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CLINICAL PRACTICE GUIDELINES FOR PRACTITIONERS

Clinical Practice Guidelines

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Page 1: Clinical Practice Guidelines

CLINICAL PRACTICE GUIDELINES

FOR

PRACTITIONERS

Page 2: Clinical Practice Guidelines

CLINICAL PRACTICE GUIDELINES

FOR PRACTITIONERS

This combined reference has been developed as an educational tool by a statewide, interdisciplinary panel of providers, in collaboration with Blue Cross and Blue Shield of Missouri. It is intended to identify leading “best practices” and help practitioners reduce variation in practice patterns. It is not intended to include all possible methods of care for a particular condition, to identify all criteria for recommending a specific procedure, or to be a required treatment of a particular condition.

The practitioner, at his/her discretion, is expected to exercise reasonable clinical judgment regarding the care each patient needs. Individual patient circumstances should always be taken into account. These guidelines are intended to serve as a foundation for a continuous process of collaboration with physicians and allied health providers to maintain and advance the knowledge base associated with “best practices”.

Each of the Guidelines is based on recommendations from recognized specialty societies (i.e., ACOG, ACOG, AAFP, ACC, AAP, ACP-ASIM), national organizations (i.e., American Cancer Society, American Heart Association, March of Dimes), and governmental entities (i.e., U.S. Department of Health and Human Services, the Centers for Disease Control and Prevention). An external panel of BCBSMo physicians and the BCBSMo Quality Improvement and Physician Review Committee (QIPRC) reviewed the revised guidelines on the basis of content, clarity and appropriateness.

We hope you will find this manual useful in your practice. Information regarding current issues will be provided from time to time through guideline updates and periodic mailings. We invite your comments and suggestions. Please direct your communications to:

Sharon Hoffarth, MD, MPH, FACPMMedical Director, Quality Management

Blue Cross and Blue Shield of Missouri1831 Chestnut Street

St. Louis, MO 63103-2275Fax: (314) 923-8542

John J. Seidenfeld, MD, MSHA, FACPSenior Vice President and Corporate Medical Director

Page 3: Clinical Practice Guidelines

CONTENTS

CLINICAL PRACTICE GUIDELINES

! Evaluation of Abnormal Uterine Bleeding – Premenopausal Patients! Evaluation of Abnormal Uterine Bleeding – Perimenopausal Patients! Evaluation of Abnormal Uterine Bleeding – Postmenopausal Patients! Management of Vaginal Vault Prolapse! Management of Uterine Leiomyomas! Treatment of Endometriosis

! Dysfunctional Labor! Induction of Labor! Breech Presentation! Non-Reassuring Fetal Status! Fetal Macrosomia! Vaginal Birth after Cesarean (VBAC)! Pregnancy-Associated Hypertensive Disease

! Hypertension! Hyperlipidemia! Stable Angina! Unstable Angina! Congestive Heart Failure (CHF)

! Peptic Ulcer Disease! GERD! Diverticulosis and Diverticulitis

! Low Back Pain! Carpal Tunnel Syndrome

! Uncomplicated Acute Bronchitis! Community-Acquired Pneumonia (CAP)! Asthma

! Depression

! Diabetes

Page 4: Clinical Practice Guidelines

Evaluation of Abnormal Uterine Bleeding PREMENOPAUSAL PATIENTS

Abnormal excessive uterine bleeding

Differential Diagnosis Includes:• Complications of pregnancy• Infections - uterus, cervix, vagina• Trauma - laceration, abrasion, foreign body• Cancer - gynecologic malignancy• Benign lesions - uterus, cervix, vagina• Systemic disease - thyroid, liver, coagulopathy, von Willebrand’s disease• Iatrogenic - hormones, anticoagulants, intrauterine contraceptive devices

Includes:• Gynecological and Obstetrical history• Medication history• Pelvic exam with Papanicolaou smear

Diagnostic aids, to consider, as appropriate:• Liver function tests• Thyroid function tests• Coagulation profile• Pregnancy test• CBC

Is cause of bleeding due to

pelvic pathology,medication,

systemic disease?

Is pregnancy

test positive?

Pregnancyevaluation

Address cause of bleeding, such as:Treat infectionFollow-up malignancy work-up:- Risk Factors:

• >35 years old• <30 years old with a long-term history of

oligoovulation or anovulation with exposure to unopposed estrogen.

• ObesityEvaluate for leiomyoma.

•Evaluate for Dysfunctional Uterine Bleeding (DUB - bleeding not controlled by hormones , D&C or nonsteroidal anti-inflammatory agents)

•Determine ovulatory status

Ovulatory Anovulatory

Determine bleeding pattern

Menorrhagia Polymenorrhea OligomenorrheaIntermenstrual bleeding

Evaluate for bleeding disorder

Consider evaluation for luteal phase

defect

Progesterone withdrawal every 3 months, OCPs or clomiphene

induction.

Remove IUD or begin a period of observation

Treat

OCPsBegin

period of observation

Determine TSH and prolactin

levels

Reassure the patient or initiate Oral

Contraceptive Pills (OCPs)

Normal Abnormal

Treat the disorder

Consider evaluation for polycystic ovarian syndrome versus chronic anovulation

(examination, consider determination of LH, FSH, DHEA-s and free testosterone on day 3 of cycle)

Treat with OCPS or

clomiphene

OCPs, progesterone withdrawal every 3 months, or clomiphene

for ovulation induction

Perform biopsy or ultrasonography to

exclude uterine pathology

OCPs or domiphene (serophene)

Yes YesNo

No

No

Yes

Yes

No

No Yes

YesNo

No Yes

Adolescent?

IUD?

Cervicalpathology?

Bleeding at

ovulation?

Risk for hypothalamic disorder (stress, eating disorder,

high level of exercise)?

Focused History & Physical Exam

DHEA-S - dihydroepiandrosterone sulfate DUB - dysfunctional uterine bleedingFSH - follicle - stimulating hormone IUD - intrauterine deviceLH - luteinizing hormoneOCP - oral contraceptive pillsTSH - thyroid-stimulating hormone

Legend:

Page 5: Clinical Practice Guidelines

Physician focus for managing patients with abnormal uterine bleeding:

• As initial approach, to pre- and perimenopausal patients without genital tract lesions, uterineenlargement, IUDs, and not pregnant, treat conservatively.

IndicatorFor those patients with DUB, and no other documented abnormal findings, the percentage of patientstreated pharmacologically.

References:

Oriel KA, Schrager S. Abnormal uterine bleeding. American Family Physician. 1999;10(5);1371-1380.Available online: http://www.aafp.org/afp/991001ap/1371.html. Accessed May 23, 2001.

New Zealand Guidelines Group. Guidelines for the management of heavy menstrual bleeding.(1999, May) Available online: National Guideline Clearinghouse, http://www.guidelines.gov. Accessed May 21, 2001.

Chuong CJ, Brenner PF. Management of abnormal uterine bleeding. American Journal of Obstetricsand Gynecology. 1996;175(3);787-792.

Long C. Evaluation of patients with abnormal uterine bleeding. American Journal of Obstetrics andGynecology. 1996;175(3);784-786.

Page 6: Clinical Practice Guidelines

Evaluation of Abnormal Uterine Bleeding PERIMENOPAUSAL PATIENTS

Abnormal uterine bleeding

Perform history and physical exam, including:• Gynecological and Obstetrical history• Medication history• Pelvic exam with Papanicolaou smear

Laboratory tests to consider, as appropriate:• Follicle-stimulating hormone (FSH)• Liver function tests• Thyroid function tests• Coagulation profile• Pregnancy test (If positive, evaluate for complication of pregnancy)• CBC

Genital tract lesion present Uterine enlargement present

Treat, perform biopsy or refer as appropriate

Consider transvaginal ultrasonography or sonohysterography

Determine beta human chorionic

gonadotropin (β-HCG)

Perform transvaginal ultrasonography,

sonohysterography or hysteroscopy, or dilation and

curettage

Positive

Negative

Evaluate for pregnancy

Perform endometrial biopsy Biopsy not possible

Etiology still unclear

Etiology identified

Perform hysteroscopy

Treat

Normal pathology or atrophy Hyperplasia Atypia or carcinoma

Cyclic hormonal regulation or begin a period of observation

Cyclic progesterone therapy; hyperplasia that persists requires D&C

Refer patient for treatment

Page 7: Clinical Practice Guidelines

Physician focus for managing patients with abnormal uterine bleeding:

• As initial approach, to pre- and perimenopausal patients without genital tract lesions, uterineenlargement, IUDs, and not pregnant, treat conservatively.

IndicatorFor those patients with DUB, and no other documented abnormal findings, the percentage of patientstreated pharmacologically.

References:

Oriel KA, Schrager S. Abnormal uterine bleeding. American Family Physician. 1999;10(5);1371-1380.Available online: http://www.aafp.org/afp/991001ap/1371.html. Accessed May 23, 2001.

New Zealand Guidelines Group. Guidelines for the management of heavy menstrual bleeding.(1999, May) Available online: National Guideline Clearinghouse, http://www.guidelines.gov. Accessed May 21, 2001.

Chuong CJ, Brenner PF. Management of abnormal uterine bleeding. American Journal of Obstetricsand Gynecology. 1996;175(3);787-792.

Long C. Evaluation of patients with abnormal uterine bleeding. American Journal of Obstetrics andGynecology. 1996;175(3);784-786.

Page 8: Clinical Practice Guidelines

Evaluation of Abnormal Uterine Bleeding POSTMENOPAUSAL PATIENTS

Abnormal uterine bleeding

Perform history and physical exam, including:• Gynecological and Obstetrical history• Medication history• Pelvic exam with Papanicolaou smear

Laboratory tests to consider, as appropriate:• Liver function tests• Thyroid function tests• Coagulation profile• Pregnancy test• CBC

Genital tract lesion present Uterine enlargement present

Treat, perform biopsy or refer as appropriate

Consider performing transvaginal ultrasonography or sonohysterography

Determine which HRT regimen (continuous-combined or sequential) and duration of HRT

Duration > 6 months Duration < 6 months If early withdrawal bleeding, increase progesterone dosage

Begin a period of observation

Perform endometrial biopsy or transvaginal ultrasonography to exclude endometrial carcinoma

Heavy or prolonged bleeding or breakthrough bleeding in > 2 cycles

Endometrial biopsy performed Transvaginal ultrasonography performed

Abnormal findings Normal findings

Refer patient for treatment

Endometrial stripe < 5 mm

Endometrial stripe > 5 mm

Uterine pathology identified

Atrophic endometrium

Perform endometrial

biopsy or hysteroscopy with biopsy

Refer patient for treatment

Perform transvaginal ultrasonography,

sonohysterography or hysteroscopy, depending on

clinical suspicion

Begin period of observation

Yes

No

No Yes

Normal findings, receiving

HRT?

Bleeding stopped?

Page 9: Clinical Practice Guidelines

Physician focus for managing patients with abnormal uterine bleeding:

• As initial approach, to postmenopausal patients without genital tract lesions, or uterine enlargement,treat conservatively.

IndicatorFor those patients with DUB, and no other documented abnormal findings, the percentage of patientstreated pharmacologically.

References:

Oriel KA, Schrager S. Abnormal uterine bleeding. American Family Physician. 1999;10(5);1371-1380.Available online: http://www.aafp.org/afp/991001ap/1371.html. Accessed May 23, 2001.

New Zealand Guidelines Group. Guidelines for the management of heavy menstrual bleeding.(1999, May) Available online: National Guideline Clearinghouse, http://www.guidelines.gov. Accessed May 21, 2001.

Chuong CJ, Brenner PF. Management of abnormal uterine bleeding. American Journal of Obstetricsand Gynecology. 1996;175(3);787-792.

Long C. Evaluation of patients with abnormal uterine bleeding. American Journal of Obstetrics andGynecology. 1996;175(3);784-786.

Page 10: Clinical Practice Guidelines

Management of Vaginal Vault Prolapse

Symptoms of Vaginal Prolapse

Symptoms may include:• Asymptomatic• Pelvic Pressure• Pulling, aching sensation• Urinary symptoms• Bowel symptoms• Sexual dysfunction• Protrusion of uterus or vagina through introitus• Vaginal/cervical ulceration with discharge/odor

Symptoms may include:• Asymptomatic• Pelvic Pressure• Pulling, aching sensation• Urinary symptoms• Bowel symptoms• Sexual dysfunction• Protrusion of uterus or vagina through introitus• Vaginal/cervical ulceration with discharge/odor

History:• Family• Pregnancy• Occupation• Physical activity• Medication

Physical Exam:• Gynecological exam• Assess degree of prolapse (supine and standing)• Evaluate incontinence, and post-void residual urine

Lab and diagnostic tests:If clinically indicated:• Cervical cytology• Urinalysis and culture• Urodynamics• Cystoscopy/urethroscopy

History:• Family• Pregnancy• Occupation• Physical activity• Medication

Physical Exam:• Gynecological exam• Assess degree of prolapse (supine and standing)• Evaluate incontinence, and post-void residual urine

Lab and diagnostic tests:If clinically indicated:• Cervical cytology• Urinalysis and culture• Urodynamics• Cystoscopy/urethroscopy

Focused History and Physical Exam

Postmenopausal?

Consider hormone treatment:• Hormone Replacement Therapy (HRT)• Estrogen Replacement Therapy (ERT)

• Pills, patch, cream• Estrodial vaginal ring (e.g., Estring)

Good response?

Follow up office visit in 6 months.

Clinical observation with lifestyle modifications:• Diet/weight control• Increase fiber, fruit juice• Decrease caffeine• Avoid heavy lifting• Quit smoking• Medication• Pelvic floor exercise (e.g. Kegel)• Mechanical vault support (e.g. tampon, diaphragm, pessary)

Indications for Pessary use:• Stress urinary incontinence• Vaginal vault prolapse• Cystocele• Enterocele• Rectocele• Uterine prolapse• Preoperative preparation

Indications for Pessary use:• Stress urinary incontinence• Vaginal vault prolapse• Cystocele• Enterocele• Rectocele• Uterine prolapse• Preoperative preparation

Good response?Follow up office visit in 6

months or based on treatment option.

Counsel patient and consider surgical options:• Reconstruction of pelvic anatomy with/without hysterectomy• Vaginal obliterative procedures

(e.g. colpocleisis, sacrospinous ligament fixation)

Preoperative estrogen replacement therapy:associated with reducing duration of postoperative bladder catheterization in women undergoing reconstructive surgery for pelvic organ prolapse.

Preoperative estrogen replacement therapy:associated with reducing duration of postoperative bladder catheterization in women undergoing reconstructive surgery for pelvic organ prolapse.

Yes

No

Yes

No

No

Yes

Page 11: Clinical Practice Guidelines

Management of Vaginal Vault Prolapse

References:

Margolis MT. Surgical options for treatment of vaginal vault prolapse procidentia and vaginalreconstruction. Contemporary OB-GYN. March 1999. Availableonline:http://obgyn.pdr.net/obgyn/public.htm?path=content/journals/g/data/1999/g3a/g3a023.html Accessed May 15, 2001.

Viera AJ, Larkins-Pettigrew M. Practical use of the pessary. American Family Physician. May 1,2000. Available online: http://www.aafp.org/afp/20000501/2719.html. Accessed May 21, 2001.

Theofrastous JP, Addison WA, Timmins MC. Voiding function following prolapse surgery. Impactof estrogen replacement. Journal of Reproductive Medicine. December 1996; 41(12):881-4.

Eriksen B. A randomized, open parallel-group study on the preventive effect of an estradiol-releasing vaginal ring (Estring) on recurrent urinary tract infections in postmenopausal women.American Journal of Obstetrics and Gynecology. 1999;180:1072-1079.

ACOG. Pelvic Support Problems. (ACOG Patient Education). Washington, DC. 1995.

Page 12: Clinical Practice Guidelines

Management of Uterine LeiomyomasFibroids - benign smooth muscle tumors found in the submucous, intramural and/or subserosal regions of the uterus.

Differential diagnosis:• Fibroma• Leiomyosarcoma• Endometrial hyperplasia• Adnexal mass

Differential diagnosis:• Fibroma• Leiomyosarcoma• Endometrial hyperplasia• Adnexal mass

Risk factors:• Increasing age prior to

menopause• Family history• African and Caribbean

American ethnicity• Obesity• Nulliparity/infertility

Risk factors:• Increasing age prior to

menopause• Family history• African and Caribbean

American ethnicity• Obesity• Nulliparity/infertility

Medical therapy may improve hematologic profile or reduce

mass in preparation for surgery, but should not be

used for more than six months, or on an ongoing or

repeated basis.

Medical therapy may improve hematologic profile or reduce

mass in preparation for surgery, but should not be

used for more than six months, or on an ongoing or

repeated basis.

Symptoms may include:• Asymptomatic• Excessive uterine bleeding• Pelvic discomfort:

• Pain/pressure• Low back pain• Abdominal swelling• Dyspareunia• Urinary

urgency/frequency• Recurrent miscarriage• Preterm labor• Infertility

Symptoms may include:• Asymptomatic• Excessive uterine bleeding• Pelvic discomfort:

• Pain/pressure• Low back pain• Abdominal swelling• Dyspareunia• Urinary

urgency/frequency• Recurrent miscarriage• Preterm labor• Infertility

Suspected Uterine Fibroids

Perform history and physical exam, including:• Gynecological and Obstetrical history• Medication history• Pelvic exam with Papanicolaou smear

Laboratory tests to consider, as appropriate• Liver function tests• Thyroid function tests• Coagulation profile• Pregnancy test• CBC• Endometrial sampling

Confirm by:• Transvaginal ultrasound,• Transvaginal sonohysterogram (TVSH)• Transabdominal ultrasound or• Magnetic Resonance Imaging (MRI) (if

location or nature of fibroid is uncertain or patient refuses TVSH)

Symptomatic?

Asymptomatic with fibroids >14 weeks

size?

Follow-up in office in 6 months unless

symptoms change.

Discuss options, including observation

with patients.

Offer medical management:• Iron supplementation• Non-steroidal anti-inflamatory drugs (NSAIDS)• Hormone therapy

• Progestins• Oral contraceptives

• GnRH - agonists: (+ “add back” therapy as indicated)

Successful treatment of symptoms?

Continue therapy 4-6

months.

Review at 6

months.

