Clinical Events

None of the studies examined clinical event outcomes.

Blood Pressure Outcomes

BP outcomes were reported by 23 studies (25 comparisons in total). Four studies were rated quality A, 5 studies were rated quality B, and 13 quality C. The conference abstract was not graded for quality due to insufficient data. Followup durations ranged from 2 to 36 months, with only two studies (Bosworth 2009; Stahl 1984) having one of more than a year. Reported BP outcomes included both categorical outcomes, where the outcomes were defined as achieving a predefined BP target (e.g., clinic SBP <140 mmHg), and continuous outcomes, where net differences of SBP and DBP between baseline and final measurements (or, in some studies, differences between final values) were calculated. Clinic BP and ambulatory (24-hour, awake, and asleep) BP measurements were reported.

Categorical BP Outcomes

(Table D-4, Figure 4)

Figure 4

Forest plot, with meta-analyses, of relative risk of “adequate” BP at followup in RCTs of SMBP with or without additional support versus usual care, by time of outcome measurement. (Note: Estimates favoring SMBP are to the right, in contrast (more...)

Thirteen studies reported categorical BP outcomes.^{20,44,51,53,58,62,67,68,71,77,79,85,87} Six RCTs provided data for the outcome of reaching a predefined BP threshold (considered as “adequate” BP control) at 6-month followup. The SBP thresholds used by studies considering the whole population or only nondiabetic patients ranged from 130 to 140 mmHg and DBP thresholds from 80 to 95 mmHg. Three studies specified lower BP thresholds for diabetic patients, however, reporting values which ranged from 125 to 130 mmHg for SBP and 75 to 85 mmHg for DBP.

Meta-analysis of six studies (two quality A, one quality B and three quality C studies) at 6 months followup revealed a nonstatistically significant increase in the probability of achieving adequate BP control with SMBP monitoring (summary relative risk [RR] 1.24; 95 percent confidence interval [CI] 0.94 to 1.63), with statistically significant heterogeneity (I² = 73 percent). All studies reported a point estimate indicating a favorable effect of SMBP monitoring, with the exception of Dalfo i Baqué 2005, which reported a nonsignificant odds ratio (OR) of 0.79 (95 percent CI 0.56 to 1.12) favoring usual care. In a sensitivity meta-analysis that included only the three quality A or B studies, a statistically significant summary RR of 1.53 (95 percent CI 1.22 to 1.93) favoring SMBP was found, with no statistical heterogeneity (I² = 0 percent).

Three RCTs (all rated as quality B studies) reported data for the adequate BP control outcome at 12 months (defined as <140/90 mmHg in one study, and as <140/90 mmHg for nondiabetic and <130/80 mmHg for diabetic patients in the other two studies). Meta-analysis of these results indicated that the summary estimate did not show a statistically significant effect of SMBP monitoring (summary RR 1.18; 95 percent CI 0.95 to 1.46) and that extensive statistical heterogeneity was present (I² = 86 percent). Two comparisons from the same trial (Bosworth 2009) also reported nonsignificant SMBP effects at 24 months followup; however, this study had a more than 20 percent dropout rate at this timepoint.

Four studies reporting categorical BP outcomes were not included in the aforementioned meta-analyses. Pierce 1984 and Stahl 1984 were not included because these were quasi-RCTs; Fuchs 2010 was excluded because the categorical BP outcome was evaluated at 2 months only; and Rogers 2001 was excluded because the reported outcome was the proportion of patients with reductions in SBP and DBP from baseline and not the achievement of a predefined BP target. None of the Pierce 1984, Stahl 1984 and Fuchs 2010 studies found that the use of SMBP was associated with a significant increase in the probability of achieving adequate BP control (for SBP and DBP in Pierce 1984 and Fuchs 2010 and DBP in Stahl 1984). However, Rogers 2001 reported that SMBP use resulted in significantly increased odds of experiencing reductions in SBP (OR 2.52; 95 percent CI 1.13 to 5.64) and DBP (OR 2.32; 95 percent CI 1.05 to 5.15).

Continuous BP Outcomes

In total, 21 studies provided data for continuous BP outcomes.^{20,42-44,47,48,53,56,58,59,62,64,67,68,71, 72,79,83,85,87,88}

Clinic BP

(Table D-5, Figure 5)

Figure 5

Forest plot, with meta-analyses, of net change clinic BP in RCTs of SMBP alone versus usual care, by time of outcome measurement. Black and white circles indicate systolic and diastolic blood pressures, respectively. Black and white diamonds indicate (more...)

Seventeen studies examined net changes in clinic SBP and DBP between the SMBP and control arms from baseline to final measurements. Three of the studies provided data for BP changes at 2 months. Meta-analysis of these three quality C studies revealed no significant difference in the net change of SBP and DBP between SMBP and usual care: SBP summary net change = 0.1 mmHg (95 percent CI -4.1, 4.3; nonsignificant [NS]); DBP summary net change = 0.1 mmHg (95 percent CI -1.5, 1.7; NS).

For the comparison at 6 months followup, seven RCTs provided data for SBP net changes (one quality A, four quality B and two quality C studies) and nine RCTs for DBP (one quality A, four quality B and four quality C studies). By meta-analysis of these studies, a statistically significant reduction for both SBP and DBP was found favoring SMBP: SBP summary net change = -3.1 mmHg (95 percent CI -5, -1.2; P = 0.002), with low statistical heterogeneity (I² = 24 percent); DBP summary net change = -2.0 mmHg (95 percent CI -3.2, -0.8; P = 0.001), with moderate heterogeneity (I² = 41 percent). All studies had point estimates indicating a favorable effect of SMBP over usual care for both SBP and DBP, with the exception of DeJesus 2009 and Johnson 1978B that showed nonsignificant net changes in DBP favoring usual care over SMBP. In sensitivity meta-analyses that included only quality A and B studies, no material changes in the magnitude and statistical significance of the summary net changes for SBP and DBP were found.

For the 12-month followup data, seven RCTs (one quality A, five quality B and one quality C) were synthesized by meta-analysis (three of them having also contributed data for the 6 month meta-analysis). In the 12-month meta-analysis, no statistically significant net change was evident for SBP or DBP: SBP summary net change = -1.2 mmHg (95 percent CI -3.5, 1.2), with moderate heterogeneity (I² = 66 percent); DBP summary net change = −0.8 (95 percent CI -2.5, 1.0), with high heterogeneity (I² = 81 percent). These summary estimates remained essentially unchanged in sensitivity meta-analyses that included only quality A and B studies.

Beyond 12 months of followup, data were provided only by two comparisons from the same trial (Bosworth 2009). Significant reductions for SBP and DBP with SMBP were found at 24 months only in the comparison of SMBP plus telecounseling versus telecounseling alone.

Stahl 1984, a quasi-RCT not included in the aforementioned meta-analyses, reported a significant reduction in DBP favoring SMBP at 7–12 months followup. The reduction in DBP was no longer statistically significant at subsequent followup times up to 36 months, which were characterized by large proportions of dropouts (>20 percent).

