Automated provision of clinical routine data for a complex clinical follow-up study: A data warehouse solution

A deep integration of routine care and research remains challenging in many respects. We aimed to show the feasibility of an automated transformation and transfer process feeding deeply structured data with a high level of granularity collected for a clinical prospective cohort study from our hospital information system to the study’s electronic data capture system, while accounting for study-specific data and visits. We developed a system integrating all necessary software and organizational processes then used in the study. The process and key system components are described together with descriptive statistics to show its feasibility in general and to identify individual challenges in particular. Data of 2051 patients enrolled between 2014 and 2020 was transferred. We were able to automate the transfer of approximately 11 million individual data values, representing 95% of all entered study data. These were recorded in n = 314 variables (28% of all variables), with some variables being used multiple times for follow-up visits. Our validation approach allowed for constant good data quality over the course of the study. In conclusion, the automated transfer of multi-dimensional routine medical data from HIS to study databases using specific study data and visit structures is complex, yet viable.

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Feasibility and Compliance of Automated Measurement of Quality of Life in Oncology Practice

Journal of Clinical Oncology ◽

10.1200/jco.2003.11.044 ◽

2003 ◽

Vol 21 (2) ◽

pp. 374-382 ◽

Cited By ~ 87

Author(s):

E.P. Wright ◽

P.J. Selby ◽

M. Crawford ◽

A. Gillibrand ◽

C. Johnston ◽

...

Keyword(s):

Quality Of Life ◽

Data Collection ◽

Routine Care ◽

Study Data ◽

Wide Range ◽

Oncology Practice ◽

And Storage ◽

Acute Admissions

Purpose: Systematic quality-of-life (QOL) assessment may have value in oncology practice by increasing awareness of a wide range of issues, possibly increasing detection of psychologic morbidity, social problems, and changes in physical status, and improving care and its outcomes. However, logistic problems are substantial. Automated systems solve many of these problems. We field-tested the feasibility and compliance that can be achieved using a computer touchscreen system in two consecutive studies. Patients and Methods: In study 1, a prospective cohort of 272 patients was offered QOL assessment at each clinic appointment for 6 months. In study 2, all patients (N = 1,291) were offered QOL assessment as part of clinic routine during a 12-week period. Results: In study 1, 82% of patients agreed to take part, but over time, compliance was poor (median, 40%; mean, 43%) and deteriorated with longer follow-up. In study 2, the overall compliance was greatly increased (median, 100%; mean, 70%), and compliance was retained over multiple visits. In study 1, compliance was better in younger patients, males, and socially advantaged patients, but was not affected by the presence of depression or anxiety, or QOL. In the second study, building on experience in the first study, data collection and storage in the computer system was excellent, achieving 98% of collected data stored in one center. In general, patients were comfortable with the computers and the approach. Data collection on the wards was more difficult and less complete than in clinics, especially for patients undergoing acute admissions. Conclusion: Feasibility with higher compliance was demonstrated in study 2, in which the data collection was integrated into routine care, and can be improved with further technical initiatives and education of staff.

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Coexistent Osteoarthritis and Parkinson’s Disease: Data from the Parkinson’s Foundation Outcomes Project

Journal of Parkinson s Disease ◽

10.3233/jpd-202170 ◽

2020 ◽

Vol 10 (4) ◽

pp. 1601-1610

Author(s):

Jaimie A. Roper ◽

Abigail C. Schmitt ◽

Hanzhi Gao ◽

Ying He ◽

Samuel Wu ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Study Data ◽

Functional Mobility ◽

Quality Improvement Initiative ◽

Timed Up And Go ◽

Mobility Performance ◽

Risk Of Mortality ◽

The Impact

Background: The impact of concurrent osteoarthritis on mobility and mortality in individuals with Parkinson’s disease is unknown. Objective: We sought to understand to what extent osteoarthritis severity influenced mobility across time and how osteoarthritis severity could affect mortality in individuals with Parkinson’s disease. Methods: In a retrospective observational longitudinal study, data from the Parkinson’s Foundation Quality Improvement Initiative was analyzed. We included 2,274 persons with Parkinson’s disease. The main outcomes were the effects of osteoarthritis severity on functional mobility and mortality. The Timed Up and Go test measured functional mobility performance. Mortality was measured as the osteoarthritis group effect on survival time in years. Results: More individuals with symptomatic osteoarthritis reported at least monthly falls compared to the other groups (14.5% vs. 7.2% without reported osteoarthritis and 8.4% asymptomatic/minimal osteoarthritis, p = 0.0004). The symptomatic group contained significantly more individuals with low functional mobility (TUG≥12 seconds) at baseline (51.5% vs. 29.0% and 36.1%, p < 0.0001). The odds of having low functional mobility for individuals with symptomatic osteoarthritis was 1.63 times compared to those without reported osteoarthritis (p < 0.0004); and was 1.57 times compared to those with asymptomatic/minimal osteoarthritis (p = 0.0026) after controlling pre-specified covariates. Similar results hold at the time of follow-up while changes in functional mobility were not significant across groups, suggesting that osteoarthritis likely does not accelerate the changes in functional mobility across time. Coexisting symptomatic osteoarthritis and Parkinson’s disease seem to additively increase the risk of mortality (p = 0.007). Conclusion: Our results highlight the impact and potential additive effects of symptomatic osteoarthritis in persons with Parkinson’s disease.

