How reliable are self-measured blood pressures taken at home?

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How reliable are self-measured blood pressures taken at home?
EVIDENCE-BASED ANSWER

Self-measured blood pressures (SMBP) can be precise and accurate and, thus, reliably be used as an adjunct to office blood pressure measurements in selected clinical situations (strength of recommendation [SOR]: B, extrapolation and limited trials). Clinicians using SMBP need to be aware of the difference in normal reference ranges, with pressures greater than 135/85 mm Hg considered hypertensive.

Whether hypertensive treatment should be based primarily on SMBP is unclear, and currently undergoing study. Clinicians should recommend multiple daily measurements with a validated and standardized device, preferably equipped with memory or transmission capabilities, in order to avoid patient error in transcribing and reporting values. Wrist or finger devices cannot reliably be used (SOR: B, limited comparison studies).

 

Evidence summary

Office blood pressure (OBP) has traditionally been used in long-term trials to describe the relationship between blood pressure and cardiovascular morbidity and mortality, as well as to establish the efficacy of antihypertensive drug therapy. A prospective randomized trial demonstrating the relationship between therapy based on SMBP to these same outcomes is in progress.1

Two large prospective cohort studies of the relationship between SMBP and morbidity and mortality made comparative baseline blood pressure measurements and followed the cohorts without suggestions or attempts to change management. The first was a rural population-based study with 1789 subjects (90% of the population) from Ohasama, Japan.2 Mean follow-up was 6.6 years with less than 1% dropout rate. The second large cohort study (SHEAF trial) included patients 60 years old with the diagnosis of hypertension.3 A total of 4939 cases were analyzed. Mean follow-up was 3.2 years with less than 1% dropout rate. Both studies show that each mm Hg increase in SMBP was a better predictor of cardiovascular events than an equivalent increase in OBP (Table 1).

Office blood pressure measurements exhibit large variability (decreased precision) and are subject to multiple biases (decreased accuracy). Self-measured blood pressures at home became common when “white-coat hypertension” was recognized to be clinically significant. It allows for a larger number of measurements for individual patients, resulting in greater precision than OBP.4 SMBP correlates better than OBP with surrogate measures of hypertensive control, such as ambulatory blood pressure measurement5 and left ventricular mass.6 Thus, SMBP might some day become the gold standard for defining hypertension in the clinical setting. Meanwhile, the correlation between OBP and SMBP can be derived via three different mathematical models using data from multiple studies. The accepted cutoff for SMBP defined hypertension is 135/85 mm Hg.7

The THOP trial8 was a single-blinded, randomized controlled trial of hypertensive treatment based on SMBP vs OBP. Four hundred patients were randomized to SMBP or OBP, with medication adjustments made by a blinded clinician. The trial design called for both treatment groups to be titrated to a diastolic blood pressure of 80 to 89 mm Hg. The follow-up was approximately 1 year. Graphical data indicate that both groups were equally effective in meeting the blood pressure goals outlined in the methods.

Other differences in outcomes were proportional to the known difference in normotensive reference ranges (eg, that OBP tend to run higher than SMBP). Patients in the SMBP group were put on less-intensive drug treatment and incurred slightly lower medical costs. SMBP patients were twice as likely to have their blood pressure medication discontinued, possibly indicating SMBP helped to identify white-coat hypertension.

TABLE 1
Increase in cardiovascular mortality for each 1 mm Hg increase in blood pressure

 Cox Proportional Relative Hazards Ratio [95 % CI]
Home systolic BPHome diastolic BPOffice systolic BPOffice diastolic BP
Ohasama study2*1.021[1.001–1.041]1.015 [0.986–1.045]1.005 [0.990–1.020]1.008 [0.984–1.033]
SHEAF study31.02 [1.01–1.02]1.02 [1.01–1.03]1.01 [1.00–1.01]1.00 [0.99–1.02]
*Results were adjusted for age, sex, smoking status, history of cardiovascular disease, and use of antihypertensive medication.
†Increase in cardiovascular events for each 1 mm Hg increase in blood pressure. Results were adjusted for age, sex, heart rate, smoking status, history of cardiovascular events, presence of diabetes, presence of obesity, and presence of treatment for hypercholesterolemia.
‡Statistically significant.
 

 

 

Recommendations from others

In addition to diagnosing white-coat hypertension, World Health Organization/International Society of Hypertension Guidelines Committee has recommended that home blood pressure measurement is useful in the following circumstances:9

  • unusual variability of blood pressure over the same or different visits
  • office hypertension in subjects with low cardiovascular risk
  • symptoms suggesting hypotensive episodes
  • hypertension resistant to drug treatment.

Standardization and validation protocols are available from the Association for the Advancement of Medical Instrumentation,10 European Hypertension Society,11 or the British Hypertension Society (available at www.hyp.ac.uk/bhs/bp_ monitors/automatic.htm). Relatively few of the hundreds of available blood pressure measurement devices available meet these criteria. The most current Association for the Advancement of Medical Instrumentation standards are labeled as ANSI/AAMI-SP10:2002/A1:2003 standards. Table 2 lists some devices that meet the various protocols. Devices in this market change rapidly, so buyers should confirm the device they are evaluating meets current standards.

