Dataset Information

Association between full monitoring of biomedical and lifestyle target indicators and HbA1c level in primary type 2 diabetes care: an observational cohort study (ELZHA-cohort 1).

ABSTRACT: OBJECTIVE:Management of type 2 diabetes mellitus (T2DM) requires frequent monitoring of patients. Within a collective care group setting, doubts on the clinical effects of registration are a barrier for full adoption of T2DM registration in general practice. We explored whether full monitoring of biomedical and lifestyle-related target indicators within a care group approach is associated with lower HbA1c levels. DESIGN:Observational, real-life cohort study. SETTING:Primary care data registry from the Hadoks (EerstelijnsZorggroepHaaglanden) care group. EXPOSURE:The care group provides general practitioners collectively with organisational support to facilitate structured T2DM primary care. Patients are offered quarterly medical and lifestyle-related consultation. MAIN OUTCOME MEASURE:Full monitoring of each target indicator in patients with T2DM which includes minimally one measure of HbA1c level, systolic blood pressure, LDL, BMI, smoking behaviour and physical exercise between January and December 2014; otherwise, patients were defined as 'incompletely monitored'. HbA1c levels of 8137 fully monitored and 3958 incompletely monitored patients were compared, adjusted for the confounders diabetes duration, age and gender. Since recommended HbA1c values depend on age, medication use and diabetes duration, analyses were stratified into three HbA1c profile groups. Linear multilevel analyses enabled adjustment for general practice. RESULTS:Compared with incompletely monitored patients, fully monitored patients had significantly lower HbA1c levels (95% CI) in the first (-2.03 [-2.53 to -1.52] mmol/mol) (-0.19% [-0.23% to -0.14%]), second (-3.36 [-5.28 to -1.43] mmol/mol) (-0.31% [-0.48% to -0.13%]) and third HbA1c profile group (-1.89 [-3.76 to -0.01] mmol/mol) (-0.17% [-0.34% to 0.00%]). CONCLUSIONS/INTERPRETATION:This study shows that in a care group setting, fully monitored patients had significantly lower HbA1c levels compared with incompletely monitored patients. Since this difference might have considerable clinical impact in terms of T2DM-related risks, this might help general practices in care group settings to overcome barriers on adequate registration and thus improve structured T2DM primary care. From population health management perspective, we recommend a systematic approach to adjust the structured care protocol for incompletely monitored subgroups.

SUBMITTER: van Bruggen S

PROVIDER: S-EPMC6429872 | biostudies-other | 2019 Mar

REPOSITORIES: biostudies-other

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Association between full monitoring of biomedical and lifestyle target indicators and HbA<sub>1c</sub> level in primary type 2 diabetes care: an observational cohort study (ELZHA-cohort 1).

van Bruggen Sytske S Rauh Simone P SP Kasteleyn Marise J MJ Bonten Tobias N TN Chavannes Niels H NH Numans Mattijs E ME

BMJ open 20190313 3

<h4>Objective</h4>Management of type 2 diabetes mellitus (T2DM) requires frequent monitoring of patients. Within a collective care group setting, doubts on the clinical effects of registration are a barrier for full adoption of T2DM registration in general practice. We explored whether full monitoring of biomedical and lifestyle-related target indicators within a care group approach is associated with lower HbA<sub>1c</sub> levels.<h4>Design</h4>Observational, real-life cohort study.<h4>Setting< ...[more]

PMID: 30867205

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Project description:OBJECTIVE:Whether care group participation by general practitioners improves delivery of diabetes care is unknown. Using 'monitoring of biomedical and lifestyle target indicators as recommended by professional guidelines' as an operationalisation for quality of care, we explored whether (1) in new practices monitoring as recommended improved a year after initial care group participation (aim 1); (2) new practices and experienced practices differed regarding monitoring (aim 2). DESIGN:Observational, real-life cohort study. SETTING:Primary care registry data from Eerstelijns Zorggroep Haaglanden (ELZHA) care group. PARTICIPANTS:Aim 1: From six new practices (n=538 people with diabetes) that joined care group ELZHA in January 2014, two practices (n=211 people) were excluded because of missing baseline data; four practices (n=182 people) were included. Aim 2: From all six new practices (n=538 people), 295 individuals were included. From 145 experienced practices (n=21?465 people), 13?744 individuals were included. EXPOSURE:Care group participation includes support by staff nurses on protocolised diabetes care implementation and availability of a system providing individual monitoring information. 'Monitoring as recommended' represented minimally one annual registration of each biomedical (HbA1c, systolic blood pressure, low-density lipoprotein) and lifestyle-related target indicator (body mass index, smoking behaviour, physical exercise). PRIMARY OUTCOME MEASURES:Aim 1: In new practices, odds of people being monitored as recommended in 2014 were compared with baseline (2013). Aim 2: Odds of monitoring as recommended in new and experienced practices in 2014 were compared. RESULTS:Aim 1: After 1-year care group participation, odds of being monitored as recommended increased threefold (OR 3.00, 95% CI 1.84 to 4.88, p<0.001). Aim 2: Compared with new practices, no significant differences in the odds of monitoring as recommended were found in experienced practices (OR 1.21, 95% CI 0.18 to 8.37, p=0.844). CONCLUSIONS:We observed a sharp increase concerning biomedical and lifestyle monitoring as recommended after 1-year care group participation, and subsequently no significant difference between new and experienced practices-indicating that providing diabetes care within a collective approach rapidly improves registration of care.

