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1.
J Med Internet Res ; 23(1): e21382, 2021 01 22.
Article in English | MEDLINE | ID: mdl-33480859

ABSTRACT

BACKGROUND: A population-level survey (PLS) is an essential and standard method used in public health research that supports the quantification of sociodemographic events, public health policy development, and intervention designs. Data collection mechanisms in PLS seem to be a significant determinant in avoiding mistakes. Using electronic devices such as smartphones and tablet computers improves the quality and cost-effectiveness of public health surveys. However, there is a lack of systematic evidence to show the potential impact of electronic data collection tools on data quality and cost reduction in interviewer-administered surveys compared with the standard paper-based data collection system. OBJECTIVE: This systematic review aims to evaluate the impact of the interviewer-administered electronic data collection methods on data quality and cost reduction in PLS compared with traditional methods. METHODS: We conducted a systematic search of MEDLINE, CINAHL, PsycINFO, the Web of Science, EconLit, Cochrane CENTRAL, and CDSR to identify relevant studies from 2008 to 2018. We included randomized and nonrandomized studies that examined data quality and cost reduction outcomes, as well as usability, user experience, and usage parameters. In total, 2 independent authors screened the title and abstract, and extracted data from selected papers. A third author mediated any disagreements. The review authors used EndNote for deduplication and Rayyan for screening. RESULTS: Our search produced 3817 papers. After deduplication, we screened 2533 papers, and 14 fulfilled the inclusion criteria. None of the studies were randomized controlled trials; most had a quasi-experimental design, for example, comparative experimental evaluation studies nested on other ongoing cross-sectional surveys. A total of 4 comparative evaluations, 2 pre-post intervention comparative evaluations, 2 retrospective comparative evaluations, and 4 one-arm noncomparative studies were included. Meta-analysis was not possible because of the heterogeneity in study designs, types, study settings, and level of outcome measurements. Individual paper synthesis showed that electronic data collection systems provided good quality data and delivered faster compared with paper-based data collection systems. Only 2 studies linked cost and data quality outcomes to describe the cost-effectiveness of electronic data collection systems. Field data collectors reported that an electronic data collection system was a feasible, acceptable, and preferable tool for their work. Onsite data error prevention, fast data submission, and easy-to-handle devices were the comparative advantages offered by electronic data collection systems. Challenges during implementation included technical difficulties, accidental data loss, device theft, security concerns, power surges, and internet connection problems. CONCLUSIONS: Although evidence exists of the comparative advantages of electronic data collection compared with paper-based methods, the included studies were not methodologically rigorous enough to combine. More rigorous studies are needed to compare paper and electronic data collection systems in public health surveys considering data quality, work efficiency, and cost reduction. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/10678.


Subject(s)
Cost-Benefit Analysis/standards , Data Accuracy , Health Surveys/economics , Public Health/economics , Public Health/methods , Cross-Sectional Studies , Humans , Retrospective Studies
2.
JMIR Res Protoc ; 8(1): e10678, 2019 Jan 30.
Article in English | MEDLINE | ID: mdl-30698530

ABSTRACT

BACKGROUND: Population-level survey is an essential standard method used in public health research to quantify sociodemographic events and support public health policy development and intervention designs with evidence. Although all steps in the survey can contribute to the data quality parameters, data collection mechanisms seem the most determinant, as they can avoid mistakes before they happen. The use of electronic devices such as smartphones and tablet computers improve the quality and cost-effectiveness of public health surveys. However, there is lack of systematically analyzed evidence to show the potential impact on data quality and cost reduction of electronic-based data collection tools in interviewer-administered surveys. OBJECTIVE: This systematic review aims to evaluate the impact of interviewer-administered electronic device data collection methods concerning data quality and cost reduction in population-level surveys compared with the traditional paper-based methods. METHODS: We will conduct a systematic search on Medical Literature Analysis and Retrieval System Online, PubMed, CINAHL, PsycINFO, Global Health, Trip, ISI Web of Science, and Cochrane Library for studies from 2007 to 2018 to identify relevant studies. The review will include randomized and nonrandomized studies that examine data quality and cost reduction outcomes. Moreover, usability, user experience, and usage parameters from the same study will be summarized. Two independent authors will screen the title and abstract. A third author will mediate in cases of disagreement. If the studies are considered to be combinable with minimal heterogeneity, we will perform a meta-analysis. RESULTS: The preliminary search in PubMed and Web of Science showed 1491 and 979 resulting hits of articles, respectively. The review protocol is registered in the International Prospective Register of Systematic Reviews (CRD42018092259). We anticipate January 30, 2019, to be the finishing date. CONCLUSIONS: This systematic review will inform policymakers, investors, researchers, and technologists about the impact of an electronic-based data collection system on data quality, work efficiency, and cost reduction. TRIAL REGISTRATION: PROSPERO CRD42018092259; http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID= CRD42018092259. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/10678.

