evidence based management by dr/ zainab alhazmi mbbs. sbfm.abfm >>

Evidence Based ManagementBy Dr/

Zainab AlhazmiMBBS. SBFM.ABFM>>

Aim

*How to answer evidence based management questions.

*To pass Saudi Board Written Exam Insha Allah All of you .

How is the exam?

1- The questions are usually 3-4 questions.2-The resident should answer in terms of

- Harm and Benefit- Pros And Cons- Guidelines and recommendations

How is the marking?3 -The marking of the question will be as

follows;>90% : full coverage of evidence from EBM

database 80-90%: evidence content is correct but

using one EBM database60-70% : evidence content is correct but no

use of EBM database. Incorrect answer will score zero.

Important reference to study Evidence based management

1)Cochrane review ; read the summary and Author's conclusion .Easy to reach it without payment by Google search.

2 )BMJ clinical evidence needs subscription3)American Family Physician Journal ;monthly

cochrne reviw and BMJ evidence …and this is very important source***

4)Guidelins for chronic diseases and common diseases

5)USPSTF recommendations 6)Hot Topics

7)Essential evidence (previously info poem)

Evidenc Base Manegement Exam Questions 2008

1)Recommendations regarding screening of breast .cancer

2)Pharmacological modalities for smoking .cessation

.3 )Evidence regarding cranberry in UTI4)What are the effect of drug treatment in

women with premenstrual syndrome…5 )Antiplatelets and anticoagulant

in ...hypertension.

Let us start this EBM Review

Screening

A)Cancer Screening

Colorectal cancerCervical Cancer.Breast CancerProstate Cancer

Screening for Colorectal Cancer

According to the latest research evidenceThe USPSTF recommends screening for colorectal cancer (CRC) using fecal occult blood testing, sigmoidoscopy, or colonoscopy, in adults, beginning at age 50 years and continuing until age 75 years. The risks and benefits of these screening

methods vary  .

Grade: A Recommendation ..

The USPSTF recommends against routine screening for colorectal cancer in adults age 76 to 85 years. There may be considerations that support colorectal cancer screening in an individual patient.

Grade ; C Recommendation

The USPSTF recommends against screening for colorectal cancer in adults older than

age 85 years. Grade : D Recommendation .

The USPSTF concludes that the evidence is insufficient to assess the benefits and

harms of computed tomographic colonography and fecal DNA testing as

screening modalities for colorectal cancer. Grade : I Statement

According to the Cochrane Databse Systematic Reviw

Benefits of screening include; A modest reduction in colorectal cancer mortality.

A possible reduction in cancer incidence through the.. .detection and removal of colorectal adenomas

The less invasive surgery that earlier treatment of colorectal cancers may involve.

Harmful effects ;The psycho-social consequences of receiving a false positive result.

The potentially significant complications of colonoscopy or a false-negative result.

The possibility of overdiagnosis (leading to unnecessary investigations or treatment).

Breast cancer• The U.S. Preventive Services Task Force (USPSTF)

recommends screening mammography, with or without clinical breast examination, every 1-2 years for women aged 40 and older.

• The USPSTF concludes that the evidence is insufficient to recommend for or against routine clinical breast examination (CBE) alone to screen for breast cancer.

• The USPSTF concludes that the evidence is insufficient to recommend for or against teaching or performing routine breast self-examination (BSE).

• breast cancer screening after age 65 reduces mortality at reasonable costs for women without significant comorbidity

Prostate cancer•The USPSTF concludes that the

current evidence is insufficient to assess the balance of benefits and harms of prostate cancer screening in men younger than age 75 years.Grade: I Statement.

•The USPSTF recommends against screening for prostate cancer in men age 75 years or older.Grade: D Recommendation.

Prostate cancer

• The harms of screening include the discomfort of prostate biopsy and the psychological harm of false-positive test results.

• Harms of treatment include erectile dysfunction, urinary incontinence, bowel dysfunction, and death. A proportion of those treated, and possibly harmed, would never have developed cancer symptoms during their lifetime.

• For men younger than age 75 years, evidence is inadequate to determine whether screening improves health outcomes.Therefore, the balance of harms and benefits cannot be determined.

