Collaborative quality improvement to promote evidence based surfactant for preterm infants: a cluster randomised trial
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《英国医生杂志》
1 Vermont Oxford Network, 33 Kilburn Street, Burlington, VT 05401, USA, 2 University of Vermont, Burlington, VT, 3 Medical University of South Carolina, Charleston, SC, USA, 4 Center for Perinatal, Pediatric and Environmental Epidemiology, Yale University, New Haven, CT, USA, 5 Robert Wood Johnson Foundation, Princeton, NJ, USA, 6 Paul E Plsek and Associates, Atlanta, GA, USA, 7 Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada
Correspondence to: J D Horbar horbar@vtoxford.org
Abstract
Health services continue to show major gaps between routine practice and what the research evidence suggests is optimal patient care.1 In neonatology, systematic reviews indicate that prophylactic surfactant treatment of high risk preterm infants reduces risk of death and pneumothorax by 40%, and that earlier treatment is more effective than later treatment.2 3 Despite this evidence, few such infants routinely receive prophylactic surfactant treatment, and many infants, particularly those born at outlying hospitals, receive delayed treatment.4
Various strategies for promoting behaviour change and evidence based practice have been proposed.5-8 Experience from the Vermont Oxford Network suggests that multidisciplinary collaborative quality improvement based on four key "habits" (change, evidence based practice, systems thinking, and collaborative learning) modifies practice in neonatal intensive care units, improves clinical outcomes, and reduces costs.9 10
We therefore conducted a cluster randomised controlled trial11 to test whether teams in neonatal intensive care units exposed to a multifaceted collaborative quality improvement intervention based on the four key habits would administer the first dose of surfactant sooner after birth, and achieve improved patient outcomes for preterm infants of 23-29 weeks' gestation.
Methods
Baseline comparability
Table 1 shows the baseline characteristics of the participating hospitals. The hospitals in the two study arms were generally similar in types of neonatal intensive care unit, teaching status, and annual volume of preterm infant admissions, although more of the neonatal intensive care units in the control arm were type A (restricted assisted ventilation or no major surgery available).
Table 1 Baseline characteristics of 114 hospitals in the Vermont Oxford Network that participated in trial of quality improvement intervention for surfactant treatment of preterm infants. Values are medians (interquartile ranges) unless stated otherwise*
Infant characteristics in the assessment year
Tables 2 and 3 show the characteristics of the infants in the 2001 assessment year. The proportion of white infants was higher at intervention hospitals.
Table 2 Median (interquartile range) characteristics of infants treated in 114 hospitals that participated in trial of quality improvement intervention for surfactant treatment of preterm infants, in the assessment year, 2001*
Table 3 Characteristics of infants treated in 114 hospitals that participated in trial of quality improvement intervention for surfactant treatment of preterm infants, in the assessment year, 2001*
Primary outcomes
Delivery room surfactant treatment was significantly higher in the intervention than in the control arm for all infants (adjusted odds ratio 5.38 (95% confidence interval 2.84 to 10.20)), for the infants born at participating hospitals (inborn) (adjusted odds ratio 6.16 (3.03 to 12.54)), and for the infants transferred to participating hospitals after birth (outborn) (adjusted odds ratio 1.99 (1.12 to 3.53)) (table 4). First surfactant treatment more than two hours after birth was significantly lower in the intervention than in the control arm for all infants (0.35 (0.24 to 0.53)), inborn infants (0.29 (0.18 to 0.47)), and outborn infants (0.57 (0.37 to 0.89)). Infants in the intervention arm received surfactant significantly sooner after birth than did infants in the control arm (median 21 minutes (interquartile range 10-128) v 78 minutes (29-410), adjusted hazard ratio 1.57 (95% confidence interval 1.42 to 2.07)). For inborn infants, median times were 18 minutes and 75 minutes in the intervention and control arms (adjusted hazard ratio 1.83 (1.50 to 2.23); for outborn infants the median times were 74 and 103 minutes (adjusted hazard ratio 1.30 (1.00 to 1.69)). When restricted to infants who received surfactant, the median times to first dose for all infants were 15 and 52.5 minutes in the intervention and control arms (adjusted hazard ratio 1.75 (1.47 to 2.09)).
