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Cover of Evidence review for preoperative management of anaemia

Evidence review for preoperative management of anaemia

Perioperative care in adults

Evidence review E

NICE Guideline, No. 180

.

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-3827-8

1. Preoperative management of anaemia

1.1. Review question: What is the most clinically and cost effective oral iron supplementation strategy for the preoperative management of iron deficiency anaemia?

1.2. Review question: What is the most clinically and cost effective management strategy for the preoperative management of iron deficiency anaemia?

1.3. Introduction

Anaemia is a recognised predictor of adverse postoperative outcome. It is associated with an increased rate of perioperative blood transfusion and increased postoperative morbidity and mortality. Furthermore anaemia is common in the surgical population, particularly in the high risk group undergoing intermediate or major surgery. These data have led to an establishment of rapid access anaemia clinics employing patient blood management strategies including the administration of preoperative oral and intravenous iron. However, the question of whether these preoperative interventions, such as oral or intravenous iron therapy, can improve preoperative haemoglobin levels, reduce the need for postoperative blood transfusions and improve clinician and patient reported outcomes are unanswered. This section of the guideline aims to review the evidence for clinical and cost effectiveness of such strategies to inform clinical practice.

1.4. PICO table

For full details see the review protocol in Appendix A:.

Table 1. PICO characteristics of oral iron.

Table 1

PICO characteristics of oral iron.

Table 2. PICO characteristics of IV iron.

Table 2

PICO characteristics of IV iron.

1.5. Clinical evidence

1.5.1. Included studies for oral iron

No relevant clinical studies comparing alternate day oral iron therapy with daily oral iron therapy were identified.

See also the study selection flow chart in appendix C.

1.5.2. Included studies for IV iron

Four studies from three randomised controlled trials were included in the review comparing IV iron to oral iron;29, 30, 32, 48 these are summarised in Table 3 below. Evidence from these studies is summarised in the clinical evidence summary below (Table 4).

See also the study selection flow chart in appendix C, study evidence tables in appendix D, forest plots in appendix E and GRADE tables in appendix F.

1.5.3. Excluded studies

See the excluded studies list in Appendix I:.

1.5.4. Summary of clinical studies included

Table 3. Summary of clinical studies included.

Table 3

Summary of clinical studies included.

See appendix D for full evidence tables.

1.5.5. Quality assessment of clinical studies included in the evidence review

Table 4. Clinical evidence summary: IV iron compared to oral iron for preoperative management of anaemia.

Table 4

Clinical evidence summary: IV iron compared to oral iron for preoperative management of anaemia.

See appendix F for full GRADE tables.

Table 5. Clinical evidence summary: Evidence not suitable for GRADE analysis.

Table 5

Clinical evidence summary: Evidence not suitable for GRADE analysis.

1.6. Economic evidence

1.6.1. Included studies

No health economic studies were included.

1.6.2. Excluded studies

No relevant health economic studies were excluded due to assessment of limited applicability or methodological limitations.

See also the health economic study selection flow chart in Appendix G:.

1.6.3. Unit costs

Relevant unit costs are provided below to aid consideration of cost effectiveness.

Oral iron
Table 6. UK costs of oral iron drugs.

Table 6

UK costs of oral iron drugs.

IV iron

Table 7 shows the drug costs associated with IV iron administration, and Table 8 shows the additional resource use associated with this approach.

Table 7. UK costs of intravenous iron.

Table 7

UK costs of intravenous iron.

Table 8. Costs of administering intravenous iron.

Table 8

Costs of administering intravenous iron.

Potential downstream costs

As well as drug costs, the downstream costs which may arise from a series of different outcomes in the interventions being compared are of importance, and some costs are illustrated below.

Table 9. Potential downstream costs.

Table 9

Potential downstream costs.

1.6.4. Other calculations

Simple costing was conducted to estimate the impact of people requiring blood transfusions and is in Table 10. This showed that the costs associated with IV iron were much higher than oral iron when considering blood transfusion.

Table 10. Costs including blood transfusion.

Table 10

Costs including blood transfusion.

1.7. Evidence statements

1.7.1. Clinical evidence statements

No relevant published evidence was identified for oral iron strategies.

