The Centre for Pediatric Pain Research at IWK Health Centre, Halifax, Canada, recently met to discuss the study by Diana Lisi of York University, Toronto, Canada, and colleagues examining parental pain management during immunizations throughout the first year of life. These observations occurred within the naturalistic setting of community pediatric clinics and thereby offer insight into the naturally occurring strategies used by parents to manage their infants’ pain during immunizations. The study particularly focuses on the non-pharmacological techniques used by parents immediately before and after immunizations, as well as infants’ distress throughout this time.
Below, we [Ayala Gorodzinsky and Line Caes] provide a brief synopsis of the study objectives, methods, and results, as well as discussion of a letter to the editor from Denise Harrison of Children’s Hospital of Eastern Ontario Research Institute and the University of Ottawa, Canada, and a reply by Rebecca Pillai Riddell of York University, corresponding author of the study—including key points arising from our journal club discussion.
The main focus of our journal club discussion was on the ethical considerations of clinical researchers when conducting naturalistic observational research.
Lisi D, Campbell L, Pillai Riddell R, Garfield H, Greenberg S
Pain 2013 Aug;154(8):1245-53. Epub 2013 Apr 13.
Pain. 2013 Aug;154(8):1481-2. Epub 2013 Apr 6.
Pillai Riddell R.
Pain. 2013 Sep;154(9):1896-7. Epub 2013 May 24.
Journal club participants: Stephanie Allen, Kristen Bailey, Kathryn Birnie, Katelynn Boerner, Christine Chambers, Jill Chorney, Katharine Filbert, Allen Finley, Rebecca Haworth, Melissa Howlett, Anna Huguet, Kailyn Jones, Margot Latimer, Meghan Schinkel, Jennifer Parker
Synopsis of paper and discussion written by: Ayala Gorodzinsky and Line Caes
Study objectives and methods
Parent-infant pairs from a community-based sample recruited between 2007 and 2012 were observed during the immunization process at the infants’ two-, four-, six-, and 12-month immunizations. A total of 760 pairs were recruited, with 256 followed at all four time points. Infant pain-related distress was coded using the Neonatal Facial Coding System at four time periods throughout the immunization process. Parent soothing behaviors were coded using the Measure of Adult and Infant Soothing and Distress (MAISD) at three time periods.
The study had two objectives: 1) to present descriptive information about pain management techniques used by parents during their infants’ first year of immunizations, and 2) to assess the relationship between pain management techniques utilized by parents and infant pain-related distress. Though it is clear in the literature that pharmacological techniques can help alleviate pain associated with immunizations, most parents in this study did not utilize pharmacological techniques to manage immunization pain. Therefore, the study focused on non-pharmacological techniques.
Results from the study
It was observed that, across all age groups and all time periods in the immunization process, the most frequently used parent soothing behaviors were physical comfort, rocking, and verbal reassurance (used between 18 and 47 percent of the time). Overall, across all age groups parent soothing behaviors were minimally associated with infant pain-related distress. Specifically, the most variance accounted for by parent soothing behaviors was observed in infants’ pain-related distress at baseline (i.e., prior to any injections). Pacifying and distraction were related to decreased pain-related distress at two and six months of age, respectively. However, most of the parent soothing behaviors were related to increased infant distress. The authors appropriately indicate that it is not possible to infer directionality of the correlations found in the study, as there is likely a cyclical nature to infant distress and parent soothing behaviors. In addition, they note that it is possible that the immunization experience is so distressing that the parent-infant connection is disrupted and the infants are more difficult to soothe than in most other situations. The results from this study indicate that many naturally occurring parental soothing behaviors during infant immunization are not actually reducing infant distress.
Letter to the editor by D.M. Harrison
In response to the paper by Lisi et al., Denise Harrison wrote a letter to the editor addressing the potential ethical conflict of the naturalistic method used for the study. Specifically, she indicated concern about not providing infants with pain management techniques that have been found to be effective during infant immunization. She noted that while this study began prior to the availability of the synthesized evidence supporting these techniques (i.e., breastfeeding, distraction, sucrose, and topical anesthetics), the authors should have been more cognizant to modify the research protocol following the availability of the literature. Dr. Harrison wrote that healthcare professionals, including researchers, “have a duty to do no harm,” which includes providing effective pain management when it is available.
During our journal club discussion, the majority of the time was spent on discussing the issues raised by Dr. Harrison. Many individuals expressed an appreciation for Dr. Harrison’s comments, viewing them as a “wake-up call” for ensuring that ethical standards of clinical care are being incorporated into research. Our discussion focused on the responsibility of researchers with respect to the rate of dissemination of effective pain management techniques to healthcare providers.
Dr. Harrison appropriately noted that during the study’s progress, literature was growing regarding effective pain management during infant immunization. However, it takes time for research to reach primary care providers, and for them to integrate that knowledge into their practice. It would be of interest to know how the literature regarding pain management techniques during infant immunizations changed healthcare providers’ pain management recommendations to parents over the course of the study. It is possible that if the authors divided their sample by year, trends might appear in parents’ behaviors, assuming healthcare providers changed their recommendations after the research became available in 2009-2011.
This leads directly to the second area of discussion that took place during our journal club meeting, which was how to define researchers’ role within clinical settings. Ethics codes indicate that as researchers we cannot impose risks to participants over and above what they would experience in their natural, everyday environment. If we use these guidelines, we believe that the method of naturalistic observation used in this study was appropriate. It was discussed by participants in our journal club that it might not be the researchers’ role to change primary care practice, and that the infants in this study were experiencing what infants experience in their natural environment of primary care while receiving immunizations. A lot of discussion in our journal club arose around the responsibility or role of researchers with respect to changing the standard of care while conducting a study. While there are strict guidelines with respect to this issue when conducting clinical trials, fewer guidelines and standards are available to direct observational studies. Related to this issue, it was also noted that although the evidence was growing with respect to effective pain management techniques while this study was ongoing, the available evidence is not always straightforward, and effect sizes are moderate. Therefore, more in-depth research and observation might be warranted before altering a study protocol, as prematurely ending natural observations could limit our understanding of effective pain management.
Response by Rebecca Pillai Riddell to letter to the editor
In a response to Dr. Harrison’s letter to the editor, Rebecca Pillai Riddell indicated the importance of naturalistic observation, similarly to the comments made by many individuals in our journal club. Though research has identified effective pain management techniques during infant immunizations, there is a need to understand what parents are doing in the community so the discrepancy between the two can be captured and hopefully rectified. Though Dr. Pillai Riddell did not explicitly indicate this in her letter, the original article by Lisi et al. indicated they hope that if researchers can understand how parents are responding to their infants’ pain, then parent and provider education can be effectively implemented to help parents learn about more effective pain management techniques found in research.
Dr. Pillai Riddell also indicated that she is conducting an ongoing study focused on the relationships between pain management during immunizations and long-term outcomes to further understand if there are any negative long-term effects associated with poor pain management during infant immunization. We look forward to reading the results from this study and learning more about the developmental effects of pain during infant immunization.
Editors’ Note: To follow up on their discussion, Gorodzinsky and Caes submitted two questions to the study authors. Responses from corresponding author Rebecca Pillai Riddell appear in a comment, below.
1) Would the authors address the ethical issues with respect to incorporating effective pain management techniques in observational research differently if they were to conduct the same study again?
2) Do the authors have any tips or recommendations on how to address these types of ethical issues in future observational research in clinical contexts?