Table 4 Dichotomous primary study outcomes for 114 hospitals that participated in trial of quality improvement intervention for surfactant treatment of preterm infants, in the assessment year, 2001.* Values are percentages unless stated otherwise
There were no significant differences in mortality or pneumothorax. There was a trend towards decreased pneumothorax for outborn infants in the intervention arm (adjusted odds ratio 0.58 (0.33 to 1.03)).
There were significant interactions between treatment arm and location of birth for surfactant administration in the delivery room (P < 0.003) and for first surfactant treatment more than two hours after birth (P < 0.001) resulting from larger effect sizes for inborn infants than for outborn infants (table 4). There was a significant interaction between treatment arm and gestation for first surfactant treatment more than two hours after birth among inborn infants (P = 0.01) due to changes in the size, but not the direction, of the effect across gestational age. The differences between treatment arms for this measure were greatest at 25 weeks and smallest at 29 weeks.
The intraclass correlation coefficients were 0.31 for surfactant administration in the delivery room, 0.09 for first surfactant treatment more than two hours after birth, 0.25 for time to first surfactant dose, and 0.01 for both mortality and pneumothorax.
Secondary outcomes
Intervention arm infants were significantly more likely to be intubated in the delivery room (adjusted odds ratio 1.65 (1.19 to 2.29)) and to receive surfactant at any time (1.55 (1.08 to 2.23)) (table 5). The overall proportions of infants who were intubated and received conventional ventilation or high frequency ventilation were similar in the two arms (adjusted odds ratios 1.10 (0.78 to 1.56) and 1.08 (0.65 to 1.80) respectively). Severe intraventricular haemorrhage (grades 3 or 418) was significantly lower in the intervention arm (0.70 (0.56 to 0.87)); there was a trend towards a decrease for any intraventricular haemorrhage (grades 1 to 418) (0.80 (0.63 to 1.00)). There was a trend towards increased risk of patent ductus arteriosus in the intervention arm (1.27 (0.96 to 1.67)).
Changes in 2000 and 2001
We saw persistent reductions in the median time of the first surfactant dose and in interhospital variability for intervention hospitals starting in the last quarter of 2000, after the workshop (fig 2). The intervention hospitals showed significant changes in 2000 and 2001 for the proportion of all infants who received surfactant and time of first dose (both P < 0.001), but not the control hospitals (P = 0.81 and P = 0.18 respectively). The changes were significantly different between the two arms (time by treatment arm interaction, both P < 0.001).
Fig 2 Median (interquartile range) time after birth at which first dose of surfactant was administered to preterm infants in neonatal intensive care units by calendar quarter. Units in intervention group were notified of their status in May 2000, were given individualised feedback in July 2000, and were invited to a quality improvement workshop in September 2000
Discussion
Committee on Quality of Health Care in America, Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington DC: National Academy Press, 2001.
Soll RF, Morley CJ. Prophylactic versus selective use of surfactant in preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev 2001;(2): CD000510.
Yost CC, Soll RF. Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome. Cochrane Database Syst Rev 2000;(2): CD001456.
Horbar JD, Carpenter J, Buzas J, Soll RF, Suresh G, Bracken MB, et al. Timing of initial surfactant treatment for infants 23 to 29 weeks gestation: is routine practice evidence based? Pediatrics. 2004;113: 1593-602.
Jamtvedt G, Young JM, Kristoffersen DT, Thomson O'Brien MA, Oxman AD. Audit and feedback: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2003;(3): CD000259.
Thomson O'Brien MA, Freemantle N, Oxman AD, Wolf F, Davis DA, Herrin J. Continuing education meetings and workshops: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2001;(2): CD003030.
Zwarenstein M, Bryant W. Interventions to promote collaboration between nurses and doctors. Cochrane Database Syst Rev 2000;(2): CD000072.
Grimshaw JM, Thomas RE, MacLennan G, Fraser C, Ramsay CR, Vale L, et al. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess 2004;8(6): iii-iv, 1-72.
Horbar JD, Plsek P, Leahy K. NIC/Q 2000: establishing habits for improvement in neonatal intensive care units Pediatrics 2003;111: e397-410.