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Seven-Year Follow-Up of Screening for Hypertension and Diabetes at a Dental Clinic

Journal of Dentistry and Oral Sciences ◽

10.37191/mapsci-2582-3736-1(2)-011 ◽

2019 ◽

Author(s):

Göran Friman

Keyword(s):

Antihypertensive Drugs ◽

Study Data ◽

Initial Screening ◽

Pharmacological Treatments ◽

Medical Screening ◽

Follow Up Study ◽

Undiagnosed Hypertension ◽

Dental Setting ◽

Study Participants

Objective: To describe the distribution of risk, diagnosis and pharmacological treatments for diabetes and hypertension after seven years among patients provided with opportunistic medical screening in a dental setting. Material and Methods: The initial screening’s 170 participants were asked to take part in a seven-year follow-up study. Data were collected through self-reported information in a written health declaration. Outcome measures: • Number of study participants who had passed away • Prescription of antidiabetics or antihypertensives • Changes in weight and height to calculate body mass index (BMI) Results: The follow-up study consisted of 151 participants. Twenty had passed away. The risk needs for medicating with antihypertensive drugs after seven years for those not receiving pharmacological treatment at the initial screening was 3.7 times greater (p=0.025 CI 1.2-11.3) for participants with a diastolic blood pressure (BP) ≥ 90 mm Hg (85 for diabetics) than for the others. The risk was 3.9 times greater (p=0.020 CI 1.2-12.6) for those with a systolic BP of 140-159 mm Hg and 54.2 times greater (p<0.0001 CI 9.8-300.3) for those with a systolic BP ≥ 160 mm Hg than for those with a systolic BP 140 mm Hg. There were no changes in BMI. Conclusion: At least one in ten cases of incorrect medication or undiagnosed hypertension may be identifiable through opportunistic medical screening

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Development and evaluation of a patient passport to promote self-management in patients with heart diseases

BMC Health Services Research ◽

10.1186/s12913-019-4565-4 ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 2

Author(s):

Sabine Stamm-Balderjahn ◽

Rebecca Faliniski ◽

Susanne Rossek ◽

Karla Spyra

Keyword(s):

Heart Diseases ◽

Routine Care ◽

Study Phase ◽

Treatment Regimens ◽

Medication Plan ◽

Evaluation Phase ◽

Mixed Method Design ◽

Treatment Data ◽

Qualitative Phase

Abstract Background Patients with cardiovascular diseases (CVD) are treated over a long period of time by physicians and therapists from various institutions collaborating within a multidisciplinary team. Usually, medical records detailing the diagnoses and treatment regimens are long and extensive. Brief overviews of relevant diagnostic and treatment data in the form of a patient passport are currently missing in routine care for patients with CVD. This study aimed to develop and evaluate a patient passport (the Kardio-Pass) based on the needs of patients who had undergone cardiac rehabilitation, and of healthcare professionals. Methods A mixed method design was adopted consisting of an explorative qualitative phase followed by a quantitative evaluation phase. Interviews with patients and experts were conducted to develop the Kardio-Pass. CVD rehabilitees (N = 150) were asked to evaluate the passport using a semi-standardized written questionnaire. Results Patients and experts who were interviewed in the qualitative study phase considered the following passport contents to be particularly important: documentation of findings and diagnoses, cardiac diagnostics and intervention, medication plan, risk factors for heart disease, signs of a heart attack and what to do in an emergency. During the evaluation phase, 93 rehabilitees (response rate: 62%) completed the questionnaire. The Kardio-Pass achieved high overall approval: All respondents considered the information contained in the passport to be trustworthy. The professionalism and the design of the passport were rated very highly by 93 and 92% of participants, respectively. Use of the Kardio-Pass prompted 53% of participants to regularly attend follow-up appointments. The most common reasons for non-use were a lack of support from the attending doctor, failure by the patient to make entries in the passport, and loss of the passport. Conclusions By documenting the course of cardiac diseases, the patient passport pools all medical data–from diagnosis to treatment and aftercare–in a concise manner. Rehabilitees who used the cardiac passport rated it as a helpful tool for documenting follow-up data. However, with regard to this explorative study there is a need for further research, particularly on whether the patient passport can improve heart patient care.

