National Institute for Health Research

How can non-scientists influence the course of scientific research? | Cath Ennis

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Science communication should be more than the dissemination of results to the public; it should also flow in the other direction, with members of the public able to communicate their priorities to scientists and those who fund them. But how?

A researcher in biosafety protective gear

Scientists don’t conduct their research in isolation from society – at least, not all scientists, all of the time. Photograph: US Army Medical Research Institute of Infectious Disease

Scientific research has an enormous impact on modern society, with its effects felt in many aspects of our lives. But scientists are also part of that society, and can adapt their research topics and methods to reflect its ever-changing priorities. All too often, though, these priorities are dictated by governments or by the private sector, while the views of members of the public aren’t heard. However, it’s certainly possible for interested individuals to influence the course of scientific research.

Follow the (grant) money

Science is a constant cycle of applying for grants to generate data to publish in manuscripts that form the basis of the next grant application. Success rates vary enormously depending on the country and the field, among other factors, but are generally low – 10-20% wouldn’t be at all unusual. As such, the agencies that allocate research funding have more influence over trends in scientific research than any other entity. They can set aside funds for research in specific fields; they can favour one kind of research over others (eg basic versus applied research); they can favour certain methods, or types of research institution; they can decide to rank grant applications on criteria other than the quality of the scientific question and approach.

On the latter point, there’s a trend toward making funded scientists more accountable to society. For example, Genome Canada and its regional affiliates require all grant applicants to complete a lengthy section describing how their proposed project encompasses research on “genomics and its related ethical, environmental, economic, legal and social aspects” (GE3LS); the reviewers’ scores for this section can make or break an application’s success. In the US, applicants to the National Science Foundation (NSF) have to complete a “Broader Impacts” section that’s judged on criteria that include the investigator’s plan for “improved STEM [Science, Technology, Engineering and Mathematics] education and educator development at any level; increased public scientific literacy and public engagement with science and technology; improved well-being of individuals in society”. Other funding agencies have similar criteria.

(Should scientists be thinking about and doing these things anyway? Yes, of course, and many do – but many don’t, due to lack of time, resources, training, and/or interest, and some won’t ever consider these ideas unless their funding depends on it).

So how can individuals communicate their opinions and priorities to funding agencies?

A lot of support for scientific research (most or even all of it, in some fields) comes from national and local governments and is taxpayer-funded. Major players include the seven Research Councils in the UK; the Tri-Council Agencies in Canada; and the National Institutes of Health Research and National Science Foundation in the US. If you have an opinion about the research types, topics, or methods your government should be funding, or about the need for funded scientists to demonstrate commitment to public outreach or any of the factors encompassed by E3LS research, you can direct it (in order of decreasing likelihood of impact) to your science minister or equivalent, local representative, or prime minister/president.

If you think your opinion will be shared by many others, some governments have websites where you can create a petition. The government is obliged to issue some kind of response (even if it’s an official “thanks, but no thanks”) to petitions with a certain number of signatures (currently 100,000 in both the UK and the US).

Non-government sources of research funding include private sector companies and charitable organisations. No one outside the companies in question is likely to have any chance of influencing the former, but the latter – mostly medical research charities that focus on a specific disorder or group of disorders – do listen to donors. Some allow donations to be directed towards specific topics or types of research; others can be persuaded by direct communications from donors.

Some funding agencies also directly involve members of the public in grant review – for example, the government-funded UK NHS National Institute for Health Research and Canadian Institutes of Health Research recruit lay or community reviewers, as do many charities. A lay reviewer’s opinion on the importance of the proposed research is unlikely to make or break an applicant’s success (although this is certainly possible), but their broader feedback to the funders may have more of an effect, especially for smaller organisations.

Crowdfunding

The crowdfunding model exemplified by Kickstarter, in which investors can browse business and creative pitches and contribute money to help develop a new product or service, is starting to gain some traction in the research community (see articles in the journal Nature from January 2012 and May 2013). Sites specific to scientific research, including Petridish and Microryza, have sprung up, and host requests for funding from investigators in a variety of fields, from all over the world. Donors may be offered incentives such as early access to research findings, or direct participation in the research.

