scholarly journals Examining the effectiveness of telemonitoring with routinely acquired blood pressure data in primary care: challenges in the statistical analysis

2021 ◽  
Author(s):  
Richard Parker ◽  
Paul Padfield ◽  
Janet Hanley ◽  
Hilary Pinnock ◽  
John Kennedy ◽  
...  

Abstract Background Scale-up BP was a quasi-experimental implementation study, following a successful randomised controlled trial of the roll-out of telemonitoring in primary care across Lothian, Scotland. Our primary objective was to assess the effect of telemonitoring on blood pressure (BP) control using routinely collected data. Telemonitored systolic and diastolic BP were compared with surgery BP measurements from patients not using telemonitoring (comparator patients). The statistical analysis and interpretation of findings was challenging due to the broad range of biases potentially influencing the results, including differences in the frequency of readings, ‘white coat effect’, end digit preference, and missing data. Methods Four different statistical methods were employed in order to minimise the impact of these biases on the comparison between telemonitoring and comparator groups. These methods were “standardisation with stratification”, “standardisation with matching”, “regression adjustment for propensity score” and “random coefficient modelling”. The first three methods standardised the groups so that all participants provided exactly two measurements at baseline and 6-12 months follow-up prior to analysis. . The fourth analysis used linear mixed modelling based on all available data. Results The standardisation with stratification analysis showed a significantly lower systolic BP in telemonitoring patients at 6-12 months follow-up (-3.42, 95% CI -1.72 to -5.11, p<0.001). For the standardisation with matching and regression adjustment for propensity score analyses systolic BP was also significantly lower (-5.96, 95% CI -3.55 to -8.36, p<0.001) and (-3.73, -5.34 to -2.13, p<0.001) respectively, even after assuming that -5 of the difference was due to ‘white coat effect’. For the random coefficient modelling, the improvement in systolic BP was estimated to be -4.68 (95% CI -3.12 to -6.24, p<0.001) after one year.Conclusions The four analyses provide additional evidence for the effectiveness of telemonitoring in controlling BP in routine primary care. The random coefficient analysis is particularly recommended due to its ability to utilise all available data. However, adjusting for the complex array of biases was difficult. Researchers should appreciate the potential for bias in implementation studies and seek to acquire a detailed understanding of the study context in order to design appropriate analytical approaches.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Richard A. Parker ◽  
Paul Padfield ◽  
Janet Hanley ◽  
Hilary Pinnock ◽  
John Kennedy ◽  
...  

Abstract Background Scale-up BP was a quasi-experimental implementation study, following a successful randomised controlled trial of the roll-out of telemonitoring in primary care across Lothian, Scotland. Our primary objective was to assess the effect of telemonitoring on blood pressure (BP) control using routinely collected data. Telemonitored systolic and diastolic BP were compared with surgery BP measurements from patients not using telemonitoring (comparator patients). The statistical analysis and interpretation of findings was challenging due to the broad range of biases potentially influencing the results, including differences in the frequency of readings, ‘white coat effect’, end digit preference, and missing data. Methods Four different statistical methods were employed in order to minimise the impact of these biases on the comparison between telemonitoring and comparator groups. These methods were “standardisation with stratification”, “standardisation with matching”, “regression adjustment for propensity score” and “random coefficient modelling”. The first three methods standardised the groups so that all participants provided exactly two measurements at baseline and 6–12 months follow-up prior to analysis. The fourth analysis used linear mixed modelling based on all available data. Results The standardisation with stratification analysis showed a significantly lower systolic BP in telemonitoring patients at 6–12 months follow-up (-4.06, 95% CI -6.30 to -1.82, p < 0.001) for patients with systolic BP below 135 at baseline. For the standardisation with matching and regression adjustment for propensity score analyses, systolic BP was significantly lower overall (− 5.96, 95% CI -8.36 to − 3.55 , p < 0.001) and (− 3.73, 95% CI− 5.34 to − 2.13, p < 0.001) respectively, even after assuming that − 5 of the difference was due to ‘white coat effect’. For the random coefficient modelling, the improvement in systolic BP was estimated to be -3.37 (95% CI -5.41 to -1.33 , p < 0.001) after 1 year. Conclusions The four analyses provide additional evidence for the effectiveness of telemonitoring in controlling BP in routine primary care. The random coefficient analysis is particularly recommended due to its ability to utilise all available data. However, adjusting for the complex array of biases was difficult. Researchers should appreciate the potential for bias in implementation studies and seek to acquire a detailed understanding of the study context in order to design appropriate analytical approaches.


