The Evidence-Based Nursing (EBN) is defined as “the process by which the nurse makes clinical decision using the best available research evidence, their clinical expertise and patient preferences “. (Kathleen R.Steven, 1999).
Evidence based practice is of importance to nursing as it provides practical clinical guidelines that are proven to produce positive patient outcomes. And, the majority patient care organizations are required to adhere to these best practices in nursing to meet today s stringent industry practice standards. Evidence-based practice also provides opportunities for nursing care to be more individualized, more effective, streamlined, and dynamic, and to maximize effects of clinical judgment. When evidence is used to define best practices rather than to support existing practices, nursing care keeps pace with the latest technological advances and takes advantage of new knowledge developments.(Youngblut J M; Brooten D.2001) .
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The following papers present a sample of EBP simple methodology as one of the requirements for this course. We are one group of RN-BSN program students who works as community health nurses in different health centers. We are interested in studying the effect of administering both oral Rota viruses vaccine and Ora1 Polio vaccine in the same time as the Rota vaccine administration was introduced recently in the immunization schedule in Bahrain and we are administering it to children without knowing whether there is any interference of one on another . And for that purpose we have formulated our PICO question in this way:
Does the administration of Rota vaccine with Polio vaccine interfere with the efficacy of vaccine mechanisms?
Population (P): Infants
Outcome (O): Vaccine Mechanism
Protocol used :
As we are receiving our circulars and procedures from the Directorate of Public Health in Ministry of Health we have received a circular on November 2008 to start administering oral Rotarix (Rotavirus vaccine) together with Polio vaccine for infants aged 2 and 4 months. Furthermore, the circular had specified that oral Rota vaccine is to be given orally at 2 months of age with inject able polio vaccine and to be given orally with oral polio vaccine in the age of 4 months with minimum interval of 4 weeks between doses. Also, there was no evidence listed on the protocol and it’s still not updated. (Index 1)
We’ve interviewed Dr. Jalila who is a member of the public health directorate and specialized on vaccination administration protocols . “I agree with immunization protocol in Bahrain as it is one of the latest schedules recommended by WHO. We have recommended the entrance of Rota virus vaccine in Bahrain as there are several studies supports that. In Weekly epidemiological record of WHO in 9 January 2009 , it was written that In November 2005, SAGE reviewed the clinical trial data on 2 oral live attenuated rotavirus vaccines Rotarix(GlaxoSmithKline) and RotaTeq . In trials in Latin America, Europe and the United States, both vaccines have demonstrated excellent protective efficacy (>85%) against severe rotavirus disease. Ongoing review by GACVS indicated that these vaccines appear safe, with no association with intussusceptions”.
However, SAGE considered that introduction would only be appropriate in regions where successful Phase III efficacy trials had been conducted. SAGE therefore recommended that rotavirus vaccines be included in national immunization programs in countries and regions where data suggested a significant impact of rotavirus infection on public health and where infrastructure and appropriate financing mechanisms were available. .” Dr.Jalila said .(index 2)
In addition she recommended the use of both vaccines together as it is mentioned in the same WHO report that Rotavirus vaccines do not interfere with the immune response to OPV vaccines and vice versa and it is emphasized in the leaflet of Rotarix vaccine that concomitant administration of Rotarix and oral polio vaccine does not affect the immune response to the polio antigen. Although concomitant administration of OPV may slightly reduce the immune response to rotavirus vaccine there is currently no evidence that clinical protection against sever rotavirus gastro enteritis would be affected. The immune response to Rotarix is unaffected when OPV is administered two weeks apart from Rotarix.
To review the literatures available on efficacy and interference of administered oral Rota vaccine and oral polio vaccine we have searched the next engines:
The next tables show the summery of studies we found:
Tool / method used
Sricharoen Migasena, Sriluck Simasathien, Rudiwilai Samakoses, Punnee Pitisuttitham, Preyapan Sangaroon, Gijsbert van Steenis, E. Coen Beuvery, Helen Bugg, Ruth Bishop, Bruce L. Davidson and Timo Vesikari
Simultaneous administration of oral rhesus-human reassortant tetravalent (RRV-TV) rotavirus vaccine and oral poliovirus vaccine (OPV) in Thai infants
Thai infants at 2, 4 and 6 months of age
Sera for rotavirus antibody studies were taken prior to and one month after each vaccination
OPV is likely to interfere with the take of RRV-TV rotavirus vaccine but the interfering effect can largely be compensated for by giving multiple doses of RRV-TV vaccine or, possibly, by using a higher-titre rotavirus vaccine. Interference of RRV-TV vaccine with OPV may not pose a significant problem
Tool / method used
Ciarlet, Max PhD; Sani-Grosso, Ramei BS; Yuan, Guojun MS; Liu, Guanghan F. PhD; Heaton, Penny M. MD; Gottesdiener, Keith M. MD; Arredondo, José L. MD; Schödel, Florian MD
Concomitant Use of the Oral Pentavalent Human-Bovine Reassortant Rotavirus Vaccine and Oral Poliovirus Vaccine
Healthy 6- to 12 week-old Latin American infants
From 2005 to 2006, healthy 6- to 12-week-old Latin American infants were randomized to PRV and OPV concomitantly or PRV 2-4 weeks before OPV. Three doses of each vaccine were administered 8-10 weeks apart. Subjects did not receive OPV at birth. Routine licensed pediatric vaccines were allowed. Antibody responses to PRV and OPV were evaluated 42 days after the last dose of each vaccine. Adverse events were recorded for 14 days after each study visit.
PRV did not interfere with immune responses to OPV. Although co administration with OPV reduced serum antirotavirus IgA geometric mean titer, seroresponse rates were high and consistent with those observed in previous studies showing high vaccine efficacy. These results support including PRV in vaccination schedules involving OPV.
