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BP Control 3 Months Vs 6 Months
BP Control 3 Months Vs 6 Months
BP Control 3 Months Vs 6 Months
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Cite this article as: BMJ, doi:10.1136/bmj.37967.374063.EE (published 15 January 2004)
Primary care
Abstract people need lifelong medical care and follow up, and their doc-
tors must decide how often to follow up for blood pressure con-
Objective To compare blood pressure control, satisfaction, and trol and monitoring of treatment.
adherence to drug treatment in patients with treated Currently, the suggested intervals for follow up of
hypertension followed up by their family physicians either every hypertension come from consensus guidelines. The National
three months or every six months for three years. Committee on Detection, Evaluation and Treatment of High
Design Randomised equivalence clinical trial. Blood pressure (JNC7) recommends that once the blood
Settings 50 family practices in south eastern Ontario, Canada. pressure is stabilised, follow up every 3-6 months is appropriate.4
Participants 609 patients aged 30-74 years with essential The British Hypertension Society says that follow up depends on
hypertension receiving drug treatment whose hypertension had the severity of hypertension, variability of blood pressure,
been controlled for at least three months before entry into the complexity of treatment regimen, patient’s compliance with
study. treatment, and the need for non-pharmacological advice. After
Results 302 patients were randomly assigned to follow up every blood pressure is controlled, follow up every three months
three months and 307 to follow up every six months. Baseline should be adequate and the interval should generally not exceed
variables in the two groups were similar. As expected, patients six months.5 The 1999 Canadian consensus guidelines
in the six month group had significantly fewer visits, but recommend similar intervals.6 All of these recommendations are
patients in both groups visited their doctor more frequently based on level 3 evidence. Several studies have assessed doctors’
than their assigned interval. Mean blood pressure was similar in practices of treating patients with hypertension. Some saw
the groups, as was control of hypertension. Patient satisfaction patients every two weeks, some once a year.7–10 As McDonald has
and adherence to treatment were similar in the groups. About suggested, perhaps the three and six month follow up intervals
20% of patients in each group had blood pressures that were are based on phases of the moon because nothing better exists.11
out of control during the study. The hypertension follow up interval study began in Novem-
Conclusions Follow up of patients with treated essential ber 1997 and ended in July 2002. It is a randomised equivalence
hypertension every six months is equivalent to follow up every trial comparing three month and six month follow up of patients
three months. Patient satisfaction and adherence to treatment whose essential hypertension had been treated and controlled
are the same for these follow up intervals. As about 20% of for at least three months before entry into the study. This was
patients’ hypertension was out of control at any time during the designed as a pragmatic trial of the follow up of people with
study in both groups, the frequency of follow up may not the hypertension. Decisions about treatment after the initial
most important factor in the control of patients’ hypertension randomisation were left to the family doctor and the patient. The
by family practitioners. study was designed to determine whether blood pressure
control, adherence to treatment, and patient satisfaction were
Introduction equivalent between the groups after three years of follow up. We
also assessed cost of care, which will be addressed elsewhere. The
One of the achievements of contemporary health care is the figure shows the flow of patients through the trial.
decrease in morbidity and mortality through the control of
chronic cardiovascular conditions such as hypertension. The
mortality from cardiovascular disease has fallen by a third over
Methods
the past 25 years, and although the reasons for this have not Study population
been clearly established, control of hypertension may be a One hundred and thirty family doctors in the region of
central reason.1 However, control of blood pressure by patients Kingston, Ontario, were asked to participate in the study; 50
and their doctors is still far from ideal. The Canada heart health agreed and enrolled their patients. Patients were eligible for the
survey found that only about 13% of Canadians with study if they were between the ages of 30 and 74, had a diagno-
hypertension were adequately controlled.2 This result was even sis of essential hypertension, were taking at least one antihyper-
lower than the 25% found in the US National Health and Nutri- tensive drug, and had controlled blood pressure for at least three
tion Examination Survey (NHANES III).3 After initial diagnosis months before entry. Control meant blood pressure was
and treatment of chronic diseases such as hypertension, most < 140/90 mm Hg in patients aged 40 or less, < 150/95 in
Table 3 Mean (SE) numbers of systolic and diastolic blood pressure measurements (mm Hg) in patients with hypertension by family doctors
Blood pressure
Time (months) No of patients 3 month group 6 month group Difference Equivalence 90% CI*
Systolic blood pressure
0 605 140.62 (1.15) 141.16 (1.10) −0.53 (1.18) −2.48 to 1.42
12 503 139.82 (1.16) 139.87 (1.08) −0.05 (1.21) −2.04 to 1.94
18 494 138.58 (0.95) 139.32 (1.13) −0.74 (1.09) −2.54 to 1.05
24 486 140.34 (1.25) 141.51 (1.06) −1.17 (1.49) −3.61 to 1.27
36 386 137.55 (1.36) 138.52 (1.12) −0.98 (1.54) −3.50 to 1.55
Diastolic blood pressure
0 605 84.89 (0.56) 83.69 (0.61) 1.21 (0.55) 0.30 to 2.11
12 503 83.55 (0.74) 83.53 (0.61) 0.01 (0.78) −1.21 to 1.29
18 494 83.55 (0.60) 82.83 (0.70) 0.71 (0.59) −0.26 to 1.68
24 486 83.48 (0.74) 83.71 (0.63) −0.22 (0.83) −1.59 to 1.14
36 386 82.29 (0.66) 81.18 (0.79) 1.11 (0.81) −0.21 to 2.44
*If the 90% CI falls entirely within the equivalence range (±5 mm Hg), the groups are considered equivalent.
