DESIGN: This post hoc descriptive exploration of data from the large international very early rehabilitation trial (A Very Early Rehabilitation Trial (AVERT)) examined the four common post acute rehabilitation pathways (inpatient rehabilitation, home with community rehabilitation, inpatient rehabilitation then community rehabilitation and home with no rehabilitation) experienced by participants in the 3 months post stroke and describes their 12-month outcomes.

SETTING: Hospital stroke units in AUS, UK and SE Asia.

PARTICIPANTS: Patients who had an acute stroke recruited within 24 hours who were ≤65 years.

RESULTS: 668 participants were ≤65 years; 99% lived independently, and 88% no disability (modified Rankin Score (mRS)=0) prior to stroke. We had complete data for 12-month outcomes for n=631 (94%). The proportion receiving inpatient rehabilitation was higher in AUS than other regions (AUS 52%; UK 25%; SE Asia 23%), whereas the UK had higher community rehabilitation (UK 65%; AUS 61%; SE Asia 39%). At 12 months, 70% had no or little disability (mRS 0-2), 44% were depressed, 28% rated quality of life as poor or worse than death. For those working prior to stroke (n=228), only 57% had returned to work. A noteworthy number of working age survivors received no rehabilitation services within 3 months post stroke.

CONCLUSIONS: There was considerable variation in rehabilitation pathways and post acute service use across the three regions. At 12 months, there were high rates of depression, poor quality of life and low rates of return to work.

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 AND ANALYSIS: This is double-blind randomised controlled trial, with parallel group, concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. 240 adult participants who had median sternotomy from eight hospitals in Malaysia will be recruited. Sample size calculations were based on the unsupported upper limb test. All participants will be randomised to receive either standard or early supervised incremental resistance training. The primary outcomes are upper limb function and pain. The secondary outcomes will be functional capacity, multidomain recovery (physical and psychological), length of hospital stay, incidence of respiratory complications and quality of life. Descriptive statistics will be used to summarise data. Data will be analysed using the intention-to-treat principle. The primary hypothesis will be examined by evaluating the change from baseline to the 4-week postoperative time point in the intervention arm compared with the usual care arm. For all tests to be conducted, a p value of <0.05 (two tailed) will be considered statistically significant, and CIs will be reported. The trial is currently recruiting participants.

ETHICS AND DISSEMINATION: The study was approved by a central ethical committee as well as the local Research Ethics Boards of the participating sites (UKM:JEP-2019-654; Ministry of Health: NMMR-50763; National Heart Centre: IJNREC/501/2021). Approval to start was given prior to the recruitment of participants commencing at any sites. Process evaluation findings will be published in peer-reviewed journals and presented at relevant academic conferences.

DESIGN: AVERT is a prospective, parallel group, assessor-blinded randomised clinical trial. This paper presents data assessing the generalisability of AVERT.

SETTING: Acute stroke units at 44 hospitals in 8 countries.

PARTICIPANTS: The first 20,000 patients screened for AVERT, of whom 1158 were recruited and randomised.

MODEL: We use the Proximal Similarity Model, which considers the person, place, and setting and practice, as a framework for considering generalisability. As well as comparing the recruited patients with the target population, we also performed an exploratory analysis of the demographic, clinical, site and process factors associated with recruitment.

RESULTS: The demographics and stroke characteristics of the included patients in the trial were broadly similar to population-based norms, with the exception that AVERT had a greater proportion of men. The most common reason for non-recruitment was late arrival to hospital (ie, >24 h). Overall, being older and female reduced the odds of recruitment to the trial. More women than men were excluded for most of the reasons, including refusal. The odds of exclusion due to early deterioration were particularly high for those with severe stroke (OR=10.4, p<0.001, 95% CI 9.27 to 11.65).

CONCLUSIONS: A model which explores person, place, and setting and practice factors can provide important information about the external validity of a trial, and could be applied to other clinical trials.