TABLE 2
Devices that meet standards for home BP measurement

SMBP device suitable for home useValidation protocol
A&D-767BHS
A&D-779International Protocol
A&D-787International Protocol
OMRON M5-IInternational Protocol
OMRON 705ITInternational Protocol
OMRON 705 CPIIInternational Protocol
OMRON MITBHS
Microlife 3BTO-ABHS
Microlife 3AG1BHS
BHS: British Hypertension Society; International Protocol: European Hypertension Society
CLINICAL COMMENTARY

Self-measured BP may help us better diagnose and manage hypertension
Paul Pisarik, MD, MPH
Baylor College of Medicine, Houston, Tex

It has been shown that office blood pressure readings can give false-positive results in those who have “white coat hypertension” and give false-negative readings in those with “white coat normotension” or “masked hypertension”—patients who have normal blood pressure values in the office, but elevated blood pressure values outside the office. This is not a trivial issue. Ten to 20% of patients with normal blood pressure values in the office have elevated blood pressure values throughout the day, and evidence is beginning to mount that the cardiovascular consequences are the same for these patients as for those with sustained hypertension.1

The SHEAF trial (and other studies) have thrown another complexity into hypertension control by showing that OBP readings were inaccurate in 22% of treated hypertensive patients—13% had uncontrolled OBP with normal SMBP, and 9% had normal OBP but uncontrolled SMBP.3

Thus, SMBP is a potentially very powerful and cost-effective tool that may help us better diagnose and manage this complex disease. I have encouraged my hypertensive patients to do SMBP and, as one who has white-coat hypertension (and a strong family history of hypertension), I am diligent at taking my own SMBP on a regular basis to guard against the insidious onset of this disease.

References

1. Fujiwara T, Matsubara M, Ohkubo T, Imai Y. Study Design of HOMED-BP: hypertension objective treatment based on measurement by electrical devices of blood pressure. Clin Exp Hypertens 2003;25:143-144.

2. Ohkubo T, Imai Y, Tsuji I, et al. Home blood pressure measurement has a stronger predictive power for mortality than does screening blood pressure measurement: a population-based observation in Ohasama, Japan. J Hypertens 1998;16:971-975.

3. Bobrie G, Chatellier G, Genes N, et al. Cardiovascular prognosis of “masked hypertension” detected by blood pressure self-measurement in elderly treated hypertensive patients. JAMA 2004;291:1342-1349.

4. National Institutes of Health, National Heart, Lung, and Blood Institute, National High Blood Pressure Education Program. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Bethesda, MD: Public Health Service, NHLBI. NIH Publ. #03-5233, May 2003.

5. Brueren MM, Schouten JF, de Leeuw PW, van Montfrano GA, van Ree JW. A series of self-measurements by the patient is a reliable alternative to ambulatory blood pressure measurement. Br J Gen Pract 1998;48:1585-1589.

6. Verdecchia P. Reliability of home self-recorded arterial pressure in essential hypertension in relation to the stage of the disease. In: Ediziono GG (ed): Blood Pressure Recording in the Clinical Management of Hypertension. Rome: Pozzi; 1985;pp 40-42.

7. Thijs L, Staessen JA, Celis H, et al. Reference values for self-recorded blood pressure: a meta-analysis of summary data. Arch Intern Med 1998;158:481-488.

8. Staessen JA, Den Hond E, Celis H, et al. Antihypertensive treatment based on blood pressure measurement at home or in the physician’s office: a randomized controlled trial. JAMA 2004;291:955-964.

9. 1999 World Health Organization.International Society of Hypertension Guidelines for the Management of Hypertension. Guidelines Subcommittee. J Hypertens 1999;17:151-185.

10. White WB, Berson AS, Robbins C, et al. National standard for measurement of resting and ambulatory pressures with automated sphygmomanometers. Hypertension 1993;21:504-509.

11. O’Brien E, Waeber B, Parati G, Staessen J, Myers MG. Blood pressure measuring devices: recommendations of the European Society of Hypertension. BMJ 2001;322:531-536.

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James Meza, MD, MSA
Melissa Nayak, MD
Henry Ford Hospital, Detroit, Mich;

Sandra Martin, MLS
Wayne State University Detroit, Mich

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Melissa Nayak, MD
Henry Ford Hospital, Detroit, Mich;

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Wayne State University Detroit, Mich

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Melissa Nayak, MD
Henry Ford Hospital, Detroit, Mich;

Sandra Martin, MLS
Wayne State University Detroit, Mich

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EVIDENCE-BASED ANSWER

Self-measured blood pressures (SMBP) can be precise and accurate and, thus, reliably be used as an adjunct to office blood pressure measurements in selected clinical situations (strength of recommendation [SOR]: B, extrapolation and limited trials). Clinicians using SMBP need to be aware of the difference in normal reference ranges, with pressures greater than 135/85 mm Hg considered hypertensive.

Whether hypertensive treatment should be based primarily on SMBP is unclear, and currently undergoing study. Clinicians should recommend multiple daily measurements with a validated and standardized device, preferably equipped with memory or transmission capabilities, in order to avoid patient error in transcribing and reporting values. Wrist or finger devices cannot reliably be used (SOR: B, limited comparison studies).

 

Evidence summary

Office blood pressure (OBP) has traditionally been used in long-term trials to describe the relationship between blood pressure and cardiovascular morbidity and mortality, as well as to establish the efficacy of antihypertensive drug therapy. A prospective randomized trial demonstrating the relationship between therapy based on SMBP to these same outcomes is in progress.1

Two large prospective cohort studies of the relationship between SMBP and morbidity and mortality made comparative baseline blood pressure measurements and followed the cohorts without suggestions or attempts to change management. The first was a rural population-based study with 1789 subjects (90% of the population) from Ohasama, Japan.2 Mean follow-up was 6.6 years with less than 1% dropout rate. The second large cohort study (SHEAF trial) included patients 60 years old with the diagnosis of hypertension.3 A total of 4939 cases were analyzed. Mean follow-up was 3.2 years with less than 1% dropout rate. Both studies show that each mm Hg increase in SMBP was a better predictor of cardiovascular events than an equivalent increase in OBP (Table 1).