Table 4 Mean (SE) systolic and diastolic blood pressure (mm Hg) measured by nurses
Time (months) No of patients 3 month group 6 month group Difference (SE) 90% CI*
Systolic blood pressure
0 608 141.82 (1.36) 143.26 (1.33) −1.44 (1.35) −3.65 to 0.77
18 524 134.45 (0.88) 136.08 (1.09) −1.64 (1.12) −3.49 to 0.21
36 515 133.50 (1.35) 135.84 (1.23 −2.35 (1.52) −4.84 to 0.15
Diastolic blood pressure
0 608 84.80 (0.68) 84.52 (0.57) 0.28 (0.68) −0.84 to 1.40
18 524 79.43 (0.57) 78.83 (0.52) 0.60 (0.74) −0.61 to 1.82
36 515 81.70 (0.91) 81.45 (0.88) 0.25 (1.12) −1.61 to 2.11
*If the 90% CI falls entirely within the equivalence range (±5 mm Hg), the groups are considered equivalent.
Table 6 Patients’ satisfaction with their care. Values are numbers (percentages) unless otherwise indicated
Table 7 Patients’ satisfaction with their doctor’s care of their hypertension. Values are numbers (percentages) unless otherwise indicated
Variable Time (months) 3 month group 6 month group Difference (% (SE)) Equivalence 90% CI*
My doctor checks my blood pressure 0 280/298 (94) 270/297 (91) 2.61 (1.95) −0.60 to 5.82
often enough 36 255/263 (97) 247/263 (94) 3.00 (1.30) −0.87 to 5.13
My doctor does not take my blood 0 17/298 (6) 20/297 (7) −1.03 (2.05) −4.4 to 2.34
pressure problem seriously 36 15/263 (6) 23/263 (9) −3.35 (1.76) −6.24 to −0.46
I am satisfied with my doctor’s care 0 28/298 (96) 28/297 (94) 2.05 (1.70) −0.74 to 4.84
of my blood pressure 36 252/263 (96) 247/263 (94) 2.28 (1.65) −0.44 to 5.0
I understand why I have to take 0 283/298 (95) 291/297 (98) −3.04 (1.62) −5.71 to −0.37
medicine to control my blood
pressure 36 255/263 (97) 255/263 (97) −0.03 (1.41) −2.35 to 2.30
Visiting my doctor for my blood 0 20/298 (7) 14/297 (5) 1.97 (1.66) −0.77 to 4.70
pressure takes too much time 36 20/263 (8) 17/263 (6) 1.09 (2.05) −2.27 to 4.46
Number of responses vary due to missing data on questionnaires.
*If the 90% CI falls entirely within the equivalence range (±10%), the groups are considered equivalent.
Table 8 Adherence to treatment by hypertensive patients. Values are numbers (percentages) of patients unless specified otherwise
Variable Time (months) 3 month group 6 month group Difference (% (SE)) Equivalence 90% CI*
Do you ever forget to take your 0 110/298 (37) 83/297 (29) 7.50 (3.91) 1.07 to 13.92
blood pressure pills? 36 78/263 (30) 71/263 (27) 2.96 (3.92) −3.48 to 9.41
Are you careless at times about 0 26/298 (9) 24/297 (8) 0.61 (2.04) −2.74 to 3.96
taking your medicine? 36 19/263 (7) 23/263 (9) −1.56 (2.24) −5.25 to 2.13
Do you sometimes stop taking 0 7/298 (2) 7/297 (2) 0.01 (1.35) −2.21 to 2.22
your medicine? 36 3/263 (1) 5/263 (2) −0.76 (1.24) −2.80 to 1.28
If you feel worse when you take 0 17/298 (6) 11/297 (4) 1.92 (1.74) −0.95 to 4.78
the medicine, do you stop taking
it? 36 10/263 (4) 12/260 (4) −0.81 (1.65) −3.52 to 1.90
18
Standard error of the difference is estimated by the delta method.
*If the 90% CI falls entirely within the equivalence range (±10%), the groups are considered equivalent.
14 Baker R. Dialogue 3rd edition, a method for surveying patient satisfaction. Leicester: Clinical 20 Phillips LS, Branch WT, Cook CB, Doyle JP, El-Kebbi IM, Gallina DL et al. Clinical iner-
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Primary Health Care, University of Leicester, 2001.
15 Gregoire JP, Archambault A, Contrandriopoulos AP, Guilbert R. Medication (Accepted 26 November 2003)
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16 Dunnet CW, Gent M. Significance testing to establish equivalence between treatments, doi 10.1136/bmj.37967.374063.EE
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17 Hsu JC, Hwang JT, Liu HK, Ruberg SJ. Confidence intervals associated with tests for
bioequivalence. Biometrika 1994;81:103-14. Centre for Studies in Primary Care, Queen’s University, PO Bag 8888, Kingston,
18 Diggle PJ, Liang KY, Zegler SL. The analysis of longitudinal data. New York: Oxford Uni- ON, Canada K7L 5E9
versity Press, 1994. Richard V Birtwhistle professor of family medicine
19 Agresti A. Categorical data analysis. New York: Wiley, 1990:419. Marshall S Godwin professor of family medicine