Safety Assessment Immunization In Pregnancy

Safety Assessment Immunization In Pregnancy

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Safety Assessment Immunization In Pregnancy

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Safety Assessment Immunization In Pregnancy

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Discuss About The Safety Assessment Immunization In Pregnancy.


Purpose of the study was clearly mentioned in the later part of the introduction and background section. Authors arrived to the research question or purpose of the study after performing detailed literature survey. Literature mentioned that parents views on their children’s vaccination were not explored in an efficient manner. Hence, purpose of this study was to explore the perceptions of parents on their child’s vaccination in Singapore to identify gaps in current healthcare practice and therefore help develop future programmes to improve parents’ experiences regarding their children’s vaccination (Kurup et al., 2017).
Relevance to nursing/midwifery practice

Explain how this question was relevant to nursing/midwifery practice.

Nurse need to interact with parents for effective and timely immunization of the children. Through communication, nurse can improve parent’s perception towards positive side. It can be helpful in improving adherence of parents for their children’s immunization. Nurse can improve parent’s knowledge about immunization. They can also help parents to reduce their anxiety during painful injection to their children (Holland, 2014).

What were the possible risks of participating in the study?

Risk identified for the participation of parents in the study were negative perceptions of parents about impact of immunization on child’s growth, issues while immunization process, previous negative experience in immunization and religious beliefs
 (Kurup et al., 2017).

Were these risks clearly identified by the authors?   

If risks were identified by the authors, how did they propose to minimise risk?

Did the authors state that they had approval from an ethics committee to undertake the study?

How did the authors obtain informed consent from participants?

Participants were asked to give written consent for voluntary participation and confidentiality of data. Prior taking individual written consent from the participants, information was provided to the participants both through verbally and in written format (Kurup et al., 2017).

Did you identify and potential risks associated with the study that were not identified by the authors and if so, what were they?

There were no identified potential risks other than identified by the author.
Study Methodology

What the chosen methodology for this study?

In this study, descriptive qualitative method was implemented. These types of studies can be useful in demonstrating health-care and nursing related phenomenon. More insight of the poorly understood phenomenon can be obtained from the qualitative research designs (Gray et al., 2013). Information in the form of description and interviews or questionnaires can be obtained from the descriptive qualitative analysis. Thematic analysis is the preferred method of analysis for descriptive qualitative research method. In the present study also, thematic analysis method was being used. It is evident that, there is overlap between the thematic and content analysis; hence there not should be any confusion when employing these two methods of analysis (Chesnay, 2014).

Was this choice suitable for the given research problem/question?                                           

Explain your response to (b):

Complete summary of perceptions of people with respect to specific phenomenon can be demonstrated in qualitative research methods. Observation and interviews can be used to obtain information related to participants experience. In this, study perceptions of parents about their children’s immunization need to be collected. This information was collected from the parents through personal and telephonic interviews. By using this research methodology, information related to parents perceptions can be collected; hence implemented research methodology is fit for this research study (Morris, 2015; Bell, 2014).  
Data Collection/Rigour

Describe how the data was collected for this study (interview, observation, etc).

Interview using interview guide, surveys, observations and field notes can be used for data collection in descriptive qualitative studies. Interview using interview guide was used for data collection in this study. Appropriateness and applicability of the interview and interview guide were approved after conducting pilot study. Interviews can be asked in both structured and semi-structured format in which closed and open questions can be asked respectively. Closed and open questions can be used to obtain both fixed and variable information respectively. In qualitative research, these structured and semi-structured interviews proved effective (Fisher, 2011). Semi-structured interview was conducted in this study. Both face-to-face and telephone interviews were being conducted in this study and duration of each interview was around 10-30 minutes. Audio-records were made for these interviews. Audio-records of these interviews can be used to demonstrate more insight of interview process, accurate assessment and monitoring of the interview process. These audio-records can be achieved and these can be used as reference for future use. Sampling is very important aspect in interview based qualitative research because outcome of the study depends on the experience and expression of feelings of participants. Interview questions should fit to the aim of the study and overall outcome of the study based on interview questions. Interview guide used in the study should be considered as valid because it was framed based on the literature survey and by taking opinion of two experts. Details of the experts should have been mentioned in this study; however this information was mentioned in this study (Morris, 2015; Erlingsson & Brysiewicz, 2013).  
Information collected during interview-based data collection can be considered as accurate data because participants can not lie about their age and gender. Both verbal and non-verbal ques from the participants can be collected in the interview based qualitative research. This type of data collection can be helpful in assessing extent of knowledge, emotions, behaviour and comfort level of participants in expressing their perceptions. There would not be any distraction in interview process; hence precise and detailed data can be collected (Levickis, 2013).