3.
BMJ Open ; 9(1): e021766, 2019 01 24.
Article in English | MEDLINE | ID: mdl-30679284

ABSTRACT

OBJECTIVES: This study aimed at determining access to mobile phone and willingness to receive mobile phone-based diabetes health services as well as identify associated factors in Northwest Ethiopia. DESIGN: An institution-based cross-sectional survey was conducted from February to March 2016. PARTICIPANTS: Systematic randomly selected 423 patients with diabetes. SETTING: University of Gondar Hospital diabetic clinic. MAIN OUTCOME MEASURES: The main outcome measure was willingness to receive diabetic health service via mobile phone voice call or messaging services. RESULTS: Out of 423 patients with diabetes, 329 (77.8%) had access to a mobile phone. Among the latter, 232 (70.5%) were willing to receive mobile phone-based health services. The educational status of patients (adjusted OR (AOR): 2.6 (95% CI: 1.2 to 5.58)), route of medication (AOR: 3.2 (95% CI: 1.44 to 7.1)), transportation mechanism (AOR: 4.1 (95% CI: 1.2 to 13.57)), travel time to health facility (AOR: 0.3 (95% CI: 0.12 to 0.82)), current use of mobile phone as appointment reminder (AOR: 2.6 (95% CI: 1.07 to 6.49)) and locking mobile phone with passwords (AOR: 4.6 (95% CI: 1.63 to 12.95)) were significantly associated with the willingness to receive mobile phone-based diabetic health services. CONCLUSION: Access to a mobile phone and willingness to receive mobile phone-based health services were high. Educational status, route of medication, transportation mechanism, time to reach the service, using mobile phone as appointment reminder and locking mobile phone with passwords were significantly associated factors. Given the high proportion of access and willingness of patients to receive mobile phone-based health services, mHealth interventions could be helpful.


Subject(s)
Diabetes Mellitus/therapy , Patient Acceptance of Health Care , Reminder Systems , Text Messaging/statistics & numerical data , Adult , Cross-Sectional Studies , Ethiopia , Female , Humans , Logistic Models , Male , Middle Aged , Telemedicine
4.
Online J Public Health Inform ; 10(2): e212, 2018.
Article in English | MEDLINE | ID: mdl-30349630

