Evidence map›Paper›PMID 32669121›Full record

ArticleTrials2020

A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analyses plan.

Andrew Lawson, Justine Naylor, Rachelle Buchbinder, Rebecca Ivers, Zsolt Balogh, Paul Smith, Rajat Mittal, Wei Xuan, Kirsten Howard, Arezoo Vafa and 22 more

Open access · goldAbstract readClinical Trial ProtocolLetter
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

32 authors at 20 institutions in 2 countries.

Andrew LawsonWhitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Sydney, NSW, Australia. aalawson@tpg.com.au.ORCID http://orcid.org/0000-0002-1367-6443
Justine NaylorWhitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Sydney, NSW, Australia.
Rachelle BuchbinderMonash University, Melbourne, VIC, Australia.
Rebecca IversSchool of Public Health and Community Medicine, UNSW Sydney, Sydney, NSW, Australia.
Zsolt BaloghJohn Hunter Hospital, Newcastle, NSW, Australia.
Paul SmithCanberra Hospital, Canberra, ACT, Australia.
Rajat MittalSouth Western Sydney Clinical School, UNSW, Sydney, NSW, Australia.
Wei XuanIngham Institute for Applied Medical Research, Sydney, NSW, Australia.
Kirsten HowardFaculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Arezoo VafaWhitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Sydney, NSW, Australia.
Piers YatesFiona Stanley Hospital, Perth, WA, Australia.
Bertram RiegerFiona Stanley Hospital, Perth, WA, Australia.
Geoff SmithSt George and Sutherland Hospitals, Sydney, NSW, Australia.
Ilia ElkinsonWellington Hospital, Wellington, New Zealand.
Woosung KimWellington Hospital, Wellington, New Zealand.
Jai SungaranConcord Hospital, Sydney, NSW, Australia.
Kim LatendresseNambour Hospital and Sunshine Coast University Hospital, Nambour, QLD, Australia.
James WongWestmead Hospital, Sydney, NSW, Australia.
Sameer ViswanathanCampbelltown Hospital, Sydney, NSW, Australia.
Keith LandaleCampbelltown Hospital, Sydney, NSW, Australia.
Herwig DrobetzMackay Base Hospital, Mackay, QLD, Australia.
Phong TranWestern Health, Melbourne, VIC, Australia.
Richard PageUniversity Hospital Geelong, Barwon Health, Geelong, NSW, Australia.
Raphael HauNorthern Health, Melbourne, VIC, Australia.
Jonathan MulfordLaunceston Hospital, Launceston, TAS, Australia.
Ian IncollGosford and Wyong Hospitals, Gosford, NSW, Australia.
Michael KaleGosford and Wyong Hospitals, Gosford, NSW, Australia.
Bernard SchickPrince of Wales Hospital, Sydney, NSW, Australia.
Andrew HiggsSt Vincent's Hospital, Sydney, NSW, Australia.
Andrew OppyRoyal Melbourne Hospital, Melbourne, VIC, Australia.
Diana PerrimanCanberra Hospital, Canberra, ACT, Australia.
Ian HarrisWhitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Sydney, NSW, Australia.
Ingham Institute · AUUNSW Sydney · AUCamden and Campbelltown Hospitals · AUCanberra Hospital · AUFiona Stanley Hospital · AUGosford Hospital · AUWellington Hospital · NZBarwon Health · AUCabrini Hospital · AUConcord Repatriation General Hospital · AUJohn Hunter Hospital · AULaunceston General Hospital · AULiverpool Hospital · AUMackay Base Hospital · AUNorthern Health · AUPrince of Wales Hospital · AUSt Vincent's Hospital Sydney · AUSunshine Coast University Hospital · AUSutherland Hospital · AUThe Royal Melbourne Hospital · AU

Funding

National Health and Medical Research Council 2016, APP1098550
6 · The paper itself

Abstract

backgroundWe are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan. METHODS/

designA Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance. DISCUSSION: This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients.

trial registrationCROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460 ). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution.

Indexed as

Fracture Fixation, InternalRadiusRadius FracturesAgedAustraliaBone PlatesFemaleHumansMaleObservational Studies as TopicPatient Reported Outcome MeasuresQuality of LifeRandomized Controlled Trials as TopicSelection BiasAgedFracture fixationPlaster castsRadius fracturesRandomised controlled trialRecovery of functionStatistical analysis plan

Identifiers

PMID32669121
PMCPMC7364640
OpenAlexW3042411592

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.