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Role of Home Blood Pressure Monitoring in Overcoming Therapeutic Inertia and Improving Hypertension Control

A Systematic Review and Meta-Analysis
Originally publishedhttps://doi.org/10.1161/HYPERTENSIONAHA.110.160911Hypertension. 2011;57:29–38

Abstract

Hypertension remains the most common modifiable cardiovascular risk factor, yet hypertension control rates remain dismal. Home blood pressure (BP) monitoring has the potential to improve hypertension control. The purpose of this review was to quantify both the magnitude and mechanisms of benefit of home BP monitoring on BP reduction. Using a structured review, studies were selected if they reported either changes in BP or percentage of participants achieving a pre-established BP goal between randomized groups using home-based and office-based BP measurements. A random-effects model was used to estimate the magnitude of benefit and relative risk. The search yielded 37 randomized controlled trials with 9446 participants that contributed data for this meta-analysis. Compared with clinic-based measurements (control group), systolic BP improved with home-based BP monitoring (−2.63 mm Hg; 95% CI, −4.24, −1.02); diastolic BP also showed improvement (−1.68 mm Hg; 95% CI, −2.58, −0.79). Reductions in home BP monitoring-based therapy were greater when telemonitoring was used. Home BP monitoring led to more frequent antihypertensive medication reductions (relative risk, 2.02 [95% CI, 1.32 to 3.11]) and was associated with less therapeutic inertia defined as unchanged medication despite elevated BP (relative risk for unchanged medication, 0.82 [95% CI, 0.68 to 0.99]). Compared with clinic BP monitoring alone, home BP monitoring has the potential to overcome therapeutic inertia and lead to a small but significant reduction in systolic and diastolic BP. Hypertension control with home BP monitoring can be enhanced further when accompanied by plans to monitor and treat elevated BP such as through telemonitoring.

See Editorial Commentary, pp 21–23

Although clinic blood pressure (BP) measurement still remains the cornerstone hypertension management, the broad availability of electronic BP measurement devices has led to their widespread adoption. Home BP monitoring is now uniformly advocated for the evaluation and management of hypertension.1,2 This is so because BP control among treated hypertensives remains poor, and it is believed that home BP monitoring can improve hypertension control.1,2 This improvement may be attributable to both better adherence with antihypertensive therapy and detection and treatment of masked hypertension. Further, in contrast to clinic BP measurement, which is associated with a white coat effect, home BP monitoring may reduce white coat effect and may obviate unnecessary therapy. In addition to improving hypertension control, home BP is superior to clinic BP in predicting cardiovascular prognosis3 and end-stage renal disease.4

A previous meta-analysis reported that home BP monitoring may improve hypertension control by only a small amount;5 however, even this small reduction was considered to be of public health importance. Since the publication of that meta-analysis, several trials have been published that provide important information on how home BP monitoring may improve BP control. The purpose of this systematic review and meta-analysis is to update the magnitude of benefit in BP reduction with home BP monitoring. Further, and more important, it is to discover factors that may lead to improvement in BP control with this simple measurement technique.

Methods

Identification and Selection of Trials

To identify randomized controlled trials that evaluated home BP monitoring to clinic BP measurements, we performed a structured Medline (1966 to May 2010), Cochrane Library, EMBASE, Science Citation Index, ISI Proceedings search using a search strategy reported in the appendix. Briefly, we included studies that used a randomized design to allocate patients to home or clinic monitoring strategies to test the notion whether home BP monitoring results in improvement in either BP or medications used to control it. In addition, bibliographies of individual articles included in the systematic search and relevant review articles and previous meta-analyses were searched for potential articles to be considered for inclusion in this systematic review. Our search strategy yielded 489 articles. Each article was evaluated for suitability for inclusion in this meta-analysis.

To be eligible, the study had to randomize patients to a control group and a home BP monitoring group. We did not exclude articles published in languages other than English. Data were extracted using structured form by one of the investigators. All data were reviewed by ≥2 investigators and confirmed for accuracy by the lead investigator (R.A.).

