Generalizability of Blood Pressure Lowering Trials to Older Patients: Cross‐Sectional Analysis
BACKGROUND/OBJECTIVES Randomized controlled trials are used to inform clinical guidelines on the management of hypertension in older adults, but it is unclear to what extent these trials represent the general population attending routine clinical practice. This study aimed to define the proportion a...
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| Vydáno v: | Journal of the American Geriatrics Society (JAGS) Ročník 68; číslo 11; s. 2508 - 2515 |
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| Hlavní autoři: | , , , , , , , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
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Hoboken, USA
John Wiley & Sons, Inc
01.11.2020
Wiley Subscription Services, Inc |
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| ISSN: | 0002-8614, 1532-5415, 1532-5415 |
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| Abstract | BACKGROUND/OBJECTIVES
Randomized controlled trials are used to inform clinical guidelines on the management of hypertension in older adults, but it is unclear to what extent these trials represent the general population attending routine clinical practice. This study aimed to define the proportion and characteristics of patients eligible for hypertension trials conducted in older people.
DESIGN
Cross‐sectional study.
SETTING
A total of 24 general practices in England.
PARTICIPANTS
Anonymized electronic health record data from all individuals aged 80 and older.
MEASUREMENTS
Descriptive statistics were used to define the proportion and characteristics of patients eligible for two previous medication intensification trials (HYVET, SPRINT) and one medication reduction trial (OPTiMISE). A logistic regression model was constructed to estimate predictors of eligibility for each trial.
RESULTS
Of 15,376 patients identified, 268 (1.7%; 95% confidence interval [CI] = 1.5–2.0%), 5,290 (34.4%; 95%CI = 33.7–35.2%), and 3,940 (25.6%; 95%CI = 24.9–26.3%) were eligible for the HYVET, SPRINT, and OPTiMISE trials, respectively. Between 5.6% and 30.7% of exclusions from each trial were due to eligibility criteria excluding those with high or uncontrolled blood pressure. Frailty (odds ratio [OR] = .44; 95%CI = .36–.54 [OPTiMISE]), cardiovascular polypharmacy (OR = .61; 95%CI = .55–.68 [SPRINT]) and multimorbidity (OR = .72; 95%CI = .64–.82 [SPRINT]) were associated with a lower likelihood of being eligible for one or more of the trials.
CONCLUSION
A possible unintended consequence of blood pressure criteria used by trials attempting to answer different primary questions is that for many older patients, no trial evidence exists to inform treatment decisions in routine practice. Caution should be exercised when applying results from existing trials to patients with frailty or multimorbidity.
See related editorial by Jeff D. Williamson in this issue. |
|---|---|
| AbstractList | BACKGROUND/OBJECTIVESRandomized controlled trials are used to inform clinical guidelines on the management of hypertension in older adults, but it is unclear to what extent these trials represent the general population attending routine clinical practice. This study aimed to define the proportion and characteristics of patients eligible for hypertension trials conducted in older people.DESIGNCross‐sectional study.SETTINGA total of 24 general practices in England.PARTICIPANTSAnonymized electronic health record data from all individuals aged 80 and older.MEASUREMENTSDescriptive statistics were used to define the proportion and characteristics of patients eligible for two previous medication intensification trials (HYVET, SPRINT) and one medication reduction trial (OPTiMISE). A logistic regression model was constructed to estimate predictors of eligibility for each trial.RESULTSOf 15,376 patients identified, 268 (1.7%; 95% confidence interval [CI] = 1.5–2.0%), 5,290 (34.4%; 95%CI = 33.7–35.2%), and 3,940 (25.6%; 95%CI = 24.9–26.3%) were eligible for the HYVET, SPRINT, and OPTiMISE trials, respectively. Between 5.6% and 30.7% of exclusions from each trial were due to eligibility criteria excluding those with high or uncontrolled blood pressure. Frailty (odds ratio [OR] = .44; 95%CI = .36–.54 [OPTiMISE]), cardiovascular polypharmacy (OR = .61; 95%CI = .55–.68 [SPRINT]) and multimorbidity (OR = .72; 95%CI = .64–.82 [SPRINT]) were associated with a lower likelihood of being eligible for one or more of the trials.CONCLUSIONA possible unintended consequence of blood pressure criteria used by trials attempting to answer different primary questions is that for many older patients, no trial evidence exists to inform treatment decisions in routine practice. Caution should be exercised when applying results from existing trials to patients with frailty or multimorbidity. Randomized controlled trials are used to inform clinical guidelines on the management of hypertension in older adults, but it is unclear to what extent these trials represent the general population attending routine clinical practice. This study aimed to define the proportion and characteristics of patients eligible for hypertension trials conducted in older people. Cross-sectional study. A total of 24 general practices in England. Anonymized electronic