I don’t believe crowdfunding will be an eventual replacement for current sources of research monies – government and charitable funding, and (most importantly) peer review, should and will remain an essential component of scientific research. Besides, research in my field (genomics) and many others is far too expensive to be supported by individual small-scale donations. However, a crowdfunded project can be perfect for early-career researchers, pilot studies, research ideas outside the mainstream, and other niches. These projects can provide the crucial preliminary data required by mainstream funding agencies, to demonstrate the validity of the approach and the idea, and thereby have the potential to launch much larger studies. One high-impact paper in a new area can even initiate a whole new sub-field, magnifying the influence of any individual donor’s money.

In conclusion, there are a number of ways in which members of the public can communicate their opinions and priorities to scientists and those who fund them, none of which necessitate pitchforks and flaming torches. Money talks, but so do time, effort, and votes – so get cracking, and good luck!

The ideas in this post originated and evolved from an impromptu session I led at this year’s Vancouver Change Camp about what responsibilities science owes to society, and vice versa. Many thanks to all the participants for a fascinating discussion, and especially to Sara Mimick for her support on the day.

Probiotics Do Not Reduce Diarrhea Risk in Large Trial.

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Probiotic supplements did not prevent antibiotic-associated diarrhea (AAD) or Clostridium difficile diarrhea (CDD) in a large randomized, double-blind, placebo-controlled trial.

Stephen J. Allen, MD, from Swansea University, United Kingdom, and colleagues reported the results in an article published onlineAugust 8 in the Lancet.

The researchers recruited patients 65 years or older to the Probiotic lactobacilli and bifidobacteria in antibiotic-associated diarrhoea andClostridium difficile diarrhoea in the elderly (PLACIDE) trial if they were exposed to 1 or more oral or parenteral antibiotics in the preceding 7 days or were about to begin antibiotic therapy. Participants were enrolled from 5 hospitals between December 1, 2008, and February 28, 2012, and were excluded if there were existing diarrhea or CDD in the previous 3 months, significant immune system compromise, any illness requiring intensive care, prosthetic heart valve, or underlying gastrointestinal disease. The primary study outcomes were the occurrence of AAD within 8 weeks of recruitment and CDD within 12 weeks of recruitment.

Overall, 1493 patients were randomly assigned to the microbial preparation group and 1488 to the placebo group. Of those, the researchers included 1470 and 1471, respectively, in the primary-endpoint analyses. Antibiotic exposure was similar between the 2 groups. The probiotic preparation consisted of a capsule containing 2 strains of Lactobacillus acidophilus and 2 strains of bifidobacterium.

The researchers found no difference between the groups in the incidence of ADD (including CDD). In the probiotics group,159 (10.8%) patients developed ADD compared with 153 (10.4%) patients in the placebo group (relative risk [RR], 1.04; 95% confidence interval [CI], 0.84 – 1.28; P = 0.71).

The study authors also found that CDD was an uncommon cause of ADD, occurring in only 12 (0.8%) participants in the microbial preparation group and 17 (1.2%) participants in the placebo group (RR, 0.71; 95% CI, 0.34-1.47; P = 0.35).

“Our trial suggests that properties common to many so-called probiotic bacteria, such as the production of lactic acid, are not effective against AAD in older inpatients,” write Dr. Allen and colleagues.

Although the authors note that this “is the largest trial so far for this problem,” they acknowledge study weaknesses such as low ethnic diversity and lack of participation by eligible patients resulting from an unwillingness to take an additional preparation.

“Our findings do not provide statistical evidence to support recommendations for the routine use of microbial preparations for the prevention of AAD and CDD,” conclude the study authors.

In an accompanying editorial, Nick Daneman, MD, FRCPC, from the University of Toronto, Ontario, Canada, points out that recent meta-analyses have shown large positive effects with the use of probiotic supplements. He also notes that statistical variations such as a low event rate in the current study and overlapping confidence intervals between this study and the meta-analysis may account for the differing results.