• For men age 75 years or older and for those whose life expectancy is 10 years or fewer, the incremental benefit from treatment of prostate cancer detected by screening is small to none. Therefore, harms outweigh benefits.

Cervical cancer• The USPSTF strongly recommends screening for cervical cancer in women

who have been sexually active and have a cervix.Grade: A Recommendation.

• The USPSTF recommends against routinely screening women older than age 65 for cervical cancer if they have had adequate recent screening with normal Pap smears and are not otherwise at high risk for cervical cancer (go to Clinical Considerations).Grade: D Recommendation.

• The USPSTF recommends against routine Pap smear screening in women who have had a total hysterectomy for benign disease.Grade: D Recommendation.

• The USPSTF concludes that the evidence is insufficient to recommend for or against the routine use of new technologies to screen for cervical cancer. Grade: I Statement.

• The USPSTF concludes that the evidence is insufficient to recommend for or against the routine use of human papillomavirus (HPV) testing as a primary screening test for cervical cancer. Grade: I recommendation.

Diabetes Mellitus

ScreeningPrevention

DiagnosTreatment Glycemic controlSelf Monitoring D.M; manging dyslipedemiaD.m;Prevention of cardiovascular eventsD.m; Treating hypertesionD.M;Nephropathy

Question;Discuss the evidence regarding the

effectiveness of the following intervention in the primary care management of type 2 D.M. :

A) Universal screeningB)prevention of type 2 D.M

A) Universal screeningAccording to the American Diabetic

association Guideline

The effectiveness of early identification of pre-diabetes and diabetes through mass testing of asymptomatic individuals has not been definitively proven (and rigorous trials to provide such proof are unlikely to occur)

The argument for screening is

Important public health problem D.M is commonImpose significant public health burdens. There is a long presymptomatic phase before the

diagnosis of type 2 diabetes is usually made.Relatively simple tests are available to detect preclinical diseaseThe duration of glycemic burden is a strong predictor of

adverse outcomes,Effective interventions exist to prevent progression of

pre-diabetes to diabetes and to reduce risk of complications of diabetes according g to the DCCT and

UKDPS(i.e. fulfill many of Wilson and Jungr’s criteria)

Argument against this areCommunity screening outside a health care setting is not recommended because;

People with positive tests may not seek, or have access to, appropriate follow-up testing and care.Conversely, there may be failure to ensure appropriate repeat testing for individuals who test negative .

Community screening may also be poorly targeted, i.e., it may fail to reach the groups most at risk and inappropriately test those at low risk (the worried well) or even those

already diagnosed.… .

Because of the need for follow-up anddiscussion of abnormal results, testingshould be carried out within the healthcare setting. And to target those at risk

according to ADA recommendations…

Prevention of type 2 D.MAcccording to ADA Guideline 2009 recommendations;

*Patients with IGT (A) or IFG (E) should be

referred to an effective ongoing support program for weight loss of 5–10% of body weight and for increasing physical activity to at least 150 min per week of moderate

activity such as walking According to th Diabetes Prevention

Program(DPP) research Group outcome study ..)

* Follow-up counseling appears to be important for success. (B)

* In addition to lifestyle counseling, metformin may be considered in those who are at very high risk for developing diabetes (combined IFG and IGT plus other risk factors such as A1C 6%, hypertension, low HDL cholesterol, elevated triglycerides, or family history of diabetes in a first-degree relative) and who are obese and under 60 years of age. (E)

* Monitoring for the development of diabetes in those with pre-diabetes should be performed every year. (E)

According to the Diabetes Prevention Program(DPP) Research Group /Outcome

Over 3000 patients with impaired fasting glucose or glucose intolerance were randomized to placebo, metformin, 0r intensive lifestyle modification program(150 minutes of exercise per week and 5-10% weight reduction)..The most effective intervention was found to

be lifestyle intervention(NNT 7) ..

D.M and Dyslipedemia

•What are the evidence for statin use in diabetics?

/ِADA recommendations

Statin therapy should be added to lifestyle therapy, regardless of baseline lipid

levels, for diabetic patients : - with overt CVD (A) - without CVD who are >40 and have one or

more other CVD risk factors. (A)

-For lower-risk patients than the above(e.g., without overt CVD and under the

age of 40:) statin therapy should be considered in

addition to lifestyle therapy if LDL cholesterol remains above 100 mg/dl or in those with multiple CVD risk factors. (E)

Important to consider patient individual risk

* Statin are containdicated in Pregnancy.