2020 ◽  
Author(s):  
Richard Parker ◽  
Paul Padfield ◽  
Janet Hanley ◽  
Hilary Pinnock ◽  
John Kennedy ◽  
...  

Abstract BackgroundScale-up BP was a quasi-experimental implementation study, following a successful randomised controlled trial of the roll-out of telemonitoring in primary care across Lothian, Scotland. Our primary objective was to assess the effect of telemonitoring on blood pressure (BP) control using routinely collected data. Telemonitored systolic and diastolic BP were compared with surgery BP measurements from patients not using telemonitoring (comparator patients). The statistical analysis and interpretation of findings was challenging due to the broad range of biases potentially influencing the results, including differences in the frequency of readings, ‘white coat effect’, end digit preference, and missing data.MethodsThree different statistical methods were employed in order to minimise the impact of these biases on the comparison between telemonitoring and comparator groups. These methods were “standardisation with stratification”, “standardisation with matching”, and “random coefficient modelling”. The first two methods standardised the groups so that all participants provided exactly two measurements at baseline and 6-12 months follow-up before using stratification or matched cohort analysis to compare the groups. The third analysis used linear mixed modelling based on all available data. ResultsThe standardisation with stratification analysis showed a significantly lower systolic BP in telemonitoring patients at 6-12 months follow-up (-3.42, 95% CI -1.72 to -5.11, p<0.001). For the standardisation with matching analysis, systolic BP was also significantly lower (-5.96, 95% CI -3.55 to -8.36, p<0.001), even after assuming that -5 of the difference was due to ‘white coat effect’. For the random coefficient modelling, the improvement in systolic BP was estimated to be -4.68 (95% CI -3.12 to -6.24, p<0.001) after one year. ConclusionsThe three analyses provide additional evidence for the effectiveness of telemonitoring in controlling BP in routine primary care. However, adjusting for the complex array of biases was difficult. Researchers should appreciate the potential for bias in implementation studies and seek to acquire a detailed understanding of the study context in order to design appropriate analytical approaches.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
B S Stender ◽  
J Stender

Abstract Introduction The gold standard in non-invasive assessment of blood pressure (BP) is 24-hour ambulatory BP measurement (24h-ABPM) due to frequent “office-” or “white coat hypertension” effects by measurement in the clinic. But 24h-ABPM is demanding, patients may report discomfort and stress from disturbed sleep. We compared BP measured automatically during one hour (1h-BP) in the waiting room of our clinic with that of 24h-ABPM among elderly hypertensives. Our aim was to investigate whether this less stressful procedure may replace 24h-ABPM in the outpatient follow-up of hypertensives. Hypotheses I) Mean diastolic and systolic BP values measured during one hour in a clinic equal those obtained by 24h-ABPM. II) The minimal BP during 1h-BP measurement equals mean 24h-BP during sleep. Material and methods The population comprised patients referred with known or suspected hypertension. Office BP was measured with Omron M7 Intelli IT. An ABPM apparatus reprogrammed to every 5 min. for one hour was mounted, and 1h-BP was obtained with the patient seated in the waiting room. 24h-ABPM was then performed at home. 110 patients were considered, 11 were excluded due to reported pain, stress or changes of medication, leaving 99 (m/f 32/66, age (SD) 70 (11)) for analysis. Sample size was set in a pilot study by a=0.05, b=0.05, effect size of BP differences systolic 5 (SD 13) and diastolic 3 (SD 8) mmHg. Results were analyzed with Student's paired t-test. Results We found a significant BP drop from office- to 1h- and 24h- BP measurements, i.e. a “white coat” effect. However, mean systolic 1h-BP and mean systolic 24h-BP did not differ, neither did minimal systolic 1h-BP and mean systolic 24h-BP during sleep. Mean diastolic 1h-BP was 4 mm Hg higher than that of 24h-ABPM, and minimal diastolic 1h-BP was 4 mmHg higher than mean diastolic 24h-BP during sleep. mmHg avg (SD) Office-BP 1h-BP mean 24h-BP mean 1h-BP minimum 24h-BPs mean during sleep Systolic 155 (18) 136 (13)* 135 (11)* 127 (12) 127 (13) Diastolic 90 (11) 80 (9)* 76 (8)* 74 (9) 70 (7) *“White-coat effect” significant in comparison with office-BP. No difference between mean systolic 1h-BP and mean systolic 24h-BP, p=0.67. No difference between mean diastolic 1h-BP minus 4 and mean diastolic 24h-BP, p=0.92. No difference between systolic 1h-BP minimum and mean systolic 24h-BP during sleep, p=0.65. Conclusion BP measurement for one hour in the waiting room by an ABPM apparatus may provide sufficient elimination of “office-” or “white coat effects” to replace 24h-ABPM in selected instances. The finding should be challenged in different clinical subpopulations to ensure general applicability.


