General obstetrics
DOI: 10.1111/1471-0528.12507 www.bjog.org
Determining obstetric patient safety indicators: the differences in neonatal outcome measures between different-sized delivery units A Pyyko¨nen,a M Gissler,b,c M Jakobsson,a J Peta¨ja¨,d A-M Tapperd a
Department of Obstetrics and Gynaecology, Helsinki University Hospital, Helsinki, Finland b THL National Institute for Health and Welfare, Helsinki, Finland c Nordic School of Public Health, Gothenburg, Sweden d Department of Gynecology and Pediatrics, Helsinki University Central Hospital, Helsinki, Finland Correspondence: Dr A Pyykönen, c/o Dr A-M Tapper, Department of Obstetrics and Gynaecology, Helsinki University Central Hospital, PO Box 140, FI-00029 HUS, Finland. Email [email protected] Accepted 13 August 2013. Published Online 3 December 2013.
Objective To study the differences in neonatal outcome and
treatment measures in Finnish obstetric units. Design A registry study with Medical Birth Register data. Setting and population All births (n = 2 94 726) in Finland from
2006 to 2010 with a focus on term, singleton non-university deliveries. Methods All 34 delivery units were grouped into small (below
1000), mid-sized (1000–2999) and large (3000 or more) units, and the adverse outcome rates in neonates were compared using logistic regression. Main outcome measures Early neonatal deaths, stillbirths, Apgar
scores, arterial cord pH, Erb’s paralysis, respirator treatment, the proportion of post-term deliveries (gestational age beyond 42 weeks) and the proportion of newborns still hospitalised 7 days after delivery.
Results From an analysis of term, singleton non-university deliveries, the early neonatal mortality was significantly higher in the small relative to the mid-sized delivery units [odds ratio (OR), 2.07; 95% confidence interval (CI), 1.19–3.60]. The rate of Erb’s paralysis was lowest in the large units (OR, 0.65; 95% CI, 0.50– 0.84). The use of a respirator was more than two-fold more common in large relative to mid-sized units (OR, 2.38; 95% CI, 2.00–2.83). The proportion of post-term deliveries was highest in the large units (OR, 1.36; 95% CI, 1.31–1.42), where a significantly higher percentage of post-term newborns were still hospitalised after 7 days (OR, 1.50; 95% CI, 1.19–1.89). Conclusions There are significant differences in several neonatal
indicators dependent on the hospital size. An international consensus is needed on which indicators should be used. Keywords Neonatology, obstetrics, patient safety indicator.
Please cite this paper as: Pyykönen A, Gissler M, Jakobsson M, Petäjä J, Tapper A-M. Determining obstetric patient safety indicators: the differences in neonatal outcome measures between different-sized delivery units. BJOG 2014;121:430–437.
Introduction The identification and definition of reliable, nationally and internationally useful quality measures in obstetrics have remained great challenges.1 This has not been caused solely by a lack of interest or investigation on the topic – there have been a few comprehensive, mostly American, papers addressing the issue,1–3 and it has been shown that the implementation of an obstetric patient safety programme is likely to decrease the incidence of adverse outcomes.2,4 Despite this, an international consensus on recommended indicators is still lacking. The first and most fortunate problem within obstetric patient safety measures is that adverse outcomes are rare.
430
Second, process measures are not as clearly and easily reported as outcome measures, and they are less likely to engage public attention because of the inclusion of several intermediate steps rather than easy-to-understand outcomes. The traditional, widely recommended patient safety indicators in the field of obstetrics include three outcome measures: obstetric trauma with and without instrument and birth trauma – injury to the neonate.3,5,6 In our previous paper,7 we studied maternal outcome (obstetric trauma) as a patient safety indicator, whereas the aim of this study was to focus on perinatal measures. In previous publications, a variety of neonatal outcomes, as well as process measures, have been studied with different conclusions with regard to their usability. In addition
ª 2013 Royal College of Obstetricians and Gynaecologists
Neonatal outcome measures as patient safety indicators
to birth trauma, the main indicators used have included stillbirths,8,9 early and late neonatal deaths,9 low Apgar score,8–10 low arterial cord pH8 or standard base excess,10 admittance to a neonatal intensive care unit (NICU)8 and a set of different maternal and neonatal indicators merged into an adverse outcome index (AOI).2 With the highly reliable Finnish Medical Birth Register (MBR),11 many of these indicators are easily accessible and can be readily used to analyse patient safety nationwide or, for example, within healthcare districts or between different hospitals. This would be useful in tracking the trends in quality of care and would probably result in a decreased incidence of adverse outcomes. The aim of this study was to report the current situation in Finland among the low-risk population by studying the differences between different-sized delivery units using an ample set of different neonatal outcome and process measures, and to analyse their utility as patient safety indicators within obstetrics and neonatology.
