Revised Original Manuscript Submission R1

A ‘BEST PRACTICE’ CARE PATHWAY

IMPROVES MANAGEMENT OF MASTITIS AND BREAST ABSCESS

Authors: Patani N1, MacAskill F1, Eshelby S1, Omar A1, Kaura A1, Contractor K1,

Thiruchelvam P1,4, Curtis S2, Main J3, Cunningham D1, Hogben K1, Al-Mufti R1, Hadjiminas

DJ1,4, Leff DR1,4.

1Breast Unit, Imperial College Healthcare NHS Trust, London, UK

2Department of Microbiology, Imperial College Healthcare NHS Trust, London, UK

3Department of Infectious Diseases, Imperial College Healthcare NHS Trust, London, UK

4Department of Surgery and Cancer, Imperial College, London, UK

*Correspondence to:

Daniel Richard Leff MBBS FRCS (Gen Surg) MS Oncoplastic (Hons) PhD

Clinical Senior Lecturer and Honorary Consultant Oncoplastic Breast Surgeon

Department of Surgery and Cancer, BioSurgery and Surgical Technology, 10th Floor, QEQM

Wing, St Mary’s Hospital, Paddington, London, W2 1NY

Also: The Breast Unit, Imperial College Healthcare NHS Trust, 1st Floor, Charing Cross Hospital,

Fulham Palace Road, London, W6 8RF

Tel: 0203 311 1077, Fax: 0203 311 7624

E-mail address: College: d.leff@imperial.ac.uk Trust: daniel.leff@imperial.nhs.uk

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Running head: Management of mastitis and breast abscess

Key words: Mastitis, breast abscess, antibiotics, ultrasound, aspiration,

admission, incision and drainage, follow-up

Word count: 3500

Funding: Imperial NIHR Biomedical Research Centre and Imperial Health

Charity, Imperial Healthcare NHS Trust.

Category: Original article

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ABSTRACT

Background: As a result of surgical sub-specialisation, mastitis and breast abscess may

be managed with unnecessary hospitalisation, prolonged admission, variable antibiotic

prescribing, incision and drainage rather than aspiration, and loss to follow-up.

Objective: To evaluate a ‘best-practice’ algorithm to improve management across a

multi-site NHS Trust; focusing on uniformity of antibiotic prescribing, ultrasound

assessment, admission rates, length of stay, intervention by aspiration or incision and

drainage, and follow-up.

Methods: Management was initially evaluated in a retrospective cohort (Phase-I: “PRE-

pathway”, n=53) and subsequently compared to two prospective cohorts (Phase II and

III = “POST-pathway”, n=141), one immediately following pathway introduction (Phase

II n=61), and a further loop-closing audit (Phase-III, n=80) to assess sustainability of

quality improvements.

Results: The management pathway and referral proforma improved compliance with

antibiotic guidelines (Pre=34.0% vs. Post=58.2%, p<0.01), which was maintained

(Phase-II=54.1% vs. III=61.3%, p=0.68) and sustainably increased ultrasound

assessment (Pre=37.7% vs. Post=77.3%, p<0.001; Phase-II=75.4% vs. III=78.8%,

p=0.89). Reductions in rates of incision and drainage (Pre=7.5% vs. Post=0.7%, p<0.01)

were maintained (Phase-II=0% vs. III=1.3%, p=0.38), and follow-up consistently

improved (Pre=43.4% vs. Post=95.7%, p<0.001; Phase-II=91.8% vs. III=98.8%, p=0.12).

Reduced hospital admission (Pre=30.2% vs. Post=20.6%, p=0.25) and median length of

stay [Pre=2 days (range=1-5) vs. Post=1 day (range=1-6), p=0.07] were not statistically

significant.

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Conclusion: A standardised approach to mastitis and breast abscess using a ‘best-

practice’ algorithm and referral proforma reduced practice variation, with sustained

improvements in process and patient outcomes. Barriers to optimal care are not unique

to this Trust, and the care pathway could have reproducible benefits across the wider

NHS.

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MAIN MANUSCRIPT

Introduction

Mastitis refers to inflammation of the breast, the aetiology of which is most commonly

infectious, but can occasionally be granulomatous in nature. Infection of the breast

typically affects lactating women and has been linked to milk stagnation and nipple

trauma, which weakens the barrier function of the skin and permits bacterial entry (1).