ABSTRACT

BACKGROUND: Anti-Retroviral Therapy (ART) care is a lifelong treatment, which needs accurate and reliable data collected for long period of time. Poor quality of medical records data remains a challenge and is directly related to the quality of care of patients. To improve this, there is an increasing trend to implement electronic medical record (EMR) in hospitals. However, there is little evidence on the impact of EMR on the quality of health data in low- resource setting hospitals like Ethiopia. This comparative study aims to fill this evidence gap by assessing the completeness and reliability of paper-based and electronic medical records and explore the challenges of ensuring data quality at the Anti-Retroviral Therapy (ART) clinic at the University of Gondar Referral Hospital in Northwest Ethiopia. METHODS: An institution-based comparative cross-sectional study, supplemented with a qualitative approach was conducted from February 1 to March 30, 2017 at the ART clinic of the University of Gondar Hospital. A total of 250 medical records having both electronic and paper-based versions were collected and assessed. A national ART registration form which consists of 40 ART data elements was used as a checklist to assess completeness and reliability dimensions of data quality on medical records of patients on HIV care. Kappa statistics were computed to describe the level of data agreement between paper-based and electronic records across patient characteristics. In-depth interviews were conducted using semi-structured questionnaires with ten key informants to explore the challenges related with the quality of medical records. Responses of the key informant interviews were analyzed using thematic analysis. RESULTS: The overall completeness of medical records was 78% with 95% CI (70.8% - 85.1%) in paper-based and 76% with 95%CI (67.8% - 83.2%) EMR. The data reliability measured in Kappa statistics shows strong agreements on the socio-demographic data such as educational status 0.93 (0.891, 0.963), WHO staging 0.86 (0.808, 0.906); general appearance 0.83 (0.755, 0.892) and patient referral record 0.87 (0.795, 0.932). The major challenges hindering good data quality was the current side by side dual data documentation practice (the need to document both on the paper and the EMR for a single record), patient overload and low data documentation practice of health workers. CONCLUSION: The overall completeness of ART medical records was still slightly better in paper-based records than EMR. The main reason affecting the EMR data quality was the current dual documentation practice both on the paper and electronic for each patient in the hospital and the high load of patients in the clinic. The hospital management need to decide to use either the paper or the electronic system and build the capacity of health workers to improve data quality in the hospital.

6.
Acta Haematol ; 137(3): 163-172, 2017.
Article in English | MEDLINE | ID: mdl-28399522

ABSTRACT

Within this retrospective single-center study, we analyzed the survival of 320 multiple myeloma (MM) patients receiving melphalan high-dose chemotherapy (HDCT) and either single (n = 286) or tandem (n = 34) autologous stem cell transplantation (ASCT) from 1996 to 2012. Additionally, the impact of novel induction regimens was assessed. Median follow-up was 67 months, median overall survival (OS) 62 months, median progression-free survival (PFS) 33 months (95% CI 27-39), and treatment-related death (TRD) 3%. Multivariate analysis revealed age ≥60 years (p = 0.03) and stage 3 according to the International Staging System (p = 0.006) as adverse risk factors regarding PFS. Median OS was significantly better in newly diagnosed MM patients receiving induction therapy with novel agents, e.g., bortezomib, thalidomide, or lenalidomide, compared with a traditional regimen (69 vs. 58 months; p = 0.01). More patients achieved at least a very good partial remission in the period from 2005 to 2012 than from 1996 to 2004 (65 vs. 30%; p < 0.001), with a longer median OS in the later period (71 vs. 52 months, p = 0.027). In conclusion, our analysis confirms HDCT-ASCT as an effective therapeutic strategy in an unselected large myeloma patient cohort with a low TRD rate and improved prognosis due to novel induction strategies.


Subject(s)
Multiple Myeloma/drug therapy , Multiple Myeloma/therapy , Stem Cell Transplantation , Adult , Aged , Antineoplastic Agents, Alkylating/administration & dosage , Antineoplastic Protocols , Cohort Studies , Combined Modality Therapy , Disease-Free Survival , Female , Humans , Induction Chemotherapy , Male , Melphalan/administration & dosage , Middle Aged , Prognosis , Retrospective Studies , Transplantation, Autologous
7.
Clin Res Cardiol ; 106(1): 1-9, 2017 Jan.
Article in English | MEDLINE | ID: mdl-27557678

ABSTRACT

Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research.


Subject(s)
Cardiovascular Diseases , Clinical Trials as Topic/methods , Comparative Effectiveness Research/methods , Data Mining , Electronic Health Records , Research Design , Access to Information , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/therapy , Clinical Trials as Topic/ethics , Comparative Effectiveness Research/ethics , Confidentiality , Data Accuracy , Data Mining/ethics , Electronic Health Records/ethics , Humans , Medical Record Linkage , Systems Integration
8.
Biomed Res Int ; 2015: 801436, 2015.
Article in English | MEDLINE | ID: mdl-26539525