Land mark studies for evidence of benifit of lipid lowering treatment in Diabetic patient

*Heart Protection study ;(simvastatin could reduce the risk of M.I ,stoke or need for revasulrization in diabetic patients by third regardless of their cholesterol level

*CARDS Study(Collaborative Atorvastatin Diabetes Study).

•Baaed on evidence :

•Are all diabetics in need for self –monitoring of their blood glucose.?

According to the American Diabetic Association Recommendations ●SMBG should be carried out three or more times daily for patients using multiple insulin injections or insulin pump therapy. (A)

●For patients using less frequent insulin injections, noninsulin therapies, or medical nutrition therapy (MNT) and physical activity alone, SMBG may be useful as a guide to the success of therapy. (E)

●To achieve postprandial glucose targets, postprandial SMBG may be appropriate

(E)

• When prescribing SMBG, ensure that patients receive initial instruction in and routine follow-up evaluation of, SMBG technique and their ability to use data to adjust therapy. (E)

• Continuous glucose monitoring (CGM) in conjunction with intensive insulin regimens can be a useful tool to lower A1C in selected adults (age 25 years) with type 1 diabetes (A).

• CGM may be a supplemental tool to SMBG in those with hypoglycemia unawareness and/or frequent hypoglycemic episodes. (E)

• Insulin monotherapy versus combinations of insulin with oral

hypoglycaemic agents

• in patients with type 2 diabetes mellitus which is more effective?

According to the cochrane Database systematic Review

Bedtime NPH insulin combined with oral hypoglycaemic agents provides comparable glycaemic control to insulin monotherapy and is associated with less weight gain if metformin is used .

Hypertension

Important Landmarks Study To Know in :Hypertension

*Hypertension Optimal Treatment Trial(HOT)trial;Unique in that it was designed to evaluate

optimum targetB.P level *ALLHAT(antihypertensive and Lipid Lowering to

Prevent Heart Attack Trial);the largest ever hypertensive trial; Thiazide diuretics first line treatment of hypertension in absence of compelling indicatinos.

*Angio-Scandinivian cardiac Outcome trial, B.P ASCOT))lowering arm

Should beta blockers be used as first-linetreatments for lowering blood pressure?

Evidence-Based Answer According to the cochrane database

Systematic Review and JNC 7th Report;Current evidence(ALLHAT STUDY) does not support the use of beta blockers as initial therapy fo hypertension

Beta-blockers for hypertension

•According to The Cochrane Database of Systematic Reviews •The available evidence does not support the use of beta-

blockers as first-line drugs in the treatment of hypertension .

•This conclusion is based on the relatively weak effect of beta-blockers to reduce stroke and the absence of an effect on coronary heart disease when compared to placebo or no treatment .

•More importantly, it is based on the trend towards worse outcomes in comparison with calcium-channel blockers, renin-angiotensin system inhibitors, and thiazide diuretics .

•Most of the evidence for these conclusions comes from trials where atenolol was the beta-blocker used (75% of

beta-blocker participants in this review). .

What are the recommendations for screening for Hypertesion?

Evidence Based Answer

*The U.S. Preventive Services Task Force (USPSTF) recommends screening for high blood pressure in adults aged 18 and older .

(This is a grade "A" recommendation ) *The Joint National Committee on

Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) recommends:Screening every 2 years with BP <120/80 .

Screening every year with SBP of 120-139 mmHg or DBP of 80-90 mmHg.

The American Academy of Family Physicians strongly recommends that family physicians screen adults aged 18 and older for high blood pressure

•What are the effects of dietary modification for people with

hypertension?

What are the effects of dietary modification for people with hypertension?

According to the BMJ clinical evidence and JNC 7th report and SHMS Guideline.BenefitAdvice to reduce dietary intake of salt to below 50 mmol/day, fish oil supplementation, potassium supplementation, and calcium supplementation may all reduce systolic blood pressure by approximately 1 to 5 mm Hg and reduce diastolic blood pressure by 1 to 3 mm Hg in people with hypertension .

