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Light works, Prozac ties placebo

A total of 122 patients were randomized (light monotherapy, 32; fluoxetine monotherapy, 31; combination therapy, 29; placebo, 30). The mean (SD) changes in MADRS score for the light, fluoxetine, combination, and placebo groups were 13.4 (7.5), 8.8 (9.9), 16.9 (9.2), and 6.5 (9.6), respectively. The combination (effect size [d] = 1.11; 95% CI, 0.54 to 1.64) and light monotherapy (d = 0.80; 95% CI, 0.28 to 1.31) were significantly superior to placebo in the MADRS change score, but fluoxetine monotherapy (d = 0.24; 95% CI, −0.27 to 0.74) was not superior to placebo.

Fake doctor saved thousands of infants and changed medical history

But for all his showbiz, Couney was in the lifesaving business, and he took it seriously. The exhibit was immaculate. When new children arrived, dropped off by panicked parents who knew Couney could help them where hospitals could not, they were immediately bathed, rubbed with alcohol and swaddled tight, then “placed in an incubator kept at 96 or so degrees, depending on the patient. Every two hours, those who could suckle were carried upstairs on a tiny elevator and fed by breast by wet nurses who lived in the building. The rest [were fed by] a funneled spoon.”

NEJM Journal Watch: Summaries of and commentary on original medical and scientific articles from key medical journals

Rivaroxaban (Xarelto) and apixaban (Eliquis) are the most commonly prescribed direct-acting oral anticoagulants (DOACs) in the U.S., but no head-to-head comparisons are available to guide physicians' choices between these drugs. In this study, researchers used a large U.S. claims database to compare the effectiveness and safety of rivaroxaban and apixaban in patients with newly diagnosed venous thromboembolism (VTE). About 3000 apixaban users were compared with about 12,000 propensity-score-matched rivaroxaban users. During average follow-up of about 3 months, recurrent VTE occurred significantly less often in apixaban users than in rivaroxaban users (3 vs. 7 events per 100 person-years). Major bleeding also occurred significantly less often with apixaban (3 vs. 6 events per 100 person-years). These findings were consistent across various subgroups.

Pattern Analysis of Oxygen Saturation Variability in Healthy Individuals: Entropy of Pulse Oximetry Signals Carries Information about Mean Oxygen Saturation

Pulse oximetry is routinely used for monitoring patients' oxygen saturation levels with little regard to the variability of this physiological variable. There are few published studies on oxygen saturation variability (OSV), with none describing the variability and its pattern in a healthy adult population.

Debunking a study by citing zero studies

Professor Helen Stokes-Lampard, Chair of the Royal College of GPs, said: “It is well-established that it often takes a while for patients to feel the full benefits of modern antidepressants and that they work best when taken for significant periods of time, which is one reason why doctors will often review patients after several weeks of use and then prescribe a fairly long course of the drugs, if they appear to be beneficial.”

Medicine as a turtle

In medicine, good ideas still take an appallingly long time to trickle down. Recently, the American Academy of Neurology and the American Headache Society released new guidelines for migraine-headache-treatment. They recommended treating severe migraine sufferers—who have more than six attacks a month—with preventive medications and listed several drugs that markedly reduce the occurrence of attacks. The authors noted, however, that previous guidelines going back more than a decade had recommended such remedies, and doctors were still not providing them to more than two-thirds of patients. One study examined how long it took several major discoveries, such as the finding that the use of beta-blockers after a heart attack improves survival, to reach even half of Americans. The answer was, on average, more than fifteen years.

The Heroism of Incremental Care | The New Yorker

In the United Kingdom, where family physicians are paid to practice in deprived areas, a ten-per-cent increase in the primary-care supply was shown to improve people’s health so much that you could add ten years to everyone’s life and still not match the benefit.

The Heroism of Incremental Care | The New Yorker

We have a certain heroic expectation of how medicine works. Following the Second World War, penicillin and then a raft of other antibiotics cured the scourge of bacterial diseases that it had been thought only God could touch. New vaccines routed polio, diphtheria, rubella, and measles. Surgeons opened the heart, transplanted organs, and removed once inoperable tumors. Heart attacks could be stopped; cancers could be cured. A single generation experienced a transformation in the treatment of human illness as no generation had before. It was like discovering that water could put out fire. We built our health-care system, accordingly, to deploy firefighters. Doctors became saviors. “Let me preface my remarks by saying that the chain is a lot longer than it looks.” But the model wasn’t quite right. If an illness is a fire, many of them require months or years to extinguish, or can be reduced only to a low-level smolder. The treatments may have side effects and complications that require yet more attention. Chronic illness has become commonplace, and we have been poorly prepared to deal with it. Much of what ails us requires a more patient kind of skill.