ABSTRACT

The Electronic Health Records for Clinical Research (EHR4CR) project aims to develop services and technology for the leverage reuse of Electronic Health Records with the purpose of improving the efficiency of clinical research processes. A pilot program was implemented to generate evidence of the value of using the EHR4CR platform. The user acceptance of the platform is a key success factor in driving the adoption of the EHR4CR platform; thus, it was decided to evaluate the user satisfaction. In this paper, we present the results of a user satisfaction evaluation for the EHR4CR multisite patient count cohort system. This study examined the ability of testers (n = 22 and n = 16 from 5 countries) to perform three main tasks (around 20 minutes per task), after a 30-minute period of self-training. The System Usability Scale score obtained was 55.83 (SD: 15.37), indicating a moderate user satisfaction. The responses to an additional satisfaction questionnaire were positive about the design of the interface and the required procedure to design a query. Nevertheless, the most complex of the three tasks proposed in this test was rated as difficult, indicating a need to improve the system regarding complicated queries.


Subject(s)
Biomedical Research/methods , Clinical Trials as Topic/methods , Electronic Health Records , Humans , Program Evaluation , Task Performance and Analysis
9.
BMC Med Inform Decis Mak ; 15: 65, 2015 Aug 13.
Article in English | MEDLINE | ID: mdl-26268394

ABSTRACT

BACKGROUND: Non-adherence to Antiretroviral Treatment (ART) is strongly associated with virologic rebound and drug resistance. Studies have shown that the most frequently mentioned reason for missing ART doses is the forgetfulness of patients to take their medications on time. Therefore using communication devices as reminder tools, for example alarms, pagers, text messages and telephone calls could improve adherence to ART. The aim of this study is to measure access to cellphones, willingness to receive text message medication reminders and to identify associated factors of ART patients at the University of Gondar Hospital, in North West Ethiopia. METHODS: An institution based cross sectional quantitative study was conducted among 423 patients on ART during April 2014. Data were collected using structured interviewer-administered questionnaires. Data entry and analysis were done using Epi-Info version 7 and SPSS version 20 respectively. Descriptive statistics and multivariable logistic regression analysis were used to describe the characteristic of the sample and identify factors associated with the willingness to receive text message medication reminders. RESULTS: A total of 415 (98% response rate) respondents participated in the interview. The majority of respondents 316 (76.1%) owned a cellphone, and 161(50.9%) were willing to receive text message medication reminders. Positively associated factors to the willingness were the following: Younger age group (AOR = 5.18, 95% CI: [1.69, 15.94]), having secondary or higher education (AOR = 4.61, 95% CI: [1.33, 16.01]), using internet (AOR = 3.94, 95% CI: [1.67, 9.31]), not disclosing HIV status to anyone other than HCP (Health Care Provider) (AOR = 3.03, 95% CI: [1.20, 7.61]), availability of radio in dwelling (AOR = 2.74 95% CI: [1.27, 5.88]), not answering unknown calls (AOR = 2.67, 95% CI: [1.34, 5.32]), use of cellphone alarm as medication reminder (AOR = 2.22, 95%CI [1.09, 4.52]), and forgetting to take medications (AOR = 2.13, 95% CI: [1.14, 3.96]). CONCLUSIONS: A high proportion of respondents have a cell phone and are willing to use it as medication reminders. Age, educational status and using internet were the main factors that are significantly associated with the willingness of patients to receive text message medication reminders.


Subject(s)
Anti-Retroviral Agents/administration & dosage , HIV Infections/drug therapy , Medication Adherence/ethnology , Patient Acceptance of Health Care/ethnology , Reminder Systems , Text Messaging , Adolescent , Adult , Cross-Sectional Studies , Ethiopia , Female , Humans , Male , Middle Aged , Young Adult
10.
Stud Health Technol Inform ; 216: 1029, 2015.
Article in English | MEDLINE | ID: mdl-26262329

ABSTRACT

With the growing complexity and cost of clinical trials (CTs) over the past few decades, Protocol Feasibility (PF) studies have become one of the most critical CT steps in order to avoid costly protocol amendments and ensure the success of CTs. The PF process includes interaction with clinicians located at targeted clinical sites, which results in slow and cumbersome process steps. These process steps are normally supported by information systems that allow users to create, share and collect responses to feasibility questionnaires. This investigation analyzes the systems and questionnaires utilized at several clinical research companies for PF. In addition, it provides recommendations that could eventually improve current methods and systems in place.


