Direct Data Capture Research Articles

Effectiveness of remote risk-based monitoring and potential benefits for combination with direct data capture

BackgroundIn recent years, alternative monitoring approaches, such as risk-based and remote monitoring techniques, have been recommended instead of traditional on-site monitoring to achieve more efficient monitoring. Remote risk-based monitoring (R2BM) is a monitoring technique that combines risk-based and remote monitoring and focuses on the detection of critical data and process errors. Direct data capture (DDC), which directly collects electronic source data, can facilitate R2BM by minimizing the extent of source documents that must be reviewed and reducing the additional workload on R2BM. In this study, we evaluated the effectiveness of R2BM and the synergistic effect of combining R2BM with DDC.MethodsR2BM was prospectively conducted with eight participants in a randomized clinical trial using a remote monitoring system that uploaded photographs of source documents to a cloud location. Critical data and processes were verified by R2BM, and later, all were confirmed by on-site monitoring to evaluate the ability of R2BM to detect critical data and process errors and the workload of uploading photographs for clinical trial staff. In addition, the reduction of the number of uploaded photographs was evaluated by assuming that the DDC was introduced for data collection.ResultsOf the 4645 data points, 20.9% (n = 973, 95% confidence interval = 19.8–22.2) were identified as critical. All critical data errors corresponding to 5.4% (n = 53/973, 95% confidence interval = 4.1–7.1) of the critical data and critical process errors were detectable by R2BM. The mean number of uploaded photographs and the mean time to upload them per visit per participant were 34.4 ± 11.9 and 26.5 ± 11.8 min (mean ± standard deviation), respectively. When assuming that DDC was introduced for data collection, 45.0% (95% confidence interval = 42.2–47.9) of uploaded photographs for R2BM were reduced.ConclusionsR2BM can detect 100% of the critical data and process errors without on-site monitoring. Combining R2BM with DDC reduces the workload of R2BM and further improves its efficiency.

Development of 3‐D point cloud imaging and 2‐D image processing methods for high‐throughput phenotyping of perennial ryegrass spikes

AbstractAdvances in technology have increased the adoption of high‐throughput phenotyping (HTP) methodologies, potentially replacing laborious and time‐consuming measurements and data recording. One promising HTP tool for fine‐featured and small‐sized characteristics is the three‐dimensional (3‐D) scanning and imaging system, but the utility of present two‐dimensional (2‐D) technology has not been fully explored for this purpose. The objective of this work was to reduce assessment and field evaluation time by developing 2‐D photogrammetric and 3‐D point cloud imaging methods for HTP of spike characteristics in perennial ryegrass (Lolium perenne L.), with special attention to traits that might be associated with seed retention. These HTP imaging systems were compared with direct data capture by hand on spikes of 21 diverse global accessions of perennial ryegrass. The Fiji (ImageJ) open‐source imaging software was used for photogrammetric analysis of spike structure, including spike length, spikelet number, internode length, and 2‐D curvature of the spike. An original approach to nondestructive HTP for crop characterization was developed using the commercially available Artec Space Spider. This 3‐D optical sensor was used to generate dense 3‐D point clouds to measure spike length, spikelet number, internode length, spikelet length, spikelet angle, and 3‐D curvature of the spike. Both methods were found to accurately characterize the subject; the 3‐D method was slower than 2‐D but was more precise (p ≤ 0.01) than 2‐D image analysis with a linear measurement deviation of only 0.17%. Fiji was effectively used for post‐processing image analysis, and the Space Spider can be used directly in the field to support HTP data collection. This non‐destructive field measurement system facilitates HTP in perennial ryegrass spikes and likely in other applications.

