Task Force

PCOS: Endocrine Society Issues New Guidelines.

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An Endocrine Society task force has developed new guidelines for the treatment of polycystic ovary syndrome (PCOS).

The guidelines published online October 24 in the Journal of Clinical Endocrinology & Metabolism, are aimed at helping physicians and patients understand a complex condition that often has diverse symptoms.

Task Force Chair Richard S. Legro, MD, professor in obstetrics and gynecology, Penn State University College of Medicine, Hershey, Pennsylvania, and colleagues developed the evidence-based guidelines, using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to rate the strength and quality of recommendations.

“The Society’s recommendations allow physicians to make the diagnosis [of PCOS] if clear symptoms are present without resorting to universal hormone tests or ultrasound screenings,” Dr. Legro said in a press release.

The guidelines advise that an adult woman be diagnosed with PCOS if she has at least 2 of the following symptoms: excess androgen, ovulatory dysfunction, or polycystic ovaries. In addition, any diagnosis of PCOS must rule out other androgen-excess disorders. Physicians should also screen patients for endometrial cancer, mood disorders, obstructive sleep apnea, diabetes, and cardiovascular disease.

Diagnosis of PCOS in adolescent girls should be based on clinical or biochemical signs of hyperandrogenism, after excluding other possible causes, in the presence of persistent oligomenorrhea, the task force advises. A PCOS diagnosis during perimenopause and menopause should be based on a documented, long-term history of oligomenorrhea and hyperandrogenism in reproductive years, the report advises. A finding of PCO morphology via ultrasound would also provide supportive evidence, although the authors note this is least likely in menopausal women. The guidelines recommend against routine ultrasound for endometrial thickness in women with PCOS.

In diagnosing and treating women with PCOS, physicians should look for terminal hair growth, acne, alopecia, acanthosis nigricans, and skin tags during physical examination, according to the new guidelines. The guidelines also recommend screening for ovulatory status using menstrual history.

The guidelines advise assessment of body mass index, waist circumference, blood pressure, and oral glucose tolerance. Overweight and obese patients with PCOS symptoms should be screened for obstructive sleep apnea. Adults and adolescents should be screened and treated for depression and anxiety.

The committee recommends treatment with hormonal contraceptives as the first-line therapy for menstrual abnormalities and hirsutism/acne. Exercise therapy is recommended to manage weight, alone or with a calorie-restricted diet.

The task force advises against the use of metformin as a first-line PCOS treatment, but metformin is recommended for women with PCOS and type 2 diabetes or impaired glucose tolerance who do not succeed with weight loss and exercise. Metformin is also recommended for women who cannot take hormonal contraceptives.

For infertility, the report recommends clomiphene citrate as a first-line treatment. For women undergoing in vitro fertilization, the guidelines recommend metformin as adjuvant therapy to prevent ovarian hyperstimulation.

 

 

Evidence Insufficient for Routine Dementia Screening.

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There is still not enough clear evidence to recommend routine screening for dementia, a draft recommendation  posted today by the US Preventive Services Task Force (USPSTF) concludes.

The new recommendation was based on a systematic review of literature on the topic published online October 22 in the Annals of Internal Medicine, reported by Medscape Medical News at that time.

But while the overall evidence on routine screening is insufficient, clinicians should remain alert to early signs or symptoms of cognitive impairment and evaluate accordingly, the USPSTF said in a statement.

The draft recommendation applies to adults over age 65 years without signs or symptoms of cognitive impairment. It will be posted on the USPSTF Web site and be open for public comment before the Task Force develops a final recommendation.

This recommendation updates the 2003 USPSTF statement that also concluded that the evidence was insufficient to recommend for or against routine screening for dementia. Unlike that earlier recommendation, this updated version considered the evidence on screening for and treatment of mild cognitive impairment in addition to dementia, and on how screening affects decision-making and planning.