Subject(s)
Clinical Trials as Topic/methods , Clinical Trials as Topic/standards , Feasibility Studies , Guideline Adherence/standards , Practice Guidelines as Topic/standards , Surveys and Questionnaires/standards , Checklist/standards
11.
Stud Health Technol Inform ; 216: 1042, 2015.
Article in English | MEDLINE | ID: mdl-26262341

ABSTRACT

OBJECTIVE: In the treatment of chronic pruritus-related, scratch-induced skin lesions the categorization, counting and temporal comparison are common methodologies. The observation requires a good memory and expertise in this field to gain comparable findings for this time-consuming process. Digital image processing aims at supporting such manual detections. The objective is to develop a software tool for automatic image detection and comparison. The new photographic setting implies the usage of markers to derive the brightness and size of lesions. MATLAB has been used for the software development. The newly defined setting allows taking standardized images of pruritus-associated cutaneous lesions for detection and comparison. The tool named PIACS (Prurigo Image Analyzing and Comparing System) allows automatically detecting, categorizing and comparing lesions based on digital images.


Subject(s)
Fiducial Markers , Image Interpretation, Computer-Assisted/methods , Photography/instrumentation , Photography/methods , Pruritus/diagnostic imaging , Skin/injuries , Dermoscopy/instrumentation , Dermoscopy/methods , Diagnosis, Differential , Humans , Machine Learning , Pattern Recognition, Automated/methods , Reproducibility of Results , Sensitivity and Specificity , Skin/pathology
12.
BMC Med Inform Decis Mak ; 15: 61, 2015 Aug 01.
Article in English | MEDLINE | ID: mdl-26231051

ABSTRACT

BACKGROUND: With the increasing implementation of Electronic Medical Record Systems (EMR) in developing countries, there is a growing need to identify antecedents of EMR success to measure and predict the level of adoption before costly implementation. However, less evidence is available about EMR success in the context of low-resource setting implementations. Therefore, this study aims to fill this gap by examining the constructs and relationships of the widely used DeLone and MacLean (D&M) information system success model to determine whether it can be applied to measure EMR success in those settings. METHODS: A quantitative cross sectional study design using self-administered questionnaires was used to collect data from 384 health professionals working in five governmental hospitals in Ethiopia. The hospitals use a comprehensive EMR system since three years. Descriptive and structural equation modeling methods were applied to describe and validate the extent of relationship of constructs and mediating effects. RESULTS: The findings of the structural equation modeling shows that system quality has significant influence on EMR use (ß = 0.32, P < 0.05) and user satisfaction (ß = 0.53, P < 0.01); information quality has significant influence on EMR use (ß = 0.44, P < 0.05) and user satisfaction (ß = 0.48, P < 0.01) and service quality has strong significant influence on EMR use (ß = 0.36, P < 0.05) and user satisfaction (ß = 0.56, P < 0.01). User satisfaction has significant influence on EMR use (ß = 0.41, P < 0.05) but the effect of EMR use on user satisfaction was not significant. Both EMR use and user satisfaction have significant influence on perceived net-benefit (ß = 0.31, P < 0.01; ß = 0.60, P < 0.01), respectively. Additionally, computer literacy was found to be a mediating factor in the relationship between service quality and EMR use (P < 0.05) as well as user satisfaction (P < 0.01). Among all the constructs, user satisfaction showed the strongest effect on perceived net-benefit of health professionals. CONCLUSION: EMR implementers and managers in developing countries are in urgent need of implementation models to design proper implementation strategies. In this study, the constructs and relationships depicted in the updated D&M model were found to be applicable to assess the success of EMR in low resource settings. Additionally, computer literacy was found to be a mediating factor in EMR use and user satisfaction of health professionals. Hence, EMR implementers and managers in those settings should give priority in improving service quality of the hospitals like technical support and infrastructure; providing continuous basic computer trainings to health professionals; and give attention to the system and information quality of the systems they want to implement.