24 Hour Ambulatory BP

(Table D-6, Figure 6)

Figure 6

Forest plot of net change 24 hour ambulatory BP in RCTs of SMBP alone versus usual care, by time of outcome measurement. (see notes below Figure 8)

For the net change in 24 hour ambulatory BP measurement, five studies contributed data; however, the followup durations varied from 2 to 12 months, thus no meta-analysis was feasible for this outcome. At 2 months, three studies (one quality A, one quality C and one conference abstract not rated for quality) reported significant differences in SBP measurements between SMBP monitoring and usual care but different directions of effects were noted. By meta-analysis, no statistically significant net change was found for 2 hour ambulatory SBP or DBP: SBP summary net change = -1.3 mmHg (95 percent CI -8.5, 5.9), with high heterogeneity (I² = 84 percent); DBP summary net change = -2.7 (95 percent CI -5.9, 0.4), with moderate heterogeneity (I² = 63 percent). Of these three studies, Rogers 2001 was rated as quality A and reported significant results favoring SMBP for both 24 hour ambulatory SBP and DBP. Of the two studies reporting 12 month followup data, Goodwin 2010 showed a significant net change in DBP favoring SMBP (-2.0 mmHg), whereas Verberk 2007 reported that the 24 hour ambulatory SBP and DBP were significantly higher in the SMBP group (SBP: +2.1 mmHg; DBP: +1.1 mmHg), thus favoring the usual care arm.

Awake (or day) Ambulatory BP

(Table D-7, Figure 7)

Figure 7

Forest plot of net change awake (day) ambulatory BP in RCTs of SMBP alone versus usual care, by time of outcome measurement. (see notes below Figure 8)

Six studies reported awake ambulatory BP. The majority of reported comparisons between the SMBP and usual care arms were nonsignificant in individual studies. Statistically significant results were reported only for SBP by Bailey 1999 (2 months) favoring usual care, for DBP by the conference abstract by Fuchs 2010 (2 months) favoring SMBP, and for both SBP and DBP by Verberk 2007 (12 months) favoring usual care.

Asleep (or Night) Ambulatory BP

(Table D-8, Figure 8)

Figure 8

Forest plot of net change asleep (night) ambulatory BP in RCTs of SMBP alone versus usual care, by time of outcome measurement (see notes below). Figures 6–8: Black and white circles indicate systolic and diastolic blood pressures, respectively. (more...)

A similar pattern of results was also observed for the net change in asleep ambulatory BP in four studies published in full reports, with all but one comparison for SBP and DBP showing no significant differences between SMBP and usual care arms; a marginally statistically significant result was reported by Verberk 2007 showing a 2.2 mmHg net change in SBP with SMBP at 12 months, favoring usual care. The conference abstract by Fuchs 2010 reported a statistically significant change in both SBP and DBP at 2 months, favoring SMBP.

Medication Dosage

(Tables D-9&10)

Eight studies provided data on outcomes relating to the number of medications prescribed and dosage (1 quality A, 5 quality B, and 2 quality C).^{42,62,72,77,86-88,90} The followup duration in these studies ranged from 2 to 12 months. Reported medication outcomes included both categorical outcomes (Table D-9), where the outcomes were defined as the number of patients with a specified change in medication (e.g., an increase in dosage or ceasing treatment with a particular class of medication), and continuous outcomes (Table D-10), which included number of medications and dosages. Due to the heterogeneity in outcome definitions between studies, no meta-analyses were feasible.

Six out of these eight studies reported categorical medication outcomes.^{42,72,77,87,88,90} Medication changes were reported in a variety of ways. Three examined an increase in medications, defined variously as either an increase in medication number, medication dose, an added medication class, or physician assessment of strength of medication regimen; none found a significant different between groups.^42,67,77 Four looked at medication inertia, defined as no change in medication regimen; none of the four found a difference between groups,^67,77,87,88 Two studies reported on a decrease of medication, either as a lower strength of mediation regiment as assessed by a physician or by a cessation of treatment with a particular class of medication.^42,77 Neither found a difference between groups. In addition, Midanik 1991 found no difference in the number of patients using medication after study completion at 12 months.

Four of seven studies reported continuous medication outcomes.^62,86,88,90 Two compared the number of antihypertensive medications used per patient between SMBP and usual care groups; neither found a significant difference.^88,90 Halme 2005 reported no difference between groups in the number of medication changes per patient. van Onzenoort 2010 found the SMBP group to be prescribed 1.9 daily doses of antihypertensive medication compared to 2.4 in the usual care group (P = 0.001).

Medication Adherence

(Tables D-11&12)

Seven studies in total provided data on outcomes relating to medication adherence (3 quality B and 4 quality C).^{42,47,68,71,77,86,88} Followup durations in these studies ranged from 2 to 12 months. Reported medication outcomes included both categorical outcomes (Table D-11), where the outcomes were defined as the number of patients with a specified level of medication adherence, and continuous outcomes (Table D-12), where adherence was measured on a continuous scale (e.g. tablet count).

Five of these seven studies reported categorical medication adherence outcomes.^{42,47,68,77,86} In Marquez-Contreras 2006, patients with SMBP exhibited significantly different rates of adherence compared to those with usual care (P<0.001). Most notably, patients using SMBP were less likely to have adherences <80 percent as assessed by tablet count (RR 0.31; 95 percent CI 0.15, 0.65). Pierce 1984 found that the SMBP group was less likely to be rated as poor at medication adherence by a visiting nurse (RR 0.54; 95 percent CI 0.21, 1.37). However, neither Bailey 1999 (assessed by tablet count), van Onzenoort 2010 (electronic pill box monitoring), or Broege 2001 found any difference in medication adherence between groups (no specific adherence assessment method described).

Four studies reported continuous medication adherence outcomes.^68,71,86,88 Mehos 2000 did not find a difference between groups in adherence as defined by percent of prescribed medications refilled. However, Marquez-Contreras 2006 found the SMBP group to take antihypertensive medication correctly on a greater percentage of study days (difference = 5.7 percent; 95 percent CI 2.87, 8.71; P<0.001), as did van Onzenoort 2010 (difference = 1.4 percent; P = 0.043). Marquez-Contreras 2006 also found that a greater percentage of patients using SMBP took medication at the prescribed time (88.1 versus 79.9 percent; P = 0.006). Zarnke 1997 found no difference between SMBP with self-titration versus usual care in the number of drug doses missed.

Quality of Life

(Table D-13)

Three studies provided data on outcomes relating to quality of life (2 quality B and 1 quality C).^47,71,90 Followup durations in these studies ranged from 3 to 6 months. Mehos 2000 found no difference between groups in any domain of the Short Form-36 Health Survey (SF-36), while Broege 2001 found no difference between groups in SF-36 total score. Madsen 2008 found the SMBP group to fare better in bodily pain compared to the usual care group, as measured by the SF-36 (Scale 0–100, with higher score indicating better health; net difference = 7.0; P = 0.026), but did not find a significant difference between groups in any other SF-36 domain. Madsen 2008 also found that significantly fewer patients in the SMBP group felt that their health was worse after a year.

Health Care Encounters

(Tables D14&15)

Six quality C studies provided data on outcomes relating to health care encounters.^{42,71,72,83,87,88} Only one of these provided categorical data on health care encounters: Soghikian 1992 found no difference between groups in number of patients with no office visits for hypertension. However, each of the six studies provided continuous data on health care encounters.^{42,71,72,83,88} Two of these found no difference in the number of visits with a primary care or an otherwise unspecified provider,^42,71 while two found no difference in the number of visits specifically related to hypertension.^72,83 In Soghikian 1992, the difference remained nonsignificant after adjustment for age, race, sex, baseline DBP, use of baseline antihypertensive meds, and use of outpatient services for hypertension care in the prior year. Zarnke 1997 found that patients in the SMBP with self-titration group had 0.85 more physician visits than the usual care group over a period of eight weeks (95 percent CI 0.30, 1.40; P=0.045). Varis 2010 found that patients in the SMBP group had significantly fewer extra visits than the usual care group (1.4 versus 5.3, P < 0.05). Soghikian 1992 found no difference between groups in the number of medical procedures received for hypertension, but did find the SMBP group to have 1.3 fewer outpatient visits over the one year study period (no statistical comparison performed).