Horbar JD, Rogowski J, Plsek PE, Delmore P, Edwards WH, Hocker J, et al. Collaborative quality improvement for neonatal intensive care. Pediatrics 2001;107: 14-22.
Campbell MK, Elbourne DR, Altman DG for the CONSORT Group. CONSORT statement: extension to cluster randomized trials. BMJ 2004;328: 702-8.
Vermont Oxford Network. Database manual of operations. Release 4.0. Burlington, VT: Vermont Oxford Network, 1999.
Lee E, Dubin N. Estimation and sample size considerations for clustered binary responses. Stat Med 1994;13: 1241-52.
Collett D. Modelling survival data in medical research. 2nd ed. London: Chapman and Hall, 2003.
Plsek PE. Quality improvement methods in clinical medicine. Pediatrics. 1999;103: 203-14.
Donner A, Klar N. Design and analysis of cluster randomization trials in health research. London: Arnold, 2000.
Campbell MK, Grimshaw JM, Elbourne DR. Intracluster correlation coefficients in cluster randomized trials: empirical insights into how they should be reported. BMC Med Res Methodol 2004;4: 9.
Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1500 gm. J Pediatr. 1978;92: 529-34.
Horbar JD, Badger GJ, Carpenter JH, Fanaroff AA, LaCorte M, Phibbs R, et al for the members of the Vermont Oxford Network. Trends in mortality and morbidity for very low birth weight (VLBW) infants, 1991-1999. Pediatrics 2002;110: 143-51.
Wilson T, Berwick DM, Cleary PD. What do improvement collaboratives do? Experience from seven countries. Jt Comm J Qual Saf 2003;29: 85-93.
Langley GJ, Nolan KM, Nolan TW, Norman CL, Provost LP. The improvement guide. A practical approach to enhancing organizational performance. San Francisco CA: Jossey-Bass, 1996.
Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Evidence-based medicine. How to practice and teach EBM. 2nd ed. Edinburgh: Churchill Livingstone, 2000.
Berwick DM. Disseminating innovations in health care. JAMA 2003;289: 1969-75.
Puffer S, Torgerson DJ, Watson J. Evidence for risk of bias in cluster randomized trials: review of recent trials published in three general medical journals. BMJ 2003;327;785-9.(Jeffrey D Horbar, chief e)
Correspondence to: J D Horbar horbar@vtoxford.org
Abstract
Health services continue to show major gaps between routine practice and what the research evidence suggests is optimal patient care.1 In neonatology, systematic reviews indicate that prophylactic surfactant treatment of high risk preterm infants reduces risk of death and pneumothorax by 40%, and that earlier treatment is more effective than later treatment.2 3 Despite this evidence, few such infants routinely receive prophylactic surfactant treatment, and many infants, particularly those born at outlying hospitals, receive delayed treatment.4
Various strategies for promoting behaviour change and evidence based practice have been proposed.5-8 Experience from the Vermont Oxford Network suggests that multidisciplinary collaborative quality improvement based on four key "habits" (change, evidence based practice, systems thinking, and collaborative learning) modifies practice in neonatal intensive care units, improves clinical outcomes, and reduces costs.9 10
We therefore conducted a cluster randomised controlled trial11 to test whether teams in neonatal intensive care units exposed to a multifaceted collaborative quality improvement intervention based on the four key habits would administer the first dose of surfactant sooner after birth, and achieve improved patient outcomes for preterm infants of 23-29 weeks' gestation.
Methods
Baseline comparability
Table 1 shows the baseline characteristics of the participating hospitals. The hospitals in the two study arms were generally similar in types of neonatal intensive care unit, teaching status, and annual volume of preterm infant admissions, although more of the neonatal intensive care units in the control arm were type A (restricted assisted ventilation or no major surgery available).
Table 1 Baseline characteristics of 114 hospitals in the Vermont Oxford Network that participated in trial of quality improvement intervention for surfactant treatment of preterm infants. Values are medians (interquartile ranges) unless stated otherwise*
Infant characteristics in the assessment year
Tables 2 and 3 show the characteristics of the infants in the 2001 assessment year. The proportion of white infants was higher at intervention hospitals.