health record data from all individuals aged 80 and older. Descriptive statistics were used to define the proportion and characteristics of patients eligible for two previous medication intensification trials (HYVET, SPRINT) and one medication reduction trial (OPTiMISE). A logistic regression model was constructed to estimate predictors of eligibility for each trial. Of 15,376 patients identified, 268 (1.7%; 95% confidence interval [CI] = 1.5-2.0%), 5,290 (34.4%; 95%CI = 33.7-35.2%), and 3,940 (25.6%; 95%CI = 24.9-26.3%) were eligible for the HYVET, SPRINT, and OPTiMISE trials, respectively. Between 5.6% and 30.7% of exclusions from each trial were due to eligibility criteria excluding those with high or uncontrolled blood pressure. Frailty (odds ratio [OR] = .44; 95%CI = .36-.54 [OPTiMISE]), cardiovascular polypharmacy (OR = .61; 95%CI = .55-.68 [SPRINT]) and multimorbidity (OR = .72; 95%CI = .64-.82 [SPRINT]) were associated with a lower likelihood of being eligible for one or more of the trials. A possible unintended consequence of blood pressure criteria used by trials attempting to answer different primary questions is that for many older patients, no trial evidence exists to inform treatment decisions in routine practice. Caution should be exercised when applying results from existing trials to patients with frailty or multimorbidity. Randomized controlled trials are used to inform clinical guidelines on the management of hypertension in older adults, but it is unclear to what extent these trials represent the general population attending routine clinical practice. This study aimed to define the proportion and characteristics of patients eligible for hypertension trials conducted in older people.BACKGROUND/OBJECTIVESRandomized controlled trials are used to inform clinical guidelines on the management of hypertension in older adults, but it is unclear to what extent these trials represent the general population attending routine clinical practice. This study aimed to define the proportion and characteristics of patients eligible for hypertension trials conducted in older people.Cross-sectional study.DESIGNCross-sectional study.A total of 24 general practices in England.SETTINGA total of 24 general practices in England.Anonymized electronic health record data from all individuals aged 80 and older.PARTICIPANTSAnonymized electronic health record data from all individuals aged 80 and older.Descriptive statistics were used to define the proportion and characteristics of patients eligible for two previous medication intensification trials (HYVET, SPRINT) and one medication reduction trial (OPTiMISE). A logistic regression model was constructed to estimate predictors of eligibility for each trial.MEASUREMENTSDescriptive statistics were used to define the proportion and characteristics of patients eligible for two previous medication intensification trials (HYVET, SPRINT) and one medication reduction trial (OPTiMISE). A logistic regression model was constructed to estimate predictors of eligibility for each trial.Of 15,376 patients identified, 268 (1.7%; 95% confidence interval [CI] = 1.5-2.0%), 5,290 (34.4%; 95%CI = 33.7-35.2%), and 3,940 (25.6%; 95%CI = 24.9-26.3%) were eligible for the HYVET, SPRINT, and OPTiMISE trials, respectively. Between 5.6% and 30.7% of exclusions from each trial were due to eligibility criteria excluding those with high or uncontrolled blood pressure. Frailty (odds ratio [OR] = .44; 95%CI = .36-.54 [OPTiMISE]), cardiovascular polypharmacy (OR = .61; 95%CI = .55-.68 [SPRINT]) and multimorbidity (OR = .72; 95%CI = .64-.82 [SPRINT]) were associated with a lower likelihood of being eligible for one or more of the trials.RESULTSOf 15,376 patients identified, 268 (1.7%; 95% confidence interval [CI] = 1.5-2.0%), 5,290 (34.4%; 95%CI = 33.7-35.2%), and 3,940 (25.6%; 95%CI = 24.9-26.3%) were eligible for the HYVET, SPRINT, and OPTiMISE trials, respectively. Between 5.6% and 30.7% of exclusions from each trial were due to eligibility criteria excluding those with high or uncontrolled blood pressure. Frailty (odds ratio [OR] = .44; 95%CI = .36-.54 [OPTiMISE]), cardiovascular polypharmacy (OR = .61; 95%CI = .55-.68 [SPRINT]) and multimorbidity (OR = .72; 95%CI = .64-.82 [SPRINT]) were associated with a lower likelihood of being eligible for one or more of the trials.A possible unintended consequence of blood pressure criteria used by trials attempting to answer different primary questions is that for many older patients, no trial evidence exists to inform treatment decisions in routine practice. Caution should be exercised when applying results from existing trials to patients with frailty or multimorbidity.CONCLUSIONA possible unintended consequence of blood pressure criteria used by trials attempting to answer different primary questions is that for many older patients, no trial evidence exists to inform treatment decisions in routine practice. Caution should be exercised when applying results from existing trials to patients with frailty or multimorbidity. See related editorial by Jeff D. Williamson in this issue. BACKGROUND/OBJECTIVES Randomized controlled trials are used to inform clinical guidelines on the management of hypertension in older adults, but it is unclear to what extent these trials represent