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Six monthly follow-up is as effective as 3 monthly follow-up for people with hypertension
ARTICLE IN PRESS Evidence-based Healthcare (2004) 8, 183–185
www.elsevier.com/locate/ebhc
EVIDENCE-BASED HEALTHCARE MANAGEMENT
Six monthly follow-up is as effective as 3 monthly follow-up for people with hypertension$ Mark R Nelson, MBBS(Hons), MFM, FRACGP, PhD, FAFPHM (Commentary Author) Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, Australia
KEYWORDS
Summary
Hypertension; Family practice;
Question In people with treated hypertension, how effective is 3 month follow-up by a family physician compared with 6 month follow-up, in terms of blood pressure control, patient satisfaction and adherence to drug treatment over 3 years?
Randomised controlled
Study design Randomised controlled trial.
Monitoring;
trial
Main results At 36 months, mean blood pressure, patient satisfaction and adherence to treatment was equivalent between treatment groups (see Table 1). Table 1 Outcome measures at 36 months for people receiving 3 or 6 month follow-up by a family practitioner.
% Participants with out of control blood pressure* Mean systolic blood pressure Mean diastolic blood pressure General satisfaction with clinical care % of participants answering ‘yes’ to the question: ‘Did I ever forget to take my pills?’
3 months (N ¼ 302)
6 months (N ¼ 307)
Difference (SE)
Equivalence 90% CIw
18%
16%
Not stated
133.50
135.84
2.35 (1.52)
4.84 to 0.15
81.70
81.45
0.25 (1.12)
1.61 to 2.11
73%
75%
2.69
5.76 to 0.38
78/263 (30%)
71/263 (27%)
2.96 (3.92)
3.48 to 9.41
*
As assessed by doctor; authors state no significant difference between groups, but statistics not presented.
$ Abstracted from: Birtwhistle RV, Godwin MS, Delva MD et al. Randomised equivalence trial comparing three and six months follow up of patients with hypertension by family practitioners. BMJ 2004; 328: 204–206.
1462-9410/$ - see front matter & 2004 Elsevier Ltd. All rights reserved. doi:10.1016/j.ehbc.2004.05.020
ARTICLE IN PRESS 184
M.R. Nelson w
If the 90% CI falls entirely within the predefined equivalence range (75 mmHg for both systolic and diastolic blood pressure and 710% for patient satisfaction and adherence), the groups are considered equivalent. Authors’ conclusions In people with controlled hypertension, 6 monthly follow-up is as effective as 3 monthly follow-up over 3 years for control of blood pressure, patient satisfaction and adherence to treatment, and has no effect on the proportion of participants with out of control blood pressure. & 2004 Elsevier Ltd. All rights reserved.
Commentary The management of hypertension in general practice remains problematic. In Australia it is the most frequently managed problem in primary care and yet, as elsewhere, is dogged by unidentified, untreated, or under treated cases.1 Birtwhistle et al. conducted a pragmatic randomised equivalence trial in the Canadian family practice setting, comparing three and six monthly family physician visit regimens of ‘controlled’ hypertensive patients. Outcomes measured were clinic and home systolic and diastolic blood pressure (mean and percentage at goal), patient satisfaction, and adherence to medication. Participants were followed for an average 33.6 months (range not specified). The authors found no significant differences between groups for the end-points studied and, as to be expected, those with a 6 month visit schedule had fewer physician visits. Most hypertension is managed in primary care and therefore it is appropriate, indeed imperative, that research be conducted in this setting. Any trial that seeks to reduce the workload of family practitioners by reprioritising the frequency of controlled hypertensive patient review is welcome as there are plenty in the community who could potentially benefit. Unfortunately the pool of patients that could have their visits reduced is low as evidenced in this study. Only 13% of hypertensive patients in the Canadian family practices collaborating in this trial met inclusion criteria for ‘‘controlled’’ blood pressure (o140/ 90 mmHg for aged p40 years, o150/95 mmHg 41– 59 years, or o160/95 mmHg in patients 60 years plus) for at least 3 months prior to study entry. These definitions are high and by now historic and reflect the long recruitment period (November 1997 to July 2002) of the trial. The authors acknowledge this, and the analysis is based on lower blood pressure goals of o140/90 mmHg for all ages. Over this period there has been a shift from the management of hypertension in isolation to management based on absolute cardiovascular
risk.2,3 Frequency of visits is likely to depend upon the presence of other cardiovascular risk factors or disease, and the need for their management. Frequency of review advice should therefore be based on absolute cardiovascular risk rather than the level of a single risk factor such as blood pressure.
Study parameters Question
In people with treated hypertension, how effective is 3 month follow-up by a family physician compared with 6 month follow-up, in terms of blood pressure control, patient satisfaction and adherence to drug treatment over 3 years?
Study design Randomised controlled trial. Setting
Fifty family practices in south eastern Ontario, Canada; November 1997 to July 2002.