However, non-lactating women with other diagnoses, such as duct ectasia can also

develop peri-ductal mastitis. This has been associated with squamous metaplasia

impeding clearance, resulting in an obstructive ductopathy (2). Lactational mastitis and

peri-ductal mastitis occur relatively frequently, with many studies reporting rates in the

order of 5-10% (3-5), of which a similar proportion progress to abscess formation. This

amounts to considerable disease burden and healthcare costs (3, 4). The magnitude of

these remain unknown, but will be informed by data from national quality improvement

initiatives, such as the breast surgery work stream of “Getting It Right First Time”

(GIRFT) (6). An abscess develops when the infected tissue, frequently in the peri-areola

region, is localised and purulent material becomes walled-off. The pathogenesis most

frequently involves bacterial infection following skin colonisation with staphylococcus

aureus. Less commonly, coagulase-negative staphylococci and/or anaerobic organisms

are isolated, particularly in smokers (7).

Patients with lactational or peri-ductal mastitis, including those with abscess formation,

who are systemically well without skin necrosis or immuno-compromise can be safely

discharged on appropriate oral antibiotics. Thereafter, expedited out-patient

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assessment in breast clinic can be followed by image-guided intervention where

appropriate (1, 8-11). Indeed, hospitalisation is best avoided in the post-partum period as it

unnecessarily separates mother and baby. Simple analgesia and systemic antibiotic

therapy may be sufficient treatment for uncomplicated mastitis. Early ultrasound-

guided therapeutic aspiration is recommended for abscesses, in order to relieve

symptoms, effectively drain collections with minimal scarring and breast deformation,

and provide microbiology samples to rationalise empirical antibiotics. Biopsies can also

be taken for histology if granulomatous inflammation or malignancy is suspected (12-16).

While surgical incision and drainage represents the archetypal treatment, in

contemporary practice this is increasingly reserved for situations where image-guided

aspiration is unavailable within an appropriate timeframe, has been ineffective for large

abscesses, or there is necrotising infection requiring formal debridement (4, 17-20). The

Guidelines and Audit Implementation Network (GAIN) and the National Institute for

Health and Care Excellence (NICE) have published recommendations for the

management of breast abscess and mastitis, which include the timing and choice of

antibiotic therapy, use of ultrasound-guided needle aspiration and the need for

specialist referral and follow-up (21, 22).

Major barriers to optimal management of women with breast sepsis, include the

potentially limited experience of front-line healthcare providers owing to sub-

specialisation, inadequate access to interventional radiology, and the inability to access

breast specialists out of hours. Despite published guidelines (4, 21, 22), recent data suggests

that many surgical units in the United Kingdom (UK) do not have clear protocols for

treating breast infections referred to secondary care (19). The combination of local

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organisational and logistical factors, in addition to patients presenting acutely to non-

specialists out-of-hours, may result in undesirable practice variation, sub-optimal

management and unnecessary healthcare costs (23). Examples of this include diagnostic

uncertainty, indecision regarding the need for hospitalisation, inconsistency of

antibiotic choice and route of administration, contradictory advice regarding breast

feeding and/or expressing milk, delayed investigation(s) or therapeutic intervention(s),

and timely arrangements for clinical and radiological follow-up (23). Against this

background, the objective of this work was threefold: (a) to evaluate practices in the

management of breast sepsis across a four-site hospital network; (b) to develop a ‘best-

practice’ care pathway algorithm for mastitis and breast abscess; and finally (c) to

monitor pathway implementation and impact on patient outcomes and key process

measures.