HarmPotassium supplementation should not be used in people with kidney failure, or in people taking drugs that can increase potassium levels .

Magnesium supplementation has not been shown to be beneficial at reducing blood pressure .

According to theThe Cochrane Database of Systematic Reviews Showed that reduction in salt intake lowers blood pressure both in individuals with elevated blood pressure and in those with normal blood pressure .

The current recommendations to reduce salt intake to 5 grams per day will lower blood pressure, but a further reduction to 3 grams per day will lower blood pressure more .

•Anti-platelet agents and anti-

coagulants for HTN ?

Antiplatelet agents and anticoagulants for hypertension

According To cochrane database of systematic reviewFor primary prevention in patients with elevated blood pressure, anti-platelet therapy with ASA cannot be recommended since the magnitude of benefit, a reduction in myocardial infarction, is negated by a harm of similar magnitude, an increase in major haemorrhage Based on one large trial (HOT trial), ASA taken for 5 years reduced myocardial infarction (ARR, 0.5%, NNT 200 for 5 years), increased major haemorrhage (ARI, 0.7%, NNT 154), and did not reduce all cause mortality or cardiovascular mortality

For secondary prevention in patients with elevated blood pressure (ATC;Antithrombotic Trialits collaboration meta-analysis: APTC 1994) antiplatelet therapy is recommended because the magnitude of the of the absolute benefit is many times greater than

the risk …

Warfarin therapy alone or in combination with aspirin in patients with elevated blood pressure cannot be recommended because of lack of demonstrated benefit .

Glycoprotein IIb/IIIa inhibitors as well as ticlopidine and clopidogrel have not been sufficiently evaluated in patients with elevated blood pressure .

• According To cochrane database of systematic review:

• 1st prevention (who have not had a prior stroke or heart attack) :▫ Aspirin is therefore not recommended (The antiplatelet drug, aspirin,

reduces the incidence of heart attacks to a small degree,but it increases the incidence of major bleeding events to a similar degree).

• 2nd prevention (In patients with elevated blood pressure who have had a stroke or heart attack):▫ daily low-dose aspirin is recommended, (as the benefits outweigh the

harms)

• Antithrombotic therapy with warfarin alone or in combination with aspirin:▫ is not recommended in patients with elevated blood pressure.

• newer drugs glycoprotein IIb/IIIa inhibitors, ticlopidine and clopidogrel▫ No sufficient evaluation in patients with elevated blood pressure.

Backache

•What are the effects of oral drug treatments for acute back pain?

According To the BMJ clinical evidence And cochrane System.ReviewNSAIDs

.NSAIDs are effective for short-term symptomatic relief in patients with acute and chronic low-back pain without sciatica.

However, their use is associated with gastrointestinal adverse effects. There does not seem to be a specific type of NSAID which is clearly more effective than others .

The selective COX-2 inhibitors showed fewer side effects compared to traditional NSAIDsRecent studies have shown that COX-2 inhibitors are associated with increased cardiovascular risks in specific patient populations .

Muscle relaxants Reduce pain and improve overall clinical assessment,

but are associated with some severe adverse effects including drowsiness, dizziness, and nausea .

The studies examining the effects of analgesics such as paracetamol or opioids were generally too small to detect any clinically important differences .

•Q/What are the effects of non-drug

treatments for acute back pain?

According to BMJ clinical evidence and cochrane System.Rev.

•With regard to non-drug treatments;• Advice to stay active (be it as a single

treatment or in combination with other interventions such as back schools, a graded activity programme, or behavioural counselling) seems the most l

effective •(likely to be beneficial)

•(Likely to be ineffective or harmful( Bed rest

•does not improve symptoms any more effectively than other treatments

• But does produce a number of adverse effects including joint stiffness, muscle wasting, loss of bone mineral density,

pressure sores, and venous thromboembolism .

Unknown effectiveness

Spinal manipulation AcupunctureBackscgoolBehavioral therapy

Massage multidisciplinary treatment programmes (for either acute or subacute low back pain), or

.Back exercises do not seem to increase recovery time compared with no treatment, although there is considerable heterogeneity among studies with regard to the definition of back exercise .

• Q/What are the effects of oral drug

treatments for people with chronic low back pain?