2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Xavier Humbert ◽  
Sophie Fedrizzi ◽  
Joachim Alexandre ◽  
Alessandro Menotti ◽  
Alain Manrique ◽  
...  

AbstractTo assess the impact of sex on office white-coat effect tail (OWCET), the waning of systolic blood pressure (SBP) after its waxing during office visit, on the incidence of long-term major fatal and non-fatal events in two Italian residential cohorts [from the Gubbio Study and the Italian Rural Areas of the Seven Countries Study (IRA)]. There were 3565 persons (92 with missing data, 44% men, 54 ± 11 years) included in the Gubbio and 1712 men (49 ± 5 years) in the IRA studies. OWCET was defined as a decrease of ≥10 mmHg in SBP between successive measurements with slight measurement differences between the two cohorts. Cardiovascular (CVD), coronary heart disease (CHD) and stroke (STR) incidences were considered. Over an approximately 20-year follow-up, women with OWCET had an increased risk of CVD [HR: 1.591 (95%CI: 1.204–2.103)], CHD [HR: 1.614 (95%CI: 1.037–2.512)] and STR [HR: 1.696 (95%CI: 1.123–2.563)] events independently of age, serum and HDL cholesterol, cigarettes, BMI and SBP in the Gubbio study. However, there was no increased risk of CVD, CHD or STR in men with OWCET neither in the Gubbio 20-year follow-up nor in the IRA 50-year follow-up. These results were not modified significantly by the correction of the regression dilutions bias between the first and the subsequent SBP measurements. Thus, in primary care, OWCET should be actively evaluated in women as it can improve stratification of long-term CVD, CHD and STR risks.


2004 ◽  
Vol 57 (7) ◽  
pp. 652-660
Author(s):  
Francisco Villalba Alcalá ◽  
José Lapetra Peralta ◽  
Eduardo Mayoral Sánchez ◽  
Antonio Espino Montoro ◽  
Aurelio Cayuela Domínguez ◽  
...  

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
F Saladini ◽  
C Fania ◽  
L Mos ◽  
A Mazzer ◽  
O Vriz ◽  
...  

Abstract Aim The prognostic significance of different hypertension subtypes in young hypertensives, in particular of isolated systolic hypertensives (ISHs) is still debated. The aim of the present study was to investigate clinical and haemodynamic characteristics and blood pressure (BP) evolution of different hypertension subtypes in young stage I hypertensives. Methods We investigated 1206 young subjects from the HARVEST study: 81 normotensives (NTs), 146 ISHs, 281 isolated diastolic hypertensives (IDHs) and 698 systolic-diastolic hypertensives (SDHs) according to office BP values at baseline. Data on baseline haemodynamic and metabolic characteristics, BP and heart rate changes during follow-up (mean 7 years) were collected. ANCOVA analysis was used for all comparisons adjusting for age and sex. Results Males were more frequent among ISHs (90.4%) compared to other categories (70.4, 67.3, 71.5% among NTs, IDHs, SHDs). Moreover, ISHs were younger compared to the others (25.6±6.6 years, p&lt;0.001) and thinner compared to SDHs (24.6±.2.6 vs 25.8±3.6 kg/m2, p=0.028). Heart rate was higher among ISHs (75.7±9.4 bpm) and SDHs (75.8±9.7) compared to other categories (p&lt;0.001). Metabolic characteristics were not significantly different among groups. ISHs were more active in sports (55.5%) and drank less alcohol compared to others (p&lt;0.001, p=0.05 respectively). Systolic white coat effect was higher among ISH (17.6±12.4 mmHg) compared to others (p&lt;0.001), as was cardiac output ISH (6.3±1.2 ml/min) compared to NTs and IDHs (p&lt;0.001); Peripheral resistances were similar in ISHs and NTs and were lower than in IDHs and SDHs (p&lt;0.001). Small and large artery compliance was higher, central systolic BP and augmentation index were lower among NTs and ISHs compared to IDHs and SDHs, even if these differences were not statistically significant. During follow-up systolic BP decreased (−7.6±14.4 mmHg) among ISHs, while it increased among NTs and IDHs (p&lt;0.001). Heart rate decreased in all categories but to a higher extent among ISHs (−3.8±10.9 bpm) and SDHs (−3.4±10.8 bpm) (p=0.002 vs others). Changes in diastolic BP were similar among ISHs and NTs and higher than those observed among IDHs and SDHs (p&lt;0.001). The percent of patients who started pharmacological treatment during follow-up was 70.6% among SDHs, 54.1% among IDHs, 41.1% among ISHs, and 39.5% among NTs (p&lt;0.001). Conclusions ISHs had increased cardiac output and white coat effect and lower peripheral resistances compared to other hypertension subtypes while distensibility parameters did not differ significantly among groups. The percent of patients who developed hypertension needing treatment was lower among ISHs than other hypertensives. This was due to a favourable time course of BP during follow-up. Longer follow-ups are needed to confirm the lower risk profile of ISH of the young Funding Acknowledgement Type of funding source: None