Methods

Management of Mastitis and Breast Abscess

A retrospective audit (Phase-I) was undertaken between January 2010 and December

2011 to evaluate the management of patients diagnosed with mastitis and/or breast

abscess (n=53) presenting acutely to xxxxxx Healthcare NHS Trust. The Trust’s

database was searched using the terms “mastitis” and/or “breast abscess”, in order to

capture patients presenting with breast sepsis over a two-year period. Junior clinicians

(authors AO, AK and DL) working in the breast unit collected data through a process of

hospital record review, focussing on the clerking case notes, imaging, pathology and

microbiology reports, pharmacy records, and where applicable operation notes. Key

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information regarding patient management was retrieved from hospital records,

including adherence to Trust antibiotic guidelines, rates of hospital admission and

length of in-patient stay. Use of breast ultrasound and intervention by aspiration,

frequency of operative incision and drainage, involvement of breast surgeons and rates

of specialist breast surgical follow-up were also monitored. Data was collected using

standard templates and populated into a secure electronic database. The audit was

registered with the Trust (ID=047529) and the staged results presented at clinical

governance meetings.

Development of Mastitis and Breast Abscess Protocol

Having evaluated the existing processes and key outcome measures for patients

presenting with mastitis and/or breast abscess, a referral proforma and ‘best-practice’

management algorithm was developed by the senior clinical team (PT, SC, JM, DC, RAM,

KH, DH, and DL). This involved consultation with surgeons, radiologists, microbiologists

and emergency physicians, using the Delphi method to reach consensus (24). This was

subject to ratification by the hospitals antibiotic review group (SC), and the Trust’s

quality and safety review board (DL). Local ethics committee approval was not required

for this process. Thereafter, the resulting ‘Mastitis and Breast Abscess Management

Pathway’ (Figure 1) was introduced across xxxxxx NHS Trust in 2014.

The purpose of the management algorithm was to equip non-specialists with an

evidence-based decision tool and aide-memoire regarding the clinical indications for

hospital admission and Trust antibiotic guidelines in order to minimise practice

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variation. Using the pathway parameters, patients could be triaged effectively,

appropriate initial treatment started, and breast specialists alerted by completion of the

referral proforma. The completed proformas were faxed to the breast services booking

office, centralised at xxxxxx hospital. Patients were then contacted to arrange an

appointment with a breast surgeon and undergo specialist ultrasound assessment with

aspiration if appropriate, typically on the next working day.

The management pathway was uploaded onto the Trust’s intra-net and the referral

proforma (Figure 1) was made available online across four xxxxxx teaching hospitals,

namely, xxxxxx hospital, xxxxxx hospital, xxxxxx hospital and xxxxxx hospital. At each

site, education and training sessions were undertaken upon pathway implementation to

ensure relevant accident and emergency staff, general surgery teams and the breast unit

administrative team had familiarised themselves with the ‘best practice’ pathway and

were notified of critical changes in practice (e.g. first-line antibiotic choice(s),

preference for out-patient care, access to emergency breast ultrasound and systems for

referring to breast specialists for follow-up). Pathway education and training sessions

were repeated on several occasions to account for rotating junior trainees in breast,

general and accident emergency departments and repeated again prior to re-audit

phases, with emphasis placed on the benefits of the pathway for the non-specialist.

Indeed, prior to each phase of the prospective re-audit, education and training sessions

were undertaken within emergency departments and among general surgeons

participating in acute “on-calls” in order to raise awareness of the management pathway

and encourage uptake.

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Following implementation of the new management pathway, a loop-closing audit (25)

was conducted between January 2015 and February 2016 to reassess practice and

determine if there had been any improvement in the quality of care provided. This

focussed on the following five key domains:

Improvements in compliance with recommended hospital antibiotic guidelines

and uniformity of antibiotic prescribing.

Reduction in hospital admissions with optimal out-patient management and

expedited specialist assessment.

Reduction in hospital length of stay.

Reduction in operative intervention and curtailment of incision and drainage.

Improved rates of specialist follow-up and minimisation of loss to follow-up.

The prospective re-audit comprised two consecutive time-intervals (Figure 2), the first

re-audit (Phase-II; authors AK, KC, NP and DL) occurred between January 2015 and July

2015 (n=61), and the second (Phase-III; authors FM, SE, NP and DL) occurred between

August 2015 and February 2016 (n=80). Prospective data was collected from all four

centres for mastitis and/or breast abscess cases, referred either to the on-call surgical

team or breast services. On a daily basis, one of the clinicians (AK, KC, FM, SE and /or

NP) would screen all general surgical admissions from the preceding day to identify

cases of mastitis and breast abscess admitted to the relevant Trust hospitals.

