N-of-1 trials are a tapestry of heterogeneity.

OBJECTIVES: To summarize the methods of design, analysis, and meta-analysis used in N-of-1 trials. STUDY DESIGN AND SETTING: Electronic search for English language articles published from 1950 to 2013. N-of-1 trials were selected if they followed an ABAB design and if they assessed a health intervention for a medical condition. Elements of design, analysis, and meta-analysis were extracted. RESULTS: We included 100 reports representing 1,995 participants. N-of-1 trials have been conducted in over 50 health conditions. Most reports incorporated the use of elements that maintain methodological rigor, including randomization, blinding, and formal outcome assessment; however, many failed to address trial registration, funding source, and adverse events. Most reports statistically analyzed individual N-of-1 trials; however, only a small proportion of included series meta-analyzed their results. CONCLUSIONS: N-of-1 trials have the ability to assess treatment response in individual participants and can be used for a variety of health interventions for a wide range of medical conditions in both clinical and research settings. Considerable heterogeneity exists in the methods used in N-of-1 trials.

CONSORT extension for reporting N-of-1 trials (CENT) 2015: explanation and elaboration.

N-of-1 trials are a useful tool for clinicians who want to determine the effectiveness of a treatment in a particular individual. The reporting of N-of-1 trials has been variable and incomplete, hindering their usefulness in clinical decision making and by future researchers. This document presents the CONSORT (Consolidated Standards of Reporting Trials) extension for N-of-1 trials (CENT 2015). CENT 2015 extends the CONSORT 2010 guidance to facilitate the preparation and appraisal of reports of an individual N-of-1 trial or a series of prospectively planned, multiple, crossover N-of-1 trials. CENT 2015 elaborates on 14 items of the CONSORT 2010 checklist, totalling 25 checklist items (44 sub-items), and recommends diagrams to help authors document the progress of one participant through a trial or more than one participant through a trial or series of trials, as applicable. Examples of good reporting and evidence based rationale for CENT 2015 checklist items are provided.

CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement.

N-of-1 trials provide a mechanism for making evidence-based treatment decisions for an individual patient. They use key methodological elements of group clinical trials to evaluate treatment effectiveness in a single patient, for situations that cannot always accommodate large-scale trials: rare diseases, comorbid conditions, or in patients using concurrent therapies. Improvement in the reporting and clarity of methods and findings in N-of-1 trials is essential for reader to gauge the validity of trials and to replicate successful findings. A Consolidated Standards of Reporting Trials (CONSORT) extension for N-of-1 trials (CENT 2015) provides guidance on the reporting of individual and series of N-of-1 trials. CENT provides additional guidance for 14 of the 25 items of the CONSORT 2010 checklist, recommends a diagram for depicting an individual N-of-1 trial, and modifies the CONSORT flow diagram to address the flow of a series of N-of-1 trials. The rationale, development process, and CENT 2015 checklist and diagrams are reported in this document.

Rhodiola rosea for physical and mental fatigue: a systematic review.

BACKGROUND: Rhodiola rosea (R. rosea) is grown at high altitudes and northern latitudes. Due to its purported adaptogenic properties, it has been studied for its performance-enhancing capabilities in healthy populations and its therapeutic properties in a number of clinical populations. To systematically review evidence of efficacy and safety of R. rosea for physical and mental fatigue. METHODS: Six electronic databases were searched to identify randomized controlled trials (RCTs) and controlled clinical trials (CCTs), evaluating efficacy and safety of R. rosea for physical and mental fatigue. Two reviewers independently screened the identified literature, extracted data and assessed risk of bias for included studies. RESULTS: Of 206 articles identified in the search, 11 met inclusion criteria for this review. Ten were described as RCTs and one as a CCT. Two of six trials examining physical fatigue in healthy populations report R. rosea to be effective as did three of five RCTs evaluating R. rosea for mental fatigue. All of the included studies exhibit either a high risk of bias or have reporting flaws that hinder assessment of their true validity (unclear risk of bias). CONCLUSION: Research regarding R. rosea efficacy is contradictory. While some evidence suggests that the herb may be helpful for enhancing physical performance and alleviating mental fatigue, methodological flaws limit accurate assessment of efficacy. A rigorously-designed well reported RCT that minimizes bias is needed to determine true efficacy of R. rosea for fatigue.

Disclosure of HIV status: the role of ethnicity among people living with HIV in London.