Did the researchers provide the participants with the opportunity to check the collected dataor research findings? No

Did the researchers continue recruiting people to the study until data saturation was reached?

Did the study use multiple data collection methods (eg collect data from more than one source)?                                      No
Explain how the points in (b), (c) and (d) contribute to the trustworthiness of the overall research findings.

Participants should not be allowed to check the data. Biasness can be reduced and rigour can be improved for the collected data by blinding participants for the collected data. Inclusion and exclusion criteria were considered for the recruitment of the participants at the start of the study (Isaacs, 2014). Participants were recruited until saturation of the data. It indicates that new data was not collected. Hence, collected data was valid and it can improve trustworthiness of the study. Biasness can be reduced by collecting data by the experts in the field and blinding of the researchers for the participants. In this study also, data was collected by senior researcher who was not participated in the study. One researcher was involved in the data collection; hence inconsistency in the data was reduced. Trustworthiness of the findings were incorporated by considering all these aspects (Fisher, 2011).

How many participants were included in the study?

22 participants were recruited and data was collected for 19 participants. One participant was used for pilot study and two participants were withdrawn from the study.  Number of participants were mentioned in the data collection section of the article. It could have been mentioned in the sampling or methodology section of the article.

What were the inclusion and exclusion criteria?

Incorporation of inclusion and exclusion criteria can be helpful in the defining sample universe and also decision making in sample selection can be improved. It can also be useful in reducing variability of data; hence robust and valid outcome can be obtained. The inclusion criteria included a parent who: (i) had a healthy child aged 0–18 months undergoing vaccination, (ii) was the main caregiver of the child and (iii) was able to speak and read English. The exclusion criteria were parents who had: (i) visual and/or hearing impairments and/or (ii) cognitive impairment (Kurup et al., 2017).

Explain how the participants were recruited.

Participants were recruited through purposive sampling method. These participants would have specific purpose. In this study, purpose of the participants was to verbalize their perceptions about their children’s immunization. Recruited participants were from the different ethnic groups. These participants were recruited by considering inclusion and exclusion criteria.  
In this study, purposive sampling method was used for the recruitment of the participants. In this purposive sampling method, recruited participants would be specific purpose. In this study, participants whose children would receive immunization and these participants would express their perception. These participants were recruited from different ethnic groups. Inclusion and exclusion criteria were considered prior to recruitment of participants. Participants recruitment was done in the stepwise manner with inclusion of 44 participants in the initial phase. Out of these, 22 participants were eliminated because 16 were not willing to take part in the study and 6 didn’t fulfil inclusion criteria. Hence, 22 participants were recruited and data was collected for 19 participants (Kurup et al., 2017).

Describe the setting in which the study took place (hospital, community, etc).

Place for immunization was immunization clinic in Singapore. School going children used to take vaccines in this clinic.
Research Findings (outcomes)

What were the main findings of this study? (provide a dot point summary)

Many of the participants adhered to the recommended vaccination schedule. These participants also followed optional vaccination schedule.
There was trust and confidence of parents on Government and healthcare sector on immunization policies and procedures. It helped in delivering standard practices of delivery of immunization. Parents exhibited their positive opinion on immunization. Parents were thinking that immunization can prevent children from the community disease. Participants also mentioned that vaccines can make available at affordable prices, these are easily available and these are available with relevant subsidies.
Many of the participants stated that fear of probable revaccination makes them to adhere to vaccination. They also stared that they have fear of probable adverse effects as a result of non-adherence to immunization.
Some of the parents stated negative aspects of vaccination. These participants were late for immunization and they didn’t followed optional vaccination. Reasons for delay in vaccination are probable allergy, fever, pain and crying in the children. Reasons mentioned for non-adherence to vaccination are negative influence of vaccines on child’s growth, concerns related to immunization, past negative understanding about immunization and religious belief.
Some participants mentioned that they were not adhering to immunization because of scheduling constraints. It was difficult for them to maintain balance between work and immunization schedule.
Non-availability of vaccines and disease with less severity were reasons responsible for circumventing optional vaccination.  
Participants were also assisted during immunization procedure. They handled child and observed immunization procedure.
Distraction techniques were used for reducing pain and crying.
Waiting time was mentioned as the drawback for non-adherence for immunization and waiting time was reduced by using instant messaging.
All the participants didn’t have same level of knowledge related to immunization. Some of the participants were with enough knowledge and others were with less knowledge about immunization.
Some of the participants exhibited satisfaction with services and knowledge of nurses related to immunization. Other participants didn’t exhibit satisfaction with services and knowledge of nurses related to immunization (Kurup et al., 2017).
Study limitations

What were the limitations of this study stated by the author/s?