Three studies looked at the number of hypertension-related telephone calls made by study subjects, and found no difference between groups.^72,83,87 In Soghikian 1992, the difference remained nonsignificant after adjusting for the aforementioned factors (i.e., age, race, etc.).

Miscellaneous Outcomes

(Table D-16)

Two studies reported miscellaneous outcomes.^20,51 Dalfó i Baqué 2005, a quality C study, did not find a difference between SMBP and usual care in patient satisfaction (not defined). Verberk 2007, a quality B study, did not find a significant difference in left ventricular mass index change in the SMBP group compared to the usual care group.

Subgroups and Heterogeneity

Summary

Clinical Events

Sawicki 1995, in a quality C trial of 91 patients with Type 1 diabetes and diabetic kidney disease, found lower mortality in the SMBP plus self-titration plus education group (4 percent and 28 percent respectively; RR 0.16; 95 percent CI 0.04, 0.66), with the difference remaining significant after adjustment for proteinuria, age, and creatinine clearance (P=0.047).⁸¹ The study also found a lower composite of mortality and end-stage renal disease (RR 0.27; 95 percent CI 0.11, 0.66; P=0.006). This result also remained statistically significant after adjustment for DBP and age (P=0.018). However, incidence of end-stage renal disease by itself was not significantly different between groups (RR 0.41; 95 percent CI 0.14, 1.21).

Blood Pressure Outcomes

All 24 studies provided data on BP outcomes. The majority of the studies had followup durations of no more than 12 months. Seven studies also reported followup data of more than 12 months.^{44,45,55,60,73,81,93} Reported BP outcomes included both categorical outcomes, where the outcomes were defined as achieving a predefined BP target (e.g., clinic SBP/DBP ≤140 mmHg), and continuous outcomes, where net differences of SBP and DBP between baseline and final measurements (or, in some instances, differences between final values) were calculated.

Nearly all studies reported clinic BP measurements; in two studies BP measurements were taken at home by research personnel.^57,64. Two studies also reported ambulatory (24 hour, awake, or asleep) BP measurements.^75,78 Meta-analyses were not performed due to the great heterogeneity of the interventions.

Continuous BP Outcomes

In total, 24 studies (reported in 25 articles) provided data for continuous BP outcomes.^{40,41,43-45,53-55,57,60,61,63,64,69,70,73,75-78,80-82,89,93}

Clinic BP

(Table D-18, Figure 9)

Figure 9

Forest plot, with meta-analyses, of net change clinic BP in RCTs of SMBP monitoring with additional support versus usual care, by time of outcome measurement. Black and white circles indicate systolic and diastolic blood pressures, respectively. Studies (more...)

All 24 studies reported clinic-measured BP outcomes or home BP measured by research personnel. Eleven trials reported statistically significant greater reductions in either the clinic SBP or DBP at followup favoring the SMBP intervention with additional support compared to usual care.^{41,44,45,57,61,70,73,78,80,82,89} The additional support examined in these 11 trials were telecounseling;^41,44,57,80 Web training with pharmacist counseling;⁶¹ self-titration plus provider alert;⁷⁰ education;⁷³ medication monitoring with provider alert;⁷⁸ personalized Web site plus videoconference counseling;⁸² pharmacist counseling;⁸⁹ and combined medication-behavioral management (as needed whenever there were inadequate BP control).⁴⁵

For followup from 3 to 12 months, the mean net change in SBP ranged from -1.6 to -8.5 mmHg, favoring SMBP with additional support; the mean net change in DBP ranged from -1.9 to -4.4 mmHg. Of note, one trial comparing SMBP plus behavioral and medication management against usual care reported statistically a significant reduction of SBP at 12 months (net change -4.3 mmHg; 95 percent CI -8.5, -0.2, P=0.04), but not at 18 months.⁴⁵ However, in this study, the other interventions (SMBP plus either behavioral management or medication management) did not differ from usual care at any timepoint. Three of four trials reported statistically significant mean net BP reductions for followup periods of 18 to 60 months. With the exception of the single quality A study, Bosworth 2011⁴⁵ at 18 months, net changes in SBP ranged from -2.6 to -5.0 mmHg and in DBP from -1.3 to -4.0 mmHg.^44,73,93

Statistical analyses for the between-group differences were not reported in five trials.^{40,43,53,54,77} Meta-analysis was not undertaken because of the heterogeneity of the interventions across trials. An examination of the forest plot suggests a pattern of reduction in either the SBP or DBP favoring the intervention at longer term followup (12 months and beyond) but not at shorter term followup (3 or 6 months).

Two^76,81 of three nonrandomized studies^60,76,81 also reported a statistically significant greater reduction in either the SBP or the DBP at followup favoring the intervention (personalized Web site plus nurse counseling⁷⁶ or self-titration plus education⁸¹).

Ambulatory BP

(Table D-19, Figures 6–8)

Two trials also provided outcomes on ambulatory continuous BP measurements.^75,78 Rinfret 2009 reported a statistically significant greater reduction in 24 hour ambulatory BP (mean net change SBP: -4.8 mmHg; P<0.001; DBP: -2.1 mmHg; P=0.007); awake BP (mean net change SBP: -5.9 mmHg; P<0.001; DBP: -2.5 mmHg; P=0.05); and asleep time BP (mean net change SBP: -3.8 mmHg; P<0.001; DBP: -1.9 mmHg; P=0.05) at 12 months followup favoring those with SMBP plus medication monitoring with provider alert compared to usual care.⁷⁸ Parati 2009 reported a statistically significant greater reduction of awake SBP in those who had SMBP plus reminder compared to usual care (mean net change: -1.6 mmHg; P<0.05).⁷⁵ No statistically significant difference was reported for awake DBP.

Medication Dosage

(Tables D-20 and 21)

Eleven studies provided data on outcomes relating to the number of medications prescribed and dosage (three quality A, two quality B, and six quality C).^{41,61,69,70,73,75,77,78,80,81,89} The followup durations in these studies ranged from 2 to 60 months. Reported medication outcomes included both categorical outcomes (Table D-20), where the outcomes were defined as the number of patients with a specified change in medication (e.g. an increase in medication dosage or cessation of a class medication) and continuous outcomes (Table D-21), which reported on quantities of medication or number of medication classes used. Due to the heterogeneity in outcome definitions between studies, no meta-analyses were feasible.