Subject(s)
Attitude of Health Personnel/ethnology , Computer Literacy , Electronic Health Records , Hospitals , Adult , Cross-Sectional Studies , Ethiopia/ethnology , Female , Humans , Male , Middle Aged , Surveys and Questionnaires
13.
Dermatology ; 231(3): 253-9, 2015.
Article in English | MEDLINE | ID: mdl-26278551

ABSTRACT

BACKGROUND: It is unknown if health-related quality of life (HRQoL) differs between diseases associated with chronic pruritus (CP). OBJECTIVE: To analyze HRQoL in relation to age, gender, skin lesions (primary vs. scratch-induced secondary) and itch intensity. METHODS: Consecutive patients of our itch clinic were assessed with the Dermatology Life Quality Index (DLQI) and visual analogue scale (VAS). RESULTS: In 510 CP patients (282 females; median age, 61.4 years), DLQI scores and VAS values were highly correlated, irrespective of the type of skin lesion. Overall, women had a lower HRQoL compared to men (females: 10.7 ± 6.7, males: 8.9 ± 6.7), but female gender was only associated with worse quality of life in patients <65 years old. CONCLUSION: HRQoL impairment in CP is highly influenced by pruritus intensity but not to the visible skin lesion or underlying cause. With limitations to item bias, DLQI is a suitable instrument for estimating quality of life impairment by CP.


Subject(s)
Pruritus/psychology , Quality of Life , Skin/pathology , Adult , Aged , Aged, 80 and over , Chronic Disease , Female , Follow-Up Studies , Humans , Male , Middle Aged , Pruritus/diagnosis , Pruritus/etiology , Retrospective Studies , Severity of Illness Index , Surveys and Questionnaires , Young Adult
14.
Article in English | MEDLINE | ID: mdl-26262229

ABSTRACT

With the increasing implementation of different health information systems in developing countries, there is a growing need to measure the main determinants of their success. The results of this evaluation study on the determinants of HIS success in five low resource setting hospitals show that service quality is the main determinant factor for information system success in those kind of settings.


Subject(s)
Health Information Systems/standards , Adult , Consumer Behavior , Developing Countries , Female , Humans , Male , Program Evaluation , Surveys and Questionnaires
15.
Article in English | MEDLINE | ID: mdl-26262283

ABSTRACT

Cost and benefit analyses are crucial for eHealth interventions, especially in low and middle income countries (LMIC). We performed a scoping review, with goals to acquire an overview of cost-benefit studies and to collect indicators that are being used for costs and savings with respect to eHealth. Of all retrieved articles, 29 were included in our analysis and 21 contained cost/savings indicators which we categorized into outcome measures with respect to providers, patients and other stakeholders. Nearly all authors stated that more evidence from economic analyses by health economists are urgently needed and that pilot projects should collect cost related data for evaluation.


Subject(s)
Developing Countries , Telemedicine/economics , Cost Savings , Cost-Benefit Analysis , Developing Countries/economics , Developing Countries/statistics & numerical data , Health Services Needs and Demand , Humans , Program Evaluation
16.
Stud Health Technol Inform ; 212: 88-93, 2015.
Article in English | MEDLINE | ID: mdl-26063262

ABSTRACT

The design of clinical trial (CT) study protocols, currently supported by clinicians, is often a slow and cumbersome process. The Electronic Health Records for Clinical Research (EHR4CR) project supports the design of study protocols through a multi-site patient count cohort system. However, there is still a need to improve the process step in which the clinicians are involved. This research aims to enhance the EHR4CR platform with a tool to support the contact of CT sponsors with clinical investigators to obtain their input regarding feasibility data for the CT protocol design. From a list of requirements, a technical architecture that responds to the needs of feasibility assessments was modelled. With this architecture as a basis, a system that allows users to generate, send, fill out and visualise results of feasibility questionnaires across clinical sites was developed and integrated within the EHR4CR platform. The resulting system improves the current methods by providing direct contact to clinical investigators, facilitating the creation and answer of feasibility questionnaires for CTs.