Data capture in the 80's

This paper argues that social and economic pressures plus the rapid development of electronic devices will, through the present decade. produce a significant shift from face to face interviewing at private addresses, towards centralised interviewing, postal surveys, telephone surveys, qualitative research and direct data capture via specialised event recorders. The advantages of postal and telephone surveys will come to be better appreciated, and improved techniques will be adopted in both. The use of increasingly sophisticated and cos: effective electronics equipment will at first extend and improve existing techniques of data capture, but by the end of this decade electronic developments will have brought about fundamental and permanent changes in the way data can be collected.Survey research data capture techniques are going to change dramatically in the next decade, but this change can be expected to come about as the result of any single development in facilities, fashion, or philosophy. In fact these techniques will come about gradually, as a result of the changing pattern of commercial incentives and disincentives that face the individual and corporate researcher. By far the biggest disincentive is going to be the increasing difficulty and cost of arranging traditional face-to-face interviews at the home of the respondent, plus a growing awareness of the technical disadvantages of this technique.

Accuracy of Proximal and Occlusal Contacts of Single Implant Crowns Fabricated Using Different Digital Scan Methods: An In Vitro Study.

The purpose of this in vitro study was to compare the accuracy of the proximal and occlusal contacts of single implant crowns fabricated with four data capture methods. The resin models were mounted on an articulator, digitized using a laboratory scanner, and saved as a standard tessellation language (STL) file to serve as the master reference model (MRM). Two different intraoral scan body (ISB) systems were evaluated: polyetheretherketone (PEEK) short scan body (SSB) and PEEK long scan body (LSB) (n = 12). The digital impressions (SSB and LSB) were acquired using an intraoral scanner with ISB. Two different conventional techniques were also evaluated: PEEK short scan body with coping plastic cap (CPC) and pick-up coping (PUC) (n = 12). The implant impressions (CPC and PUC) were recorded using a conventional impression technique. The crown and abutment were fabricated with a milling machine and then placed on the resin model and scanned using a laboratory scanner. The scanned files were saved as STL files to serve as test datasets. The MRM and test datasets were superimposed, and the mesial, distal, and occlusal distances were calculated using a 3D inspection software and statistically analyzed using the Kruskal–Wallis H test (α = 0.05). The direct data capture group had more accurate contact points on the three surfaces, with mesial contact of 64.7 (12.8) µm followed by distal contact of 65.4 (15) µm and occlusal contact of 147 (35.8) µm in the SSB group, and mesial contact of 84.9 (22.6) µm followed by distal contact of 69.5 (19.2) µm and occlusal contact of 115.9 (27.7) µm in the LSB group (p < 0.001). The direct data capture groups are closer to the ideal proximal and occlusal contacts for single implant crowns than the indirect data capture groups. There was no difference in the accuracy between the two types of scan body (SSB and LSB).

Predicting depressive symptoms using smartphone data

Depression is a serious mental illness. The symptoms associated with depression are both behavioral (in appetite, energy level, sleep) and cognitive (in interests, mood, concentration). Currently, survey instruments are commonly used to keep track of depression symptoms, which are burdensome and difficult to execute on a continuous basis. In this paper, we explore the feasibility of predicting all major categories of depressive symptoms automatically using smartphone data. Specifically, we consider two types of smartphone data, one collected passively on smartphones (through an app running on the phones) and the other collected from an institution's WiFi infrastructure (that does not require direct data capture on the phones), and construct a family of machine learning based models for the prediction. Both scenarios require no efforts from the users, and can provide objective assessment on depressive symptoms. Using smartphone data collected from 182 college students in a two-phase study, our results demonstrate that smartphone data can be used to predict both behavioral and cognitive symptoms effectively, with F1 score as high as 0.86. Our study makes a significant step forward over existing studies that only focus on predicting overall depression status (i.e., whether one is depressed or not).

Building clinical trials around patients: Evaluation and comparison of decentralized and conventional site models in patients with low back pain.

