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Messaging Scripts are scripts for scripts. Messaging scripts are targeted treatment messaging & decision support tools for specific clinical topics. This tool, and accompanying template, can help you construct your own. This tool can also be used in conjunction with the Delfini Patient Information & Decision Aid Tool for greater depth of script or aid development. [PDF] [WORD]

The clinical content in the messaging scripts is no longer being updated. The information in the messaging scripts should be used only to understand a method for developing evidence-based decision-support messaging scripts for various target groups—not for informing clinical decisions. It is the responsibility of the user to update any information.

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Features

Messaging scripts can be used for a variety of purposes – some examples:
1. Information and decision aids for clinicians, pharmacists and nurses
2. Scripts for academic detailing
3. Customized chart-based advisements from pharmacists to clinicians
4. Information, decision & action aids for patients

Legal Information & Disclaimers

Use of this website implies your agreement to our Notices. Terms of Use: Please include a credit statement acknowledging this work, such as this one: Consulted Delfini Rx Messaging Scripts ™ Template—www.delfini.org.

Page Navigation

Attributes of Good Scripts

A good messaging script is—

  • Concise, text table-based
  • Patient-centered and customizable to individual patient, caretaker or clinician
  • Evidence-based with short evidence statements plus key references
  • Informative and quantitative
    • Presents quantified information on baseline risk, benefits and harms in natural language and in ways research suggests may be most easily understood
    • Informs about the benefits and harms of relevant choices, including no treatment
  • Flexible—can add prescribing info, cost info, patient preferences, value considerations, action steps, etc. to customize to topic and need
  • Utility oriented
    • Helps prepare for prepare for communication of healthcare information using various media

Quantifying Information

Communicating Results to Physicians and Patients

Quantified information is important to convey likelihood of benefit or harm. Physician and patients’ selection of interventions varies dramatically depending upon how study results are communicated.

Four primary methods are—

1. Risk with and without intervention Recommended
Two-by-two table information.
Example: Out of 100 people, 10% died without treatment and 5% of people died with treatment within 5 years.

2. Absolute risk reduction (ARR) Recommended
The actual percent risk.
From above example: 5% ARR (5 yrs), meaning “Five percent of people benefited from using treatment x within 5 years.”

Effect out of 100 *Highly Recommended*
ARR can also be expressed as benefit or risk out of 100.
Example: “For every 100 people who used treatment x, 5 people benefited within 5 years.”

3. Number-needed-to-treat (NNT) Recommended
The reciprocal of ARR.
(1/ARR).
Easy conversion tip: ARR # goes into 100 how many times?
From above example: NNT 20 (5 yrs)
NNT is always expressed in terms of 1 person benefiting. For example NNT 20 (5yrs) is expressed as, “For every 20 people treated, 1 person will benefit from treatment x within 5 years.”

4. Relative Risk Reduction (RRR) NOT Recommended without one or more from above
The relative percent difference in the proportion of the outcomes.
(Comparison group outcomes - Intervention group outcomes) / Comparison group outcomes
RRR can overstate results size.
From the above example: RRR 50% (5 yrs).

Associated Time Period
Results should always be conveyed with the associated time period within which benefit or risk has been observed to occur. This is the study time period. “Within” is important as it is usually not known when, within the time period, the benefit or harm might be realized.

Template for Scripting (more available by downloading the tool)

This patient is a good candidate for [INTERVENTION]

Baseline Risk
The best available valid and useful evidence indicates that [population description summarized from study inclusion, exclusions and baseline characteristics including ages and other meaningful prognostic characteristics such as with a history of…] have a [x percent] % risk of developing [condition] within [time period].

Medical Intervention Benefits and Risks
The best available valid and useful evidence [evidence rating] indicates that the risk drops to [x percent] within [study period] for those treated with [intervention]. However, the risk drops to [x percent] within [study period] for those treated with [intervention]. This is a [ARR] % decrease in risk. Out of 100 patients, [ARR without % symbol] will benefit.
[List below quantified information for benefits, harms and risks.]