2021 ◽  
Vol 10 (2) ◽  
pp. e000839
Author(s):  
Heather Cassie ◽  
Vinay Mistry ◽  
Laura Beaton ◽  
Irene Black ◽  
Janet E Clarkson ◽  
...  

ObjectivesEnsuring that healthcare is patient-centred, safe and harm free is the cornerstone of the NHS. The Scottish Patient Safety Programme (SPSP) is a national initiative to support the provision of safe, high-quality care. SPSP promotes a coordinated approach to quality improvement (QI) in primary care by providing evidence-based methods, such as the Institute for Healthcare Improvement’s Breakthrough Series Collaborative methodology. These methods are relatively untested within dentistry. The aim of this study was to evaluate the impact to inform the development and implementation of improvement collaboratives as a means for QI in primary care dentistry.DesignA multimethod study underpinned by the Theoretical Domains Framework and the Kirkpatrick model. Quantitative data were collected using baseline and follow-up questionnaires, designed to explore beliefs and behaviours towards improving quality in practice. Qualitative data were gathered using interviews with dental team members and practice-based case studies.ResultsOne hundred and eleven dental team members completed the baseline questionnaire. Follow-up questionnaires were returned by 79 team members. Twelve practices, including two case studies, participated in evaluation interviews. Findings identified positive beliefs and increased knowledge and skills towards QI, as well as increased confidence about using QI methodologies in practice. Barriers included time, poor patient and team engagement, communication and leadership. Facilitators included team working, clear roles, strong leadership, training, peer support and visible benefits. Participants’ knowledge and skills were identified as an area for improvement.ConclusionsFindings demonstrate increased knowledge, skills and confidence in relation to QI methodology and highlight areas for improvement. This is an example of partnership working between the Scottish Government and NHSScotland towards a shared ambition to provide safe care to every patient. More work is required to evaluate the sustainability and transferability of improvement collaboratives as a means for QI in dentistry and wider primary care.


2021 ◽  
pp. 193229682199872
Author(s):  
Gregg D. Simonson ◽  
Richard M. Bergenstal ◽  
Mary L. Johnson ◽  
Janet L. Davidson ◽  
Thomas W. Martens

Background: Little data exists regarding the impact of continuous glucose monitoring (CGM) in the primary care management of type 2 diabetes (T2D). We initiated a quality improvement (QI) project in a large healthcare system to determine the effect of professional CGM (pCGM) on glucose management. We evaluated both an MD and RN/Certified Diabetes Care and Education Specialist (CDCES) Care Model. Methods: Participants with T2D for >1 yr., A1C ≥7.0% to <11.0%, managed with any T2D regimen and willing to use pCGM were included. Baseline A1C was collected and participants wore a pCGM (Libre Pro) for up to 2 weeks, followed by a visit with an MD or RN/CDCES to review CGM data including Ambulatory Glucose Profile (AGP) Report. Shared-decision making was used to modify lifestyle and medications. Clinic follow-up in 3 to 6 months included an A1C and, in a subset, a repeat pCGM. Results: Sixty-eight participants average age 61.6 years, average duration of T2D 15 years, mean A1C 8.8%, were identified. Pre to post pCGM lowered A1C from 8.8% ± 1.2% to 8.2% ± 1.3% (n=68, P=0.006). The time in range (TIR) and time in hyperglycemia improved along with more hypoglycemia in the subset of 37 participants who wore a second pCGM. Glycemic improvement was due to lifestyle counseling (68% of participants) and intensification of therapy (65% of participants), rather than addition of medications. Conclusions: Using pCGM in primary care, with an MD or RN/CDCES Care Model, is effective at lowering A1C, increasing TIR and reducing time in hyperglycemia without necessarily requiring additional medications.