OBJECTIVE: To examine HIV disclosure among people living with HIV in London. METHODS: Between June 2004 and June 2005, 1687 people living with HIV (73% response) receiving medical care in National Health Service (NHS) clinics in northeast London completed a confidential, self-administered questionnaire. Respondents were asked whether they had told anyone else that they had HIV, and if so, whom. RESULTS: The analysis included 1407 people: 667 black African heterosexual respondents (453 women, 214 men) and 740 gay men (633 white, 107 ethnic minority). The majority of respondents (88.0%) had told at least 1 other person about their HIV infection, but this varied between groups: white gay men, 95.0%; ethnic minority gay men, 93.5%; black African heterosexual women, 84.8%; black African heterosexual men, 76.6% (P < 0.001). Black African heterosexual men (65.3%) and women (60.4%) were less likely to have told their current partner about their HIV infection than white (86.2%) or ethnic minority gay men (85.2%): black African men, adjusted odds ratio (AOR) 0.25, 95% confidence interval (CI) 0.14, 0.44, P < 0.001; black African women, AOR 0.24, 95% CI 0.15, 0.39, P < 0.001 (reference group, white gay men). Only 1 in 5 respondents (21.6%) had disclosed their HIV status to their employer (white gay men, 30.5%; ethnic minority gay men, 15.8%; black African heterosexual women, 10.5%; black African heterosexual men, 8.8%; P < 0.001). CONCLUSIONS: In this London study there were striking differences, by ethnicity, in the extent to which people with HIV disclosed their infection. This has important implications in light of the 2005 Disability Discrimination Act and recent prosecutions in the UK for the reckless transmission of HIV.

HIV-related discrimination reported by people living with HIV in London, UK.

The objective was to examine the extent to which people living with HIV in London reported being discriminated against because of their infection. In 2004-2005, people living with HIV attending NHS outpatient HIV clinics in north east London were asked: "Have you ever been treated unfairly or differently because of your HIV status-in other words discriminated against?". Of the 1,687 people who returned a questionnaire (73% response rate), data from 1,385 respondents were included in this analysis; 448 heterosexual women and 210 heterosexual men of black African origin, 727 gay/bisexual men (621 white, 106 ethnic minority). Overall, nearly one-third of respondents (29.9%, 414/1,385) said they had been discriminated against because of their HIV infection. Of those who reported experiencing HIV-related discrimination, almost a half (49.6%, 200/403) said this had involved a health care worker including their dentist (n = 102, 25.3%) or primary care physician (n = 70, 17.4%).

Sexual behaviour of people living with HIV in London: implications for HIV transmission.

OBJECTIVE: To examine the sexual behaviour of gay men as well as black African heterosexual men and women living with diagnosed HIV in London, and to consider the implications for HIV transmission. METHODS: People living with HIV receiving treatment and care in outpatient clinics in north east London were asked to complete a confidential, self-administered questionnaire in 2004-2005. Respondents were asked about unprotected anal or vaginal intercourse in the previous 3 months, and the type (main or casual) and HIV status of their partner(s). RESULTS: A total of 1687 people with diagnosed HIV returned a completed questionnaire (response rate 73% of eligible clinic attenders) including 480 black African heterosexual women, 224 black African heterosexual men and 758 gay/bisexual men (464 white, 112 ethnic minority). One in five gay men with HIV (20.1%, 144/715) reported unprotected anal intercourse with a partner of unknown or discordant HIV status (usually a casual partner). This presents a risk of HIV transmission. By comparison, one in 20 (5.1%, 32/623) black African heterosexual men and women with HIV reported unprotected vaginal intercourse that presented a risk of HIV transmission; odds ratio (gay men versus black African men and women combined) 5.28, 95% confidence interval 3.52, 7.91, P<0.001. Neither viral load nor being on HAART were significantly associated with unprotected intercourse among gay men or black African heterosexual men and women (P>0.05). CONCLUSION: Behavioural research among people with diagnosed HIV in London shows that gay men are more likely than black African heterosexual men and women to engage in sexual behaviour that presents a risk of HIV transmission.

HIV in East London: ethnicity, gender and risk. Design and methods.

BACKGROUND: While men who have sex with men remain the group at greatest risk of acquiring HIV infection in the UK, the number of new diagnoses among heterosexuals has risen steadily over the last five years. In the UK, three-quarters of heterosexual men and women diagnosed with HIV in 2004 probably acquired their infection in Africa. This changing epidemiological pattern is particularly pronounced in East London because of its ethnically diverse population. DESIGN AND METHODS: The objective of the study was to examine the social, economic and behavioural characteristics of patients with HIV infection currently receiving treatment and care in hospitals in East London. The research focused on ethnicity, gender, sexuality, education, employment, housing, HIV treatment, stigma, discrimination, religion, migration and sexual risk behaviour. People diagnosed with HIV infection attending outpatient treatment clinics at St Bartholomew's, the Royal London, Whipp's Cross, Homerton, Newham and Barking hospitals (all in East London) over a 4-6 month period were invited to participate in the study in 2004-2005. Those who agreed to participate completed a confidential, self-administered pen-and-paper questionnaire. During the study period, 2680 patients with HIV attended the outpatient clinics in the six participating hospitals, of whom 2299 were eligible for the study and 1687 completed a questionnaire. The response rate was 73% of eligible patients and 63% of all patients attending the clinics during the survey period. DISCUSSION: A clinic-based study has allowed us to survey nearly 1700 patients with HIV from diverse backgrounds receiving treatment and care in East London. The data collected in this study will provide valuable information for the planning and delivery of appropriate clinical care, social support and health promotion for people living with HIV not only in East London but in other parts of the capital as well as elsewhere in the UK.