Clinical trials are slow and costly, built around the research centers that study local participants. Building clinical trials around patients in their homes and community through remote visits and monitoring could enhance recruitment and increase convenience for participants. This study evaluated different trial settings, a decentralized arm via telemedicine center (virtual study conduct), a conventional arm via health clinic (onsite study conduct) and a mixed model arm. Acute low-back pain patients (20–65 years) were recruited to this non-interventional trial in Switzerland. The study consisted of a screening period and a 2-week data collection period using direct data capture (eSource), electronic informed consent form (eICF), electronic diary (eDiary) and wearable actigraphy sensor.A higher number of patients were enrolled in the decentralized arm (N = 18) compared to the conventional arm (N = 5) and none in the mixed model arm. The decentralized arm consisted of a diverse population with increased participation from rural areas. In the decentralized arm 89% of enrolled patients completed the study compared to 60% in the conventional arm. All the patients reported satisfaction with the use of eICF, eDiary and remote visits; whereas patients reported a lower level of satisfaction with the wearable sensor.The decentralized setting was operationally feasible and well accepted by patients. Faster recruitment and improved access to patients was observed in the decentralized arm. This study supports broader adoption of the decentralized model in clinical trials, though further investigations in larger interventional trials are needed to confirm the benefits from this patient-centric approach.

Randomised controlled trial of high versus ad libitum water intake in patients with autosomal dominant polycystic kidney disease: rationale and design of the DRINK feasibility trial

IntroductionVasopressin stimulates cyst growth in autosomal dominant polycystic kidney disease (ADPKD) leading to enlarged kidneys, hypertension and renal failure. Vasopressin receptor blockade slows disease progression. Physiological suppression of vasopressin secretion...

Collecting verbal autopsies: improving and streamlining data collection processes using electronic tablets

BackgroundThere is increasing interest in using verbal autopsy to produce nationally representative population-level estimates of causes of death. However, the burden of processing a large quantity of surveys collected with paper and pencil has been a barrier to scaling up verbal autopsy surveillance. Direct electronic data capture has been used in other large-scale surveys and can be used in verbal autopsy as well, to reduce time and cost of going from collected data to actionable information.MethodsWe collected verbal autopsy interviews using paper and pencil and using electronic tablets at two sites, and measured the cost and time required to process the surveys for analysis. From these cost and time data, we extrapolated costs associated with conducting large-scale surveillance with verbal autopsy.ResultsWe found that the median time between data collection and data entry for surveys collected on paper and pencil was approximately 3 months. For surveys collected on electronic tablets, this was less than 2 days. For small-scale surveys, we found that the upfront costs of purchasing electronic tablets was the primary cost and resulted in a higher total cost. For large-scale surveys, the costs associated with data entry exceeded the cost of the tablets, so electronic data capture provides both a quicker and cheaper method of data collection.ConclusionsAs countries increase verbal autopsy surveillance, it is important to consider the best way to design sustainable systems for data collection. Electronic data capture has the potential to greatly reduce the time and costs associated with data collection. For long-term, large-scale surveillance required by national vital statistical systems, electronic data capture reduces costs and allows data to be available sooner.

Development and Application of Direct Data Capture for Monitoring Medication Compliance in Clinical Trials.

ObjectivesThe monitoring of medication compliance in clinical trials is important but labor intensive. To check medication compliance in clinical trials, a system was developed, and its technical feasibility evaluated.MethodsThe system consisted of three parts: a management part (clinical trial center database and a developed program), clinical trial investigator part (monitoring), and clinical trial participant part (personal digital assistant [PDA] with a barcode scanner). The system was tested with 20 participants for 2 weeks, and compliance was evaluated.ResultsThis study developed a medication compliance monitoring system that used a PDA with a barcode scanner, which sent reminder/warning messages, logged medication barcode data, and provided compliance information to investigators. Registered participants received short message service (SMS) reminder/warning messages on their PDA and sent barcode data at the dosing time. The age range of the participants was 29 to 73 years. Five participants were <50 years old and 8 were ≥65 years old. The total mean compliance rate was 82.3%. The mean compliance rate was 83.1% in participants <65 years old and 81.1% in those ≥65 years old.ConclusionsThe system was feasible, usable, and effective, even with elderly participants, for monitoring medication compliance in clinical trials using a PDA with a barcode scanner, and may improve the quality of clinical trials.

