Effect of a Physiotherapist-Guided Home-Based Exercise Intervention on Physical Capacity and Patient-Reported Outcomes Among Patients With Acute Pulmonary Embolism: A Randomized Clinical Trial.

Importance: Survivors of acute pulmonary embolism (PE) experience long-term negative physical and mental consequences, but the effects of rehabilitation on outcomes among these patients have not been investigated. Objective: To investigate the effect of a rehabilitation intervention, comprising an 8-week home-based exercise program and nurse consultations, on physical capacity and patient-reported outcomes among patients with acute PE. Design, Setting, and Participants: This multicenter randomized clinical superiority trial was conducted at 4 regional hospitals and 1 university hospital in Denmark. The 140 consecutively included participants had been diagnosed with an acute PE between April 2016 and February 2018 and had 6 months of follow-up. An intention-to-treat analysis was conducted. Intervention: Patients in the control group received a brief nurse consultation, while patients in the exercise group participated in an 8-week home-based exercise program in addition to receiving nurse consultations. Main Outcomes and Measures: The primary outcome was the Incremental Shuttle Walk Test, and secondary outcomes were the Pulmonary Embolism Quality of Life and the EuroQol-5 Dimensions-3 Levels questionnaires, self-reported number of sick-leave days, and self-reported use of psychotropic drugs. Results: A total of 140 patients (90 [64.3%] men) were included, with a mean (SD) age of 61 (11) years. Of 70 participants (50.0%) randomized to each group, 69 participants (49.3%) received the intervention and 68 (48.6%) received the control intervention. Both groups achieved improvements in all outcomes (eg, mean [SD] improvement on Incremental Shuttle Walk Test: control group, 78 (127) m; intervention group, 104 [106] m; median [interquartile range] improvement on Pulmonary Embolism Quality of Life: control group, -17 [-22 to -11] points; intervention group, -20 [-24 to -15] points). Between-group differences were nonsignificant. The mean differences between the intervention group and the control group were 25 m (95% CI, -20 to 70 m; P = .27) on the Incremental Shuttle Walk Test, 3.0 points (95% CI, -3.7 to 9.9 points; P = .39) on the Pulmonary Embolism Quality of Life questionnaire, and 0.017 point (95% CI, -0.032 to 0.065 point; P = .50) on the EuroQol-5 Dimensions-3 Levels questionnaire. Of the 27 patients in the intervention group on sick leave at baseline, 24 (88.9%) reported fit-for-duty at the 6-month follow-up, and of 18 patients in the control group on sick leave, 17 (94.4%) reported fit-for-duty at the 6-month follow up. The between-group risk difference was not significant (5.5 points; P = .49). Conclusions and Relevance: An 8-week rehabilitation intervention with exercise added to nurse consultations did not show significantly better outcomes than nurse consultations alone. However, because of a ceiling effect on the primary outcome of physical capacity and an inclusion of patients with a low comorbidity burden and low PE disease severity, definitive conclusions could not be drawn. Initiating an exercise intervention shortly after pulmonary embolism was safe and without adverse events. Trial Registration: ClinicalTrials.gov Identifier: NCT02684721.

Does an 8-week home-based exercise program affect physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients with pulmonary embolism? Study protocol for a multicenter randomized clinical trial.

BACKGROUND: The existing evidence base in pulmonary embolism (PE) is primarily focused on diagnostic methods, medical treatment, and prognosis. Only a few studies have investigated how everyday life is affected by PE, although many patients are negatively affected both physically and emotionally after hospital discharge. Currently, no documented rehabilitation options are available for these patients. We aim to examine whether an 8-week home-based exercise intervention can influence physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients medically treated for PE. METHODS: One hundred forty patients with incident first-time PE will be recruited in five hospitals. After inclusion, patients will be randomly allocated to either the control group, receiving usual care, or the intervention group, who will be exposed to an 8-week home-based exercise program in addition to usual care. The intervention includes an initial individual exercise planning session with a physiotherapist, leading to a recommended exercise program of a minimum of three weekly training sessions of 30-60 minutes' duration. The patients have regular telephone contact with the physiotherapist during the 8-week program. At the time of inclusion, after 2 months, and after 6 months, the patients' physical capacity is measured using the Incremental Shuttle Walk test. Furthermore the patients' quality of life, sick leave, and use of psychotropic drugs is measured using self-reported questionnaires. In both randomization arms, all follow-up measurements and visits will take place at the hospital from which the patient was discharged. Levels of eligibility, consent, adherence, and retention will be used as indicators of study feasibility. DISCUSSION: We expect that the home-based exercise program will improve the physical capacity and quality of life for the patients in the intervention group. The study will furthermore contribute significantly to the limited knowledge about the optimal rehabilitation of PE patients, and may thereby form the basis of future recommendations in this field. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02684721 . Registered on 20 January 2016.

Economic evaluation of endoscopic versus open vein harvest for coronary artery bypass grafting.

BACKGROUND: A short saphenous vein segment is commonly used as a conduit for coronary artery bypass grafting, and clinicians must decide whether to obtain it by performing open (OVH) or endoscopic vein harvest (EVH). We conducted a health economic evaluation, using data on resource usage collected alongside a randomized controlled trial, to investigate whether EVH is cost-effective compared with OVH. METHODS: Analyses were performed in accordance with international guidelines for health economic evaluations. We constructed 3 cost-levels as the current literature is inconclusive as to which resource consumptions differ significantly between harvesting methods. Outcomes were measured as purulent infections avoided in the cost-effectiveness analysis and for the cost-utility analysis we estimated quality-adjusted life-years gained. Results were presented as incremental cost-effectiveness ratios: ie, the extra cost of obtaining one extra quality-adjusted life-year and the extra cost of avoiding one purulent infection. To handle uncertainties, we performed bias corrected bootstrap analyses on 5,000 resamples and constructed cost-effectiveness acceptability curves. RESULTS: The incremental cost-effectiveness ratio was $79,391/quality-adjusted life-year and $1,970/purulent infection avoided when costs and outcomes within 35 days postoperatively were compared. Within 35 days postoperatively, EVH was less than 1% cost-effective at a willingness-to-pay threshold of $50,000/quality-adjusted life-year. CONCLUSIONS: The EVH was not cost-effective within 35 days postoperatively. Future studies should investigate long-term cost effectiveness.

Precautions related to midline sternotomy in cardiac surgery: a review of mechanical stress factors leading to sternal complications.

BACKGROUND: After midline sternotomy patients are instructed on activity precautions to avoid sternal wound complications. We questioned how restrictive these precautions must be, since they can lead to a postoperative decrease in quality of life. AIMS: To identify mechanical stress factors causing sternal instability and infection in order to create evidence based guidelines for activity following sternotomy. METHODS: Literature review. RESULTS: No evidence was found to support weight limitation regarding activity, as long as the upper arms are kept close to the body and activity is within a pain-free range. RECOMMENDATIONS: Avoid stretching both arms backwards at the same time (10 days); loaded activities should be done with the elbows close to the body (eight weeks); only move arms within a pain-free range; use leg rolling with counterweighing when getting in and out of bed; when coughing cross the arms in a "self-hugging" posture; supportive bra or vest is recommended when breast cup>or=D, body mass index>or=35 or frequent cough. CONCLUSION: This study provides insights into mechanical stress factors acting upon sternum and the overlying skin. RECOMMENDATIONS on activity precautions based on these finding have a patient supportive approach focusing on possibilities and not restrictions.