Popular mobile games can be used to detect signs of cognitive decline -- ScienceDaily

Their research put 21 healthy participants through standard paper-based cognitive assessment tests, followed by 10-minute sessions of playing Tetris, Candy Crush Saga and Fruit Ninja over two separate periods, a fortnight apart. The three games selected were chosen because they are easy to learn, engaging for most players and involve intensive interactions using multiple gestures. Using the sensors built into the mobile phones to collect data, the team showed how users interacted with the games and illustrated a clear link between the subjects' touch gestures, or taps and swipes, their rotational gestures and their levels of cognitive performance. The study revealed the participants' ability to perform visuo-spatial and visual search tasks, as well as testing their memory, mental flexibility and attention span.

Pragmatic trials revisited: applicability is about individualization - Journal of Clinical Epidemiology

Classically, clinical research has centered on studying groups of individuals to extrapolate the findings to the general population. It is time to walk back from the population (the average patient) to the individual patient, understanding that population-oriented research is actually exploratory and individual-oriented research is confirmatory [24].

Pragmatic trials revisited: applicability is about individualization - Journal of Clinical Epidemiology

These designs represent an important step toward stratified therapy, but N-of-1 trials [14] are the purest form of pragmatic patient-centered design [15]. N-of-1 trials are multiple-period, crossover experiments comparing two or more treatments within individual patients. They are the optimal design to estimate individual treatment effects directly and to identify the best treatment for each individual patient in each specific setting. The Journal of Clinical Epidemiology has recently published a number of articles reviewing the main features and applications of N-of-1 trials [16].

Cancer drugs don't always work as intended, researchers warn -- ScienceDaily

In a new paper recently published in the journal Science Translational Medicine, a team of researchers led by Sheltzer and researchers Ann Lin and Chris Giuliano, detail how the "mechanism of action" of the 10 drugs were mischaracterized, just like MELK. "The idea for many of these drugs is that they block the function of a certain protein in cancer cells. And what we showed is that most of these drugs don't work by blocking the function of the protein that they were reported to block," Sheltzer explained. "So that's what I mean when I talk about mechanism of action." All 10 of the drugs are currently being tested in clinical trials and involve about 1000 human cancer patients. And while they do appear capable of killing cancer cells, it's just not in the way researchers had thought. So how can this be? "In some sense, this is a story of this generation's technology," Sheltzer said.

Survey shows many primary care doctors are unprepared to help patients avoid diabetes -- ScienceDaily

The researchers received 298 completed surveys, or 34% of the 888 ultimately found eligible for inclusion in the study. "Our results revealed that there are substantial gaps in the knowledge that PCPs have in all three categories we tested," Tseng says. For instance: - On average, respondents selected just 10 out of 15 correct risk factors for prediabetes, most often missing that African Americans and Native Americans are two groups at high risk. - Only 42% of respondents chose the correct values of the fasting glucose and Hb1Ac tests that would identify prediabetes. - Only 8% knew that a 7% weight loss is the minimum recommended by the American Diabetes Association as part of a diabetes prevention lifestyle change program. "Our results also suggests that 25% of PCPs may be identifying people as having prediabetes when they actually have diabetes, which could lead to delays in getting those patients proper diabetes care and management," Maruthur says.

Educate Your Patients…or They Will Take Medical Advice From Their Hairdresser |

“One of the bigger distractions in sports medicine practices is that patients often focus on what we do with professional athletes…everyone wants to try what worked for Kobe Bryant. But I tell them that is an n of 1, and what they should truly be basing their decision on is the result of a large prospective study where you are looking at efficacy of a specific dosage and formulary, for their particular type of orthopaedic problem. And this is our job to present that data in a fair fashion, particularly because of the appearance of conflict involved in these cash-based procedures that are rarely covered by insurance.  “Because medicine has become a consumer field we must focus on public education. If we were to poll the physicians who are performing most of these treatments, they will likely agree that the evidence is still pending but looking promising, and furthermore that the patients are asking for it.” I spend a good amount of time in my clinic talking to these patients about the current evidence (and lack of such) behind these treatments, and some still do choose to move forward with this option.

Persistence of Contradicted Claims in the Literature | Dementia and Cognitive Impairment | JAMA | JAMA Network

For the 2 vitamin E epidemiological studies, even in 2005, 50% of citing articles remained favorable. A favorable stance was independently less likely in more recent articles, specifically in articles that also cited the HOPE trial (odds ratio for 2001, 0.05 [95% confidence interval, 0.01-0.19; P < .001] and the odds ratio for 2005, 0.06 [95% confidence interval, 0.02-0.24; P < .001], as compared with 1997), and in general/internal medicine vs specialty journals. Among articles citing the HOPE trial in 2005, 41.4% were unfavorable. In 2006, 62.5% of articles referencing the highly cited article that had proposed beta-carotene and 61.7% of those referencing the highly cited article on estrogen effectiveness were still favorable; 100% and 96%, respectively, of the citations appeared in specialty journals; and citations were significantly less favorable (P = .001 and P = .009, respectively) when the major contradicting trials were also mentioned. Counterarguments defending vitamin E or estrogen included diverse selection and information biases and genuine differences across studies in participants, interventions, cointerventions, and outcomes. Favorable citations to beta-carotene, long after evidence contradicted its effectiveness, did not consider the contradicting evidence.