Discuss surgical options:• Endometrial ablation to arrest bleeding.• Myomectomy

• Hysteroscopic• Laparascopic• Abdominal

• Hysterectomy indicators:• Bleeding causing anemia, lifestyle or hygiene problems• Intractable pelvic pain + progressive dysmenorrhea• Rapidly enlarging size• Enlargement postmenopausal (R/O sarcoma)• Pressure symptoms

Consider preoperative therapy with GnRH in women with large uteri (>18 weeks size) for reduction in operative blood loss

Consider preoperative therapy with GnRH in women with large uteri (>18 weeks size) for reduction in operative blood loss

With pre/peri-menoapausal patients, discuss options of Salpingo-oophorectomy or sparing ovaries

With pre/peri-menoapausal patients, discuss options of Salpingo-oophorectomy or sparing ovaries

Yes

No

YesNo

Yes

No

Page 13: Clinical Practice Guidelines

Physician focus for Management of Uterine Leiomyomas:

• For symptomatic women with first time diagnosis of leiomyomata, consider initial medical management.

Indicator: Percentage of women with first time diagnosis receiving conservative medical management.

Indicator: Percentage of women with first time diagnosis receiving surgical treatment.

• For symptomatic women with a > 1year history of leiomyomata, unresponsive to conservative treatment,consider surgical management.

Indicator: Percentage of women with a > 1year history of leiomyomata and one or more of thefollowing: anemia, intractable pain or pressure, rapidly enlarging tumor size who received surgicalintervention.

References /Resources:

New Zealand Guidelines Group. Guidelines for the management of uterine fibroids.(1999, August). Available online: National Guideline Clearinghouse,http://www.guideline.gov/VIEWS/summary.asp?guideline=1505. Accessed May 21, 2001.

Garcia CR, Pfeifer S, Wallach E. Gynecologic disorders uterine fibroids: Treat or ignore? Patient CareArchive (1997, January). Available online:http://pc.pdr.net/pc/public.htm?path=content/journals/p/data/1997/p1a/p1a048.html. Accessed May 22, 2001.

Shoupe, D. Hysterectomy or an alternative? Hospital Practice (2000, September). Available online:http://www.hosppract.com/issues/2000/09/shoupe.htm. Accessed May 22, 2001.

Page 14: Clinical Practice Guidelines

Treatment of EndometriosisSymptoms suggestive of

endometriosis

Mild to Moderate PainMild to Moderate Pain Moderate to Severe PainModerate to Severe Pain

Empiric treatment with OCPSGnRH agonist or progestins Operative laparoscopy

with postoperative empiric GnRH agonist

therapy

Operative laparoscopyDiagnostic laparoscopy

Normal pelvis

Disease missedProgressive disease

because of inadequate resection

Residual disease

Empiric therapy with GnRH agonist for 2-3

mos

Operative excision or biopsy

Empiric GnRH agonist for 6 mos + add-back

therapy

Operative laparoscopy

Second operative

laparoscopy with

postoperative GnRH agonist

Laparoscopy with resection if disease present

Empiric treatment

withGnRHagonist

Retreatment with

GnRH agonist with add-back

therapy

Consider prolonged medical

suppression with add-back

therapy

Pain improves?

Consider:Diagnostic laparoscopyorOperative laparoscopy

Review in 6 months

Pain improves

Pain not improved

Full 6-mo course of

GnRH agonist add-back therapy

Operative laparoscopy

Postoperative GnRH agonist for residual disease

+ add-back therapy

Consider prolonged medical

suppression with add-back

therapy

Persistent problems or

treatment failure?

Review in 6 months

Bilateral oophorectomy, Hysterectomy

Pelvic pain persists or returns

Retreatment with GnRH - α

Symptoms may include:• Chronic pelvic pain• Abnormal uterine bleeding• Low abdominal pain• Dysmenorrhea• Dyspareunia• Pain with defecation• Infertility

NoYes

NoYes

A B

A

B

Prompt attention and treatment may prove to be the best way of ameliorating

the recurrence of symptoms.

Prompt attention and treatment may prove to be the best way of ameliorating

the recurrence of symptoms.

Diagnostic laparoscopy provides method of diagnosing most anatomic gynecologic disease states; only definitive test for detecting endometriosis.

Operative laparoscopy allows surgical excision and ablation to be completed at time of diagnosis, decreasing time, cost, and side effects. Patient is spared a second surgery (laparotomy) if performed at time of diagnosis.

A

B

Page 15: Clinical Practice Guidelines

TREATMENT OF ENDOMETRIOSIS

Medical Treatment of Endometriosis

Drug Dosage Adverse EffectsDanazol (Danocrine) 800 mg per day in 2 divided doses Estrogen deficiency, androgenic side

effectsOral contraceptives 1 pill per day (continuous or cyclic) Headache, nausea, hypertension

Medroxyprogesteronesuspension (Depo-Provera)

100 mg IM every 2 weeks for 2 months;then 200 mg IM every month for 4months or 150 mg IM every 3 months

Weight gain, depression, irregularmenses or amenorrhea

Medroxyprogesterone (Provera) 5-20 mg orally per day Same as other oral progestinsNorethindrone acetate(Aygestin)

5 mg per day orally for 2 weeks; thenincrease by 2.5 mg per day every 2weeks up to 15 mg per day

Same as other oral progestins

Leuprolide (Lupron) 3.75 mg IM every month for 6 months Decrease in bone density, estrogendeficiency

Gosarelin (Zoladex) 3.6 mg SC (in upper abdominal wallevery 28 days

Estrogen deficiency

Nafarelin (Synarel) 400 mg per day: 1 spray in 1 nostril ina.m.; 1 spray in other nostril in p.m.;start treatment on day 2 to 4 ofmenstrual cycle

Estrogen deficiency, bone densitychanges, nasal irritation

Surgical vs. Medical Treatment

Treatment Advantages DisadvantagesSurgical Beneficial for infertility Expensive

Long-term results may be better InvasiveDefinitive diagnosisOption for definitive treatment

Medical Lower initial cost Adverse effects commonEmpiric treatment Not likely to improve fertilityEffective for pain relief

Physician focus for Treating Endometriosis:

• For appropriate patients with mild to moderate pain, try pharmacotherapy for initial treatment.Indicator:Percentage of patients receiving endocrine-based drug therapy.

• Bilateral oophorectomy and hysterectomy should be reserved for use in women with intractable painwho no longer desire pregnancy, and for whom conservative therapy failed.

Indicator:Percentage of women who received operative laparoscopy with postoperative empiric drug therapyprior to definitive surgery.

References/Resources:

Wellbery C. Diagnosis and treatment of endometriosis. Am Fam Physician . 1999;60:1753-68. Availableonline: http://www.aafp.org/afp/991015ap/1753.html. Accessed May 10, 2001.

Winkel C. Laparoscopy plus GnRH analogues: a practical approach to endometriosis. Contemporary Ob-Gyn. April 1999.

Page 16: Clinical Practice Guidelines

Dysfunctional Labor

Intrapartum care may include:

•Chart evaluation•Cervical exam•Supportive care/comfort measures

•po fluids•position changes•back rubs, music, etc•ambulation•bath/shower

•Adequate pain relief•nalbuphine hydrochloride (Nubain)•butorphanol tartrate (Stadol)•meperidine (Demerol)•hydroxyzine hydrochloride (Vistaril)•epidural or intrathecal narcotics for patients in active progressing labor

•Documentation of progress of labor•Monitoring of fetal heart rate

This guideline applies only to women in labor who meet ALL of the following criteria:•Nulliparous•No concomitant medical problems•Term pregnancy (36 weeks completed)•Having contractions•Singleton fetus•Cephalic presentation•No evidence of fetal distress•Caregiver expects normal spontaneous vaginal delivery•labor is NOT induced

Patient in labor(see guideline limits to left

and definition to right)

Intrapartumcare (see box to left)

<1 cmdilation x2consecutive

hours?

no

yes

Stage II Labor

yes

Consider amniotomy,unless contraindicated*

Operativevaginal delivery

contra-indicated?

***

no

Operative vaginal delivery

Cesarean-section

Has SROMoccurred?

Normal vaginal delivery

yes

no

yes

Failure to progress diagnosis--initiate active management of labor and consider:

•Artificial rupture of membranes•Ensure adequate maternal analgesia•Oxytocin augmentation**•Obtain an obstetrical/surgical consult if necessary

* Contraindications to amniotomy include:•Presentation unknown, floating or unstable•Cervix dilated <3cm•Patient refuses

**Contraindications to oxytocin augmentation include:•unknown presentation or floating/unstable•unable to monitor contractions adequately•patient refuses

***Contraindications to operative vaginal delivery include:•presenting part is too high•provider is inexperienced•fetal distress with inability to do timely operative vaginal delivery•patient refuses

Progress?(fetal descent

>1 cm/hr)

Management of protraction disorder, consider:•Evaluation of maternal position and fetal position•Evaluation of fluid balance•Oxytocin augmentation**•Obtain an obstetrical/surgical consult if necessary

Descentor rotation?

yes

no

no

Labor is defined as:•Regular contractions resulting in progressive dilation/effacement of cervix•Cervical dilation 3 cm or greater•Spontaneous rupture of membrane

Page 17: Clinical Practice Guidelines

Physician focus for managing dysfunctional labor:

• Emphasize close monitoring for early detection and intervention of failure to progress.• Emphasize close monitoring for early detection and intervention of protracted labor

References/Resources:

Dystocia and the Augmentation of Labor. ACOG Technical Bulletin. Number 218, December 1995.

Hadi H. Cervical Ripening and Labor Induction: Clinical Guidelines. Clinical Obstetrics and Gynecology2000;43(3):524-536.

Institute for Clinical Systems Improvement. Health Care Guideline: Prevention, Diagnosis and Treatmentof Failure to Progress in Obstetrical Labor. December 1999. http://www.icsi.org (2001, April 17)

Ramsey, PS, Ramin KD, Ramin SM. Labor Induction. Current Opinion in Obstetrics and Gynecology2000;12(6):463-473.

http://www.acog.org http://www.aafp.org http://www.icsi.org

Page 18: Clinical Practice Guidelines

Induction of Labor

ACOG Dating Criteria for term gestation:

•Fetal heart tones documented for 20 wks by non-electronic fetoscope or for 30 wks by Doppler•36 weeks since positive serum or urine HCG pregnancy test was performed by a reliable laboratory•An U/S measurement of crown-rump length, obtained at 6-12 weeks, supports a gestational age of at least 39 wks•An U/S obtained a 13-20 weeks confirms the gestational age of at least 39 weeks determined by clinical history and physical examination

Indications for inducing labor may include:•Pregnancy-induced hypertension, pre-eclampsia, or chronic hypertension•Premature rupture of membranes•Chorioamnionitis•Suspected fetal jeopardy (i.e. fetal growth restriction, isoimmunization)•Maternal medical problems (i.e. DM, renal disease, chronic pulmonary disease)•Fetal demise•Logistical factors (i.e. risk of rapid labor, distance from the hospital, psychosocial indications)•Postdate pregnancy•Oligohydramnios•Abruptio placentae

Consideration of Labor Induction

Do benefits

to mother andfetus outweigh therisks of continuing

the pregnancy?

no

Reconsider Induction

yes

Iscervix

favorable?no Repeat doses of

ripening agent as appropriate

Proceed with amniotomy and/or oxytocininduction (10U of oxytocin in 1 L of IV solution) as appropriate.

Does thepatient meet

dating criteriafor term?

yes

Initiate cervical ripening (if appropriate) with one of the following:•IV Oxytocin (Pitocin)--0.5-6 mU/min initial dose (max 25mU/min)•Intracervical Dinoprostone gel (Prepidil)--0.5 mg initial dose, may repeat q6 hours (maximum of 3 doses in 24 hours)•Intravaginal Dinoprostone insert (Cervidil)--10 m (once only)•Intravaginal Misoprostol* (Cytotec)--25 ug initial dose, may repeat q3-6 hours (maximum of 6-8 doses) Wait at least 4 hours to begin oxytocin.Other options for cervical ripening include: stripping of the membranes,amniotomy, balloon catheters

Absolute contraindications for inducing labor include:•Placenta or vasa previa•Transverse fetal lie•Prolapsed umbilical cord•Previous transfundal uterine surgery•Active genital herpes infection•Pelvic structural abnormality•Invasive cervical cancer

Obstetric conditions that may require special care during induction (relative contraindications):•Mulitfetal gestation•Polyhydramnios•Maternal cardiac disease•Abnormal fetal heart rate patterns not requiring emergency birth•Grand mulitparity•Severe hypertension•Breech presentation•Presenting part above the pelvic inlet•One or more previous low-transverse cesarean deliveries

yes

no

Consider Bishopscore (see page 2)

Isinduction

likely to besuccessful?

no

yes

*Do not use Misoprostol in patients with prior c-section or major uterine surgery.

Fetal heart rate and uterine activity should be continuously monitored from the time the PGE2 vaginal insert is placed until at least 15 minutes after it is removed

Page 19: Clinical Practice Guidelines

Induction of Labor p.2

Assessment score

Dilation (cm)

Effacement (%)

Fetal station

Consistency Position

0 0 0-30 -3 Firm Posterior1 1-2 40-50 -2 Medium Mid2 3-4 60-80 -1, 0 Soft Anterior3 4-5 90-100 +1, +2, +3 -- --

Bishop System of Cervical Scoring (Table from Harman et al)

Note: Add the score for each of the clinical assessments. If the total score is greater than 8, the success of induction approaches that of spontaneous labor. A Bishop score of "5 is associated with induction failure.

Possible complications associated with oxytocin infusion include:

•Uterine Hyperstimulation --> uterine contractions more often than every 2 minutes that lastlonger than 90 seconds with or without fetal heart changes. Excessive uterine contractions may lead to uteroplacental hypoperfusion and fetal hypoxia, uterine rupture, or abruptio placentae. Hyperstimulation may be treated by decreasing or stopping the oxytocin and with administration of terbutaline 0.125 mg IV or SC.

•Water Intoxication --> because of its similarity to pituitary antidiuretic hormone (ADH), large doses can result in water intoxication that can lead to hyponatremia, confusion, convulsion, coma, congestive heart failure, and death. To avoid this complication, monitor intake and output closely and use oxytocin judiciously.

•Uterine Rupture --> occurs more commonly in multiparous patients, in those with previous uterine scar, with fetal malpresentations, and with multiple pregnancy or overdistended uterus. These conditions are relative contraindications to oxytocin use.

•Other complications of oxytocin infusion include: abruptio placentae, precipitous delivery, postpartum uterine atony and hemorrhage, neonatal hyperbilirubinemia, hypotension, and amniotic fluid embolism.

Page 20: Clinical Practice Guidelines

Physician focus for managing labor induction:

• Discuss risks/benefits with women considering induction and document in chart.• Confirm adequate fetal dates prior to induction and document in chart.

References/Resources:

Hadi H. Cervical Ripening and Labor Induction: Clinical Guidelines. Clnical Obstetrics and Gynecology2000;43(3):524-536.

Harman JH, Kim A. Current Trends in Cervical Ripening and Labor Induction. Am Fam Physician1999;60:477-84.

Induction of Labor. ACOG Practice Bulletin Number 10, November 1999.

Ramsey, PS, Ramin KD, Ramin SM. Labor Induction. Current Opinion in Obstetrics and Gynecology2000;12(6):463-473.

Response to Searle’s Drug Warning on Misoprostol. ACOG Committee on Obstetric Practice. Number 248,December 2000.

Rinehart BK, Terrone DA, Hudson C, Isler CM, Larmon JE, Perry KG. Lack of utility of standard laborcurves in the prediction of progression during labor induction. Am J Obstet Gynecol 2000;182:1520-6.

Simpson KR, Poole JH, Simpson KR. Labor Induction and Augmentation: Knowing When, and How, toAssist Women in Labor. AWHONN Lifelines 1998;2(6):39-42.

Zlatnik FJ. Elective Induction of Labor. Clinical Obstetrics and Gynecology 1999;42(4):757-765.

http://www.acog.org/ http://www.aafp.org

Page 21: Clinical Practice Guidelines

Breech Presentation

Selection Criteria for Vaginal Breech Delivery:•Estimated fetal weight from 2,000 to 4,000 g (4 lb, 6 oz to 8 lb, 13 oz)•Frank or complete breech presentation•Flexed fetal head•No major fetal anomalies or placenta previa on ultrasound•Adequate magnetic resonance, computed tomography, x-ray, or clinical pelvimetry

Exclusion Criteria for External Cephalic Version:•Multiple pregnancy•Evidence of uteroplacental insufficiency•Significant third-trimester bleeding•Suspected intrauterine growth restriction•Amniotic fluid abnormalities•Uterine malformation•Placenta previa•Maternal cardiac disease•Pregnancy-induced hypertension•Uncontrolled hypertension•A nonreassuring fetal monitoring pattern•Major fetal anomaly

Successfulversion?

no Maternalself-assessment

Consider repeat version attempt weekly and monitorfor spontaneous conversion to vertex

Breech presentationby Leopold’s maneuver or vaginal examinationand at least 36 weeks

gestation

Perform U/S to:•Confirm position•Determine amniotic fluidindex (AFI)

•Note placental location•r/o congenital anomalies•r/o presence of nuchal cord

Confirms breech?

no Routine prenatalcare

Attempt external cephalicversion when >=37 weeks gestation (consider tocolysis for nulliparas)

yes

Assess for C-sectionor trial of labor

Presenceof exclusion

criteria?

yes

Prior to version attempt:•Draw CBC and type/screen•Establish IV access•Assess NST or BPP

Following version attempt:•Administer Rhogam (Rho (D)immune globulin) to Rh-negative

women•Perform NST and Ultrasound

yes

no

Monitor for reversion to breech

Advise patient of risk of cord prolapse with rupture of membranes and need for immediate evaluation if PROM occurs.

•Review contraindications•Obtain informed consent

Page 22: Clinical Practice Guidelines

Physician focus for Treating Breech Presentation:

• Perform a confirmatory ultrasound prior to performing external cephalic version attempt. Indicator: Percentage of women diagnosed with breech presentation (>35 weeks gestation) that

receive a confirmatory ultrasound prior to undergoing external cephalic version attempt.

• Perform a non-stress test (NST) and an ultrasound following external cephalic version attempts.Indicator: Percentage of women undergoing external cephalic version attempts that receive post-attempt NST and ultrasound.

References/Resources:

Coco AS, Silverman SD. External Cephalic Version. American Family Physician 1998;58(3):731-744.

External Cephalic Version. ACOG Practice Bulletin Number 13, February 2000.

Hofmeyr GJ. External cephalic version facilitation for breech presentation at term (Cochrane Review) In:The Cochrane Library, 1, 2001. Oxford: Update Software.

Hofmeyr GJ. External cephalic version for breech presentation before term (Cochrane Review). In: TheCochrane Library, 1, 2001. Oxford: Update Software.

Hofmeyr GJ, Kulier R. External cephalic version for breech presentation at term (Cochrane Review). In:The Cochrane Library, 1, 2001. Oxford: Update Software.