Statistical Analysis

We used a random-effects model to estimate the standardized mean difference in the change from baseline in BP: systolic, diastolic, and mean arterial pressure. Heterogeneity was tested using the I-squared statistic. Interaction effects were sought for effect modification for several a priori selected explanatory variables. Some of these explanatory variables include the following: age, study size, study duration, BP measurement technique (ambulatory or clinic), specification of target BP, specification of protocol for titration of antihypertensive medications, telemonitoring, chronic kidney disease, and whether reduction in BP was specified as a primary end point.

To assess the quality of the study, we used the following variables to create a modified Jadad score: whether the dropout rate was reported, description of randomization, appropriateness of randomization, concealment of randomization, and double-blind nature of the study. High dropout rate (exceeding 20%) was also included as a separate quality metric. This dropout rate was in line with criteria used by the Agency for Healthcare Research and Quality for evaluating studies.6

Several studies did not report an estimate of variance of the difference between the change from baseline in BP results. For these studies, SE of change was calculated by taking the square root of the sum of the variance of the change from baseline in each of the groups (home and clinic) divided by the respective group sizes.

Therapeutic inertia was defined as no change in medications combined with uncontrolled BP; uncontrolled BP was that defined by the study as failure to achieve target BP (see supplemental Table I for these definitions).

Publication bias was tested using the Begg test and funnel plot. All analyses were performed with commands including metan, metabias, and metafunnel using Stata 11.0.

Results

The inclusion and exclusion flow diagram of the studies is shown in Figure 1. A list of excluded studies is reported in the data supplement (available online at http://hyper.ahajournals.org).

Figure 1.

Figure 1. QUORUM statement flow diagram. RCT refers to randomized controlled trials. Each study contributed to ≥1 parameter reported in this meta-analysis. However, not all studies contributed to each of the outcomes reported. For example, mean arterial pressure was only reported by 3 studies (resulting in withdrawal of 34 studies for this outcome).

Major characteristics of the included studies are reported in Table. The size of these trials varied from 15 to 1325 patients, with duration of follow-ups from 2 to 36 months. The location of these trials was in the community (n=5), dialysis unit (n=2), general practices (n=18), hospitals and general practice (n=1), and hospital-based outpatient units (n=11). Outcome BP was measured in the clinic (n=24) or by ambulatory BP monitoring (n=10). The method of measuring outcome BP was not reported for 3 trials. Reduction in BP was the primary goal in 32 of the 37 trials. A more detailed list of study characteristics can be found in supplemental Table I.

Table. Characteristics of Trials Included in Meta-Analysis

No.Author, YearTotal nDuration (Months)Mean Age (y)
CountrySettingMethod of Taking Outcome BPReduction in BP Goal of Study?
HomeControl
1Carnahan, 19758100656.953.5United StatesHospital outpatientClinic BPYes
2Haynes, 19769396CanadaCommunityClinic BPNo
3Johnson, 19781068653.352.2CanadaCommunityClinic BPYes
4Earp, 198211162244947United StatesHospital outpatientClinic BPYes
5Pierce, 1984125665658AustraliaGeneral practiceClinic BPYes
6Stahl, 1984133173647.347.7United StatesHospital outpatientClinic BPYes
7Binstock, 1988145512United StatesHospital outpatientNot reportedYes
8Midanik, 1991152041247.547United StatesGeneral practiceClinic BPYes
9Soghikian, 1992164301253.854.7United StatesGeneral practiceClinic BPNo
10Mühlhauser, 199317200185151GermanyGeneral practiceClinic BPYes
11Friedman, 19961830167677United StatesCommunityClinic BPNo
12Zarnke, 1997193125652CanadaGeneral practiceABPMYes
13Bailey, 1999206225654AustraliaGeneral practiceClinic BPYes
14Mehos, 2000213666057.6United StatesHospital outpatientClinic BPYes
15Vetter, 2000226222SwitzerlandGeneral practiceClinic BPYes
16Artinian, 200123153United StatesCommunityClinic BPYes
17Broege, 2001244037372.5United StatesHospital outpatientABPMYes
18Rogers, 200125121262.660.3United StatesHospital outpatientABPMYes
19Rudd, 20042615065960United StatesHospital outpatientClinic BPYes
20Staessen, 2004274001254.252.6Belgium and IrelandHospital outpatientABPMYes
21Dalfó I Baqué, 200528132566062SpainGeneral practiceClinic BPYes
22Halme, 200529269657.457.1FinlandGeneral practiceClinic BPYes
23McManus, 2005304411262.862.4EnglandGeneral practiceClinic BPYes
24Zillich, 200531125366.164United StatesCommunityClinic BPYes
25Marquez-Contreras, 200632226659.358.9SpainGeneral practiceNot reportedNo
26Kauric-Klein, 20073336347.849.5United StatesDialysis unitNot reportedYes
27Verberk, 200734430125555NetherlandsHospital and general practiceABPMNo
28Green, 2008355171259.558.6United StatesHospital outpatientClinic BPYes
29Madsen, 200836236656.755DenmarkGeneral practiceABPMYes
30Tobe, 2008373241.562.663.5CanadaGeneral practiceClinic BPYes
31da Silva, 20093837651.351.9BrazilDialysis unitABPMYes
32DeJesus, 2009395526United StatesHospital outpatientClinic BPYes
33Marquez-Contreras, 200940329661.962.5SpainGeneral practiceClinic BPYes
34Parati, 200941223657.258.1ItalyGeneral practiceABPMYes
35Rinfret, 20094297125557CanadaGeneral practiceABPMYes
36Bosworth, 201043318246262United StatesGeneral practiceClinic BPYes
37Godwin, 2010445521267.868.8CanadaGeneral practiceABPMYes