Office blood pressure measurements exhibit large variability (decreased precision) and are subject to multiple biases (decreased accuracy). Self-measured blood pressures at home became common when “white-coat hypertension” was recognized to be clinically significant. It allows for a larger number of measurements for individual patients, resulting in greater precision than OBP.4 SMBP correlates better than OBP with surrogate measures of hypertensive control, such as ambulatory blood pressure measurement5 and left ventricular mass.6 Thus, SMBP might some day become the gold standard for defining hypertension in the clinical setting. Meanwhile, the correlation between OBP and SMBP can be derived via three different mathematical models using data from multiple studies. The accepted cutoff for SMBP defined hypertension is 135/85 mm Hg.7

The THOP trial8 was a single-blinded, randomized controlled trial of hypertensive treatment based on SMBP vs OBP. Four hundred patients were randomized to SMBP or OBP, with medication adjustments made by a blinded clinician. The trial design called for both treatment groups to be titrated to a diastolic blood pressure of 80 to 89 mm Hg. The follow-up was approximately 1 year. Graphical data indicate that both groups were equally effective in meeting the blood pressure goals outlined in the methods.

Other differences in outcomes were proportional to the known difference in normotensive reference ranges (eg, that OBP tend to run higher than SMBP). Patients in the SMBP group were put on less-intensive drug treatment and incurred slightly lower medical costs. SMBP patients were twice as likely to have their blood pressure medication discontinued, possibly indicating SMBP helped to identify white-coat hypertension.

TABLE 1
Increase in cardiovascular mortality for each 1 mm Hg increase in blood pressure

 Cox Proportional Relative Hazards Ratio [95 % CI]
Home systolic BPHome diastolic BPOffice systolic BPOffice diastolic BP
Ohasama study2*1.021[1.001–1.041]1.015 [0.986–1.045]1.005 [0.990–1.020]1.008 [0.984–1.033]
SHEAF study31.02 [1.01–1.02]1.02 [1.01–1.03]1.01 [1.00–1.01]1.00 [0.99–1.02]
*Results were adjusted for age, sex, smoking status, history of cardiovascular disease, and use of antihypertensive medication.
†Increase in cardiovascular events for each 1 mm Hg increase in blood pressure. Results were adjusted for age, sex, heart rate, smoking status, history of cardiovascular events, presence of diabetes, presence of obesity, and presence of treatment for hypercholesterolemia.
‡Statistically significant.
 

 

 

Recommendations from others

In addition to diagnosing white-coat hypertension, World Health Organization/International Society of Hypertension Guidelines Committee has recommended that home blood pressure measurement is useful in the following circumstances:9

  • unusual variability of blood pressure over the same or different visits
  • office hypertension in subjects with low cardiovascular risk
  • symptoms suggesting hypotensive episodes
  • hypertension resistant to drug treatment.

Standardization and validation protocols are available from the Association for the Advancement of Medical Instrumentation,10 European Hypertension Society,11 or the British Hypertension Society (available at www.hyp.ac.uk/bhs/bp_ monitors/automatic.htm). Relatively few of the hundreds of available blood pressure measurement devices available meet these criteria. The most current Association for the Advancement of Medical Instrumentation standards are labeled as ANSI/AAMI-SP10:2002/A1:2003 standards. Table 2 lists some devices that meet the various protocols. Devices in this market change rapidly, so buyers should confirm the device they are evaluating meets current standards.

TABLE 2
Devices that meet standards for home BP measurement

SMBP device suitable for home useValidation protocol
A&D-767BHS
A&D-779International Protocol
A&D-787International Protocol
OMRON M5-IInternational Protocol
OMRON 705ITInternational Protocol
OMRON 705 CPIIInternational Protocol
OMRON MITBHS
Microlife 3BTO-ABHS
Microlife 3AG1BHS
BHS: British Hypertension Society; International Protocol: European Hypertension Society
CLINICAL COMMENTARY

Self-measured BP may help us better diagnose and manage hypertension
Paul Pisarik, MD, MPH
Baylor College of Medicine, Houston, Tex

It has been shown that office blood pressure readings can give false-positive results in those who have “white coat hypertension” and give false-negative readings in those with “white coat normotension” or “masked hypertension”—patients who have normal blood pressure values in the office, but elevated blood pressure values outside the office. This is not a trivial issue. Ten to 20% of patients with normal blood pressure values in the office have elevated blood pressure values throughout the day, and evidence is beginning to mount that the cardiovascular consequences are the same for these patients as for those with sustained hypertension.1

The SHEAF trial (and other studies) have thrown another complexity into hypertension control by showing that OBP readings were inaccurate in 22% of treated hypertensive patients—13% had uncontrolled OBP with normal SMBP, and 9% had normal OBP but uncontrolled SMBP.3

Thus, SMBP is a potentially very powerful and cost-effective tool that may help us better diagnose and manage this complex disease. I have encouraged my hypertensive patients to do SMBP and, as one who has white-coat hypertension (and a strong family history of hypertension), I am diligent at taking my own SMBP on a regular basis to guard against the insidious onset of this disease.

