Evidence map›Paper›PMID 36178598›Full record

ArticleJournal of patient-reported outcomes2022

Listening to the elephant in the room: response-shift effects in clinical trials research.

Carolyn E Schwartz, I-Chan Huang, Gudrun Rohde, Richard L Skolasky

Open access · goldAbstract read
In one paragraph

Article in Journal of patient-reported outcomes, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
0.8field-weighted citation impact, top 26% 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, 2 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Impact of response shift on change in patient-reported outcomes: a systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026
    Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Advancing response-shift assessment: insights and directions from a series of ISOQOL SIG meetings.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
    Article
  8. 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

4 authors at 4 institutions in 3 countries.

Carolyn E SchwartzDeltaQuest Foundation, Inc., 31 Mitchell Road, Concord, MA, 01742, USA. carolyn.schwartz@deltaquest.org.ORCID http://orcid.org/0000-0002-9173-7774
I-Chan HuangDepartment of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, USA.ORCID http://orcid.org/0000-0002-1194-3923
Gudrun RohdeDepartment of Clinical Research Sorlandet Hospital, Faculty of Health and Sport Sciences, University of Agder, Kristiansand, Norway.ORCID http://orcid.org/0000-0002-8538-7237
Richard L SkolaskyDepartment of Orthopaedic Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0002-2598-4427
Johns Hopkins University · USSt. Jude Children's Research Hospital · USTufts Medical Center · USUniversity of Agder · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhile a substantial body of work postulates that adaptation (response-shift effects) may serve to hide intervention benefits, much of the research was conducted in observational studies, not randomized-controlled trials. This scoping review identified all clinical trials that addressed response shift phenomena, and characterized how response-shift effects impacted trial findings.

methodsA scoping review was done of the medical literature from 1968 to 2021 using as keywords "response shift" and "clinical trial." Articles were included if they were a clinical trial that explicitly examined response-shift effects; and excluded if they were not a clinical trial, a full report, or if response shift was mentioned only in the discussion. Clinical-trials papers were then reviewed and retained in the scoping review if they focused on randomized participants, showed clear examples of response shift, and used reliable and valid response-shift detection methods. A synthesis of review results further characterized the articles' design characteristics, samples, interventions, statistical power, and impact of response-shift adjustment on treatment effect.

resultsThe search yielded 2148 unique references, 25 of which were randomized-controlled clinical trials that addressed response-shift effects; 17 of which were retained after applying exclusion criteria; 10 of which were adequately powered; and 7 of which revealed clinically-important response-shift effects that made the intervention look significantly better.

conclusionsThese findings supported the presumption that response shift phenomena obfuscate treatment benefits, and revealed a greater intervention effect after integrating response-shift related changes. The formal consideration of response-shift effects in clinical trials research will thus not only improve estimation of treatment effects, but will also integrate the inherent healing process of treatments. KEY POINTS: This scoping review supported the presumption that response shift phenomena obfuscate treatment benefits and revealed a greater intervention effect after integrating response-shift related changes. The formal consideration of response-shift effects in clinical trials research will not only improve estimation of treatment effects but will also integrate the inherent healing process of treatments.

Indexed as

Clinical trialsOutcomesResponse shiftScoping review

Identifiers

PMID36178598
PMCPMC9525509
OpenAlexW4298088029

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.