Evidence map›Paper›PMID 25891679›Full record

Observational studyThe Journal of surgical research2015

Do surgeons and patients discuss what they document on consent forms?

Daniel E Hall, Barbara H Hanusa, Michael J Fine, Robert M Arnold

Open access · greenAbstract readComparative StudyObservational Study
In one paragraph

Observational study in The Journal of surgical research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
6.1field-weighted citation impact, top 4% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Role of procedure-specific consent forms in clinical practice: a systematic review.Annals of the Royal College of Surgeons of England · 2025
    Pooled it
  2. Article
  3. Article
  4. Litigation claims following laparoscopic and open inguinal hernia repairs.Hernia : the journal of hernias and abdominal wall surgery · 2020
    Article
  5. Current use of procedure specific consent forms for laparoscopic cholecystectomy.Annals of the Royal College of Surgeons of England · 2018
    Article
  6. How Does the Patient React After Reading the Informed Consent Form of a Gynecological Surgery? A Qualitative Study.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2018
    Article
  7. Article
  8. Review
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

4 authors at 2 institutions in 1 country.

Daniel E HallCenter for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania; Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania. Electronic address: hallde@upmc.edu.
Barbara H HanusaMIRECC, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania.
Michael J FineCenter for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania.
Robert M ArnoldDivision of General Internal Medicine, Department of Medicine, University of Pittsburgh, UPMC Montefiore Hospital, Pittsburgh, Pennsylvania.
University of Pittsburgh · USVA Pittsburgh Healthcare System · US

Funding

HSRD VA CDA 08-281Intramural VA VA999999
6 · The paper itself

Abstract

backgroundPrevious studies of surgeon behavior report that surgeons rarely meet basic standards of informed consent, raising concerns that current practice requires urgent remediation. We wondered if the Veterans Affairs Healthcare System's recent implementation of standardized, procedure-specific consent forms might produce a better practice of informed consent than has been reported previously. Our goal was to determine how the discussions shared between surgeons and patients correspond to the VA's standardized consent forms.

methodsWe enrolled a prospective cohort of patients presenting for possible cholecystectomy or inguinal herniorrhaphy and the surgical providers for those patients. Audio recordings captured the clinical encounter(s) culminating in a decision to have surgery. Each patient's informed consent was documented using a standardized, computer-generated form. We abstracted and compared the information documented with the information discussed.

resultsOf 75 consecutively enrolled patients, 37 eventually decided to have surgery and signed the standardized consent form. Patients and providers discussed 37% (95% confidence interval, 0.07-0.67) and 33% (95% confidence interval, 0.21-0.43) of the information found on the cholecystectomy and herniorrhaphy consent forms, respectively. However, the patient-provider discussions frequently included relevant details nowhere documented on the standardized forms, culminating in discussions that included a median 27.5 information items for cholecystectomy and 20 items for herniorrhaphy. Fully, 80% of cholecystectomy discussions and 76% of herniorrhaphy discussions mentioned at least one risk, benefit or alternative, indication for, and description of the procedure.

conclusionsThe patients and providers observed here collaborated in a detailed process of informed consent that challenges the initial reports suggesting the need to remediate surgeon's practice of informed consent. However, because the discrepancy between the information documented and discussed exposes legal and ethical liability, there is an opportunity to improve the iMed system so that it better reflects what surgeons discuss and more frequently includes all the information patients need.

Indexed as

Physician-Patient RelationsSurgeonsAdultAgedCholecystectomyConsent FormsFemaleHerniorrhaphyHumansMaleMiddle AgedPatient ParticipationProspective StudiesUnited StatesUnited States Department of Veterans AffairsCholecystectomyEthicsHerniorrhaphyInformed consentShared decision making

Identifiers

PMID25891679
PMCPMC4603654
OpenAlexW1981253188

What OpenQuestion holds

Textmetadata
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.