Tool / method used
Ho, Mei-Shang Md; Floyd, R. Louise Dsn; Glass, Roger I. Md; Pallansch, Mark A. Phd; Jones, Betty Rn; Hamby, Beverlie Bs; Woods, Patricla Bs; Penaranda, Maria E. Phd; Kapikian, Albert Z. Md; Bohan, Gunar Md; Wilcox, W. D. Md; Blumberg, Richard Md
Simultaneous administration of rhesus rotavirus vaccine and oral poliovirus vaccine: immunogenicity and reactogenicity
Infants 2 to 3 months of age
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A placebo-controlled randomized trial giving oral rhesus rotavirus vaccine (RRV) (strain MMU 18006) alone and together with a child’s first dose of OPV and diphtheria-tetanus toxoids-pertussis to examine the possible interaction of these vaccines. A total of 102 infants 2 to 3 months of age were randomized into 3 groups to receive (1) RRV with OPV, (2) placebo with OPV and (3) RRV 2 weeks after OPV. All infants were given diphtheria-tetanus toxoids-pertussis. Serum sample were collected at the time of OPV immunization and 3 to 5 weeks later.
The rate of antibody response to poliovirus did not differ by RRV groups but a lower rate was correlated with a shorter interval (3 vs. 5 weeks) between OPV vaccination and antibody measurement. Fifty-six percent of infants had a 4-fold rise of IgA and 62% had a 4-fold rise of neutralizing antibody to RRV; this risc did not differ according to time of OPV immunization. RRV was not associated with side effects and may be safely given with OPV to infants 2 to 3 months of age.
Tool / method used
Steele, , B. De Vos, J. Tumbo, J. Reynders, F. Scholtz, P. Bos, M.C. de Beer, C.F. Van der Merwe and A. Delem
Co-administration study in South African infants of a live-attenuated oral human rotavirus vaccine (RIX4414) and poliovirus vaccines
450 Healthy infants 6-10 and 10-14 weeks of age in South Africa
infants (n = 450) were randomized into three groups (RIX4414 + OPV, RIX4414 + IPV or Placebo + OPV) to receive two oral doses of RIX4414/placebo with OPV or IPV using two vaccination schedules (6-10 weeks and 10-14 weeks). Serum anti-rotavirus IgA antibodies (ELISA) and neutralizing antibodies (micro-neutralization assay) to poliovirus serotypes 1, 2 and 3 were measured.
Co-administration of RIX4414 with OPV did not result in a decrease in the high sero-protection rates against poliovirus serotypes 1, 2 and 3 detected after the third OPV dose (98-100%). The anti-rotavirus IgA antibody sero-conversion rates were higher for the 10-14 weeks schedule (55-61%) compared to the 6-10 weeks schedule (36-43%). Solicited symptoms were reported at similar rates between RIX4414 and placebo groups and no serious adverse events related to RIX4414 were reported. This study provided evidence that RIX4414 can be co-administered with routine EPI immunizations including OPV and that two doses of RIX4414 were well tolerated and immunogenic in South African infants.
Tool / method used
Fehmida Jalil, Shakila Zaman, Barbro Carlsson, Roger I. Glass, Albert Z. Kapikian, Lotta Mellander, Lars Å. Hanson
Immunogenicity and reactogenicity of rhesus rotavirus vaccine given in combination with oral or inactivated poliovirus vaccines and diphtheria-tetanus-pertussis vaccine
infants (6 weeks old) in Lahore, Pakistan
RRV was given to the infants at the same time as diphtheria-tetanus-pertussis (DTP), oral poliovirus vaccine (OPV), or inactivated poliovirus vaccine (IPV). The immune response to RRV was assessed by plaque-reduction neutralization 3 weeks after immunization and serum immunoglobulin (Ig) G and IgA antibody levels to poliovirus type 1 were tested by enzyme-linked immunosorbent assay (ELISA) after polio immunizations
Of the infants in the group given RRV with OPV, 50% had a two- to four-fold rise in neutralization titre against rotavirus, compared with 22% in the group given RRV with DTP and 20% in the group given RRV and IPV (P < 0·05). Interference by live oral polio vaccination in the response to RRV seems unlikely. An observed no significant difference in rates of seroconversion of IgG antibodies to poliovirus type 1 among infants aged 18 and 21 weeks who received RRV and OPV (81%), RRV with delayed OPV (67%), or RRV and IPV (59%). Administration of RRV was safe and was not associated with adverse reactions in the 6 weeks old infants. The low rate of seroconversion to rotavirus suggests that a more antigen-rich vaccine or multiple doses of the same vaccine might produce a better immune response.
Most of reviewed literature had emphasized that the efficacy of both vaccines won’t be affected by administering both together and that what the protocol of vaccination in Bahrain had recommended. But the studies that had shown that the efficacy of Rota vaccine was reduced while administering it together with polio vaccine were less and recommended that a more antigen-rich vaccine or multiple doses of the same vaccine might produce a better immune response. Also, these studies had shown that the efficacy of polio vaccine will not be affected by administering Rota vaccine with it in the same time.
After reviewing the protocol and the previous studies we would recommend the following:
Increase the times of administration of Rota vaccine from 2 to 3 times.
Administering polio virus vaccine two weeks apart from Rota vaccine as recommended by the manufacturer of Rotarix vaccine.
More studies have to be conducted on interference of both vaccines especially in gulf area infants.
Working on this project had increased our knowledge on using the appropriate engines to search on evidence based articles. Not only that but we have learned how much it is important to have an evidenced based practices in nursing to empower our knowledge and actions.
We’ve faced some encountered problem while preparing this project but fortunately our teacher was there to help us overcoming the next issues:
Short period available to interpret our project.
Unavailability of full articles related to our search.
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