For Lay Users
You may wish to substitute “risk” for “harms” unless harms are 100% known.

Considerations

  • Consider what matters to patients: morbidity, mortality, symptom relief, functioning, health-related quality of life, satisfaction, costs, uncertainties and alternatives.
  • Consider patient preferences, value considerations and action steps, etc.
  • Customize and personalize as you can.

+ [ARR #] out of 100 people: text statement

- [ARR #] out of 100 people: text statement

Prescribing Information: ----------------

Drug Information for Patients
Detailed information is available at MEDLINEPlus. www.nlm.nih.gov/medlineplus/druginformation.html

About Safety of Health Care Interventions
Safety is often difficult to assess.  Patients should be informed about known safety issues and the quality of the safety evidence even when the evidence is weak. Patients should also be informed that there may be unknown risks of adverse events from healthcare interventions. Reports of no differences between groups should be viewed with caution because the population studied may have been too small for a true difference to be revealed. However, reports of adverse events might not, in fact, be due to the intervention.

Other Information [optional]: ----------------

Evidence
[brief statement]
[references]

[documentation: date prepared & by whom; update info as applicable]

Consulted Delfini Rx Messaging Scripts ™ Template — www.delfini.org

........

Or Substitution for Possible but Unproven Benefits of [Intervention X], including information from above as applicable: 

Conclusion
There is insufficient evidence to conclude that for [CONDITION A], [INTERVENTION X] produces better clinical outcomes than [INTERVENTION Y]. Lack of valid evidence for efficacy does not prove that [INTERVENTION X] is ineffective, but complications may be significant and should be considered prior to [INTERVENTION X].

This conclusion results from a critical appraisal of [EXAMPLE: a Cochrane systematic review [ref] which was based on 4 randomized controlled trials (RCTs) of 40 potentially valid and useful RCTs found in the Cochrane search and a updating of the review (DATE) through a PubMed search for, and evaluation of, RCTs published after the Cochrane review.  All received a Grade U (uncertain validity and/or clinical usefulness)].

Evidence for Efficacy
The above studies are [Grade __ (grade tag): Threats to validity include [THREATS, E.G., NON-BLINDING, LARGE LOSS TO F/U, ETC.]. 

Possible Harms of [INTERVENTION X]: ---------------- 

Evidence of Harms
The following estimates of adverse outcomes are based on grade U evidence [ref]

Samples only for ideas—complete and verify for accuracy and currency

The clinical content in the messaging scripts is no longer being updated. The information in the messaging scripts should be used only to understand a method for developing evidence-based decision-support messaging scripts for various target groups—not for informing clinical decisions. It is the responsibility of the user to update any information.

Ace Inhibitors
Alendronate

Antidepressants
Blood Pressure Treatment (personalized example)
Diabetic Retinopathy
Hormone Replacement Therapy
Sciatica (Low Back Pain)
Statins
Statins and Lipids (for use directly with a patient)
Venous Thromboemobolism (VTE) Prevention in Total Hip and Total Knee [PDF] & [WORD]
Also read about the VTE Project and access the clinical practice guideline and the clinician 1-pager. Plus from the Agency for Healthcare Research & Quality, general information for patients about blood thinners.

Sample: ACE Inhibitors

This patient is a good candidate for…

ACE Inhibitors because the patient is at least age 55 and has a history of coronary artery disease (CAD), stroke, peripheral (legs) vascular disease, or diabetes plus one other risk factor (elevated blood pressure, elevated total cholesterol, low HDL cholesterol, cigarette smoking or protein in the urine).

Estimates of benefit cannot be precise because of differing study results. The largest amount of benefit from an ACE Inhibitor was an absolute risk reduction of 3.8% reported in the HOPE trial which means that for every 100 people, 3 to 4 people will avoid a cardiovascular death, myocardial infarction or stroke.