Validation of electronic administration of knee surveys among ACL-injured patients.

Knee-specific patient reported outcome measures (PROMs) are important tools in evaluating the effectiveness of sports medicine interventions. The PROMs were originally developed for paper administration, but electronic data capture technologies offer potential benefits such as increased efficiency and accuracy. The aim of this study was to assess the validity of touch screen versus paper administration using several common knee-specific and general health surveys. Agreement between scores was compared for knee-specific PROMs administered on paper versus computer; paper versus tablet; computer versus tablet in 60 patients per group undergoing ACL reconstruction. Surveys were given at pre-operative assessment and between 1 and 7days later. Weighted kappa statistic (κ) and intraclass correlation coefficients (ICC) were calculated to test agreement between the two modalities in: IKDC Subjective Knee Form, Marx Activity Scale, Tegner Activity Level Scale, and Lysholm Knee Scale. SF-12 Physical and Mental Component Summary scores were also assessed. Response rate was over 90%. Mean age was 29.6±10.9years, with patients in the paper-computer cohort being 4years older than in the other groups. Agreement was substantial or better for all PROMs collected: IKDC Subjective (ICC: 0.79); Marx (ICC: 0.70); Lysholm (ICC: 0.65); and Tegner (κ=0.67). Agreement for the SF-12 PCS (ICC: 0.77) and MCS (ICC: 0.73) was also found to have substantial agreement. In conclusion, touch screen-based PROMs are a valid capture method, providing reliable results relative to traditional paper survey administration. Digital methods of direct data capture may also foster multi-centre collaborations and allow for more accurate comparisons of outcomes between patient groups in clinical practice and orthopaedic research. II.

Experience with digital entry of national iodine survey data in Senegal

There is growing evidence and enthusiasm for the use of technology to enhance accuracy and speed and minimize the costs of quantitative data surveys. Handheld computers have the potential to facilitate high quality data collection and timely analysis for large complex surveys in developing country contexts. The objective of this paper is to document the experience of using handheld computers for direct data capture in a national survey to monitor progress toward universal salt iodization in Senegal. Twenty-five personal digital assistants (PDAs) were programmed and used by five teams across 13 regions for entering data from 3768 households over a period of three weeks. The health staff selected to collect the data learned how to manipulate the PDAs within a short amount of time. The PDAs contributed to improved quality of data collection due to automatic skipping of non-applicable questions and selection of individuals eligible for goitre assessment. The PDAs also were programmed to randomly select one woman and one school-age child within each household for biochemical sample collection. Data on geographic locations were collected for 82% of households surveyed using the PDA’s in-built Global Positioning System (GPS) functionality, which showed the geographical dispersion of these households and which will be used for analysis of results for key indicators by location. Problems with household selection processes, identification coding and standardized interview methods were observed. While costs for printing questionnaires and manual data entry were saved, significant costs were incurred for PDA technical support by an international consultant. The use of PDAs significantly reduced data processing time. Data were stored and downloaded to a central database, with the full dataset and preliminary results available to stakeholders within one week following the survey completion. The PDAs are an excellent tool for enhancing capacity to collect complex household survey data and make it available for analysis in a timely manner. Quality training and adequate pre-testing of questionnaires are still essential. Increased use of direct data capture methods in health program design, monitoring and evaluation is recommended, along with efforts to build local technical capacity.

