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Archive for October, 2013

Primary Care Corner with Geoff Modest MD: Lifestyle interventions to prevent heart disease

23 Oct, 13 | by EBM

the american heart association published a position paper focusing on lifestyle interventions to prevent heart disease (see ).  they note:


— there is abundant evidence that the risk of heart disease is much lower in those with better cardiovascular health metrics (nonsmoking, good diet, physical activity, normal BMI, normal BP, optimal lipids and normal fasting glucose): 78% less heart disease over 5.8 years in those with 5 or more of the above compared to those with none, with similar numbers in longer term studies

–younger adults with healthy behaviors track to having lower biological risk as they age.

–those with initially poorer health behaviors who can change them do better clinically.

–health care providers, even with brief interventions, are able to help patients quit smoking, improve their diets, and increase physical activity.

–on a public health scale, these interventions would not only save lots of lives but reduce costs dramatically


but in order to do this:

–we need to increase the focus on high-value preventive and chronic care and promote healthier behaviors, which requires

–expanded health care coverage (so people can be part of the health care system)

–better reimbursement for these interventions (currently, as we know only too well, it is really hard to do this and take care of all the chronic medical problems and all the array of social issues in 15 minutes)  and better reimbursement to primary care would allow for more time with patients.

–more training for providers in counseling skills (eg motivational interviewing, patient-centered care).

–team approach may also help a lot with this, integrating other health professionals, as well as interfacing with commmunity resources to reinforce the message and provide concrete support (biking trails, farmers’ markets…)


so, all in all, i think this represents a good call-to-action to prevent heart disease (and lots of other diseases as well, but this is from the am heart assn) which focuses on both the specific clinical interaction between the provider and patient and the more global public health imperative.



Primary Care Corner with Geoff Modest MD: BP goal in kidney disease

23 Oct, 13 | by EBM

there seems to be several recent recommendations suggesting higher BP goals than JNC7.  the american diabetes assn set the new goal at 140/80, given the results of the ACCORD trial. the european society of cardiology came out with guidelines which i sent out before (see  doi:10.1093/eurheartj/eht151 ), which in brief set their goals as:

–systolic bp < 140 in patients with low-to-mod cardiovasc risk and those with diabetes (best data) as well as those with hx stroke/TIA, coronary art dz, diabetic or nondiabetic chronic kidney dz, without differentiating the presence of proteinuria (less good data)

–in elderly <80yo with SBP >160, decrease SBP to 140-150 range

–in fit elderly <80, SBP <140 should be considered (though i would add to check orthostatics in elderly esp with the lower goal, as well as checking symptoms). in fragile elderly, individualize goal

–in elderly >80yo and SBP>160, goal of 140-150 range

–DBP <90 in all, <85 in diabetics but 80-85 is safe


the quality of date for these recommendations is quite variable, as they note.


specifically for kidney disease,  KDIGO (kidney disease– improving global outcomes) came out with guidelines in 2012 suggesting goal of 140/90 in patients without proteinuria and 130/80 if either micro or macroalbumenuria present. in this light, there was a recent retrospective analysis in the annals looking at massive VA database of patients with chronic kidney dz and all-cause mortality, stratified by achieved systolic and diastolic blood pressures (see Ann Intern Med. 2013;159(4):233-242. doi:10.7326/0003-4819-159-4-201308200-00004).  650K almost all men stratified into 96 different blood pressure groupings (from <80/40 to >210/110) in 10mmHg increments.  they used eGFR calculations using the Chronic Kidney Disease Epidemiology Collaboration equation. findings:

–average age 73.8, 2.7% female, mean BMI 29

–pretty sick population with 43% having CAD, 43% diabetes,15% cerebrovasc dz, 15% CHF and mean eGFR 50.  62% CKD stage 3A (eGFR 45-59) or 3B (30-45). not much albumenuria, with microalb/creat ratio median of 40.

–mean baseline SBP 135 and DBP 72 (though not explicitly stated, this is pretty undoubtedly the mean baseline on lots of meds)

–240K deaths recorded

–the best mortality outcomes were with syst bp 140-160 and diast bp 80-90. no diff in group with proteinuria (though not much proteinuria overall) – see graph in article

–“U”-shaped curve, with mortality pretty similar if DBP 60 or 100. SBP 120 or 180.