Subject(s)
Clinical Trials as Topic/methods , Electronic Health Records/organization & administration , Information Storage and Retrieval/methods , Internet/organization & administration , Software , Surveys and Questionnaires , Cohort Studies , Europe , Feasibility Studies
17.
BMC Med Res Methodol ; 15: 44, 2015 May 01.
Article in English | MEDLINE | ID: mdl-25928269

ABSTRACT

BACKGROUND: With the increase of clinical trial costs during the last decades, the design of feasibility studies has become an essential process to reduce avoidable and costly protocol amendments. This design includes timelines, targeted sites and budget, together with a list of eligibility criteria that potential participants need to match. The present work was designed to assess the value of obtaining potential study participant counts using an automated patient count cohort system for large multi-country and multi-site trials: the Electronic Health Records for Clinical Research (EHR4CR) system. METHODS: The evaluation focuses on the accuracy of the patient counts and the time invested to obtain these using the EHR4CR platform compared to the current questionnaire based process. This evaluation will assess the patient counts from ten clinical trials at two different sites. In order to assess the accuracy of the results, the numbers obtained following the two processes need to be compared to a baseline number, the "alloyed" gold standard, which was produced by a manual check of patient records. RESULTS: The patient counts obtained using the EHR4CR system were in three evaluated trials more accurate than the ones obtained following the current process whereas in six other trials the current process counts were more accurate. In two of the trials both of the processes had counts within the gold standard's confidence interval. In terms of efficiency the EHR4CR protocol feasibility system proved to save approximately seven calendar days in the process of obtaining patient counts compared to the current manual process. CONCLUSIONS: At the current stage, electronic health record data sources need to be enhanced with better structured data so that these can be re-used for research purposes. With this kind of data, systems such as the EHR4CR are able to provide accurate objective patient counts in a more efficient way than the current methods. Additional research using both structured and unstructured data search technology is needed to assess the value of unstructured data and to compare the amount of efforts needed for data preparation.


Subject(s)
Algorithms , Biomedical Research/standards , Clinical Trials as Topic/standards , Electronic Health Records/standards , Multicenter Studies as Topic/standards , Biomedical Research/methods , Biomedical Research/statistics & numerical data , Clinical Protocols/standards , Clinical Trials as Topic/methods , Clinical Trials as Topic/statistics & numerical data , Cohort Studies , Electronic Health Records/statistics & numerical data , Feasibility Studies , Internationality , Multicenter Studies as Topic/methods , Multicenter Studies as Topic/statistics & numerical data , Patient Dropouts , Patient Selection
18.
Stud Health Technol Inform ; 210: 506-10, 2015.
Article in English | MEDLINE | ID: mdl-25991199

ABSTRACT

INTRODUCTION: In the last few years much work has been conducted in creating systems that support clinical trials for example by utilizing electronic health record data. One of these endeavours is the Electronic Health Record for Clinical Research project (EHR4CR). An unanswered question that the project aims to answer is which data elements are most commonly required for patient recruitment. METHODS: Free text eligibility criteria from 40 studies were analysed, simplified and elements were extracted. These elements where then added to an existing inventory of data elements for protocol feasibility. RESULTS: We simplified and extracted data elements from 40 trials, which resulted in 1170 elements. From these we created an inventory of 150 unique data elements relevant for patient identification and recruitment with definitions and referenced codes to standard terminologies. DISCUSSION: Our list was created with expertise from pharmaceutical companies. Comparisons with related work shows that identified concepts are similar. An evaluation of the availability of these elements in electronic health records is still ongoing. Hospitals that want to engage in re-use of electronic health record data for research purposes, for example by joining networks like EHR4CR, can now prioritize their effort based on this list.


