PMID- 33630699
OWN - NLM
STAT- MEDLINE
DCOM- 20210818
LR  - 20220531
IS  - 1651-226X (Electronic)
IS  - 0284-186X (Linking)
VI  - 60
IP  - 6
DP  - 2021 Jun
TI  - Prospective study for establishing minimal clinically important differences in 
      patients with surgery for lower extremity metastases.
PG  - 714-720
LID - 10.1080/0284186X.2021.1890333 [doi]
AB  - BACKGROUND: The clinical relevance of patient-reported outcomes score changes is 
      often unclear. Especially in patients undergoing surgery due to lower extremity 
      metastases - where surgery is performed in the palliative setting and the goal is 
      to optimize functional mobility, relieve pain and improve overall quality of 
      life. This study assessed the minimal clinically important difference (MCID) of 
      Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 
      Interference, Cancer-specific Physical Function, and Global (Physical and Mental 
      Health) in patients treated surgically for impending or completed pathologic 
      fractures. METHODS: Patients undergoing surgery for osseous metastasis of the 
      lower extremity because of an impending or completed pathologic fracture were 
      consecutively enrolled in this tertiary center study. Patients completed the 
      three PROMIS questionnaires preoperatively (n = 56) and at postoperative 
      follow-up (n = 33) assessment one to three months later. Of the 23 patients that 
      did not complete the postoperative survey, 5 patients died within 1-3 months and 
      18 patients were alive at 3-months but did not respond or show up at their 
      postoperative consult. Thirty-one patients (94%) of the 33 included patients 
      reported at least minimal improvement and two patients (6.1%) no change 
      1-3 months after the surgery based on an anchor-based approach. RESULTS: The 
      PROMIS MCIDs (95% confidence interval) for Pain Interference was 7.5 (3.4-12), 
      Physical Function 4.1 (0.6-7.6), Global Physical Health 4.2 (2.0-6.6), and Global 
      Mental Health 0.8 (-4.5-2.9). CONCLUSION: This prospective study successfully 
      defined a MCID for PROMIS Pain Interference of 7.5 (3.4-12), PROMIS Physical 
      Function of 4.1 (0.6-7.6), and Global Physical Health of 4.2 (2.0-6.6) in 
      patients with (impending) pathological fractures due to osseous metastases in the 
      lower extremity; no MCID could be established for PROMIS Global Mental Health. 
      Defining a narrower MCID value for each subpopulation requires a large, 
      prospective, multicenter study. Nevertheless, the provided MCID values allow 
      guidance to clinicians to evaluate the impact of surgical treatment on a 
      patient's QoL. LEVEL OF EVIDENCE: Level II Diagnostic study.
FAU - Bongers, M E R
AU  - Bongers MER
AUID- ORCID: 0000-0003-4628-4793
AD  - Department of Orthopaedic Surgery, Massachusetts General Hospital, Harvard 
      Medical School, Boston, MA, USA.
AD  - Department of Orthopaedic Surgery, Academic University Medical Center, University 
      of Amsterdam, Amsterdam, The Netherlands.
FAU - Groot, O Q
AU  - Groot OQ
AUID- ORCID: 0000-0002-5091-3110
AD  - Department of Orthopaedic Surgery, Massachusetts General Hospital, Harvard 
      Medical School, Boston, MA, USA.
AD  - Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, 
      The Netherlands.
FAU - Thio, Q C B S
AU  - Thio QCBS
AD  - Department of Orthopaedic Surgery, Massachusetts General Hospital, Harvard 
      Medical School, Boston, MA, USA.
FAU - Bramer, J A M
AU  - Bramer JAM
AD  - Department of Orthopaedic Surgery, Academic University Medical Center, University 
      of Amsterdam, Amsterdam, The Netherlands.
FAU - Verlaan, J J
AU  - Verlaan JJ
AD  - Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, 
      The Netherlands.
FAU - Newman, E T
AU  - Newman ET
AD  - Department of Orthopaedic Surgery, Massachusetts General Hospital, Harvard 
      Medical School, Boston, MA, USA.
FAU - Raskin, K A
AU  - Raskin KA
AD  - Department of Orthopaedic Surgery, Massachusetts General Hospital, Harvard 
      Medical School, Boston, MA, USA.
FAU - Lozano-Calderon, S A
AU  - Lozano-Calderon SA
AD  - Department of Orthopaedic Surgery, Massachusetts General Hospital, Harvard 
      Medical School, Boston, MA, USA.
FAU - Schwab, J H
AU  - Schwab JH
AD  - Department of Orthopaedic Surgery, Massachusetts General Hospital, Harvard 
      Medical School, Boston, MA, USA.
LA  - eng
PT  - Journal Article
DEP - 20210225
PL  - Sweden
TA  - Acta Oncol
JT  - Acta oncologica (Stockholm, Sweden)
JID - 8709065
SB  - IM
MH  - Humans
MH  - *Lower Extremity/surgery
MH  - *Minimal Clinically Important Difference
MH  - *Neoplasm Metastasis
MH  - Patient Reported Outcome Measures
MH  - Prospective Studies
MH  - *Quality of Life
MH  - Tertiary Care Centers
OTO - NOTNLM
OT  - Minimal clinically important difference
OT  - PROMIS
OT  - anchor-based
OT  - lower extremity metastases
OT  - pathologic fracture
OT  - prophylactic fixation
EDAT- 2021/02/26 06:00
MHDA- 2021/08/19 06:00
CRDT- 2021/02/25 17:12
PHST- 2021/02/26 06:00 [pubmed]
PHST- 2021/08/19 06:00 [medline]
PHST- 2021/02/25 17:12 [entrez]
AID - 10.1080/0284186X.2021.1890333 [doi]
PST - ppublish
SO  - Acta Oncol. 2021 Jun;60(6):714-720. doi: 10.1080/0284186X.2021.1890333. Epub 2021 
      Feb 25.