Five of these ten studies reported categorical medication outcomes.^{73,75,77,80,89} Among these, Pierce 1984 and Zillich 2005 both examined an increase in medications. Pierce 1984 found no difference between SMBP plus education versus usual care in physician assessment of the strength of medication regimen, while Zillich 2005 found that more subjects in the SMBP plus pharmacist counseling group exhibited an increase in the amount of medication used or number of medications compared with the pharmacist BP measurement group (RR 2.26; 95 percent CI 1.42, 3.61; P>0.05). Pierce 1984 reported on medication inertia, defined as no change in medication regimen, and did not find a difference between groups. Rudd 2004 however found more patients having SMBP plus counsel to report no change in drug therapy (RR 0.05; 95 percent CI 0.01, 0.20). With respect to physician assessment of decreased medication, Pierce 1984 found no difference between groups; however, Muhlhauser 1993 found more patients in the SMBP plus education group to show a decrease in the number of medications prescribed than in the usual care group.(RR 0.3; 95 percent CI 0.17, 0.43; P<0.001). Additionally, Zillich 2005 found no difference between groups in the number of patients discontinuing medication after the study. Rudd 2004 found more patients in the SMBP plus counsel group to be taking two or more drugs (RR 1.53; 95 percent CI 1.13, 2.07) or no drugs (RR 1.77; 95 percent CI 1.04, 3.03) at the completion of the 6 month study. Parati 2009 found no difference between groups in percentage of visits at which physicians modified their patient's treatment, but did find that the SMBP group had a significantly smaller percent of visits at which patients were found to have modified their own treatment schedule (P = 0.04).

Seven of 11 reported continuous medication outcomes.^{41,61,69,70,78,80,81} Four of these reported on the number of hypertension medication classes used.^61,70,78,81 Green 2008 found that both the SMBP plus Web training with pharmacist counseling group and the SMBP plus Web training used a greater number of medication classes than the usual care group (SMBP plus Web with pharmacy versus usual care difference: 0.5; 95 percent CI 0.3, 0.6; P<0.05. SMBP plus Web versus usual care difference: 0.3; 95 percent CI 0.1, 0.4; P<0.05). Rinfret 2009 found that the SMBP plus provider alert with medication monitoring group used an average of 1 more medication class than the usual care group (adjusted P = 0.007) and also had 1 more physician-driven medication change (adjusted P=0.03). McManus 2010 found that patients in the SMBP plus alert with self-titration group were prescribed a greater number of additional antihypertensive medications (net difference = 0.46; 95 percent CI 0.34, 0.58; P = 0.001), and Sawicki 1995 found that patients in the SMBP plus education with self-titration group were prescribed a greater number of antihypertensive medications (net difference = 0.46; 95 percent CI 0.34, 0.58; P = 0.001). Marquez-Contreras 2009 found no difference between either SMBP plus educational material, SMBP plus medication monitoring, or SMBP plus educational material with medication monitoring in comparison to usual care with respect to the number of tablets taken per day. Rudd 2004 found a greater number of medication changes in the SMBP plus counsel group (net difference = 2.0; P<0.01). Artinian 2007 found no difference in Treatment Intensity Score, which approximates dosage strength, between SMBP plus telecounseling versus enhanced usual care.

Medication Adherence

(Tables D-22 and 23)

Six studies provided data on outcomes relating to medication adherence (one quality A, two quality B, and three quality C).^{57,63,77,78,80,89} The followup durations in these studies ranged from 2 to 12 months. Reported medication outcomes included both categorical outcomes (Table D-22), where the outcomes were defined as the number of patients with a specified level of medication adherence, and continuous outcomes (Table D-23), where adherence was measured on a continuous scale (e.g., tablet count).

Three of these six studies provided data on categorical medication adherence outcomes.^63,77,89 Haynes 1976 found that SMBP plus encouragement resulted in greater medication adherence, defined as a patient having greater adherence at study completion than at baseline, as assessed by a surreptitious pill count conducted by a home visitor (RR 2.06; 95 percent CI 1.11, 3.82; P<0.05). Pierce 1984 found no significant difference in medication adherence between SMBP plus education versus usual care, as assessed by medication count and nurse-administered survey. Zillich 2005 found no difference between SMBP plus pharmacist counseling versus pharmacist BP measurement, as assessed by self-report.

Four of six studies examined continuous medication adherence outcomes.^57,63,78,80 Haynes 1976 found that patients in the SMBP plus encouragement group showed a greater increase in percentage of prescribed pills taken than the usual care group (net difference: 23 percent; 95 percent CI 2.9, 43; P=0.025). Friedman 1996 found greater medication adherence in terms of percentage of pills taken in the SMBP plus telecounseling group compared with the usual care group (net difference: 6 percent; 95 percent CI 0.6, 2.8; P=0.03) after adjustment for age, sex, and baseline adherence. Rudd 2004 found the SMBP plus counsel group to take antihypertensive medication correctly on a greater percentage of study days (difference = 11.3 percent; P = 0.03). Rinfret 2009 found no difference between SMBP plus provider alert plus medication monitoring and usual care in “continuous measure of medication acquisition” (cumulative days supply of medication obtained divided by the total days to the next prescription refill, based on pharmacy data) and “continuous measure of medication gaps” (total days of treatment gaps divided by the total days to the next prescription refill, based on pharmacy data). (Outcome definitions are based on the cited reference.⁹⁴)

Quality of Life

(Table D-24)

Three studies provided data on quality of life outcomes (two quality A, one quality C).^61,70,75 Followup durations in these studies ranged from 3 to 12 months. Green 2008 found no difference in either the SMBP plus Web training or SMBP plus Web training with pharmacist counseling group compared to usual care with regards to SF-12 score or the Consumer Assessment of Healthcare Providers and Systems score. Parati 2009 found no difference between SMBP plus reminder versus usual care in the Short Form-12 Health Survey (SF-12) score. McManus 2010 found no difference between SMBP plus alert with self-titration in Anxiety score (a six item scale of the State Trait Anxiety Inventory) or Euro Quality of Life Group 5-Dimension Self Report Questionnaire (Euro QoL 5D) score.

Health Care Encounters

(Table D-25)

Eight quality C studies provided data on outcomes relating to health care encounters.^{45,53,61,70,73,78,81,89} DeJesus 2009 found no difference between the SMBP plus one class versus usual care groups in the number of physician and nurse visits. The remaining seven studies provided data on the number of physician visits per study group.^{45,61,70,73,78,81,89} Five studies found no difference compared to usual care, when looking at SMBP plus education, SMBP plus provider alert with medication monitoring, SMBP plus self-titration with provider alert, and SMBP plus medication management and/or behavioral management.^{45,61,70,73,78} Zillich 2005 found that patients in the SMBP plus pharmacist counseling group had 0.61 fewer visits than the pharmacist BP measurement group, over a period of 3 months (P=0.007). Sawicki 1995 found that the SMBP group had 2.5 more visits, over a study period of five years (P<0.001). Green 2008 found no difference between either group versus usual care in terms of inpatient and emergency care use.

Green 2008 also found that patients using SMBP plus Web training did not have a different number of message threads or phone encounters compared to the usual care group over a period of 12 months. Patients using SMBP plus Web training with pharmacy counseling had a greater number of message threads (net difference = 19.9, P<0.05) and phone encounters (net difference = 3.5, P<0.001) compared to the usual care group. Patients using SMBP plus Web training had a greater number of patient-initiated message threads compared to the usual care group (net difference = 0.9, P=0.01), as did patients using SMBP plus Web training with pharmacy counseling (net difference = 2.4, P<0.01).

Miscellaneous Outcomes

(Table D-26)

One study (quality C), Marquez-Contreras 2009, found no difference between groups with regards to adverse drug reactions, when comparing usual care, SMBP plus medication monitoring, SMBP plus educational material, and SMBP plus medication monitoring with educational material using an ANOVA analysis across the three intervention groups.⁶⁹

Subgroups and Heterogeneity

BP Outcomes

(Table 1)

Table 1

Post hoc categorization of types of additional support reported in studies.