Additionally, accident and emergency records were reviewed to identify patients

diagnosed with mastitis and/or breast abscess that were discharged pending out-

patient review; and uptake of the proforma was recorded. Proformas faxed to the breast

unit were similarly reviewed and cross-referenced against accident and emergency

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(out-patient managed) and general surgical (in-patient managed) records. For each

case, the following data were collected: uptake of the proforma, rates of hospital

admission, compliance with Trust antibiotic policy, use of ultrasound assessment,

frequency of interventions such as percutaneous aspiration and surgical drainage, and

rates of specialist follow-up after the acute phase. Data were collected using standard

templates and populated into a secure electronic database. The re-audits were also

registered with the Trust and presented at clinical governance meetings.

Statistical analysis

Data from each phase of the study (n=194) were analysed across five key domains,

including compliance with antibiotic guidelines, ultrasound assessment, aspiration

rates, hospital admission and length of stay, operative incision and drainage rates, and

specialist follow-up. In order to determine if there had been any significant

improvement following implementation of the care pathway, data acquired in the

retrospective audit prior to pathway instigation (Phase-I, n=53, referred to as ‘Pre’) was

compared to data from the two prospective re-audit cycles (Phase-II and III combined,

n=141, referred to as ‘Post’). Further comparisons were then undertaken to determine

when the improvement occurred (Phase-I vs. II and Phase-I vs. III). In order to

determine if any improvements in practice were sustained, direct comparisons were

made between the two prospective re-audits (Phase-II, n=61 and Phase-III, n=80) post-

pathway implementation (Figure 2). Unavailable data were assumed to reflect non-

compliance with the management pathway and/or Trust guidelines. For certain

outcome measures such as rates of antibiotic use, hospital admission, operative incision

and drainage, and specialist follow-up, data were expressed as frequencies (%) and

11

analysed using the 2 test. Length of stay (days) data was expressed as median (range)

and analysed using non-parametric tests of significance such as the Mann Whitney U-

test. For all analyses, a p-value of <0.05 was deemed statistically significant and

corrections were not made for multiple testing. Analyses were conducted using SPSS

Statistics V.24.

Results

The overall compliance with antibiotic prescribing policy improved significantly

following pathway implementation [Pre=34.0% (18/53) vs. Post=58.2% (82/141),

p<0.01]. Unavailable data (Pre=10 and Post=26) were assumed to reflect non-

compliance. The improved adherence to antibiotic policy was primarily attributable to

the increased prescription of co-amoxiclav as the recommended first-line agent. The

three most frequently prescribed antibiotics before and after pathway implementation

were co-amoxiclav, flucloxacillin and clindamycin. However, after pathway

implementation there was greater uniformity and a reduction in the range of antibiotics

prescribed (Appendix 1 and Figure 3). Improvements in practice were evident in both

post-pathway cohorts [Phase-I=34.0% vs. Phase-II=54.1% (p<0.05) and vs. Phase-

III=61.3% (p<0.01)]. Notably, greater compliance with Trust antibiotic guidelines was

maintained in the post-pathway cohort [Phase-II vs. Phase-III, (p=0.68)].

The assessment of women with mastitis and/or breast abscess using ultrasound was

markedly increased and maintained following pathway implementation [Pre=37.7%

(20/53) vs. Post=77.3% (109/141), p<0.001 and Phase-II=75.4% (46/61) vs. Phase-

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III=78.8% (63/80), p=0.89]. Unavailable data were assumed to reflect the lack of

imaging (Phase-I=13, Phase-II=9 and Phase-III=10). Although the greater use of

ultrasound assessment in the post-pathway cohort provided an opportunity for image-

guided intervention when appropriate, interestingly as highlighted in Appendix 1, rates

of aspiration did not differ significantly [Pre/Phase-I=22.6% (12/53), Phase-II=24.6%

(15/61), Phase-III=21.3% (15/80), and Post=21.3% (30/141)].