Table 2 Median (interquartile range) characteristics of infants treated in 114 hospitals that participated in trial of quality improvement intervention for surfactant treatment of preterm infants, in the assessment year, 2001*
Table 3 Characteristics of infants treated in 114 hospitals that participated in trial of quality improvement intervention for surfactant treatment of preterm infants, in the assessment year, 2001*
Primary outcomes
Delivery room surfactant treatment was significantly higher in the intervention than in the control arm for all infants (adjusted odds ratio 5.38 (95% confidence interval 2.84 to 10.20)), for the infants born at participating hospitals (inborn) (adjusted odds ratio 6.16 (3.03 to 12.54)), and for the infants transferred to participating hospitals after birth (outborn) (adjusted odds ratio 1.99 (1.12 to 3.53)) (table 4). First surfactant treatment more than two hours after birth was significantly lower in the intervention than in the control arm for all infants (0.35 (0.24 to 0.53)), inborn infants (0.29 (0.18 to 0.47)), and outborn infants (0.57 (0.37 to 0.89)). Infants in the intervention arm received surfactant significantly sooner after birth than did infants in the control arm (median 21 minutes (interquartile range 10-128) v 78 minutes (29-410), adjusted hazard ratio 1.57 (95% confidence interval 1.42 to 2.07)). For inborn infants, median times were 18 minutes and 75 minutes in the intervention and control arms (adjusted hazard ratio 1.83 (1.50 to 2.23); for outborn infants the median times were 74 and 103 minutes (adjusted hazard ratio 1.30 (1.00 to 1.69)). When restricted to infants who received surfactant, the median times to first dose for all infants were 15 and 52.5 minutes in the intervention and control arms (adjusted hazard ratio 1.75 (1.47 to 2.09)).
Table 4 Dichotomous primary study outcomes for 114 hospitals that participated in trial of quality improvement intervention for surfactant treatment of preterm infants, in the assessment year, 2001.* Values are percentages unless stated otherwise
There were no significant differences in mortality or pneumothorax. There was a trend towards decreased pneumothorax for outborn infants in the intervention arm (adjusted odds ratio 0.58 (0.33 to 1.03)).
There were significant interactions between treatment arm and location of birth for surfactant administration in the delivery room (P < 0.003) and for first surfactant treatment more than two hours after birth (P < 0.001) resulting from larger effect sizes for inborn infants than for outborn infants (table 4). There was a significant interaction between treatment arm and gestation for first surfactant treatment more than two hours after birth among inborn infants (P = 0.01) due to changes in the size, but not the direction, of the effect across gestational age. The differences between treatment arms for this measure were greatest at 25 weeks and smallest at 29 weeks.
The intraclass correlation coefficients were 0.31 for surfactant administration in the delivery room, 0.09 for first surfactant treatment more than two hours after birth, 0.25 for time to first surfactant dose, and 0.01 for both mortality and pneumothorax.
Secondary outcomes
Intervention arm infants were significantly more likely to be intubated in the delivery room (adjusted odds ratio 1.65 (1.19 to 2.29)) and to receive surfactant at any time (1.55 (1.08 to 2.23)) (table 5). The overall proportions of infants who were intubated and received conventional ventilation or high frequency ventilation were similar in the two arms (adjusted odds ratios 1.10 (0.78 to 1.56) and 1.08 (0.65 to 1.80) respectively). Severe intraventricular haemorrhage (grades 3 or 418) was significantly lower in the intervention arm (0.70 (0.56 to 0.87)); there was a trend towards a decrease for any intraventricular haemorrhage (grades 1 to 418) (0.80 (0.63 to 1.00)). There was a trend towards increased risk of patent ductus arteriosus in the intervention arm (1.27 (0.96 to 1.67)).
Changes in 2000 and 2001
We saw persistent reductions in the median time of the first surfactant dose and in interhospital variability for intervention hospitals starting in the last quarter of 2000, after the workshop (fig 2). The intervention hospitals showed significant changes in 2000 and 2001 for the proportion of all infants who received surfactant and time of first dose (both P < 0.001), but not the control hospitals (P = 0.81 and P = 0.18 respectively). The changes were significantly different between the two arms (time by treatment arm interaction, both P < 0.001).