Generalized applicability of the results was not possible because this study was conducted at single site. Information from the Non – English speaking parents was not collected. In this study, parents of children between 0 – 18 months were recruited. Information was not collected for the parents those who delayed vaccination for their children for more than 18 months (Kurup et al., 2017).

Explain why these are study limitations.

This study can not be considered as evidence based study because this study was conducted on small number of population and at single site. Outcome of this study can not be extrapolated to parents in low-socioeconomic class and less educated parents (Harreveld, 2016)

Did the researchers disclose any personal ideas, experiences or knowledge (bias) that might influence the conduct and outcomes of the study?                                                                           No
Explain why personal ideas, experiences or knowledge (bias) may reduce the validity of the study

Results of study can be influenced by personal ideas and experiences or knowledge (bias). In qualitative study, subjective data used to be collected. Personal ideas and experiences or knowledge (bias) can impact data collection and data analysis in case of subjective data. To eliminate this bias, data need to be blinded or coded. Bias can produce reduced transparency in outcome of the study. Overall, validity of the study gets reduced (Smith and Noble, 2014).
Applicability to clinical practice

According to the Levels of Evidence pyramid, what level of evidence are the reported results from this paper?

According to levels of Evidence pyramid, reported results in the paper are of level VI.

Overall, should the outcomes of this study be used to inform evidence-based practice?                 

Explain your rationale for your responses to questions (a) and (b).

