Evidence map›Paper›PMID 23829442›Full record

Trial reportTrials2013

Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial.

Jennica Platt, Nancy Baxter, Jennifer Jones, Kelly Metcalfe, Natalie Causarano, Stefan O P Hofer, Anne O'Neill, Terry Cheng, Elizabeth Starenkyj, Toni Zhong

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
3.0field-weighted citation impact, top 8% 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.

NCT01857882 nacompletednot on this map

Breast Reconstruction Decision Workshop Pilot RCT (Randomized Controlled Trial)

TypeinterventionalSponsorUniversity Health Network, TorontoRan2012 to 2013Enrolled41ConditionsBreast CancerArmsDecision Support Workshop
NCT02071238 nacompletednot on this mapstarted 2014, after this paper: background citation

Factors Affecting Risk Recall in Open Carpal Tunnel Release Surgery

TypeinterventionalSponsorMichael BezuhlyRan2014 to 2015Enrolled140ConditionsCarpal TunnelArmsPamphlet, Group Consultation
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2015
    Trial
  3. Article
  4. Article
  5. Article
  6. Article
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

10 authors at 1 institution in 1 country.

Jennica PlattUHN Breast Restoration Program, Division of Plastic and Reconstructive Surgery, 8N 871, 200 Elizabeth Street, Toronto, ON M5G 2C4, Canada.
Nancy Baxter
Jennifer Jones
Kelly Metcalfe
Natalie Causarano
Stefan O P Hofer
Anne O'Neill
Terry Cheng
Elizabeth Starenkyj
Toni Zhong
Breast Cancer Care · GB

Funding

Canadian Institutes of Health Research
6 · The paper itself

Abstract

backgroundThe Pre-Consultation Educational Group INTERVENTION pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients. METHODS/

designThis is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design.

settingThe University Health Network, a tertiary care cancer center in Toronto, Canada.

participantsAdult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction.

interventionWe designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient. CONTROL: Usual care includes access to an informational booklet, website, and patient volunteer if desired. OUTCOMES: Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial. DISCUSSION: Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013.

trial registrationNCT01857882.

Indexed as

Breast ImplantationDecision MakingHealth Knowledge, Attitudes, PracticeMastectomyPatient Education as TopicReferral and ConsultationResearch DesignBreast NeoplasmsClinical ProtocolsFeasibility StudiesFemaleHumansOntarioPatient ParticipationPatient SatisfactionPilot Projects

Identifiers

PMID23829442
PMCPMC3708760
OpenAlexW2087036040

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.