Methods All hospital births (n = 2 94 726) between the years 2006 and 2010 in Finland were included in the study. However, we focused our analyses on a low-risk population, which we considered to comprise term, singleton deliveries with a gestational age (GA) of 37 weeks or more taking place in non-university clinics (n = 1 80 368). Because of the very well-implemented centralisation in Finland, e.g. 85% of the significantly preterm (GA < 32 weeks) newborns are born in university clinics, we could exclude most of the high-risk pregnancies and eliminate the confounding factor of the superior neonatological responsiveness in university clinics by leaving them out of our main analyses. In addition, we performed separate analyses for deliveries with a GA of 42 weeks or more (n = 15 020) and also analysed the proportion of these significantly post-term deliveries, because they are known to be associated with higher neonatal mortality and complication rates.12,13 We analysed several different adverse neonatal outcome and process measures, and compared the outcome rates between different-sized delivery units. The studied indicators (Table 1) were chosen on the basis of previous publications2,8–10,14 and on preliminary analyses of the availability of register data needed for the indicators and their feasibility in Finland. Admittance to an NICU was left out because, with this specific parameter, there are known differences in terminology and reporting between hospital districts, which would have confounded the results excessively. Instead, we included respirator treatment and the proportion of newborns still hospitalised 7 days after delivery as process measures because of their clear definitions.
ª 2013 Royal College of Obstetricians and Gynaecologists
Table 1. Studied indicators Outcome measures Perinatal mortality* Neonatal mortality* Early neonatal mortality* Stillbirths (per 1000 live births) Apgar below 4 and 7 at 5 minutes pH below 6.95, 7.00, 7.05 and 7.10 Birthweight more than 4500 g Erb’s paralysis** Fracture of clavicula** Birth trauma***
Process measures Respirator treatment The number of newborns still hospitalised 7 days after delivery
*Perinatal mortality was defined as the number of stillbirths and deaths in the first week of life per 1000 births, early neonatal mortality as the number of deaths in the first week of life per 1000 live births and neonatal mortality as the number of deaths during the first 28 days of life per 1000 live births (World Health Organization, 2006). In Finland, the stillbirth rate is calculated from 22 weeks onwards. **Discharges with International Classification of Diseases, Tenth Revision (ICD-10) codes for Erb’s paralysis (P14) and fracture of the clavicula (P13.4). ***Discharges with ICD-10 codes for birth trauma (P10–15) and intraventricular nontraumatic haemorrhage (P52), including all deliveries with a newborn weighing more than 2000 g [modified from the Agency for Healthcare Research and Quality (AHRQ) definition].
