TASK DEFINITION: Given a paragraph and a claim, classify it this way: If the claim contradicts the evidence present in the paragraph, classify the claim as '0'. If the claim has multiple supporting *AND* contradicting evidences, classify the claim as '1'. If the claim has supporting evidence and the paragraph is in overall favor of the claim, then classify the claim as '2'.
PROBLEM: Paragraph: There are three costs not mentioned in this news release that are critical in evaluating the relevance of this unpublished study. First, the release could have compared the costs of “dual mobility cup” hip transplants vs. conventional implants. We’re told the former are “more expensive” but it would be helpful to know by how much, since the study suggests dual mobility cup transplants may be indicated in patients at high risk for dislocation. Second, the study is based on a “novel risk assessment tool” which suggests pre-operative scans in the sitting and standing positions. How much does this cost? It’s not mentioned. Third, how much money could potentially be saved by reducing the need for “revision surgeries” in patients whose implant becomes dislocated? It is unlikely that this will reduce costs overall given the small number of individuals who may require repeat surgery, even in this high risk group. Thus, the question is whether this is a cost-effective strategy or not. This study was done in two parts. Part one: a retrospective review of 1,082 conventional (not dual cup) total hip replacements (THRs), over 2 years, in which the dislocation rate was 1.8% (19 patients). We’re told about a third of the total cohort (320 of the 1,082) had “spinal disease and deformity” on imaging scans. In this group of 320, 10 patients (3.1%) had subsequent dislocations. Part two: Beginning in 2016 researchers began employing their risk assessment tool — pre-operative sitting/standing scans of the hip, and factoring in other risk factors like previous spinal fusion — and identified 192 of 1,009 patients (19%) as ‘high risk’ for dislocation. About three-fourths of these patients received dual cup transplants with only 1 having a subsequent dislocation (0.5%). The news release gives us the absolute rate of dislocations in both high-risk groups (3.1% vs. 0.5%), which is vital information to understand the scope of the potential benefit. And on that basis we’ll award a satisfactory grade here. However, we note limitations under the Evidence criterion below that have a bearing on these statistics. The news release does not mention any risks associated with hip replacement surgery in general, nor does it address potential harms specific to dual mobility cups, which are described in the release as the recommended approach to reduce risk for dislocations. The release notes that dual mobility cups may carry risks “if implanted unnecessarily” but doesn’t describe or quantify those risks. Of note, there is some concern that this type of replacement joint may release higher levels of metal ions than conventional joints when implanted in younger, more active patients. As presented, the only downside of these newer devices are the increased cost. It would be helpful to know if there are any other risks. Newer devices may have some risk simply due to not having long-term experience with them. Current hip replacement devices have been shown to work for 20+ years. It will take considerable time to know whether the same may hold for these newer devices. The release provides a relatively thorough description of how the study was conducted, noting that one group of patients was treated before the introduction of a new assessment protocol (in 2014-2015), and that the second group had their treatment guided by the new protocol (introduced in 2016). The fact that the second group had better outcomes (i.e. a lower rate of dislocations following hip replacement) indicates that the protocol must be helpful for identifying high-risk patients and treating them more appropriately, the release suggests. What’s lacking, though, is any acknowledgment that these two groups of patients might not be directly comparable. For example, did these two groups have the same types of “spinal disease and deformity” — the nature of which might impact the failure rate for their hip replacements? Did they also have the same level of mobility and co-existing illnesses? Did anything else about the treatment provided to patients change in the time between the first group’s treatment and the second group? Were both groups followed for the same length of time post-surgery? Differences in any of these areas could have biased the results. To conclusively demonstrate the effectiveness of the new protocol, researchers would need to randomly assign patients to receive the new protocol, or not, and document how both groups fared following treatment. A brief note to that effect, or at least a mention of some of the limitations inherent in the current study’s design, would have been helpful. The report should have mentioned that the comparison was not a direct one. The best way to examine these outcomes would be to compare patients screened to be at high risk and then randomize them to the new device or a standard one. It is possible that the benefit is from knowing that they are at higher risk. For example, physical therapy or other instruction may be given to mitigate the risk, irrespective of the device inserted. No disease mongering. The release states that dislocations occur in about 1% of patients following hip replacement. The release doesn’t discuss funding for the study or possible conflicts of interest among the study authors. A quick search of the federal Open Payments database shows that the lead author, Dr. Jonathan Vigdorchik, receives payments from a number of device companies, including those that make dual mobility hip implants. Since we’re not aware of alternatives to this tool we’ll rate this criteria Not Applicable. It’s clear that patients who undergo hip replacement at NYU Langone Orthopedic Hospital have access to the risk assessment screening and treatment algorithm prior to surgery. But what about patients who can’t travel to New York? Is anything similar in use at other institutions? The release is silent on this point. The release clarifies the problem this new assessment tool is trying to solve and why it’s worth reading about: Some newer hip implants are designed with dual mobility cups that allow for increased range of motion, which helps reduce dislocation risk. However, no guidelines currently exist to aid clinicians in deciding when to use these more flexible implants, which are often more expensive than conventional implants, may not be medically necessary, and may carry added risks if implanted unnecessarily. No unjustifiable language. Claim: New tool helps identify risk for post-surgical dislocations following hip replacement

