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Foot thermometry with mHeath-based supplementation to prevent diabetic foot ulcers: A randomized controlled trial

2020· preprint· en· W4239934003 on OpenAlex
María Lazo‐Porras, Antonio Bernabé‐Ortiz, Álvaro Taype-Rondán, Robert H. Gilman, Germán Málaga, Hélard Manrique, Luis Neyra, Jorge Calderón‐Parra, Miguel E. Pinto, David G. Armstrong, Víctor M. Montori, J. Jaime Miranda

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

fundA Canadian funder is recorded on the work.
no affNo Canadian affiliation: this work is invisible to an affiliation-only frame.
No Canadian affiliation. An affiliation-only frame, the usual design, would never have seen this work. It is one of the works that make the case for inverting the frame.

Bibliographic record

VenueWellcome Open Research · 2020
Typepreprint
Languageen
FieldMedicine
TopicDiabetic Foot Ulcer Assessment and Management
Canadian institutionsnot available
FundersNational Cancer InstituteFogarty International CenterNational Institute of Mental HealthNational Heart, Lung, and Blood InstituteMedical Research CouncilAlliance for Health Policy and Systems ResearchInter-American Institute for Global Change ResearchConsejo Nacional de Ciencia, Tecnología e Innovación TecnológicaWellcomeNational Science FoundationGrand Challenges CanadaInternational Development Research CentreSchweizerischer Nationalfonds zur Förderung der Wissenschaftlichen ForschungNational Institutes of HealthWellcome TrustConsejo Nacional de Ciencia y TecnologíaDepartment for International Development, UK Government
KeywordsMedicineIncidence (geometry)Randomized controlled trialFoot (prosody)Diabetes mellitusDiabetic footClinical endpointPhysical therapyInternal medicine

Abstract

fetched live from OpenAlex

<ns4:p> <ns4:bold>Background</ns4:bold> : Three previous clinical trials have found that thermometry use reduced diabetic foot ulcers (DFUs) incidence four- to ten-fold among individuals with diabetes at high-risk of developing a DFU. However, these benefits depend on patient adherence to self-assessment. Therefore, novel approaches to improve self-management thermometry adherence are needed. Our objective was to compare incidence of DFUs in the thermometry plus mobile health (mHealth) reminders intervention arm vs. thermometry-only control arm. </ns4:p> <ns4:p> <ns4:bold>Methods</ns4:bold> : We conducted a randomized trial, enrolling adults with type 2 diabetes mellitus at risk of foot ulcers (risk groups 2 or 3) but without foot ulcers at the time of recruitment and allocating them to control (instruction to use a liquid crystal-based foot thermometer daily) or intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care) groups and followed for 18 months. The primary outcome was time to occurrence of DFU. A process evaluation was also conducted. </ns4:p> <ns4:p> <ns4:bold>Results</ns4:bold> : A total of 172 patients (63% women, mean age 61 years) were enrolled; 86 to each study group. More patients enrolled in the intervention arm had a history of DFU (66% vs. 48%). Follow-up for the primary endpoint was complete for 158 of 172 participants (92%). DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm. After adjusting for history of foot ulceration and study site, the Hazard Ratio (HR) for DFU was 1.44 (95% CI 0.65, 3.22). Adherence to ≥80% of daily temperature measurements was 87% (103 of 118) among the study participants who returned the logbook, with no difference between the intervention and control arms. </ns4:p> <ns4:p> <ns4:bold>Conclusions</ns4:bold> : This trial contributes to the evidence about the value of mHealth in preventing diabetes foot ulcers. </ns4:p> <ns4:p> <ns4:bold>Trial registration</ns4:bold> : ClinicalTrials.gov <ns4:ext-link xmlns:ns3="http://www.w3.org/1999/xlink" ext-link-type="uri" ns3:href="https://clinicaltrials.gov/ct2/show/NCT02373592">NCT02373592</ns4:ext-link> (27/02/2015) </ns4:p>

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.013
metaresearch head score (Gemma)0.001
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow), Scholarly communication, Insufficient payload (model declined to judge)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: none
Teacher disagreement score0.655
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0130.001
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0040.001
Bibliometrics0.0010.001
Science and technology studies0.0000.000
Scholarly communication0.0010.000
Open science0.0020.003
Research integrity0.0000.002
Insufficient payload (model declined to judge)0.0040.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.104
GPT teacher head0.424
Teacher spread0.320 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it