06Jun

Here’s good news for those seniors who overdid it at the Thanksgiving table: It’s as easy for those over 60 to lose weight by making lifestyle changes as it is for those younger.

It still takes discipline and effort, but the study from the United Kingdom shows that with dietary changes, physical activity and appropriate support obese seniors can lose as much weight as younger people following the same regimen.

“Weight loss is important at any age,” said lead researcher Dr. Thomas Barber of Warwick Medical School, “but as we get older we’re more likely to develop the weight-related co-morbidities of obesity. Many of these are similar to the effects of aging, so you could argue that the relevance of weight loss becomes heightened as we get older.”

Researchers compared the weight loss of two groups of patients at the Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism. One group was under 60 and the other was between 60 and 78. Both groups followed the same lifestyle interventions and participated in the weight reduction program at the institute for an average of 41.5 months for the younger group and 33.6 months for the 60 and over group.

The older group lost an average of 7.3% of their body weight. The younger group lost an average of 6.9%. Most of the patients were morbidly obese when they started the program.

The researchers hope their findings dispel misconceptions about the effectiveness of weight loss programs for older people, as well as myths about the potential benefits of weight loss to seniors.

“There are a number of reasons why people may discount weight loss in older people. These include an ‘ageist’ perspective that weight-loss is not relevant to older people and misconceptions of reduced ability of older people to lose weight through dietary modification and increased exercise,” said Dr. Barber.

“Age should be no barrier to lifestyle management of obesity. Rather than putting up barriers to older people accessing weight loss programs, we should be proactively facilitating that process. To do otherwise would risk further and unnecessary neglect of older people through societal ageist misconceptions.”

The findings were published in Clinical Endocrinology.

Photo by Samuel Ramos on Unsplash

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Jun 6, 2023

2 Fruit + 3 Vegetables = Longer, Healthier Life

When mom told you to eat your vegetables because they were good for you, she was on to something.

The apple and carrot sticks moms pack into lunch boxes and the other fruit and vegetables at dinner are more than just good healthy food. They help you live longer and have a lower risk of dying from heart disease and cancer.

If that all sounds familiar, it should. Medical professionals and the US Department of Agriculture have been telling us for years to eat more fruit and vegetables.

But what’s the right mix? And how much?

The rule of thumb, at least from the American Heart Association, has been 4-5 servings each of fruit and vegetables a day. Here’s an infographic showing us what a serving should be.

Now comes a new study published this month in the journal Circulation telling us there’s nothing wrong with that many servings, but the optimal amount for good health and the lowest risk of death is five servings.Total. Two servings a day of fruit and three of vegetables was found by researchers to be associated with the greatest longevity. More doesn’t hurt, but it doesn’t appreciably make a difference.

“This amount likely offers the most benefit in terms of prevention of major chronic disease and is a relatively achievable intake for the general public,” said Dong D. Wang, M.D., Sc.D., an epidemiologist, nutritionist and a member of the medical faculty at Harvard Medical School and Brigham and Women’s Hospital in Boston.

The lead author of the study, Wang went on to tell ScienceDaily that it makes a difference what the fruit and vegetables are. “We also found that not all fruits and vegetables offer the same degree of benefit, even though current dietary recommendations generally treat all types of fruits and vegetables, including starchy vegetables, fruit juices, and potatoes, the same.”

Peas and corn, as popular as the latter may be, offered no real benefit in lowering mortality. However, green leafy vegetables, nonstarchy vegetables, cruciferous vegetables, citrus fruit, vitamin C–rich, and β-carotene-rich fruit and vegetables did.

Anne Thorndike, M.D., M.P.H., chair of the American Heart Association’s nutrition committee and an associate professor of medicine at Harvard Medical School, said, “This research provides strong evidence for the lifelong benefits of eating fruits and vegetables and suggests a goal amount to consume daily for ideal health.”

Photo by Louis Hansel @shotsoflouis on Unsplash

Jun 6, 2023

How to Write a Clinical Study Report

If you’re new to clinical research, or even if you’re not, sooner or later you’ll be tasked with authoring a clinical study report.

These reports are required by regulatory agencies here in the US and globally. They follow standards and guidelines set by an international group to facilitate creating a standard accepted by agencies in multiple countries.

“A clinical study report (or CSR for short),” explains Eli Lilly in a blog post, “Describes the endpoints or outcomes being researched, provides details on how the data were collected and analyzed, and confirms whether the study endpoints were met or outcomes were achieved. They help regulatory agencies determine if a potential new medication is safe and effective.”

The first questions a novice report writer may have, therefore, are “What do I include in the report,” “What’s the report structure,” “How do I write the report”?

The International Conference On Harmonisation answers those questions in a 49 page guideline that spells out the details and includes sample forms.

Even with the guidelines, preparing a study report is complicated work, requiring the collection of data, analysis and making sure it is both accurate and complete.

Fortunately, the Association of Clinical Research Professionals recently published a much less intimidating primer answering those questions and many more. “Clinical Study Reports 101: Tips and Tricks for the Novice” provides an overview of the CSR, giving us a framework for writing and organizing a report.

The author, Sheryl Stewart, goes into just enough background to give a first time author or contributor an understanding of what needs to be in these reports and why. That goes a long way to helping us know what a report must include. She helpfully points to templates, and reassures us that “there are no requirements to follow the template precisely. Not every section is appropriate for every study.”

Her top level discussion tells us the first step is to review the templates she recommends to help you organize the report. Outlining it will tell you what documents and data you’ll need.

The next step is to identify all the stakeholders. These will certainly include the clinical study management team, those tasked with responsibility for the data and others. In a “Tips and Tricks” section Stewart suggests, “Drafting a project charter or scope document to ensure commitment from all required teammates on scope, deliverables, and timelines.”

Each of the stakeholders should be given a time table for their deliverables. “Time management is paramount for clinical trial submissions to regulatory authorities,” Stewart says.

In her section on the writing of the CSR, Stewart briefly discusses each of the six sections, offering insights into the process. Write the executive summary last, she suggests, because it will be easier then.

She also has a few tips about the review process. Have the reviewers initially focus on content. Formatting and grammar errors are much less important at this stage. She also says that once the review team has signed off on a section, discourage backtracking unless something major changes.

How long should you expect the process to take? Experienced writers surveyed at medical writing conferences came up with an average of 17 days from delivery of the final tables, listings, and figures to first draft. And 26 days from first draft to the final draft sent out for review.

Photo by Scott Graham on Unsplash

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