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Low dose oral ketamine treatment in chronic suicidality: An open-label pilot study

Translational Psychiatry ◽

10.1038/s41398-021-01230-z ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Adem T. Can ◽

Daniel F. Hermens ◽

Megan Dutton ◽

Cyrana C. Gallay ◽

Emma Jensen ◽

...

Keyword(s):

Suicidal Ideation ◽

Low Dose ◽

Suicide Ideation ◽

Well Being ◽

Primary Outcome Measure ◽

Open Label ◽

Oral Ketamine ◽

High Level ◽

Chronic Suicidality

AbstractRecently, low-dose ketamine has been proposed as a rapid-acting treatment option for suicidality. The majority of studies to date have utilised intravenous (IV) ketamine, however, this route of administration has limitations. On the other hand, oral ketamine can be administered in a range of settings, which is important in treating suicidality, although studies as to safety and feasibility are lacking. n = 32 adults (aged 22–72 years; 53% female) with chronic suicidal thoughts participated in the Oral Ketamine Trial on Suicidality (OKTOS), an open-label trial of sub-anaesthetic doses of oral ketamine over 6 weeks. Participants commenced with 0.5 mg/kg of ketamine, which was titrated to a maximum 3.0 mg/kg. Follow-up assessments occurred at 4 weeks after the final dose. The primary outcome measure was the Beck Scale for Suicide Ideation (BSS) and secondary measures included scales for suicidality and depressive symptoms, and measures of functioning and well-being. Mean BSS scores significantly reduced from a high level of suicidal ideation at the pre-ketamine (week 0) timepoint to below the clinical threshold at the post-ketamine (week 6) timepoint. The proportion of participants that achieved clinical improvement within the first 6 weeks was 69%, whereas 50% achieved a significant improvement by the follow-up (week 10) timepoint. Six weeks of oral ketamine treatment in participants with chronic suicidality led to significant reduction in suicidal ideation. The response observed in this study is consistent with IV ketamine trials, suggesting that oral administration is a feasible and tolerable alternative treatment for chronic suicidality.

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Lower perception of pharmacological treatment increases risk of non-adherence to medication

European Journal of Preventive Cardiology ◽

10.1093/eurjpc/zwab061.258 ◽

2021 ◽

Vol 28 (Supplement_1) ◽

Author(s):

CB Graversen ◽

JB Valentin ◽

ML Larsen ◽

S Riahi ◽

T Holmberg ◽

...

Keyword(s):

Pharmacological Treatment ◽

Poisson Regression ◽

Drug Class ◽

Angiotensin Receptor Blockers ◽

Adverse Outcomes ◽

Adherence To Medication ◽

Increased Risk ◽

Patient Reported ◽

High Level

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): The Danish Heart Foundation Background A large proportion of patients fail to reach optimal adherence to medication following incident ischemic heart disease (IHD) despite amble evidence of the beneficial effect of medication. Non-adherence to medication increases risk of disease-related adverse outcomes but none has explored how perception about pharmacological treatment detail on non-adherence using register-based follow-up data. Purpose To investigate the association between patients’ perception of pharmacological treatment and risk of non-initiation and non-adherence to medication in a population with incident IHD. Methods This cohort study followed 871 patients until 365 days after incident IHD. The study combined patient-reported survey data on perception about pharmacological treatment (categorised by ‘To a high level’, ‘To some level’, and ‘To a lesser level’) with register-based data on reimbursed prescription of cardiovascular medication (antithrombotics, statins, ACE-inhibitors/angiotensin receptor blockers, and β-blockers). Non-initiation was defined as no pick-up of medication in the first 180 days following incident IHD and analysed by Poisson regression. Two different measures evaluated non-adherence in patients initiating treatment: 1) proportion of days covered (PDC) analysed by Poisson regression, and 2) risk of discontinuation analysed by Cox proportional hazard regression. All analyses were adjusted for confounding variables (age, sex, ethnicity, income, educational level, civil status, occupation, charlson comorbidity index, supportive relatives, and individual consultation in medication) identified by directed acyclic graph and obtained from national registers and the survey. Item non-response was handled by multiple imputation and item consistency was evaluated by McDonalds omega. Results Lower perceptions about pharmacological treatment was associated with increased risk of non-initiation and non-adherence to medication irrespectively of drug class and adherence measure in the multiple adjusted analyses (please see figure illustrating results on antithrombotics). A dose-response relationship was observed both at 180- and 365-days of follow-up, but the steepest decline in adherence differed when comparing the two adherence measures (results not shown). Moderate internal consistency was found for the summed measure of perception (McDonalds omega = 0.67). Conclusion Lower perception of pharmacological treatment was associated with subsequent non-initiation and non-adherence to medication, irrespectively of measurement method and drug class. Abstract Figure. Figre: Multiple adjusted analyses