SOLUTION: 1

PROBLEM: Paragraph: The story mentions that beta-blockers are available as generics but doesn’t specifically mention costs. As a class, beta blockers drugs are low cost ($10 to $200 a month according to some estimates). The article describes the median survival time afforded the women with ovarian cancer under different scenarios – with or without beta blockers in addition to their chemotherapy. For example, women who had been taking any beta blocker at the time of their chemotherapy had a median survival of 47.8 months while women who were not being treated with beta blockers while on chemo had median survival time of 42 months. The article notes that the quoted source and the study authors cautioned that beta blockers carry some side effects and additional research is needed to determine if the drugs’ benefits outweigh their risks for cancer patients. It specifically mentions risks for people with asthma. Other specific harms from beta-blockers for the general population include depression and diarrhea. Beta-blockers may also cause complications for people with diabetes. The article provides a good overall description of the size of the study and how patients were followed. It describes the median survival time afforded the 1,425 women with ovarian cancer under different scenarios – with or without beta blockers in addition to their chemotherapy. The use of language is appropriate in that it says these drugs were “linked to” and “associated with” benefits, but never claims that the drugs “prolonged survival” as stated in the MD Anderson news release. The story also briefly touched on the study limitations. Because the research was a retrospective look at 1,425 cases in a database of ovarian cancer cases, it wasn’t randomized. The article also notes that more research is needed to determine if the findings will translate into new treatments, and that “This is not something that people should rush out and start taking.” One area of concern is that the subheadline touts the dramatic benefits seen in a subgroup of patients taking nonselective beta-blockers — “A type of beta blocker is tied to more than four-year increase in survival for women with ovarian cancer, study finds” — but the story never specifically cautions readers about the small size of this group (only 75 people). Findings from such a small subgroup should be treated very carefully, and we’re not sure that they should have been highlighted for readers in the headline. We say this knowing full well that reporters often have no control over what gets put in the headline. We observed no evidence of fear-mongering language in the story. The story includes an independent source who wasn’t affiliated with the research. Christina Annunziata, a director with the Center for Cancer Research at the National Institutes of Health, said that while she found the study “interesting” and “thought-provoking,” she cautioned that “I don’t think it’s practice-changing quite yet.” Annunziata co-authored an editorial accompanying the report which were both published in the American Cancer Society’s Cancer journal. The story would have been even stronger had it outlined the funding sources for this study, which included government and foundation grants. However, since we didn’t find any significant conflicts in the list of funding sources, we didn’t think this omission unbalanced the coverage. The relevant research is based on evaluating the use of beta blockers in conjunction with conventional chemotherapy, not as an alternative to chemotherapy or other courses of treatment. As such, we’ll rate “Compare Alternatives” as Not Applicable. Beta blockers are called “common heart drugs” in the story and are thus generally understood to be widely available. Beta-blockers first came on the market more than 50 years ago and their use has become widespread as researchers found more applications for this class of drugs. Generic versions are available, making them some of the most affordable prescription drugs. A close call here. The story acknowledges previous research in this areas when it says, “Mouse and test-tube studies have shown that so-called nonselective beta blockers inhibit molecular pathways that promote tumor growth. Selective versions, designed to minimize side effects for heart patients, are less effective in hitting such targets. Dr. Sood and his colleagues wondered if the same effect would be found in people.” That’s good context, but the story could also have noted that a number of studies have indeed examined the impact of beta-blocker use on ovarian cancer patients, and did not find the same prolonged survival rates that are reported on in this story. The researchers think that’s because these earlier studies didn’t distinguish between the two types of beta-blockers. Because the article quotes an independent, unaffiliated cancer expert, we are confident the article doesn’t rely solely on a press release. Claim: Heart Drug Linked to Extra Years for Cancer Patients

SOLUTION: 2

PROBLEM: Paragraph: The story never mentions costs. Quantitative estimate is provided in relative frame only. The lead author of the study says that 1 to 9% of the plaque was gone, but we have no context for these numbers, nor do we know if this is clinically meaningful. No harms or side effects are mentioned. Although there is mention of a trial, so little information is provided that the viewer cannot evaluate the strength of the evidence. There is no obvious disease mongering. Only a single source, the lead author of the study, is quoted. Although there is mention of diet and exercise, there is no mention of the advantages/disadvantages of high-dose Crestor by comparison. There was also no mention of current practice – use of regular doses of statins. There is no explanation of the availability of Crestor. Is it FDA approved? Is it on the market? The story can’t assume that everyone knows. The story does not explain if the drug is new, old, investigational, or already approved. We can’t be sure if the story relied solely or largely on a news release. But only the lead author is interviewed. Claim: Encouraging news about reversing heart disease

SOLUTION:
0