Management of the Breech Presentation. ACOG Technical Bulletin Number 95, August 1986.

http://www.acog.org/ http://www.aafp.org

Page 23: Clinical Practice Guidelines

Non-Reassuring Fetal Status

Non-Reassuring Patterns:

• Fetal tachycardia• Fetal bradycardia• Saltatory variability• Variable decelerations associated

with a non-reassuring pattern• Late decelerations with preserved

beat-to-beat variability

Ominous Patterns:

• Persistent late decelerations with loss of beat-to-beat variability

• Non-reassuring variable decelerations associated with loss of beat-to-beat variability

• Prolonged severe bradycardia• Sinusoidal pattern• Confirmed loss of beat-to-beat

variability not associated with fetal quiescence, medications or severe prematurity

Labor with ElectronicFetal Monitoring (EFM)

ReassuringFHR pattern?

no

Continuelabor monitoring

until delivery

yes

ReassuringFHR

pattern?

no

Vaginal delivery

Perform Cesarean Section

yes

Emergency Interventions for Non-reassuring Patterns:

• Check maternal blood pressure - if hypotensive and epidural in place, administer IVF bolus

• Change maternal position (lateral or knee-chest)• Call anesthesia to evaluate, if no improvement• If no epidural, give IVF bolus, and reposition - if no

improvement, evaluate for cause of maternal hypotension• Consider tocolysis (for uterine tetany or hyperstimulation)• Decrease or discontinue oxytocin if infusing• Consider amnioinfusion (for variable decelerations)• Determine whether operative intervention is warranted and, if

so, how urgently it is needed

Deliveryimminent?

no

yes

Fetal Heart Rate (FHR) tracing should be interpreted ONLY in the context of the clinical scenario, and any therapeutic intervention should consider the maternal condition as well as that of the fetus.

Page 24: Clinical Practice Guidelines

Non-Reassuring Fetal Status p.2

Causes of Fetal Tachycardia:• Fetal hypoxia• Maternal fever• Hyperthyroidism• Maternal or fetal anemia• Parasympatholytic drugs

•Atropine•Hydeoxyzine (Atarax)

• Sympathomimetic drugs•Ritodrine (Yutopar)•Terbutaline (Bricanyl)

• Chorioamnionitis• Fetal Tachyarrhythmia• Prematurity

Signs of Non-Reassuring Variable Decelerations that Indicate Hypoxemia:• Increased severity of the deceleration• Late onset and gradual return phase• Loss of “shoulders” on fetal heart rate (FHR) recording• A blunt acceleration or “overshoot” after severe deceleration• Unexplained tachycardia• Saltatory variability• Late decelerations or late return to baseline• Decreased variability

Causes of Severe Fetal Bradycardia:• Prolonged cord compression• Cord prolapse• Tetanic uterine contractions• Paracervical block• Epidural and spinal anesthesia• Maternal seizures• Rapid descent• Vigorous vaginal examination

Page 25: Clinical Practice Guidelines

Physician focus for managing non-reassuring fetal heart rate (FHR) patterns: • Emphasize appropriate emergency interventions for non-reassuring or ominous fetal heart rate patterns.

References/Resources:

Fetal Heart Rate Patterns: Monitoring, Interpretation, and Management. ACOG Technical Bulletin Number207, July 1995.

Institute for Clinical Systems Improvement. Health Care Guideline: Intrapartum Fetal Heart RateManagement. December 1999. http://www.icsi.org (2001, April 17)

Morrison EH. Common Peripartum Emergencies. Am Fam Phys 1998;58(6):1593-1607

Sweha A, Hacker TW, Nuovo J. Interpretation of the Electronic Fetal Heart Rate During Labor. Am FamPhys 1999;59(9):2487-2506.

ACOG practice guideline.

http://www.acog.org http://www.aafp.org http://www.icsi.org

Page 26: Clinical Practice Guidelines

Fetal Macrosomia

Risk Factors for Fetal Macrosomia:

•Maternal diabetes•Maternal impaired glucose intolerance•Multiparity•Previous macrosomic infant•Prolonged gestation•Maternal obesity•Excessive maternal weight gain•Male fetus•Parental stature•Maternal age•Maternal race•Paternal birth weight•Need for labor augmentation•Prolonged second stage

# Prepare and drill labor and delivery staff in the basics and management of shoulder dystocia, including:

⇒ McRoberts maneuver⇒ Suprapubic pressure on the

impacted shoulder⇒ Wood’s maneuver⇒ Delivery of the posterior arm⇒ Zavanelli maneuver

“To date, no management algorithm involving selective interventions based on estimates of fetal weight has demonstrated efficacy in reducing the incidence of either shoulder dystocia or brachial plexus injury…planned interventions based on estimates of fetal weight do not reduce the incidence of shoulder dystocia and do not decrease adverse outcomes attributable to fetal macrosomia.”

--Sacks and Chen, Obstetrical and Gynecological Survey 2000“Current guidelines state that a planned cesarean delivery for a diabetic pregnant woman whose fetal weight estimates exceed 4250 to 4500 gm may be reasonable...”

--ACOG Practice Patterns Number 7, October 1997“With an estimated fetal weight greater than 4500 gm, a prolonged second stage of labor or arrest of descent in the second stage is an indication for cesarean delivery”

--ACOG Practice Bulletin Number 22, November 2000“For almost all macrosomic pregnancies including diabetic mothers, previous deliveries with shoulder dystocia, or women considering VBAC, expectant management with vigilance for evidence of fetopelvic disproportion will have optimal results.”

--Zamorski and Biggs, American Family Physician 2001

Labor Pattern Nulligravida MultiparaProtraction disorders Dilation Descent

<1.2 cm/h<1.0 cm/h

<1.5 cm/h<2.0 cm/h

Arrest Disorders Dilation Descent

>2 hours>1 hour

>2 hours>1 hour

From ACOG Technical Bulletin No. 218

Abnormal labor patterns and diagnostic criteria

Forceps should be used cautiously - if at all -with fetal macrosomia.

Page 27: Clinical Practice Guidelines

Physician focus for delivery of the macrosomic fetus:

• Emphasize preparedness of staff for management of shoulder dystocia.

References/Resources:

Fetal Macrosomia. ACOG Practice Bulletin Clinical Management Guidelines for Obstetrician-Gynecologists. Number 22, November 2000.

Berkus MD, Conway D, Langer O. The Large Fetus. Clinical Obstetrics and Gynecology 1999;42(4):766-784.

Conway DL, Oded L. Elective delivery of infants with macrosomia in diabetic women: Reduced shoulderdystocia versus increased cesarean deliveries. Am J Obstet Gynecol 1998;178(5):922-25.

Dystocia and the Augmentation of Labor. ACOG Technical Bulletin. Number 218, December 1995.

Gonen R, Bader D, Ajami M. Effects of a policy of elective cesarean delivery in cases of suspected fetalmacrosomia on the incidence of brachial plexus injury and the rate of cesarean delivery. Am J ObstetGynecol 2000;183:1296-300.

Rasmussen TL. The Use of Ultrasound to Identify Fetuses with Macrosomia in Diabetic Pregnancies: AReview of Current Literature. Journal of Diagnostic Medical Sonography 2000;16(2):76-79.

Sacks DA, Chen W. Estimating Fetal Weight in the Management of Macrosomia. Obstetrical andGynecological Survey 2000;55(4):229-239.

Shoulder Dystocia. ACOG Practice Patterns, Evidence-Based Guidelines for Clinical Issues in Obstetricsand Gynecology. Number 7, October 1997.

Sokol RJ, Chik L, Dombrowski MP, Zador IE. Correctly identifying the macrosomic fetus: Improvingultrasonography-based prediction. Am J Obstet Gynecol 2000;182;1489-95.

Zamorski MA, Biggs WS. Management of Suspected Fetal Macrosomia. American Family Physician2001;63:302-6.

http://www.acog.org http://www.aafp.org http://www.icsi.org

Page 28: Clinical Practice Guidelines

Vaginal Birth afterCesarean Section

Complicated labor results from:•Failure to progress (see Dysfunctional Labor guideline)•Fetal distress (see Non-Reassuring Fetal Status During Labor guideline)•Maternal complication (e.g. cardiac disease, exhaustion)•Uterine RuptureThe same considerations for intervention in labor apply to VBACs as for other attempted deliveries.

Contraindications to VBAC (and see page 2):•Previous classic C-section or T-shaped incision or other transfundal uterine surgery•Contracted pelvis•Previous uterine rupture or dehiscence•Some maternal/fetal medical conditions (e.g., open neural tube defect or complete placenta previa)•Inability to perform emergency cesarean delivery because of unavailable surgeon, anesthesia, sufficient staff, or facility•Unknown uterine scar if there is a high likelihood of classical scar•Rare psychological or social conditions

Pregnant woman with history of

previous C-section

•Obtain previous operative records fortype of uterine incision

•Perform thorough history and physical

Contra-indications

to VBAC?

no

Routine prenatal care and appropriatelytimed cesarean delivery

Patientdesires trial

of labor?noyes

•Routine prenatal care until labor•Instruct patient to report to hospital in active labor

yesNormallabor?

no

Vaginal birth

Complicated labormanagement (see Page 2)

yes

Special considerations of labor management (see page 2)

Counsel patient regarding benefits and risks of VBAC

Vaginalbirth

appropriate?Repeat

C-sectionyesno

Page 29: Clinical Practice Guidelines

Vaginal Birth after Cesarean Section(page 2)

Special considerations of labor management for VBAC candidates:

•C-section team should be available within a short time (20-30 min).•Intermittent auscultation or continuous electronic fetal heart rate monitoring should be done.•Augmentation or induction of labor is not contraindicated.•Uterine scars do not require manual exploration post-partum.•Epidural anesthesia is not contraindicated.•Amnioinfusion is not contraindicated•Intrauterine pressure catheters are not necessary unless there are other obstetric indications.•The use of prostaglandins in women with previous c-sections has not been thoroughly studied. Each situation should be weighed individually.

The following are NOT contraindications to VBAC:

•Two or more previous C-sections•Previous failure to progress in labor and/or CPD•Post C-section infection•Vaginal delivery with a known overdistended uterus (i.e., twins, macrosomia, hydramnios)

Page 30: Clinical Practice Guidelines

Physician focus for Vaginal Birth after C-section (VBAC):

• Discuss risks/benefits of VBAC with patient and document in chart• Document prior uterine surgeries, including c-section(s) in patient’s chart.• Facilities are encouraged to have a general VBAC policy that is agreed on by the obstetrics and

gynecology department, with a built-in monitoring and evaluation system.

References/Resources:

Vaginal Birth After Previous Cesarean Delivery. ACOG Practice Bulletin, Clinical ManagementGuidelines for Obstetrician-Gynecologists. Number 5, July 1999

AAFP Reference Manual—Clinical Policies. Trial of Labor versus Elective Repeat Cesarean Section forthe Woman with a Previous Cesarean Section. April 1995. http://www.aafp.org/policy/camp/rep-505.html/ (2001, April 16)

Appleton B, Targett C, Rasmussen M, Readman E, Sale F, Permezel M. Vaginal Birth After CaesareanSection: An Australian Multicentre Study. Obstetrical and Gynecological Survey 2000;55(11):680-682

Jongen VHWM, Halfwerk MGC, Brouwer WK. Vaginal Delivery After Previous Caesarean Section forFailure of Second Stage of Labour. Obstetrical and Gynecological Survey 1999;54(4):226-227.

Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Vaginal Birth After Cesarean.December 1999 http://www.icsi.org/guidelst.htm/ (2001, April 16)

Wing DA and Paul RH. Vaginal Birth After Cesarean Section: Selection and Management. ClinicalObstetrics and Gynecology 1999;42(4):836-848.

ACOG practice guideline. VBAC.

http://www.acog.org http://www.aafp.org http://www.icsi.org

Page 31: Clinical Practice Guidelines

Pregnancy-Associated Hypertensive Disease

Findings suggestive of preeclampsia syndrome:

•Blood pressure>=160 systolic or >=110 diastolic•Proteinuria of 2.0 g or more in 24 hours (2+ or 3+ on qualitative examination)•Increased serum creatinine (>1.2 mg/dL)•Platelet count less than 100,000 cells/mm3 and/or evidence of microangiopathic hemolytic anemia•Elevated hepatic enzymes (ALT or AST)•Pulmonary edema•Oliguria - <400cc/240•Intrauterine growth retardation or oligohydramnios•Persistent headache or other cerebral or visual disturbances•Persistent epigastric pain

Hypertension inpregnancy

(>140/90 mmHg on two or more

determinations)

Always carefully consider the risks and benefits to a woman and her fetus with continuing or initiating pharmacotherapy for hypertensive disease during pregnancy. Antihypertensive treatment for mild chronic hypertension benefits the mother, but the impact on perinatal outcomes is less clear.

HTNdiagnosedbefore 20

weeks gesta-tion?

no•Consider reducing dose or weaning current regimen. ACE-Inhibitors and Angiotensin II Receptor Blockers MUST be discontinueddue to risk of fetal abnormalities. •If SBP >=150 mmHg or DBP >=100 mmHg and treatment has not yet been initiated, see page 2 for options•Consider work-up of secondary hypertension

Ispatient at

<32 weeks’gestation?

Attempt to postpone delivery if hypertension is mild, and no renal, liver, or coagulation abnormalities are evident.

yes

no

Continue close observation of woman and fetus. Initiate antihypertensive therapy if/when benefits to mother appear to outweigh risk to fetus.

Pre-eclampsiasymptomsor signs present?

yes

Consider corticosteroids to accelerate fetal lung development.

Likely chronic hypertension

The use of alcohol and tobacco during pregnancy should be strongly discouraged.

yes

no

Consider labor induction

yes

no

Hospitalize patient and monitor closely for signs of fetal distress and symptoms of headache, visual disturbances, and right upper quadrant pain

Consider initiation of antihypertensive agent if DBP is 100 mmHg or higher

Haspatient

experienced severehypertension

for 24-48 hours? ORDoes patient have another qualifying

diagnosis?

•Continue close observation and monitoring of woman and fetus•Bed rest•Antihypertensive medications•Magnesium sulfate for seizure prophylaxis

Qualifying diagnosis for labor induction when pregnancies are at or near term:

•HELLP syndrome•Progressive renal failure•Premonitory signs of eclampsia (including

mild)•Elevated blood pressure•Fetal distress

Administer magnesium sulfate for seizure prophylaxis during labor and delivery and for at least 24 hours post-partum by continuous IV infusion.

Consider bed rest

Outpatient management may be considered if compliance is expected to be good, hypertension is mild, and the fetus is normal.

Monitor deep tendon reflexes, respiratory rate, and urinary output during magnesium sulfate administration

Page 32: Clinical Practice Guidelines

Pregnancy-Associated HypertensiveDisease (page 2)

Antihypertensive Drugs Used in Pregnancy (from NHLBI*):

Suggested Drug CommentsCentral alpha-agonist Methyldopa is the drug of choice recommended by the NHBPEP** Working Group.

Beta-blockers Atenolol and metoprolol appear to be safe and effective in late pregnancy.Labetalol also appears to be effective. Beta-blockers can cause IUGR and lowplacental weight when used during the second trimester. Other potentially adverseeffects include fetal bradycardia, impaired fetal compensatory response to hypoxia,and neonatal hypoglycemia.

Calcium antagonists Potential synergism with magnesium sulfate may lead to precipitous hypotension.

ACE-Inhibitors, Fetal abnormalities, including death, can be caused, and these drugs should not beAngiotensin II receptor blockers used in pregnancy.

Diuretics Diuretics are recommended for chronic hypertension if prescribed before gestationor if patients appear to be salt-sensitive. They are not recommended in preeclampsia.

Direct vasodilators Hydralazine was the parenteral drug of choice, but is being replaced by IV labetalolor oral /SL nifedipine based on fewer maternal and perinatal adverse effects.

Conditions Sometimes Confused with Preeclampsia or Eclampsia:

•Viral hepatitis•Acute fatty liver of pregnancy•Acute pancreatitis•Gallbladder disease•Appendicitis•Kidney stones•Glomerulonephritis•Hemolytic-uremic syndrome•Exacerbation of systemic lupus erythematosus•Autoimmune thrombocytopenia•Thrombotic thrombocytopenic purpura•Cerebral venal thrombosis•Encephalitis of various causes•Cerebral hemorrhage

Laboratory tests to consider in early gestation for women who are “High-risk” for preeclampsia*** or who present with hypertension before gestation week 20:•CBC•serum creatinine and uric acid levels•24-hour urine collection for protein and creatinine IF routine urine analysis shows 1+ or greater protein with clean catch specimen•Early sonogram for dating if conditions not optimal for clinical dating•Baseline sonogram for evaluating fetal growth at 25 to 28 weeks

*NHLBI, National Heart, Lung, and Blood Institute (a division of the NIH).

**NHBPEP, National High Blood Pressure Education Program

***High-risk for preeclampsia includes a history of increased blood pressure before conception or in a previous gestation; women with diabetes, collagen vascular disease, or underlying renal vascular or renal parenchymal disease; and those with a multifetal pregnancy.

Laboratory evaluation for women who develop hypertension after gestation week 20--at initial diagnosis of hypertension, and consider repeating biweekly:•CBC•protein excretion quantification (e.g., 24-hour collection)•serum creatinine, uric acid, and transaminase levels•serum albumin, lactic acid dehydrogenase, blood smear, and coagulation profile

Page 33: Clinical Practice Guidelines

Hypertension

*Consider simultaneous initiation ofpharmacotherapy if patient is a diabetic or has signs/symptoms of end-organ damage.**B-blockers should not be started during an acute worsening of clinical status or when patient has fluid overload. FDA-approved B-blockers for CHF include Carvedilol (Coreg), Bisoprolol (Zebeta) and Metoprolol succinate (Toprol XL)

Goal blood pressure:<140/90 for adult without diabetes<130/80 for adults with diabetes

Elevated bloodpressure identified

Perform additional work-upas indicated.

Begin or continuelifestyle modifications*•Smoking cessation•Weight reduction•Regular physical activity•Moderation of alcohol intake•Reduction of sodium intake•Lipid measurement

Confirm elevated blood pressure within1-8 weeks and perform

diagnostic testing ifBP still above normal

ACE-Inhibitor•Diabetes mellitus•Heart failure (CHF)**•Myocardial infarction•Vascular disease

Is asecondary

causesuspected?

Encourage maintenanceof lifestyle modificationsand regular follow-up for

monitoring

yes no

no

Beta blocker•Uncomplicated hypertension•Myocardial infarction•Heart failure

Diuretic•Uncomplicated hypertension•Heart failure•Isolated systolic hypertension(in older persons)

Long-acting dihydropyridine calcium antagonist•Isolated systolic hypertension(in older persons)

Complete history andphysical exam, look

for signs of end-organdamage

Diagnostic tests to consider:•CBC•Electrolytes•Creatinine•Fasting glucose•Urinalysis•Lipid profile•Electrocardiogram

Adequateresponse?

yes

Initiate one of the following medications based upon

the compelling indication:

Start with a low dosage of a long-acting once-daily drug and titrate.