According to BMJ clinical evidenceOpioid analgesics, with or without paracetamol, and NSAIDs;

May improve pain And function compared with placebo

Antidepressants decrease chronic low back pain compared with placebo in people with or without depression, but their effects on function are unclear.But according to Cochrane review There is no clear evidence that antidepressants are more effective than placebo in the management of patients with chronic low-back pain .

These findings do not imply that severely depressed patients with back pain should not be treated with antidepressants .

Muscle relaxants may improve pain, but studies have given conflicting results.

•What are the effects of non-drug treatments for people with chronic

low back pain?

•BeneficialExerciseimproves pain and function compared with other conservative treatments .

Intensive multidisciplinary treatmentprogrammes improve pain and function compared with usual care, but less-intensive programmes do not seem to be beneficial .

Likely to be benificialback schools and behavioural therapy

Unknown effectivenessspinal manipulationmay

Electromyographic biofeedback

lumbar supports,massage,traction,or TENS

Upper Respiratory Tract Infection

What are the evidence for prescribing the following for common cold in both

children and Adults

A)DecongestantB)Antihistamine

Nasal decongestants for the common cold

According to Cochrane systematic review and Clinical Evidence;AdultsBenefit A single oral dose of nasal decongestant in the common cold is modestly effective for the short term relief of congestion in adults, and these drugs also provide benefit in some individuals after regular use over three to five days.

Adverse events in adults are rare and mild. The most common adverse effect on treatment was insomnia (5%) .

ChildrenThere is insufficient data on the use of these medications in children and therefore they are not recommended for use in children younger than 12 years of age with the common cold .

Antihistamines for the common cold

Antihistamines alone are not an effective treatment for the common cold, but might have a small effect in combination with decongestants.

Harm First generation antihistamines also cause more

side-effects than placebo, in particular they increase sedation in cold sufferers.Combinations of antihistamines with decongestives are not effective in small children..

•What is benefit of Decongestants and antihistamines for acute otitis media in

children?..

Decongestants and antihistamines for acute otitis media in children

Given lack of benefit and increased risk of side effects, these data do not support the use of decongestant treatment in children with AOM.

There was a small statistical benefit from combination medication use but the clinical significance is minimal. Thus, the routine use of antihistamines for treating AOM in children cannot be recommendedHarm

Both medications have side effects including drowsiness and hyperactivity.

According to the evidence,what is role of antibiotics in ;

acute bronchitisAcute Sinusitis Acute Otits Media

Antibiotics for acute bronchitis

•According to BMJ CE AND Coch. Review•Benefit;

•Overall, antibiotics appear to have a modest beneficial effect in patients who are diagnosed with acute bronchitis.

•Harm•However, the magnitude of this benefit needs to

be considered in the broader context of potential side effects, medicalization for a self-limiting condition, increased resistance to respiratory pathogens and cost of antibiotic treatment.

Antibiotics for acute maxillary sinusitis

•According to the Cochrane Syest.Review•Antibiotics have a small treatment effect in

patients with uncomplicated acute sinusitis in a primary care setting with symptoms for more than seven days .

•However, 80% of participants treated without antibiotics improve within two weeks.

• Clinicians need to weigh the small benefits of antibiotic treatment against the potential for adverse effects at both the individual and general population level

Antibiotics for acute otitis media in children

Benefit Antibiotics provide a small benefit for acute otitis media in children(absolute reduction of 7% or that about 15 children must be treated with antibiotics to prevent one child having some pain after two

days) . As most cases will resolve spontaneously(approximately

80% of patients will have settled spontaneously) There was no effect of antibiotics on hearing problems of acute otitis media, as measured by subsequent tympanometry.

HarmThis benefit must be weighed against the possible adverse Antibiotics caused unwanted effects such as diarrhoea, stomach pain, and rash, (and may increase resistance to antibiotics in the community) .

It is difficult to balance the small benefits against the small harms of antibiotics for most children. However, they may be necessary in the very young or in severe or prolonged cases reactions .

Antibiotic treatment may play an important role in reducing the risk of mastoiditis in populations where it is more common.

•What are the effects of treatments for seasonal allergic rhinitis in

adolescents and adults?

Beneficial*Oral antihistamines

reduce symptoms and improve quality of life compared with placebo, but can cause drowsiness .

