TY - JOUR
T1 - A Randomized Trial of Initiation of Chronic Noninvasive Mechanical Ventilation at Home vs In-Hospital in Patients With Neuromuscular Disease and Thoracic Cage Disorder The Dutch Homerun Trial
AU - van den Biggelaar, Ries J. M.
AU - Hazenberg, Anda
AU - Cobben, Nicolle A. M.
AU - Gaytant, Michael A.
AU - Vermeulen, Karin M.
AU - Wijkstra, Peter J.
PY - 2020/12
Y1 - 2020/12
N2 - BACKGROUND: There is an increasing demand for home mechanical ventilation (HMV) in patients with chronic respiratory insufficiency. At present, noninvasive ventilation is exclusively initiated in a clinical setting at all four centers for HMV in the Netherlands. In addition to its high societal costs and patient discomfort, commencing HMV is often delayed because of a lack of hospital bed capacity.RESEARCH QUESTION: Is HMV initiation at home, using a telemonitoring approach, noninferior to in-hospital initiation in a nationwide study?STUDY DESIGN AND METHODS: We conducted a nationwide, randomized controlled non-inferiority trial, in which every HMV center recruited 24 patients (home [n = 12] vs hospital [n = 12] ) with a neuromuscular disease or thoracic cage disorder, all with an indication to start HMV. Change in arterial CO2 (PaCO2) over a 6-month period was considered the primary outcome, and quality of life and costs were assessed as secondary outcomes.RESULTS: A total of 96 patients were randomized, most of them diagnosed with neuromuscular disease. We found a significant improvement in PaCO2 within both groups (home: from 6.1 to 5.6 kPa [P <.01]; hospital: from 6.3 to 5.6 kPa [P <.01]), with no significant differences between groups. Health-related quality of life showed significant improvement on various subscales; however, no significant differences were observed between the home and hospital groups. From a societal perspective, a cost reduction of more than (sic)3,200 ((sic)3,793) per patient was evident in the home group.INTERPRETATION: This nationwide, multicenter study shows that HMV initiation at home is noninferior to hospital initiation, as it shows the same improvement in gas exchange and health-related quality of life. In fact, from a patient's perspective, it might even be a more attractive approach. In addition, starting at home saves over (sic)3,200 ($3,793) per patient over a 6-month period.
AB - BACKGROUND: There is an increasing demand for home mechanical ventilation (HMV) in patients with chronic respiratory insufficiency. At present, noninvasive ventilation is exclusively initiated in a clinical setting at all four centers for HMV in the Netherlands. In addition to its high societal costs and patient discomfort, commencing HMV is often delayed because of a lack of hospital bed capacity.RESEARCH QUESTION: Is HMV initiation at home, using a telemonitoring approach, noninferior to in-hospital initiation in a nationwide study?STUDY DESIGN AND METHODS: We conducted a nationwide, randomized controlled non-inferiority trial, in which every HMV center recruited 24 patients (home [n = 12] vs hospital [n = 12] ) with a neuromuscular disease or thoracic cage disorder, all with an indication to start HMV. Change in arterial CO2 (PaCO2) over a 6-month period was considered the primary outcome, and quality of life and costs were assessed as secondary outcomes.RESULTS: A total of 96 patients were randomized, most of them diagnosed with neuromuscular disease. We found a significant improvement in PaCO2 within both groups (home: from 6.1 to 5.6 kPa [P <.01]; hospital: from 6.3 to 5.6 kPa [P <.01]), with no significant differences between groups. Health-related quality of life showed significant improvement on various subscales; however, no significant differences were observed between the home and hospital groups. From a societal perspective, a cost reduction of more than (sic)3,200 ((sic)3,793) per patient was evident in the home group.INTERPRETATION: This nationwide, multicenter study shows that HMV initiation at home is noninferior to hospital initiation, as it shows the same improvement in gas exchange and health-related quality of life. In fact, from a patient's perspective, it might even be a more attractive approach. In addition, starting at home saves over (sic)3,200 ($3,793) per patient over a 6-month period.
KW - neuromuscular disease
KW - noninvasive ventilation
KW - telemedicine
KW - thoracic cage abnormality
KW - QUALITY-OF-LIFE
U2 - 10.1016/j.chest.2020.07.007
DO - 10.1016/j.chest.2020.07.007
M3 - Article
C2 - 32682770
VL - 158
SP - 2493
EP - 2501
JO - Chest
JF - Chest
SN - 0012-3692
IS - 6
ER -