Is the drug well tolerated?

yes

no

Substitute another drug

from a different class

Is goalblood pressure

achieved?

•Follow up at least every 6 months. •Continue lifestyle modifications

Increase dose of initial agent.If maximal dose inadequate,

add a second agent.

no

yes

Consider ARBs as an alternative to ACE inhibitors in patients unable to tolerate the latter.

Page 34: Clinical Practice Guidelines

Physician focus for Evaluating and Treating Hypertension (HTN):

• Prescribe ACE-Inhibitors (or nitrates plus hydralazine) for all CHF patients withoutcontraindications.*

Indicator: Percentage of adults with diagnosis of CHF treated with ACE-Inhibitors (OR nitratesplus hydralazine)

• Titrate ACE-Inhibitors to target dose, as tolerated, in patients with CHF.Indicator: Percentage of adults with diagnosis of CHF, treated with ACE-Inhibitors, at targetdoses. These target doses are outlined on page 2 of the CHF guideline.

• Prescribe B-blockers for CHF patients, NYHA Class I-III, without contraindications.Indicator: Percentage of adults with diagnosis of CHF treated with B-blockers.

* Angiotensin II Receptor Antagonists (ARB) may be used as an alternative to ACE inhibitors inpatients who cannot tolerate the latter but have comorbid conditions for which ACE inhibitors areindicated.

References/Resources:

Kaplan NM. What is goal blood pressure for the treatment of hypertension? Archives of Internal Medicine2001;161:1480-1482.

Kaplan NM. Angiotensin II receptor antagonists in the treatment of hypertension. American FamilyPhysician 1999;60:1185-90.

Yarows S et al. University of Michigan Medical Center. UMMC Hypertension Guidelines. February 1997.

Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Hypertension Diagnosis andTreatment. November 2000. http://www.icsi.org/guidelst.htm/ (2001, March 7)

Kaplan NM. Treatment of Hypertension: Insights from the JNC-VI Report. Am Fam Physician1998;58:1323-30..

U.S. Department of Health and Human Services, Public Health Service, Agency for Health Care Policy andResearch. (1994, June). Heart Failure: Evaluation and Care of Patients with Left-Ventricular SystolicDysfunction. Clinical Practice Guideline No. 11. Retrieved from http://www.ahrq.gov/ (2001, March 7)

University of Michigan Health System. Guidelines for Clinical Care: Heart Failure—Systolic Dysfunction.http://cme.med.umich.edu/iCME/default.asp/ (2001, March 7)

University of Washington Physicians. Heart Failure Due to Systolic Dysfunction (HF) Guidelines.http://healthlinks.washington.edu/guideline/hf/processes.html/ (2001, February 20)

http://www.ahcpr.gov/clinic/cpgonline.htm http://www.americanheart.org http://www.hfsa.org http://www.praxis.md.com

Page 35: Clinical Practice Guidelines

HyperlipidemiaCoronary Artery Disease (CAD) Risk Factors:

PositiveRiskFactors

Age:• Male >=45• Female >=55, or premature menopause

without HRT

Family history of premature CHD:Definite MI or sudden death• before 55 y/o in father or other male first-

degree relative• before 65 y/o in mother or other female first-

degree relativeCurrent cigarette smoking

Hypertension:• >140/90*• or on antihypertensive medication

Low HDL-cholesterol• <40 mg/dL*

Diabetes mellitus

NegativeRiskFactors

High HDL-cholesterol• > 60 mg/DL If HDL-cholesterol is > 60, subtract one risk factor

*Confirmed by more than one measurement.

YesRepeat screening every 5 years

No

Perform fasting lipid panel for all adults >20 years old

every 5 years

Calculate number ofrisk factors

(see table to right)

Does patient have

any risk factors?

LDL-cholesterolless than

160 ?

Determine goal LDL,based upon risk factors

and baseline LDL-cholesterol

No Yes

0-1 risk factor

GOAL LDL-cholesterolis <160

2+ risk factors(10-year risk ≤20%)*

GOAL LDL-cholesterolis <130

CHD or CHD equivalents(10-year risk >20%)*

GOAL LDL-cholesterolis <100

Discuss with patient their risklevel and preferences regardingcontinuing a trial of behavioral

and dietary therapies or initiating lipid-lowering

medication.Consider estrogen-replacementtherapy in appropriate women

Continue health maintenance and

management

Non-pharmacological treatment trial (3-12 months):Initiate dietary therapy: Step I diet (or Step II diet if known CAD or if patient is already on a Step I diet)Consider referral to dieticianInitiate physical activity, weight management, and smoking cessation programs as indicated.Consider ruling out secondary causes of hyperlipidemia with urinalysis, TSH, blood sugar, alk phos, etc.

Has goal LDL-cholesterol

been met?

Recheck lipid levels in 6 weeks

YesNo

Decisionto initiate

lipid-loweringtherapy? Initiate lipid-

loweringpharmacotherapy

(see page 2)

Has goal LDL-cholesterol

been met?

Recheck lipidlevels in 6 weeks

No

Yes

Consider increasing doseof lipid-lowering agent or

adding a second agent(see page 2)

*Using Framingham projections of 10-year absolute CHD risk to identify certain patients for more intensive treatment

Follow-up in officeevery 4-6 months forthe first year, then

at least annually

Yes

No

Is LDL>130?

Consider immediateinitiation of a Statin for

aggressive lipid reduction

No

Yes

Page 36: Clinical Practice Guidelines

Hyperlipidemia Page 2

Focus on the Patient:• Simplify medication regimens• Provide explicit patient instruction and use good counseling techniques to teach the patient how to follow the

prescribed treatment• Encourage the use of prompts to help patients remember treatment regimens• Use systems to reinforce adherence and maintain contact with the patient• Encourage the support of family and friends• Reinforce and reward adherence• Increase visits for patients unable to achieve treatment goal• Increase the convenience and access to care• Involve patients in their care through self-monitoring

Drug Class Indication Cautions/ContraindicationsStatins(HMG-CoAreductase inhibitors)

• Drug of choice in patients with knownCAD

• Reduces LDL-C 25-40%• Reduces triglyceride levels• Modest increase in HDL-C• Demonstrated decreased mortality from

CAD

• Contraindicated in active liver disease• Hepatotoxicity occurs in <2% of

patients, and is usually reversible• Myositis is unusual complication• Caution when combining with

fibrates or niacin

Bile AcidSequestrants(Cholestyramine andcolestipol HCl)

• Typically first-line for primaryprevention (hyperlipidemia withoutknown CAD)

• Can reduce total cholesterol and LDL-C 15-30%• Increases triglyceride levels• Can be combined with other drugs (e.g.

statins)for severe forms ofhypercholesterolemia

• Gastrointestinal side effects maypreclude or limit dosage

Niacin(i.e. Nicotinic acid,Niaspan)

• Reduces LDL-C cholesterol andtriglycerides

• Increases HDL-C levels

• Contraindicated in chronic liverdisease, severe gout

• Relative contraindication with pepticulcer disease

• Flushing is common side effect. Thismay be alleviated by titrating dose,taking with a meal and/orpretreatment with aspirin

• Requires monitoring of liver function

Fibrates(i.e. gemfibrozil)

• Reduces triglyceride levels—mostvaluable for treatment of very hightriglyceride levels

• May elevate both LDL-C and HDL-Clevels

• Can use as combination therapy with astatin for mixed lipid abnormalities—monitor for myopathy and potentialhepatic toxicity

• Doesn’t usually produce substantialLDL-C reduction

• May elevate both LDL-C and HDL-Clevels

• Myositis and gallstones are unusualcomplications

• Contraindicated in severe renaldisease, severe hepatic disease

EstrogenReplacementTherapy

• Should be considered as a possiblealternative or adjunct to therapy forwomen with elevated LDL-cholesterollevels

• Increases HDL-C levels• Reduces LDL-C levels

• Combine with progestins for womenwith intact uterus

Page 37: Clinical Practice Guidelines

Physician focus for Treating Hyperlipidemia:

• Select a statin for lipid-lowering therapy in patients with known coronary artery disease (CAD). Indicator: Percentage of adults diagnosed with hyperlipidemia with a co-existing diagnosis of

CAD or MI that are treated with a statin.

• See patients diagnosed with hyperlipidemia for office follow-up within 4 months of initial diagnosis.

Indicator: Percentage of adults diagnosed with hyperlipidemia with a follow-up appointmentwithin 4 months of initial diagnosis.

References/Resources:

Abookire SA, Karson AS, Fiskio J, Bates DW. Use and Monitoring of “Statin” Lipid-Lowering DrugsCompared With Guidelines. Arch Intern Med. 2001; 161:53-58.

Ansell BJ, et al. An evidence-based assessment of the NCEP Adult Treatment Panel II guidelines. JAMA1999: 282:2051-7.

Harvard Pilgrim Health Care, Inc. Guidelines for lipid screening and management for primary andsecondary prevention of coronary heart diseases (CHD) in adults. Released 1997 Oct. Accessed at theNational Guideline Clearinghouse.

National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of HighBlood Cholesterol in Adults (Adult Treatment Panel III). U.S. Department of Health and Human Services,Public Health Service, National Institutes of Health, National Heart, Lung and Blood Institute. JAMA2001:285(19): 2486-2497.

Sikkink J, et al. Health Care Guideline: Treatment of Lipid Disorder in Adults—Patients Without KnownCoronary Artery Disease. Institute for Clinical Systems Improvement (ICSI). November 2000.http://www.icsi.org/guidelst.htm/

Task Force, Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Dyslipidemia andPrevention of Atherogenesis. AACE medical guidelines for clinical practice for the diagnosis andtreatment for dyslipidemia and prevention of atherogenesis. Endocrine Practice 2000. 6(2): 162-213

American Heart Association, Step I and II Diets:http://www.americanheart.org/Heart and Stroke A Z Guide/step1.html/

Page 38: Clinical Practice Guidelines

Stable Angina

Evaluation to include (where appropriate):•Complete History and Physical•EKG (optimally during symptoms)•Blood work--CBC, chem profile, TSH, FLPs•Chest X-ray•Echocardiogram (if suspect dysfunction/failure)

Signs/Symptomsof Angina

Does patient have intermediate

or high riskunstableangina?

Go toUnstable Angina

Algorithm

yes

no

Assessmentyields

intermediate orhigh risk for

adverse event?

No

yes

Initiate Medical Therapyand Lifestyle Modification(see page 2)

Yes

NoConsider cardiac catheterization or pharmacological

stress test

Able toachieve necessary

increasedheart rate via

stress test?

No

yes

Contra-indications to

stresstesting? Follow-Up in

2-6 weeks

Baseline EKG

normal?

no

Consider ECHO ornuclear stress test

Exercise stress testTest resultssuggestive of

high risk?

no

Consider further evaluation with:•Nuclear stress test•Stress Echocardiography•Cardiac catheterization

Do test results suggest

significantlesions?

Refer for cardiac catheterization and

myocardialrevascularization.

yes

yesYes

no

Treadmill results indicating high risk:•<5 METs duration•ST segment depression•Hypotension•Inability to attain target heart rate--85% of max predicted heart rate (MPHR=220-age)•Exercise-induced angina•Ventricular ectopy at low workload

Features of intermediate or high risk unstable angina:•Rest pain lasting > 20 min.•Age >65 y/o•ST and T wave changes•Pulmonary edema•Elevated cardiac enzymes

ANGINA SIGNS/SYMPTOMS MAY INCLUDE:•Pain/discomfort in chest and/or adjacent areas•Nitroglycerin used to shorten/ alleviate/prevent angina attacks•Anginal equivalent symptoms may include: nausea, palpitations, diaphoresis, unusual weakness or fatigue, shortness of breath (often with exertion)

RISK ASSESSMENT:Low Intermediate High

Prior vascular dz. Accelerated tempo anginaatypical >20 min C.P. @ rest >20 min C.P. at rest

(resolved) (ongoing)Pulm edemaMR murmurS3hypotension

Normal EKG >.2 mV T-wave >0.05mV ST changes(or unchanged) BBB, sustained. v. tach

Page 39: Clinical Practice Guidelines

Stable Angina (page 2)

General Contraindications for Exercise Stress Test

Consider pharmacologic stress test under the following circumstances:•Acute thrombophlebitis or deep venous thrombosis•Neuromuscular, musculoskeletal or arthritic condition that precludes treadmill exercise•Patient’s inability or lack of desire to perform the test•Easy fatigability

Consider cardiac catheterization under the following circumstances:•Recent (within 6 weeks) acute myocardial infarction•Angina at rest•Severe symptomatic left ventricular dysfunction•Potentially life-threatening arrhythmias•Acute pericarditis, myocarditis or endocarditis•Severe aortic stenosis•Acute pulmonary infarct or embolus•Acute or serious general illness

Medical therapy and lifestyle modification recommendations (if no contraindications):•B-blocker--titrate to achieve a resting heart rate of 50-60 beats per minute•Calcium channel blocker* and/or nitrates** (if symptoms persist with B-blocker monotherapy)•ACE-I for patients with CHF, LV dysfunction (EF<40), hypertension, or diabetes•Aspirin 75-325 mg qd (or, Clopidogrel 75 mg/d if Aspirin contraindication)•Lipid-lowering therapy (see Hyperlipidemia guideline)•Low-cholesterol diet education•Physical exercise education•Smoking cessation•Nitroglycerin (sublingual or spray)--patient must be instructed in its use.

*Caution with negative inotropic agents IF impaired left ventricular function present (consider dihydropyridines as Ca-channel blockers of choice in compensated CHF)**Long-acting nitrates, with daily nitrate-free interval.

Page 40: Clinical Practice Guidelines

Physician focus for Evaluating and Treating Stable Angina:

• See patients diagnosed with stable angina within two months of initial diagnosis.Indicator: Percentage of adults diagnosed with stable angina who have a follow-up appointmentwith their PCP or Cardiologist within 2 months of initial diagnosis

• Prescribe beta-Blocker therapy for patients with stable angina, unless contraindicated or nottolerated.

Indicator: Percentage of adults with stable angina filling a prescription for a beta-Blocker.

• Prescribe short-acting nitrates (sublingual or spray) for all patients with stable angina, unlesscontraindicated.

Indicator: Percentage of adults with the diagnosis of stable angina with a current nitroglycerin(sublingual or spray) prescription. This prescription could be recent or up to one-year prior.

References/Resources:

Gibbons RJ, Chatterjee K, Dale J, et al. ACC/AHA/ACP-ASIM guidelines for the management of patientswith chronic stable angina: executive summary and recommendations: a report of the American College ofCardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management ofPatients With Chronic Stable Angina). Circulation 1999: 99:2829-2848.

Heidenreich PA, McDonald KM, Hastie T, Fadel B, Hagan V, Lee BK, Hlatky MA. Meta-analysis of TrialsComparing beta-Blockers, Calcium Antagonists, and Nitrates for Stable Angina. JAMA 1999;281(20):1927-1936.

Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Stable Coronary Artery Disease.January 2000. http://www.icsi.org/guidelst.htm/ (2001, March 7)

Lehman G. et al. ICSI Health Care Guideline: Stable Coronary Artery Disease. Institute for ClinicalSystems Improvement January 2000

Thadani U. Treatment of stable angina (Ischemic Heart Disease). Current Opinion in Cardiology1999;14(4):349-358.

Zanger DR, Solomon AJ, Gersh BJ. Contemporary Management of Angina: Part I. Risk Assessment.American Family Physician 1999; 60:2543-52.

Zanger DR, Solomon AJ, Gersh BJ. Contemporary Management of Angina: Part II. Medical Managementof Chronic Stable Angina American Family Physician 2000; 61:129-38.

Agency for Healthcare Research and Quality, Clinical Practice Guidelines:http://www.ahcpr.gov/clinic/cpgonline.htm

American Heart Association: http://www.americanheart.org

Praxis MD: http://www.praxis.md.com

Page 41: Clinical Practice Guidelines

Unstable AnginaSigns/Symptoms

of Angina

Evaluation to include (where appropriate):

• Complete History and Physical

• EKG (optimally during symptoms)

• Blood work--CBC, chem profile, TSH, FLPs

• Chest X-ray• Echocardiogram (if suspect

dysfunction/failure)

Intermediateor high risk

unstableangina?

Go toStable Angina

Algorithm

Assessment yields

intermediate orhigh risk for

serious cardiac event?

Outpatient management

Symptom-free after6-12 hours observation

AND repeat EKGand cardiac

markersnegative?

Inpatient management

Consider referral for cardiac catheterization

(if patient is a candidate)

Is patienthemodynamically

unstable? Consider consultation for

urgent cardiac cathetherization

Exercise Stress TestTest results

suggestive of high risk?

Outpatient managementwith re-evaluation

within 72 hours

Refer for cardiac catheterization and

myocardial revascularization.

Consider further evaluation with:• Nuclear stress test• Stress Echocardiography• Cardiac catheterization

Test resultssuggest

significantlesions?

If not already initiated, begin antithrombotic therapy

(Unfractionated heparin + Aspririnor Low molecular weight heparin)

Unable to exercise

ANGINA SIGNS/SYMPTOMS MAY INCLUDE:•Pain/discomfort in chest and/or adjacent areas•Nitroglycerin used to shorten/ alleviate/prevent angina attacks•Anginal equivalent symptoms may include: nausea, palpitations, diaphoresis, unusual weakness or fatigue, shortness of breath (often with exertion)

Features of intermediate or high risk Unstable Angina:•Rest pain lasting > 20 min.•Age >65 y/o•ST and T wave changes•Pulmonary edema•Elevated cardiac enzymes

RISK ASSESSMENT (see Table I for a comprehensive outline):Low Intermediate High

prior vasc dz. Accel tempo anginaatypical >20 min C.P. @ rest >20 min C.P. at rest

(resolved) (ongoing)Pulm edema,MR murmur, S3,hypotension

Normal EKG >.2 mV T-wave >0.05mV ST changes(or unchanged) BBB, sust. v. tach,

elevated troponin, CKMB levels

Consider the following (unless contraindications)• Aspirin (or a thienopyridine if ASA intolerant)• O2 (2-4 L/min by NC)• Nitroglycerin (SL, spray, transdermal, or IV)• MSO4 (1-5 mg IV, repeat q15-30 min prn pain• Trial of antacid if suspect GI origin of pain• B-blocker (or, if contraindicated, a nondihydropyridine calcium

antagonist)• ACE-Inhibitor if persistent HTN and LV dysfunction (or CHF)

and in patients with diabetes• Antithrombotic regimen (IV unfractionated heparin or SQ low

molecular weight heparin)• Platelet glycoprotein IIb/IIIa (GP IIB/IIIa) receptor antagonist (IF

continuing ischemia, high-risk features, or cath planned) • Close monitoring of HR, BP, and cardiac rhythm

Test results indicating high risk:

• <5 METs duration• ST segment depression• Hypotension• Unable to attain target heart

rate--85% of max predicted heart rate (MPHR=220-age)

• Exercise-induced angina• Ventricular ectopy at low

workload

InitiateMedical Therapy andLifestyle Modification

(see page 2)

No

Yes

YesNo

No

Yes

Yes

No

Yes

No

Yes

No

Yes

No

Page 42: Clinical Practice Guidelines

Physician focus for Evaluating and Treating Unstable Angina:

• See patients admitted with a diagnosis of unstable angina for office follow-up within 3 days of diagnosis.