ABPM indicates ambulatory blood pressure monitoring.

Mean Change in BP in Home BP Monitoring Group

The mean change in systolic BP in the home BP monitoring group was reported in 22 studies and averaged −2.63 mm Hg (95% CI, −4.24 to −1.02; Figure 2). The mean change was reported without SD in 8 studies. Imputing these SDs provided change in systolic BP in the home BP group to −2.21 mm Hg (95% CI, −3.03 to −1.39; supplemental Figure I).

Figure 2.

Figure 2. Forest plot depicting the systolic BP (SBP) change from baseline in “home BP group” minus change from baseline in “clinic BP group.”

The mean change in diastolic BP in home BP monitoring group in 22 studies was −1.68 mm Hg (95% CI, −2.58 to −0.79; Figure 3). After imputing SDs in 8 studies, change in diastolic BP in the home BP group was −0.82 mm Hg (95% CI, −1.37 to −0.27; supplemental Figure II). The mean change in mean arterial pressure was reported in only 3 studies and was −4.0 (95% CI, −6.22 to −1.79).

Figure 3.

Figure 3. Forest plot depicting the diastolic BP (DBP) change from baseline in “home BP group” minus change from baseline in “clinic BP group.”

There was significant heterogeneity between studies with respect to both systolic (I-squared=68.8%; P<0.0001) and diastolic BP (I-squared=63.3%; P<0.0001) but not mean arterial pressure. To explain this heterogeneity, several plausible clinical criteria were used as explanatory variables. For systolic BP, the following variables were found to be significant: study size, use of telemonitoring, study limited to dialysis patients, and whether a specific medication titration protocol was specified. Greater systolic BP reduction favoring home BP monitoring was seen when the study had the following characteristics: it was small, used telemonitoring, was limited to dialysis patients, and when a medication titration protocol was not specified (Figure 4). In the case of diastolic BP, heterogeneity was explained by size of study and specification of medication titration (supplemental Figure III). As in the case of systolic BP reduction, greater diastolic BP reduction was seen among smaller studies and among studies that did not specify a medication titration protocol.

Figure 4.

Figure 4. Subgroup analysis evaluating covariates of interest on the effect size of standardized systolic BP (SBP).

Response Rates in Home BP Monitoring Group

The definitions of response between studies were heterogeneous, as indicated in Figure 5. Some studies used reduction in systolic, others used reduction in diastolic, and yet others used reduction in both systolic and diastolic BP as criteria for response. Of the studies that reported the proportion responding, 2 studies used ambulatory BP as the response variable; the remaining used clinic BP. Compared with the clinic BP monitoring group, the risk ratio of patients responding with a change in BP for the in-home BP monitoring group was 1.11 (95% CI, 0.97 to 1.26; Figure 5). The response rates were significantly heterogeneous. The heterogeneity in response could be attributable to different definitions of response and different BP measurement modalities used to determine the responder classification. Significantly greater response rates were seen among patients who had a medication titration protocol specified (supplemental Figure IV).

