Evidence map›Paper›PMID 36054921›Full record

Trial reportSleep2022

Preferences of patients for benefits and risks of insomnia medications using data elicited during two phase III clinical trials.

Sebastian Heidenreich, Melissa Ross, Gin Nie Chua, Dalma Seboek Kinter, Andrea Phillips-Beyer

Open access · hybridAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Sleep, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 10% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Factors influencing shared decision-making for insomnia and obstructive sleep apnea treatment among Veterans with mild traumatic brain injury.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024
    Article
  9. Article
  10. Review
  11. Some disproven misconceptions about shared decision-making.Canadian pharmacists journal : CPJ = Revue des pharmaciens du Canada : RPC
    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

5 authors at 1 institution in 1 country.

Sebastian HeidenreichPatient Centered Research, Evidera, London, UK.
Melissa RossPatient Centered Research, Evidera, Bethesda, MD, USA.
Gin Nie ChuaPatient Centered Research, Evidera, London, UK.
Dalma Seboek KinterIdorsia, Allschwil, Switzerland.
Andrea Phillips-BeyerInnovus Consulting, London, UK.
Idorsia (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesTo elicit the trade-offs patients are willing to make between benefits and risks of medications for chronic insomnia, with the purpose of allowing a patient-centric interpretation of clinical trial data.

methodsA discrete choice experiment (DCE) was included in the two placebo-controlled phase III trials that evaluated the efficacy and safety of daridorexant. The DCE design was informed by a two-phase qualitative study, followed by qualitative and quantitative pilot testing before fielding. Relative attribute importance (RAI) and acceptable trade-offs between benefits and risks were obtained using a mixed logit model.

resultsPreferences were elicited from 602 trial participants (68.1% female, aged 58.6 ± 14.5 years). Preferences were most affected by daytime functioning (RAI = 33.7%) as a treatment benefit and withdrawal symptoms (RAI = 27.5%) as a risk. Patients also valued shorter sleep onset (RAI = 6.4%), longer sleep maintenance (RAI = 5.4%), reduced likelihood of abnormal thoughts and behavioral changes (RAI = 11.3%), reduced likelihood of dizziness/grogginess (RAI = 9.2%), and reduced likelihood of falls at night (RAI = 6.5%). Patients were willing to make trade-offs between these attributes. For example, they would accept an additional 18.8% risk of abnormal thoughts and behavioral changes to improve their daytime functioning from difficult to restricted and an additional 8.1% risk of abnormal thoughts and behavioral changes to avoid moderate withdrawal effects.

conclusionsPatients with insomnia were willing to make trade-offs between multiple benefits and risks of pharmacological treatments. Because patients valued daytime functioning more than sleep latency and duration, we recommend that functional outcomes and sleep quality be considered in treatment development and evaluation.

Indexed as

Sleep Initiation and Maintenance DisordersChoice BehaviorFemaleHumansLogistic ModelsMaleRisk AssessmentSleepclinical trialdiscrete choice experimentinsomniapatient preferencesphase III

Identifiers

PMID36054921
PMCPMC9644122
OpenAlexW4294335608

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.