Methodological Study to Develop Standard Operational Protocol on Intravenous ( IV ) Drug Administration For Children and to Assess its Implication

Acknowledgements: We thank Dr. Sandhya Ghai, principle, NINE to allow us to undertake this study and Dr. Sunit Singhi, head of paediatrics to permit us to complete this study in the medicine wards APC, PGIMER, Chandigarh. The author also appreciates the cooperation of bedside nurses and Delphi panelists for the study. We would also extend our gratitude to Dr. Sushma Kumari Saini for providing language help in writing and proof reading the article and Miss Sara to make audio recording of all FGDs. Funding: Nil Conflict of Interest: This study was conducted at Advanced Paediatric Center (APC), PGIMER, Chandigarh to develop SOP for drug administration for children admitted at APC, PGIMER, Chandigarh. Permission from IRB: Yes 1Sunil Kumar Bijarania, Nursing Officer, Neonatology, 2Sushma Kumari Saini, Lecturer, National Institute of Nursing Education, 3Sanjay Verma, Associate Professor, Paediatric Medicine, Advanced Paediatric Centre. All from the Post Graduate Institute of Medical Education and Research, Chandigarh 160012, India. Abstract


Introduction
S tandard Operating Protocols (SOPs) are written documents showing the steps of activities, necessary to complete tasks according to institutional policies 1 .In a Health care institute SOPs advocate the step-by-step performance of any procedure required to provide care to the patients by a trained staff 2 .It is a helpful written document for newly recruited care providers to perform their expected services in that set-up 3 .
Intravenous drug administration is the facilitation of safe and effective administration of medicine and fl uid to neonate/ infant/ toddler/ preschool/schoolgoing.Fatal consequences have been noted following wrong drug, dose, diluent and unsterile techniques [4][5][6] .Nurses are chief participant in drug administration and accountable for correct drug administration in their assigned patients 7,8 .Large numbers of drugs are used in Paediatric Medicine ward according to the severity of child's disease condition.The availability of SOPs for drug administration in such wards can make a difference in patient's prognosis [9][10][11][12][13] .In Medical Ward, APC, PGIMER, no such document is noted in respect to drug administration.As per author's knowledge none of other institute in India has a documented well-developed SOPs for drug administration in paediatric wards.The need for a well-developed drug administration protocol for reducing the errors in drug administration is must in tertiary care centres such as PGIMER, Chandigarh.
Therefor the present study aimed to provide evidencebased literature for health care providers to help themselves at the time of drug administration.

Material and Methods
Methodological research design was adapted to develop SOP on IV drug administration for children, admitted in Advanced Paediatric Centre (APC), Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh.Institutional ethical committee PGIMER, Chandigarh approved the study protocol.Permission to conduct the study was also obtained from the respective authority of the department.Researcher himself approached all the participants and briefl y explained the purpose of the study.Informed written consent was obtained from all participants before commencement of the study.Participant's confi dentiality was maintained.
The data was analyzed by SPSS software (Version-20.0).Cronbach's-alpha was calculated to assess Internal Consistency of checklists.The overall Cronbach's-alpha value of checklists was 0.947.Table-1 (Part-1 & 2) shows, when corrected item to total correlation was applied on 43 items of tool, 41 items had item score to total score correlation between 0.2-0.953whereas 2 items in the tool had item score to total score correlation < 0.2 showing their incompatibility with the overall tool.When the individual item was deleted the value of Cronbach's-alpha was increased for 8 items including one item whose score to total score correlation was < 0.2.That means these 8 items were not contributing to the total reliability of tool and could be discarded.The results were discussed with Delphi panelists; all members were in the favor of keeping all items because they were also equally important in SOP even if the low correlation indicated in the individual item score.

Results
Valid and feasible SOP for IV drug administration for children along with valid and reliable checklist was developed.For ready references SOP in the form of booklet and poster's binder carrying pictures of drug administration technique were made available to all medicine units of APC, PGIMER, Chandigarh.

Inclusion Criteria Phases of research project
Nurses who gave consent to participate in this study were involved.

Preparation Phase:
Preliminary draft of SOP and checklist was generated in the following four steps (a) Assessment of The Current Practices, (b) Literature was reviewed related to standard care practices of IV drug administration, (c) Ten Focus Group Discussions (FGDs) were conducted and (d) Consultation with specialists of Pediatric Nursing and Pediatric Medicine, incorporating the results of assessment of current practices and valuable suggestions of bed side nurses' gathered in FGDs.

Validation Phase:
Delphi technique was applied for the assessment of content validity of preliminary draft.The Delphi panel included 13 members from the fi eld of Pediatric Medicine and Nursing.Total four rounds were conducted to develop the SOP.

Pilot Study (I st Tryout):
conducted after third round of validation that revealed that the existing pictures in the protocol were not clear.The fi nal fourth SOP draft was prepared by replacing existing pictures in protocol with clear and afresh pictures.Content Validity Index (CVI) of SOP and Checklist for all items was calculated 99.77% after fourth round.