Summary
Out of 100 of these people treated for 5 years with an ACEI, as compared to placebo, during that time period—

+ 3-4 people will avoid cardiovascular death, myocardial infarction or stroke

—6 people will discontinue the ACEI because of cough

Reported Adverse Events
Cough, sleep apnea, hyperkalemia (esp if renal disease), angioedema, hypotension, renal dysfunction, congenital malformations, hepatotoxicity and other adverse events have been reported.

Prescribing Information
Before prescribing any medication, review full prescribing information, including adverse events, such as from the Physicians Desk Reference, DrugStore.Com or other source.

Drug Information for Patients
Detailed information is available at MEDLINEPlus. www.nlm.nih.gov/medlineplus/druginformation.html

About Safety of Health Care Interventions
Safety is often difficult to assess.  Patients should be informed about known safety issues and the quality of the safety evidence even when the evidence is weak. Patients should also be informed that there may be unknown risks of adverse events from healthcare interventions. Reports of no differences between groups should be viewed with caution because the population studied may have been too small for a true difference to be revealed. However, reports of adverse events might not, in fact, be due to the intervention.

Evidence
Valid study based on DynaMed Review: Risk of cardiovascular death, myocardial infarction or stroke (5 yrs): Placebo 17.8%, ACEI 14%

The Heart Outcome Prevention Evaluation Study Investigators. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med 2000;342:145–153.PMID: 10639539.

Prepared by Delfini Group, LLC, 1/1/04, Updated 11/12/12.
Consulted Delfini Rx Messaging Scripts TM Template – www.delfini.org

Sample: Alendronate

This patient is a good candidate for…

Alendronate

Valid and useful evidence demonstrates that alendronate reduces vertebral, hip and wrist fractures as compared with control in postmenopausal women with osteoporosis. The following numbers needed-to-treat (NNT) estimates are based on treatment for more than 1 year. (NNT = how many patients need to be treated to benefit by avoiding a bad outcome.)

Vertebral Fractures: 7.3% versus 12.2% NNT: 21 or ~4.8 patients out of 100
Non-vertebral Fractures: 7.2% versus 9.3%
NNT: 48 or ~2.1 out of 100
Wrist Fractures: 1.5% vs. 2.9%
NNT: 72 or ~1.4 out of 100
Hip Fractures: 0.6% vs.1.3% NNT: 143 or ~0.7 out of 100

Reported Adverse Events
Esophageal effects, stomach ulcers, atypical femur fractures have been reported.

Prescribing Information
Before prescribing any medication, review full prescribing information including adverse events found in the Physicians  Desk Reference, DrugStore.Com or other source.

Drug Information for Patients
Detailed information is available at MEDLINEPlus. www.nlm.nih.gov/medlineplus/druginformation.html

About Safety of Health Care Interventions
Safety is often difficult to assess.  Patients should be informed about known safety issues and the quality of the safety evidence even when the evidence is weak. Patients should also be informed that there may be unknown risks of adverse events from healthcare interventions. Reports of no differences between groups should be viewed with caution because the population studied may have been too small for a true difference to be revealed. However, reports of adverse events might not, in fact, be due to the intervention.

Evidence
Valid systematic review based on DynaMed Review

Wells GA, Cranney A, Peterson J, et al. Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD001155. Review. PubMed PMID: 18253985.

Prepared by DelfiniGroup, LLC, 1/1/04, Updated 11/28/12
Consulted Delfini Rx Messaging Scripts TM Template – www.delfini.org

Sample: Antidepressant Therapy

Antidepressant Therapy

Efficacy
Tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors, and venlafaxine are more effective than placebo in improving symptoms and response rates in mild, moderate or severe depression ( short term). No single class or individual antidepressant has been shown to be more effective than the others. Strength of Evidence—Moderate (GRADE):

23-51 out of 100 people treated with a placebo will improve.

45-60 out of 100 people treated with an antidepressant will improve.