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Prognostic Value of Oxygenated Hemoglobin Assessed during Acute Exacerbations of Chronic Pulmonary Disease

Respiration ◽

10.1159/000513440 ◽

2021 ◽

pp. 1-8

Author(s):

Clemens F. Hinke ◽

Rudolf A. Jörres ◽

Peter Alter ◽

Robert Bals ◽

Florian Bornitz ◽

...

Keyword(s):

Pulmonary Disease ◽

Predictive Value ◽

Hemoglobin Concentration ◽

Blood Gas Analysis ◽

Study Data ◽

Gas Analysis ◽

Chronic Obstructive ◽

Acute Exacerbations ◽

All Cause Mortality

Background: Oxygenated hemoglobin(OxyHem) is a simple-to-measure marker of oxygen content capable of predicting all-cause mortality in stable chronic obstructive pulmonary disease (COPD). Objectives: We aimed to analyze its predictive value during acute exacerbations of COPD (AECOPD). Methods: In this retrospective study, data from 227 patients discharged after severe AECOPD at RoMed Clinical Center Rosenheim, Germany, between January 2012 and March 2018, was analyzed. OxyHem (hemoglobin concentration [Hb] × fractional SpO2, g/dL) was calculated from oxygen saturation measured by pulse oximetry and hemoglobin assessed within 24 h after admission. The follow-up (1.7 ± 1.5 years) covered all-cause mortality, including readmissions for severe AECOPD. Results: During the follow-up period, 127 patients died, 56 due to AECOPD and 71 due to other reasons. Survivors and non-survivors showed differences in age, FVC % predicted, C-reactive protein, hemoglobin, Cr, Charlson Comorbidity Index (CCI), and OxyHem (p < 0.05 each). Significant independent predictors of survival were BMI, Cr or CCI, FEV1 % predicted or FVC % predicted, Hb, or OxyHem. The predictive value of OxyHem (p = 0.006) was superior to that of Hb or SpO2 and independent of oxygen supply during blood gas analysis. OxyHem was also predictive when using a cutoff value of 12.1 g/dL identified via receiver operating characteristic curves in analyses including either the CCI (hazard ratio 1.85; 95% CI 1.20, 2.84; p = 0.005) or Cr (2.04; 95% CI 1.35, 3.10; p = 0.001) as covariates. Conclusion: The concentration of OxyHem provides independent, easy-to-assess information on long-term mortality risk in COPD, even if measured during acute exacerbations. It therefore seems worth to be considered for broader clinical use.

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Decrease post-transplant relapse using donor-derived expanded NK-cells

Leukemia ◽

10.1038/s41375-021-01349-4 ◽

2021 ◽

Author(s):

Stefan O. Ciurea ◽

Piyanuch Kongtim ◽

Doris Soebbing ◽

Prashant Trikha ◽

Gregory Behbehani ◽

...

Keyword(s):

Nk Cells ◽

Nk Cell ◽

Ex Vivo ◽

Disease Free Survival ◽

Dependent Manner ◽

Post Transplant ◽

Haploidentical Transplantation ◽

High Doses ◽

High Level

AbstractIn this phase I/II clinical trial, we investigated the safety and efficacy of high doses of mb-IL21 ex vivo expanded donor-derived NK cells to decrease relapse in 25 patients with myeloid malignancies receiving haploidentical stem-cell transplantation (HSCT). Three doses of donor NK cells (1 × 105–1 × 108 cells/kg/dose) were administered on days −2, +7, and +28. Results were compared with an independent contemporaneously treated case-matched cohort of 160 patients from the CIBMTR database.After a median follow-up of 24 months, the 2-year relapse rate was 4% vs. 38% (p = 0.014), and disease-free survival (DFS) was 66% vs. 44% (p = 0.1) in the cases and controls, respectively. Only one relapse occurred in the study group, in a patient with the high level of donor-specific anti-HLA antibodies (DSA) presented before transplantation. The 2-year relapse and DFS in patients without DSA was 0% vs. 40% and 72% vs. 44%, respectively with HR for DFS in controls of 2.64 (p = 0.029). NK cells in recipient blood were increased at day +30 in a dose-dependent manner compared with historical controls, and had a proliferating, mature, highly cytotoxic, NKG2C+/KIR+ phenotype.Administration of donor-derived expanded NK cells after haploidentical transplantation was safe, associated with NK cell-dominant immune reconstitution early post-transplant, preserved T-cell reconstitution, and improved relapse and DFS. TRIAL REGISTRATION: NCT01904136 (https://clinicaltrials.gov/ct2/show/NCT01904136).