Figure 5.

Figure 5. Forest plot depicting the risk ratio of BP response in “home BP group” compared with the “clinic BP group.” Type of BP refers to whether the outcome BP was measured by ambulatory or clinic measurements.

Change in BP Medications in Home BP Monitoring Group

Decrease in Medication

Compared with clinic BP monitoring, home BP monitoring led to greater reduction in medication (relative risk, 2.02 [CI, 1.32 to 3.11]; Figure 6). There was significant heterogeneity in medication reduction. Larger studies and those with patients <60 years of age tended to have a greater reduction in medication with home BP monitoring (supplemental Figure V).

Figure 6.

Figure 6. Forest plot depicting the risk ratio of BP medication reduction in “home BP group” compared with the “clinic BP group.”

Increase in Medication

Compared with clinic BP monitoring, home BP monitoring led to no greater increase in medication (relative risk, 0.94 [CI, 0.75 to 1.19]; Figure 7). Although increments in antihypertensive medications were not significantly different between the randomized groups, there was significant heterogeneity between studies. Increases in medications in home BP group were more often seen in the following subgroups: intervention length <3 months, >60 years of age, clinic BP as primary outcome, BP reduction as primary outcome, when BP target was set, and when home BP target was set lower than clinic BP (supplemental Figure VI).

Figure 7.

Figure 7. Forest plot depicting the risk ratio of BP medication increase in “home BP group” compared with the “clinic BP group.”

No Change in Medication (Therapeutic Inertia)

When medications are not changed among hypertensive patients, it may reflect therapeutic inertia. Therapeutic inertia was less common among patients who were treated with home BP monitoring (relative risk, 0.82 [CI, 0.68 to 0.99]; Figure 8). Heterogeneity between studies was significant. Among various factors studied, therapeutic inertia was more likely among people >60 years of age (supplemental Figure VII).

Figure 8.

Figure 8. Forest plot depicting the risk ratio of BP medication nonchange or “therapeutic inertia” in “home BP group” compared with the “clinic BP group.”

Relationship of Outcomes Studied to the Quality of Study

Systolic and Diastolic BP Change

There was a significant heterogeneity in BP change among various Jadad scores (supplemental Figures VIII and IX). For both systolic and diastolic BP, one study each had a Jadad score of 1 or 5. Most studies had Jadad scores of 3 or 4; these higher quality studies showed a significant reduction in BP, favoring home BP monitoring (supplemental Figures VIII and IX). High dropout rates did not influence BP reduction.

Responder Rate

There was a significant heterogeneity in responder rates among various Jadad scores (supplemental Figure X). One study had a Jadad score of 1, and none had a score of 5. For the 5 studies that had a Jadad score of 4, the risk ratio of patients responding with a change in BP with home BP monitoring was 1.26 (95% CI, 1.10 to 1.44). High dropout rates influence BP response rates significantly. Compared with the 3 studies with higher dropout rates, among the 11 studies with a dropout rate <20%, the response rate was higher (relative risk, 1.13 [95% CI, 1.04 to 1.22]). Thus, responder rate may have been influenced by the quality of the study.

Medication Reduction

There was a significant heterogeneity in reduction in antihypertensive medications among various Jadad scores (supplemental Figure XI). No study had a Jadad score of 1, and 3 studies had a score of 2. For Jadad scores of 3, 4, or 5, the risk ratio of reduction in medication favoring home BP monitoring was statistically significant. No studies had a dropout rate of >20%.

Medication Increase

There was a significant heterogeneity in increases in antihypertensive medications among various Jadad scores (supplemental Figure XII). However, no specific pattern in Jadad scores and medication increase was seen.

No Change in Medication

There was a significant heterogeneity in therapeutic inertia as measured by no change in antihypertensive medications among various Jadad scores (supplemental Figure XIII). No study had a Jadad score of 1, and only 1 had a score of 5. For Jadad scores of 3 or 4, the risk ratio of therapeutic inertia favoring home BP monitoring was statistically significant. No studies had a dropout rate of >20%.