Indicator: Percentage of adults admitted for 24 hours or less for unstable angina having afollow-up visit within 3 days (with PCP or Cardiologist).

• Prescribe beta-Blocker therapy for patients with unstable angina, unless contraindicated or nottolerated.

Indicator: Percentage of adults with unstable angina filling a prescription for a beta-Blocker.

• Prescribe short-acting nitrates (sublingual or spray) for patients with unstable angina, unlesscontraindicated.

Indicator: Percentage of adults with the diagnosis of unstable angina with a current nitroglycerin(sublingual or spray) prescription. This prescription could be recent or up to one-year prior.

• Prescribe ASA 75 to 325 mg/d unless contraindicated. (Clopidogrel 75 mg/d may be used forpatients with contraindications to ASA.)

• Lipid lowering agents and diet for patients with low-density lipoprotein (LDL) cholesterol of>125 mg/dL.

• ACEIs for patients with CHF, LV dysfunction (EF<0.40), hypertension, or diabetes.

References/Resources:

Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D,Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE III, Steward DE, Theroux P. ACC/AHAguidelines for the management of patients with unstable angina and non-ST-segment elevation myocardialinfarction: executive summary and recommendations: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of PatientsWith Unstable Angina). Circulation 2000;102:1193-1209.

Clinical Practice Guideline, Unstable Angina: Diagnosis and Management (AHCPR Publication No. 94- 0604)

Hamm CW, Braunwald E. A Classification of Unstable Angina Revisited (Current Perspective).Circulation 2000:102:118-122.

Mozaffarian D. Non-ST Elevation Acute Coronary Syndromes (Unstable Angina and Non-Q-waveMyocardial Infarction). Best Practice of Medicine 2001. Accessed from praxis.md web site(www.praxis.md.com) Article url: http://praxis.md/index.asp?page=bpm_brief&chapter=BPM01CA14.

U.S. Department of Health and Human Services, Public Health Service, Agency for Health Care Policy andResearch. (1994, June). Clinical Practice Guideline, Unstable Angina: Diagnosis and Managment.Retrieved from http://www.ahrq.gov/ (2001, March 7)

Agency for Healthcare Research and Quality, Clinical Practice Guidelines:http://www.ahcpr.gov/clinic/cpgonline.htm

American Heart Association: http://www.americanheart.org

Page 43: Clinical Practice Guidelines

Congestive Heart Failure (CHF)

*For ACE-I and B-blockers, start with very low doses and titrate to target dosage (see page 2) as tolerated**B-blockers should not be started during an acute worsening of clinical status or when patient has fluid overload. FDA-approved B-blockers include Carvedilol (Coreg), Bisoprolol (Zebeta) and Metoprolol succinate (Toprol XL)

Common Symptoms of CHF:•Paroxysmal nocturnal dyspnea or supine cough•Orthopnea•Dyspnea or cough on exertion•Edema in the lower extremities•Decreased exercise tolerance•Unexplained confusion, altered mental status, or fatigue•Abdominal symptoms associated with ascites and/or hepatic engorgementUncommon Symptoms of CHF:•Pulmonary or systemic embolism in the absence of an obvious cause•Unexplained pleural effusions•Abnormal liver enzymes

Symptoms andsigns of heart

failure

Likely diastolic dysfunction, valvular heart disease,

or a non-cardiac etiology (beyond scope of this guideline)

Reversible cause (e.g.,ischemic or valvular

heart disease)?

Assess LV function (Echocardiogram,

Radionuclide Ventriculogram)

Asymptomatic(NYHA Class 1)•ACE-I*•B-blocker*, **

Is ejectionfraction

<40%

Consider referral to address cause, then

reconsider pharmacologictherapy

Systolic dysfunction.Determine symptom

class and treat as follows (unless contra-

indications exist)

yes yesno

no

Include comprehensive patient education (see page 2)

Symptomatic(NYHA Class II-IIIa)•ACE-I*•B-blocker*, **•Diuretic (may be prn edema and congestion)

If symptoms persist:•Digoxin

Symptomatic with history of recent rest dyspnea(NYHA Class IIIb)•ACE-I*•B-blocker*, **•Diuretic (dosing may be modified depending uponmagnitude of congestion)•Spironolactone •Digoxin

Symptomatic with rest dyspnea(NYHA Class IV)•ACE-I* •Diuretic (dosing may be modified depending uponmagnitude of congestion)•Spironolactone--monitor potassium (<5.0) and creatinine (<2.5)•Digoxin

•Consider Aspirin (especially if patient has known CAD) •Consider warfarin anticoagulation in patients with left ventricular ejection fraction of 35% or less•Warfarin anticoagulation in patients with heart failure and atrial fibrillation (goal INR= 2.0 to 3.0), unless contraindicated•In symptomatic patients, if ACE-I is not tolerated, consider Hydralazine and Isosorbide Dinitrate combination. Alternatively,may consider Angiotensin II Receptor Blockers (ARBs), although not shown to have comparable decrease in mortality, available

with beta blockers and ACE-I•Avoid drugs that may exacerbate CHF: Class I anti-arrhythmics, NSAIDs, some “first-generation” calcium channel blockers (i.e., diltiazem, nifedipine, verapamil)

Complete history andphysical exam and

clinically appropriate diagnostic tests

Diagnostic tests to consider:•CBC•AST, alkaline phosphatase•Sodium, potassium•Creatinine, BUN•Protein or albumin•Urinalysis•Thyroid function•Magnesium, calcium•Iron/ferritin•Electrocardiogram•Chest radiograph

Cath or image study

suggestsCAD?

yes

Page 44: Clinical Practice Guidelines

CHF (Page 2)

NYHA Class NYHA Symptom DescriptionI Asymptomatic. No limitation of physical activity. Ordinary physical activity does not cause undue

fatigue, palpitation, or dyspnea.II Mildly symptomatic. Slight limitation of physical activity. Comfortable at rest, but ordinary physical

activity results in fatigue, palpitation or dyspnea.III Moderately symptomatic. Marked limitation of physical activity. Comfortable at rest, but less than

ordinary activity causes fatigue, palpitation or dyspnea.IV Symptoms at rest. Unable to carry out any physical activity without discomfort. Symptoms of cardiac

insufficiency at rest. If any physical activity is undertaken, discomfort is increased.

Patient Education•Low-salt diet•Moderation of fluid intake•Alcohol restriction•Self-monitoring with daily weights (especially NYHA Class III-IV)•Symptoms of exacerbation•Smoking cessation (if applicable)•Exercise regimen•Importance of flu and pneumococcal vaccination

ACE-I target dosesCaptopril 150 mg/dEnalapril maleate 20 mg/dRamipril 10 mg/dLisinopril 40 mg/dQuinapril hydrochloride 40 mg/dTandolapril 4 mg/d*Renal function and serum potassium levels should be assessed within 1-2 weeks of initiation and every 2-3 months thereafter.

Page 45: Clinical Practice Guidelines

Physician focus for Evaluating and Treating Congestive Heart Failure (CHF):

• Prescribe ACE-Inhibitors (or nitrates plus hydralazine) for all CHF patients withoutcontraindications.

Indicator: Percentage of adults with diagnosis of CHF treated with ACE-Inhibitors (OR nitratesplus hydralazine)

• Titrate ACE-Inhibitors to target dose, as tolerated, in patients with CHF.Indicator: Percentage of adults with diagnosis of CHF, treated with ACE-Inhibitors, at targetdoses. These target doses are outlined on page 2 of the CHF guideline.

• Prescribe B-blockers for CHF patients, NYHA Class I-III, without contraindications.Indicator: Percentage of adults with diagnosis of CHF treated with B-blockers.

References/Resources:

Chavey W et al, University of Michigan Health System. UMHS Heart Failure Guideline. August 1999.

Farmer J, Torre G. Congestive Heart Failure: Specific Therapies. Current Practice of Medicine 1999;2(11)2117-2131.

Gomberg-Maitlnd M, Baran DA, Fuster V. Treatment of Congestive Heart Failure: Guidelines for thePrimary Care Physician and the Heart Failure Specialist. Arch Int Med. 2001;161:342-352

Heart Failure Society of America (HFSA). HFSA Guidelines for Management of Patients with HeartFailure Caused by Left Ventricular Systolic Dysfunction—Pharmacological Approaches. Journal ofCardiac Failure 1999;5:357-382.

Hood WB Jr, Dans A, Guyatt GH, Jaeschke R, McMurray J. Digitalis for treatment of congestive heartfailure in patients in sinus rhythm (Cochrane Review). In: The Cochrane Library, 1, 2001. Oxford: UpdateSoftware.

Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Congestive Heart Failure inAdults. November 2000. http://www.icsi.org/guidelst.htm/ (2001, March 7)

Ramahi TM. Beta Blocker Therapy for Chronic Heart Failure. Am Fam Physician 2000;62:2267-74.University of Washington Physicians. Heart Failure Due to Systolic Dysfunction (HF) Guidelines.http://healthlinks.washington.edu/guideline/hf/processes.html

Shamsham F, Mitchell J. Essentials of the Diagnosis of Heart Failure. Am Fam Physician 2000;61:1319-28.

U.S. Department of Health and Human Services, Public Health Service, Agency for Health Care Policy andResearch. (1994, June). Heart Failure: Evaluation and Care of Patients with Left-Ventricular SystolicDysfunction. Clinical Practice Guideline No. 11. Retrieved from http://www.ahrq.gov/ (2001, March 7)

University of Michigan Health System. Guidelines for Clinical Care: Heart Failure—Systolic Dysfunction.http://cme.med.umich.edu/iCME/default.asp/ (2001, March 7)

University of Washington Physicians. Heart Failure Due to Systolic Dysfunction (HF) Guidelines.http://healthlinks.washington.edu/guideline/hf/processes.html/ (2001, February 20)

http://www.ahcpr.gov/clinic/cpgonline.htm http://www.americanheart.org http://www.hfsa.org http://www.praxis.md.com

Page 46: Clinical Practice Guidelines

Peptic Ulcer DiseaseSymptoms of

Dyspepsia

Emphasize NonEmphasize Non--Medical Treatment Recommendations throughout algorithm (see pageMedical Treatment Recommendations throughout algorithm (see page 2)2)

AlarmSymptomsPresent?

Yes NoEndoscopy

Are symptoms

more consistentwith GERD?

Yes

No

Go to GERD

pathway

Urea Breath Testor

H. pylori serologicaltesting **

Positive?

Yes

No

ReconsiderDiagnosis--

Consider Barium UGI or

Endoscopy

Treat H. pyloriInfection(see FDA

approved listattached)

Symptomsresolve?

No

Yes

Review in6 months

Biopsy for H. pylori

Rapid Urease Test(CLO-test)*

Positive? Yes

ReconsiderDiagnosis

(ie. Zollinger-Ellison,Crohn’s Disease,

Malignancy)

No

*Antacids, Pepto-Bismol Antibiotics, and Proton PumpInhibitors can all interfere with diagnosis. See page 2 for recommendations.**Serology cannot distinguish between active or previousinfection in a patient with prior treatment for H. pylori.

PepticUlcer?

Yes

NoReconsiderDiagnosis

(ie. GERD)

Counsel on Non-medicalanti-reflux precautions

(see page 2)

Consider Proton Pump Inhibitor trial

(see page 2)

ALARM SYMPTOMS (and risk factors for serious disease):•GI bleeding, anemia•Anorexia, weight loss•Advanced age•Dysphagia•Long history of symptoms•Protracted vomiting•No history of ulcerogenic drugs•Palpable mass

SYMPTOMS MAY INCLUDE:•Epigastric abdominal pain•Periodic pain relieved by food/antacids•Pain may be worse at night•Upper GI bleeding•Bloating, belching, heartburn•Nausea, vomiting

Note: Some references allow for omission of initial H. pylori testing and progress directly to empiric treatment for H. pylori infection.

Page 47: Clinical Practice Guidelines

PUD Page 2Avoid known risk factors:•NSAIDS and corticosteroids•tobacco•alcohol•caffeine (coffee, tea, cola)•calcium-containing antacids

Regimen Dose Duration Precautions/Comments Omeprazole+ Clarithromycin

40 mg QD500 mg TID

2 weeks Then, Omeprazole 20 mg QD x 2weeks

Ranitadine+ Clarithromycin

400 mg BID500 mg TID

2 weeks Then, Ranitadine 400 mg BID x 2weeksDysgeusia with clarithromycin

Bismuthsubsalicylate(Pepto Bismol)+Metronidazole+Tetracycline*a.k.a. HELIDAK

525 mg QID

250 mg QID500 mg QID

2 weeks Then, H2 receptor antagonisttherapy as directed x 4 weeks

*Although not FDA approved,Amoxicillin has been substituted fortetracycline for patients for whomtetracycline is not recommended.

Lansoprazole+Clarithromycin+Amoxicillin

30 mg BID500 mg TID1 g BID

10 days Penicillin allergy; dysgeusia withclarithromycin

Ranitadine+Clarithromycin

400 mg BID500 mg BID

2 weeks Then, Ranitadine 400 mg BID x 2weeksDysgeusia with clarithromycin

Omeprazole+Clarithromycin+Amoxicillin

20 mg BID500 mg BID1 g BID

10 days Penicillin allergy; dysgeusia withclarithromycin

Lansoprazole+ClarithromycinAmoxicillina.k.a. PREVPAK

30 mg BID500 mg BID1 g BID

10 days Penicillin allergy; dysgeusia withclarithromycin

Treatment options for H. pylori eradication using FDA-approved medications:

Non-medical anti-reflux treatment recommendations:

Page 48: Clinical Practice Guidelines

Physician focus for Evaluating and Treating Peptic Ulcer Disease (PUD):

• Use FDA-approved medications in the identified regimens for H. pylori eradication.Indicator: Percentage of adults diagnosed with PUD and treated with one of the identifiedRegimens (PUD page 2) for H. pylori eradication.

• Prior to prescribing a second trial of H. pylori eradication treatment, perform appropriate diagnostic testing (endoscopy, barium swallow, or urea breath test).

Indicator: Percentage of adults receiving endoscopy, barium swallow, or urea breath test before a second trial of H. pylori eradication treatment (unless such diagnostic measures were performedprior to the first treatment trial).

• See patients with recent diagnosis of PUD in the office within 6 months of diagnosis.Indicator: Percentage of adults diagnosed with PUD with a follow-up appointment within 6months of diagnosis.

• Obtain biopsy for CLO test for H. pylori when performing endoscopy for PUD.Indicator: Percentage of adults who undergo endoscopy for PUD who have biopsy performedwith CLO test for H. pylori (unless urea breath test or serological testing was performed within 6months prior to endoscopy).

References/Resources:

Anderson J and Gonzalez J. H. pylori infection: Review of the guideline for diagnosis and treatment.Geriatrics 2000 (June);55:44-49

Bazaldua OV and Schneider FD. Evaluation and Management of Dyspepsia. American Family Physician1999;60(6):1773-1786.

Delaney BC, Innes MA, Deeks J, Wilson S, Oakes R, Moayyedi P, Hobbs FDR, Forman D. Initialmanagement strategies for dyspepsia (Cochrane Review). In: The Cochrane Library, 1, 2001. Oxford:Update Software

Graham DY. Peptic Ulcer Disease. Current Practice of Medicine 1999;2(12):2359-2366.

Helicobacter pylori: Fact Sheet for Health Care Providers. Centers for Disease Control and Prevention.Updated July 1998. http://www.cdc.gov/ulcer/hpfacts.PDF (2001, February 26)

Howden CW and Hunt RH. Guidelines for the Management of Helicobacter pylori Infection. TheAmerican Journal of Gastroenterology 1998;93(12):2330-2338.

Moayyedi P, Soo S, Deeks J, Delaney B, Harris A, Innes M, Oakes R, Wilson S, Rolfe A, Bennett C,Forman D. Eradication of Helicobacter pylori for non-ulcer dyspepsia (Cochrane Review). In: TheCochrane Library, 1, 2001. Oxford: Update Software.

Soll AH. Medical Treatment of Peptic Ulcer Disease: Practice Guidelines. JAMA 1996;275(8):622-629.

Helicobacter Foundation www.helico.com The Cochrane Group www.update-software.com American Academy of Family Practice www.aafp.org Dynamic Medical www.dynamicmedical.com CDC website on Ulcers http://www.cdc.gov/ulcer/

Page 49: Clinical Practice Guidelines

GERDReflux Symptoms

Counsel on Non-medical anti-reflux

Precautions (see page 2)

EndoscopyAlarm

SymptomsPresent?

yes no

Doesendoscopy showsigns of GERD?