Despite similar proportions of patients undergoing aspiration, the overall rate of

surgical incision and drainage under general anaesthesia was significantly reduced

following pathway implementation, from 7.5% (Pre=4/53) to 0.7% (Post=1/141),

p<0.01. This improvement was significant in the first post-pathway cohort (Phase-

I=7.5% vs. Phase-II=0%, p<0.05), but did not reach statistical significance in the second

post-pathway cohort (Phase-I=7.5% vs. Phase-III=1.3%, p=0.06]. Attenuation in rates of

incision and drainage was maintained amongst patients treated following pathway

implementation [Phase-II vs. Phase-III, p=0.38).

Although lower rates of hospital admission were observed in Phase-III following

pathway implementation, this did not reach statistical significance [Pre=30.2% (16/53)

vs. Post=20.6% (29/141), p=0.25]. Indeed, as summarised in Appendix 1, no significant

difference was found in rates of admission between any of the pre- or post-pathway

audit phases [Phase-I (30.2%) vs. II (29.5%), p=0.58; Phase-I (30.2%) vs. III (13.8%),

p=0.06; Phase-II (29.5%) vs. III (13.8%), p=0.06]. However, when patients with an

unknown admission status were excluded from the analysis, the lower admission rate in

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Phase-III was statistically significant (Phase-I vs. Phase-III, p=0.018; Phase-II vs. Phase-

III, p<0.05). Similarly, reductions in the median length of hospital stay for patients

admitted following pathway adoption did not reach statistical significance [Pre=2 days

(range 1-5) vs. Post=1 day (range 1-6), p=0.07].

Following presentation with acute breast sepsis, rates of follow-up with breast

specialists were substantially improved after pathway implementation [Pre=43.4%

(23/53) vs. Post=95.7% (135/141), p<0.001]. Significant improvement was

demonstrated in both of the post-pathway cohorts [Phase-I=43.4% vs. Phase-II=91.8%

(p<0.001) and Phase-I vs. Phase-III=98.8% (p<0.001)]. The impact of the pathway and

referral proforma on specialist follow-up rates was sustained (Phase-II=91.8% vs.

Phase-III=98.8%, p=0.12). The improved practice was attributable to a reduction in the

number of women who received no follow-up, were lost to follow-up, or with known

follow-up status (Appendix 1 and Figure 4).

Discussion

The objective of this work was to improve the management of patients presenting with

mastitis and/or breast abscess to a multi-site hospital NHS Trust. A retrospective audit

identified significant practice variation and sub-optimal management, leading to

inappropriate antibiotic prescriptions and unnecessary hospital admissions. There was

also inconsistent use of ultrasound assessment, relatively high rates of operative

incision and drainage, inadequate involvement of breast specialists and inconsistent

follow-up to resolution. Such practice may be widespread throughout the NHS and

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Trusts should be encouraged to perform service evaluations in this area. This issue

would be well suited to further study using the trainee research collaborative model;

collecting data locally and uploading into a secure centralised online repository for

nationwide analysis (26).

The prompt and effective management of mastitis and/or breast abscess has potentially

important implications for patient outcome. Refractory or recurrent infection may be

associated with delayed diagnosis, sub-optimal treatment, and contributory patient

factors such as poor breast-feeding technique, diabetes and smoking (27-29). The natural

history of complications associated with mastitis and/or breast abscess can be

influenced in most cases by prompt diagnosis and early intervention. Although there

were no patients with inflammatory breast cancer in this study, failing to involve breast

specialists and consider this important diagnosis can have profound clinical and

medico-legal implications (30). One of the key barriers to optimal management is the

frequent presentation of patients to non-specialist emergency services, particularly out

of hours, where breast surgeons may not be routinely available and access to

ultrasound assessment and image-guided intervention is limited.

These issues are unlikely to be unique to this NHS Trust and prompted the development

and implementation of an institutional ‘best-practice’ algorithm and referral proforma.

Non-specialists reported no significant issues in following the management pathway

and referral proforma and dissemination was facilitated by the Trust’s intra-net. This

standardised approach to managing women with mastitis and/or breast abscess led to

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the measurable improvement of key process and patient outcome measures. These

included appropriate antibiotic prescribing, assessment with ultrasound, reduced

numbers of women undergoing surgical incision and drainage, involvement of breast

specialists and robust follow-up arrangements. Importantly, the study design and

analytical strategy employed clearly demonstrate that improvements in practice were

not simply transient. Service evaluations undertaken after pathway implementation

demonstrated that improvements were sustained two years thereafter.

