Article type
Abstract
Background: Newborn infants are frequently admitted to neonatal intensive care units due to illness or prematurity, where they are often subject to numerous painful diagnostic and therapeutic procedures with negative implications on somatosensory processing and neurodevelopment. Although a large variety of neurophysiological tools and pain rating scales are available, their validity is often inconsistent, limiting accurate clinical application. Despite this lack of certainty, these pain scales are used routinely and trusted in clinical practice worldwide.
Objective: To systematically review the literature and to compile and describe the development, content, and measurement properties of clinical rating scales for the assessment of pain in newborn infants.
Methods: This study aimed to evaluate clinical rating scales assessing pain in newborn infants using the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology evaluating content validity, internal consistency, reliability, responsiveness, and feasibility. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the risk of bias, inconsistency, imprecision, and indirectness. Subgroup analyses based on gestational age and birth weight were conducted to explore potential variations in measurement properties.
Results: We included 77 studies involving a total of 7126 infants, 298 nurses, and 12 physicians. Twenty-seven clinical rating scales were employed in 26 countries, with 16 studies focusing on preterm infants, 10 on term infants, and 6 on infants of unspecified ages. Furthermore, 3 studies solely evaluated staff whilst 4 incorporated both staff and infants. Following in-depth methodological assessments, all rating scales were found to be of very low-quality evidence, raising concerns regarding their validity, reliability, and applicability in this vulnerable population in diverse clinical settings. This study was not coproduced.
Conclusions: Clinical staff should remain vigilant and attentive when applying and depending on neonatal rating scales currently implemented in clinical practice. There is necessity for further development of rating scale content and structural validity, as these elements are crucial in selecting appropriate rating scales to accurately assess neonatal pain. It is vital to foster collaborative efforts between clinicians and methodology experts to avoid methodological pitfalls and to ensure the reliability and validity of pain assessment scales in neonatology.
Objective: To systematically review the literature and to compile and describe the development, content, and measurement properties of clinical rating scales for the assessment of pain in newborn infants.
Methods: This study aimed to evaluate clinical rating scales assessing pain in newborn infants using the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology evaluating content validity, internal consistency, reliability, responsiveness, and feasibility. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the risk of bias, inconsistency, imprecision, and indirectness. Subgroup analyses based on gestational age and birth weight were conducted to explore potential variations in measurement properties.
Results: We included 77 studies involving a total of 7126 infants, 298 nurses, and 12 physicians. Twenty-seven clinical rating scales were employed in 26 countries, with 16 studies focusing on preterm infants, 10 on term infants, and 6 on infants of unspecified ages. Furthermore, 3 studies solely evaluated staff whilst 4 incorporated both staff and infants. Following in-depth methodological assessments, all rating scales were found to be of very low-quality evidence, raising concerns regarding their validity, reliability, and applicability in this vulnerable population in diverse clinical settings. This study was not coproduced.
Conclusions: Clinical staff should remain vigilant and attentive when applying and depending on neonatal rating scales currently implemented in clinical practice. There is necessity for further development of rating scale content and structural validity, as these elements are crucial in selecting appropriate rating scales to accurately assess neonatal pain. It is vital to foster collaborative efforts between clinicians and methodology experts to avoid methodological pitfalls and to ensure the reliability and validity of pain assessment scales in neonatology.