–so, their conclusion: optimal bp in the 130-159/70-89 range. and “it may not be advantageous to achieve ideal SBP at the expense of lower-than-ideal DBP in adults with CKD”


impressive with huge numbers of people and lots of deaths, so able to stratify by many blood pressure groupings. but:

–this is observational retrospective study, without even clean information on blood pressures prior to being put on meds

–eGFR is not so accurate, esp in older group

–the issue of diastolic hypotension is pretty murky. the higher mortality in those with lower DBP may well represent the group of patients with isolated systolic hypertension initially with a wide pulse pressure (several studies show that pts with high pulse pressures have much higher mortality, presumably related to the fact that they have stiff arteries from atherosclerotic dz). even the intervention studies in the elderly with isolated systolic hypertension (eg SHEP) are not so easy to interpret, since those with initially low DBP do worse in both the intervention and placebo groups!!– is it because of the low DBP itself (reflecting more advanced atherosclerotic disease and arterial stiffness) or because of lowering the DBP too much (and decreasing coronary blood flow in patients at high risk of CAD). given these concerns, the SHEP trial concluded that there may be increased mortality with DBP<60 (but as noted, this is true in the untreated group as well). in fact, the achieved bp in SHEP was 143/68, with significant decrease in stroke and close to significant decrease in cardiovasc dz.  other studies suggest increased risk of stroke if DBP<65. my caveat here is that most patients with isolated systolic blood pressure put on antihypertensives have much more significant lowering of their systolic than diastolic pressures (and the goal of the hypertension in elderly of achieving SBP in the 140-150 range is usually attained without lowering DBP too much). the decrease in clinical events by lowering the systolic blood pressure at least to the 140-150 range is consistent throughout the studies, but we should make sure that we treat the individual patient (watching for signs of decreased coronary perfusion, decreased mental functioning, orthostatic hypotension, etc) and use that as the ultimate guide. there are no data that i know of for treating patients with baseline high systolic pressures and very low diastolics, such as 180/55, though i would do so cautiously. (if any of you know of studies, please let me know and i will send it around).


so, this study is interesting and seemed to get a lot of play, but really does not add that much insight.  i am mostly mentioning it to bring up the complicated issue above.



Primary Care Corner with Geoff Modest MD: Choosing endocrine tests wisely

23 Oct, 13 | by EBM

endocrine society and am assn of clinical endocrinologists added their suggestions to the choosing wisely website (see ). this website in general has suggestions about unnecessary tests from many of the major specialty and primary care organizations and is really well-organized.

the endocrine society points:

  1. avoid routine daily self-glucose monitoring in adults with stable DM2 or agents not causing hypoglycemia (eg metformin).  The issue here is that it does not make sense to have patients check their fingersticks more than once a day if they are well-controlled.  There was a study in BMJ a couple of years ago suggesting that glucose self-monitoring in the aggregate did not change diabetes management, largely because physicians did not act on that information.  However, I do find there is an additional role for checking fingersticks, which is for patients to get direct feedback themselves about the effect of what they’re eating, or the effects of exercise in lowering blood sugar.  So, I do encourage patients to check their fingerstick after they have high carbohydrate meals, for example, to learn the effect of that meal on their blood sugar — as a means to educate themselves about what they should or should not eat and what quantities are okay.
  2. Do not routinely measure 1, 25-dihydroxy vitamin D unless the patient has hypercalcemia or decreased kidney function.  The issue here is that 25-hydroxy vitamin D assesses vitamin D stores more accurately than the 1,25-dihydroxy vit d.  Patients who have low vitamin D may well have preserved 1, 25 dihydroxy vitamin D levels as the body struggles to maintain appropriate levels of the active hormone (1,25-dihydroxy).
  3. Do not routinely order a thyroid ultrasound in patients with abnormal thyroid function tests in the absence of a palpable thyroid gland abnormality.  The point here is that there is not often a relationship between having thyroid nodules and thyroid dysfunction, and additionally the ultrasound are too sensitive and frequently picks up inconsequential small nodules.  As in many radiologic studies, ultrasounds beget ultrasounds beget ultrasounds ( or CT scans beget CTs or MRIs or…) for insignificant problems, leading to patient anxiety, loss of work/interference with daily life, and  cost.
  4. Do not order a total or free T3 when assessing levothyroxine dose in hypothyroid patients.  Although T3 is the more active hormone, TSH is the physiologic measure indicating appropriate thyroxine repletion.  In fact, patients on oral levothyroxine may well have high T4 and low T3 levels appropriately.  Ordering TSH to monitor thyroid replacement of course applies only to patients who have hypothyroidism from a primary thyroid dysfunction.
  5. Do not prescribe testosterone unless there is biochemical evidence of deficiency.  The issue here is that the symptoms associated with   testosterone deficiency are common and very often related to other medical or psychosocial issues.  There has been an apparent massive TV advertising campaign by the drug companies to promote  testosterone replacement, which (not surprisingly) creates a significant financial advantage to them.  However, testosterone replacement therapy is not indicated unless there is true testosterone deficiency, documented by a low total testosterone level from a morning blood sample.  This probably should be repeated on a second day if low.  In labs with high-quality assessment of free or bioavailable testosterone, that also might be helpful in documenting testosterone deficiency.