Participants 609 people aged between 30 and 74 years with a diagnosis of essential hypertension. People were included if they were taking at least one antihypertensive drug and had controlled blood pressure (defined initially as o140/90 mmHg in people aged p40 years, o150/95 mmHg in people aged between 41 and 59 and o160/ 95 mmHg in people aged X60 years; see notes) for a minimum of 3 months before study entry. People were excluded if they were pregnant, were receiving hypertension follow-up by a specialist, or if the family doctor decided that randomisation to 6 month follow-up was unsuitable due to other medical problems requiring more frequent follow-up.
ARTICLE IN PRESS Commentary on: Six monthly follow-up is as effective as 3 monthly follow-up
Intervention People were randomised to 3 month or 6 month follow-up by their family doctor for 3 years. In either case, the doctor saw the participant earlier if their blood pressure was out of control, if there were other medical reasons requiring a more frequent follow-up, or if there had been a change of drug. Mean follow-up was 33.6 months. Main outcomes
Notes
Blood pressure measurement (in the participant’s home and doctor’s surgery); blood pressure control (assessed according to whether or not the recommended target blood pressure had been achieved; see notes); patient satisfaction (assessed with a validated questionnaire), and adherence to drug treatment (assessed by questionnaire and pill counts). Participants were considered adherent if they consumed X80% of their medication. Analyses were based on current recommendations for blood pressure control, which are o140/90 mmHg for all ages. Differences in outcome measures between treatment groups were obtained
185
using generalised estimating equations models and 90% CI’s were constructed. Outcomes were considered ‘equivalent’ when the confidence intervals fell within predefined equivalence margins: 75 mmHg for both systolic and diastolic blood pressure and 710% for patient satisfaction and adherence. There was no significant difference between treatment groups in the number of unscheduled visits for blood pressure measurement or for unrelated reasons. Sources of funding: This study was funded by the Canadian Institute for Health Research; McKnight Fund of Queen’s University. Abstract provided by Bazian Ltd, London.
References 1. Britt H, Miller GC, Knox S, Charles J, Valenti L, Henderson J, et al. 2002 General practice activity in Australia 2001-02. AIHW Cat. No. GEP 10. Canberra: Australian Institute of Health and Welfare (General Practice Series No. 10). 2. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL, et al. The seventh report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. JAMA 2003;289:2560–72. 3. National Blood Pressure Advisory Committee. Guide to the Management of Hypertension for Doctors 2004. Canberra: National Heart Foundation of Australia; 2003.
www.elsevier.com/locate/ebhc
EVIDENCE-BASED HEALTHCARE MANAGEMENT
Six monthly follow-up is as effective as 3 monthly follow-up for people with hypertension$ Mark R Nelson, MBBS(Hons), MFM, FRACGP, PhD, FAFPHM (Commentary Author) Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, Australia
KEYWORDS
Summary
Hypertension; Family practice;
Question In people with treated hypertension, how effective is 3 month follow-up by a family physician compared with 6 month follow-up, in terms of blood pressure control, patient satisfaction and adherence to drug treatment over 3 years?
Randomised controlled
Study design Randomised controlled trial.
Monitoring;
trial
Main results At 36 months, mean blood pressure, patient satisfaction and adherence to treatment was equivalent between treatment groups (see Table 1). Table 1 Outcome measures at 36 months for people receiving 3 or 6 month follow-up by a family practitioner.
% Participants with out of control blood pressure* Mean systolic blood pressure Mean diastolic blood pressure General satisfaction with clinical care % of participants answering ‘yes’ to the question: ‘Did I ever forget to take my pills?’
3 months (N ¼ 302)
6 months (N ¼ 307)
Difference (SE)
Equivalence 90% CIw
18%
16%
Not stated
133.50
135.84
2.35 (1.52)
4.84 to 0.15
81.70
81.45
0.25 (1.12)
1.61 to 2.11
73%
75%
2.69
5.76 to 0.38
78/263 (30%)
71/263 (27%)
2.96 (3.92)
3.48 to 9.41
*
As assessed by doctor; authors state no significant difference between groups, but statistics not presented.
$ Abstracted from: Birtwhistle RV, Godwin MS, Delva MD et al. Randomised equivalence trial comparing three and six months follow up of patients with hypertension by family practitioners. BMJ 2004; 328: 204–206.
1462-9410/$ - see front matter & 2004 Elsevier Ltd. All rights reserved. doi:10.1016/j.ehbc.2004.05.020
ARTICLE IN PRESS 184
M.R. Nelson w
If the 90% CI falls entirely within the predefined equivalence range (75 mmHg for both systolic and diastolic blood pressure and 710% for patient satisfaction and adherence), the groups are considered equivalent. Authors’ conclusions In people with controlled hypertension, 6 monthly follow-up is as effective as 3 monthly follow-up over 3 years for control of blood pressure, patient satisfaction and adherence to treatment, and has no effect on the proportion of participants with out of control blood pressure. & 2004 Elsevier Ltd. All rights reserved.
