Evaluation of the Contribution of Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy

Official title

The Contribution of Targeted Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy for Patients With Suspected Musculoskeletal Pathology: a Before/After Study

Overview

The hypothesis of this study is that musculoskeletal point of care ultrasonography would support the GP's decision and ultimately improve patient management. The aim of this study is to evaluate, in the context of suspected musculoskeletal abnormality, the contribution of musculoskeletal point of care ultrasonography to the general practitioner's overall decision-making strategy, defined according to the following 5 axes: diagnosis (I), therapy (II), patient orientation (III), prescription of complementary examinations (IV) and follow-up (V).

Detailed description

The study circuit takes place in a single visit.

1. The investigating physician suspects a musculoskeletal anomaly following an initial clinical examination. 2. The patient (who meets the inclusion criteria and has no non-inclusion criteria) gives consent to participate, after receiving information about the study. 3. The investigator fills in the e-CRF (appendix III), clinical examination, medical interrogation and his or her decisions according to the 5 axes, which cannot be modified, as the structure of the e-CRF planned in advance does not allow backtracking. The investigator performs the targeted musculoskeletal ultrasound with his or her personal ultrasound machine, following his or her usual operating procedure. 4. The investigator fills in the e-CRF with the results of the targeted ultrasound scan and indicates any modifications to the decision axes.

Interventions

• Other musculoskeletal ultrasound
  After clinical examination and medical interrogation, The investigating physician gives her decisions in the e-CRF according to the 5 axes: diagnosis (I), therapy (II), patient referral (III), prescription of additional tests (IV) and follow-up (V). The investigator performs the targeted musculoskeletal ultrasound with his personal ultrasound machine, following his usual operating procedure and give/keep the final diagnostic.

Primary outcome measures

• Percentage of patients [Time frame: 3 years]

Secondary outcome measures (12)

• Frequency of the anatomical sites [Time frame: 3 years]
• Frequency of modifications [Time frame: 3 years]
• Frequency of diagnoses of post-CTA confirmation [Time frame: 3 years]
• Frequency of diagnoses of post-CTA modifications [Time frame: 3 years]
• Frequency of incidental diagnoses discovered at CTA [Time frame: 3 years]
• Frequency of modifications per patient [Time frame: 3 years]
• Calculation of the cost [Time frame: 3 years]
• Rates for the examinations and therapies [Time frame: 3 years]
• Frequency with which CTA [Time frame: 3 years]
• Time taken to carry out the CTA [Time frame: 3 years]
• Average number of ultrasound prints [Time frame: 3 years]
• Time taken to produce an CTA report [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

• Person who has received full information on the organization of the research and has given his/her consent
• Be over 18 years of age
• Present a symptomatology leading to suspicion of musculoskeletal pathology
• Be able to give consent
• Be affiliated to a social security scheme or benefit from such a scheme

Exclusion criteria

• Chronic inflammatory rheumatism (rheumatoid arthritis, spondylitis, psoriatic arthritis, rheumatoid pseudo-polyarthritis, juvenile idiopathic arthritis, lupus, etc.).
• Subjects benefiting from a legal protection measure (guardianship, curatorship, safeguard of justice).
• Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L3212-1 and L3213-1.
• Pregnant women
• Nursing mothers

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 1 center

• Central Hospital — Nancy

Publications

• Sorensen B, Hunskaar S. Point-of-care ultrasound in primary care: a systematic review of generalist performed point-of-care ultrasound in unselected populations. Ultrasound J. 2019 Nov 19;11(1):31. doi: 10.1186/s13089-019-0145-4. PMID 31749019
• Meyer R, Lin C, Yenokyan G, Ellen M. Diagnostic Utility of Ultrasound Versus Physical Examination in Assessing Knee Effusions: A Systematic Review and Meta-analysis. J Ultrasound Med. 2022 Jan;41(1):17-31. doi: 10.1002/jum.15676. Epub 2021 Mar 5. PMID 33675099
• Nazarian LN. The top 10 reasons musculoskeletal sonography is an important complementary or alternative technique to MRI. AJR Am J Roentgenol. 2008 Jun;190(6):1621-6. doi: 10.2214/AJR.07.3385. PMID 18492916
• Narula J, Chandrashekhar Y, Braunwald E. Time to Add a Fifth Pillar to Bedside Physical Examination: Inspection, Palpation, Percussion, Auscultation, and Insonation. JAMA Cardiol. 2018 Apr 1;3(4):346-350. doi: 10.1001/jamacardio.2018.0001. PMID 29490335
• Andersen CA, Davidsen AS, Brodersen J, Graumann O, Jensen MB. Danish general practitioners have found their own way of using point-of-care ultrasonography in primary care: a qualitative study. BMC Fam Pract. 2019 Jun 28;20(1):89. doi: 10.1186/s12875-019-0984-x. PMID 31253102

Identifiers

NCT: NCT06068595 · 2023-A01995-40

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