(i.e. erosive esophagitis,Barrett’s esophagus,

peptic strictures,etc.)

yes

no

Reconsiderdiagnosis

8-12 week empiric trial ofH2-Receptor Antagonists

BID (see page 2)

8-12 week Proton Pump Inhibitor(PPI) treatment--

titrate as needed(see page 2)

Goodresponse?

yes

no

Maintenance therapywith lowest effectivedose of H2RA or OTC H2RA or antacid(on demand or continuous, as needed)

Goodresponse?

yes

no

Maintenance therapywith lowest effective dose of PPI or H2RAor OTC H2RA orantacid (on demand or continuous, as needed)

Confirm diagnosiswith EGD, 24 hour

esophageal pH study,or Barium Esophagram,

depending upon clinical scenario

StudyconfirmsGERD?

yesno Consider surgicalconsultation forfundoplication

Follow-upin office within 6 months

Follow-upin office within 6 months

Consider furtherdiagnostic testingif patient requirescontinuous chronic

therapy OR developsalarm symptoms

Emphasize NonEmphasize Non--Medical Treatment Recommendations throughout algorithm (see pageMedical Treatment Recommendations throughout algorithm (see page 2)2)

SYMPTOMS MAY INCLUDE:•Heartburn•Substernal or epigastric burning pain or discomfort•Nocturnal cough•Belching, regurgitation, hypersalivation•Chronic cough•Hoarseness•Recurrent asthma/bronchospasm•Chronic nausea

ALARM SYMPTOMS:•Dysphagia•Weight loss•GI blood loss (acute or chronic)•Anemia•Anorexia

Page 50: Clinical Practice Guidelines

GERD page 2Non-medical anti-reflux precautions:

Lifestyle modification•smoking cessation•elevation of head of bed•avoid overeating•avoid eating within 3-4 hours of going to bed•consider weight reduction•avoid tight clothing

Consider over the counter medications for mild symptoms:•Antacids•OTC H2-receptor blockers

Avoid known risk factors:•tobacco•alcohol•onions•citrus fruits and juices•spicy food•caffeine (coffee, tea, cola)•fatty foods•chocolate•peppermints•tomato-based foods

Medication(Available Dosage Strengths)

Dosage Regimen

Cimetidine (Tagamet)(200mg, 300mg, 400mg, 800mg)

800-1600 mg/dayin divided doses

Ranitidine (Zantac)(150mg, 300mg)

300-600 mg/dayin divided doses

Nizatidine (Axid)(150mg, 300mg)

600 mg/dayin divided doses

Famotidine (Pepcid)(20mg, 40mg)

40 mg/dayin divided doses

Omeprazole (Prilosec)(10mg, 20mg)

20-60 mg/dayin divided doses

Rabeprazole (Aciphex)(20mg)

20 mg/day

Pantoprazole (Protonix)(40mg)

40 mg/day

Lansoprazole (Prevacid)(15mg, 30mg)

30-60 mg/dayin divided doses

Metoclopramide (Reglan)(5mg, 10mg)

40 mg/dayin divided doses

Gastroesophageal Reflux Disease (GERD) Medication Review

Page 51: Clinical Practice Guidelines

Physician focus for Evaluating and Treating GERD:

• See patients diagnosed with GERD for office follow-up within 6 months of diagnosis. Indicator: Percentage of adults diagnosed with GERD with a follow-up appointment within6 months of diagnosis.

References/Resources:

DeVault KR, Castell DO, and The Practice Parameters Committee of the American College ofGastroenterology. Updated Guidelines for the Diagnosis and Treatment of Gastroesophageal RefluxDisease. American Journal of Gastroenterology. 1999. 94:1434-1442.

Richter, JE. Gastroesophageal Reflux Disease. Current Practice of Medicine 1999. 2(12):2307-2315

Scott, M. and Gelhot, AR. Gastroesophageal Reflux Disease: Diagnosis and Management. AmericanFamily Physician 1999. 59(5):1161-1171.

van Pinxteren B, Numans ME, Bonis PA, Lau J. Short-term treatment with proton pump inhibitors, H2-receptor antagonists and prokinetics for gastro-oesophageal reflux disease-like symptoms and endoscopynegative reflux disease (Cochrane Review). The Cochrane Library, 1, 2001. Oxford: Update Software.

American Academy of Family Practice www.aafp.org Cochrane Library Abstracts http://www.update-software.com/cochrane/cochrane-frame.html Dynamic Medical www.dynamicmedical.com National Guideline Clearinghouse http://www.guidelines.gov/index.asp/

Page 52: Clinical Practice Guidelines

Diverticulosis and Diverticulitis

*Endoscopic exams and Barium Enema are NOT recommended during acute phase of attack because of risk of perforation.**Can increase intracolonic pressure and worsen symptoms

No

Yes

Is patient stablefor outpatient

therapy?

Is diagnosiscertain?

No

Yes

Symptoms of acute Diverticulitis

Physical exam, includingrectal and pelvic exams as

appropriate

Plain abdominal radiographs(flat and upright)

Consider CXR, CBC, U/A, blood cultures if indicated

Freeair on

XRAY?Surgical consult

YesClear liquid dietHold high-fiber foodsBroad spectrum antibiotics (see page 2)

No

IV FluidsNPO/clear liquid dietBroad spectrum IV antibiotics (see page 2)Avoid morphine for analgesia**

Goodresponse?

•Continue conservative management.•Consider Barium enema and Sigmoidoscopyor Colonoscopy in 10-14 days to corroborate diagnosis and rule out other causes of exacerbation.•High fiber diet after symptoms resolve (see Nutrition Guide)

Yes

No

Consider CT scanand/or

surgical consult

CT scan, Ultrasound (may be particularlyuseful in female patients), or water-soluble contrast enema*

Isstudy

consistentw/divertic-

ulitis?

Yes

No

Reconsider diagnosis

Note: The majority of cases of diverticulosis are asymptomatic, and the diagnosis is usually made by incidental discovery on endoscopy or barium enema.

High fiber diet (see Nutrition Guide)Adequate fluid intakeConsider fiber supplements and/or stool softeners

Asymptomatic(or non-acutesymptoms)?

Non-specific complaints:•chronic constipation•abdominal pain•fluctuating bowel habits•diarrhea and/or flatulence•LLQ abdominal pain

Physical exam, including rectalexam, stool test for occult blood,and pelvic exam for women.

Consider colonic imaging studies:•Contrast Barium Enema•Sigmoidoscopy•Colonoscopy

Yes

No

No Adequate response to

outpt.tx?

Yes

Symptoms may include:•Abdominal pain (typically LLQ but may be midline or RLQ)•Leukocytosis•Fever•Palpable, tender mass•Nausea, vomiting, constipation, diarrhea,dysuria, or urinary frequency

Page 53: Clinical Practice Guidelines

Diverticulitis page 2Broad Spectrum Antibiotic Therapy for Acute Diverticulitis•Goal is for aerobic and anaerobic coverage--below is a list of possible medications (and combinations) to meet this goal.•Recommended duration of intravenous and/or po therapy is 7-10 days.

Parenteral Options (choose one of the five listed options):1) Metronidazole or ClindamycinPLUS Aminoglycoside (e.g. gentamicin or tobramycin) or 3rd generation Cephalosporin (e.g. ceftazidime, cefotaxime, ceftriaxone)or Monobactam (e.g. aztreonam)or2) Piperacillin/Tazobactamor3) Ampicillin-sulbactam (e.g. Unasyn)or4) 2nd generation Cephalasporin (e.g. cefoxitin or cefotetan)or 5) Ticarcillin/Clavulanate (Timentin)

Enteral Options (choose one of the three listed options):1) Metronidazole or ClindamycinPLUS Ciprofloxacin or TMP/SMZ DS BIDor2) Augmentinor3)Trovafloxin

Bulk-forming over-the-counter agents:MethylcellulosePolycarbophilPsyllium

Brand name OTC bulk-forming agents:AlramucilCitrucelCologelEffer-sylliumFiberallFiberconKonsylMaltsupexMetamucilMylanta Fiber SupplementReguloid

Page 54: Clinical Practice Guidelines

Physician focus for Evaluating and Treating Diverticulosis and Diverticulitis:

• Select antibiotic therapy that covers BOTH anaerobic and aerobic bacteria. Indicator: Percentage of adults diagnosed with diverticulitis and treated with one of the identified

broad-spectrum antibiotics or antibiotic combinations.

• Select abdominal plain film XRAY and/or CT scan of the abdomen and/or Ultrasound of theabdomen for diagnostic testing during early evaluation of symptoms. Indicator: Percentage of adults receiving abdominal plain-film XRAY and/or CT scan of the

abdomen and/or Ultrasound of the abdomen within four days of initial diagnosis of acutediverticulitis.

• See patients diagnosed with diverticulitis for office follow-up within 6 months of diagnosis.

Indicator: Percentage of adults diagnosed with diverticulitis with a follow-up appointment within6 months of diagnosis.

• Perform appropriate confirmatory diagnostic evaluation following hospitalization for initialdiagnosis and treatment for acute diverticulitis (barium enema &/or sigmoidoscopy &/orcolonoscopy approximately 2 weeks after admission for acute diverticulitis).

Indicator: Percentage of adults who receive barium enema and/or sigmoidoscopy and/orcolonoscopy approximately two weeks after admission for acute diverticulitis.

• Avoid invasive diagnostic procedures (e.g. sigmoidoscopy/colonoscopy, barium enema) duringevaluation of acute diverticulitis.

Indicator: Percentage of adults receiving a barium enema and/or endoscopic exam (colonoscopyor sigmoidoscopy) during acute phase of diverticulitis.

References/Resources:

Diverticular Disease of the Colon. In L.M. Tierney, Jr., S.J. McPhee, M.A. Papadakis (Eds.), CURRENT Medical Diagnosis and Treatment 2000 (pp. 641-644). New York, NY: Lange Medical Books/McGraw- Hill.

Ferzoco LB, et al. Acute diverticulities. N Engl J Med May 21, 1998; 338:1521-6.

Roberts P, Abel M, Rosen L, et al. (The Standards Task Force American Society of Colon and RectalSurgeons). Practice Paramenters for Sigmoid Diverticulitis—Supporting Documentation. Diseases of theColon and Rectum 1995; 38(2): 125-32.

Stollman NH and Raskin JB, Diagnosis and Management of Diverticular Disease of the Colon in Adults(Practice Guidelines). The American Journal of Gastroenterology 1999; 94(11): 3110-3121.Available at www-east.elsevier.com/ajg/issues/9411/ajg1501fla.htm

Taylor TV. Diverticulitis. Current Practice of Medicine 1999; 2(12): 2422-2429.

The Cochrane Group www.update-software.com American Academy of Family Practice www.aafp.org Dynamic Medical www.dynamicmedical.com

Page 55: Clinical Practice Guidelines

Low Back PainSigns/Symptoms ofAcute Low Back

Pain

Comprehensive History and Physical Exam

Are Critical Exclusionary

Diagnoses Present?

Initiate up to 4 weeks of conservative therapy, which may include:• Patient education• Activity modification• Oral medication (ie. NSAIDs)• Self-applied thermal modalities• Manual medicine modalities (as prescribed by Osteopathic or

Chiropractic physicians)

Consider referralto appropriate

specialist for care

Repeat history.Perform AP and lateral

spine XRAYS.

Are symptomsimproved?

Continue usefulconservative measures,

perform exercise,and return to regular

activity as appropriate.

Isthere a

neuro deficiton exam OR are

X-rays abnormal?

yes

Consider treatment modifications for an additional four weeks:• Change oral analgesic• Manual medicine modalities

(as prescribed by Osteopathicor Chiropractic physicians)

Consider the following clinical pictures and consider referral to appropriate

specialist:

Are symptomsimproved

?

no

Herniated Nucleus Pulposus:• young patient (20-50 years)• predominant leg pain• with or w/o neuro deficit• tension signs present

Unremitting Low Back Pain:

Spinal Stenosis:• patients over 50 years• variable neurologic findings• leg pain and/or back pain

that is increased with upright posture

Spondylolysis or Lytic Spondylolisthesis or DegenerativeSpondylolisthesis/Stenosis:

Mild or moderatePain control and exercise training• back first aid• oral or

epiduralcorticosteroids

• joint mobility• stabilization

Clinically severeor poor responseOrder confirmatory

studies:• MRI• CT• myelogram• electrodiagnostic

studies

Consider confirmatory studies:

• MRI• CT• myelogram• electrodiagnostic

studies• bone scan• psychological eval

Rule out instabilityor neurological

deficit.

Consider non-operative options:• NSAIDs• trial of bracing• 1-3 injection

program• Active exercise

treatment• psych eval

If severe symptoms or poor response to non-operative tx, consider confirmatory studies:

•MRI•CT•myelogram

Acute Low Back Pain:• pain does not radiate past the knee• duration of symptoms <6 weeks

Critical Exclusionary Diagnoses:• Cauda equina syndrome• Progressive neurological deficit• Fracture• Neoplasm• Infection• Chronic pain syndrome• Persistent pain resulting from

previous spinal surgery• Extra-spinal conditions

Counsel patient and consider surgical options if:• Poor response to conservative measures and/or• Pathology found on confirmatory studies suggest surgical treatment and

correlate with clinical symptoms

yes

no

yesno

no

yes

Page 56: Clinical Practice Guidelines

Low Back Pain Page 2

Table 1 Differential Diagnosis of Back Pain (adapted from University of Michigan Health SystemGuideline)

Systemic Causes Dangerous local causes of back pain

Local pathology that mimics radiating low back pain

Aortic aneurysmRenal infectionRenal calculiPeritonitisTumorsSubacute bacterial endocarditisMetabolic disorders• Porphyria• Sickle cell disease• Renal osteodystrophySeronegative spondylitic arthritis:• Ankylosing spondylitis• Reiter’s syndrome• Arthritis of ulcerative colitis• Psoriatic arthritisOther arthritis:• Diffuse Idiopathic Skeletal• Hyperostosis (DISH)• Schuerman’s epiphisitis• Rheumatoid arthritis-uncommonConnective tissue disorders:• Marfan’s syndrome• Ehlers-Danlos syndromeMyopathyInflammatory radiculopathy

TumorDisk space infectionEpidural abscessFracturesOsteoporosis with fractureDisk herniationSpinal StenosisSpondylolisthesis• Congenital• Isthmic• Degenerative• Traumatic• Tumor relatedFailed back surgery syndromeArachnoiditis

Osteoarthritis of the hipAseptic necrosis of the femoral headSciatic nerve injury due to pressure, stretch or piriformis muscle entrapmentCyclic radiating low back pain— endometriosis on the sciatic nerve/ sacral plexusIntrapelvic masses—benign or malignantPeroneal (fibular) nerve entrapment at the fibular headSacroiliac joint dysfunctionFacet joint syndromeInternal disk disruption

Gordon Waddel’s five “non-organic pain” signs1. Overreaction during the exam2. Simulated testing--pain with axial loading or rotation of the pelvis and shoulders in the same plane3. Distracted testing--test straight leg raise while distracted when sitting.4. Superficial, non-anatomical or variable tenderness. When skin rolling over the back markedly increases the pain5. Non-anatomical motor or sensory disturbances. Positive when sensoryloss does not follow a dermatome or entire leg is numb or without stretch or when there is a “ratchety” giveway on strength testing.

Presence of two or more of these findings correlates with poor surgical outcome, but not rehabilitation outcome. Patient is at risk for becoming chronically disabled. Should not be interpreted as specific for malingering.

Page 57: Clinical Practice Guidelines

Physician focus for Evaluating and Treating Acute Low Back Pain

• Prescribe a conservative treatment plan for patients with Acute Low Back Pain before orderingdiagnostic radiological studies (unless critical exclusionary diagnoses are present). Indicators:

Percentage of patients with low back pain receiving AP or lateral x-rays.Percentage of patients with low back pain receiving MRI or CT.

References/Resources:

American Academy of Orthopaedic Surgeons/North American Spine Society (AAOS/NASS) SpineAlgorithm Task Force. Clinical guideline on low back pain. Released 1996. Accessed at the NationalGuideline Clearinghouse, http://www.guidelines.gov/index.asp/ (2001, February 20)

Hagen KB, Hilde G, Jamtvedt G, Winnem M. Bed rest for acute low back pain and sciatica (CochraneReview). In: The Cochrane Library, 1, 2001. Oxford: Update Software

Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Adult Low Back Pain.November 1999. http://www.icsi.org/guidelst.htm/ (2001, February 20)

Low Back Pain Syndrome (LBP). http://www.dynamicmedical.com/ (2001, February 20)

Marcus DA. Treatment of Nonmalignant Chronic Pain. Am Fam Physician 2000;61:1331-8, 1345-6.

Tulder MW van, Scholten RJPM, Koes BW, Deyo RA. Non-steroidal anti-inflammatory drugs for lowback pain (Cochrane Review). In: The Cochrane Library, 1, 2001. Oxford: Update Software.

U.S. Department of Health and Human Services, Public Health Service, Agency for Health Care Policy andResearch. (1994, December). Acute Low Back Problems in Adults—Clinical Practice Guideline Number14. Retrieved from http://www.ahrq.gov/

U.S. Department of Health and Human Services, Public Health Service, Agency for Health Care Policy andResearch. (1993, February). Acute Pain Management In Adults: Operative Procedures—Quick ReferenceGuide for Clinicians No. 1a. Retrieved from http://www.ahrq.gov/

University of Michigan Health System. (1997, November) Guidelines for Clinical Care—Acute LowBack Pain. http://cme.med.umich.edu/iCME/default.asp (2001, February 26)

University of Washington Physicians. Acute Low Back Limitation Guidelines.http://healthlinks.washington.edu/guideline/alb/processes.html/

Well Close Square rheumatology resource: the back examination. (Online).http://www.wellclosesquare.co.uk/rheum/back.htm/ (2001, February 26)

Page 58: Clinical Practice Guidelines

Carpal Tunnel SyndromeSymptoms of MedianNerve Compression

Focused Historyand

Physical Exam

Isthenar

weakness orwasting present?

yes no

Follow up in2 weeks

Perform laboratory evaluation, as indicated by history andphysical exam (see page 2)

Metabolic cause for

symptoms?

yes

no

Treat any metabolic cause for symptoms

2-6 week trial of conservative therapy:•Patient education•Activity modification/alter aggravating factors (may include ergonomic modifications at workplace)•Neutral-position splinting (full time)•Analgesics (NSAIDS if not contraindicated)•Manual medicine modalities (as prescribed byOsteopathic or Chiropractic physicians)

Goodresponse?

yes

No

Continue conservativemanagement; patientmay resume normal activities as tolerated.

CONSIDER the following diagnostic andtherapeutic options:•Physical therapy for flexibility, mobility,and strength•Corticosteroid injection•Alternative NSAID •Manual medicine modalities (as prescribedby Osteopathic or Chiropractic physicians)

Consider specialist referral AND/OR

additionaldiagnostic testing

(see page 2)

Goodresponse?

no

yes

HISTORY:•Family or personal history of

•diabetes•thyroid •connective tissue diseases

•Pregnancy•History of trauma•Occupational history•Hobbies•Change in the level of activity

PHYSICAL EXAM (may be normal):•Regional exam•Cervical spine and upper extremities exam•Tinel test•Phalen test•Thumb abduction strength testing•Proximal compression test at elbow

SYMPTOMS MAY INCLUDE:•parasthesia and/or mild pain in the distribution of the median nerve (palmar side of thumb, index, middle and part of ring finger and generally excludes the little finger)•intermittent or constant pain•weakness or clumsiness of the hand•aggravation of pain during sleep(see page 2 for Differential Diagnosis)•may have improvement of symptoms with shaking or massaging the hand

Page 59: Clinical Practice Guidelines

CTS Page 2

Differential Diagnosis for Carpal Tunnel Syndrome:•Cervical Radiculopathy (especially C7)•Angina pectoris•deQuervain’s tenosynovitis•Complex regional pain syndrome (aka Reflex Sympathetic Dystrophy)•Osteoarthritis•Rheumatoid arthritis•Brachial plexopathy•Proximal median neuropathy•Peripheral neuropathy•Vascular or neurogenic thoracic outlet syndrome•Central disorders such as multiple sclerosis and cerebral infarction

Diagnostic Testing for Carpal Tunnel Syndrome:Depending on the presenting symptoms and/or response to conservative management, consider:•Laboratory testing:

•TSH•pregnancy test•blood sugar

•Imaging (radiography or magnetic)•wrist•cervical spine•chest

•Electrophysiology•Electromyography (EMG) •Nerve conduction studies (NCS)

•Further endocrine, hematologic, or neuropathy evaluation as indicated.