Direct data capture using hand‐held computers in rural Burkina Faso: experiences, benefits and lessons learnt

To assess our experiences of using hand-held computers (personal digital assistants, PDAs) for direct data capture in a large community-based geo-referenced survey in rural Burkina Faso, highlighting benefits and lessons learnt from their use. A population-based geo-referenced survey of over 500 000 people was undertaken using PDAs with in-built GPS receivers and the resulting database analysed in terms of successful completion, error rates and interview durations. Surveys were successfully completed for 84 861 households (98.3%) by 127 interviewers. The data input error rate was assessed at 0.24%, with more than half of the errors being made by less than 10% of the interviewers. Faster interviewers were not less accurate. Time-stamped and geo-referenced data allowed reconstruction of particular interviewer-day activities. Although the survey setting was challenging, the feasibility of using direct data capture on a large scale was well established. We learnt that, with more experience, we could have made better use of real-time entry and quality control checking procedures. The work involved in designing and setting up a complex survey on PDAs prior to data collection should not be underestimated.

Methods for evaluating effectiveness and cost‐effectiveness of a Skilled Care Initiative in rural Burkina Faso

This paper aims to describe the design, methods and approaches used to assess the effectiveness and cost-effectiveness of the Skilled Care Initiative in reducing pregnancy-related and perinatal mortality in Ouargaye district, Burkina Faso. The evaluation used a quasi-experimental design, mixed methods and a composite of tools to compare mortality and severe morbidity (near-miss) of women in reproductive age, perinatal mortality, facility functionality, perceived quality of care, utilisation of maternal health services, and costs borne by families and the health care system for maternal health care in Ouargaye and Diapaga districts. Structured questionnaires and interview guides were developed, pre-tested and piloted prior to the main survey. The evaluation was carried out from January to July 2006. A household census was used to retrospectively assess pregnancy-related and perinatal mortality over the previous 5 years, and causes of pregnancy-related death were identified using a newly developed and tested probabilistic model for interpreting verbal autopsy data. Data were directly entered into Personal Digital Assistant devices at the point of interview. Analyses included univariate and multivariate regressions and incremental cost-effectiveness ratios. A population census covering over half a million people, three qualitative surveys and facility surveys in 47 health centres have been carried out. A partnership with key stakeholders and the use of mixed methods proved feasible for evaluating complex safe motherhood strategies, and the use of hand-held computers proved possible for direct data capture, even in this remote rural environment.

Use of web-enabled databases for complex animal health investigations

Web-enabled databases developed in the late 1990s to help organise large web sites and allow data capture via browser-based forms. By enabling users outside a closed network access to a central database, they permit greater flexibility than traditional 'client-server' systems. Accordingly, web-enabled databases introduce a new tool for epidemiologists, permitting direct data capture at source and thus avoiding many of the delays and errors arising from paper forms and manual data entry. In addition, real-time data collection permits sophisticated decision support and reporting, and thus improved project co-ordination and participation. Nevertheless, the technology is complex and the development of a web-application requires an attention to information technology project management equal to that of the scientific trial or investigation. The potential and problems of web database applications are illustrated by a bespoke system ('PathMan') developed by the Veterinary Laboratories Agency of the United Kingdom Department for Environment, Food and Rural Affairs to manage a large multi-site study investigating the pathogenesis of bovine tuberculosis in England and Wales.