the general population attending routine clinical practice. This study aimed to define the proportion and characteristics of patients eligible for hypertension trials conducted in older people. DESIGN Cross‐sectional study. SETTING A total of 24 general practices in England. PARTICIPANTS Anonymized electronic health record data from all individuals aged 80 and older. MEASUREMENTS Descriptive statistics were used to define the proportion and characteristics of patients eligible for two previous medication intensification trials (HYVET, SPRINT) and one medication reduction trial (OPTiMISE). A logistic regression model was constructed to estimate predictors of eligibility for each trial. RESULTS Of 15,376 patients identified, 268 (1.7%; 95% confidence interval [CI] = 1.5–2.0%), 5,290 (34.4%; 95%CI = 33.7–35.2%), and 3,940 (25.6%; 95%CI = 24.9–26.3%) were eligible for the HYVET, SPRINT, and OPTiMISE trials, respectively. Between 5.6% and 30.7% of exclusions from each trial were due to eligibility criteria excluding those with high or uncontrolled blood pressure. Frailty (odds ratio [OR] = .44; 95%CI = .36–.54 [OPTiMISE]), cardiovascular polypharmacy (OR = .61; 95%CI = .55–.68 [SPRINT]) and multimorbidity (OR = .72; 95%CI = .64–.82 [SPRINT]) were associated with a lower likelihood of being eligible for one or more of the trials. CONCLUSION A possible unintended consequence of blood pressure criteria used by trials attempting to answer different primary questions is that for many older patients, no trial evidence exists to inform treatment decisions in routine practice. Caution should be exercised when applying results from existing trials to patients with frailty or multimorbidity. See related editorial by Jeff D. Williamson in this issue. |
| Author | Hobbs, F.D. Richard Mollison, Jill Jowett, Sue Todd, Oliver Sheppard, James P. Lowe, Rebecca Mant, Jonathan Yu, Ly‐Mee Fraser, Rosalyn Ashby, Hannah Lown, Mark Ford, Gary A. Little, Paul Allen, Julie Williams, Marney McManus, Richard J. Temple, Eleanor Payne, Rupert Burt, Jenni Heneghan, Carl |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/32898307$$D View this record in MEDLINE/PubMed |
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| Keywords | cardiovascular disease frailty electronic health records randomized controlled trials hypertension |
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| Notes | in this issue. Jeff D. Williamson Part of these data were presented at these scientific meetings: Australia Association for Academic Primary Care, oral presentation, Adelaide, July 2019; European Society of Cardiology, poster presentation, Paris, August 2019; and North American Primary Care Research Group, poster presentation, Toronto 2019; All conference attendees were funded by the National Institute for Health Research School for Primary Care Research. See related editorial by ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 |
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| References | 2015; 13 2010; 58 2017; 65 2016; 387 2016; 71 2009; 338 2014; 174 2013; 5 2016; 6 2018; 8 2018; 39 2017; 71 2002; 360 2005; 365 2010; 28 2015; 175 2019; 48 2015; 373 2019 2014; 14 2018 2008; 358 2020; 68 2009; 7 2018; 71 2006; 127 2018; 34 2018; 36 2012; 41 2016; 45 2016; 67 e_1_2_6_32_1 e_1_2_6_10_1 e_1_2_6_31_1 e_1_2_6_30_1 National Guideline Centre (e_1_2_6_24_1) 2019 e_1_2_6_19_1 e_1_2_6_13_1 e_1_2_6_14_1 e_1_2_6_11_1 e_1_2_6_12_1 e_1_2_6_17_1 e_1_2_6_18_1 e_1_2_6_15_1 e_1_2_6_16_1 e_1_2_6_20_1 Sato I (e_1_2_6_21_1) 2013; 5 e_1_2_6_9_1 e_1_2_6_8_1 e_1_2_6_5_1 e_1_2_6_4_1 e_1_2_6_7_1 e_1_2_6_6_1 e_1_2_6_25_1 e_1_2_6_3_1 e_1_2_6_23_1 e_1_2_6_2_1 e_1_2_6_22_1 e_1_2_6_29_1 e_1_2_6_28_1 e_1_2_6_27_1 e_1_2_6_26_1 32947649 - J Am Geriatr Soc. 2020 Nov;68(11):2489-2491. doi: 10.1111/jgs.16750. |
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Randomized controlled trials are used to inform clinical guidelines on the management of hypertension in older adults, but it is unclear... See related editorial by Jeff D. Williamson in this issue. Randomized controlled trials are used to inform clinical guidelines on the management of hypertension in older adults, but it is unclear to what extent these... BACKGROUND/OBJECTIVESRandomized controlled trials are used to inform clinical guidelines on the management of hypertension in older adults, but it is unclear... |
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| SubjectTerms | Adults Aged, 80 and over Antihypertensive Agents - therapeutic use Blood Pressure cardiovascular disease Clinical medicine Clinical practice guidelines Clinical trials Criteria Cross-Sectional Studies Decision making Drugs electronic health records Electronic medical records Eligibility Determination Female Frailty General Practice - statistics & numerical data Generalizability Humans Hypertension Hypertension - drug therapy Male Medical decision making Medical records Medical research Medical treatment Older people Patient Selection Patients Prescription drugs randomized controlled trials Randomized Controlled Trials as Topic - statistics & numerical data Statistical analysis Statistics |
| Title | Generalizability of Blood Pressure Lowering Trials to Older Patients: Cross‐Sectional Analysis |
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