Page 60: Clinical Practice Guidelines

Potential Aims for Medical Groups When Using this Carpal Tunnel Syndrome Guideline:

• Request patient to follow-up in office within two months of initial diagnosis of carpal tunnelsyndrome.

Indicator: Percentage of adults diagnosed with carpal tunnel syndrome who have a follow-upappointment within two months.

• Treat all patients with carpal tunnel syndrome (without thenar weakness/wasting and withoutmetabolic cause for CTS) with neutral-position wrist splinting.

Indicator: Percentage of adults receiving a wrist splint at the time of initial diagnosis.• Attempt a trial of conservative management for all patients with carpal tunnel syndrome

(without thenar weakness/wasting and without metabolic cause for CTS) before ordering anEMG or nerve conduction study.

Indicator: Percentage of adults with carpal tunnel syndrome undergoing EMG or nerveconduction study that have had at least one prior claim for diagnosis of carpal tunnel syndrome (orhand parasthesias, etc.) by their PCP during the six months prior to diagnosis.

References/Resources:

American Academy of Orthopedic Surgeons (AAOS) Task Force on Clinical Algorithms; AAOSCommittee on Clinical Policies. Clinical guideline on wrist pain. 1999. Accessed at the NationalGuideline Clearinghouse, http://www.guidelines.gov/index.asp/

American Society of Plastic Surgeons (ASPS). Carpal tunnel syndrome. Released Jan 24, 1998. Accessedat the National Guideline Clearinghouse, http://www.guidelines.gov/index.asp/

D’Arcy CA, McGee S. Does This Patient Have Carpal Tunnel Syndrome? (The Rational Clinical Exam)JAMA 2000;283(23):3110-3117.

Novak LM. Carpal Tunnel Syndrome (Protocol). Lippincott’s Primary Care Practice 2000;4(6):642-648.

Report of the Quality Standards Subcommittee of the American Academy of Neurology. Practice parameterfor carpal tunnel syndrome (summary statement). Neurology 1993;43:2406-2409.

Walker WC, et al. Neutral wrist splinting in carpal tunnel syndrome: a comparison of night-only versusfull-time wear instructions. 2000;81:424-9.

American Academy of Family Practice www.aafp.org Cochrane Library Abstracts http://www.update-software.com/cochrane/cochrane-frame.html Dynamic Medical www.dynamicmedical.com National Guideline Clearinghouse http://www.guidelines.gov/index.asp/

Page 61: Clinical Practice Guidelines

Uncomplicated Acute BronchitisSymptoms suggestive of

acute bronchitis

Focused history and physical exam

Viral Bronchitis Bacterial Bronchitis Bronchitis associated with Influenza?

Symptoms may include:• Cough with/without phlegm• Cough lasting <3 weeks• Sore throat• Rhinorrhea• Minimal/no change in breath sounds• Low-grade fever• Malaise

Purulent sputum, high fever, chills,

systemic symptoms?

Epi-link to case?

Seasonal, high fever, chills,

systemic symptoms?

Severe symptoms or

suspected pneumonia?

Obtain Chest X-Ray

Chest X-ray shows

infiltrates?

Pneumonia diagnosis

Treat (See Community -

Acquired Pneumonia Guideline)

• Symptomatic treatment• Cough suppressants• Acetaminophen or aspirin

• Antibiotic treatment only if strong indication of bacterial infection, using narrow-spectrum agents:

• erythromycin• tetracycline

• Patient education• Increase fluids• Adequate rest• Avoid smoking or quit

• Symptomatic treatment• Cough suppressants• Acetaminophen or aspirin• Bronchodilators for patients

with asthma or COPD• Explain rationale for no antibiotic

treatment• Patient education

• Increase fluids• Adequate rest• Avoid smoking or quit

• Symptomatic treatment• Cough suppressants• Acetaminophen• Antiviral agents

• amantadine (flu - A)• rimantadine (flu- A)• zanamivir (flu - A/B)• oseltamivir (flu - A/B)

• Explain rationale for no antibiotic treatment

• Patient education• Increase fluids• Adequate rest• Avoid smoking or quit

Follow-up if symptoms worsen Administer flu vaccine annually to all persons at increased risk of complications

Differential Diagnosis:• Community-Acquired Pneumonia• Influenza• Pertussis• Asthma• Tuberculosis• Cystic fibrosis• Lung cancer• GERD• Medication-induced cough

Bronchitis treatment considerations:•Self-limited infection of bronchial tree•Characterized by pronounced cough•Treatment focus is the management of cough and associated symptoms•Usually viral in origin•Antibiotic therapy recommended only when bacterial component suspected•Determine presence of underlying immune compromise or coexistingdiseases (i.e., pneumonia, cystic fibrosis, COPD, heart failure)

Bronchitis treatment considerations:•Self-limited infection of bronchial tree•Characterized by pronounced cough•Treatment focus is the management of cough and associated symptoms•Usually viral in origin•Antibiotic therapy recommended only when bacterial component suspected•Determine presence of underlying immune compromise or coexistingdiseases (i.e., pneumonia, cystic fibrosis, COPD, heart failure)

History:• Signs and symptoms of cough• Exposure to persons with similar symptoms• Exposure to irritants and allergens• Underlying immune compromise or coexisting disease (i.e. heart

failure, cardiopulmonary disease, cystic fibrosis)Physical Exam:

• Assess severity and nature of cough and breathing• Pharyngeal inflammation, postnasal drip• Inspect sputum for evidence of purulence• Perform complete chest exam

Lab and diagnostic tests:• Lab tests are not indicated for otherwise healthy adults• PPD skin test for persons at increased risk of TB• Chest film - only if severe symptoms or pneumonia suspected• Bronchoscopy - only if patient is severely immunocompromised, and

biopsies and/or special cultures are required to guide therapy (i.e. presence of unusual pathogen or patient fails to respond to treatment)

History:• Signs and symptoms of cough• Exposure to persons with similar symptoms• Exposure to irritants and allergens• Underlying immune compromise or coexisting disease (i.e. heart

failure, cardiopulmonary disease, cystic fibrosis)Physical Exam:

• Assess severity and nature of cough and breathing• Pharyngeal inflammation, postnasal drip• Inspect sputum for evidence of purulence• Perform complete chest exam

Lab and diagnostic tests:• Lab tests are not indicated for otherwise healthy adults• PPD skin test for persons at increased risk of TB• Chest film - only if severe symptoms or pneumonia suspected• Bronchoscopy - only if patient is severely immunocompromised, and

biopsies and/or special cultures are required to guide therapy (i.e. presence of unusual pathogen or patient fails to respond to treatment)

Yes

YesYes Yes

Page 62: Clinical Practice Guidelines

Physician focus for Evaluating and Treating Acute Bronchitis

• For patients with diagnosis of uncomplicated acute bronchitis, consider antibiotic treatment using first-line agents.

Indicator: Percentage of patients diagnosed with uncomplicated acute bronchitis with pharmacy claimsdata for first-line agents (i.e. erythromycin or tetracycline).

Indicator: Percentage of patients with uncomplicated acute bronchitis with pharmacy claims data forsecond-line agents (i.e. clarithromycin, ofloxin).

• For patients at increased risk of complications from influenza (i.e. ≥50 years, residents of chronic carefacilities, those with cardiovascular or pulmonary disorder, and those with a chronic metabolic disorder),administer yearly flu vaccination.

Indicator: Percentage of patients at increased risk of complications of influenza receiving a flu shotwithin the measurement year.

References/Resources:

Chow AW. Acute bronchitis. Best Practices of Medicine (200,May). Available online:http://praxis.md/index.asp?page=bpm. Accessed May 11, 2001.

Snow V, Mottur-Pilson C, Gonzales R. Principles of appropriate antibiotic use for treatment of acutebronchitis in adults. Annals of Internal Medicine 2001;134:518-520.

Becker L, Glazier R, McIsaac W, et al.: Antibiotics for acute bronchitis. Oxford: Update Software CochraneLibrary. 1999.

Hafner J-P, Ferro TJ. Acute bronchitis in adults: A modern approach to management. Hospital Medicine.1998;34(8):41-50.

Page 63: Clinical Practice Guidelines

Community-Acquired Pneumonia(CAP)

•Symptomatic treatment•Patient education•Explain rationale for no antibiotic treatment•Follow-up if symptoms worsen

Symptoms suggestiveof Community Acquired

Pneumonia

Chest x-ray shows

infiltrate?

yes

no

yes

Follow-up:•By telephone 24-48 hours•In office 6-8 weeks (considerf/u CXR to confirm resolution)

1st line antibiotics:•amoxicillin/Clavulanate + macrolide*, OR•Cefuroxime axetil/cefpodoxime/cefprozil + macrolide*, OR•fluoroquinolones

*add a macrolide if there is a reasonable likelihood of an atypical agent causing the pneumonia

yes

Pneumonia Severity Index

(PSI) < 91points?

Pneumonia diagnosis--calculate PneumoniaSeverity Index (PSI)

(see box below)

Drugintolerance?

no

2nd line atibiotics:•fluoroquinolones

yes

1st line antibiotics:•macrolide or•doxycycline

no

CAP SYMPTOMS MAY INCLUDE:•rigors•pleuritic chest pain•shortness of breath•chest tightness•deep cough•sputum production•fever >1000F or lasting >72 hours•night sweats•wheezing

Obtain chest x-ray, especially if patient has two or more of these signs: •Temp >1000 F (37.80 C)•Pulse > 100•Decreased breath sounds•Rales •Respiratory rate > 20

Comorbiditiesor clinical status

suggest treatmentof LRTI?

Chest x-ray suggestsnon-infectious

process?

yesyes

Out of guidelineTreat with macrolide, doxycycline, or

TMP/SMX

nono

Patient education•Criteria for follow-up •Home care•Smoking cessation•Antibiotics•Return to function/work•Secondary prevention•Contagion and recurrence•Influenza/pneumococcal vaccine

Hospitalization(out of guideline)

no

Age >50 years?

Pneumonia Severity Index (PSI)Score = total points accumulated below

Demographic FactorsAge Males age(yrs)

Females age(yrs) -10Nursing Home Resident +10

Comorbid IllnessesNeoplastic disease +30Liver disease +20Congestive heart failure +10Cerebrovascular disease +10Renal disease +10

Physical Examination FindingsAltered mental status +20Respiratory rate ≥ 30/minute +20Systolic BP<90mmHg +15Temperature <95°F(35°C)or ≥104°F(40°C) +15Pulse ≥ 125/minute +10

Laboratory FindingspH<7.35 +30BUN ≥ 30mg/dL(11mmol/L) +20Sodium < 130mEq/L +20Glucose > 250mg/dL(14mmol/L) +10Hgb<9gm (Hematocrit<30%) +10PO2 < 60mmHg(O2sat<90%)* (room air) +10Pleural effusion +10

*patients with these findings may warrant hospitalization despite their risk classification.

Criteria for follow up:•difficulty breathing•worsening cough•worsening or onset of rigors•fever persisting >48 hours•medication intolerance

Note: some patients with psychosocial and economic considerations, but a PSI score <91 may also require hospitalization.

Page 64: Clinical Practice Guidelines

Physician focus for Evaluating and Treating Community Acquired Pneumonia (CAP):

• For adults < 50 y/o diagnosed by CXR with CAP and treated as an outpatient, prescribe amacrolide, doxycycline, or TMP/SMX as first-line antibiotic choice (unless contraindicated ornot tolerated)

Indicator: Percentage of adults with CXR-confirmed diagnosis of CAP < 50 years old treated asan outpatient with a macrolide or doxycycline.

• For adults > 50 y/o diagnosed by CXR with CAP and treated as an outpatient, prescribeamoxicillin/clavulanate or cefuroxitime axetil/cefpodoxime/cefprozil (with or without amacrolide), or a fluoroquinolone for first-line antibiotic choice.

Indicator: Percentage of adults with CXR-confirmed diagnosis of CAP > 50 years old treatedwith amoxicillin/clavulanate or cefuroxitime axetil/cefpodoxime/cefprozil (with or without amacrolide), or a fluoroquinolone.

• Counsel patients diagnosed with CAP regarding smoking cessation.Indicator: Percentage of adults diagnosed with CAP who receive smoking cessation education, asdocumented in the medical record (or billing charges).

References/Resources:

Bartlett JG, Dowell SF, Mandell LA, File TM, Musher DM, Fine MJ. Practice Guidelines for thrManagement of Community Acquired Pneumonia in Adults. Clinical Infectious Diseases 2000;31:347-82.

Fine MJ, Auble TE, Yealy DM, Hanusa BH, Weissfeld LA, Singer DE, Coley CM, Marrie TJ, KapoorWN. A Prediction Rule to Identify Low-Risk Patients with Community-Acquired Pneumonia. N Engl JMed 1997;336(4):243-50.

Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Community-AcquiredPneumonia. July 2000. http://www.icsi.org/guidelst.htm/ (2001, April 17)

Marras TK, Gutierrez C, Chan CK. Applying a Prediction Rule To Identify Low-Risk Patients WithCommunity-Acquired Pneumonia. Chest 2000;118(5):1339-1343.

Marrie TJ, Lau CY, Wheeler SL, Wong CJ, Vandervoort MK, Feagan BG. A Controlled Trial of a CriticalPathway for Treatment of Community-Acquired Pneumonia. JAMA 2000;283(6):749-755.

Moola S, et al. A multicenter study of grepafloxacin and clarithromycin in the treatment of patients witcommunity-acquired pneumonia. CHEST 1999;116:974-83.

Additional definitions from the Pneumonia Severity Index (PSI):

Neoplastic disease - any cancer, except basal or squamous cell carcinoma of theskin active at the time of presentation or within one year of presentation.Liver disease - clinical or histological cirrhosis or chronic active hepatitis.CHF - documented with history, physical exam or CXR findings; echo, MUGA; orleft ventriculogram.CVD - clinical diagnosis of stroke or TIA; or documented stroke on CT or MRI.Renal disease - chronic renal disease; or abnormal BUN or creatinine.

CAP (Page 2)

Page 65: Clinical Practice Guidelines

S E V E R I T Y D E S C R I P T I O N / D E F I N I T I O N

AsthmaEstablish a diagnosis of

asthma:• complete a thorough

history and examination

• obtain spirometry

Symptoms of Asthma

Mild intermittent:$symptoms < 2 times a week$asymptomatic and normal PEF between exacerbations$exacerbations are brief (few hours to a few days)$nighttime symptoms < 2 times a month$FEV1/FVC > 80 percent predicted and $PEF variability < 20 percent

•History and physical•Assess asthma triggers/allergens•Measure pulmonary function

•spirometry - pre- and post- bronchodilator •PEFR(designed as monitoring, not diagnostic tool)

•Consider consultation and/or allergy testing,particularly in children, as allergy vaccinations may prevent worsening of asthma

Assess asthma severityTreat and educate accordingly

Asthma symptoms may include:

•wheezing•breathlessness•cough, productive or dry•chest discomfort•nocturnal cough•history of persistent respiratory tract infections•Conditions associated with asthma (e.g. nasal polyps, rhinitis, atopic dermatitis)

Previousdiagnosis of

asthma?

yes

no

Indications for emergency care:

•Peak flow less than 50% predicted normal•Failure to respond to a β2-agonist•Severe wheezing or coughing•Extreme anxiety due to breathlessness•Gasping for air, sweaty, or cyanotic•Rapid deterioration over a few hours•Severe retractions and nasal flaring•Hunched forward

NOTE: this guideline does not include treatment of patients requiring hospital care

Mild Persistent:$symptoms > 2 times a week but < 1 time a day$exacerbations may affect activity$nighttime symptoms > 2 times a month$FEV1/FVC > 80 percent predicted and $PEF variability 20-30 percent

Moderate Persistent:$daily symptoms$daily use of inhaled short-acting beta2-agonist$exacerbations affect activity$exacerbations > 2 times a week; may last days$nighttime symptoms > 1 time a week$FEV1/FVC > 60 percent - < 80 percent predicted$PEF variability > 30 percent

Severe Persistent:$continual symptoms$limited physical activity$frequent exacerbations$frequent nighttime symptoms$FEV1/FVC < 60 percent$PEF variability > 30 percent

Step 1 actions:•Teach basic facts about asthma•Teach inhaler/spacer technique•Discuss roles of medications•Develop self-management plan•Develop action plan for when and how to take rescue actions•Discuss appropriate environmental control measures to avoid exposure to known triggers

Step 2 actions:Step 1 actions plus:•Teach self-monitoring•Refer to group education if available•Review and update self-management plan

Step 3 actions:Same as step 2 actions

Step 4 actions:Step 2 and 3 actions plus:•Refer to individual education/counseling

Acute rescue:$Inhaled β2 -agonist, prn, BUT < 1/week$Inhaled β2 -agonist, cromolyn, or nedocromil before exercise or allergen exposure$With viral infection:

Inhaled β2 -agonist q4-6 hrs up to 24 hours (longer with physician consult) but no more than once every 6-8 weeks.