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Prediction of parental alienation on depression in left-behind children: A 12-month follow-up investigation

Epidemiology and Psychiatric Sciences ◽

10.1017/s2045796021000329 ◽

2021 ◽

Vol 30 ◽

Author(s):

Xiaoxiao Sun ◽

Xuemei Qin ◽

Mengjia Zhang ◽

Aigang Yang ◽

Xiaomei Ren ◽

...

Keyword(s):

Life Events ◽

Protective Factor ◽

Stressful Life Events ◽

Parental Alienation ◽

Left Behind ◽

Resilience Scale ◽

Children’S Depression ◽

Risk Predictor ◽

High Level

Abstract Aims Alienation towards parents often occurs when parents divorce; however, it can also occur when one or both parents leave for work for more than 6 months. Our previous investigation has confirmed a high level of feelings of alienation towards parents among Chinese left-behind children. However, the longitudinal prediction of alienation on children's mental health outcomes remains largely unknown. This study aims to observe the prediction of alienation towards parents on children's depression 12 months later and potential mediators and moderators. Methods A total of 1090 Chinese left-behind children took part in this 12-month follow-up investigation, using the Chinese version of the Inventory of Alienation towards Parents (IAP), the Children's Depression Inventory (CDI), the Adolescent Self-Rating Life-events Checklist (ASLEC), and the Adolescent Resilience Scale. Results Alienation towards parents was high (16.42 ± 7.27 for mother, 15.63 ± 7.17 for father) in left-behind children, and 21.01% of children reported depression. Alienation towards parents predicted current depression of children directly and later depression indirectly; children's alienation toward their mothers was a stronger predictor of depression than alienation towards fathers. In models, stressful life-events acted as a risk mediator. Previous depression was the strongest risk predictor, resilience was the strongest protective factor, and duration of fathers’ absence and parents’ marital status moderated the predictive effects. Conclusions This study is among the first to longitudinally confirm that alienation towards parents is a predictor of children's later depression. The results provide important suggestions for families and schools; i.e. to prevent depression in left-behind children, parent−child bonds especially alienation towards mothers, should be carefully considered, and individuals with more negative life-events and weaker resilience need further attention.

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Design of a prospective follow-up study on early parenthood and smoking behaviour during pregnancy in Finnish primary healthcare

Scandinavian Journal of Public Health ◽

10.1177/14034948211022433 ◽

2021 ◽

pp. 140349482110224

Author(s):

Mikael O. Ekblad ◽

Hanna P. Wallin ◽

Marjukka Pajulo ◽

Päivi E. Korhonen

Keyword(s):

Pregnant Women ◽

Study Design ◽

Primary Healthcare ◽

Routine Data ◽

Smoking Behaviour ◽

Self Report ◽

Health Clinic ◽

Follow Up Study ◽

Study Population

Aims: The primary aim of the study is to explore different factors affecting parents’ smoking behaviour, and especially how smoking may be connected with individual differences in the psychological process of becoming a parent. In the current paper, we present the study design together with basic information on the study population. Methods: The Central Satakunta Maternity and Child Health Clinic (KESALATU) Study is an ongoing prospective follow-up study in primary healthcare of the Satakunta region of southwest Finland. Families were recruited during their first maternity clinic visit between 1 September 2016 and 31 December 2019, and participation will continue until the child is 1.5 years of age. The study combines different sources and types of data: e.g. routine data obtained from primary healthcare clinic records, specific parental self-report data and data from a new exhaled carbon monoxide meter indicating maternal smoking. The data are collected using frequently repeated assessments both during pregnancy and postnatally. The methods cover the following areas of interest: family background factors (including smoking and alcohol use), self-reported parental–foetal/infant attachment and mentalization, self-reported stress, depression and quality of life. Results: 589 pregnant women and their partners were asked to participate in the study during the collection time period. The final study population consisted of 248 (42.1%) pregnant women and 160 (27.1%) partners. Conclusions: The new methods and study design have the potential to increase our understanding about the link between early parenting psychology, prenatal psychosocial risk factors and parental health behaviour.

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