EBM Journal Club - Intro and Review of Home BP Monitoring Article

SHCC/MXC PA Program EBM Journal Club Week 1 – Introduction to the Club and Article Analysis

Introduction to the Club!

A group of individuals who meet regularly to critically evaluate medical literature

Long Hx in graduate medical education, earliest reference in mid-1800s

Three goals: (1) keep up with current lit, (2) impact clinical practice, (3) teach critical reading skills

Green BB, Cook AJ, Ralston JD, et. al. (2008). Effectiveness of Home Blood Pressure Monitoring, Web Communication, and Pharmacist Care on Hypertension Control: A Randomized Controlled Trial. JAMA. 299(24): 2857-2867

Survey/Questionnaire

Please fill out this quick survey so that we can later evaluate the performance of the club!

Possibly present this survey data at conference next spring? Publish???

Please read each statement and chose to agree or disagree as you feel TODAY:

I have prior exposure to/experience with Journal Clubs.

Strongly Diagree , I have no previous exposure/experience

Disagree , I have a little experience, not significant (1-2 times)

Agree , I have some, but not much (3-5 times)

Strongly Agree , I have much experience (>5 times)

(2) I currently feel comfortable independently CRITICALLY APPRASING journal articles.

Strongly Diagree , not comfortable at all.

Disagree , slightly comfortable, but I need more exposure

Agree , comfortable, I need a little guidance but not much

Strongly Agree , completely comfortable, I understand all aspects of critical appraisal

(3) I feel that this experience will make me more comfortable critically evaluating journal articles

Disagree , I don’t think this experience will improve my critical evaluation skills

Agree , I think this experience will help me to critically evaluate articles

(4) I feel that journal club is an appropriate use of my time in this program.

Disagree , I do not believe it is a good use of time

Agree , it is a good use of time

(5) Journal club is my preferred way of learning how to critically evaluate articles.

Disagree , I think there maybe better ways to learn these skills

Agree , I feel that this is the best way for me to learn

THANKS FOR TAKING THE SURVEY!

Our Selection for this Meeting

“ Effectiveness of Home Blood Pressure Monitoring, Web Communication, and Pharmacist Care on Hypertension Control: A Randomized Controlled Trial.”

Green B, Cook AJ, Ralston JD, et. al.

JAMA. 2008; 299(24): 2857-2867

Green BB, Cook AJ, Ralston JD, et. al. (2008). Effectiveness of Home Blood Pressure Monitoring, Web Communication, and Pharmacist Care on Hypertension Control: A Randomized Controlled Trial . JAMA . 299(24): 2857-2867

Overview

Q: What is the research question asked?

A: Does a new model of care improve BP control?

A: (More specific) Does a model including MD care, web access and access to pharmacist online improve control in pts age 25-75 with essential hypertension and internet access?

Overview

Q: What is the main outcome of interest?

A: % of pts. w/ controlled BP (<140/90) and changes in sys & dias BP @ 12 mo.

Overview

Q: Who are the subjects/participants?

A: n=778; pts 25-75 y/o with uncontrolled ESSENTIAL HTN and internet access

PANCE Point!

Q: What is essential hypertension?

A: Essential HTN = no other/secondary cause of HTN.

Secondary HTN is a sequella of some other process (e.g., Kidney dz, pheochromocytoma)

Overview

Q: What do the authors conclude?

A: Pharmacist care mgnt delivered thru secure pt web com improved BP control in pts with HTN

Are the Results Valid?!?

Q: Did the experimental and control grps begin the study with a similar prognosis?

A: Yes,

uncontrolled HTN with Rx therapies

Q: Were pts. randomized?