Systemic corticosteroid if severe attack or history of severe attacks with infection

If flares occur more often than every 6 weeks, seek consultationLong-term prevention:$None needed$Spirometry every 1-2 years in every patient; more often in unstable patients

Acute rescue:$Short-acting bronchodilator: inhaled β2 -agonist as needed for symptoms, not to exceed 3-4x/dyLong-term prevention:Daily medications:$Anti-inflammatory: either inhaled corticosteroid, 200 mcg, cromolyn sodium, or nedocromil (children usually begin with trial of cromolyn or nedocromil).$SR theophylline to serum concentration of 5-15 mcg.mL is an alternative, but NOT preferred therapy.$Zafirlukast or zileuton may be considered for pts. > 12 y.o.$Montelukast may be used in pts. > 6 y.o.$Spirometry every 1-2 years in every patient; more often in unstable patients

Acute rescue:$Short-acting bronchodilator: inhaled β2 -agonist as needed for symptoms, not to exceed 3-4x/dy$IF increased β2 -agonist use, may need to increase anti-infl tx.Long-term prevention:Daily medications:$Anti-inflammatory: inhaled corticosteroid (med. dose) ORInhaled corticosteroid AND long-acting bronchodilator, esp. for nighttime symptoms (β2 -agonist, SR theo, or long-acting β2 tablets) (inhaled preferred)If needed:$Anti-inflammatory: inhaled corticosteroids (med-high dose) AND Add a long-acting bronchodilator, esp. for nighttime symptoms (β2 -agonist, SR theo, or long-acting β2 tablets)$Spirometry every 1-2 years in every patient; more often in unstable patients

Acute rescue:$Short-acting bronchodilator: inhaled β2 -agonist as needed for symptoms, not to exceed 3-4x/dy$IF increased β2 -agonist use, may need to increase anti-infl tx.Long-term prevention:Daily medications:$Anti-inflammatory: inhaledcorticosteroid (800-2000 mcg/d)AND$Long-acting bronchodilator: either long-acting inhaled β2 -agonist, sustained release (SR) theophylline, or long-acting β2 -agonist tablets (inhaled preferred)AND$Coticosteroid tablets or syrup long term (2 mg/kg/day, max 60 mg/day)$Spirometry every 1-2 years in every patient; more often in unstable patients

E D U C A T I O N

A C U T E A N D L O N G - T E R M T R E A T M E N T S

Schedule regular follow-up appointments

Page 66: Clinical Practice Guidelines

Asthma page 2

Tobacco smoking

Passive tobacco, wood-burning stove, orfireplace smoke

Gastroesophagealreflux

Sulfites

Exercise

Cold Air

Pollutants• Air pollutants• Occupational

exposures

Medications• β-blockers• Aspirin• NSAIDs

Outdoor allergens• Pollens• Fungi

Respiratory tractinfections• Viral URI illnesses• Sinusitis• Bronchitis

Indoor allergens• Domestic mites• Animal allergens• Cockroach allergens• Fungi

Adapted from Gross and Ponte article and UMHS guideline

Common Asthma Triggers:

Problem FEV1 FVC FEV1/FVC%

Obstructivedisease

Decreased Normal ordecreased

Decreased

Restrictivedisease

Decreased ornormal

Decreased Normal orincreased

Reversibledisease

Increased by 12 to15 percent afteradministration ofbronchodilator*

FEV1=forced expiratory vlume in one second; FVC=forced vital capacity;FEV1/FVC%=FEV1 as percentage of FVC

*Increased in comparison with the baseline FEV1 measurement before thebronchodilator was administered.

Adapted from Gross and Ponte article.

Interpreting Spirometry:

Referral is recommended when:• Life threatening asthma exacerbations• Is not meeting treatement goals, or unresponsive to therapy• Atypical signs and symptoms• Complicating comorbidities (e.g. sinusitis, nasal polyps, vocal cord dysfunction, COPD)• Additional diagnostic testing indicated• Additional patient education/guidance needed• Immunotherapy considered• Patient has severe persistent asthma• Patient requires continuous oral corticosteroid therapy or high-dose inhaled corticosteroids• Patient is under age 3• Confirmation of history that suggests occupational or environmental inhalant or ingested

substance causing asthma.

General Guidelines for Referral to an Asthma Specialist:

Page 67: Clinical Practice Guidelines

Physician focus for managing patients with asthma:

• Prescribe anti-inflammatory medication to all patients with persistent asthma.Indicator: Percentage of patients with persistent asthma with prescriptions for an anti-inflammatory medication.

• Monitor patients for overuse of β-agonist medication and re-evaluate/educate patient.Indicator: Percentage of patients with greater than three MDIs filled at pharmacy in a 3 monthperiod.

• Utilize objective measures (spirometry or peak flow) for accurate assessment of lung function.Indicator: Percentage of patients with asthma with spirometry or peak flow documented in themedical record at the last visit.

• Educate patients, including an asthma action plan.Indicator: Percentage of patients with asthma with an asthma action plan in the medical record.documented in their chart at the last visit.

• Counsel patients diagnosed with asthma regarding smoking cessation.Indicator: Percentage of adults diagnosed with asthma who receive smoking cessation education,as documented in the medical record (or billing charges).

References/Resources:

Expert Panel Report 2: Guidelines for the Diagnosis and management of Asthma. National Institutes ofHealth. National Heart, Lung, and Blood Institute. NIH Publication No. 97-4051. July 1997

Green L, et al (Asthma Guideline Team). UMHS Asthma Guideline. University of Michigan HealthSystem. January 2000. http://cme.med.umich.edu/iCME/default.asp (2001, April 17)

Gross KM and Ponte CD. New Strategies in the Medical Management of Asthma. Am Fam Phys1998;58(1):89-108.

Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Diagnosis and Management ofAsthma. June 2000. http://www.icsi.org/guidelst.htm/ (2001, April 17)

www.aafp.org www.icsi.org www.nhlbi.nih.gov

Page 68: Clinical Practice Guidelines

DepressionSymptoms or

presentation suggestiveof Depression

yes

Involve mental health services/professionals

somewhat

Secondarycause?

Major depression?

no

Discuss treatment options with patient:•psychotherapy•pharmacotherapy•bothConsider severity of symptoms, presence of psychosocial stressors, and presence of co-morbid conditions

yes

Consider other mood and anxiety disorders or somatoform disorders

no

DEPRESSION SYMPTOMS AND PRESENTATION MAY INCLUDE:•multiple (>5/year) medical visits•multiple unexplained symptoms•sleep disturbances•multiple worries or distress•work or relationship dysfunction•fatigue•emotionally flat•tearful

Interview for key symptoms of depression: •Are you often sad, down, blue or teary?•Do you have your usual interest in and look forward to enjoyable activities?•Are you able to have fun or joy?•How are you sleeping?•How is your appetite?•How is your energy level?

Is patientaccepting of

diagnosis and interested intreatment?

Arekey symptoms

present?

yes Depression likelynot present

Evaluate for secondary causes of depression, including:•Psychosocial stressors (e.g. death of a loved one, job change, abuse, divorce)•Medical illness (e.g. cancer, thyroid disease, stroke)•Medications and withdrawal from medications (e.g. steroids, propanolol, hormonal therapy, reserpine, alpha-methyldopa)•Current substance abuse or withdrawal (e.g. alcohol, sedatives, anxiolytics, hypnotics, amphetamines)See CAGE (AID) screen on page 2

no

Complete evaluation and diagnosis:•DSM-IV criteria (see page 2)•History of present illness (onset, severity, previous episodes, stressors)•Pertinent medical history•History of substance abuse•Psychiatric co-morbidity (e.g., mania)

Address secondarycause and reevaluate

•Is patient suicidal or homicidal?•Is patient psychotic?•Is patient’s ability to function significantly impaired?See page 2 for assessment of suicidality

yes

no

Emergency?yes

Schedule follow-up appointment and reevaluate

•Refer to psychotherapy and/or •Initiate pharmacotherapy (see page 2)

Follow-up in 4-6 weeks

Are symptoms improving?

Continue treatment•Pharmacotherapy: consider adjusting dose•Psychotherapy: consider augmenting with medical therapy

•Augment or change treatment•Consider referral

no

Assess response in 4-6 weeks

very much

Select pharmacotherapy based upon side-effect profiles, past medical history, and patient lifestyle

These guidelines are intended for use in the primary care setting

Emergency may include:• Suicidal thoughts/plans• Assaultive or homicidal thoughts/plans• Psychosis• Significant ongoing inability to work and care for self/family

no

Page 69: Clinical Practice Guidelines

Depression page 2

CAGE(AID) Screen

Have you ever:C felt you ought to cut down on your

drinking or drug use?A had people annoy you by criticizing your

drinking or drug use?G felt bad or guilty about your drinking or

drug use?E had a drink or used drugs as an eye

opener first thing in the morning to steady your nerves or get rid of a hangover or to get the day started?

If substance abuse is present or suspected, consider referral for chemical dependency assessment.

Major Depressive Episode--DSM IV CriteriaMust have a total of five symptoms for at least two weeks. One of the symptoms must be depressed mood or loss of interest.

•Depressed mood.

•Markedly diminished interest or pleasure in all or almost all activities.

•Significant (>5% body weight) weight loss or gain or decrease or increase in appetite.

•Insomnia or hypersomnia.

•Psychomotor agitation or retardation.

•Feeling of worthlessness or inappropriate guilt.

•Diminished concentration or indecisiveness.

•Recurrent thoughts of death or suicide.

Treatment(Patient Education Considerations)

Both pharmacologic and non-pharmacologic interventions may be effective depending on the severity of symptoms. For antidepressant medications, compliance with a therapeutic dose is more important than the specific drug selected. The following educational messages may increase adherence:

•Take the medication daily.

•Antidepressants must be taken for two to four weeks for a noticeable effect.

•Continue to take medicine even if feeling better.

•Do not stop taking antidepressant without checking with your provider.

•Contact your provider if you have questions about your medication.

Referral to Psychiatrist

Consider psychiatric consultation for patients with:• History of mania or psychosis• Condition not responding to trials of one or two

medications• Need for combination therapyImmediate psychiatric evaluation is necessary if

patient may harm themselves or others.

Page 70: Clinical Practice Guidelines

Physician focus for management of depression:

• Increase the detection and diagnosis of depression in primary care through application ofspecific criteria.

Indicator: Percentage of adults complaining of depression containing documentation of DSM-IVcriteria at the time of initial diagnosis.

• Increase screening for depression in patients with somatic complaints.Indicator: Percentage of adults complaining of fatigue or sleep disorder who have documentationof screening for depression.

• Follow-up patients with newly diagnosed depression within 6 weeks of initial diagnosis.Indicator: Percentage of adult patients newly diagnosed with depression who have a follow-upappointment within 6 weeks.

References/Resources:

Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Major Depression, PanicDisorder and Generalized Anxiety Disorder in Adults in Primary Care. March 1999.http://www.icsi.org/guidelst.htm/ (2001, April 17)

Schulberg HC, Katon W, Simon GE, Rush AJ. Treating Major Depression in Primary Care Practice: AnUpdate of the Agency for health Care Policy and Research Practice Guidelines. Archives of GeneralPsyciatry 1998;55(12):1121-1127

Schwenk T and Terrell L et al (Depression Guideline Team). UMHS Depression Guideline. University ofMichigan Health System. January 2000. http://cme.med.umich.edu/iCME/default.asp (2001, April 17)

University of Washington Physicians. Major Depressive Disorder Guidelines. c. 2001http://healthlinks.washington.edu/guideline/depr/ (2001, April 17)

Whooley MA, Simon GE. Primary Care: Managing Depression in Medical Outpatients. New EnglandJournal of Medicine 2000;343(26):1942-1950.

American Academy of Family Practice: www.aafp.org Institute for Clinical Systems Improvement: www.icsi.org University of Michigan Health Systems: http://cme.med.umich.edu/iCME/default.asp University of Washington Physicians: http://healthlinks.washington.edu/guideline/depr/ Agency for Healthcare Research and Quality: http://text.nlm.nih.gov American Medical Association: www.ama-assn.org/consumer/specond.htm National Depressive and Manic-Depressive Association: www.ndmda.org National Foundation for Depressive Illness: www.depression.org National Mental Health Association: www.nmha.org/ccd Psychology Information Hotline: www.psychologyinfo.com/depression

Page 71: Clinical Practice Guidelines

Screening and Diagnosis of Type 2 Diabetes

*Impaired glucose tolerance: 2 hour glucose >140 mg/dl and <200 mg/dl. Impaired fasting glucose: FBS > 110 mg/dl and <126 mg/dl

Repeat Screening

every 3 years

Diagnosis: ImpairedGlucose

Tolerance

Discuss withpatient diet,exercise,

weight loss

Re-evaluate3-12 months.

ASee treatment goals

Asymptomatic, undiagnosed Patient meets > 1 risk factor for Diabetes

Risk factors for diabetes:• Over age 45 years • Obese (> 120% desirable body weight or a BMI > 27kg/m2)• Family history of diabetes• High risk ethnic population including Hispanics, Native Americans, African Americans, Pacific Islanders• Delivered a baby weighing > 9 lb or has been diagnosed with GDM• Hypertensive• Dyslipidemia especially HDL cholesterol level < 35mg/dl (0.90 mmol/l) and/or a triglyceride level

> 250 mg/dl (2.82mmol/l).• Had impaired glucose tolerance (IGT) or impaired fasting glucose (IFG)*

1. Consider referral to Endocrinologist/Diabetic Specialist and/or

2. Consider hospitalization A. Initiate insulin therapy B. Implement patient

management program

1. Initiate counseling for diet/nutrition, exercise, weight control;

2. Consider insulin or oral agents; and 3. Implement patient management

programs

1. Initiate insulin therapy, treat contributing factors,and

2. Implement patient management program

Is Patient

symptomaticBG>300mg/dl

and/orKetones

>2+?

Is Patient

asymptomaticnormal weight or

overweightBG < 300mg/dl and

non Ketotic orKetones

1+?

Is Patient

asymptomaticand overweight

BG > 400mg/dl and/orKetones

2+?

Repeat FBG:

>126 mg/dl or 2 hourGTT>200

mg/dl?

Screen for Diabetes Mellitus:

Random plasma glucose> 160 mg/dl or fasting

blood glucose >126mg/dl?

Yes

Diagnosis of Diabetes Confirmed: (Assess) • Blood glucose level• Ketones • Diet/nutrition

•HbA1c• Co-morbidities• H&P and Weight

Yes

Yes

No

No

YesYes Yes

Page 72: Clinical Practice Guidelines

Management of Patients with Diabetes Mellitus

* HbA1c goal < 7.0, if > 7.0 re-evaluate treatment plan and medication.

Evaluate in 3 months:Are goals

met?

A Initial Intervention

Evaluation by Diabetes Clinical Management Team:• Nutrition/diet • Blood pressure• Exercise counseling• Diabetes education• HGM (home glucose monitoring)• Establish management plan and therapy goals

(Refer to treatment goals)

Start monotherapy oral hypoglycemic agents(OHA). Refer to Continuing Care Criteria.

Evaluate quarterly:• Monitor for complications• Blood Pressure <130/8855• Review HGM <120 mg/dl pre-meal, 140mg/dL bed time• HbA1c* < 7.0• Foot exam• Reinforce diabetes education (exercise, diet,

weight control, medication compliance)• Reassess diabetes self management skills

Maximize oral hypoglycemic agentsOR Add insulin ORSwitch to InsulinMonotherapy OR Consider referral to endocrinologist

Continue quarterly/annual follow-upEvaluate therapy

Evaluate in 1 month:are goals

met?

Evaluate in 3 months:Are goals

met?

Continue quarterly follow-up:

Evaluate combination therapy

(See Evaluate quarterly box.)

Perform Annually:• Dilated funduscopic

eye (DRE) exam byophthalmologist or optometrist.

• TSH• Microalbumin measurement

if urinalysis is negative for protein• Lipid profile

Refer to endocrinologist

Yes No

Yes

No

Yes

No

Maximize Monotherapy

or Add 2nd OHA.

Evaluate after 3 months. Are

goals met?

Yes No

Page 73: Clinical Practice Guidelines

Diabetes Management Goals Testing/Examination Performance Goals:

Quarterly Goals: Annual Goals:• HbA1c• Urinary protein

analysis• Blood pressure• Foot exam

• TSH• Dilated funduscopic exam performed by an ophthalmologist or

optometrist• Fasting lipid profile• Diabetes education with nutrition/exercise assessment• Influenza vaccine yearly/pneumococcal vaccine every 10 years.

Treatment Goals:• HbA1c < 7.0 (<8.5 for children ages 5-11, 7.5-9.3 for children <5) • Home Glucose Monitoring a.c. <120mg/dl; h.s. <140mg/dl• Blood Pressure <130/85• Lipid Profile: (LDL<100mg/dl, HDL>35 (men), >45 (women)). • Triglycerides <200mg/dl

Screening for Complications:

Blood Pressure: Blood pressure should be maintained <130/85 Consider ACE inhibitor or as firstchoiceDyslipidemia: Start treatment/medication if LDL >130 mg/dl Start treatment/medication if CADis present and LDL >100 mg/dl Consider treatment/medication for TRIG>200 and LDL/HDL>5 orHDL<35 mg/dlNephropathy: Microalbuminuria/creatinine ratio anually (first a.m. urine preferred) for all Type 2diabetic patients starting at diagnosis and any patient > 12 years of age and within 5 years ofdiagnosis.Peripheral neuropathy: Comprehensive Foot examination each visit; testing with 5.07 mono-filament and clinical evaluation of nerve and vascular status at least annually.

Inform patients of the following:• Never walk barefooted.• Do not apply hot water or heating pads to feet.• Inspect feet daily, use mirror for plantar surfaces.• Keep foot clean, dry between the toes.• Lubricate dry skin using non-greasy lotion or cream to

avoid cracking.

• Wear properly fitting soft shoes.• Break in new shoes slowly.• Use second pair of shoes at night (larger size for edema).• Cut toenails straight across.• Visit Foot Care Specialist regularly.• Stop smoking.

Retinopathy: Annual dilated eye exam performed by ophthalmologist or optometrist for all Type2 diabetic patients starting at diagnosis and any patient > 10 years of age within 3 to 5 years of diagnosis.

Consider for referral:Type 1 patients on intensive management or patients not meeting treatment goals should bereferred to a diabetic specialist, diabetes nurse practitioner, and registered dietician.

• Selected patients to Endocrinology• Type 1 patients not ideally controlled and/or candidates for intensive management• Type 2 patients not optimally controlled on maximal effective oral hypoglycemic agentsand/or insulin.• Patient referral suggested by diabetes educator (and approved by PCP)• Patients with recent DKA• Complex patient with diabetes complications• All patients for diabetes education at time of diagnosis and annually• Children with Type 1 Diabetes

Page 74: Clinical Practice Guidelines

References:

AACE Clinical Practice Guidelines for the Management of Diabetes Mellitus, The AmericanAssociation of Clinical Endocrinologists and The American College of Endocrinology, 1995.

Alliance Blue Cross Blue Shield, Practice Guideline for Diagnosis and Management of Diabetes,1999.

Alliance Blue Cross Blue Shield, Practice Guideline for Cardiovascular Risk Reduction(Hyperlipidemia), 1998.

American Diabetes Association: Clinical Practice Recommendations 2000, Vol. 23, January 2000.

Applied Therapeutics, 5th edition, Mary Anne Koda-Kimble, Lloyd Y. Young, 1992.

Drug Facts and Comparisons. (Steven K. Hebel) (Facts and Comparisons, St. Louis, MO 1997).

Drug Information Handbook. 5th Edition, Charles Lacy, ed. Lexi-Comp, Hudson, Ohio, 1998.

Lovelace Healthcare Foundation, Inc. Episode of care: diabetes, 1997.

Texas Diabetes Council, Texas Department of Health, 1998.

Diabetes Mellitus