Internal vs. External Frame Backpacks

1781 Internal (IF) and external (EF) frames are used in modern load carriage systems. The perceptual and physiological impact of using these different load carriage systems have been investigated, but the biomechanical differences between these frame types have not. PURPOSE: To determine the effect of IF and EF backpacks on gait kinematics during load carriage. METHODS: 11 males (mean ± SD: age 21.6 ± 2.3 yr, height 1.77 ± 0.1 m, body mass 75.8 ± 8.0 kg) walked at 1.35 m/sec on a force sensing treadmill. Direct video data capture at 100Hz was used to collect kinematic data. In separate trials while carrying a loaded (41–43 kg) IF or EF pack, ground reaction forces and gait kinematics were measured from 25 separate strides. Repeated measures ANOVA was used for statistical analysis. RESULTS: There were significant (p<0.05) differences in both ground reaction forces and kinematic gait variables between the IF and EF load carriage systems. Means ± SD and (% differences) for IF and EF respectively, were: stride length (cm) 146 ± 0.10, 148 ± 0.11, (1.2%), stride length normalized to height 0.83 ± 0.05, 0.84 ± 0.05 (1.2%), trunk range of motion (deg) 5.96 ± 1.06, 6.47 ± 1.06 (7.9%), maximum angle of shoulder extension (deg) 4.99 ± 10.68, 6.63 ± 10.53 (24.7%), shoulder range of motion (deg) 6.67 ± 2.11, 7.12 ± 2.56 (6.4%), forward trunk inclination (deg) 12.15 ± 2.21, 12.73 ± 2.77 (4.8 %), maximum heel strike vertical ground reaction force normalized for total load 1.08 ± 0.19, 1.05 ± 0.21 (− 2.6%), and the range of hip flexion/extension (deg) 46.24 ± 5.04, 45.26 ± 5.69 (−2.2%). CONCLUSIONS: There are several small but significant differences in kinematics and kinetics between EF and IF backpacks. These small differences do not indicate a clear advantage of one frame type over the other.

The Changing Face of Electronic Data Capture: From Remote Data Entry to Direct Data Capture

For the last 10 years remote data entry (RDE) has been the great white hope of the pharmaceutical industry in achieving three main aims: cutting clinical trial duration time, saving resources, and improving data quality. But where is it? Who is using it? RDE has failed to meet the three aims. The time of the RDE paradigm is past and the future will be shaped by new study site technologies which more and more are able to provide much of the required clinical data directly without the need for the transcription to paper and then reentry to another system. Direct data capture (DDC) from machines such as patient record systems, MRI machines, ECG and EEG technologies, laboratory measurement equipment, and an increasing range of other previously manual data providers will enable error-free and resource-efficient data capture. The substantial reduction and possible elimination of errors will allow early locking of the database and therefore, potentially earlier product launch.

Capturing and using clinical outcome data: implications for information systems design.

There is an urgent need to capture and record data related to clinical outcomes, but there are many barriers. The range of problems includes lack of agreement on conceptualization of the term "outcome," inadequate measures of outcomes, and inadequate information systems to capture and manipulate data that would reflect outcomes. This article focuses on information system requirements to capture, store, and utilize clinical outcome data. For greatest accuracy, outcome data should be captured as close to the source as possible, including direct data capture from patients themselves and from their families. To make maximum use of outcome data, systems must be designed to 1) store data in multipurpose databases; 2) share data across different platforms; 3) link outcome data to other data that might influence or explain outcomes; 4) allow querying of the data by authorized personnel; and 5) protect patient confidentiality.

A strategic approach to laboratory data collection

This article considers the problems inherent in implementing direct data capture from laboratory instruments and in communicating with laboratory information management systems in general, taking account of both technical and operational differences between laboratory environments. It briefly describes the theoretical design of the architecture of a software system to perform these functions, discusses an implementation of this architecture in more detail, and includes an example of its application to a large laboratory organisation with multiple sites and a wide range of instruments.

Precision Micrometer Measurement of Mouth Gape of Larval Fish

A precision micrometer device is described which standardizes measurement of mouth gape of larval fish and provides a greater degree of accuracy and speed than the conventional manual method. We compared gape measurements of larval lake whitefish (Coregonus clupeaformis) and lake herring (Coregonus artedii) using the gape micrometer versus the manual method. The micrometer measurements revealed a greater increase in gape with body length and resulted in a greater proportion of the variance in gape being explained, indicating that the gape micrometer is more sensitive and accurate than the manual method. Coefficient of variation of gape measurements on 238 larval yellow perch (Perca flavescens) decreased with body size from 0.5–4.0% at 0.8–1.2 cm standard length to 0.2–0.5% at 3.0 cm. The device has the added advantage that it could be adapted to connect to a microcomputer for direct data capture.

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