A: Yes,

Randomized Control Trial (RCT)

Randomized Control Trial (RCT)

Entire group was randomized to balance within medical centers (not too many one type of pt. at any one) and with reference to baseline systolic BP. ( First Randomization – usual group working with just MD and therapy group)

Those with high systolic BPs (160-199) were stratified into a separate subgroup  now there are two therapy groups, three grps total. ( Second Randomization )

Within these two groups patients were then randomly assigned in blocks to the 3 study groups. (block randomization ensures balance of controls and experimental groups) ( third randomization )

Randomized Control Trial (RCT) Green BB, Cook AJ, Ralston JD, et. al. (2008). Effectiveness of Home Blood Pressure Monitoring, Web Communication, and Pharmacist Care on Hypertension Control: A Randomized Controlled Trial. JAMA. 299(24): 2857-2867 778 Randomized 520 Randomized to receive active intervention 258 randomized to rec’v usual care 259 Randomized to home + web only 261 randomized to home + web + pharm 246 completed follow up and included in analysis 237 completed follow up and included in analysis 247 completed follow up and included in analysis 520 randomized again after rec’v BP mon and web training

Q: Was the randomization concealed?

A: Yes,

Research assistants were BLINDED to group assignment. Obviously, pts and clinicians could not be. Analysts were blinded.

Q: Were pts. analyzed in the grps to which they were randomized?

A: Yes,

They were STRATIFIED BY INTERVENTION GROUP.

Q: Were pts in the tx and control groups similar with respect to known prognostic factors?

A: Yes,

Except for female sex, and already having a home BP monitor. These were controlled for in primary analyses.

Did Experimental and Control Groups Maintain a Similar Prognosis?

Q: Were 5 important groups aware of group allocation?

A: Yes and No, but not an issue.

Pts. Aware (obviously), caregivers aware, outcome collectors (rsch assistants) NOT aware, data analysts NOT aware.

Appropriate BLINDING.

Q: Aside from experimental intervention, were the groups treated equally?

A: Yes.

Q: Was follow-up complete?

A: Yes.

Attempted for all pts & even if they did not receive assigned intervention or deviated from protocol.

Enough Already! What are the RESULTS!?!

Q: What were the PRIMARY OUTCOMES?

A: Home BP + Web did NOT improve BP vs. usual therapy (did improve Systolic BP).

+Pharm  25% increase in pts w/ controlled HTN vs. usual // 20% vs. home + web

Q: What were the PRIMARY OUTCOMES?

A: Systolic BP decreased stepwise across groups.

Diastolic BP was decr. only in pharm care grp.

In >160 sys grp with home, web, pharm vs. usual:

Greater net reduction in sys BP

“ “ diastolic BP

And overall improved control

(RELATIVE RISK, 3.32)

What is RELATIVE RISK?

RR = P exposed /P unexposed

Prob of those w/ new tx improving

Prob of those w/o new tx improving

So, those in the >160 grp with home + web + pharm are 3.32 TIMES more likely to improve with the tx vs. usual.

Q: What were the SECONDARY OUTCOMES?

A: Several:

Home + web has incr in HTN Rx classes vs. usual (more drugs!)

Home + web + pharm had incr in HTN Rx classes vs both; incr ASA use vs. both

Lifestyle, BMI, QOL did not change in any group

Q: What statistical methods are employed?

A: Linear regression models (think: controlling for confounders!) adjusted for baseline outcome measures and characteristics related to outcome.

Q: Do these results refute the null hypothesis?

A: Yes. The null hypothesis is:

A new model of care will not improve BP control.

This is refuted by the results (i.e., the new model does improve control)!

How Can I Apply the Results to My Future Pt Care?

Q: Were the study pts similar to my pts/potential/future pts?

Q: Were all pt important outcomes considered?

Q: Are the likely benefits worth the potential harms/cost?

What are the WEAKNESSES of this Study?

Limited to pts with uncontrolled essential HTN and were required to have computers, internet, and email access

Pts w/o computer access were more likely to be older, a racial/ethnic minority, less education  digital divide

Pts ineligible with comorbidities (DM, CVD, etc.)

To keep medication protocols simple

Pts in home + web grp might have shown similar reductions if sent email reminders

Will BP control be maintained long-term?

What are the STRENGTHS of this Study?

RCT

Care mgmt over the web a novel concept, combining with EMR trend

“… an essential element for the transformation of health care is continuous access (24/7) to health care”

Chronic Care Model applied to HTN

Has shown improvements in other chronic illnesses

CONCLUSIONS!

“ Our findings demonstrate the effectiveness of using home BP monitoring combined with pharmacy care over the web to improve BP control for patients with essential hypertension.”