EVIDENCE-BASED ANSWER

Self-measured blood pressures (SMBP) can be precise and accurate and, thus, reliably be used as an adjunct to office blood pressure measurements in selected clinical situations (strength of recommendation [SOR]: B, extrapolation and limited trials). Clinicians using SMBP need to be aware of the difference in normal reference ranges, with pressures greater than 135/85 mm Hg considered hypertensive.

Whether hypertensive treatment should be based primarily on SMBP is unclear, and currently undergoing study. Clinicians should recommend multiple daily measurements with a validated and standardized device, preferably equipped with memory or transmission capabilities, in order to avoid patient error in transcribing and reporting values. Wrist or finger devices cannot reliably be used (SOR: B, limited comparison studies).

 

Evidence summary

Office blood pressure (OBP) has traditionally been used in long-term trials to describe the relationship between blood pressure and cardiovascular morbidity and mortality, as well as to establish the efficacy of antihypertensive drug therapy. A prospective randomized trial demonstrating the relationship between therapy based on SMBP to these same outcomes is in progress.1

Two large prospective cohort studies of the relationship between SMBP and morbidity and mortality made comparative baseline blood pressure measurements and followed the cohorts without suggestions or attempts to change management. The first was a rural population-based study with 1789 subjects (90% of the population) from Ohasama, Japan.2 Mean follow-up was 6.6 years with less than 1% dropout rate. The second large cohort study (SHEAF trial) included patients 60 years old with the diagnosis of hypertension.3 A total of 4939 cases were analyzed. Mean follow-up was 3.2 years with less than 1% dropout rate. Both studies show that each mm Hg increase in SMBP was a better predictor of cardiovascular events than an equivalent increase in OBP (Table 1).

Office blood pressure measurements exhibit large variability (decreased precision) and are subject to multiple biases (decreased accuracy). Self-measured blood pressures at home became common when “white-coat hypertension” was recognized to be clinically significant. It allows for a larger number of measurements for individual patients, resulting in greater precision than OBP.4 SMBP correlates better than OBP with surrogate measures of hypertensive control, such as ambulatory blood pressure measurement5 and left ventricular mass.6 Thus, SMBP might some day become the gold standard for defining hypertension in the clinical setting. Meanwhile, the correlation between OBP and SMBP can be derived via three different mathematical models using data from multiple studies. The accepted cutoff for SMBP defined hypertension is 135/85 mm Hg.7

The THOP trial8 was a single-blinded, randomized controlled trial of hypertensive treatment based on SMBP vs OBP. Four hundred patients were randomized to SMBP or OBP, with medication adjustments made by a blinded clinician. The trial design called for both treatment groups to be titrated to a diastolic blood pressure of 80 to 89 mm Hg. The follow-up was approximately 1 year. Graphical data indicate that both groups were equally effective in meeting the blood pressure goals outlined in the methods.

Other differences in outcomes were proportional to the known difference in normotensive reference ranges (eg, that OBP tend to run higher than SMBP). Patients in the SMBP group were put on less-intensive drug treatment and incurred slightly lower medical costs. SMBP patients were twice as likely to have their blood pressure medication discontinued, possibly indicating SMBP helped to identify white-coat hypertension.

TABLE 1
Increase in cardiovascular mortality for each 1 mm Hg increase in blood pressure

 Cox Proportional Relative Hazards Ratio [95 % CI]
Home systolic BPHome diastolic BPOffice systolic BPOffice diastolic BP
Ohasama study2*1.021[1.001–1.041]1.015 [0.986–1.045]1.005 [0.990–1.020]1.008 [0.984–1.033]
SHEAF study31.02 [1.01–1.02]1.02 [1.01–1.03]1.01 [1.00–1.01]1.00 [0.99–1.02]
*Results were adjusted for age, sex, smoking status, history of cardiovascular disease, and use of antihypertensive medication.
†Increase in cardiovascular events for each 1 mm Hg increase in blood pressure. Results were adjusted for age, sex, heart rate, smoking status, history of cardiovascular events, presence of diabetes, presence of obesity, and presence of treatment for hypercholesterolemia.
‡Statistically significant.
 

 

 

Recommendations from others

In addition to diagnosing white-coat hypertension, World Health Organization/International Society of Hypertension Guidelines Committee has recommended that home blood pressure measurement is useful in the following circumstances:9

  • unusual variability of blood pressure over the same or different visits
  • office hypertension in subjects with low cardiovascular risk
  • symptoms suggesting hypotensive episodes
  • hypertension resistant to drug treatment.

Standardization and validation protocols are available from the Association for the Advancement of Medical Instrumentation,10 European Hypertension Society,11 or the British Hypertension Society (available at www.hyp.ac.uk/bhs/bp_ monitors/automatic.htm). Relatively few of the hundreds of available blood pressure measurement devices available meet these criteria. The most current Association for the Advancement of Medical Instrumentation standards are labeled as ANSI/AAMI-SP10:2002/A1:2003 standards. Table 2 lists some devices that meet the various protocols. Devices in this market change rapidly, so buyers should confirm the device they are evaluating meets current standards.