In this study, a phenomenon was systematically assessed, and efforts were to identify exploration of the phenomenon. Main aim of these types of studies were to understand and describe human experience. This type of data collection can provide meaning and pattern of phenomenon. Hence, this type of data collection can be considered as narrative data. This narrative information can be considered as level 6 evidence. Hence, evidence of this study can be considered as level 6 evidence. Outcome of this study cannot be used as evidence-based because in this study number of participants were less and this study was conducted at single healthcare facility. Repeated and rigorous data collection need to be there for consideration as evidence-based research. However, in this rigorous and repeated data was not collected. Study can be considered as evidence-based, if rigour and biasness of the study is being mentioned in the study. Research question in the evidence-based research should be designed based on the evidence-based research. However, in this study research question was not designed based on the evidence-based research. Level of evidence should be in the top level for consideration as evidence-based research. However, in this study research evidence of level VI based on the evidence pyramid. Assessment of effectiveness of evidence need to be carried out for generating valid data. However, in this study, assessment of evidence was not carried out.  Contradictory and incomplete evidence cannot be considered as evidence-based practice. In this study also, incomplete and contradictory information is provided. Perceptions of the parents are mentioned in both positive and negative manner. It reflects this data is more of narrative nature. Hence, finding solutions of the identified perceptions is not possible. This type of data collection is inadequate and uninterpretable. Hence, it is difficult to make conclusion. This data cannot be considered as evidence-based data because this data was not compared to other evidence-based studies. Comparison of the studies with the previously conducted evidence-based studies can be considered as studies with  valid studies. However, rigour and biasness of this study were not discussed properly in this study (Dean et al., 2016).  
I was well aware of vaccination safety in children and pregnant women. Needle prick during immunization can produce painful events in children which can lead to anxiety, distress and fear in children and their parents. Parental nonadherence, deficient knowledge and evasion of medical care lead to these events. Pain management and anxiety control can reduce needle fear and phobia, scheduled immunizations, and later avoidance of medical care (Faucette et al., 2015).
There are variable sources available like internet sources, clinical online databases, professional organisations for clinical data collection. Discussion with colleagues is the most effective way of gathering information and it was used effectively for collection of information. Through these discussions, analysis and interpretation of the patient condition can be done. Information collected through discussion with colleagues helped me to improve my decision-making capability and improving confidence in immunization. Medical textbooks were used effectively for collecting information related to immunization. Information collected through medical textbooks comprises of benefits of immunization, adherence to immunization, parent’s perceptions and barriers to immunization. There is availability of different databases like Pubmed, PsycINFO, Web of Science, or CINAHL for the collection of information and these databases were used for collection of information. Disease registers belonging to hospitals, epidemiological and clinical health surveys and clinical trials were used for the collecting information about child immunization (Liu et al., 2013).
Pregnant women are highly susceptible for changes in their immune system. Vaccine preventable infections can occur in women due to changes in the immune system. Vaccine preventable infections can be protected through immunization and during this foetus also get protected. Definite antibody transmitted from mother to foetus through immunization can protect foetus and infant (Marshall et al., 2016). In my opinion, safety of vaccines should not be questioned because several efficacy and safety tests are being carried out prior to marketing of these vaccines. However, it can be argued that immunization in children can produce redness, pain, or swelling. At the same time, it should be noted that these reactions are minor and these can disappear in short time. I have a strong belief that vaccines are safe and effective because since long time millions of people are getting benefited due to vaccines (Kochhar et al., 2017).
I understood that procedure of vaccine administration can produce pain in children and few of the minor adverse reactions. These disadvantages of vaccines can be easily managed. As compared to broader advantages of it, these disadvantages should be considered significantly. Nurse and parents need to play significant role in immunization of the children. Nurse should understand perceptions of the parents about immunization, hence it can be helpful in improving adherence of parents to the immunization. Several clinical trials were conducted for the safety and efficacy of the vaccines; hence, these should be considered as safe in children and pregnant women (Jones et al., 2016)
Bell E, 2014, Rethinking quality in qualitative research. Australian Journal of Rural Health, 22(3), pp. 90-1.
Chesnay MD, 2014, Qualitative Designs and Methods in Nursing. Springer Publishing Company.
Dean W, Sophie D, Isabel H, 2016, Common qualitative methods. In Z. Schneider, D. Whitehead, G. LoBiondo-Wood & J. Haber (Eds.), Nursing and midwifery research: Methods and appraisal for evidence based practice (5th ed., pp. 93 – 109). Chastwood : Elsevier Australia.
Erlingsson C, Brysiewicz P, 2013, Orientation among multiple truths : An introduction to qualitative research. African Journal of Emergency Medicine, 3(2), pp. 92 – 99.
Faucette AN, Pawlitz MD, Pei B, Yao F, Chen K, 2015, Immunization of pregnant women: future of early infant protection. Human Vaccines & Immunotherapeutics,  11, pp. 2549–2555.
Fisher K, 2011, The qualitative interview and challenges for clinicians undertaking research: a personal reflection. Australian Journal of Primary Health, 17(1), .pp. 102-6.
Gray JR, Grove SK, Burns N, 2013, The Practice of Nursing Research – E-Book: Appraisal, Synthesis, and Generation of Evidence. Elsevier Health Sciences.
Harreveld B, Danaher M, Celeste L, Knight BA, Busch G, 2016, Constructing Methodology for Qualitative Research: Researching Education and Social Practice. Springer.
Holland WG, 2014, Nurses as primary advocates for immunization adherence. American Journal of Maternal Child Nursing, 39(6), pp. 351-6.
Isaacs A, 2014,  An overview of qualitative research methodology for public health researchers. International Journal of Medicine and Public Health, 4(4),  p. 318.
Jones CE, Munoz FM, Kochhar S, Vergnano S, Cutland CL, Steinhoff M, 2016, Guidance for the collection of case report form variables to assess safety in clinical trials of vaccines in pregnancy. Vaccine, 34, pp. 6007–6014.
Kochhar S, Bauwens J, Bonhoeffer J, 2017, Safety assessment of immunization in pregnancy. Vaccine, 35(48), pp. 6469–6471.
Kurup L, He HG, Wang X, Wang W, Shorey S, 2017, A descriptive qualitative study of perceptions of parents on their child’s vaccination.  Journal of Clinical Nursing, 26(23-24), pp. 4857-4867.
Levickis P, Naughton G, Gerner B, Gibbons K, 2013, Why families choose not to participate in research: feedback from non-responders. Journal of Paediatrics and Child Health, 49(1),  pp. 7-62.
Liu H, Bielinski SJ, Sohn S, Murphy S, Wagholikar KB, Jonnalagadda SR, Ravikumar KE, Wu ST, Kullo IJ, Chute CG, 2013, An information extraction framework for cohort identification using electronic health records. AMIA Jt Summits Translational Science Proceedings, pp. 149-53.
Marshall H, McMillan M, Andrews RM, Macartney K, Edwards K, 2016, Vaccines in pregnancy: the dual benefit for pregnant women and infants. Human Vaccines & Imm
Morris A, 2015, A Practical Introduction to In-depth Interviewing. SAGE.
Smith J, Noble H, 2014, Bias in research. Evidence-Based Nursing, 17, pp. 2–3.

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