Project description:Background: Acute high-altitude (HA) exposure results in blood pressure (BP) and cardiac function variations in most subjects, some of whom suffer from acute mountain sickness (AMS). Several previous studies have found that cardiovascular function indicators are potentially correlated with AMS. Objectives: This study aims to examine HA-induced cardiovascular adaptations in AMS patients and compare them with healthy subjects. It also aims to investigate the relationship between cardiovascular function indicators and AMS, as well as to provide some insightful information about the prevention and treatment of AMS. Methods: Seventy-two subjects were enrolled in this cohort study. All the subjects ascended Litang (4,100 m above sea level). They were monitored by a 24-h ambulatory blood pressure (ABP) device and underwent echocardiography examination within 24 h of altitude exposure. The 2018 Lake Louise questionnaire was used to evaluate AMS. Results: Acute mountain sickness group consisted of more women (17 [60.7%] vs. 10 [22.7%], p = 0.001) and fewer smokers (5 [17.9%] vs. 23 [52.3%], p = 0.003). Compared with subjects without AMS, subjects with AMS had lower pulse pressure (PP) (daytime PP, 45.23 ± 7.88 vs. 52.14 ± 4.75, p < 0.001; nighttime PP, 42.81 ± 5.92 vs. 49.39 ± 7.67, p < 0.001) and lower effective arterial elastance (Ea) (1.53 ± 0.24 vs. 1.73 ± 0.39, p = 0.023). Multivariate regression indicated that female sex (OR = 0.23, p = 0.024), lower daytime PP (OR = 0.86, p = 0.004), and lower Ea (OR = 0.03, p = 0.015) at low altitude (LA) were independent risk factors for AMS. Combined daytime PP and Ea at LA had a high predictive value for AMS (AUC = 0.873; 95% CI: 0.789-0.956). Correlation analysis showed that AMS-induced headache correlated with daytime PP (R = -0.401, p < 0.001) and nighttime PP at LA (R = -0.401, p < 0.001). Conclusion: Our study demonstrated that AMS patients had a lower PP and Ea at LA. These baseline indicators of vasodilation at LA were closely associated with AMS, which may explain the higher headache severity in subjects with higher PP at LA.

Project description:BackgroundClinical data collection requires correct and complete data sets in order to perform correct statistical analysis and draw valid conclusions. While in randomized clinical trials much effort concentrates on data monitoring, this is rarely the case in observational studies- due to high numbers of cases and often-restricted resources. We have developed a valid and cost-effective monitoring tool, which can substantially contribute to an increased data quality in observational research.MethodsAn automated digital monitoring system for cohort studies developed by the German Rheumatism Research Centre (DRFZ) was tested within the disease register RABBIT-SpA, a longitudinal observational study including patients with axial spondyloarthritis and psoriatic arthritis. Physicians and patients complete electronic case report forms (eCRF) twice a year for up to 10 years. Automatic plausibility checks were implemented to verify all data after entry into the eCRF. To identify conflicts that cannot be found by this approach, all possible conflicts were compiled into a catalog. This "conflict catalog" was used to create queries, which are displayed as part of the eCRF. The proportion of queried eCRFs and responses were analyzed by descriptive methods. For the analysis of responses, the type of conflict was assigned to either a single conflict only (affecting individual items) or a conflict that required the entire eCRF to be queried.ResultsData from 1883 patients was analyzed. A total of n = 3145 eCRFs submitted between baseline (T0) and T3 (12 months) had conflicts (40-64%). Fifty-six to 100% of the queries regarding eCRFs that were completely missing were answered. A mean of 1.4 to 2.4 single conflicts occurred per eCRF, of which 59-69% were answered. The most common missing values were CRP, ESR, Schober's test, data on systemic glucocorticoid therapy, and presence of enthesitis.ConclusionProviding high data quality in large observational cohort studies is a major challenge, which requires careful monitoring. An automated monitoring process was successfully implemented and well accepted by the study centers. Two thirds of the queries were answered with new data. While conventional manual monitoring is resource-intensive and may itself create new sources of errors, automated processes are a convenient way to augment data quality.