Commentary The management of hypertension in general practice remains problematic. In Australia it is the most frequently managed problem in primary care and yet, as elsewhere, is dogged by unidentified, untreated, or under treated cases.1 Birtwhistle et al. conducted a pragmatic randomised equivalence trial in the Canadian family practice setting, comparing three and six monthly family physician visit regimens of ‘controlled’ hypertensive patients. Outcomes measured were clinic and home systolic and diastolic blood pressure (mean and percentage at goal), patient satisfaction, and adherence to medication. Participants were followed for an average 33.6 months (range not specified). The authors found no significant differences between groups for the end-points studied and, as to be expected, those with a 6 month visit schedule had fewer physician visits. Most hypertension is managed in primary care and therefore it is appropriate, indeed imperative, that research be conducted in this setting. Any trial that seeks to reduce the workload of family practitioners by reprioritising the frequency of controlled hypertensive patient review is welcome as there are plenty in the community who could potentially benefit. Unfortunately the pool of patients that could have their visits reduced is low as evidenced in this study. Only 13% of hypertensive patients in the Canadian family practices collaborating in this trial met inclusion criteria for ‘‘controlled’’ blood pressure (o140/ 90 mmHg for aged p40 years, o150/95 mmHg 41– 59 years, or o160/95 mmHg in patients 60 years plus) for at least 3 months prior to study entry. These definitions are high and by now historic and reflect the long recruitment period (November 1997 to July 2002) of the trial. The authors acknowledge this, and the analysis is based on lower blood pressure goals of o140/90 mmHg for all ages. Over this period there has been a shift from the management of hypertension in isolation to management based on absolute cardiovascular
risk.2,3 Frequency of visits is likely to depend upon the presence of other cardiovascular risk factors or disease, and the need for their management. Frequency of review advice should therefore be based on absolute cardiovascular risk rather than the level of a single risk factor such as blood pressure.
Study parameters Question
In people with treated hypertension, how effective is 3 month follow-up by a family physician compared with 6 month follow-up, in terms of blood pressure control, patient satisfaction and adherence to drug treatment over 3 years?
Study design Randomised controlled trial. Setting
Fifty family practices in south eastern Ontario, Canada; November 1997 to July 2002.
Participants 609 people aged between 30 and 74 years with a diagnosis of essential hypertension. People were included if they were taking at least one antihypertensive drug and had controlled blood pressure (defined initially as o140/90 mmHg in people aged p40 years, o150/95 mmHg in people aged between 41 and 59 and o160/ 95 mmHg in people aged X60 years; see notes) for a minimum of 3 months before study entry. People were excluded if they were pregnant, were receiving hypertension follow-up by a specialist, or if the family doctor decided that randomisation to 6 month follow-up was unsuitable due to other medical problems requiring more frequent follow-up.
ARTICLE IN PRESS Commentary on: Six monthly follow-up is as effective as 3 monthly follow-up
Intervention People were randomised to 3 month or 6 month follow-up by their family doctor for 3 years. In either case, the doctor saw the participant earlier if their blood pressure was out of control, if there were other medical reasons requiring a more frequent follow-up, or if there had been a change of drug. Mean follow-up was 33.6 months. Main outcomes
Notes
Blood pressure measurement (in the participant’s home and doctor’s surgery); blood pressure control (assessed according to whether or not the recommended target blood pressure had been achieved; see notes); patient satisfaction (assessed with a validated questionnaire), and adherence to drug treatment (assessed by questionnaire and pill counts). Participants were considered adherent if they consumed X80% of their medication. Analyses were based on current recommendations for blood pressure control, which are o140/90 mmHg for all ages. Differences in outcome measures between treatment groups were obtained
185
using generalised estimating equations models and 90% CI’s were constructed. Outcomes were considered ‘equivalent’ when the confidence intervals fell within predefined equivalence margins: 75 mmHg for both systolic and diastolic blood pressure and 710% for patient satisfaction and adherence. There was no significant difference between treatment groups in the number of unscheduled visits for blood pressure measurement or for unrelated reasons. Sources of funding: This study was funded by the Canadian Institute for Health Research; McKnight Fund of Queen’s University. Abstract provided by Bazian Ltd, London.
References 1. Britt H, Miller GC, Knox S, Charles J, Valenti L, Henderson J, et al. 2002 General practice activity in Australia 2001-02. AIHW Cat. No. GEP 10. Canberra: Australian Institute of Health and Welfare (General Practice Series No. 10). 2. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL, et al. The seventh report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. JAMA 2003;289:2560–72. 3. National Blood Pressure Advisory Committee. Guide to the Management of Hypertension for Doctors 2004. Canberra: National Heart Foundation of Australia; 2003.