However, the size of the current study “dwarfs” previous studies, most of which, he says, were small single institution efforts. “PLACIDE is a large and rigorous negative study, and we must judge whether it can tip the balance of probiotic evidence,” he writes.

“At the very least, the low absolute risk reductions in PLACIDE question the cost-effectiveness of probiotics,” writes Dr. Daneman. In addition, “lactobacilli and bifidobacteria are only two types of non­pathogenic bacteria, and we must consider whether they can really tip the balance of a diverse gut ecosystem,” he concludes.

Funding for this study was provided by the Health Technology Assessment program of the National Institute for Health Research, with additional funding provided by the County Durham and Tees Valley, National Institute for Health Research Comprehensive Local Research Network. Dr. Allen has done research in probiotics supported by Cultech, UK; has been an invited guest at the Yakult Probiotic Symposium; and has received research funding from Yakult, UK. The other authors and the editorialist have disclosed no relevant financial relationships.

Source: Lancet.

 

 

 

Source: Medscape.com

 

New EASD/ADA Position Paper Shifts Diabetes Treatment Goals?

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A new position statement for the treatment of type 2 diabetes takes an approach much more focused on the individual patient compared with the “one number fits all” target of glycated hemoglobin (HbA1c) used up to now.

These new recommendations from the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA), announced here today in a news conference at the European Association for the Study of Diabetes (EASD) 48th Annual Meeting, put the patient’s condition, desires, abilities, and tolerances at the center of the decision-making process about the goals and methods of treatment. “Our recommendations are less prescriptive than and not as algorithmic as prior guidelines,” the authors write.

In light of the increasing complexity of glycemic management in type 2 diabetes and the wide array of antidiabetic agents now available, as well as uncertainties about the benefits of intensive glycemic control on macrovascular complications, a joint task force of the EASD and the ADA sought to develop recommendations for the treatment of nonpregnant patients with type 2 diabetes to help clinicians determine optimal therapies. Their aim was to take into account the benefits and risks of glycemic control, the efficacy and safety of the drugs used to achieve it, and each patient’s situation. The resulting guidelines are published simultaneously in Diabetes Care (2012;35:1364-1379) and Diabetologia (2012;55:1577-1596) by the EASD and the ADA and are available on the EASD Web site.

“What we’re trying to do is encourage people to really engage in a complex world with the patient, given the variety of choices,” said David Matthews, MD, DPhil, from the Oxford Centre for Diabetes, Endocrinology and Metabolism at Churchill Hospital and the National Institute for Health Research, Oxford Biomedical Research Centre, United Kingdom, and cochair of the Position Statement Writing Group of the EASD and ADA. “And the algorithmic approach, in our view, has finally had its day. We can’t do that anymore.”

Dr. Matthews said the EASD and ADA writing group decided not to issue guidelines but rather to take positions and issue recommendations. “Published guidelines tend to be algorithmic, yet few clinicians prescribe by algorithms…and so there’s a lot of lip service to explicit guidelines,” he said.

Furthermore, there’s a danger in guidelines in that some payers and regulatory bodies focus on them as an absolute measure of success or failure and pay accordingly, or not. So for this reason, the authors did not put a specific HbA1c number in their position statement, and in addition, they did not want to give the impression that it is all right for the number to drift upward if it is below a certain level.

On the other hand, a lower HbA1c value may not be best for some patients. “We’ve got trial data challenging the simplistic view of the lower-the-better approach to glycemic control…. That tells us we need to be careful about just using numbers, however important they may be, to treat patients,” Dr. Matthews said.

So the plan is to have the physician and patient combine the best available evidence with clinical expertise and patient preferences to determine the course of treatment, which may include lifestyle interventions such as physical activity, dietary advice, and oral or injectable antidiabetic drugs, including insulin.

