METHODS: A prospective observational study was undertaken at two tertiary care hospitals in Australia. Seventy-two (72) adults (mean age, 63±11 years) were included following cardiac surgery via a median sternotomy. Participants completed the Patient Identified Cardiac Pain using numeric and visual prompts (PICP), the McGill Pain Questionnaire-Short Form version 2 (MPQ-2) and the Medical Outcome Study 36-item version 2 (SF-36v2) Bodily Pain domain (BP), which were administered prior to hospital discharge, 4 weeks and 3 months postoperatively.

RESULTS: Participants experienced a high incidence of mild (n=45, 63%) to moderate (n=22, 31%) pain prior to discharge, which reduced at 4 weeks postoperatively: mild (n=28, 41%) and moderate (n=5, 7%) pain; at 3 months participants reported mild (n=14, 20%) and moderate (n=2, 3%) pain. The most frequent location of pain was the anterior chest wall, consistent with the location of the surgical incision and graft harvest. Most participants equated "pressure/weight" to "aching" or a "heaviness" in the chest region (based on descriptor of pain in the PICP) and the pain topography was persistent at 4 weeks and 3 months postoperatively. Each pain measurement tool provided different information on pain location, severity and description, with significant change (p<0.005) over time.

METHODS/DESIGN: This study is a phase II, double-blind, randomised controlled trial with concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. Patients (n = 72) will be recruited following cardiac surgery via a median sternotomy. Sample size calculations were based on the minimal important difference (two points) for the primary outcome: Short Physical Performance Battery. Thirty-six participants are required per group to counter dropout (20%). All participants will be randomised to receive either standard or modified sternal precautions. The intervention group will receive guidelines encouraging the safe use of the upper limbs. Secondary outcomes are upper limb function, pain, kinesiophobia and health-related quality of life. Descriptive statistics will be used to summarise data. The primary hypothesis will be examined by repeated-measures analysis of variance to evaluate the changes from baseline to 4 weeks post-operatively in the intervention arm compared with the usual-care arm. In all tests to be conducted, a p value <0.05 (two-tailed) will be considered statistically significant, and confidence intervals will be reported.

DISCUSSION: The Sternal Management Accelerated Recovery Trial (S.M.A.R.T.) is a two-centre randomised controlled trial powered and designed to investigate whether the effects of modifying sternal precautions to include the safe use of the upper limbs and trunk impact patients' physical function and recovery following cardiac surgery via median sternotomy.

DESIGN: This is a multisite observational study.

SETTING: The study was conducted in four tertiary care hospitals in Australia.

SUBJECTS: A total of 225 participants, following cardiac surgery, were involved in the study.

INTERVENTION: Participants completed the original 13-item FDQ and other measures of physical function, pain and health-related quality of life.

METHOD: Item reduction was utilized to develop the shortened version. Reliability was evaluated using intraclass correlation coefficients (ICCs), the smallest detectable change and Bland-Altman plots. The validity and responsiveness were evaluated using correlation. Anchor and distribution-based calculation was used to calculate the minimal clinical important difference (MCID).

RESULTS: Item reduction resulted in the creation of a 10-item shortened version of the questionnaire (FDQ-s). Within the cohort of cardiac surgery patient, the mean (SD) for the FDQ-s was 38.7 (19.61) at baseline; 15.5 (14.01) at four weeks and 7.9 (12.01) at three months. Validity: excellent internal consistency (Cronbach's α > 0.90) and fair-to-excellent construct validity (>0.4). Reliability: internal consistency was excellent (Cronbach's α > 0.8). The FDQ-s had excellent test-retest reliability (ICC = 0.89-0.92). Strong responsiveness overtime was demonstrated with large effect sizes (Cohen's d > 1.0). The MCID of the FDQ-s was calculated between 4 and 10 out of 100 (in cm).

METHODS: Four electronic databases were searched from inception to December 2022 (MEDLINE via Ovid, EMBASE via Ovid, CINAHL via Healthcare Databases Advanced Search, CENTRAL via Cochrane). Studies were included if they examined at least one clinimetric property of a CONCISE measurement instrument or recognised variation in adults ≥ 18 years with critical illness or recovering from critical illness in any language. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist for systematic reviews of Patient-Reported Outcome Measures was used. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses were used in line with COSMIN guidance. The COSMIN checklist was used to evaluate the risk of bias and the quality of clinimetric properties. Overall certainty of the evidence was rated using a modified Grading of Recommendations, Assessment, Development and Evaluation approach. Narrative synthesis was performed and where possible, meta-analysis was conducted.

RESULTS: A total of 4316 studies were screened. Forty-seven were included in the review, reporting data for 12308 participants. The Short Form-36 Questionnaire (Physical Component Score and Physical Functioning), sit-to-stand test, 6-m walk test and Barthel Index had the strongest clinimetric properties and certainty of evidence. The Short Physical Performance Battery, Katz Index and handgrip strength had less favourable results. There was limited data for Lawson Instrumental Activities of Daily Living and the Global Leadership Initiative on Malnutrition criteria. The risk of bias ranged from inadequate to very good. The certainty of the evidence ranged from very low to high.

CONCLUSIONS: Variable evidence exists to support the clinimetric properties of the CONCISE measurement instruments. We suggest using this review alongside CONCISE to guide outcome selection for future trials of nutrition and metabolic interventions in critical illness.