The officially recommended patient safety indicator, birth trauma, consists of a set of different diagnose codes, and there are significant differences between the definitions for the indicator.5,15 In addition, all definitions are based on the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes16 not widely used in Europe. Therefore, we decided to use the rate of Erb’s paralysis and fracture of the clavicula as birth trauma measures. In addition, we modified a separate birth trauma indicator adapted from the Agency for Healthcare Research and Quality’s latest definition15 using International Classification of Diseases, Tenth Revision (ICD-10) codes.17 According to the latest definition, we performed the analysis including all newborns with a birthweight of 2000 g or more. All 34 delivery units were grouped into six categories according to the number of total annual deliveries (Table 2) and the rates for all measures listed in Table 1 were analysed for each size category. The comparisons were then performed between the small (
DOI: 10.1111/1471-0528.12507 www.bjog.org
Determining obstetric patient safety indicators: the differences in neonatal outcome measures between different-sized delivery units A Pyyko¨nen,a M Gissler,b,c M Jakobsson,a J Peta¨ja¨,d A-M Tapperd a
Department of Obstetrics and Gynaecology, Helsinki University Hospital, Helsinki, Finland b THL National Institute for Health and Welfare, Helsinki, Finland c Nordic School of Public Health, Gothenburg, Sweden d Department of Gynecology and Pediatrics, Helsinki University Central Hospital, Helsinki, Finland Correspondence: Dr A Pyykönen, c/o Dr A-M Tapper, Department of Obstetrics and Gynaecology, Helsinki University Central Hospital, PO Box 140, FI-00029 HUS, Finland. Email [email protected] Accepted 13 August 2013. Published Online 3 December 2013.
Objective To study the differences in neonatal outcome and
treatment measures in Finnish obstetric units. Design A registry study with Medical Birth Register data. Setting and population All births (n = 2 94 726) in Finland from
2006 to 2010 with a focus on term, singleton non-university deliveries. Methods All 34 delivery units were grouped into small (below
1000), mid-sized (1000–2999) and large (3000 or more) units, and the adverse outcome rates in neonates were compared using logistic regression. Main outcome measures Early neonatal deaths, stillbirths, Apgar
scores, arterial cord pH, Erb’s paralysis, respirator treatment, the proportion of post-term deliveries (gestational age beyond 42 weeks) and the proportion of newborns still hospitalised 7 days after delivery.
Results From an analysis of term, singleton non-university deliveries, the early neonatal mortality was significantly higher in the small relative to the mid-sized delivery units [odds ratio (OR), 2.07; 95% confidence interval (CI), 1.19–3.60]. The rate of Erb’s paralysis was lowest in the large units (OR, 0.65; 95% CI, 0.50– 0.84). The use of a respirator was more than two-fold more common in large relative to mid-sized units (OR, 2.38; 95% CI, 2.00–2.83). The proportion of post-term deliveries was highest in the large units (OR, 1.36; 95% CI, 1.31–1.42), where a significantly higher percentage of post-term newborns were still hospitalised after 7 days (OR, 1.50; 95% CI, 1.19–1.89). Conclusions There are significant differences in several neonatal
indicators dependent on the hospital size. An international consensus is needed on which indicators should be used. Keywords Neonatology, obstetrics, patient safety indicator.
Please cite this paper as: Pyykönen A, Gissler M, Jakobsson M, Petäjä J, Tapper A-M. Determining obstetric patient safety indicators: the differences in neonatal outcome measures between different-sized delivery units. BJOG 2014;121:430–437.
Introduction The identification and definition of reliable, nationally and internationally useful quality measures in obstetrics have remained great challenges.1 This has not been caused solely by a lack of interest or investigation on the topic – there have been a few comprehensive, mostly American, papers addressing the issue,1–3 and it has been shown that the implementation of an obstetric patient safety programme is likely to decrease the incidence of adverse outcomes.2,4 Despite this, an international consensus on recommended indicators is still lacking. The first and most fortunate problem within obstetric patient safety measures is that adverse outcomes are rare.
430
Second, process measures are not as clearly and easily reported as outcome measures, and they are less likely to engage public attention because of the inclusion of several intermediate steps rather than easy-to-understand outcomes. The traditional, widely recommended patient safety indicators in the field of obstetrics include three outcome measures: obstetric trauma with and without instrument and birth trauma – injury to the neonate.3,5,6 In our previous paper,7 we studied maternal outcome (obstetric trauma) as a patient safety indicator, whereas the aim of this study was to focus on perinatal measures. In previous publications, a variety of neonatal outcomes, as well as process measures, have been studied with different conclusions with regard to their usability. In addition
ª 2013 Royal College of Obstetricians and Gynaecologists
Neonatal outcome measures as patient safety indicators
to birth trauma, the main indicators used have included stillbirths,8,9 early and late neonatal deaths,9 low Apgar score,8–10 low arterial cord pH8 or standard base excess,10 admittance to a neonatal intensive care unit (NICU)8 and a set of different maternal and neonatal indicators merged into an adverse outcome index (AOI).2 With the highly reliable Finnish Medical Birth Register (MBR),11 many of these indicators are easily accessible and can be readily used to analyse patient safety nationwide or, for example, within healthcare districts or between different hospitals. This would be useful in tracking the trends in quality of care and would probably result in a decreased incidence of adverse outcomes. The aim of this study was to report the current situation in Finland among the low-risk population by studying the differences between different-sized delivery units using an ample set of different neonatal outcome and process measures, and to analyse their utility as patient safety indicators within obstetrics and neonatology.
