This release started out very strong in describing the major findings of a study of vitamin D for preventing falls — an issue of critical importance to the nation’s growing universe of senior citizens and the people who care for them. The release offers a clear summary of the problem and intervention. It also describes the intermediate endpoint (raising vitamin D levels) and the clinically important endpoint (falls). It would have been stronger if it had given the absolute reduction in fall risk (we need to know the fall rate in the control or intervention group to figure out how important the 50% reduction mentioned in the story would be), discussed cost and harm, and told us more about prior similar research.
More than a third of home-bound older adults fall in any given year, and about one in 10 of those falls results in serious injury that can result in disability, placement in long-term care or death, according to a 2003 New England Journal of Medicine study. If Vitamin D supplementation via Meals on Wheels can reduce that risk, that would be important information that could help guide this vulnerable population and their caregivers. Although we have some interventions to reduce falls (e.g. balance programs), simple ways to reduce risk like vitamin supplementation are also important.
The news release makes no mention of the cost of Vitamin D supplements, which would likely be important to the elderly population, many of whom live on fixed incomes. Nor does it mention a key fact about the Older Americans Act that was cited in the study itself: “Although OAA nutrition programs can provide education and counseling to encourage the use of vitamin-mineral supplements, the provision of vitamin-mineral supplements is currently not a fundable OAA service.” Relatively speaking, the cost of such supplements is minimal, but readers may not be aware of that.
On the positive side, the release notes that participants in the vitamin D group had higher blood levels of the vitamin and tells us how many achieved “sufficient” and “optimal” levels. It provides the cutoffs that were used to determine those outcomes.
However, with respect to the key clinical outcome — falls — the story says, “people in the vitamin D group reported approximately half the falls of those in the control group.” It’s not clear from this description how many falls were actually prevented. The study itself clarifies this in absolute terms: “The mean number of reported falls over the 5-month follow-up period was 0.5 (range 0–
4) in participants randomized to vitamin D3 and 1.1 (range 0–8) in participants randomized to active placebo.”
The release makes no mention of possible harms caused by Vitamin D supplements, though the FDA website cites a laundry list of concerns that it attributes to the American Association of Family Physicians: Nausea, vomiting, poor appetite, constipation, weakness, weight loss, confusion, heart rhythm problems, deposits of calcium and phosphate in soft tissues.
The release makes it clear that this was a randomized placebo-controlled trial and explained the purpose and delivery of the vitamin. It also closes with a restraining comment from one of the study researchers: “Although these initial findings are encouraging, we need to confirm the results in a larger trial,” Houston said. We’ll call that good enough for a Satisfactory rating here.
The news release did not appear to exaggerate the severity of the problem.
The news release cites funding sources. It makes no mention of possible conflicts of interest, but the study itself says none were found.
Neither the news release nor the study makes any mention of other possible interventions that might result in fewer or less-serious falls. For example, balance programs such as Tai Chi are known to decrease fall risk. Other steps that may help include the installation of hand rails, the use of carpeting on steps, the use of bright-colored tape on steps to increase depth perception, etc.
We’ll rate this Not Applicable. Although no mention was made of the availability of the vitamin supplements, it is fair to assume most readers know that they are readily available in nearly any supermarket or drug store. However, the high dose vitamin D used in this study is typically available by prescription only.
The news release says that “some studies suggest vitamin D may reduce the risk of falls,” but this area has been more thoroughly studied than this statement would suggest. On the basis of available research summarized in a systematic review, the U.S. Preventive Services Task Force recommends vitamin D supplementation in community-dwelling adults aged 65 years or older who are at increased risk for falls.
In addition, the study authors state that they believe their work to be the first such study conducted in homebound older adults — an important statement of novelty. The release doesn’t mention this.
The news release does not use language that goes beyond what the study itself justifies.
Systematic, Criteria-Driven
The @nytimeswell effort is shown to be unwell once again.
There's pervasive media bias toward hyping treatment benefits while neglecting negative results & harms.
Big part of this is reliance on experts with financial &/or intellectual conflicts of interest.
Att'n journalists: Use this list 100 independent experts to correct imbalance https://twitter.com/garyschwitzer/status/1177189641218330625
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