JOURNAL CLUB PRESENTATION

Dr Siti Aisyah Idris

24^th May 2022

‘Self-ignored onsite adverse donor reaction among whole blood donors’

INTRODUCTION

• Adverse donor reaction (ADR) can be defined as the clinical symptoms or signs of donor discomfort severe enough to be noticed either by the donor or the blood center staff

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• Incidence of the same ranges from 1% to 9% globally and varies from center to center

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• Most common adverse reaction related to whole blood donation is vasovagal reaction (VVR) while the most common injury is hematoma

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• ADR can occur before, during, or after donation. These reactions can be onsite or offsite.

• Donors are educated and motivated to notify the blood center team if they develop any onsite or offsite ADR to ensure the proper management and documentation.

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• However, some of these adverse reactions may not get reported.

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• These unreported adverse donor reactions (UADR) may result in:��-delay or failure in detection and management, or subsequent complications related to it��-can have a negative impact on the future donation by the donor

• Few studies regarding UADR were done mainly focused on off-site reactions such as:��- Newman et al. ‘Adverse effect in blood donor after blood donation’. Transfusion (2003)�- Kansay et al. ‘Underreporting of mild adverse event during plateletapheresis donation’. J Pharm Negative Result (2017)�- Tiwari et al. ‘Post donation telephonic interview of blood donors; providing an insight into delayed adverse reaction events’. Trans Apher Sci (2017)

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• However, information on the onsite self-ignored adverse donor reactions (SIADR) are less discussed.

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A better understanding of the SIADR helps in:

• early detection
• avoidance of complications
• adoption of mitigation strategies
• retention of donors

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• Main outcome addressed by authors from this study is donor related factors attributing to onsite SIADR by determining its incidence and the reasons among whole blood donors.

METHOD

• A prospective single-center observational study was conducted in authors’ blood center for a study duration of 4 months from December 2020 to March 2021.�
• Inclusion criteria were donors who completed whole blood donation and who gave valid written consent for participation.

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• Exclusion criteria were donors who developed reactions during the current donation and donors who were lost to study follow-up. �

• All the participants underwent standard of care blood donation practices which includes the provision of information education and communication (IEC) materials, pre-donation counselling, donation care, and post-donation counselling.
• During the study period, each donor was approached to participate in the study after the completion of whole blood donation in the center.
• Participants were interviewed on two time-points; in-person soon after the enrolment and two days post-enrollment over the telephone.

• During the study period, a total of 6342 donors completed whole blood donation in the centre.

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• In the study, a total of 508 donors consented to participate and 501 attended both the interviews. �(Seven participants were lost on follow up for the second interview and were excluded from the study)

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RESULTS

Among 6342 donors, 76 donors (1.20%) were reported to develop ADR.

�The common reactions were VVR (78.9%) followed by hematoma (18.4%)

�Based on the severity grading 85.0% of the VVR were grade I, �11.7% were grade II and �3.3% were grade III.

• 12 participants (2.39%) were found to have experienced onsite SIADR and out of them, 9 (75%) were VVR.
• Other reactions were allergic reaction to iso-propyl alcohol, excessive pain at the site of venipuncture, and numbness at the site of venipuncture
• 9 VVR were of grade I severity and all of them experienced dizziness. Among the 9 donors, 2 experienced sweating, and 2 experienced nausea.
• Allergic reaction noticed was of mild type.
• 9 donors (75%) revealed about the SIADR during the first interview and 3 donors (25%) revealed during the second interview.
• All the reactions disclosed during the second interview were VVR.
• Donors who admitted the reaction during the first interview were given immediate symptomatic management as per the standard practice and later interview was conducted.

• Out of the 12 donors, 9 were repeat donors and 3 were first time donors. �
• 2 out of 9 repeat donors revealed about experiencing similar SIADR in the previous donations too. �
• Among the 12 onsite SIADR occurred, 8 (75%) were in the post-donation phase, and 4 (25%) were in the donation phase. �
• None of the donors required medical attention and all the reactions subsided by itself.

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RESULTS

• Participants demographic:��-Mean age 25-44 (60.1%)�-Most are male (93%)�-Repeat donors (72%)�-More than 50% of donors had an educational background of graduation and above.�

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Age: The incidence of SIADR among donors with age between 18–24, 25–44, and above 45 were 1.88, 2.32, and 5.0 percent respectively. (P = 0.508)

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Gender: The incidence of SIADR among female and male donors was 2.86 and 2.36 percent respectively (P = 0.852)

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Number of donations: The incidence of SIADR among first time donors, repeat donors with less than or equal to 5 donations, and donors with more than 5 donations were 3.59, 2.21, and 1.10 percent respectively. (P = 0.460)

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Education: The incidence of SIADR among donors with education less than 10th standard, 10th standard, pre-degree, graduate, and postgraduate was 1.25, 3.45, 2.38, 1.49, and 16.67 percent respectively. The incidence of SIADR was significantly higher among donors with postgraduation when compared to other categories of education status. (P = 0.003)

REASONS OF SIADR

• 7donors (58.3%) revealed that they experienced symptoms of donor reaction, perceived it to be a reaction, however ignored to report as the symptoms were mild.
• 3 donors (25%) experienced the symptoms but failed to interpret as a reaction related to donation and hence were not reported.
• 2 donors experienced the symptoms, perceived it to be a reaction that needs to be reported, however did not report probably due to inertia to report��Only during the second interview, both of them revealed to have experienced the reaction.

