Evidence map›Paper›PMID 37436494›Full record

SynthesisArchives of orthopaedic and trauma surgery2023

Pearls and pitfalls of PROMIS clinically significant outcomes in orthopaedic surgery.

Ron Gilat, Ilan Y Mitchnik, Sumit Patel, Jeremy A Dubin, Gabriel Agar, Eran Tamir, Dror Lindner, Yiftah Beer

Abstract readMeta-AnalysisReview
PubMed Publisher
In one paragraph

Synthesis in Archives of orthopaedic and trauma surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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.

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

7 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Effect of complications and reoperations on PROMIS scores for tibial plateau fractures.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2025
    Article
  6. Observational
  7. 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

8 authors.

Ron GilatDepartment of Orthopaedic Surgery, Shamir Medical Center and Tel Aviv University, Tel Aviv, Israel. ron.gilat@gmail.com.ORCID http://orcid.org/0000-0002-9283-1439
Ilan Y MitchnikDepartment of Orthopaedic Surgery, Shamir Medical Center and Tel Aviv University, Tel Aviv, Israel.
Sumit PatelWestern Michigan University, Kalamazoo, MI, USA.
Jeremy A DubinSackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Gabriel AgarDepartment of Orthopaedic Surgery, Shamir Medical Center and Tel Aviv University, Tel Aviv, Israel.
Eran TamirDepartment of Orthopaedic Surgery, Shamir Medical Center and Tel Aviv University, Tel Aviv, Israel.
Dror LindnerDepartment of Orthopaedic Surgery, Shamir Medical Center and Tel Aviv University, Tel Aviv, Israel.
Yiftah BeerDepartment of Orthopaedic Surgery, Shamir Medical Center and Tel Aviv University, Tel Aviv, Israel.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatient-Reported Outcome Measurement Information System (PROMIS) was developed as a uniform and generalizable PROM system using item response theory and computer adaptive testing. We aimed to assess the utilization of PROMIS for clinically significant outcomes (CSOs) measurements and provide insights into its use in orthopaedic research. MATERIALS AND

methodsWe reviewed PROMIS CSO reports for orthopaedic procedures via PubMed, Cochrane Library, Embase, CINAHL, and Web of Science from inception to 2022, excluding abstracts and missing measurements. Bias was assessed using the Newcastle-Ottawa Scale (NOS) and questionnaire compliance. PROMIS domains, CSO measures, and study populations were described. A meta-analysis compared distribution and anchor-based MCIDs in low-bias (NOS ≥ 7) studies.

resultsOverall, 54 publications from 2016 to 2022 were reviewed. PROMIS CSO studies were observational with increasing publication rates. Evidence-level was II in 10/54, bias low in 51/54, and compliance ≥ 86% in 46/54. Most (28/54) analysed lower extremity procedures. PROMIS domains examined Pain Function (PF) in 44/54, Pain Interference (PI) in 36/54, and Depression (D) in 18/54. Minimal clinically important difference (MCID) was reported in 51/54 and calculated based on distribution in 39/51 and anchor in 29/51. Patient acceptable symptom state (PASS), substantial clinical benefit (SCB), and minimal detectable change (MDC) were reported in ≤ 10/54. MCIDs were not significantly greater than MDCs. Anchor-based MCIDs were greater than distribution based MCIDs (standardized mean difference = 0.44, p < 0.001).

conclusionsPROMIS CSOs are increasingly utilized, especially for lower extremity procedures assessing the PF, PI, and D domains using distribution-based MCID. Using more conservative anchor-based MCIDs and reporting MDCs may strengthen results. Researchers should consider unique pearls and pitfalls when assessing PROMIS CSOs.

Indexed as

Orthopedic ProceduresOrthopedicsHumansInformation SystemsPainPatient Reported Outcome MeasuresTreatment OutcomeClinically significant outcomesMinimal clinically important differencePatient outcome assessmentPatient reported outcome measuresPROMIS

Identifiers

What OpenQuestion holds

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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.