Primary Care Corner with Geoffrey Modest MD: Colon cancer screening, the latest

23 Oct, 13 | by EBM

2 new articles on colorectal cancer screening in NEJM last month.

1. retrospective review of the nurses’ health study and the health professionals follow-up study (not a randomized controlled trial), of 90K people followed 22 years (see  DOI: 10.1056/NEJMoa1301969).  results:

— total of 1815 incident cancers and 474 colorectal cancer deaths

–with any lower endoscopy done, 43% fewer colorectal cancers in those who had a polypectomy for adenoma, 40% fewer in those with negative sigmoidoscopy, and 56% fewer in those with negative colonoscopy. data consistent for men and women.

–for proximal lesions (prior data suggested less efficacy of screening on proximal lesions), 27% fewer cancers

–for death from colorectal cancers: 41% fewer with screening sigmoidoscopy and 68% fewer with colonosc

–reduced mortality from proximal cancers by 53% with colonoscopy and no difference with sigmoidoscopy

–(not surprisingly) those with cancer diagnosed within 5 years of colonoscopy had more aggressive cancers (CpG island methylator phenotype — CIMP — and microsatellite instability)

–benefit of colonoscopy extended 15 years for both proximal and distal tumors.  the numbers of individuals are significantly smaller in the group getting screening in the 10-15 year range (and it appears that they do even better), though the group with screening >15 years was worse (but still 31% lower than the controls) — so these authors suggest sticking with 10 years as the appropriate screening interval in those with normal initial colonoscopy.

–also, aspirin had no benefit beyond colonoscopy alone

so, this study did show significant benefit of colonoscopy for proximal tumors (there were articles a couple of years ago suggesting that we only do sigmoidoscopy because it is safer/cheaper/easier on the patient and the data on efficacy for proximal tumors was pretty questionable) and a clear/persistent benefit to screening, even if not repeated for more than 15 years

2. 30 year followup of the minnesota colon cancer control study (see DOI: 10.1056/NEJMoa1300720). 47K people studied, randomized to usual care vs annual or biennial fecal occult blood testing (this was a pretty profound study at the time, though 82.5% of the FOBT slides were rehydrated, which creates 4 times as many false positive results — 9.8% per screening in those with rehydrated slides vs 2.4% in those without rehydration — and then leading to 38% of those in the annual and 28% in those in the biennial groups getting colonoscopy (12,246 colonoscopies!!!). in some ways, this perhaps ended up being more of a colonoscopy study, since so many were done…..). the initial study results reported in 1993 (see Mandel J, NEJM 1993; 328: 1365-71) found a 33% decrease in colorectal cancer mortality, leading to the generalized recommendations to screen for colon ca. results of the longterm followup:

–732 deaths from colorectal cancer (by death certificates)

–screening led to 32% decreased colorectal cancer mortality in the annual screening group and 22% in the biennial group through the 30 years of followup. no diff in all-cause mortality. men benefited more than women in the biennial screening group

–no diff in total mortality

so, pretty clear that colon cancer screening is important, has durable benefit over the longterm, and (i think) both studies ultimately reinforce colonoscopy as the most effective tool.



Primary Care Corner with Geoff Modest MD: HPV vaccine–time to use it

23 Oct, 13 | by EBM

a couple of articles on HPV and vaccine:


1. CDC reports: A new study looking at the prevalence of human papillomavirus (HPV) infections in girls and women before and after the introduction of the HPV vaccine shows a significant reduction in vaccine-type HPV in U.S. teens. The study, published in [the June issue of] The Journal of Infectious Diseases  reveals that since the vaccine was introduced in 2006, vaccine-type HPV prevalence decreased 56 percent among female teenagers 14-19 years of age. this is in spite of the fact that <1/3 of eligible teenage females get the full vaccine series, suggesting perhaps that there is either herd immunity and/or there is functionally effective immunity with fewer than the full series of shots.


2. article in the lancet on association of oral HPV with oropharyngeal cancers (see

S0140-6736(13)60809-0). oropharyngeal cancers disproportionately affect men (oral HPV infections 3x more common in men than women) and some are caused by oral HPV infection, esp with HPV 16 (this HPV type is associated with the rapid increase in oropharyngeal infections in some areas of the world, and one the main culprits for cervical ca in women).  the lancet study looked at the incidence and natural history of oral HPV infections in men from Brazil, Mexico and the US. they checked oral samples every 6 months for up to 4 years. findings:


–1626 men aged 18-73 followed for median of 1 year.

–4.4% of men acquired an incident oral HPV infection within 1 year, 1.7% with oncogenic strain (13 strains including HPV 16 and 18), 0.6% with HPV16 (which was most common of the oncogenic strains).

–higher incidence in smokers, independent of sexual behaviors (though other studies have found that oral sex is associated with higher oral HPV infections, this study did not find that oral sex in the past 6 months or ever having oral sex was associated), more common in bisexual than heterosexual men.

–median duration of infection 7 months, with 8 of 18 oral HPV16 infections persisting for 2 or more study visits (20% lasting 12-18 months, but very low n)


so, oral HPV infections quite uncommon and mostly cleared within one year (as with vaginal infections in women). reinforces widespread use of vaccine. there was one study in costa rica, reported in PLOS One, which did find a decrease in oral HPV in women who were vaccinated. i do not know of any studies in men. but makes sense to immunize men and women, as recommended by CDC.



Primary Care Corner with Geoffrey Modest MD: Influenza 2013

23 Oct, 13 | by EBM

see below. mmwr on influenza control. i felt proud to know that one of the influenza strains covered by the vaccine is from massachusetts.  we finally made it.

you can click on the link to read the whole article. just a couple of changes:

–Boston added!

–several new formulations, including quadrivalent, egg-free (for ages 18-49 only).  we only have the trivalent at the health center at this point

there was info a couple of years ago suggesting deceasing efficacy of the live attenuated vaccine (LAIV) vs inactivated as people reach the ripe old age of around 35-40. (i don’t have that reference). not mentioned in   mmwr. there was an article comparing vaccines (see DOI:10.1111/j.1750-2659.2010.00183.x) which suggested that the live vaccine may be more effective as a priming vaccine and the TIV more effective in boosting pre-existing immunity.  which could explain the age difference (if it is real). i personally stopped using the LAIV in patients over late 30’s because of the data from a few years ago, but since not mentioned in MMWR, probably it is okay to use it.




From: Centers for Disease Control & Prevention []
Sent: Thursday, September 19, 2013 12:19 PM
To: Modest, Geoffrey A.,M.D.
Subject: MMWR Vol. 62 / No. RR-7


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Recommendations and Reports
Volume 62, No. RR-7
September 20, 2013

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Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization
United States,

This report updates the 2012 recommendations by CDC’s Advisory Committee on Immunization Practices (ACIP) regarding the use of influenza vaccines for the prevention and control of seasonal influenza. Routine annual influenza vaccination is recommended for all persons aged ≥6 months. For the 2013–14 influenza season, it is expected that trivalent live attenuated influenza vaccine (LAIV3) will be replaced by a quadrivalent LAIV formulation (LAIV4). Inactivated influenza vaccines (IIVs) will be available in both trivalent (IIV3) and quadrivalent (IIV4) formulations. Vaccine virus strains included in the 2013–14 U.S. trivalent influenza vaccines will be an A/California/7/2009 (H1N1)–like virus, an H3N2 virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011, and a B/Massachusetts/2/2012–like virus. Quadrivalent vaccines will include an additional influenza B virus strain, a B/Brisbane/60/2008–like virus, intended to ensure that both influenza B virus antigenic lineages (Victoria and Yamagata) are included in the vaccine. This information is intended for vaccination providers, immunization program personnel, and public
health personnel.

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Primary Care Corner with Geoffrey Modest: Diet, exercise can lead to fatty liver disease (NAFLD) remission

16 Oct, 13 | by EBM

non-alcoholic fatty liver disease is the most common cause of abnormal liver chemistries throughout the world, with purported incidence of 15-40% (16% in the recent NHANES3 data), often associated with obesity, metabolic syndrome, diabetes, dyslipidemia. we certainly see more NAFLD in patients with increased ALT than hepatitis C at the health center, which is also quite common. recent article found that weight loss was associated with reversal of NAFLD (see in brief:

–154 pts with NAFLD in community-based study in Hong Kong identified by increased ALT (median 43) and negative viral serologies/ANA, randomized to diet (dietician-led individual education weekly x 4 months, then monthly for 8 months, focusing on exercise and reducing calorie intake) vs control, assessing intrahepatic triglyceride content (IHTG) by proton-magnetic resonance spectroscopy at start and end of study (following ALT levels is a less reliable indicator of NAFLD activity). primary outcome was remission of NAFLD, as evidenced by IHTG <5% (average initial IHTG was 12%, overall a group with pretty mild NAFLD). average BMI = 25.

–results: NAFLD remitted in 64% of patients in intervention group vs 20% of controls. body weight dec 5.6 vs 0.6 kg, but of those who lost >10% of body weight, 97% had remission of NAFLD. 41% of those with wt loss of 3-5% also achieved remission. of parameters assessed, only weight reduction significantly correlated with NAFLD remission. intervention group also had decreased in ALT and LDL-cholesterol

so, NAFLD is very common, recent studies have suggested that the long-term outcome is pretty much the same as with hepatitis C infection in terms of progression to cirrhosis/hepatoma, but in this community-based study there was significant remission with aggressive weight loss. one caveat is that though it seems that IHTG is a more reliable indicator of NAFLD than ALT, it does not reveal important histologic data (eg necroinflammation) which can only be assessed by biopsy and seems to be more associated with adverse hepatic outcomes. this study was done in hong kong, so although the average BMI was not so high compared to our standards, asian people tend to have more metabolic syndrome at lower waist circumference/BMI than westerners. but, the bottom line in this community-based study is that diet/exercise really seems to lead to remission of NAFLD in large % of people who are successful with weight loss, in a dose response relationship.


Primary Care Corner with Geoffrey Modest: Update on OI prevention in HIV

16 Oct, 13 | by EBM

recent update on prevention and treatment of opportunistic infections in HIV infected adolescents and adults.


reference: Panel on Opportunistic Infections in HIV-Infected Adults and Adolescents. Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health [trunc]. Atlanta (GA): Centers for Disease Control and Prevention (CDC); 2013 Jul 8.


on-line access:


some new info incorporated.  the guidelines provide very specific recommendations, without a lot of text, for the myriad of HIV-related infections. a couple of notable changes:


–hep b. vaccination is as per non-HIV infected. important to check post-vaccination HbsAb to assess response. if non-responder, can wait til increase of CD4 if low, and then repeat; can give another series of vaccines; can give double dose vaccines (there have been a couple of articles in past year showing increased immunogenicity of the double-dose vaccine in HIV patients, so this is my preferred approach)


–hep c. includes use of protease inhibitors (boceprevir, telaprevir) along with interferon/ribivarin

Primary Care Corner with Geoffrey Modest MD: Antibiotics and ibuprofen (still) don’t help acute bronchitis

16 Oct, 13 | by EBM

recent online article in BMJ finding lack of efficacy of antibiotics or ibuprofen on acute bronchitis with discolored sputum (see BMJ 2013;347:f5762 doi: 10.1136/bmj.f5762). 416 adults aged 18-70 in primary care centers in spain with sx of respiratory tract infection of less than 1 week, cough predominant with discolored sputum, and at least one other sx suggesting lower resp tract infection (dyspnea, wheezing, chest discomfort or pain). chest xray not required to r/o pneumonia — the dx of acute bronchitis was a clinical one. randomized to ibuprofen 600 TID, amox/clavulanic acid 500/125 TID, or placebo for 10 days.  patients reported sx in diary. overall, 40% of patients were smokers, 10% had diabetes, 8% with fever, >50% had increased CRP with 25% quite high CRP (>21). results


–median # days from the initial presentation of frequent cough slightly decreased with ibuprofen (9 days) vs those on abx (11 days) or placebo (11 days), not statistically different

–no diff in probability of cough resolution

–adverse effects common with abx (12%), vs ibuprofen (5%) or placebo (3%).


so, not a lot to do for patients with acute bronchitis. (note: this does not apply to patients with copd and exacerbation with change in color of their sputum). cochrane reviews do not show benefit from b-agonists or anti-tussives. it is pretty clear that providers do prescribe antibiotics a lot for acute bronchitis (>60% of the time), and even more so if there is discolored sputum (3.2 times as likely as in patients without discolored sputum). would have been better in this study if they evaluated utility of antibiotics or ibuprofen in patient subgroups (eg, smokers, or diabetics, or those with higher CRP), but overall this article provides further impetus to avoid prescribing antibiotics, with their adverse effects on the patients and on society overall from resistant bacteria.

Primary Care Corner with Geoffrey Modest MD: absence of 4 factors may rule out cardiac syncope and need for specialist referral in kids

16 Oct, 13 | by EBM

in recent study looked at factors which might distinguish cardiac syncope from vasovagal syncope in children up to 18 years old (see ). the study was set in a pediatric cardiology clinic including 89 patients who had vasovagal syncope over a one year period, compared with children with known cardiac syncope (given the relative rarity of cardiac syncope, they searched their files and found 17 patients who had significant cardiac disease and syncope).  8 with cardiac syncope had long QT syndrome, 3 had cardiomyopathy (2 HOCM), and one of each had  left coronary artery originating from the right aortic cusp, primary pulmonary hypertension, myocarditis with ventricular tachycardia, catecholaminergic polymorphic ventricular tachycardia, cardiac fibroma, and idiopathic ventricular tachycardia (notably, no Brugada or arrhythmogenic right ventricular dysplasia). results (only statistically significant ones noted), comparing cardiac syncope with vasovagal syncope:


–71% those with cardiac syncope had no previous syncopal event, versus 36% with vasovagal syncope.

–trigger event (noxious stimuli or frightening events) was not found in any patient with cardiac syncope but 24% of those with vasovagal syncope

–presyncopal symptoms not leading to syncope in 12% with cardiac syncope and 69% with vasovagal

–preceding symptoms such as lightheadedness or visual changes in 41% with cardiac etiology vs 84% with vasovagal

–prolonged standing was found in none with cardiac syncope but 82% with vasovagal syncope

–syncope with activity in 65% in cardiac syncope vs 18%; syncope at peak exercise in 53% vs 6%

–PE overall abnormal in 29% vs 0%

–EKG abnormal in 76% vs 0%

–but no difference in chest pain or palpitations before the syncope or history of decreased exercise tolerance preceding the event.


–overall: if compare the combo of exertional syncope (at peak or post exercise), concerning cardiac family history (syncope; heart probs including arrhythmia, congenital heart dz, cardiomyopathy; sudden death younger than 50 yo), abnl PE or abnormal EKG – mean number of these items found in cardiac syncope was 2.1 vs 0.4 with vasovagal.  And, if use the presence of any one of these 4 as basis for referral to cardiology, would have identified 100% of those with cardiac syncope, and (perhaps most importantly), would have avoided 60% of those with vasovagal being referred to this cardiology clinic.


so, small study, esp in the number of kids with cardiac syncope (though this is really pretty uncommon), but suggests that the rather common vasovagal syncope typically does not require referral if the above 4 items are assessed


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