IV iron versus oral iron

No evidence was found for all-cause mortality, POMS, as the critical outcomes, unplanned ICU admission, ICU length of stay, and adverse events from transfusion (for example, infections, reactions (compatibility), hypersensitivity).

Health-related quality of life

One study found no clinically important difference between IV iron and oral on quality of life (physical component summary score of the SF-39 questionnaire) at the day of surgery compared to oral iron. (1 study, n=116, moderate quality evidence).

One study found a clinically important benefit of IV iron on quality of life (mental component summary score of the SF-39 questionnaire) at the day of surgery compared to oral iron. (1 study, n=116, low quality evidence).

One study found a clinically important benefit of IV iron on quality of life (physical component summary score of the SF-39 questionnaire) at 2–3 months compared to oral iron. (1 study, n=92, low quality evidence).

One study found a clinically important benefit of IV iron on quality of life (mental component summary score of the SF-39 questionnaire) at 2–3 months compared to oral iron. (1 study, n=92, low quality evidence).

Haemoglobin levels

One study found a clinically important benefit of IV iron on haemoglobin levels at 3 weeks compared to oral iron (1 study, n=56, moderate quality evidence).

One study found no clinically important difference between IV iron and oral iron on pre-operative haemoglobin levels (1 study, n=44, very low quality evidence).

Blood transfusions

One study showed a clinically important harm of IV iron on number of patients transfused compared to oral iron (1 study, n=40, low quality evidence). A single study demonstrated a clinical important benefit of IV iron for pre-operative blood transfusions, but no clinically important difference with IV iron of intra-operative or postoperative blood transfusions, or perioperative transfusion volume compared to oral iron (1 study, n=105, low quality evidence).

Adverse events

Two studies showed no clinically important difference between IV and oral iron for rate of complications (2 studies, n=96, very low quality evidence).

Outcomes not suitable for GRADE analysis

One study showed no notable difference of IV iron compared to oral iron on quality of life (1 study, n=44, very high risk of bias).

One study found a trend to benefit with IV iron on haemoglobin levels at 3 weeks compared to oral iron (1 study, n=105, low risk of bias).

One study showed no notable difference of IV iron compared to oral iron on transfusion requirement (1 study, n=44, high risk of bias).

One study showed a significant benefit with IV iron compared to oral iron for delays in surgical procedures (1 study, n=76, very high risk of bias).

Two studies showed no notable difference for IV iron on post-operative length of stay when compared to oral iron (2 studies, n=105 & 44, low & high risk of bias).

One study showed no notable difference for IV iron on post-operative length of ICU stay when compared to oral iron (n=44, high risk of bias).

One study showed no notable difference between IV and oral iron for rate of complications (1 study, n=105, high risk of bias).

1.7.2. Health economic evidence statements

  • No relevant economic evaluations were identified for either review.

1.8. The committee’s discussion of the evidence

1.8.1. Interpreting the evidence

Please see recommendations 1.3.4 – 1.3.7 in the guideline.

1.8.1.1. The outcomes that matter most
Oral iron

Anaemia is a recognised predictor of adverse postoperative outcome and associated with an increased rate of perioperative blood transfusion and increased postoperative morbidity and mortality. As such, the committee identified all-cause mortality, health-related quality of life, preoperative Hb level, transfusion (pre-, intra- and post-surgery), postoperative morbidity score (POMS), and change in healthcare management (for example, delayed surgery or surgery cancellation) as the critical outcomes for decision making on strategies of oral iron therapy. The following outcomes were identified as important for the preoperative management of iron-deficiency anaemia: length of hospital stay, unplanned ICU admission, ICU length of stay (planned and unplanned), adherence, adverse events from iron tablets (for example, constipation, nausea).

No relevant clinical studies were identified; therefore, no evidence was available for any of these outcomes.

IV iron

The committee also identified all-cause mortality, health-related quality of life, preoperative Hb level, blood transfusion (pre-, intra- and post-surgery), postoperative morbidity score (POMS), and change in healthcare management (for example, delayed surgery or surgery cancellation) as the critical outcomes for decision making on oral or IV iron therapy. The following outcomes were identified as important for the preoperative management of iron-deficiency anaemia: length of hospital stay, unplanned ICU admission, ICU length of stay (planned and unplanned), adverse events from transfusion (for example, infections, reactions (compatibility), hypersensitivity), and adverse events from iron supplementation (for example, constipation, nausea).

