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Record W2551053764 · doi:10.1136/bmjopen-2016-013081

ACCESS HD pilot: A randomised feasibility trial Comparing Catheters with fistulas in Elderly patientS Starting haemodialysis

2016· article· en· W2551053764 on OpenAlexafffundabout
Robert R. Quinn, Pietro Ravani

Bibliographic record

VenueBMJ Open · 2016
Typearticle
Languageen
FieldHealth Professions
TopicCentral Venous Catheters and Hemodialysis
Canadian institutionsLibin Cardiovascular Institute of AlbertaUniversity of Calgary
FundersCanadian Institutes of Health ResearchLeslie Dan Faculty of Pharmacy, University of TorontoMemorial University of NewfoundlandKidney Foundation of CanadaOttawa Hospital Research InstituteMax Rady College of Medicine, University of ManitobaUniversity of AlbertaInstitute of Nutrition, Metabolism and DiabetesCumming School of Medicine, University of CalgaryDepartment of Medicine, University of TorontoUniversity of OttawaInstitute for Clinical Evaluative SciencesArts and Humanities Research CouncilMcMaster UniversitySchulich School of Medicine and DentistryUniversity of TorontoHamilton Health Sciences
KeywordsMedicineHemodialysisRandomized controlled trialClinical trialIntensive care medicinePhysical therapySurgeryEmergency medicineInternal medicine

Abstract

fetched live from OpenAlex

INTRODUCTION: The selection of the type of vascular access for haemodialysis is an important intervention question. However, only observational studies are available to inform decision-making in this area, and they are at high risk of selection bias. While a clinical trial comparing the effects of the 2 most frequently chosen strategies for haemodialysis access (fistulas and catheters) on patient important and 'hard' clinical end points is needed, the feasibility of such a trial is uncertain. METHODS AND ANALYSIS: This open-label pilot randomised controlled trial will test the feasibility and safety of randomising elderly people (≥65 years) who start haemodialysis with a central venous catheter (the most common initial type of haemodialysis access), and are eligible to receive a fistula, to a catheter-based strategy (comparator) or to a fistula-based strategy (intervention). We will enrol 100 patients at 10 centres across Canada. Participants assigned to the catheter-strategy arm will continue to use catheters; participants assigned to the fistula-strategy arm will receive a surgical attempt at fistula creation. The inclusion criteria are designed to minimise the risk of protocol violation and attrition. The primary outcome is feasibility, which we will assess by measuring: (1) the proportion of participants deemed eligible for the trial who consent to randomisation; and (2) the proportion of participants randomised to the intervention who receive the fistula surgery within 90 days of randomisation. Secondary outcomes will include safety outcomes, the reasons people and healthcare providers may not accept randomisation, and the reasons sites may not adhere to the trial protocol. ETHICS AND DISSEMINATION: The Conjoint Health Research Ethics Board at the University of Calgary approved the study protocol. We will submit the results of this feasibility study in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02675569, Pre-results.

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.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.011
metaresearch head score (Gemma)0.017
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.013
Threshold uncertainty score0.059

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0110.017
Meta-epidemiology (narrow)0.0020.001
Meta-epidemiology (broad)0.0020.002
Bibliometrics0.0010.001
Science and technology studies0.0010.002
Scholarly communication0.0010.002
Open science0.0010.001
Research integrity0.0030.002
Insufficient payload (model declined to judge)0.0130.001

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 head0.253
GPT teacher head0.473
Teacher spread0.220 · 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

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations24
Published2016
Admission routes3
Has abstractyes

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