Seven trials reported results from subgroup analyses: Friedman 1996 (quality A), DeJesus 2009 (quality C), McManus 2010 (quality A), Green 2008, (quality A), Bosworth 2011 (quality A), Shea 2006 (quality A), and a second Bosworth 2011, which is an update of Bosworth 2009 (quality B) ^{44,45,53,61,70,82,91}. Friedman 1996 reported that patients who were nonadherent with their antihypertensive medications at baseline were most affected by SMBP with computer-controlled telephone system intervention.⁵⁷ Mean DBP decreased by 6 mmHg in this group versus an increase of 2.8 mmHg in the usual care group (P=0.01). Quantitative analysis for the adherent group was not reported. DeJesus 2009, using a multivariate logistic model, did not find that body mass index, number of nurse or physician visits, or baseline SBP or DBP predicted the achievement of target BP in a study of patients with diabetes comparing SMBP and nurse education with usual care.⁵³ McManus 2010 reported a greater reduction in SBP in those with higher socioeconomic status who had SMBP plus telemonitoring compared to those with lower socioeconomic status (net difference: -5.7 mmHg at 6 months, P=0.05; -5.4 mmHg at 12 months, P=0.08).⁷⁰ Green 2008 reported that the subgroup of patients with baseline SBP ≥160 mmHg who had SMBP plus Web-based pharmacist counseling had lower SBP (-13.2 mm, P<0.001) and DBP (-4.6 mm, P<0.001) compared to those with usual care at 12 months followup.⁶¹ Quantitative analysis for those with baseline SBP <160 mmHg was not reported. Bosworth 2011 compared 348 patients with adequate BP control (≤140/90 mmHg in patients without diabetes or ≤130/80 mmHg in those with diabetes) to 243 patients with inadequate control in a post hoc analysis.⁴⁵ The study reported that patients with adequate control at baseline continued to remain in control over the 18 months of the study. For those with inadequate control, comparing SMBP plus behavioral management with usual care, SBP net change was -8.3 mmHg (95 percent CI -15.1, -1.6, P=0.02) at 12 months, but there was no significant difference at 18 months. Comparing SMBP plus medication management with usual care, SBP net change was -7.9 mmHg (95 percent CI -14.5, -1.4, P=0.02) at 12 months and DBP net change was -4.2 mmHg (95 percent CI -8.3, -0.2, P=0.04) at 18 months. Comparing SMBP plus combined medication-behavioral management with usual care, SBP net change was -14.8 mmHg (95 percent CI -21.8, -7.8, P<0.001) at 12 months and 8 mmHg (95 percent CI -15.5, -0.5, P=0.04) at 18 months; DBP was lowered by 5.3 mmHg (95 percent CI -9.5, -1.2, P=0.01) at 12 months and 5.5 mmHg (95 percent CI -9.7, -1.2, P=0.01) at 18 months.

Shea 2006, an RCT of SMBP plus personalized Web site and videoconference counseling versus usual care, also analyzed separately the 12 months outcomes from patients recruited in the Upstate New York area and those from the New York City regions and reported similar magnitude of effects in the two regions for BP outcomes.⁸² For upstate New York, the adjusted mean net difference for SBP was -3.98 mmHg (ANCOVA P=0.006) versus -2.76 mmHg (ANCOVA P=0.06) for New York City region. For DBP, the adjusted mean net difference in upstate New York was -2.13 mmHg (ANCOVA P=0.003) versus -1.73 mmHg (ANCOVA P=0.02) for New York City region.

As noted in the previous section on SMBP versus usual care, a post hoc data analysis of Bosworth 2009 reported a subgroup analysis by whites versus nonwhites, where nonwhites were 95 percent African American.^44,91 In white patients, there was no significant difference in SBP or DBP between the SMBP plus telecounseling group versus the usual care group at either 12 or 24 months of followup. In contrast, nonwhite patients in the SMBP plus telecounseling group had significantly lower (P< 0.05) SBP and DBP at 12 months, compared to the usual care group. These differences remained significant at the 24-month followup.

To try to gain an insight into the heterogeneous nature of the additional supports across studies, we have post hoc classified the various interventions for each group into four categories, which are described in Table 1. This was based on our assessment of the key component, since the categories are not exclusive. Five of the nine studies in category “C” (Counseling with regular one-on-one encounters with study personnel) reported statistically significant reductions in either the SBP or the DBP at followup favoring the additional support with SMBP.^{41,44,61,80,89} The mean net change in SBP ranged from -3.3 to -8.9 mmHg; the mean net change in DBP ranged from -2.2 to -3.2 mmHg. Green 2008 also reported a significantly higher proportion of patients achieved controlled BP target at followup in the intervention group compared with usual care (57 percent versus. 31 percent; P<0.001).⁶¹ Three of five studies in category “E” (Education offered in regular hypertension education classes) reported statistically significant reduction in either the SBP or the DBP at followup favoring those who attended the classes in addition to SMBP.^45,73,81 Two studies were conducted by the same group of investigators.^73,81 The mean net changes of SBP were -5 mmHg (95 percent CI -10, 0; NS) in the first study⁷³ and -19 mmHg (95 percent CI -33, -5.2; P=0.007) in the second study.⁸¹ The mean net changes of DBP were -4 mmHg (95 percent CI -7, -1; P=0.018) in the first study⁷³ and -6.1 mmHg (95 percent CI -13.1, 0.9; NS) in the second study.⁸¹ Bosworth 2011 reported an estimated net change in SBP of -4.3 mmHg (95 percent CI -8.5, 0.2; P=0.04) in the combined medication-behavioral management group (versus usual care) at 12 months, but no significant difference at 18 months.⁴⁵ The estimated net change in DBP was -0.01 mmHg (95 percent CI -2.6, 2.6; P=NS) at 12 months. Six of seven studies in category “W” (Web-based or telephonic tools) reported statistically significant reductions in either the SBP or the DBP at followup favoring those who had additional support.^{57,61,70,75,76,78,82} The mean net change in SBP ranged from -1.6 to -5.4 mmHg; the mean net change in DBP ranged from -1.9 to -4.4 mmHg. The seventh study reported a significantly higher proportion of patients achieved controlled BP target at followup in the intervention group compared with usual care (62 percent versus. 50 percent; P<0.05).⁷⁵ Four studies were in category “M” (Miscellaneous).^43,53,54,69 The additional support in one study was a single class offered by a diabetes educator and instruction by a nurse on SMBP monitoring.⁵³ The second study used leaflet with educational materials on hypertension and/or a card for recording BP and pill counts.⁶⁹ Neither study reported a statistically significant difference in continuous BP outcomes. Márquez Contreras 2009 reported a significantly higher proportion of patients achieved controlled BP target at followup in the intervention group compared with usual care (65 percent versus. 35 percent; P=0.01).⁶⁹ The third study compared SMBP plus contract plus pill pack with control and both groups received education.⁴³ The fourth study compared SMBP via telephone upload with letters for treatment recommendation to patients and providers with usual care.⁵⁴ Statistical analyses for the between-group differences in the last two studies were not reported.

Summary

Clinical Events

No trial examined clinical event outcomes.

Blood Pressure Outcomes

All 12 studies provided data on BP outcomes. Followup durations ranged from 3 to 24 months, with only Bosworth 2009 and Bosworth 2011 having followup periods longer than 1 year. The BP outcome was based on clinic BP in nine studies,^{43-45,49,50,52,61,69,77} home BP in one study,⁶⁴ both in one study⁴⁶ and 24 hour ABPM in one study⁷⁴ . Reported BP outcomes included both categorical outcomes, where the outcomes were defined as achieving a predefined BP target (e.g., clinic SBP <140 mmHg), and continuous outcomes, where net differences of SBP and DBP between baseline and final measurements, or, in one study, differences between final values were given. Meta-analyses were not performed due to the great heterogeneity of interventions across trials.