Book Review: ‘Ending Medical Reversal’ Laments Flip-Flopping - The New York Times

“Often the study of the study of how therapies should work is much more extensive and comes before the study of whether therapies do work,” the authors write. Thus a medical culture based on “should work” rather than “does work” is condemned to constantly correct itself when the science is finally evaluated for outcomes that matter. To fix this constant backtracking would require nothing less than a revolution in how doctors are trained, with an emphasis on the proven and practical rather than the theoretical. (It would also require a second revolution in how doctors practice, with less prestige and remuneration for coming up with new ideas and more for validating old ones.)

The Influence of Industry Sponsorship on the Research Agenda: A Scoping Review

Corporate interests can drive research agendas away from questions that are the most relevant for public health. Strategies to counteract corporate influence on the research agenda are needed, including heightened disclosure of funding sources and conflicts of interest in published articles to allow an assessment of commercial biases. We also recommend policy actions beyond disclosure such as increasing funding for independent research and strict guidelines to regulate the interaction of research institutes with commercial entities.

Coca-Cola Funds Scientists Who Shift Blame for Obesity Away From Bad Diets - The New York Times

“Coca-Cola’s sales are slipping, and there’s this huge political and public backlash against soda, with every major city trying to do something to curb consumption,” said Michele Simon, a public health lawyer. “This is a direct response to the ways that the company is losing. They’re desperate to stop the bleeding.” Coke has made a substantial investment in the new nonprofit. In response to requests based on state open-records laws, two universities that employ leaders of the Global Energy Balance Network disclosed that Coke had donated $1.5 million last year to start the organization.

Pharmaceutical industry sponsorship and research outcome and quality: systematic review. - PubMed - NCBI

30 studies were included. Research funded by drug companies was less likely to be published than research funded by other sources. Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors (odds ratio 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons). None of the 13 studies that analysed methods reported that studies funded by industry was of poorer quality.

Study casts doubt on evidence for 'gold standard' psychological treatments -- ScienceDaily

"One of the things that becomes really obvious when you look at the literature is researchers are collecting and analyzing their data in ways that are extremely flexible," Sakaluk said. "If you don't follow certain rules of statistical inference, you can inadvertently trick yourself into claiming effects that aren't really there. For EST research, it may become important to define in advance what researchers are going to do -- like how they'll analyze data -- and go on record in a way that restricts what they're going to do. This would coincide with a movement to encourage researchers to propose what they'd like to do and get reviewers and journal editors to weigh in before -- not after -- scientists do research, and to publish it irrespective of what they find."

Saving the Endangered Physician-Scientist — A Plan for Accelerating Medical Breakthroughs | NEJM

In the past four decades, however, the proportion of U.S. physicians engaged in research has dwindled from a peak of 4.7% of the overall physician workforce in the 1980s to approximately 1.5% today.

The Hidden Costs of Automated Thinking | The New Yorker

Taken in isolation, oracular answers can generate consistently helpful results. But these systems won’t stay in isolation: as A.I.s gather and ingest the world’s data, they’ll produce data of their own—much of which will be taken up by still other systems. Just as drugs with unknown mechanisms of action sometimes interact, so, too, will debt-laden algorithms.

How a data detective exposed suspicious medical trials

One problem, several researchers in the field say, is that funders, journals and many in the scientific community give a relatively low priority to such checks. “It is not a very rewarding type of work to do,” Nuijten says. “It’s you trying to find flaws in other people’s work, and that is not something that will make you very popular.”

Industrial n-of-1

The N-of-1 trials propose replacing large-scale trials of whole groups with methodical study of individual patients. However, the requirement to provide specific treatment to different subgroups of patients will make clinical trials more complex, so the industry needs to redesign how it interacts with patients. CROs will need to establish expert teams to structure and run precision-medicine-oriented trials for their sponsor clients.

Why clinical trial outcomes fail to translate into benefits for patients | Trials | Full Text

We highlight problems with trial outcomes that make evidence difficult or impossible to interpret and that undermine the translation of research into practice and policy. These complex issues include the use of surrogate, composite and subjective endpoints; a failure to take account of patients’ perspectives when designing research outcomes; publication and other outcome reporting biases, including the under-reporting of adverse events; the reporting of relative measures at the expense of more informative absolute outcomes; misleading reporting; multiplicity of outcomes; and a lack of core outcome sets.

Clinical Trials of Therapy versus Medication: Even in a Tie, Medication wins | The BMJ

The medical community strives to make decisions based on evidence, but as this case illustrates we have unfortunately arrived at a point where taking the conclusions of clinical trials at face value is apparently a sign of naivette. Conflicts of interest may play an important role in the reporting of scientific findings. The problem is not limited to just a couple of isolated cases but involves the entire culture of medicine that has developed over the past ten years. Put bluntly, the scientific machinery is broken. There is no easy fix, but surely patients deserve better.