Safety
Compared with SSRIs, about twice as many people taking TCAs report dry mouth, constipation, and dizziness, but that slightly more people taking SSRIs report nausea, diarrhea, anxiety, agitation, insomnia, nervousness, and headache. 50% to 60% of patients report at least one adverse event. Rare but severe adverse events, such as seizures, cardiovascular events (events relating to systolic and diastolic blood pressure and pulse or heart rate), hyponatraemia, hepatotoxicity, and the serotonin syndrome have been reported. Strength of Evidence—Moderate (GRADE).

Prescribing Information
Before prescribing any medication, review full prescribing information, including adverse events, such as from the Physicians Desk Reference, DrugStore.Com or other source.

Drug Information for Patients
Detailed information is available at MEDLINEPlus. www.nlm.nih.gov/medlineplus/druginformation.html

About Safety of Health Care Interventions
Safety is often difficult to assess.  Patients should be informed about known safety issues and the quality of the safety evidence even when the evidence is weak. Patients should also be informed that there may be unknown risks of adverse events from healthcare interventions. Reports of no differences between groups should be viewed with caution because the population studied may have been too small for a true difference to be revealed. However, reports of adverse events might not, in fact, be due to the intervention.

Evidence
1.  AHRQ systematic review 248 studies of good or fair quality. Gartlehner G, Hansen RA, Thieda P et al. Second-Generation Antidepressants in the Pharmacologic Treatment of Adult Depression: An Update of the 2007 Comparative Effectiveness Review December 2011. www.effectivehealthcare.ahrq.gov/reports/final.cfm.

2.  Cipriani A, Barbui C, Butler R, Hatcher S, Geddes J. Depression in adults: drug and physical treatments. Clin Evid (Online). 2011 May 25;2011. pii: 1003. PubMed PMID: 21609510.

Prepared by Delfini Group, LLC, 1/1/04, Updated 01/02/2012
Consulted Delfini Rx Messaging Scripts TM Template – www.delfini.org

Sample: Blood Pressure Treatment (Personalized Example)

This patient is a good candidate for…

Blood Pressure Treatment

This 70 year old patient has a BP of 195/90. With this blood pressure, he has a 28% mortality risk over the next 5 years. The best available valid and useful evidence indicates that if 25 people with systolic hypertension, who are similar in age, are treated for their elevated blood pressure for 5 years, during that time period, as compared to placebo—

1 person may avoid dealth due to cardiovascular disease

24 people will not receive a mortality benefit from blood pressure treatment, but may avoid a cardiovascular event.

Prescribing Information
Before prescribing any medication, review full prescribing information, including adverse events, such as from the Physicians Desk Reference, DrugStore.Com or other source.

Drug Information for Patients
Detailed information is available at MEDLINEPlus. www.nlm.nih.gov/medlineplus/druginformation.html

About Safety of Health Care Interventions
Safety is often difficult to assess.  Patients should be informed about known safety issues and the quality of the safety evidence even when the evidence is weak. Patients should also be informed that there may be unknown risks of adverse events from healthcare interventions. Reports of no differences between groups should be viewed with caution because the population studied may have been too small for a true difference to be revealed. However, reports of adverse events might not, in fact, be due to the intervention.

Evidence
A well-done systematic review of patients > age 60 with systolic hypertension (systolic BP >160) – Active treatment reduced total mortality (RR 0.87, 95% CI 0.78 to 0.98; P = 0.02).

Staessen JA, Gasowski J, Wang JG, et al. Risks of untreated and treated isolated systolic hypertension in the elderly: meta-analysis of outcome trials. Lancet 2000;355:865–872.

Prepared by Delfini Group, LLC, 1/1/04, Updated 4/3/07
Consulted Delfini Rx Messaging Scripts TM Template – www.delfini.org

Sample: Diabetic Retinopathy

This patient is a good candidate for…

Retinopathy Screening

This patient is a good candidate for retinopathy screening every two years. If screening is positive for diabetic retinopathy, the ophthalmologist is likely to adjust the screening frequency.