1.8.1.2. The quality of the evidence
Oral iron

No relevant clinical studies were identified for this review.

IV iron

The quality of evidence that was suitable for GRADE analysis ranged from very low to moderate. The majority of the evidence was graded at low quality. This was mostly due to outcome reporting bias and imprecision. The committee also noted that the studies were relatively small, limiting the confidence with which they could draw conclusions from the evidence.

Outcomes which were not suitable for GRADE analysis were considered to be a low and high risk of bias.

1.8.1.3. Benefits and harms
Oral iron

No relevant clinical studies were identified for this review. However, the committee felt that a research recommendation in this area was warranted.

The committee acknowledged the possible side-effects of oral iron supplementation including constipation or diarrhoea, nausea and vomiting. It was considered that an understanding of varying oral iron therapy regimes may elucidate potential benefits with regards to managing the side effects of supplementation as well as patient compliance with therapy. The committee agreed that alternate day iron regimens can be considered if the side effects of daily dosing cannot be tolerated.

IV iron

The committee discussed the evidence on the preoperative management of iron deficiency anaemia.

The committee discussed evidence from three studies showing IV iron had an improved capacity to increase preoperative haemoglobin levels compared with oral iron. This benefit was considered by the committee to be clinically important.

Evidence from one study showed a clinical benefit of IV iron for the number of preoperative transfusions. However, the committee noted that there was no clinically important difference between oral iron and IV iron on the number of patients transfused on the day of surgery, after surgery or the total blood transfusion volume. A second study showed an increased risk of patients requiring blood transfusion with IV iron compared to oral iron. Given that blood transfusion was recognised as a critically important outcome, the committee felt that the overall lack of difference between oral and IV iron therapy to an extent negated the potential benefits of the aforementioned increase in haemoglobin levels.

The committee also considered the evidence from two studies reporting the health-related quality of life of people with iron deficiency anaemia planned to undergo surgery. Evidence from one study with 116 participants showed no difference in the physical component summary score of the SF-39 questionnaire at the day of surgery, but noted a clinically important benefit with IV iron administration in mental component summary score of the SF-39 questionnaire at the day of surgery, and in both the physical and mental component summary scores at the day of surgery. The second study found with 44 participants found no statistically significant differences in any subset of the EQ-5D or SF-36 considering the effects of treatment during study visits.

Evidence reviewed by the committee also showed no significant difference in, length of hospital stay or rate of complications between those receiving oral or IV iron. The committee also noted that there was no data reported on any complications from blood transfusion.

No evidence was found for all-cause mortality, POMS as the critical outcomes, or unplanned ICU admission, and adverse events from transfusion (for example, infections, reactions (compatibility), hypersensitivity).

The committee referenced a general acceptance that increased haemoglobin levels in anaemic patients reduces the risk of morbidity associated with surgery and recognised this as a noteworthy benefit of IV iron therapy. However, the committee noted that a reduction in morbidity was not reflected in the reported rates of transfusions in people receiving IV iron therapy compare to oral iron therapy. The committee were aware of the recommendations in the NICE guideline on blood transfusions to offer iv iron if the time interval between the diagnosis of anaemia and surgery is predicted to be too short for oral iron to be effective.

The committee highlighted that preoperative anaemia is associated with adverse post-operative outcomes. However, there is uncertainty that treating anaemia in the preoperative period reduces these risks.

1.8.2. Cost effectiveness and resource use

Oral iron

No economic evidence was identified.