• In this study, the incidence of the onsite SIADR was 2.39 percent, which was twice (1.2%) the incidence of the onsite ADR
• Around two-thirds of the onsite adverse donor events were going under-reported, which indicates an iceberg phenomenon in the reporting of onsite ADR
• A study by Newman et al., noted that 36% of the donors experienced ADR and recommended post donation interviews as a good tool to identify off-site reactions
• Desai et al., interviewed donors over the phone on the next day of donation to identify the delayed reactions and concluded that most reactions occurred off-site.

DISCUSSION

• Similar post-donation interviews (after 3 weeks) were conducted by Tiwari et al.,to explore the frequency of delayed reactions and reported that offsite reactions are common than onsite reactions
• An ananonymous online survey by Orru’ S et al., among blood donors identified the incidence of ADR as 27.5% and also concluded that delayed reactions were common than onsite reactions.

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Therefore, early identification of mild symptoms and implementation of appropriate prophylactic measures may prevent the occurrence of delayed reactions

• In this study, the commonest type of onsite SIADR was found to be VVR (75%). Likewise, the most common onsite ADR in authors’ blood center was VVR (78.9%).
• Generally, VVR is the commonest donor reaction as reported by Pathak et al. and Crocco et al. in their studies

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• Also, this study noted that all the VVR among onsite SIADR were grade I. There may be a tendency to ignore such reaction as the symptoms were mild. This was highlighted in a study by Kansay et al., which stated that donors tend to neglect mild reactions.

DISCUSSION

• Majority of the onsite SIADR occurred in the post-donation phase. This was also reported by Desai et al., wherein the majority of the donor reactions occurred post-donation.

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• There was a significant positive association found between education and SIADR. Higher the education, higher was the incidence of SIADR.

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• Age, gender, and number of previous donations were found to have no significant association with SIADR.
• In contrast to that, female gender and first-time donors are prone for ADR (Argawal et al., Desai et al.)

• In this study, perception of reaction as mild was revealed to be the commonest reason (58.3%) for SIADR. They were able to interpret the symptoms as reaction, but were not aware about the need of reporting the mild reaction.

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• Another common reason (25%) found was failure to interpret the symptoms as reaction related to blood donation. Here they have experienced symptoms, but considered it as normal symptoms during the blood donation process.

DISCUSSION

• Another reason observed was inertia to report to the blood center. Here participants have experienced the symptoms, interpreted as reaction, and were aware about the need of reporting to the blood center. They revealed the reaction during the second interview.
• Repeated enquiries and follow up on reaction may be adopted for breaking the barrier of reporting. Majority of the donors who had SIADR (83.3%) were not aware of reporting the discomfort or symptoms experienced by them.

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• Donors should be encouraged to report even mild symptoms if any to the blood center.

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CONCLUSION

• Incidence of onsite SIADR is double the incidence of onsite ADR in this study.
• Most common SIADR were VVR grade I and majority occurred in the post-donation phase.
• Major reasons for SIADR were perception of the reaction as mild and failure to interpret the symptoms as reaction.
• Blood center team shall play a proactive role to identify and report onsite SIADR

ADR IN PUSAT DARAH NEGARA (JAN-MAR 2022)

ADR IN PUSAT DARAH NEGARA (JAN-MAR 2022)

ROLE OF PRE-DONATION SCREENING/ COUNSELLING

• Vigilant screening of donors
• Ensure staffs are retrained periodically and to identify risk groups and triggering factors
• First time donors may be given special attention during counselling
• Awareness and education to donors during counselling regarding ADR�- Its important for all ADRs to be reported in order to ensure donor’s well being/safety and prevention of further incident, ensure donor retention

- Emphasize regarding ‘Do and Donts’

• Pre-donation refreshment/advised on AMT/CUE card given
• Donor-friendly environment

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DURING DONATION/ POST-DONATION

• Ensure staffs are trained to identify signs of ADR, triggering factors, immediate management
• Donor-friendly environment
• Ensure enough rest, post donation refreshment
• Repeating education to donors
• Ensure all ADR reported and recorded
• Donor’s follow- up if necessary

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SUGGESTION

• Implementation of structured questionnaires/checklist enlisting various symptoms of reactions during post-donation can act as an additional check point to identify mild ADR and prevention of untoward delayed ADR

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CUE CARD

TAKE HOME MESSAGE

• Donor education regarding ADR prevention, identifying and reporting ADR to medical personnel- either onsite or offsite
• Staff must be able to identify risk groups, ADR and trained for immediate management
• Proper ADR reporting/documentation
• Donor retention strategies

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REFERENCES

• Rutman RC, Dpasuale-Barrios S. Donor reactions. In: Green TS, Steckler D, editors. Donor Room Policies and Procedures. Arlington: American Association of Blood Banks; 1985, p. 81–90
• Newman BH, Pichette S, Pichette D, Dzaka E. Adverse effects in blood donors after whole-blood donation: a study of 1000 blood donors interviewed 3 weeks after whole blood donation. Transfusion 2003;43:598–603.
• Kansay S. Underreporting of mild adverse events during plateletpheresis donations. J Pharm Negative Results 2017;8:56–7.
• Tiwari AK, Aggarwal G, Dara RC, Arora D, Srivastava K, Raina V. Post-donation telephonic interview of blood donors providing an insightinto delayed adverse reactions: first attempt in India. Transfus Apher Sci 2017;56:141–6.