*Combined treatment with pseudoephedrine plus oral antihistamines may be more effective compared with either treatment alone.

* Intranasal corticosteroids improve symptoms compared with placebo

Likely to be beneficial ) (Corticosteroids systemic

) (Leukotriene receptor antagonists oral Leukotriene receptor antagonists plus

) (antihistamines oral ) (Levocabastine intranasal

•Unknown effectiveness •Azelastine ) (intranasal

• ) ( Decongestants oral alone •Ipratropium ) (bromide intranasal

•Likely to be ineffective or harmful• Astemizole ) (oral •Terfenadine ) (oral

Topical analgesia for acute otitis media

•The evidence is insufficient to know whether topical analgesics ear drops are effective or not .

What are the evidence regardingVitamin C and Common Cold ?

Vitamin C for preventing and treating the common cold

•The failure of vitamin C supplementation to reduce the incidence of colds in the normal population indicates that routine mega-dose prophylaxis is not rationally justified for community use .

•But evidence suggests that it could be justified in people exposed to brief periods of severe physical exercise or cold environments .

Cochrane For The Physician

Should physicians recommend thyroid hormone therapy for any nonpregnant

patientwith subclinical hypothyroidism?

According to the Cochrane Syest. ReviewAlthough there is evidence that thyroid hormone therapy in patients with subclinicalhypothyroidism may improve lipid profiles,cognitive function, and echographic left ventricular function.

There is no evidence that•this will decrease morbidity or mortality.

2004 recommendations from the U.S. Preventive Services Task Force, which state that the benefit of treatment is inconsistent and the potential adverse effects of over-treatment may affect a substantial number of persons..

Should inhaled corticosteroids be used totreat stable COPD?

Evidence-Based AnswerAlthough the use of inhaled corticosteroidsfor COPD will not reduce mortality or affectlong-term disease progression, inhaled corticosteroids can be useful for reducing COPDexacerbations and slowing declines in quality

A healthy 44-year-old woman with no family history of breast cancer has never had mammogram. Her best friend was recently diagnosed with breast cancerClinical QuestionHow should physicians counsel women aboutMammography?

Evidence-Based AnswerStudies of mammography show a 0.1 percent absolute reduction in breast cancer mortality with mammography .

This means that if 2,000 women are offered mammography over 10 years, one woman would have her life prolonged,

10 healthy women would be treated unnecessarily for breast cancer,

and about 200 women would undergo psychological distress and additional testing because of false-positive results. Women should be informed of the potential benefits and harms of mammography before undergoing the screening test at any age

•According to the latest evidence what is the role of Aspirin for the Primary

Prevention of Cardiovascular?.

•The USPSTF recommends the use of aspirin for men age 45 to 79 years when the potential benefit due to a reduction in myocardial infarctions outweighs the potential harm due to an increase in gastrointestinal hemorrhage. Grade: A recommendation

•The USPSTF recommends the use of aspirin for women age 55 to 79 years when the potential benefit of a reduction in ischemic strokes outweighs the potential harm of an increase in gastrointestinal hemorrhage.

•Grade: A recommendation • .

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of aspirin for cardiovascular disease prevention in men and women 80 years or older

Grade : I statement .The USPSTF recommends against the use of aspirin for stroke prevention in women younger than 55 years and for myocardial infarction prevention in men younger than 45 years .

• .In 2005, data from the Women's Health Study4 provided important information about the benefit of aspirin for women .

•The Women's Health Study was a trial of 39 876 women randomly assigned to receive aspirin or placebo and followed for 10 years for cardiovascular events .

•New evidence from controlled trials is limited to 1 study in women, the Women's Health Study, that reported benefit in the reduction of ischemic strokes with aspirin use.

• The Women's Health Study was a good-quality, double-blind RCT that evaluated the risks and benefits of aspirin for the primary prevention of cardiovascular disease. The investigators reported a benefit from aspirin use for the reduction of strokes (relative risk [RR], 0.83 [95% CI, 0.69 to 0.99]), specifically ischemic strokes (RR, 0.76 [CI, 0.63 to 0.93]), and no statistically significant benefit in the reduction of combined cardiovascular events, myocardial infarctions, death from CVD, or all-cause mortality .

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