TABLE 2
Devices that meet standards for home BP measurement

SMBP device suitable for home useValidation protocol
A&D-767BHS
A&D-779International Protocol
A&D-787International Protocol
OMRON M5-IInternational Protocol
OMRON 705ITInternational Protocol
OMRON 705 CPIIInternational Protocol
OMRON MITBHS
Microlife 3BTO-ABHS
Microlife 3AG1BHS
BHS: British Hypertension Society; International Protocol: European Hypertension Society
CLINICAL COMMENTARY

Self-measured BP may help us better diagnose and manage hypertension
Paul Pisarik, MD, MPH
Baylor College of Medicine, Houston, Tex

It has been shown that office blood pressure readings can give false-positive results in those who have “white coat hypertension” and give false-negative readings in those with “white coat normotension” or “masked hypertension”—patients who have normal blood pressure values in the office, but elevated blood pressure values outside the office. This is not a trivial issue. Ten to 20% of patients with normal blood pressure values in the office have elevated blood pressure values throughout the day, and evidence is beginning to mount that the cardiovascular consequences are the same for these patients as for those with sustained hypertension.1

The SHEAF trial (and other studies) have thrown another complexity into hypertension control by showing that OBP readings were inaccurate in 22% of treated hypertensive patients—13% had uncontrolled OBP with normal SMBP, and 9% had normal OBP but uncontrolled SMBP.3

Thus, SMBP is a potentially very powerful and cost-effective tool that may help us better diagnose and manage this complex disease. I have encouraged my hypertensive patients to do SMBP and, as one who has white-coat hypertension (and a strong family history of hypertension), I am diligent at taking my own SMBP on a regular basis to guard against the insidious onset of this disease.

References

1. Fujiwara T, Matsubara M, Ohkubo T, Imai Y. Study Design of HOMED-BP: hypertension objective treatment based on measurement by electrical devices of blood pressure. Clin Exp Hypertens 2003;25:143-144.

2. Ohkubo T, Imai Y, Tsuji I, et al. Home blood pressure measurement has a stronger predictive power for mortality than does screening blood pressure measurement: a population-based observation in Ohasama, Japan. J Hypertens 1998;16:971-975.

3. Bobrie G, Chatellier G, Genes N, et al. Cardiovascular prognosis of “masked hypertension” detected by blood pressure self-measurement in elderly treated hypertensive patients. JAMA 2004;291:1342-1349.

4. National Institutes of Health, National Heart, Lung, and Blood Institute, National High Blood Pressure Education Program. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Bethesda, MD: Public Health Service, NHLBI. NIH Publ. #03-5233, May 2003.

5. Brueren MM, Schouten JF, de Leeuw PW, van Montfrano GA, van Ree JW. A series of self-measurements by the patient is a reliable alternative to ambulatory blood pressure measurement. Br J Gen Pract 1998;48:1585-1589.

6. Verdecchia P. Reliability of home self-recorded arterial pressure in essential hypertension in relation to the stage of the disease. In: Ediziono GG (ed): Blood Pressure Recording in the Clinical Management of Hypertension. Rome: Pozzi; 1985;pp 40-42.

7. Thijs L, Staessen JA, Celis H, et al. Reference values for self-recorded blood pressure: a meta-analysis of summary data. Arch Intern Med 1998;158:481-488.

8. Staessen JA, Den Hond E, Celis H, et al. Antihypertensive treatment based on blood pressure measurement at home or in the physician’s office: a randomized controlled trial. JAMA 2004;291:955-964.

9. 1999 World Health Organization.International Society of Hypertension Guidelines for the Management of Hypertension. Guidelines Subcommittee. J Hypertens 1999;17:151-185.

10. White WB, Berson AS, Robbins C, et al. National standard for measurement of resting and ambulatory pressures with automated sphygmomanometers. Hypertension 1993;21:504-509.

11. O’Brien E, Waeber B, Parati G, Staessen J, Myers MG. Blood pressure measuring devices: recommendations of the European Society of Hypertension. BMJ 2001;322:531-536.

References

1. Fujiwara T, Matsubara M, Ohkubo T, Imai Y. Study Design of HOMED-BP: hypertension objective treatment based on measurement by electrical devices of blood pressure. Clin Exp Hypertens 2003;25:143-144.

2. Ohkubo T, Imai Y, Tsuji I, et al. Home blood pressure measurement has a stronger predictive power for mortality than does screening blood pressure measurement: a population-based observation in Ohasama, Japan. J Hypertens 1998;16:971-975.

3. Bobrie G, Chatellier G, Genes N, et al. Cardiovascular prognosis of “masked hypertension” detected by blood pressure self-measurement in elderly treated hypertensive patients. JAMA 2004;291:1342-1349.

4. National Institutes of Health, National Heart, Lung, and Blood Institute, National High Blood Pressure Education Program. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Bethesda, MD: Public Health Service, NHLBI. NIH Publ. #03-5233, May 2003.

5. Brueren MM, Schouten JF, de Leeuw PW, van Montfrano GA, van Ree JW. A series of self-measurements by the patient is a reliable alternative to ambulatory blood pressure measurement. Br J Gen Pract 1998;48:1585-1589.

6. Verdecchia P. Reliability of home self-recorded arterial pressure in essential hypertension in relation to the stage of the disease. In: Ediziono GG (ed): Blood Pressure Recording in the Clinical Management of Hypertension. Rome: Pozzi; 1985;pp 40-42.

7. Thijs L, Staessen JA, Celis H, et al. Reference values for self-recorded blood pressure: a meta-analysis of summary data. Arch Intern Med 1998;158:481-488.

8. Staessen JA, Den Hond E, Celis H, et al. Antihypertensive treatment based on blood pressure measurement at home or in the physician’s office: a randomized controlled trial. JAMA 2004;291:955-964.

9. 1999 World Health Organization.International Society of Hypertension Guidelines for the Management of Hypertension. Guidelines Subcommittee. J Hypertens 1999;17:151-185.