Brief Screening Tools

With new data on screening accuracy, the Task Force was able to conclude that there is adequate information on the accuracy of some brief screening tools to identify dementia. The most widely studied instrument is the Mini-Mental State Examination. For the most commonly reported cut points (23/24 or 24/25), the pooled sensitivity from 14 studies was 88.3% (95% confidence interval [CI], 81.3% – 92.9%) and specificity was 86.2% (95% CI, 81.8% – 89.7%).

Other screening tools include the Clock Draw Test, Mini-Cog, Memory Impairment Screen, Abbreviated Mental Test, Short Portable Mental Status Questionnaire, Free and Cued Selective Reminding Test, 7-Minute Screen, Telephone Interview for Cognitive Status, and Informant Questionnaire on Cognitive Decline in the Elderly. These tests have reasonable test performance according to some studies, but their sensitivity or specificity ranged widely and optimal diagnostic cut-points for many are unclear, the statement said.

The new data suggest that treatment of mild to moderate dementia with acetylcholinesterase inhibitors (AChEIs) and memantine, and with nonpharmacologic interventions, such as cognitive stimulation and exercise, results in small improvement in cognitive function, and that interventions aimed at caregivers result in reduced caregiver burden and depression. However, the clinical significance of these improvements is uncertain, according to the Task Force report.

No published evidence was found on the effect of screening on decision-making or planning by patients, clinicians, or caregivers, the Task Force concluded.

Critical Gap

“This is a critical gap in the evidence, and more research is needed so we can better understand the benefits and risks of screening and understand the impact early detection can have on the lives of patients and their families,” commented Task Force member Douglas K. Owens, MD, in press materials accompanying the draft document.

More data will be required before such screening could be recommended. “If we had information on treatments that might be available in early dementia that were highly effective, I think that would be one thing,” Task Force co-vice chair Albert Siu, MD, told Medscape Medical News. “And, if we found interventions that would be effective in terms of helping individuals with early dementia and their family members to make decisions and plan, we would consider that to be important evidence.”

The Task Force also determined that there is inadequate evidence on nonpharmacologic interventions and on the harms of screening (eg, the impact of labeling and of false-positive results). There is, however, evidence that AChEIs are associated with adverse events, some of which are serious, for example, central nervous system disturbances and arrhythmia.

“Overall, the USPSTF was unable to estimate the balance of benefits and harms of screening for cognitive impairment,” the draft recommendation statement concludes.

The Task Force noted that no professional organization has formal guidelines on screening for dementia or cognitive impairment. However, earlier this year, the Alzheimer’s Association published guidance on the detection of cognitive impairment during the Annual Wellness Visit and recommended an algorithm starting with a health risk assessment, patient observation, and unstructured questioning. Use of a brief structured assessment is recommended if signs or symptoms of cognitive impairment are present or if an informant is unavailable to confirm the absence of signs or symptoms.

Dr. Siu noted that dementia screening for patients showing signs and symptoms of dementia was beyond the scope of the Task Force review. “The scope was what do you do on a population basis for individuals who are not complaining of any symptoms and there have been no signs,” he said. “The question is, should you be automatically screening these people? Certainly, if someone comes in with signs or symptoms, that requires evaluation.”

Dementia affects up to about 5.5 million Americans. Its prevalence increases with age, affecting 5% in those aged 71 to 79 years, 24% in those aged 80 to 89 years, and 37% in those older than age 90 years.

The estimated total health, long-term care, and hospice care costs for dementia in the United States were $183 billion in 2011. These costs don’t include the estimated $202 billion in uncompensated care that informal caregivers provide annually.

“Dementia is a very serious issue that has a significant impact on the lives of older adults and their families,” said Dr. Siu in the press statement. “Although the benefits and harms of what we can offer patients through routine screening are unclear right now, clinicians should remain alert to early signs or symptoms of cognitive impairment and evaluate their patients as appropriate.”

The Task Force is now providing an opportunity for public comment on the draft recommendation until December 2. All public comments will then be considered as the Task Force develops its final recommendation. Dr. Siu expects a final recommendation in the spring of 2014.

“Regardless of what our recommendation is, it will serve as guidance to physicians,” rather than a directive, Dr. Siu told Medscape Medical News.