The best available valid and useful evidence indicates that type I diabetics ages 10 and older who have had diabetes for 5 years, type II diabetics, and diabetic women who become pregnant have a significant risk of developing retinopathy.

Out of 100 people with advanced retinopathy treated for 5 years with photocoagulation as compared to no treatment during that time period—

14 people will avoid visual loss.

Evidence
Well-done systematic reviews of randomized controlled trials provide sufficient evidence for concluding benefit from photocoagulation in patients with diabetic retinopathy.

1. Bachmann M O, Nelson S J, Impact of diabetic retinopathy screening on a British district population: case detection and blindness prevention in an evidence-based model. Journal of Epidemiology and Community Health 1998;52:45-52.
2. Singer DE, Nathan DM, Fogel HA, Schachat AP. Screening for diabetic retinopathy. Ann Intern Med. 1992 Apr 15;116:660-71.
3. Clinical Evidence, June 2003. Issue 9.

Prepared by Delfini Group, LLC, 1/7/04, Updated 4/3/07
Consulted Delfini Rx Messaging Scripts TM Template – www.delfini.org

Sample: Hormone Replacement Therapy
(also see Menopause Decision Aid)

You may wish to review this patient’s need for …

Hormone Replacement Therapy

The best available valid and useful evidence indicates there are benefits (+) and risks (–) of taking estrogen and progestin. Compared to placebo, within the treatment period below, out of 400 women, the following is expected:

+ Benefit
—Risk

# of Women

Treatment
Years

Outcome

+ 133 3 will avoid hot flashes
+ 1 5 will be prevented from having a hip fracture
+ ~9 5 will be prevented from having anyfracture
+ 1 5 will be prevented from having colon cancer
~1.2* 5 will have coronary heart disease (CHD)
~1.2* 5 will have a stroke
~1.2*^ 5 will have invasive breast cancer
~1.2 5 will have a pulmonary embolism
~1.2 5 will have a deep venous thrombosis in the leg
3-4 4 will develop dementia
~36 1 will develop urinary incontinence

*Note: Some risks may be lower in younger postmenopausal women. Important mortality data was obtained by pooling data from the 2 large Women's Health Initiative (WHI) trials [4]. The two trials included 8,832 women aged 50 to 59 years. There were some methodological limitations (grade B-U evidence), but the evidence is suggestive that women < 60 years of age who use HRT for the first time in early menopause for around 10 years may not be at increased risk for breast cancer, CHD or stroke. According to this data for women with no history of cardiovascular disease, approximately 1 death per 1,000 women per year would be prevented by taking HRT.

^Note: Based on a follow-up WHI study published in 2011, women with prior hysterectomy taking conjugated equine estrogens may not be at increased risk for CHD and may even be at lower risk for breast cancer than women not taking HRT. However, the breast cancer risk data is conflicting and because of chance or bias, the difference in risk for developing breast cancer in HRT users and non-users in this population is inconclusive.

Prescribing Information
Before prescribing any medication, review full prescribing information, including adverse events, such as from the Physicians Desk Reference, DrugStore.Com or other source.

Drug Information for Patients
Detailed information is available at MEDLINEPlus. www.nlm.nih.gov/medlineplus/druginformation.html

About Safety of Health Care Interventions
Safety is often difficult to assess.  Patients should be informed about known safety issues and the quality of the safety evidence even when the evidence is weak. Patients should also be informed that there may be unknown risks of adverse events from healthcare interventions. Reports of no differences between groups should be viewed with caution because the population studied may have been too small for a true difference to be revealed. However, reports of adverse events might not, in fact, be due to the intervention.

