Nobis Nobis Cartel windows 7 home premium activation key 70-290

In Reporting Symptoms, Don’t Patients Know Best?

About six years ago, my doctor gave me some samples of a drug to treat pain from an injury. I took it for a few days and then woke up one morning with a big red blister on my tongue. I’d never had anything like it before, and I wondered if the pills might be to blame. They weren’t helping much anyway, so I quit taking them. The blister went away. I mentioned it the next time I saw the doctor, but he said it must have been a coincidence.

Not long after, the drug, Bextra, was taken off the market in the United States. It had been linked to heart attacks and also to a dangerous condition called Stevens-Johnson syndrome — which can cause mouth blisters, among other things.

There’s no way to know if Bextra caused my problem, but it seemed like a reasonable idea, and I never understood why my doctor was so quick to dismiss it.

The episode came to mind when I read an article in the March 11 New England Journal of Medicine Dr. Ethan Basch, an oncologist who treats men with prostate cancer does research at Memorial Sloan-Kettering Cancer Center in New York. He argues that doctors, researchers, drug makers and regulators should pay more attention to patients’ firsthand reports of their symptoms while they take medicines, because their information could help to guide treatment and research, and uncover safety problems.

Direct reports from patients are rarely used during drug approval or in clinical trials, Dr. Basch says. If patients’ comments are sought at all, they are usually filtered through doctors and nurses, who write their own impressions of what the patients are feeling.

In addition, he writes, doctors and nurses “systematically downgrade the severity of patients’ symptoms” and sometimes miss side effects altogether. One result is “preventable adverse events” — for instance, suicidal thoughts in young people taking antidepressants, or severe constipation in people taking a drug for irritable bowel syndrome, both of which might have been detected earlier if symptoms had been systematically tracked.

Dr. Basch, 42, said he first became interested in this subject around 2003, when he attended a presentation of the results from a study of a new cancer drug. The researchers had not found fatigue to be much of a problem, but other doctors in the audience said their patients had suffered terribly from it while on the drug, so much that some had to quit taking it. Somehow, the study had completely missed that finding.

Intrigued, Dr. Basch began to study people receiving chemotherapy, and to compare symptom reports by patients with those from doctors and nurses. The differences were striking. For every problem — fatigue, nausea, appetite loss, vomiting, diarrhea, constipation — patients reported it earlier and more often than did doctors and nurses.

Why does this happen so often? There’s no simple answer.

“There is a sensibility among some old-school clinicians that they have a better sense of their patients’ experience than patients do themselves,” Dr. Basch said. “But doctors and nurses bring their own biases to the evaluation. They might say, ‘Mrs. Smith always exaggerates her fatigue — she says 9, but I rate it a 6.’ ”

Three clinicians asked to rate the same patient’s nausea will often give three different scores, he said.

The tendency to downgrade symptoms may be based on the doctor’s knowledge that a patient is in the early stages of an illness and could be much worse. Or the doctor may be making mental comparisons with other patients who are sicker: “You think your nausea is bad, you should have seen the patient I saw this morning, let me tell you,” as Dr. Basch put it.

Sometimes, he said, the downgrading may reflect wishful thinking by doctors, who may think that a certain drug will help patients and don’t want to take them off it.

Another reason, Dr. Basch said, is that “we live in a litigious society.” Describing a problem in a chart creates a record that the doctor may have to act on. “There may be a defensive lack of documentation,” he said.

But he went on, “Increasingly, scientifically, we believe that whatever Mrs. Smith says is what Mrs. Smith is experiencing, and it’s important to know how patients themselves feel about how they’re doing.”

But the doctor’s perspective is important, too, he said, and he suggested that symptoms be rated the way the Web site Metacritic rates movies: it posts two types of score, one from the public and one from professional critics.

“I want both,” Dr. Basch said.

Sometimes the information is lost altogether, when doctors and patients, distracted by test results and treatment plans, forget to discuss symptoms. “This is where a checklist could help,” he said.

Mistakes and distortions in reporting symptoms can be compounded in studies, where one researcher collects the information, another retrieves it from the chart and enters it into the study record, and still others evaluate it. The results can be like playing telephone.

“There are multiple steps of transcription and information filtering,” Dr. Basch said. “We know there are omissions and misinterpretations at every step of data transmission. We know information gets lost.”

Patients may also tell doctors one thing and then write another in their own reports, Dr. Basch said; most say their written accounts are closer to reality.

The idea of not telling doctors the whole truth struck a guilty chord with me. Growing up, I got weekly hay fever shots that I don’t think helped me at all. But I kept hoping they would, and the doctor was very kind, so whenever he asked if I was feeling better, I said yes, even though I actually spent most of August and September sneezing my brains out. This charade went on for years. Would I have been more honest in a diary? Maybe.

The Food and Drug Administration does have a system, Medwatch, that lets doctors and patients report problems that they think are adverse events from drugs already on the market. But it’s a passive system that waits for reports instead of actively surveying patients. Many people don’t know about it, and it has failed to catch some important adverse events, Dr. Basch said.

A better approach, he says, would be to have large numbers of patients filling out questionnaires before and after drugs are marketed. In an e-mail message, he said, “For example, in the postmarket setting we could ask 5,000 selected patients starting Bextra to report monthly (you would have reported the mouth sore without knowing if relevant or not, and this would then be pieced together with other reports).

If patients had been asked to report their symptoms while the drug was still being tested, he added, problems might have been detected before it was even approved.

Gathering the patients’ information would cost money, but not much compared with the overall cost of drug development and clinical trials, Dr. Basch said, adding that it would also save money by heading off potentially expensive problems.

Dr. Basch said he was surprised to find drug companies enthusiastic about his research.

“You’d think it would not be appealing to them, because you’re generating more adverse events,” he said. “But the grade of the data is superior. You catch a lot of baseline symptoms before people start the drug, so you can understand what’s probably related to the drug versus what’s related to the patient’s arthritis or whatever they had before the trial.”

Although the regular reporting may sound like a nuisance for patients, researchers find that many people are eager to have their say. In one study, Dr. Basch said, subjects “typed volumes” into a small online text box, even though they couldn’t see what they were typing after the first few sentences.

“We’d get two pages of stream of consciousness,” Dr. Basch said. “The clinicians became overwhelmed.”

The challenge is to create surveys that focus on what’s relevant — and yet still provide a way to describe symptoms the researchers hadn’t anticipated. Dr. Basch is working on it, for the National Cancer Institute.

“Patients have a lot to say,” Dr. Basch said.

We’re just waiting for someone to listen.

Source: http://www.nytimes.com/2010/04/13/health/13seco.html?scp=1&sq=%20Second%20Opinion%20-%20In%20Reporting%20Symptoms,%20Don%E2%80%99t%20Patients%20Know%20Best?&st=cse

전세계 에 올린 글

오늘 가입!

P/P 레지스트리 서쪽 기관 검토 위원회에 의해 승인 되었습니다. (WIRB) 그리고 적극적으로 등록 하는 참가자는.

영어 버전