Quality of Data Entry Using Single Entry, Double Entry and Automated Forms Processing–An Example Based on a Study of Patient-Reported Outcomes

Paulsen, Aksel; Overgaard, Søren; Lauritsen, Jens

doi:10.1371/journal.pone.0035087

Cited by 95 publications

(78 citation statements)

References 26 publications

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“…The gold standard for data entry is the double entry of 5-10% of all patient points, to check and verify. 30 An even better option is to include a quality and control committee, for central and/or local monitoring, in order to guarantee the quality of data. Such a committee should monitor electronic data collection and visit different sites for quality checks.…”

Section: Data Qualitymentioning

confidence: 99%

Creating an effective clinical registry for rare diseases

D’Agnolo

Kievit²,

Andrade

et al. 2015

United European Gastroenterology Journal

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The exposure of clinicians to patients with rare gastrointestinal diseases is limited. This hurts clinical studies, which impedes accumulation of scientific knowledge on the natural disease course, treatment outcomes and prognosis in these patients. An excellent method to detect patterns on an aggregate level that would not be possible to discover in individual cases, is a registry study. This paper aims to describe a template to create a successful international registry for rare diseases. We focus mainly on rare hepatic diseases, but lessons from this paper serve other fields in medicine, as well.

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Section: Data Qualitymentioning

confidence: 99%

Creating an effective clinical registry for rare diseases

D’Agnolo

Kievit²,

Andrade

et al. 2015

United European Gastroenterology Journal

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“…‘Automatic Forms Processing’ is a possible alternative to double entry, a method by which data collected can be ‘automatically’ entered by scanning, and converting it into an electronic format through techniques such as ‘Optical Mark Recognition’ or ‘Intelligent Character Recognition’ [9]. This would also require relatively expensive equipment and computer expertise that are often not available in resource-limited settings.…”

Section: Discussionmentioning

confidence: 99%

Open access tools for quality-assured and efficient data entry in a large, state-wide tobacco survey in India

Shewade¹,

Vidhubala

Subramani

et al. 2017

Global Health Action

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Background: A large state-wide tobacco survey was conducted using modified version of pretested, globally validated Global Adult Tobacco Survey (GATS) questionnaire in 2015–22016 in Tamil Nadu, India. Due to resource constrains, data collection was carrid out using paper-based questionnaires (unlike the GATS-India, 2009–2010, which used hand-held computer devices) while data entry was done using open access tools. The objective of this paper is to describe the process of data entry and assess its quality assurance and efficiency. Methods: In EpiData language, a variable is referred to as ‘field’ and a questionnaire (set of fields) as ‘record’. EpiData software was used for double data entry with adequate checks followed by validation. Teamviewer was used for remote training and trouble shooting. The EpiData databases (one each for each district and each zone in Chennai city) were housed in shared Dropbox folders, which enabled secure sharing of files and automatic back-up. Each database for a district/zone had separate file for data entry of household level and individual level questionnaire. Results: Of 32,945 households, there were 111,363 individuals aged ≥15 years. The average proportion of records with data entry errors for a district/zone in household level and individual level file was 4% and 24%, respectively. These are the errors that would have gone unnoticed if single entry was used. The median (inter-quartile range) time taken for double data entry for a single household level and individual level questionnaire was 30 (24, 40) s and 86 (64, 126) s, respectively. Conclusion: Efficient and quality-assured near-real-time data entry in a large sub-national tobacco survey was performed using innovative, resource-efficient use of open access tools.

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“…Missing and incomplete outcome data are detailed further in Appendix 11. Manual double data entry, considered to be the gold standard for data transfer, 76 was used by two independent researchers and ensured the high quality of data entry onto the electronic database.…”