Categorical BP Outcomes

(Table D-29, Figure 10)

Figure 10

Forest plot of relative risk of “adequate” BP at followup in RCTs of SMBP with additional support versus SMBP monitoring alone, by time of outcome measurement. ABP = ambulatory blood pressure; BP = blood pressure (systolic/diastolic); (more...)

Eight studies reported findings for categorical BP outcomes, which consisted of seven fully reported RCTs (two quality A study, 4 quality B studies and one quality C study), and one quasi-randomized study graded quality C.^{44-46,49,61,69,74,77} BP targets varied from <120/80 to <140/90 mmHg across studies, and in one study consisted of discrete reductions in SBP and DBP.⁷⁷ In three studies, BP targets were lower for individuals with diabetes (clinic BP <130/80 rather than 140/90 mmHg).^44,45,69

Green 2008 reported a significantly higher proportion of patients achieving a BP target with the addition of pharmacist counseling to combined SMBP plus Web training (56 versus 36 percent; RR 1.54; 95 percent CI 1.26, 1.88; P<0.001). Marquez Contreras 2009 reported that individuals using SMBP who also received a card for medication monitoring were more likely to achieve BP control at 6 months than those who received the educational material (RR 1.2; 95 percent CI 1.02, 1.38), though the study did not explicitly analyze this comparison. In the same study, comparisons of SMBP plus leaflet with educational material versus SMBP alone or of SMBP plus the card for medication monitoring versus SMBP plus the leaflet with educational material were not statistically significant. Differences in six other studies were not statistically significant or were indeterminate. In these studies, the additional types of support consisted of telecounseling, telemonitoring, educational material, medication monitoring, Web training, physician counseling, nurse counseling, behavior or medication management. One of these studies contained three relevant groups for this Key Question: SMBP plus combined behavior and medication management, SMBP plus behavior management, and SMBP plus medication management.⁴⁵ The comparisons between these groups were not prespecified, and since the results were reported as adjusted risk differences in percent of patients with BP control, it was not possible to calculate CIs. However, a higher proportion of patients in the SMBP plus behavior and medication management group achieved improvement in BP control compared to SMBP plus medication management at 18 months (estimated difference 8 percent). A higher proportion of patients in the SMBP plus behavior and medication management group achieved BP control compared to SMBP plus behavior management at 18 months (estimated difference 11 percent). And a higher proportion of patients in the SMBP plus medication management group achieved BP control compared to SMBP plus behavior management at 18 months (estimated difference 2.6 percent). Based on relative risk values derived from a figure of estimated proportions in BP control, none of the risk ratios appeared to differ statistically.

Continuous BP Outcomes

Ten studies reported continuous clinic BP outcomes. Two studies were rated quality A, three quality B, and four quality C. The conference abstract was not graded for quality due to insufficient data.^{43-46,49,50,52,61,64,69} One quality B study provided results for continuous 24 hour ABPM.⁷⁴

Clinic BP

(Table D-30, Figure 11)

Figure 11

Forest plot of net change clinic BP in RCTs of SMBP with additional support versus SMBP monitoring alone, by time of outcome measurement. Black and white circles indicate systolic and diastolic blood pressures, respectively. Studies without 95 percent (more...)

Ten trials reported changes in clinic BP.^{43-46,49,50,52,61,64,69} Seven found no evidence or did not provide a measure of statistical difference for a change in BP with the addition of nurse telecounseling, behavioral management, medication management, Web plus physician counseling, telemedicine, home visitor for BP measurement, compliance contracts plus calendar pill packs plus education, or educational material plus BP and medication tracker.^{43-45,49,50,52,64} One of the studies reporting indeterminate results was Bosworth 2011, which included three intervention groups of SMBP plus medication and behavioral management, SMBP plus medication management, and SMBP plus behavioral management.⁴⁵ Again, the comparisons of interest for Key Question 2 were not the comparisons for the study's primary analysis, and while the net differences for BP could be calculated, the confidence intervals could not. The largest net difference was for the comparison of SMBP plus combined medication and behavioral management versus SMBP plus behavioral management (-5.8 for SBP and -2.0 for DBP at 18 mos). The remaining three trials showed some benefit for BP reduction from more intense additional support.^46,61,69 Brennan 2010 showed statistically lower BP for SMBP plus counseling by a nurse versus SMBP for SBP at 12 months (mean difference -3.0; P=0.03), but no statistically significant difference for DBP. Green 2008 reported statistically significant results favoring the addition of pharmacist counseling to SMBP plus a Web training for SBP and DBP at 12 months. Results were consistently significant before and after adjustment for baseline BP, sex, having a home BP monitor before trial, and clinic (mean difference for adjusted SBP -6.0 mmHg; P<0.001 and for adjusted DBP -2.6 mmHg; P<0.001). Márquez Contreras 2009 reported statistically significant results for DBP (mean net difference -2.2; 95 percent CI -3.9, -0.5) but not SBP at 6 months favoring the addition of a card for recording BP and monitoring of medication pill counts to SMBP plus educational material on a leaflet, though the study did not explicitly analyze this comparison. However, comparisons of the SMBP with and without the educational material or of SMBP plus the card for medication monitoring versus SMBP plus educational material on a leaflet groups were not statistically significant.

Only two studies provided results regarding more intensive versus less intensive additional support in addition to SMBP beyond 12 months. These were nonsignificant or of uncertain statistical significance.^44,45 In Bosworth 2009, the loss to followup was 30 percent at 24 months.

Ambulatory BP

(Table D-31)

One study evaluated SMBP with telemonitoring versus SMBP and examined 24 hour SMBP and DBP on ABPM.⁷⁴ The study showed a statistically significant net difference for SBP of -7.2 (95 percent CI -13.8, -0.6, P=0.032) in favor of SMBP with telemonitoring, but not for DBP (-2.0, 95 percent CI -6.2, 2.2, P=0.35).

Quality of Life

(Table D-32)

Two studies reported continuous outcomes for quality of life and for mental health.^49,61 The quality of life instruments were SF-36 and SF-12 questionnaires, the mental health instrument the State-Trait Anxiety Inventory for Adults with the “state anxiety” and “trait anxiety” components.

Green 2008, a quality A trial, had a followup of 1 year, and compared SMBP plus Web training with pharmacist counseling versus SMBP plus Web training. Carrasco 2008 (quality B) had a followup of 6 months, and compared SMBP plus Web plus physician counseling versus SMBP alone. Both studies found no statistically significant differences in comparative outcomes concerning quality of life or anxiety.

Medication Dosage

(Tables D-33 and 34)

Five studies reported outcomes related to medication prescriptions, three of which reported categorical outcomes and two a continuous outcome.^46,64,74,77 Two studies were rated quality A, two quality B and one quality C for these outcomes. Followup durations ranged from 3 to 13 months.

Brennan 2010 compared SMBP plus nurse counseling versus SMBP alone and found no statistically significant difference in the proportion of patients taking two or more antihypertensive medication drug-classes as reported by the patient or determined by pharmacy claims after a mean followup of 13 months. Johnson 1978 and Pierce 1984 looked at medical inertia (defined as no medication change versus either an increase or decrease in medication). In addition to SMBP, Johnson 1978 used home visits for BP measurement and Pierce 1984 used education. Neither found any statistically significant difference between groups.

