Evidence map›Paper›PMID 39026124›Full record

Trial reportJournal of assisted reproduction and genetics2024

The impact of an adapted SPIKES protocol vs routine care in the delivery of bad news to IVF patients: an exploratory pilot multicenter randomized controlled trial.

A D Domar, A Korkidakis, P Bortoletto, N Gulrajani, D Khodakhah, K L Rooney, A Gompers, M R Hacker, E Grill

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of assisted reproduction and genetics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04917445 (A Comparison of the SPIKES Protocol for Delivering Bad News to the Current Standard of Care in the in Vitro Fertilization Population), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT04917445 nacompletednot on this map

A Comparison of the SPIKES Protocol for Delivering Bad News to the Current Standard of Care in the in Vitro Fertilization Population

TypeinterventionalSponsorBoston IVFRan2021 to 2022Enrolled136ConditionsInfertilityArmsSpikes-focused bad news protocol
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

9 authors.

A D DomarInception Fertility, Inception Research Institute, 4828 Loop Central Drive, Houston, TX, 77081, USA. adomar@inceptionllc.com.ORCID http://orcid.org/0000-0001-7397-8366
A KorkidakisBoston IVF, 130 Second Avenue, Waltham, MA, 02451, USA.
P BortolettoBoston IVF, 130 Second Avenue, Waltham, MA, 02451, USA.
N GulrajaniBoston IVF, 130 Second Avenue, Waltham, MA, 02451, USA.
D KhodakhahBoston IVF, 130 Second Avenue, Waltham, MA, 02451, USA.
K L RooneyBoston IVF, 130 Second Avenue, Waltham, MA, 02451, USA.
A GompersDepartment of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA.
M R HackerDepartment of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA.
E GrillWeill Cornell Center for Reproductive Medicine, 1305 York Avenue, New York, NY, 10021, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDetermine if the SPIKES method was associated with less distress and more compassion than current modes of delivering negative pregnancy test results to patients undergoing in vitro fertilization.

methodsTwenty-seven nurses from two centers were randomized to use the modified SPIKES script or continue their standard of care; 136 patients with a negative hCG following embryo transfer were included. SPIKES nurses received 1 h of training by a study psychologist; nurses in the control group were instructed to deliver the news as done previously. Patients who underwent embryo transfer and received a call by a participating nurse with a negative test result received an email invitation on the following day.

resultsControl patients reported significantly less distress than SPIKES patients; 33% of SPIKES patients reported that they had felt "extremely sad," compared to 15.2% of the control patients (p = 0.01). Perceived compassion did not differ between the groups (all p ≥ 0.22).

conclusionPatients who received a negative pregnancy test result from the nurses who received a brief training and a script on how to deliver bad news via the modified SPIKES protocol reported significantly more distress than patients receiving negative results from nurses utilizing their standard of care. It is unclear whether a modified SPIKES method to deliver negative pregnancy test results will benefit patients undergoing in vitro fertilization.

trial registrationClinical trials.gov NCT04917445.

Indexed as

Embryo TransferFertilization in VitroAdultEmpathyFemaleHumansPilot ProjectsPregnancyPregnancy TestsBad newsCompassionIVFSPIKES protocol

Identifiers

PMID39026124
PMCPMC11405549

What OpenQuestion holds

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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.