The Lancet

Souzou: Outsider Art from Japan is a title, and an exhibition, rich with ambiguity. According to Wellcome Collection curator Shamita Sharmacharja, the word souzou has no direct English translation, but has a double meaning in Japanese. In one written form, it means creation; in the other, imagination. The term “outsider art” also suggests a peculiar tension, palpable throughout the exhibition. It was coined in the 1970s following Jean Dubuffet's mid-1940s theory of art brut, which recognised works by artists who were perceived to inhabit the margins of society, such as mental health patients.

Closed for a decade, the reborn Rijksmuseum reopened last month. Its vast collection spans some 800 years and is now presented in chronological order across 80 galleries. More than 30 galleries celebrate the Dutch Golden Age (1600–1700), a time when the nation made great advances in trade, science, and the arts. Among the museum's most well known works are those by Johannes Vermeer, Rembrandt van Rijn, and Jan Steen, which are now displayed to great effect. Not having seen its exemplary collection of 17th-century paintings for some years, my recollection that I would find Rembrandt's sobering The Anatomy Lesson of Dr Joan Deyman (1676) proved to be mistaken.

Next year will mark the 50th anniversary of the Declaration of Helsinki. Consequently, the World Medical Association (WMA) is developing its eighth version of the Declaration. This anniversary presents an excellent opportunity to reconsider the problems of the Declaration and how they can be remedied to ensure the document retains its prominent status.

In assessing a potential causal association, one should take into account the latency period from exposure to effect, and the potential duration of the effect of the exposure. In the analysis by Robert Pickard and colleagues (Dec 1, p 1927), it seems that the effect of the coated catheters was assumed to start on the first day of exposure and to continue up to 6 weeks after catheterisation, regardless of when the device was removed. A latency period could elapse from catheterisation to the first possible catheter-associated urinary tract infection (CAUTI), and the rate of colonisation and infection caused by the catheter should start to increase only after the latency period is over.

Robert Pickard and colleagues used self-reported, subsequently validated symptomatic catheter-associated urinary tract infection (CAUTI) as the outcome in their pragmatic trial on catheters. Although such trials are more practical, false-positive and false-negative results are of concern especially when the outcomes were validated only in those who reported a positive episode. The probabilities of false-negative and false-positive results might be related to the diagnostic sensitivity and specificity, which will influence the magnitude of important non-differential misclassification bias in this trial setting.

We thank Bing-Shun Wang and Olof Akre and colleagues for their careful reading of our paper, and the insightful comments on possible different analyses.

We congratulate Axel Grothey and colleagues for their study (Jan 26, p 303). However, we would like to highlight two important issues.

Axel Grothey and colleagues report that regorafenib prolongs survival of patients with chemorefractory metastatic colorectal carcinoma (mCRC). However, the benefit might not be enough to support the cost-effectiveness of regorafenib. Therefore, as stated by the authors, the search of markers of clinical benefit is important for future development.

Axel Grothey and colleagues report the results of CORRECT, a randomised, placebo-controlled phase 3 trial of regorafenib monotherapy for patients with refractory metastatic colorectal cancer. The treatment with regorafenib increased overall survival compared with best supportive care in previously heavily treated patients with colorectal cancer. However, patients with KRAS mutation showed less favourable survival benefit with regorafenib treatment compared with wild type (hazard ratio 0·87 vs 0·65).

The letters by Thierry André and colleagues, Riccardo Ricotta and colleagues, and Myung Han Hyun and colleagues in reference to the publication of the CORRECT trial raise several interesting points about the use of regorafenib for patients with metastatic colorectal cancer (CRC).

More than 16 000 dead pigs were found floating in Shanghai Huangpu River last month. It was unbelievable.

4 years after the global pandemic of H1N1 influenza, a new type of avian influenza, H7N9, is emerging in mainland China. It was first reported in Shanghai on Feb 19, 2013. As of April 17, 2013, a total of 77 cases of H7N9 human infection have been confirmed, including 16 deaths. 30 cases, including 11 deaths, have been confirmed in Shanghai; 20 cases, including two deaths, in Jiangsu province; 21 cases, including two deaths, in Zhejiang province; three cases, including one death, in Anhui province; one case in Beijing; and two cases in Henan province.

I am writing to formally question your Editorial on children's heart surgery in Leeds, UK (April 13, p 1248). Readers need to be fully aware of the inaccuracies on the issue of the mortality and safety of children's heart surgery in Leeds.

Gabay C, Emery P, van Vollenhoven R, et al, on behalf of the ADACTA Study Investigators. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet 2013; published online March 18. DOI:10.1016/S0140-6736(13)60250-0—In this Article the dose of adalimumab given was 40 mg subcutaneously every 2 weeks, not 40 mg per kg bodyweight subcutaneously every 2 weeks as stated in the Summary and Randomisation and Masking sections.

Gabay C, Emery P, van Vollenhoven R, et al; on behalf of the ADACTA Study Investigators. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet 2013; 381: 1541–50—In the Study design and participants section of this Article (published online March 18), lines 11–15 should have been “patients had to stop taking all synthetic disease-modifying anti-rheumatic drugs except leflunomide 2 weeks or more before baseline; leflunomide had to be withdrawn 12 weeks or more before baseline or after standard washout”.

Tocilizumab monotherapy was superior to adalimumab monotherapy for reduction of signs and symptoms of rheumatoid arthritis in patients for whom methotrexate was deemed inappropriate. The adverse event profiles of tocilizumab and adalimumab were consistent with previous findings.

Whole genome sequencing has revealed frequent transmission of multidrug resistant NTM between patients with cystic fibrosis despite conventional cross-infection measures. Although the exact transmission route is yet to be established, our epidemiological analysis suggests that it could be indirect.

Because of the large contribution of extra-couple transmission to new HIV infections, interventions for HIV prevention should target the general sexually active population and not only serodiscordant couples.