Main Points to New Approach

The position statement lays out 7 key points:

  • Individualized glycemic targets and glucose-lowering therapies
  • Diet, exercise, and education as the foundation of the treatment program
  • Use of metformin as the optimal first-line drug unless contraindicated
  • After metformin, the use of 1 or 2 additional oral or injectable agents, with a goal of minimizing adverse effects if possible (despite limited data to guide specific therapy)
  • Ultimately, insulin therapy alone or with other agents if needed to maintain blood glucose control
  • Where possible, all treatment decisions should involve the patient, with a focus on “patient preferences, needs and values”
  • A major focus on “comprehensive cardiovascular risk reduction”

The authors highlight several elements that need to be gauged for making decisions about the appropriate levels of effort to reach glycemic targets. Patient attitudes and expected efforts may range from highly motivated with good adherence and self-care abilities to poor motivation, nonadherence, and poor self-care abilities. The potential risks for hypoglycemia and other adverse effects are another element in decision-making.

The recommendations also focus on duration of disease, life expectancy, significant comorbidities, established vascular complications, and the patient’s resources and support system.

The authors make the point that although the recommendations focus on glycemic control, clinicians and patients should also pay attention to other risk factors, and specifically, “aggressive management of cardiovascular risk factors” in light of the increased risk for cardiovascular morbidity and mortality among patients with type 2 diabetes. Physicians should encourage as much physical activity as possible, aiming for a minimum of 150 min/week, consisting of aerobic, resistance, and flexibility training if possible.

If newly diagnosed patients are at or near the HbA1c target of less than 7.5% and they are highly motivated, they should be given a trial of lifestyle changes for 3 to 6 months with a goal of avoiding pharmacotherapy. But for patients with moderate hyperglycemia or for whom lifestyle changes are expected to be unsuccessful, antidiabetic drug therapy, usually with metformin, should be initiated. If lifestyle efforts are eventually successful, drug therapy may be modified or discontinued.

Information to Guide Pharmacotherapy

Many of the drugs to control blood glucose have similar efficacy, said Writing Group cochair Silvio Inzucchi, MD, professor of medicine, clinical director of the Section of Endocrinology, and director of the Yale Diabetes Center at the Yale School of Medicine in New Haven, Connecticut.

Based on an extensive review of more than 500 articles, “all of these drugs work more or less to the same extent,” he said. “In the grand scheme of things, when you’re talking about a patient taking a medication for years, perhaps decades, and being faced with side effects of medications, the differences in hemoglobin A1c may actually pale in comparison to how they experience that medication.”

To guide choices of glucose-lowering agents, the authors provide in tabular form summaries of the cellular mechanisms, physiological actions, advantages, disadvantages, and costs of classes of agents and drugs within the classes. They also show an algorithm for escalating treatment, starting with lifestyle changes and progressing to initial drug monotherapy, 2- and then 3-drug therapy, and finally to basal and then more complex insulin strategies.

The recommendations end with considerations of the effects of age, weight, sex/racial/ethnic/genetic differences, the comorbidities of coronary artery disease, heart failure, chronic kidney disease, liver dysfunction, and concerns about hypoglycemia. The authors also point out several areas where data are insufficient and therefore where research efforts should be aimed.

When asked if the new recommendations are feasible given the time allotted to seeing a patient, Andreas Pfeiffer, MD, DrMed, chief of the Department of Clinical Nutrition at the German Institute of Human Nutrition Potsdam-Rehbruecke in Nuthetal, Germany, and professor of internal medicine and director of the Department of Endocrinology, Diabetes and Nutrition at Charité Universitaetsmedizin Berlin, Germany, was cautious in his answer.

“If you calculate the time a doctor has per patient, it’s something like 7 minutes or so, and most patients are used to the physician telling him what he’s supposed to do,” Dr. Pfeiffer said. “In some ways it’s unrealistic” for a physician to explore a patient’s desires, capabilities, tolerances, and social support systems in that amount of time. On the other hand, patients return to the doctor several times over the course of a year, so there are more chances to expand the discussion.

But Dr. Pfeiffer worries whether diabetes specialists may become lax if they are not trying to treat to a specific goal. “Diabetologists have average HbA1c’s in Germany of around 7%, which is pretty good, actually…. And now if you relax the guidelines and say, ‘You don’t really have to care so much about it,’ so where do they go?” he wondered.

Source: Mescape.com