Project description:BackgroundTimely recognition of patient deterioration remains challenging. Ambulatory monitoring systems (AMSs) may provide support to current monitoring practices; however, they need to be thoroughly tested before implementation in the clinical environment for early detection of deterioration.ObjectiveThe objective of this study was to assess the wearability of a selection of commercially available AMSs to inform a future prospective study of ambulatory vital sign monitors in an acute hospital ward.MethodsFive pulse oximeters (4 with finger probes and 1 wrist-worn only, collecting pulse rates and oxygen saturation) and 2 chest patches (collecting heart rates and respiratory rates) were selected to be part of this study: The 2 chest-worn patches were VitalPatch (VitalConnect) and Peerbridge Cor (Peerbridge); the 4 wrist-worn devices with finger probe were Nonin WristOx2 3150 (Nonin), Checkme O2+ (Viatom Technology), PC-68B, and AP-20 (both from Creative Medical); and the 1 solely wrist-worn device was Wavelet (Wavelet Health). Adult participants wore each device for up to 72 hours while performing usual "activities of daily living" and were asked to score the perceived exertion and perception of pain or discomfort by using the Borg CR-10 scale; thoughts and feelings caused by the AMS using the Comfort Rating Scale (CRS); and to provide general free text feedback. Median and IQRs were reported and nonparametric tests were used to assess differences between the devices' CRS scores.ResultsQuantitative scores and feedback were collected in 70 completed questionnaires from 20 healthy volunteers, with each device tested approximately 10 times. The Wavelet seemed to be the most wearable device (P<.001) with an overall median (IQR) CRS score of 1.00 (0.88). There were no statistically significant differences in wearability between the chest patches in the CRS total score; however, the VitalPatch was superior in the Attachment section (P=.04) with a median (IQR) score of 3.00 (1.00). General pain and discomfort scores and total percentage of time worn are also reflective of this.ConclusionsOur results suggest that adult participants prefer to wear wrist-worn pulse oximeters without a probe compressing the fingertip and they prefer to wear a smaller chest patch. A compromise between wearability, reliability, and accuracy should be made for successful and practical integration of AMSs within the hospital environment.

Project description:BackgroundUndergraduate studies are challenging, and mental health issues can frequently occur in undergraduate students, straining campus resources that are already in demand for somatic problems. Cost-effective measures with ubiquitous devices, such as smartphones, offer the potential to deliver targeted interventions to monitor and affect lifestyle, which may result in improvements to student mental health. However, the avenues by which this can be done are not particularly well understood, especially in the Canadian context.ObjectiveThe aim of this study is to deploy an initial version of the Smart Healthy Campus app at Western University, Canada, and to analyze corresponding data for associations between psychosocial factors (measured by a questionnaire) and behaviors associated with lifestyle (measured by smartphone sensors).MethodsThis preliminary study was conducted as an observational app-based ecological momentary assessment. Undergraduate students were recruited over email, and sampling using a custom 7-item questionnaire occurred on a weekly basis.ResultsFirst, the 7-item Smart Healthy Campus questionnaire, derived from fully validated questionnaires-such as the Brief Resilience Scale; General Anxiety Disorder-7; and Depression, Anxiety, and Stress Scale-21-was shown to significantly correlate with the mental health domains of these validated questionnaires, illustrating that it is a viable tool for a momentary assessment of an overview of undergraduate mental health. Second, data collected through the app were analyzed. There were 312 weekly responses and 813 sensor samples from 139 participants from March 2019 to March 2020; data collection concluded when COVID-19 was declared a pandemic. Demographic information was not collected in this preliminary study because of technical limitations. Approximately 69.8% (97/139) of participants only completed one survey, possibly because of the absence of any incentive. Given the limited amount of data, analysis was not conducted with respect to time, so all data were analyzed as a single collection. On the basis of mean rank, students showing more positive mental health through higher questionnaire scores tended to spend more time completing questionnaires, showed more signs of physical activity based on pedometers, and had their devices running less and plugged in charging less when sampled. In addition, based on mean rank, students on campus tended to report more positive mental health through higher questionnaire scores compared with those who were sampled off campus. Some data from students found in or near residences were also briefly examined.ConclusionsGiven these limited data, participants tended to report a more positive overview of mental health when on campus and when showing signs of higher levels of physical activity. These early findings suggest that device sensors related to physical activity and location are useful for monitoring undergraduate students and designing interventions. However, much more sensor data are needed going forward, especially given the sweeping changes in undergraduate studies due to COVID-19.

Dataset Information

Association between full monitoring of biomedical and lifestyle target indicators and HbA1c level in primary type 2 diabetes care: an observational cohort study (ELZHA-cohort 1).

Publications

Association between full monitoring of biomedical and lifestyle target indicators and HbA<sub>1c</sub> level in primary type 2 diabetes care: an observational cohort study (ELZHA-cohort 1).

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