Evidence
1. The Cochrane Database of Systematic Reviews The Cochrane Collaboration Volume (1), 2003. PMID 15213207
2. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. Authors: Writing Group for the Women's Health Initiative Journal: JAMA 2002;288:321–333. PMID 15467059
3. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. Authors: Writing Group for the Women's Health Initiative Journal: JAMA 2002-2005. PMID 15657326
4. Rossouw JE, Prentice RL, Manson JE, et al. Postmenopausal hormone therapy and risk of cardiovascular disease and years since menopause. JAMA. 2007; 297(13):1465-1477. PMID 17405972
5. Lacroix AZ, Chlebowski RT, Manson JE, et al. Health Outcomes After Stopping Conjugated Equine Estrogens Among Postmenopausal Women With Prior Hysterectomy: A Randomized Controlled Trial. JAMA. 2011 Apr 6;305(13):1305-1314. PMID: 21467283

Prepared by Delfini Group, LLC, 11/02, Updated 04/11
Consulted Delfini Rx Messaging Scripts TM Template – www.delfini.org

Sample: Sciatica (Low Back Pain)

Surgery versus Conservative Care for Acute Herniation of a Lumbar Disc with Radicular Symptoms

All evidence is grade U (Uncertain validity and/or usefulness)  

Surgical Treatment
Sciatica resolves in most patients by 4 months; recovery occurs in 80 to 90 patients out of 100 at 6 months and 95 out of 100 patients by 1 year.

Non-surgical Treatment
Sciatica resolves in 50 to 60 patients out of 100 within 6 months and up to 95 out of 100 patients by 1 year.

Harms
Surgical complications may be severe and should be considered before deciding to have surgery.

Risks of Surgery
Below are the estimated risks of surgery based on poor quality evidence. Assuming patients undergo surgery approximately—

  • 1/100 will develop blood clots in their lungs
  • 1-2/100 will develop a spinal disc infection
  • 1-3/100 will develop a wound infection
  • 2-4/100 will have tears in the sac (called the Dura) around the spinal cord which requires additional care
  • 1/1000 will die during surgery
  • 3/1000 will develop meningitis
  • 1-3/1000 will have permanent damage to a spinal nerve
  • 1-4/1000 will require blood transfusions

References
1. Gibson JNA, Waddell G. Surgical interventions for lumbar disc prolapse. Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: CD001350. DOI: 10.1002/14651858.CD001350.pub4.

2. Weber H (1983) Lumbar disc herniation. A controlled, prospective study with ten years of observation. Spine. 1983. 8:131–140

3. Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006;296:2441-2450. PMID: 17119141

4. Jordan J, Konstantinou K, Morgan TS, Weinstein J. Herniated lumbar disc. Clin Evid 2005;14:1–4. Search date May 2005.

5. Lewis R et al. The clinical effectiveness and cost-effectiveness of management strategies for sciatica: systematic review and economic model. Health Technol Assess. 2011 Nov;15(39):1-578. PMID: 22078311.

6. Jacobs WC et al. Surgery versus conservative management of sciatica due to a lumbar herniated disc: a systematic review. Eur Spine J. 2011 Apr;20(4):513-22. Epub 2010 Oct 15. Review. PubMed PMID: 20949289.

Prepared by Delfini Group, LLC, 5/23/07, Updated 11/29/12
Consulted Delfini Rx Messaging Scripts TM Template – www.delfini.org

Sample: Statins

This patient is a good candidate for treatment with a…

Statin

This 70 year old patient has a history of myocardial infarction. The best available valid and useful evidence (Grade B-U) indicates that if 28 people with coronary artery disease are treated with a statin for 5 years, during that time period, compared to placebo—

1 person will avoid dying.

Other benefits include decreased risk of cardiac death, non-fatal MI, stroke, angina, peripheral artery disease and revascularization.

Safety

Abnormal liver function tests, muscles pains and injury, diabetes, cancer and other rare adverse events have been reported (Grade U evidence).

Prescribing Information
Before prescribing any medication, review full prescribing information, including adverse events, such as from the Physicians Desk Reference, DrugStore.Com or other source.

Drug Information for Patients
Detailed information is available at MEDLINEPlus. www.nlm.nih.gov/medlineplus/druginformation.html

About Safety of Health Care Interventions
Safety is often difficult to assess.  Patients should be informed about known safety issues and the quality of the safety evidence even when the evidence is weak. Patients should also be informed that there may be unknown risks of adverse events from healthcare interventions. Reports of no differences between groups should be viewed with caution because the population studied may have been too small for a true difference to be revealed. However, reports of adverse events might not, in fact, be due to the intervention.