Green 2008 reported that the number of hypertension medication drug-classes used after 1 year followup was greater with the addition of pharmacist counseling to combined SMBP plus Web training (net difference 0.2; 95 percent CI 0.1, 0.4; P<0.01). Neumann 2011 reported “No significant change was observed during the study period” in number of HTN medication classes.

Medication Adherence

(Tables D-35 and 36)

Three quality C trials provided data on outcomes related to medication adherence.^44,64,77 Duration of followup ranged from 6 to 24 months. Measures for medication adherence were proportion of individuals returning their logs with BP recordings (Bosworth 2009), proportion of prescribed pills that were consumed (Johnson 1978), or undefined (Pierce 1984). None of the three studies found a statistically significant difference between groups in medication adherence.

Health Care Encounters

(Table D-37 and 38)

Five studies provided data on health care encounters.^44-46,49,61 All five studies were graded quality C for these outcomes. Followup durations ranged from 6 to 24 months. In four studies, the addition of a behavioral intervention had no statistically significant effect on the number of outpatient encounters and the proportion of hospitalized individuals over 2 years; the addition of disease management had no effect the number of primary care visits, cardiac visits, or specialist visits per patient per year; the addition of telemedicine had no effect on the median number of consultations or number of hospital admissions; and the number of primary care and specialty care encounters over 18 months was similar across 4 groups of SMBP plus medication and behavioral management, SMBP plus medication management, SMBP plus behavioral management and usual care without SMBP. In the fifth study, Green 2008, there was also no statistically significant difference for primary care visits, or for inpatient and urgent care/emergency use. The study reported a modest but significant decrease in the percentage of patients with office visits to a specialist in 12 months in the SMBP plus Web training plus pharmacist counseling group relative to baseline and to patients in the other arms but the statistical significance was not clear.

Green 2008 also looked at communication and found a statistically significantly higher number of electronic message thread (P nd), patient initiated electronic message threads (P<0.01) and phone encounters (P<0.001) in the SMBP plus Web training plus pharmacist counseling group than in the SMBP plus Web training group.

Miscellaneous Outcomes

(Tables D-26 and 39)

Two trials reported miscellaneous outcomes.^61,69 Marquez Contreras 2009 (quality C) provided data on adverse drug reactions after 6 months. These did not differ statistically significantly across all four study groups of SMBP plus use of educational leaflet, SMBP plus use of card for recording of medication, SMBP plus use of leaflet plus card, and usual care.

Green 2008 (quality A) reported consumer satisfaction concerning patient's experiences and satisfaction with health care service measured with the Consumer Assessment of Healthcare Providers and Systems instrument after 1 year. This study found no statistically significant differences when comparing SMBP plus Web training with pharmacist counseling versus SMBP plus Web training.

Subgroups and Heterogeneity

Four trials reported results from subgroup analyses: Bosworth 2011 (quality A), Green 2008 (quality A), Johnson 1978 (quality C), and a second Bosworth 2011, which is an update of Bosworth 2009 (quality B).^{44,45,61,64,91} Bosworth 2011 compared subgroups of 348 patients with adequate BP control (≤140/90 mmHg in patients without diabetes or ≤130/80 mmHg in those with diabetes) to 243 patients with inadequate control in a post hoc analysis.⁴⁵ The study reported that patients with adequate control at baseline continued to remain in control over the 18 months of the study. For those with inadequate control, SBP net change was -1.4 mmHg at 18 months, and DBP net change was -1.3 mmHg (comparing SMBP plus combined medication and behavioral management with SMBP plus medication management). Comparing SMBP plus combined medication and behavioral management with SMBP plus behavioral management, SBP net change was -8.3 mmHg at 18 months and DBP net change was -6.6 mmHg. Comparing SMBP plus medication management with SMBP plus behavioral management, SBP net change was -6.9 mmHg at 18 months; DBP net change was -5.3 mmHg. For these comparisons, a confidence interval or P value could not be calculated as the study reported adjusted results with usual care being the reference group.

Green 2008 reported categorical and continuous BP outcomes from the subgroup of patients whose SBP at baseline was ≥160 mmHg. In this subgroup, the addition of pharmacist counseling to combined SMBP plus Web training resulted in better BP control at 12 months (RR 2.11; CI 1.22, 3.65; P<0.001) and greater reductions in SBP and DBP. This was consistently found for unadjusted SBP outcomes and after adjustment for baseline BP, sex, having a home BP monitor before trial, and clinic (net difference for adjusted SBP was not provided but P<0.001). For the DBP the unadjusted comparison was not statistically significantly different (P=0.10), although the adjusted analysis was (P<0.03). In the overall group, all 12-month BP outcomes (SBP and DBP, unadjusted and adjusted) were significantly different. However, data for the subgroup with SBP <160 mmHg at baseline were not reported, limiting the interpretability of their subgroup finding.

Johnson 1978 reported changes in adherence among subjects with initial adherence of less than 80 percent. In this subgroup, the percentage of prescribed pills that had been consumed did not differ with the addition of a visitor taking home BP measurement. This was consistent with the results in the entire study. Again, the lack of data on the study subjects with better initial adherence limits the interpretability of these findings.

As noted in the previous section on SMBP versus usual care, a post hoc data analysis of Bosworth 2009 reported a subgroup analysis by whites versus nonwhites, where nonwhites were 95 percent African American.^44,91 At both 12 and 24 months of followup, white patients in the SMBP plus telecounseling group had a similar SBP and DBP compared with those in the SMBP group. In non-white patients, SBP and DBP were also similar at 12 months in the two groups. However, at 24 months, SBP was 8.8 mmHg lower and DBP was 2.9 mmHg lower in the SMBP plus telecounseling group compared with the SMBP group. These results were not statistically analyzed.

We attempted to gain an insight into the heterogeneous nature of the additional modalities of support across comparisons using the classification scheme described in Table 1. This scheme was based on our assessment of the key component differing between the two groups, as the categories are not exclusive. Six studies examined the addition of an intervention from category “C” (Counseling with regular one-on-one encounters with study personnel).^{44-46,50,61,64} Two of these studies showed some benefit for BP control or BP reduction.^46,61 As described above, Green 2008 reported a significantly higher proportion of patients achieving a BP target at 12 months and lower SBP and DBP at 12 months with the addition of pharmacist counseling. Brennan 2010 also showed a benefit with the addition of counseling by a nurse at 12 months, albeit only for SBP and not for DBP. Two other studies showed no benefit with addition of telephonic counseling by a nurse⁴⁴ or home visits.⁶⁴ The conference abstract by Cheltsova 2010 examined the addition of telephonic counseling by a nurse and also found no difference. The findings from Bosworth 2011 were indeterminate for the comparison of SMBP plus combined medication and behavioral management (C+E) versus SMBP plus behavioral management (E).

Two studies^45,77 examined the addition of an intervention from category “E” (Education offered in regular hypertension education classes), the addition of four educational classes. Pierce 1984 found no difference. Bosworth 2011 compared SMBP plus combined medication and behavioral management (C+E) versus SMBP plus medication management (C). The results were indeterminate.

Two studies^49,74 examined the addition of an intervention from category “W” (Web-based or telephonic tools). Carrasco 2008 study added a Web site and physician counseling to SMBP, but failed to detect a difference in BP at 6 months. Neumann 2011 with addition of telemonitoring to SMBP showed statistically significant greater net change for SBP on 24 hour ABPM at 3 months but not for DBP.