The Task Force is an independent, volunteer panel of national experts in prevention and evidence-based medicine that works to improve the health of all Americans by making evidence-based recommendations about clinical preventive services, such as screenings, counseling services, and preventive medications.

The USPSTF Recommendation on PSA Screening: Our Readers Have Spoken.

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Results of an online poll and reader feedback about prostate-specific antigen screening.

After the U.S. Preventive Services Task Force (USPSTF) published its final recommendation opposing prostate-specific antigen (PSA) screening, we conducted an online poll of readers’ reactions. A total of 177 readers responded to the question “Please choose the statement that best fits your reaction to the USPSTF recommendation against PSA screening.”

As shown in the table, 78% of respondents agreed with the USPSTF recommendation, but a substantial proportion still will offer screening selectively. I’m guessing — based on informal discussions with other physicians — that some of these responses reflect concerns about litigation for failure to diagnose cancer.

Many readers shared their perspectives by posting “reader remarks” in response to our recent summary of the USPSTF recommendation (JW Gen Med Jun 7 2012). One reader will continue to screen because she “has probably saved the life” of several men with screening. She might be right: Even skeptics must concede that individual lives occasionally are saved by screening. After all, if enough men undergo prostatectomy, somewhere in the mix are men who eventually would have died of prostate cancer. But, the important question is this: How many people must undergo screening, biopsies, prostatectomies, and radiation therapy to benefit one person? The Task Force concluded that the number needed to screen (NNS) and number needed to treat (NNT) are too high and result in adverse outcomes for too many people, whereas advocates of screening believe otherwise. Nothing is wrong with arguing that a particular NNS or NNT is too high, as long as we remember that selection of “appropriate” cutoffs are value judgments and not scientific truths.

Another reader entitled his remark “Can’t tell who is saved.” He correctly implies that when a man survives (cancer-free) after treatment for PSA-detected cancer, we can’t determine whether his particular life was saved by screening. From the European randomized screening trial (JW Gen Med Mar 14 2012), we can infer that roughly 1 of every 30 patients who received treatment for screening-detected cancer had his life extended, but we don’t know which particular man was “saved” and which 29 underwent treatment unnecessarily.

Several respondents claimed that mismanagement of PSA results and overtreatment of patients with low-risk prostate cancer — and not PSA screening — are the real problems. In my view, both the PSA test and overtreatment are problematic. No screening test has perfect sensitivity and specificity, but PSA test accuracy is especially poor: Fully 25% of men with PSA levels between 2 and 4 ng/mL have prostate cancer (JW Gen Med Jun 8 2004), and many men with PSA levels between 4 and 10 ng/mL don’t have prostate cancer. Sensitivity and specificity can be refined somewhat by using age-specific cutoffs, change in PSA level over time, or other variations; but so far, these other approaches have not been tested rigorously in controlled studies. Management approaches are all over the map because clinicians don’t quite know what to do when PSA levels go up a little: Biopsy now? Repeat in 1 year? Repeat in 6 months? Give antibiotics for “prostatitis,” and repeat in 1 month? And, regarding overtreatment of men with low-risk cancer, thoughtful urologists have told me, “I agree that we overtreat. But if a patient who doesn’t really need surgery says, ‘I want my cancer treated,’ what are we supposed to do? If we don’t do the surgery, he’ll go elsewhere.”

Another reader suggested that PSA screening is most beneficial in men older than 75. However, in the European screening trial, among men 70 or older at the time of randomization, researchers noted a trend toward higher mortality in screened versus nonscreened men. And, in the largest treatment trial (prostatectomy vs. watchful waiting in men with localized cancer; JW Gen Med Sep 16 2008), prostatectomy was associated with lower mortality only in men younger than 65.

One final interesting comment: A physician reader notes that when patients ask him whether he gets PSA tests himself, he replies that he does not, even though “my father and father-in-law had prostate cancer.” In some clinical encounters, it might be appropriate to share one’s personal medical decisions. But, I believe that when patients ask about PSA testing, physicians should explain why they agree or disagree with screening and leave their own healthcare decisions out of the discussion.

Source: Journal Watch General Medicine.