Fig 2 Median (interquartile range) time after birth at which first dose of surfactant was administered to preterm infants in neonatal intensive care units by calendar quarter. Units in intervention group were notified of their status in May 2000, were given individualised feedback in July 2000, and were invited to a quality improvement workshop in September 2000
Discussion
Committee on Quality of Health Care in America, Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington DC: National Academy Press, 2001.
Soll RF, Morley CJ. Prophylactic versus selective use of surfactant in preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev 2001;(2): CD000510.
Yost CC, Soll RF. Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome. Cochrane Database Syst Rev 2000;(2): CD001456.
Horbar JD, Carpenter J, Buzas J, Soll RF, Suresh G, Bracken MB, et al. Timing of initial surfactant treatment for infants 23 to 29 weeks gestation: is routine practice evidence based? Pediatrics. 2004;113: 1593-602.
Jamtvedt G, Young JM, Kristoffersen DT, Thomson O'Brien MA, Oxman AD. Audit and feedback: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2003;(3): CD000259.
Thomson O'Brien MA, Freemantle N, Oxman AD, Wolf F, Davis DA, Herrin J. Continuing education meetings and workshops: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2001;(2): CD003030.
Zwarenstein M, Bryant W. Interventions to promote collaboration between nurses and doctors. Cochrane Database Syst Rev 2000;(2): CD000072.
Grimshaw JM, Thomas RE, MacLennan G, Fraser C, Ramsay CR, Vale L, et al. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess 2004;8(6): iii-iv, 1-72.
Horbar JD, Plsek P, Leahy K. NIC/Q 2000: establishing habits for improvement in neonatal intensive care units Pediatrics 2003;111: e397-410.
Horbar JD, Rogowski J, Plsek PE, Delmore P, Edwards WH, Hocker J, et al. Collaborative quality improvement for neonatal intensive care. Pediatrics 2001;107: 14-22.
Campbell MK, Elbourne DR, Altman DG for the CONSORT Group. CONSORT statement: extension to cluster randomized trials. BMJ 2004;328: 702-8.
Vermont Oxford Network. Database manual of operations. Release 4.0. Burlington, VT: Vermont Oxford Network, 1999.
Lee E, Dubin N. Estimation and sample size considerations for clustered binary responses. Stat Med 1994;13: 1241-52.
Collett D. Modelling survival data in medical research. 2nd ed. London: Chapman and Hall, 2003.
Plsek PE. Quality improvement methods in clinical medicine. Pediatrics. 1999;103: 203-14.
Donner A, Klar N. Design and analysis of cluster randomization trials in health research. London: Arnold, 2000.
Campbell MK, Grimshaw JM, Elbourne DR. Intracluster correlation coefficients in cluster randomized trials: empirical insights into how they should be reported. BMC Med Res Methodol 2004;4: 9.
Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1500 gm. J Pediatr. 1978;92: 529-34.
Horbar JD, Badger GJ, Carpenter JH, Fanaroff AA, LaCorte M, Phibbs R, et al for the members of the Vermont Oxford Network. Trends in mortality and morbidity for very low birth weight (VLBW) infants, 1991-1999. Pediatrics 2002;110: 143-51.
Wilson T, Berwick DM, Cleary PD. What do improvement collaboratives do? Experience from seven countries. Jt Comm J Qual Saf 2003;29: 85-93.
Langley GJ, Nolan KM, Nolan TW, Norman CL, Provost LP. The improvement guide. A practical approach to enhancing organizational performance. San Francisco CA: Jossey-Bass, 1996.
Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Evidence-based medicine. How to practice and teach EBM. 2nd ed. Edinburgh: Churchill Livingstone, 2000.
Berwick DM. Disseminating innovations in health care. JAMA 2003;289: 1969-75.
Puffer S, Torgerson DJ, Watson J. Evidence for risk of bias in cluster randomized trials: review of recent trials published in three general medical journals. BMJ 2003;327;785-9.(Jeffrey D Horbar, chief e)