Section: Summary Of Findingsmentioning

confidence: 99%

Facet-joint injections for non-specific low back pain: a feasibility RCT

Snidvongs

Taylor

Ahmad

et al. 2017

Health Technol Assess

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BackgroundPain of lumbar facet-joint origin is a common cause of low back pain in adults and may lead to chronic pain and disability, with associated health and socioeconomic implications. The socioeconomic burden includes an inability to return to work resulting in loss of productivity in addition to direct and indirect health-care utilisation costs. Lumbar facet-joints are paired synovial joints between the superior and inferior articular processes of consecutive lumbar vertebrae and between the fifth lumbar vertebra and the sacrum. Facet-joint pain is defined as pain that arises from any structure that is part of the facet-joints, including the fibrous capsule, synovial membrane, hyaline cartilage and bone. This pain may be treated by intra-articular injections with local anaesthetic and steroid, although this treatment is not standardised. At present, there is no definitive research to support the use of targeted lumbar facet-joint injections to manage this pain. Because of the lack of high-quality, robust clinical evidence, the National Institute for Health and Care Excellence (NICE) guidelines on the management of chronic low back pain [NICE.Low Back Pain in Adults: Early Management. Clinical guideline (CG88). London: NICE; 2009] did not recommend the use of spinal injections despite their perceived potential to reduce pain intensity and improve rehabilitation, with NICE calling for further research to be undertaken. The updated guidelines [NICE.Low Back Pain and Sciatica in Over 16s: Assessment and Management. NICE guideline (NG59). London: NICE; 2016] again do not recommend the use of spinal injections.ObjectivesTo assess the feasibility of carrying out a definitive study to evaluate the clinical effectiveness and cost-effectiveness of lumbar facet-joint injections compared with a sham procedure in patients with non-specific low back pain of > 3 months’ duration.DesignBlinded parallel two-arm pilot randomised controlled trial.SettingInitially planned as a multicentre study involving three NHS trusts in the UK, recruitment took place in the pain and spinal orthopaedic clinics at Barts Health NHS Trust only.ParticipantsAdult patients referred by their GP to the specialist clinics with non-specific low back pain of at least 3 months’ duration despite NICE-recommended best non-invasive care (education and one of a physical exercise programme, acupuncture or manual therapy). Patients who had already received lumbar facet-joint injections or who had had previous back surgery were excluded.InterventionsParticipants who had a positive result following a diagnostic test (single medial branch nerve blocks) were randomised and blinded to receive either intra-articular lumbar facet-joint injections with steroids (intervention group) or a sham procedure (control group). All participants were invited to attend a group-based combined physical and psychological (CPP) programme.Main outcome measuresIn addition to the primary outcome of feasibility, questionnaires were used to assess a range of pain-related (including the Brief Pain Inventory and Short-Form McGill Pain Questionnaire version 2) and disability-related (including the EuroQol-5 Dimensions five-level version and Oswestry Low Back Pain Questionnaire) issues. Health-care utilisation and cost data were also assessed. The questionnaire visits took place at baseline and at 6 weeks, 3 months and 6 months post randomisation. The outcome assessors were blinded to the allocation groups.ResultsOf 628 participants screened for eligibility, nine were randomised to receive the study intervention (intervention group,n = 5; sham group,n = 4), six completed the CPP programme and eight completed the study.LimitationsFailure to achieve our expected recruitment targets led to early closure of the study by the funder.ConclusionsBecause of the small number of participants recruited to the study, we were unable to draw any conclusions about the clinical effectiveness or cost-effectiveness of intra-articular lumbar facet-joint injections in the management of non-specific low back pain. Although we did not achieve the target recruitment rate from the pain clinics, we demonstrated our ability to develop a robust study protocol and deliver the intended interventions safely to all nine randomised participants, thus addressing many of the feasibility objectives.Future workStronger collaborations with primary care may improve the recruitment of patients earlier in their pain trajectory who are suitable for inclusion in a future trial.Trial registrationEudraCT 2014-003187-20 and Current Controlled Trials ISRCTN12191542.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 74. See the NIHR Journals Library website for further project information.

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Quality of Data Entry Using Single Entry, Double Entry and Automated Forms Processing–An Example Based on a Study of Patient-Reported Outcomes

Cited by 95 publications

References 26 publications

Creating an effective clinical registry for rare diseases

Creating an effective clinical registry for rare diseases

Open access tools for quality-assured and efficient data entry in a large, state-wide tobacco survey in India

Facet-joint injections for non-specific low back pain: a feasibility RCT

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