Subject(s)
Clinical Trials as Topic/methods , Data Mining/methods , Electronic Health Records/classification , Electronic Health Records/statistics & numerical data , Eligibility Determination/methods , Patient Selection , Databases, Factual , Europe , Terminology as Topic
19.
JMIR Med Inform ; 3(2): e22, 2015 May 25.
Article in English | MEDLINE | ID: mdl-26007237

ABSTRACT

BACKGROUND: Electronic medical record (EMR) systems are increasingly being implemented in hospitals of developing countries to improve patient care and clinical service. However, only limited evaluation studies are available concerning the level of adoption and determinant factors of success in those settings. OBJECTIVE: The objective of this study was to assess the usage pattern, user satisfaction level, and determinants of health professional's satisfaction towards a comprehensive EMR system implemented in Ethiopia where parallel documentation using the EMR and the paper-based medical records is in practice. METHODS: A quantitative, cross-sectional study design was used to assess the usage pattern, user satisfaction level, and determinant factors of an EMR system implemented in Ethiopia based on the DeLone and McLean model of information system success. Descriptive statistical methods were applied to analyze the data and a binary logistic regression model was used to identify determinant factors. RESULTS: Health professionals (N=422) from five hospitals were approached and 406 responded to the survey (96.2% response rate). Out of the respondents, 76.1% (309/406) started to use the system immediately after implementation and user training, but only 31.7% (98/309) of the professionals reported using the EMR during the study (after 3 years of implementation). Of the 12 core EMR functions, 3 were never used by most respondents, and they were also unaware of 4 of the core EMR functions. It was found that 61.4% (190/309) of the health professionals reported over all dissatisfaction with the EMR (median=4, interquartile range (IQR)=1) on a 5-level Likert scale. Physicians were more dissatisfied (median=5, IQR=1) when compared to nurses (median=4, IQR=1) and the health management information system (HMIS) staff (median=2, IQR=1). Of all the participants, 64.4% (199/309) believed that the EMR had no positive impact on the quality of care. The participants indicated an agreement with the system and information quality (median=2, IQR=0.5) but strongly disagreed with the service quality (median=5, IQR=1). The logistic regression showed a strong correlation between system use and dissatisfaction (OR 7.99, 95% CI 5.62-9.10) and service quality and satisfaction (OR 8.23, 95% CI 3.23-17.01). CONCLUSIONS: Health professionals' use of the EMR is low and they are generally dissatisfied with the service of the implemented system. The results of this study show that this dissatisfaction is caused mainly and strongly by the poor service quality, the current practice of double documentation (EMR and paper-based), and partial departmental use of the system in the hospitals. Thus, future interventions to improve the current use or future deployment projects should focus on improving the service quality such as power infrastructure, user support, trainings, and more computers in the wards. After service quality improvement, other departments (especially inter-dependent departments) should be motivated and supported to use the EMR to avoid the dependency deadlock.

20.
J Am Med Inform Assoc ; 22(2): 479-88, 2015 Mar.
Article in English | MEDLINE | ID: mdl-25769683

ABSTRACT

OBJECTIVE: Electronic medical record (EMR) systems have the potential of supporting clinical work by providing the right information at the right time to the right people and thus make efficient use of resources. This is especially important in low-resource settings where reliable data are also needed to support public health and local supporting organizations. In this systematic literature review, our objectives are to identify and collect literature about success criteria of EMR implementations in low-resource settings and to summarize them into recommendations. MATERIALS AND METHODS: Our search strategy relied on PubMed queries and manual bibliography reviews. Studies were included if EMR implementations in low-resource settings were described. The extracted success criteria and measurements were summarized into 7 categories: ethical, financial, functionality, organizational, political, technical, and training. RESULTS: We collected 381 success criteria with 229 measurements from 47 articles out of 223 articles. Most papers were evaluations or lessons learned from African countries, published from 1999 to 2013. Almost half of the EMR systems served a specific disease area like human immunodeficiency virus (HIV). The majority of criteria that were reported dealt with the functionality, followed by organizational issues, and technical infrastructures. Sufficient training and skilled personnel were mentioned in roughly 10%. Political, ethical, and financial considerations did not play a predominant role. More evaluations based on reliable frameworks are needed. CONCLUSIONS: Highly reliable data handling methods, human resources and effective project management, as well as technical architecture and infrastructure are all key factors for successful EMR implementation.


Subject(s)
Developing Countries , Diffusion of Innovation , Electronic Health Records , Medical Records Systems, Computerized/organization & administration , Electronic Health Records/ethics , Health Resources , Humans , Organizational Innovation
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