Publication Bias

The Begg test and Funnel plot did not show evidence for publication bias for any of the outcomes tested (supplemental Figures XIV through XVI).

Discussion

The major findings of this systematic review and meta-analysis of 37 randomized controlled trials are as follows. First, among patients with hypertension, compared with clinic BP monitoring alone, home BP monitoring plays a small but significant role in improving systolic, diastolic, and mean BP. Second, although the proportion reaching BP target favored home BP monitoring by 11%, it did not reach statistical significance. This may have been because of significant heterogeneity between studies; in fact, exclusion of lower quality studies statistically favored home BP monitoring. Third, home BP monitoring provokes more down-titrations of antihypertensive drugs. This may be presumably attributable to recognition of the white coat effect. However, home BP monitoring overcomes therapeutic inertia and results in greater change in antihypertensive medications. Finally, home BP monitoring may result in greater BP improvement if accompanied by specific programs to titrate antihypertensive drugs. One such strategy is telemonitoring, in which BP readings obtained at home are relayed to the provider who can then take appropriate action.

There was a paradox noted in the meta-analysis: there was greater mean BP lowering when no antihypertensive titration protocol was specified; however, there was greater response rate when a titration protocol was specified. Studies that report the mean change in BP and those that report responder state were not the same. Clinically, it stands to reason that if a protocol is specified to lower BP, then it is more likely to result in lowering of BP. The heterogeneity in the study designs may have led to the paradoxical finding that when no protocol was specified to titrate medications, it led to a greater mean lowering of BP.

After we performed our meta-analysis, a multicenter randomized controlled open-label trial was published that compared the use of self-management by people with poorly controlled hypertension with usual care.7 This 527-patient trial was unique because the intervention group not only had home BP monitoring but also allowed self-titration of antihypertensive medication combined with telemonitoring of home BP. The control group received usual care. Mean systolic BP decreased by 12.9 mm Hg from baseline to 6 months in the self-management group and by 9.2 mm Hg in the control group (difference between groups 3.7 mm Hg; 0.8 to 6.6; P=0.013). From baseline to 12 months, systolic BP decreased by 17.6 mm Hg in the self-management group and by 12.2 mm Hg in the control group (difference between groups 5.4 mm Hg; 2.4 to 8.5; P=0.0004). These data support the use of home BP monitoring, especially when accompanied by a program to titrate antihypertensive drugs. These data are also consistent with the results of this meta-analysis.

As is frequent in any quantitative review, the studies included in this analysis used a variety of study designs and end points. For example, different inclusion and exclusion criteria, different BP measurement techniques, drug titration protocols, patient populations, and duration of follow-up may have introduced significant heterogeneity in effect size. Although there was no statistical evidence of publication bias, there was a trend toward one. Given the different definitions of response to home BP monitoring, it is difficult to generalize the results to all people. The study quality differed significantly, and this affected the outcome on BP. A strength of this study is the thorough analysis of covariates that may influence outcomes. Indeed, we found several clinical characteristics that could be predictive of response. For example, if a telemonitoring program (and a concomitant scheme to titrate antihypertensive drugs) was specified, it resulted in better BP control. Similarly, among patients on long-term hemodialysis, the benefits of home BP monitoring seem to be more compared with those not on dialysis.

Perspective

We conclude that a small but significant improvement for all BPs, systolic, diastolic, or mean, results when home BP monitoring is used. However, simply monitoring home BP is of little value if the patients or their physicians do not act on the results. When home BP monitoring is accompanied by specific programs to treat elevated BP, such as through titration of antihypertensive drugs, it can result in more meaningful change in BP. Compared with no program to titrate antihypertensive therapy, programs that incorporate a strategy of antihypertensive therapy, such as through telemonitoring, may provide even better hypertension control. Larger studies are warranted among hemodialysis patients, for whom this strategy may be particularly beneficial.

Sources of Funding

This work was supported by a grant from the VA Merit Review.

Disclosures

None.

Footnotes

Continuing medical education (CME) credit is available for this article. Go to http://cme.ahajournals.org to take the quiz.

Correspondence to Rajiv Agarwal,
Professor of Medicine, Indiana University and VAMC, 1481 West 10th St, Indianapolis, IN 46202
. E-mail

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