Evidence
1. Afilalo J, et al.. Statins for Secondary Prevention in Elderly Patients: A Hierarchical Bayesian Meta-Analysis. Journal of the American College of Cardiology 2008; 51: 37-45. PMID: 18174034.
2. Mills EJ et al.  Efficacy and safety of statin treatment for cardiovascular  disease: a network meta-analysis of 170,255 patients from 76 randomized trials. QJM. 2011 Feb;104(2):109-24. Epub 2010 Oct 7. Review. PubMed PMID: 20934984.
3. Alberton M et al. Adverse events associated with  individual statin treatments for cardiovascular disease: an indirect comparison meta-analysis. QJM. 2011 Sep 14. [Epub ahead of print] PubMed PMID: 21920996.

Prepared by Delfini Group, LLC, 1/1/04, Updated 11/29/12
Consulted Delfini Rx Messaging Scripts TM Template – www.delfini.org

Sample: Statins & Lipids (Example to Use Directly With a Patient)

Information about your elevated cholesterol level…

Your Risk

The best available valid and useful scientific evidence (Cochrane risk of bias: low to moderate) indicates that you have a risk of approximately 23% for experiencing a fatal or non-fatal heart attack or stroke within 5 years. This means that almost 1 in 4 people like you will have a heart attack or stroke in the next 5 years if you have no treatment for your cholesterol. 

You can reduce your risk by taking a statin medication to lower your cholesterol.

Benefits for Reduced Risk of Heart Attack or Stroke

Research studies of reasonable quality tell us that out of 100 patients like you—

  • 23 people will have a heart attack or stroke if they choose no treatment over 3 to 5 years.
  • 16 people will have a heart attack or stroke if they choose to take a statin drug.
  • This means that 7 people will be prevented from having a heart attack with statins over 3 to 5 years.

Risks and Harms (Low Quality Evidence)

  • Do not take a statin medication if you are pregnant, nursing or if you might get pregnant while taking the drug because statins may interfere with normal development of a fetus.
  • If you notice muscle weakness, stop the statin medication and notify you doctor— statins can, on rare occasion, cause muscle injury.
  • Abnormal liver function tests, diabetes, cancer and other adverse events have been reported.

Prescribing Information
Before prescribing any medication, review full prescribing information including adverse effect in the Physicians Desk Reference, DrugStore.Com or other source.

Drug Information for Patients
Detailed information is available at MEDLINEPlus. www.nlm.nih.gov/medlineplus/druginformation.html

About Safety of Health Care Interventions
Safety is often difficult to assess.  Patients should be informed about known safety issues and the quality of the safety evidence even when the evidence is weak. Patients should also be informed that there may be unknown risks of adverse events from healthcare interventions. Reports of no differences between groups should be viewed with caution because the population studied may have been too small for a true difference to be revealed. However, reports of adverse events might not, in fact, be due to the intervention.

References
1. Randomized Trial of cholesterol lowering in 4444 patients with coronary heart disease. The Scandinavian Simvastatin Survival Study. Lancet 1994; 344:1383-89
2. LaRosa JC, He J, Vupputuri S. Effect of statins on risk of coronary disease: a meta-analysis of randomized controlled trials. JAMA 1999;282:2340–2346.
3. Alberton M et al. Adverse events associated with  individual statin treatments for cardiovascular disease: an indirect comparison meta-analysis. QJM. 2011 Sep 14. [Epub ahead of print] PubMed PMID: 21920996.
4. Taylor F et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2011 Jan 19;(1):CD004816. Review. PubMed PMID: 21249663.

Prepared by Delfini Group, LLC, 2/18/04, Updated 11/29/12
Consulted Delfini Rx Messaging Scripts TM Template – www.delfini.org

 

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