Discussion
SOPs describe the activities necessary to complete tasks according to institutional regulations, provincial laws.These are used to remove variation in procedure performance because every individual develops his/her own concept of procedure's process on scientifi c basis 1 .Present study was undertaken because no such SOP on IV drug administration notifi ed in APC wards, PGIMER.
Initially the review of literature was done to check the availability of SOPs and checklists for drug administration worldwide.Only national and international literature of SOPs and checklists related to drug administration was not enough to gather suffi cient information for development of SOP and checklist.Assessment of current-practices of drug administration was also equally important to know about the regular practices of drug administration.In fi ve observations of IV drug administration at APC, PGIMER, Chandigarh, researchers observed that all bedside-nurses followed few steps but few were totally ignored though those steps were also equally important to be performed.
To know the reason of ignorance, a series of FGDs were conducted.The number of FGDs to be conducted depends upon the purpose of study, along with the heterogeneity of group 14 .Another study favors that FGDs should be continued until repetition of themes is not started 15 .During this study, the saturation of information was achieved after 10 FGDs.The size of the group should be of between 6-12 people because large group precludes adequate participation by most members and small group fails to provide signifi cant greater coverage on the topic 16 .In present study all FGDs were conducted with small group of 6-7 members who had 4-5 years of exclusive-experience of pediatric bedside nursing because few guidelines suggest that smaller groups (4-6 members) are allowed when the members have much experience to share 16,17 .On the base of gathered information fi nally a preliminary draft of SOP and checklist was prepared.
For further refi nement in the preliminary draft of protocol and checklist Delphi-technique was used.The Delphi-technique is well suited as a method for consensus building and to establish content validity 18 .Current study had a heterogeneous Delphi panel of 13 experts included seven members of nursing faculty and six faculty members from pediatrics medicine.In a Similar study done by Kaushal et al.Delphi members were eleven 19 .D'Souza et al. used an interdisciplinary panel of seven national and international experts for development of a tool for assessing preterm infants 20 .George et al. had a panel comprised of 10 members 21 .
Delphi-technique employs repeated rounds in which printed drafts of drug administration procedures are given to the Delphi-panelists until a common consensus is reached.In the present study, though the consensus of panelists was achieved after third round but few changes were required after fi rst tryout.To make these changes feasible fourth round was conducted before development of fi nal version of SOP and checklist.In similar studies conducted by Kaushal et al. common consensus was reached in four Delphirounds 19 , according to George et.al. three rounds were suffi cient 21 .
The overall CVI of current study from the panel of experts was calculated 99.77% indicating the validity of the individual item.In a similar study, conducted by D'Souza et al. the overall CVI was 95% 20 .
The reliability of these Checklists was ensured by Cronbach's alpha to determine the internal consistency or average correlation of items in a survey-instrument to gauge its reliability 22 .The overall Cronbach's alpha value of checklists was 0.947 and item score correlation to overall score was in-betweens 0.2-0.953.In a similar study by George et al. overall value of alpha was 0.76 21 .Another study Kaushal et al. revealed Cronbach's alpha value 0.97 19 .The corrected item to total correlation was applied upon 43 items of tool, 41 items had item score to total score correlation between 0.2-0.953whereas two items in the tool had item score to total score correlation < 0.2 showing their incompatibility with the overall tool.When the individual item was deleted the value of Cronbach's alpha was increased for 8 items including one item whose score to total score correlation was < 0.2.That means these 8 items were not contributing to the total reliability of tool and could be discarded.The results were discussed with Delphi-panelists; all members were in the favor of keeping all items because they were also equally important in SOP even if the low correlation indicated in the individual item score.

Conclusion
No institutes in India have documented any welldeveloped SOPs for IV drug administration in paediatric wards.SOP on IV drug administration is established which is valid and feasible along with reliable and valid checklists.It is recommended to use this SOP for IV drug administration for children at all levels (primary, secondary and tertiary).Checklist should be used by nurse administrators to assess the implementation of SOP.
Tryout): was performed at Medicine units (4-B, 4-C, 5-B and 5-C), Emergency and PICU, APC, PGIMER, Chandigarh.Researcher observed 30 procedures of IV drug administration during second and third week of September 2015.5.Evaluation:seven FGDs were conducted to get reviews of bedside nurses about the usefulness of SOP.

Table 1 :
Reliability of checklist on IV drug administration (Part-1) (N=30) Items in the tool whose Cronbach's Alpha value increased if Item deleted.

Alpha if Item Deleted i Steps for preparation of drug with Burette (PD set)
Overall scale mean is 26.50, Overall reliability is .947(standardised Cronbach's alpha), * Items in the tool which shows item to total correlation <0.2, ** Items in the tool whose Cronbach's Alpha value increased if Item deleted. Notes: