Sex and Age Differences in Ambulatory Blood Pressure Monitoring Tolerability Free

Abstract

BACKGROUND

Clinical practice guidelines endorse using ambulatory blood pressure monitoring (ABPM) for the diagnosis and management of hypertension. However, ABPM is not always tolerated by patients, and differences between individuals according to age and sex remain unexplored.

METHODS

This is a post hoc analysis of a prospective, single-arm clinical trial (NCT03920956) that evaluated the feasibility of an ABPM service provided at 2 community pharmacies. Tolerability was assessed using a previously published survey, which included 7 yes/no questions and 8 answered on a scale of 0–10. Descriptive statistics and Chi-square analyses were used to summarize the data for the patient surveys and to describe sex and age differences in device tolerability.

RESULTS

Of the 52 subjects enrolled, 50 (96%) completed the survey; half were female with a mean (SD) age of 57.5 years (15.8). Chi-square analyses showed that compared with their male counterparts, females were more likely to find the monitor cumbersome to wear (76.2% vs. 40%, P = 0.014). Subjects under 55 years of age were more likely to be disturbed by the noise of the monitor during driving (38.1% vs. 4.2%, P = 0.005) and at other times (35.0% vs. 8.3%, P = 0.029), and to find the monitor embarrassing to wear (33.3% vs. 7.1%, P = 0.019).

CONCLUSIONS

Although ABPM was generally well-tolerated overall, we did identify age and sex differences in tolerability. These factors should be considered to ensure patient acceptance and tolerability of ABPM.

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Hypertension (HTN) is a leading risk factor for cardiovascular disease, contributing to 25% of all cardiovascular events, including coronary artery disease, stroke, and heart failure.^1–3 Controlling blood pressure (BP) greatly mitigates these risks, yet approximately 50% of Americans do not achieve desired goals.^3,4 Diagnosing and managing HTN requires reliable BP measurements. While office-based measurement has historically been the primary method for BP assessment, out-of-office BP measurements have been shown to be more predictive of cardiovascular disease risk and mortality.³ Accordingly, the 2018 High Blood Pressure Guidelines gave a 1A recommendation for the use of out-of-office BP measurements for the diagnosis and management of HTN, specifically stating that 24-hour ambulatory BP monitoring (ABPM) is the preferred out-of-office measurement.³

Patient tolerability of ABPM devices is critical for the successful implementation. Patients who experience discomfort with the device may be more likely to remove it prior to obtaining the requisite number of readings required for further diagnosis of various BP phenotypes (e.g., white coat HTN).⁵ In one study, half of patients who reported poor tolerability during their second time wearing an ABPM had inadequate data for the entire 24-hour period.⁵ Furthermore, patients who find ABPM monitors heavy and cumbersome or who experience disrupted sleep while wearing one may be more likely to decline future ABPM testing.⁶

Preliminary data suggest that both age and sex may impact ABPM device tolerability. For example, older women have reported a higher tendency to experience severe pain from the pressure of the cuff during BP measurements.⁵ Gender differences in tolerability are particularly relevant given the underdiagnosis and underestimation of HTN in women.^3,7 Additionally, women with HTN experience poorer health outcomes compared with men with HTN.³ This discrepancy highlights the importance of obtaining accurate BP data to diagnose and manage at-risk patients, including older women.⁸

To date, only limited data are available on sex and age differences in patient perceptions of ABPM device tolerability. To our knowledge, no study has comprehensively investigated associations between sex, age, and diverse aspects of ABPM tolerability. This study aims to examine differences in ABPM device tolerability across sex and age.

METHODS

This is a post hoc analysis of a prospective, single-arm clinical trial (NCT03920956), where an ABPM service was developed and implemented in collaboration between an academic partner and pharmacists at 2 independent community pharmacies. As previously reported, eligible patients were referred by their provider or self-referred for white coat, masked, or sustained HTN, symptoms of hypotension, or requiring confirmation of an initial diagnosis of HTN. Patients enrolling in this service scheduled an appointment at the pharmacy, at which time they were fitted with an Oscar 2 (Suntech Medical) ABPM device which measured BP every 30 minutes during the day and every 45 minutes overnight for a 24-hour period.⁸ This study was reviewed and approved by the local Institutional Review Board.

Patients completed 2 surveys in the course of their study participation: (i) a baseline demographic and health history questionnaire when they were fitted with the device, and (ii) a survey about their ABPM experience when they returned the device to the pharmacy. Both surveys were administered via hardcopy and the participants completed the surveys by hand. Results from the surveys about the participant’s experience with the ABPM service, itself, have been reported elsewhere.⁸ A previously published 2-part survey was used to evaluate patient perceptions of wearing the ABPM device.⁵ Seven questions were yes/no, while 8 were answered on a scale of 0–10 (0 = “not at all,” 5 = “somewhat,” 10 = “extremely”). Responses were dichotomized as either “favorable” (0–4) or “unfavorable” (5–10), with reverse coding for positively worded questions. Descriptive statistics (counts, proportions) and Chi-square analyses were used to summarize the data for the patient surveys and to describe sex and age differences in device tolerability, with P < 0.05 denoting statistical significance. Stata/IC v16.1 (College Station, TX) was used for analysis.

RESULTS

A total of 50 surveys (96%) were completed and returned. Respondents were 50% female (n = 25) with a mean (SD) age of 57.5 (15.8), and 58% (n = 29) were at least 55 years old. White, non-Hispanic patients made up 74% (n = 37) of respondents, while 26% were non-White (n = 13). Clinical findings and patient satisfaction with the ABPM service have been previously reported.⁸

While 71.4% of participants found the ABPM device easy to use, a majority felt the monitor was uncomfortable (59.2%) and cumbersome to wear at home (52.1%) or work (56.8%) (Table 1). Additionally, nearly half (46%) of respondents reported the ABPM device interfered with their normal sleep pattern. Female respondents were more likely than their male counterparts to find the monitor cumbersome to wear at times other than at home, work, or driving (76.2% vs. 40%, P = 0.014). Although nonsignificant, male respondents were more likely to find the monitor embarrassing to wear (28.0% vs. 8.3%, P = 0.076). There were no significant differences in likelihood of reporting pain with the monitor by age or sex. Bruising was reported by 2 (4%) participants, both of whom were women.

In comparisons of tolerability by age, subjects under 55 years old were more likely to report being disturbed by the pump’s noise while driving (38.1% vs. 4.2%, P = 0.005), at other times (35.0% vs. 8.3%, P = 0.029), and found the monitor embarrassing to wear (33.3% vs. 7.1%, P = 0.019). Furthermore, of the 22 participants whose sleep was disturbed by the monitor (45.8%), younger subjects were nominally more likely to report being awakened by the monitor after falling asleep (75.0% vs. 45.0%, P = 0.069).

DISCUSSION

Consistent with previous reports of patient experiences with ABPM devices, a majority of participants in this trial found the devices easy to use, but half reported sleep interference and discomfort.^9,10 This study, however, identified age and sex differences in specific aspects of ABPM device tolerability. Younger subjects (less than 55 years) were significantly more likely to be disturbed by the noise of the pump while driving. This may reflect past findings that middle-aged adults (30–59 years) spend, on average, twice as much time driving than those 60 years and older.¹¹ Though literature is conflicting, some research suggests that middle-aged adults more commonly talk on the phone while driving. Therefore, one could hypothesize that they found the pump noise to be disruptive during calls.^11,12

While past studies have reported that older women more commonly report pain with ABPM devices, this study found no age or sex differences in the likelihood of experiencing pain from wearing the monitor, with only 2 women reporting bruising from the monitor.^5,10 Notably, the overall percentage of participants reporting pain (20.8%) was lower than that reported by Viera et al., who also examined the tolerability of the Oscar 2 ABPM device (33.8%).¹⁰ Overall, pain was reported by a smaller number of participants in our study, which may have limited the ability to detect sex differences in monitor-associated pain.

A small number (18.4%) of participants in this study reported feeling embarrassed while wearing the ABPM device. In contrast, one study concluded that embarrassment in public is a primary factor in patient preferences for self-monitoring of BP over ABPM, and others note that focus groups consistently report embarrassment as a barrier to ABPM.^13–15 Notably, this study enrolled patients from July through December 2019, with a majority of patients recruited in the fall and winter. The ability to wear a device under a sweater or coat could minimize feelings of embarrassment. Further, most study participants (74%) were non-Hispanic Whites, and published focus groups suggest that minority ethnic groups may feel more embarrassed about ABPM giving others the impression that they have a medical problem.¹⁴ The lower percentage of minorities in this study may have contributed to the overall low observed levels of embarrassment. Finally, younger patients were significantly more likely to report embarrassment about the ABPM device. This finding is consistent with those of a study on hearing aids, which reported that younger patients more often rejected hearing aids as a result of age-related stigmas with the devices.¹⁰ Additionally, men commonly report embarrassment as a major barrier toward medical help-seeking.¹⁶

This study had several limitations, as this was a feasibility trial of a community pharmacy-based ABPM service with a modest sample size. With a larger sample size, the study may have detected additional sex and age differences, such as bruising, which was only experienced by 2 female patients. Additionally, the survey, though used in a previously published study of tolerability of the Oscar 2 ABPM device, lacks validation.¹⁰ Finally, this was a two-site trial in a single metropolitan area, limiting generalizability.

In closing, this study identified sex and age differences in the degree to which patients perceived ABPM devices to be cumbersome, noisy, or embarrassing. Given previous findings that patients who experience discomfort are more likely to remove their devices or reject future ABPM testing, additional counseling on the ABPM devices and the importance of obtaining the requisite number of readings for accurate diagnosis and management of HTN may be needed in younger patients referred for testing to promote ABPM adherence.

FUNDING

This work was supported by the Community Pharmacy Foundation (grant #214).

DISCLOSURE

The authors declared no conflict of interest.

REFERENCES