10. White WB, Berson AS, Robbins C, et al. National standard for measurement of resting and ambulatory pressures with automated sphygmomanometers. Hypertension 1993;21:504-509.

11. O’Brien E, Waeber B, Parati G, Staessen J, Myers MG. Blood pressure measuring devices: recommendations of the European Society of Hypertension. BMJ 2001;322:531-536.

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Is pneumococcal vaccine effective in nursing home patients?

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Is pneumococcal vaccine effective in nursing home patients?
EVIDENCE-BASED ANSWER

Evidence from clinical trials supports the use of pneumococcal polysaccharide vaccine for prevention of pneumonia in nursing home patients (strength of recommendation: B, based on randomized, nonblinded clinical trials).

Case-control studies have consistently shown the efficacy of pneumococcal vaccine in preventing invasive pneumococcal disease and bacteremia for patients with chronic medical illnesses and the elderly, patients typically found in nursing home populations (SOR: B, based on consistent case-control studies).

 

Evidence summary

Two clinical trials directly addressed the prevention of pneumonia in nursing home patients. A prospective, risk-stratified, randomized study of the 14-valent pneumococcal vaccine in 1686 patients living in hospices and nursing homes in France showed an absolute risk reduction (ARR) of 2.9% in the incidence of all-cause pneumonia, corresponding to a number needed to treat (NNT) of 35.1 This study has 2 major limitations: the authors did not comment on whether the study was blinded, and 31% of patients were lost to follow-up.

A 6-year randomized clinical trial that studied the trivalent pneumococcal vaccine in preventing pneumonia in New York City Home (a nursing home) subjects showed an ARR=2.7% and NNT=37.2 While this report also did not specify whether there was blinding, any bias introduced by absence of blinding is unlikely to account for the large effect size (relative risk reduction=0.56).

Nursing home residents may be especially vulnerable to acquiring pneumococcal infection due to advanced age, chronic illnesses, and their communal setting. The Centers for Disease Control and Prevention (CDC) has reported outbreaks of invasive pneumococcal disease in nursing homes where vaccination rates are low.3 Pneumococcal bacteremia is seen in only 10%–20% of patients with pneumococcal pneumonia but confers a significant risk of death. Therefore, pneumococcal vaccination is indicated for patients ≥ 65 years or those with chronic medical conditions.

Case-control studies have consistently shown efficacy in preventing invasive pneumococcal disease. Farr and colleagues found efficacy of 70% (95% confidence interval [CI], 37%–86%) among 2 groups of patients: those ≥ 2 years of age with chronic disease or those ≥ 65 years.4 A case-control study by Sims and colleagues also found the vaccine to have efficacy of 70% (95% CI, 37%– 86%) in preventing invasive pneumococcal disease in immunocompetent patients aged ≥ 55 years.5

Recommendations from others

The CDC Advisory Committee on Immunization Practices (ACIP) recommends pneumococcal vaccination of persons aged ≥65 years and those aged 2 to 64 who have chronic cardiovascular disease, chronic pulmonary disease, or diabetes mellitus (SOR: A).6

The ACIP also recommends the pneumococcal vaccine for persons aged 2 to 64 years who have alcoholism, chronic liver disease, or cerebrospinal fluid leaks (SOR: B).

The Canadian Task Force on Preventive Health Care endorses vaccination for immunocompetent patients 55 years residing in institutions (SOR: A).7

CLINICAL COMMENTARY

Paul Tatum, MD, MSPH
Department of Family Medicine, University of Colorado, Boulder.

The importance of pneumococcal vaccine for the elderly is well established. However, the vaccine is underused in long-term care settings, despite being indicated for most residents.

Patient confusion about the need for both influenza and pneumococcal vaccines, poor documentation of adult immunization status, poor availability of records from previous care facilities, and frequent changes in physician all contribute to low vaccination rates.

An optimal strategy to ensure high vaccination rates is to administer the pneumococcal vaccine to patients on admission to long-term care facilities. Patients who are uncertain about their vaccination status may safely receive the vaccine, as revaccination is relatively well tolerated.8

ACKNOWLEDGMENTS

The authors wish to thank Yves LeBlanc, MD, and Khalil Nasrallah, MD, for assistance with translation.

References

1. Gaillet J, Zmirou D, Mallaret MR, et al. Essai clinique du vaccin antipneumococcoique chez des personnees agees vivant en institution [Clinical trial of an antipneumococcal vaccine in elderly subjects living in institutions]. Rev Epidemiol Sante Publique 1985;33:437-44.

2. Kaufman P. Pneumonia in old age. Arch Intern Med 1947;79:518-31.

3. Centers for Disease Control and Prevention. Outbreaks of pneumococcal pneumonia among unvaccinated residents of a nursing home—New Jersey, April 2001. MMWR Morb Mortal Wkly Rep 2001;50:707-10.

4. Farr BM, Johnston BL, Cobb DK, et al. Preventing pneumococcal bacteremia in patients at risk. Arch Intern Med 1995;155:2336-40.

5. Sims RV, Steinmann WC, McConville JH, King LR, Zwick WC, Schwartz JS. The clinical effectiveness of pneumococcal vaccine in the elderly. Ann Intern Med 1988;108:653-7.

6. Centers for Disease Control and Prevention. Prevention of pneumococcal disease: recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 1997;46:1-24.