Open Heart ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. e001425
Author(s):  
Marc Meller Søndergaard ◽  
Johannes Riis ◽  
Karoline Willum Bodker ◽  
Steen Møller Hansen ◽  
Jesper Nielsen ◽  
...  

AimLeft bundle branch block (LBBB) is associated with an increased risk of heart failure (HF). We assessed the impact of common ECG parameters on this association using large-scale data.Methods and resultsUsing ECGs recorded in a large primary care population from 2001 to 2011, we identified HF-naive patients with a first-time LBBB ECG. We obtained information on sex, age, emigration, medication, diseases and death from Danish registries. We investigated the association between the PR interval, QRS duration, and heart rate and the risk of HF over a 2-year follow-up period using Cox regression analysis.Of 2471 included patients with LBBB, 464 (18.8%) developed HF during follow-up. A significant interaction was found between QRS duration and heart rate (p<0.01), and the analyses were stratified on these parameters. Using a QRS duration <150 ms and a heart rate <70 beats per minute (bpm) as the reference, all groups were statistically significantly associated with the development of HF. Patients with a QRS duration ≥150 ms and heart rate ≥70 bpm had the highest risk of developing HF (HR 3.17 (95% CI 2.41 to 4.18, p<0.001). There was no association between the PR interval and HF after adjustment.ConclusionProlonged QRS duration and higher heart rate were associated with increased risk of HF among primary care patients with LBBB, while no association was observed with PR interval. Patients with LBBB with both a prolonged QRS duration (≥150 ms) and higher heart rate (≥70 bpm) have the highest risk of developing HF.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S Ikeda ◽  
M Iguchi ◽  
H Ogawa ◽  
Y Aono ◽  
K Doi ◽  
...  

Abstract Background Hypertension is one of the major risk factors of cardiovascular events in patients with atrial fibrillation (AF). However, relationship between diastolic blood pressure (DBP) and cardiovascular events in AF patients remains unclear. Methods The Fushimi AF Registry is a community-based prospective survey of AF patients in Japan. Follow-up data were available in 4,466 patients, and 4,429 patients with available data of DBP were examined. We divided the patients into three groups; G1 (DBP&lt;70 mmHg, n=1,946), G2 (70≤DBP&lt;80, n=1,321) and G3 (80≤DBP, n=1,162), and compared the clinical background and outcomes between groups. Results The proportion of female was grater in G1 group, and the patients in G1 group were older and had higher prevalence of heart failure (HF), diabetes mellitus (DM), chronic kidney disease (CKD). Prescription of beta blockers was higher in G1 group, but that of renin-angiotensin system-inhibitors and calcium channel blocker was comparable. During the median follow-up of 1,589 days, in Kaplan-Meier analysis, the incidence rates of cardiovascular events (composite of cardiac death, ischemic stroke and systemic embolism, major bleeding and HF hospitalization during follow up) were higher in G1 group and G3 group than G2 group (Figure 1). When we divided the patients based on the systolic blood pressure (SBP) at baseline (≥130 mmHg or &lt;130 mmHg), the incidence of rates of cardiovascular events were comparable among groups. Multivariate Cox proportional hazards regression analysis including female gender, age (≥75 years), higher SBP (≥130 mmHg), DM, pre-existing HF, CKD, low left ventricular ejection fraction (&lt;40%) and DBP (G1, G2, G3) revealed that DBP was an independent determinant of cardiovascular events (G1 group vs. G2 group; hazard ratio (HR): 1.40, 95% confidence intervals (CI): 1.19–1.64, G3 group vs. G2 group; HR: 1.23, 95% CI: 1.01–1.49). When we examined the impact of DBP according to 10 mmHg increment, patients with very low DBP (&lt;60 mmHg) (HR: 1.50,95% CI:1.24–1.80) and very high DBP (≥90 mmHg) (HR: 1.51,95% CI:1.15–1.98) had higher incidence of cardiovascular events than patients with DBP of 70–79 mmHg (Figure 2). However, when we examined the impact of SBP according to 20 mmHg increment, SBP at baseline was not associated with the incidence of cardiovascular events (Figure 3). Conclusion In Japanese patients with AF, DBP exhibited J curve association with higher incidence of cardiovascular events. Funding Acknowledgement Type of funding source: None


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