The committee were presented with some examples of unit costs for the different oral iron administrations, as well as excess bed day costs and blood transfusion costs. Ferrous sulfate is a common type of oral iron that is prescribed in the NHS, and requires adults taking 200mg tablets three times a day. For the daily oral iron regime, the total cost is £10.36. For the alternate day regime the total cost is £5.18. Costs were based on taking the tablets for three months, as this is the time it usually takes to get iron and haemoglobin levels back to normal. The committee discussed that oral iron results in unpleasant side effects such as constipation and nausea, which can lead to adherence issues particularly if people have to take it on a daily basis. No clinical evidence was identified. However, the committee noted that there may be emerging evidence in non-surgical populations that taking oral iron on alternate days results in the same effectiveness on haemoglobin levels, but fewer side effects which can also resolve the issue around adherence. A higher adherence rate could reduce the chances of adults having their surgery delayed, which can have a negative impact on the adult’s quality of life and their condition. Also, a more effective intervention, in terms of increasing an adult’s haemoglobin level, could reduce the chances of needing a blood transfusion and of having an adverse event, which can lead to extra days in hospital

Current practice is to administer daily oral iron, which is the more expensive option. As there was no relevant clinical evidence in the surgical population, there is uncertainty about which intervention is more effective and therefore on the impact of downstream costs and effects. If further research could demonstrate that the alternate day option is as, or more, effective than the daily option, it could lead to future savings for the NHS. Therefore the committee made a research recommendation.

IV iron

No economic evaluations were identified.

The committee were presented with some examples of unit costs for oral iron and IV iron, as well as excess bed day and blood transfusion costs.

The committee felt the clinical data demonstrated that oral and IV iron had similar effectiveness. Oral iron is a very cheap drug to administer, costing only £1.19 for three weeks. On the other hand, IV iron can cost an average of £112 for three weeks. IV iron results in much higher costs, as the drug is more expensive and requires staff time in hospital and clinic space and some adults may require NHS transport. Other downstream costs were considered, such as the cost of a blood transfusion, which can cost around £133 and the cost of excess bed days, which ranges from £260 to £415.

The IV iron group had a larger increase in haemoglobin levels in all three studies. This can prevent other complications, such as wound infections, which were not measured in the studies. Wound infections can have a negative impact on the patient’s quality of life and incur downstream costs to the NHS in order to manage and treat them. Also, if an adult has not reached an optimum haemoglobin level their surgery might be delayed, which is another outcome that was not measured. This can have a negative impact on their condition and quality of life. However, the committee felt that although there is evidence to support the increase in haemoglobin levels in IV iron, it is an area that requires more evidence to indicate whether this increase in haemoglobin levels leads to less surgeries being delayed and a reduction in complications. The committee also highlighted that although the haemoglobin levels increased, the magnitude of benefit is dependent on the baseline haemoglobin level. For example, if an adult’s haemoglobin level increases from 8 to 10, this is an important clinical difference. But if their haemoglobin level increases from 10 to 12, this is likely to be less significant.

A simple costing example was calculated to see what the estimated cost per patient would be if we were to include the number of blood transfusions reported in the clinical review, as well as the intervention costs. The intervention cost for oral iron was based on a cost of £1.19 for taking ferrous sulfate for 3 weeks, and the unweighted average cost of intravenous iron was £397. One study reported blood transfusions on the day of surgery as well as pre and post-operatively. This showed that 20% of people in the IV iron group had a blood transfusion and 25% in the oral iron group. Using the cost of blood transfusion and adding it to the cost of the drug (as well as administration costs) resulted in IV iron costing £424per person and oral iron costing £36 per person, a difference of £387. This is a large difference and the committee felt that this cost magnitude of IV iron was too high to justify. The committee discussed that there were risks associated with blood transfusions, and felt that there would be an additional cost associated with these. They felt that the quality of clinical evidence was too weak to make any judgment on the number of transfusions in total, based on the wide confidence intervals.

The blood transfusion guideline indicated that IV iron should be considered when the interval between diagnosis of anaemia and surgery was too short for oral iron to work. This question aimed to clarify what constitutes ‘too short’, as there is uncertainty and variation in current practice. As the committee discussed that the quality and quantity of the evidence was insufficient, and therefore considered the costs associated with IV iron and agreed that the magnitude of benefit that IV iron produced was not great enough to result in it being cost-effective. Therefore they recommended offering oral iron and considering IV iron in circumstances where oral iron was not tolerated or sufficient. All studies had a similar time frame so there was no information to help inform the issue around timing, and a research recommendation was made around this.