7. Wang EEL. Administration of pneumococcal vaccine. Canadian Task Force on Preventive Health Care 1994;385-6.

8. Jackson LA, Benson P, Sneller VP, et al. Safety of revaccination with pneumococcal polysaccharide vaccine. JAMA 1999;281:243-8.

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Owen McCormack, DO
James Meza, MD, MSA
Department of Family Practice, Henry Ford Hospital, Detroit, Mich.

Sandra Martin, MLS
Wayne State University, Shiffman Medical Library, Detroit, Mich.

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Wayne State University, Shiffman Medical Library, Detroit, Mich.

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James Meza, MD, MSA
Department of Family Practice, Henry Ford Hospital, Detroit, Mich.

Sandra Martin, MLS
Wayne State University, Shiffman Medical Library, Detroit, Mich.

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EVIDENCE-BASED ANSWER

Evidence from clinical trials supports the use of pneumococcal polysaccharide vaccine for prevention of pneumonia in nursing home patients (strength of recommendation: B, based on randomized, nonblinded clinical trials).

Case-control studies have consistently shown the efficacy of pneumococcal vaccine in preventing invasive pneumococcal disease and bacteremia for patients with chronic medical illnesses and the elderly, patients typically found in nursing home populations (SOR: B, based on consistent case-control studies).

 

Evidence summary

Two clinical trials directly addressed the prevention of pneumonia in nursing home patients. A prospective, risk-stratified, randomized study of the 14-valent pneumococcal vaccine in 1686 patients living in hospices and nursing homes in France showed an absolute risk reduction (ARR) of 2.9% in the incidence of all-cause pneumonia, corresponding to a number needed to treat (NNT) of 35.1 This study has 2 major limitations: the authors did not comment on whether the study was blinded, and 31% of patients were lost to follow-up.

A 6-year randomized clinical trial that studied the trivalent pneumococcal vaccine in preventing pneumonia in New York City Home (a nursing home) subjects showed an ARR=2.7% and NNT=37.2 While this report also did not specify whether there was blinding, any bias introduced by absence of blinding is unlikely to account for the large effect size (relative risk reduction=0.56).

Nursing home residents may be especially vulnerable to acquiring pneumococcal infection due to advanced age, chronic illnesses, and their communal setting. The Centers for Disease Control and Prevention (CDC) has reported outbreaks of invasive pneumococcal disease in nursing homes where vaccination rates are low.3 Pneumococcal bacteremia is seen in only 10%–20% of patients with pneumococcal pneumonia but confers a significant risk of death. Therefore, pneumococcal vaccination is indicated for patients ≥ 65 years or those with chronic medical conditions.

Case-control studies have consistently shown efficacy in preventing invasive pneumococcal disease. Farr and colleagues found efficacy of 70% (95% confidence interval [CI], 37%–86%) among 2 groups of patients: those ≥ 2 years of age with chronic disease or those ≥ 65 years.4 A case-control study by Sims and colleagues also found the vaccine to have efficacy of 70% (95% CI, 37%– 86%) in preventing invasive pneumococcal disease in immunocompetent patients aged ≥ 55 years.5

Recommendations from others

The CDC Advisory Committee on Immunization Practices (ACIP) recommends pneumococcal vaccination of persons aged ≥65 years and those aged 2 to 64 who have chronic cardiovascular disease, chronic pulmonary disease, or diabetes mellitus (SOR: A).6

The ACIP also recommends the pneumococcal vaccine for persons aged 2 to 64 years who have alcoholism, chronic liver disease, or cerebrospinal fluid leaks (SOR: B).

The Canadian Task Force on Preventive Health Care endorses vaccination for immunocompetent patients 55 years residing in institutions (SOR: A).7

CLINICAL COMMENTARY

Paul Tatum, MD, MSPH
Department of Family Medicine, University of Colorado, Boulder.

The importance of pneumococcal vaccine for the elderly is well established. However, the vaccine is underused in long-term care settings, despite being indicated for most residents.

Patient confusion about the need for both influenza and pneumococcal vaccines, poor documentation of adult immunization status, poor availability of records from previous care facilities, and frequent changes in physician all contribute to low vaccination rates.

An optimal strategy to ensure high vaccination rates is to administer the pneumococcal vaccine to patients on admission to long-term care facilities. Patients who are uncertain about their vaccination status may safely receive the vaccine, as revaccination is relatively well tolerated.8

ACKNOWLEDGMENTS

The authors wish to thank Yves LeBlanc, MD, and Khalil Nasrallah, MD, for assistance with translation.

EVIDENCE-BASED ANSWER

Evidence from clinical trials supports the use of pneumococcal polysaccharide vaccine for prevention of pneumonia in nursing home patients (strength of recommendation: B, based on randomized, nonblinded clinical trials).

Case-control studies have consistently shown the efficacy of pneumococcal vaccine in preventing invasive pneumococcal disease and bacteremia for patients with chronic medical illnesses and the elderly, patients typically found in nursing home populations (SOR: B, based on consistent case-control studies).

 

Evidence summary

Two clinical trials directly addressed the prevention of pneumonia in nursing home patients. A prospective, risk-stratified, randomized study of the 14-valent pneumococcal vaccine in 1686 patients living in hospices and nursing homes in France showed an absolute risk reduction (ARR) of 2.9% in the incidence of all-cause pneumonia, corresponding to a number needed to treat (NNT) of 35.1 This study has 2 major limitations: the authors did not comment on whether the study was blinded, and 31% of patients were lost to follow-up.

