While the HVTN 505 trial showed no overall efficacy of the tested vaccine to prevent HIV infection over placebo, markers measuring immune response to vaccination were strongly correlated with infection. This finding generated the hypothesis that some marker-defined vaccinated subgroups were partially protected whereas others had their risk increased. This hypothesis can be assessed using the principal stratification framework (Frangakis and Rubin, 2002) for studying treatment effect modification by an intermediate response variable, using methods in the sub-field of principal surrogate (...) (PS) analysis that studies multiple principal strata. Unfortunately, available methods for PS analysis require an augmented study design not available in HVTN 505, and make untestable structural risk assumptions, motivating a need for more robust PS methods. Fortunately, another sub-field of principal stratification, survivor average causal effect (SACE) analysis (Rubin, 2006) – which studies effects in a single principal stratum – provides many methods not requiring an augmented design and making fewer assumptions. We show how, for a binary intermediate response variable, methods developed for SACE analysis can be adapted to PS analysis, providing new and more robust PS methods. Application to HVTN 505 supports that the vaccine partially protected individuals with vaccine-induced T-cells expressing certain combinations of functions. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:"Spirituality":"Weasel-Word" or Gateway to New Understanding?Peter Gilbert (bio)Keywordsspirituality, faith communities, NIMHEVisiting the Samuel Palmer Exhibition at the British Museum, I was struck, not only by the spiritual power of the paintings, especially in the late Shoreham period such as, my favorite: The Magic Apple Tree (circa 1830)—but how Palmer appeared to bring both Christian and Pantheistic themes into his work. The museum's exhibition collator remarks that Palmer saw the (...) fruitfulness of the earth as an intimation of Divine creativity. The artist sought to capture "The essential vivifying spirit, vital spark" (Palmer's words) of the physical world in which we live.I was reminded as I moved from The Magic Apple Tree, to In a Shoreham Garden, and The Golden Valley, how these paintings had been used by a record company when they had issued all of Ralph Vaughan Williams' orchestral and choral works in the 1970s, to mark his anniversary. Vaughan Williams was not a signed up Christian, but many of his choral works express a strong yearning for the transcendent using Christian imagery. The day before I visited the Palmer exhibition, I listened to Professor Robert Winston on Start the Week (28th November, 2005), in which he spoke of his BBC series The Story of God (Winston, 2005). As a scientist, Winston is intrigued as to why humans seek the transcendent. He continually refers to this desired other as "God," although I think it would be more accurate to call it a search for the transcendent. Winston puzzles over why there appears to be "a God-shaped hole" within humanity (Start the Week, November, 28, 2005), and again, as a scientist, postulates that: "the more we understand about science, the less we understand about the Universe."In the light of the most popular films and books at present, the search for something beyond ourselves appears to be very much at the center, rather than at the periphery of humanity's consciousness at the present time. Reading Philip Pullman's His Dark Materials trilogy, and reading his various essays, we are struck by his articulation of the human search:We need a story, a myth that does what the traditional religious stories did. It must explain. It must satisfy our hunger for a Why... There are two kinds of Why, and our story must deal with both. There's the one that asks What brought us here? and the other that asks What are we here for?(Pullman, 2001)The author's article is very helpful in its practical approach to psychotherapy and spirituality. I particularly liked her reference to the work of Charles Corr (1991) and his work with people [End Page 197] who are dying and considering the physical, psychological, social, and spiritual aspects of the last days. The spiritual aspects being around identifying, developing, or reaffirming spiritual sources of energy and hope. This is the kind of approach that the National Institute for Mental Health in England (NIMHE) national Project on Spirituality and Mental Health has been engaged in since 2001, the approach being to stress the spiritual dimension as an integral part of a whole person and whole systems approach to mental health; work with mental health services and their partners to engage with this agenda; and work toward a better understanding between faith communities and mental health services (see Gilbert and Nicholls, 2003). Service users and their carers are increasingly stating strongly to services that they wish to have their spiritual dimension and spiritual needs addressed properly—and certainly not in a "tick-box" method! The author quotes Samson and Zerter (2003) as saying that the person's spiritual dimension "draws a thread of identity, relationship, meaning and purpose, which weave through each of these aspects" (i.e. the life events and other aspects of their being).I welcome the author's stress on a "relational approach," and her breadth of reference, for example, the diary of Marcus Aurelius, the Roman emperor and philosopher, but I had some concerns about her use of the term personal theology, and talk of the personal aspect of religion and "the Divine," in that I think that this could... (shrink)