This recommendation could result in some changes to current practice and could lead to some cost-savings as clinicians might stop using IV iron and prescribe oral iron during a ‘short’ time frame.

1.8.3. Other factors the committee took into account

Oral iron

The committee reviewed recommendations made in [NG24] the blood transfusion guideline and agreed that these were relevant to the perioperative care population.

The committee commented that alternate day therapy may address an issue of non-adherence in patients undergoing surgery; however, this needs to be balanced against the possibility that alternate-day therapy might be complicated for patients who are required to take multiple tablets otherwise taken daily. As a large proportion of adults presenting with iron-deficiency anaemia may be elderly, the committee expressed some concern around introducing the alternate day regime as it can be confusing. However, this could be rectified by adherence strategies like adults using compliance devices (for example, pill boxes). The committee also made consideration for the side effects associated with oral iron treatment which may be affected with alternate day therapy.

After the commencement of an alternate day oral iron regimen for iron deficiency, people should be followed up by healthcare professionals. This would enable assessment of how effective the treatment has been.

IV iron

The committee also noted that the evidence from one of the three included studies was taken from a specific population of menorrhagic women scheduled to undergo gynaecologic surgery. While this group of people were identified as having iron deficiency anaemia, the committee questioned whether it would be possible to generalise the findings from this study for all people with iron deficiency anaemia.

The committee noted that IV iron is indicated in people with FID who have normal iron levels but are unable to use it efficiently.

The committee was aware of a large ongoing trial (PREVENTT) which may add insight into the efficacy of IV iron in major abdominal/pelvic surgery.

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Appendices

Appendix B. Literature search strategies

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual 2014, updated 2018.44

For more detailed information, please see the Methodology Review.

B.1. Clinical search literature search strategy

Searches were constructed using a PICO framework where population (P) terms were combined with Intervention (I) and in some cases Comparison (C) terms. Outcomes (O) are rarely used in search strategies for interventions as these concepts may not be well described in title, abstract or indexes and therefore difficult to retrieve. Search filters were applied to the search where appropriate.

Table 14. Database date parameters and filters used

Medline (Ovid) search terms

Embase (Ovid) search terms

Cochrane Library (Wiley) search terms

B.2. Health Economics literature search strategy

Health economic evidence was identified by conducting a broad search relating to the perioperative care population in NHS Economic Evaluation Database (NHS EED – this ceased to be updated after March 2015) and the Health Technology Assessment database (HTA) with no date restrictions. NHS EED and HTA databases are hosted by the Centre for Research and Dissemination (CRD). Additional health economics searches were run on Medline and Embase.

Table 15. Database date parameters and filters used

Medline (Ovid) search terms

Embase (Ovid) search terms

NHS EED and HTA (CRD) search terms

Appendix D. Clinical evidence tables

1.8.4. Oral iron

No clinical evidence identified.

1.8.5. IV iron

Download PDF (171K)

Appendix H. Health economic evidence tables

None.

Appendix J. Research recommendations

J.1. Management of anaemia

Research question: For people with iron-deficiency anaemia, how long before surgery should oral iron supplementation be started, and what is the clinical and cost effectiveness of daily oral iron compared with oral iron given on alternative days?

Why this is important:

Iron deficiency anaemia is common in the surgical population. The time from identification of iron deficiency anaemia in a surgical patient, to the time of surgery is variable; it can be months for an elective procedure such as joint replacement or two weeks for cancer surgery. Treatment options include oral supplementation and/or intravenous preparations. There are limited randomised controlled clinical trials examining the clinical and cost effectiveness of oral versus intravenous iron for the treatment of iron deficiency anaemia prior to surgery. This has led to variation in clinical practice in the treatment of iron deficiency prior to surgery and requires further research to inform development of guidelines and standardisation of routine care.

Criteria for selecting high-priority research recommendations

Final

Evidence reviews underpinning recommendations 1.3.4 to 1.3.7 in the NICE guideline

This evidence review was developed by the National Guideline Centre

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and, where appropriate, their carer or guardian.

Local commissioners and providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Copyright © NICE 2020.
Bookshelf ID: NBK561977PMID: 32931174

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