A 6-year randomized clinical trial that studied the trivalent pneumococcal vaccine in preventing pneumonia in New York City Home (a nursing home) subjects showed an ARR=2.7% and NNT=37.2 While this report also did not specify whether there was blinding, any bias introduced by absence of blinding is unlikely to account for the large effect size (relative risk reduction=0.56).

Nursing home residents may be especially vulnerable to acquiring pneumococcal infection due to advanced age, chronic illnesses, and their communal setting. The Centers for Disease Control and Prevention (CDC) has reported outbreaks of invasive pneumococcal disease in nursing homes where vaccination rates are low.3 Pneumococcal bacteremia is seen in only 10%–20% of patients with pneumococcal pneumonia but confers a significant risk of death. Therefore, pneumococcal vaccination is indicated for patients ≥ 65 years or those with chronic medical conditions.

Case-control studies have consistently shown efficacy in preventing invasive pneumococcal disease. Farr and colleagues found efficacy of 70% (95% confidence interval [CI], 37%–86%) among 2 groups of patients: those ≥ 2 years of age with chronic disease or those ≥ 65 years.4 A case-control study by Sims and colleagues also found the vaccine to have efficacy of 70% (95% CI, 37%– 86%) in preventing invasive pneumococcal disease in immunocompetent patients aged ≥ 55 years.5

Recommendations from others

The CDC Advisory Committee on Immunization Practices (ACIP) recommends pneumococcal vaccination of persons aged ≥65 years and those aged 2 to 64 who have chronic cardiovascular disease, chronic pulmonary disease, or diabetes mellitus (SOR: A).6

The ACIP also recommends the pneumococcal vaccine for persons aged 2 to 64 years who have alcoholism, chronic liver disease, or cerebrospinal fluid leaks (SOR: B).

The Canadian Task Force on Preventive Health Care endorses vaccination for immunocompetent patients 55 years residing in institutions (SOR: A).7

CLINICAL COMMENTARY

Paul Tatum, MD, MSPH
Department of Family Medicine, University of Colorado, Boulder.

The importance of pneumococcal vaccine for the elderly is well established. However, the vaccine is underused in long-term care settings, despite being indicated for most residents.

Patient confusion about the need for both influenza and pneumococcal vaccines, poor documentation of adult immunization status, poor availability of records from previous care facilities, and frequent changes in physician all contribute to low vaccination rates.

An optimal strategy to ensure high vaccination rates is to administer the pneumococcal vaccine to patients on admission to long-term care facilities. Patients who are uncertain about their vaccination status may safely receive the vaccine, as revaccination is relatively well tolerated.8

ACKNOWLEDGMENTS

The authors wish to thank Yves LeBlanc, MD, and Khalil Nasrallah, MD, for assistance with translation.

References

1. Gaillet J, Zmirou D, Mallaret MR, et al. Essai clinique du vaccin antipneumococcoique chez des personnees agees vivant en institution [Clinical trial of an antipneumococcal vaccine in elderly subjects living in institutions]. Rev Epidemiol Sante Publique 1985;33:437-44.

2. Kaufman P. Pneumonia in old age. Arch Intern Med 1947;79:518-31.

3. Centers for Disease Control and Prevention. Outbreaks of pneumococcal pneumonia among unvaccinated residents of a nursing home—New Jersey, April 2001. MMWR Morb Mortal Wkly Rep 2001;50:707-10.

4. Farr BM, Johnston BL, Cobb DK, et al. Preventing pneumococcal bacteremia in patients at risk. Arch Intern Med 1995;155:2336-40.

5. Sims RV, Steinmann WC, McConville JH, King LR, Zwick WC, Schwartz JS. The clinical effectiveness of pneumococcal vaccine in the elderly. Ann Intern Med 1988;108:653-7.

6. Centers for Disease Control and Prevention. Prevention of pneumococcal disease: recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 1997;46:1-24.

7. Wang EEL. Administration of pneumococcal vaccine. Canadian Task Force on Preventive Health Care 1994;385-6.

8. Jackson LA, Benson P, Sneller VP, et al. Safety of revaccination with pneumococcal polysaccharide vaccine. JAMA 1999;281:243-8.

References

1. Gaillet J, Zmirou D, Mallaret MR, et al. Essai clinique du vaccin antipneumococcoique chez des personnees agees vivant en institution [Clinical trial of an antipneumococcal vaccine in elderly subjects living in institutions]. Rev Epidemiol Sante Publique 1985;33:437-44.

2. Kaufman P. Pneumonia in old age. Arch Intern Med 1947;79:518-31.

3. Centers for Disease Control and Prevention. Outbreaks of pneumococcal pneumonia among unvaccinated residents of a nursing home—New Jersey, April 2001. MMWR Morb Mortal Wkly Rep 2001;50:707-10.

4. Farr BM, Johnston BL, Cobb DK, et al. Preventing pneumococcal bacteremia in patients at risk. Arch Intern Med 1995;155:2336-40.

5. Sims RV, Steinmann WC, McConville JH, King LR, Zwick WC, Schwartz JS. The clinical effectiveness of pneumococcal vaccine in the elderly. Ann Intern Med 1988;108:653-7.

6. Centers for Disease Control and Prevention. Prevention of pneumococcal disease: recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 1997;46:1-24.

7. Wang EEL. Administration of pneumococcal vaccine. Canadian Task Force on Preventive Health Care 1994;385-6.

8. Jackson LA, Benson P, Sneller VP, et al. Safety of revaccination with pneumococcal polysaccharide vaccine. JAMA 1999;281:243-8.

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