Methods All hospital births (n = 2 94 726) between the years 2006 and 2010 in Finland were included in the study. However, we focused our analyses on a low-risk population, which we considered to comprise term, singleton deliveries with a gestational age (GA) of 37 weeks or more taking place in non-university clinics (n = 1 80 368). Because of the very well-implemented centralisation in Finland, e.g. 85% of the significantly preterm (GA < 32 weeks) newborns are born in university clinics, we could exclude most of the high-risk pregnancies and eliminate the confounding factor of the superior neonatological responsiveness in university clinics by leaving them out of our main analyses. In addition, we performed separate analyses for deliveries with a GA of 42 weeks or more (n = 15 020) and also analysed the proportion of these significantly post-term deliveries, because they are known to be associated with higher neonatal mortality and complication rates.12,13 We analysed several different adverse neonatal outcome and process measures, and compared the outcome rates between different-sized delivery units. The studied indicators (Table 1) were chosen on the basis of previous publications2,8–10,14 and on preliminary analyses of the availability of register data needed for the indicators and their feasibility in Finland. Admittance to an NICU was left out because, with this specific parameter, there are known differences in terminology and reporting between hospital districts, which would have confounded the results excessively. Instead, we included respirator treatment and the proportion of newborns still hospitalised 7 days after delivery as process measures because of their clear definitions.
ª 2013 Royal College of Obstetricians and Gynaecologists
Table 1. Studied indicators Outcome measures Perinatal mortality* Neonatal mortality* Early neonatal mortality* Stillbirths (per 1000 live births) Apgar below 4 and 7 at 5 minutes pH below 6.95, 7.00, 7.05 and 7.10 Birthweight more than 4500 g Erb’s paralysis** Fracture of clavicula** Birth trauma***
Process measures Respirator treatment The number of newborns still hospitalised 7 days after delivery
*Perinatal mortality was defined as the number of stillbirths and deaths in the first week of life per 1000 births, early neonatal mortality as the number of deaths in the first week of life per 1000 live births and neonatal mortality as the number of deaths during the first 28 days of life per 1000 live births (World Health Organization, 2006). In Finland, the stillbirth rate is calculated from 22 weeks onwards. **Discharges with International Classification of Diseases, Tenth Revision (ICD-10) codes for Erb’s paralysis (P14) and fracture of the clavicula (P13.4). ***Discharges with ICD-10 codes for birth trauma (P10–15) and intraventricular nontraumatic haemorrhage (P52), including all deliveries with a newborn weighing more than 2000 g [modified from the Agency for Healthcare Research and Quality (AHRQ) definition].
The officially recommended patient safety indicator, birth trauma, consists of a set of different diagnose codes, and there are significant differences between the definitions for the indicator.5,15 In addition, all definitions are based on the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes16 not widely used in Europe. Therefore, we decided to use the rate of Erb’s paralysis and fracture of the clavicula as birth trauma measures. In addition, we modified a separate birth trauma indicator adapted from the Agency for Healthcare Research and Quality’s latest definition15 using International Classification of Diseases, Tenth Revision (ICD-10) codes.17 According to the latest definition, we performed the analysis including all newborns with a birthweight of 2000 g or more. All 34 delivery units were grouped into six categories according to the number of total annual deliveries (Table 2) and the rates for all measures listed in Table 1 were analysed for each size category. The comparisons were then performed between the small (