One study compared SMBP with an intervention from category “C” to and intervention from category “E”. The findings from Bosworth 2011 were indeterminate for the comparison of SMBP plus medication management (C) versus SMBP plus behavioral management (E).

Three studies were placed in category “M” (Miscellaneous).^43,69 Binstock 1988 examined the addition of compliance contract plus calendar pill packs to SBMP plus education and found effect estimates in favor of the less intensive treatment group, but did not provide statistical testing. Marquez Contreras 2009 compared addition of a leaflet with educational materials on hypertension in one group, a card for recording BP and pill counts in another group, and a combination of both in a third group. The combination of the card plus leaflet compared to the addition of the leaflet only resulted in significantly lower DBP at 6 months (SBP did not differ significantly between groups). The addition of the card plus leaflet versus just the leaflet also resulted in better BP control. However, as previously mentioned, the study did not explicitly analyze this comparison. Further, comparisons of the SMBP plus the leaflet containing educational material versus SMBP, or of SMBP plus the card for medication monitoring versus SMBP plus the leaflet containing educational material were not statistically significant. Finally, Dawes 2010 found no difference in BP when comparing SMBP plus educational material plus a BP and medication tracking tool with SMBP plus educational material alone.

Summary

SMBP With Graphical Display Versus SMBP Without Graphical Display

(Tables D-40 Through 42)

Kabutoya 2009, a quality C RCT, compared SMBP plus a graph-equipped SMBP monitor versus use of the SMBP monitor without the graphic display. The graph-equipped SMBP monitor displayed weekly and monthly averaged BPs, while in the control group the same SMBP monitor displayed only a single BP-value. The study included 65 patients, and was rated quality C because of incomplete and selective reporting.

At 6 months, the percentage of patients with home BP below 135⁄85 mmHg in the graph-equipped SBPM group did not differ from that in the conventional SMBP group (Table D-40). However, the graph-equipped monitor group displayed better BP control at 2 months (41 versus 13 percent, P<0.05), 4 months (40 versus 11 percent, P<0.05), and 5 months (37 versus 16 percent, P<0.05).

At 6 months, continuous home DBP and SBP did not differ between groups (Table D-41). However, at 2 months, home SBP was significantly lower in the group with the graph-equipped SMBP monitor than in the control monitor group (estimated mean difference in home SBP approximately -6.3 mmHg; P<0.05). Clinic BP results were incompletely reported. It was stated only that clinic SBP was significantly lower in the graph-equipped SMBP group at 3 months (net difference -9.7 mmHg; P<0.05), and presumably did not differ at the other time points.

The number of medications was significantly greater in the graph-equipped SMBP group than in the conventional SMBP group at 5 and 6 months (3.74 versus 2.76 at 6 months; P<0.02) (Table D-42). It was not explicitly reported for other timepoints, presumably because it did not differ.

This study provides insufficient evidence for use of a graphical display along with SMBP.

SMBP With BP Medication Titration Based on Home BP Versus SMBP With Titration Based on Clinic BP

(Tables D-41 Through 43)

Staessen 2004 randomized a total of 400 patients into two groups. Both groups used SMBP and had their BPs transmitted to study personnel. This was followed by blinded stepwise medication titration to reach the same BP target: a target DBP between 80 and 89 mmHg, but in one group drug treatment was adjusted based on home BP, while in the other group, it was adjusted based on clinic BP. This study was rated quality A for all outcomes except for those related to left ventricular hypertrophy, for which it was rated quality C.

At 12 month followup, BP in the home BP titration group was significantly higher than in the clinic BP titration group (Table D-41). This was consistent for all BP outcomes. For clinic BP, the differences were 6.8 mmHg for SBP (95 percent CI 3.6, 9.9; P<0.001) and 3.5 mmHg for DBP (95 percent CI 1.9, 5.1; P<0.001). For home BP, the differences were 4.9 mmHg for SBP (95 percent CI 2.5, 7.4; P<0.001) and 2.9 mmHg for DBP (1.5, 4.4; P<0.001). For daytime ambulatory BP, the differences were 5.3 mmHg for SBP (95 percent CI 2.6, 7.9; P<0.001) and 3.2 mmHg for DBP (95 percent CI 1.5, 4.8; P<0.001). For nighttime ambulatory BP, the differences were 4.8 mmHg for SBP (95 percent CI 2.1, 7.5; P<0.001) and 3.0 mmHg for DBP (95 percent CI 1.3, 4.7; P<0.001). For 24 hour ABPM, the differences were 4.9 mmHg in SBP (95 percent CI 2.5, 7.4; P<0.001) and 2.9 mmHg in DBP (95 percent CI 1.4, 4.4; P<0.001).

The antihypertensive treatment score, which measured the intensity of equipotent drugs, was significantly lower with home BP titration than with clinic BP titration (P=0.007 at last visit, approximately after 12 months) (Table D-42). Adverse events as assessed by symptom score did not differ significantly between groups.

The number of patients who permanently stopped antihypertensive treatment was significantly greater in the home BP titration group than in the clinic BP titration group (RR 2.34; 95 percent CI 1.48, 3.69; P<0.01) (Table D-43). The proportion of patients proceeding to multiple-drug treatment was not significantly different between the two groups (RR 0.84; 95 percent CI 0.66, 1.06).

Also reported were left ventricular hypertrophy outcomes in a subgroup of patients in both groups. Serial electrocardiograms were available in 355 patients, as well as echocardiographic results in 54 patients. Outcome measures were left ventricular wall thickness, fractional shortening, and the ratio of the peak left ventricular inflow velocities in early diastole and at atrial contraction. After adjustment for baseline values, sex, age, and body mass index, the between-group differences in the changes in most electrocardiographic and echocardiographic measurements were small and statistically nonsignificant. The only statistically significant finding was a marginal clinical benefit for the echocardiographic ratio of the peak left ventricular inflow velocities in early diastole and at atrial contraction (between group difference -0.22; 95 percent CI -0.39, 0.05; P=0.02) in the clinic BP titration versus the home BP titration group.

This study provides insufficient evidence to clarify whether medication titration should be based on SMBP or clinic BP. But it highlights the challenge of selecting a BP target for SMBP since SMBP is generally lower than clinic BP. In a response to a letter to the editor about their study, the study authors suggest that a lower limit for the diastolic blood pressure needs to be chosen for adjusting antihypertensive drug treatment based on SMBP than on clinic BP if the same clinic BP is to be achieved.³² Another study, Verberk 2007, included under KQ1, also adjusted antihypertensive therapy in a blinded fashion based on the same BP target of 120-140/80-90 for either SMBP or clinic BP.²⁰ It also showed a reduction in the number of drugs, with a trend for worse clinic BP control in the SMBP group.

Home BP Monitoring by a Family Member Versus SMBP

(Tables D-40 and 41)

Stahl 1984 was a quasi-RCT of 202 patients assigned either to home BP monitoring by a family member or SMBP by the patient. This study was rated quality C due to a lack of randomization, a dropout rate of 67 percent at 36 months, and apparent reporting errors. There was no clear pattern for consistent differences in BP control (Table D-40) or DBP (Table D-41) between groups over time. Although a significantly greater reduction in DBP was observed in the SMBP group versus the family measured group for the 7–12 months interval, this effect reversed at subsequent followup.

There is insufficient evidence to clarify whether the efficacy for BP reduction depends on home BP measurement by a family member versus the patient.