality of reports of complementary and alternative medicine (CAM) randomized controlled trials (RCTs) in the pediatric population. We also examined whether there was a change in the quality of reporting over time. METHODS: We used a systematic sample of 251 reports of RCTs that used a CAM intervention. The quality of each report was assessed using the number of CONSORT checklist items included, the frequency of unclear allocation concealment, and a 5-point quality assessment instrument. RESULTS: Nearly half (40%) of the CONSORT checklist items were included in the reports, with an increase in the number of items included. The majority (81.3%) of RCTs reported unclear allocation concealment with no significant change over time. The quality of reports achieved approximately 40% of their maximum possible total score as assessed with the Jadad scale with no change over time. Information regarding adverse events was reported in less than one quarter of the RCTs (22%) and information regarding costs was mentioned in only a minority of reports (4%). CONCLUSIONS: RCTs are an important tool for evidence based health care decisions. If these studies are to be relevant in the evaluation of CAM interventions it is important that they are conducted and reported with the highest possible standards. There is a need to redouble efforts to ensure that children and their families are participating in RCTs that are conducted and reported with minimal bias. Such studies will increase their usefulness to a board spectrum of interested stakeholders

Guidance for Developers of Health Research Reporting Guidelines

David Moher and colleagues from the EQUATOR network offer guidance and recommended steps for developing health research reporting guidelines

CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials

Kenneth Schulz and colleagues describe the 2010 version of the CONSORT Statement, which updates the previous reporting guideline based on new methodological evidence and accumulated experience