It is noteworthy that the improvement of some key performance indicators, such as

reductions in hospital admission rates, did not occur until Phase-III of the study. This

reflects the importance on-going education and training sessions even after Phase-II

implementation, in order to hardwire best-practice (31). Such observations also highlight

the need to maintain staff engagement with quality improvement initiatives (32). Human

factors are not trivial; education and training sessions were regularly repeated to risk

mitigate the behaviour of newly rotating accident and emergency and general surgical

trainees. The fact that pathway training was repeated prior to episodes of practice re-

audit may account for the positive impact in eventually curtailing admission rates.

Notwithstanding this, the uptake of the proforma for referrals was found to vary across

the hospital sites and during the course of the audit. The management of change,

particularly protocol awareness and compliance, represents an important issue for the

sustainability of quality improvement endeavours and is a potential area for further

improvement in this study.

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The high turnover of front-line staff in emergency services, general surgery and indeed

the breast unit itself, poses an insidious threat to securing sustainability after the initial

intervention (31, 33-36). This could be addressed by change leaders engaging with new

practitioners for targeted education and training, although repeating training

interventions indefinitely is labour intensive and probably impractical. Ideally,

innovative strategies should be sought to embed the new norm, so that in-coming staff

are able to rapidly familiarise themselves with clinical best-practice pathways in their

specialty. These include harnessing system-based opportunities through information

technology, such as introducing standardised online induction modules for new

employees (24), linking breast-specific clerking proformas to the best-practice pathway

using the Electronic Patient Record (EPR) (37, 38), facilitating direct peer-to-peer

handover of conditions for which integrated management pathways exist (39), and

reinforcing mechanisms to provide positive feedback and discourage non-compliant

practice (35). Change leaders also have the responsibility to encourage and respond to

practitioner feedback from the front-line. Logistical issues, such as accessing a

functional facsimile machine, have been addressed by setting up a dedicated e-mail

account within breast services to receive completed proformas.

Although the data support a considerable reduction in hospital admission rates and

length of stay following pathway implementation, these failed to reach statistical

significance. While the observed reduction in hospital admission rates from Phase I

(30.2%) to Phase III (13.8%) following pathway introduction is meaningful (e.g.

reduced associated healthcare costs, reduced risk of nosocomial infections, etc), one still

has to question the appropriateness of an admission rate of 13.8% for this condition.

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This study was not designed to prospectively scrutinize the appropriateness of

admissions, since to reliably do so would have required prospective independent

clinical review, which was prohibitively expensive in terms of time and labour. Future

initiatives to curtail hospital admission rates for mastitis and breast abscess may wish

not only to capitalize on the current pathway, but to also couple implementation to live

independent case review.

In addition to the integrated management pathway improving key process measures

and patient relevant outcomes, there are potentially significant cost benefits of getting

management ‘right first time’ (6), including oral rather than intravenous antibiotics,

ambulatory out-patient care rather than acute hospital admission, and ultrasound-

guided aspiration rather than emergency surgery under general anaesthesia. However,

such changes in practice have downstream consequences and an impact assessment

would highlight the additional cost of out-patient appointments, specialist ultrasound

assessments and image-guided aspirations. Interestingly here, while access to

ultrasound improved, the aspiration rate did not significantly change. The reasons for

this are likely multi-factorial, perhaps indicating the availability of staff with

appropriate skills in image-guided aspirations, or more likely due to the relative

proportions of inflammatory change (mastitis) versus collection (abscess), observed

sonographically. The latter may reflect scans being undertaken earlier in the natural

history of mastitis in patients managed promptly through the pathway, prior to abscess

development

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In summary, an integrated care pathway and referral proforma, along with sustained

education and training of staff, achieved significant and sustained improvements in the

management of patients with mastitis and/or breast abscess presenting to this NHS

Trust. These quality improvements may be generalisable to other acute Trusts with

similar organisational structures. Building upon this work to achieve large-scale change

requires strong leadership, anticipation of potential challenges, integration into

institutional quality improvement strategies, and pathway adaptation to reflect local

differences in healthcare resources (31, 35, 40, 41). Current ongoing work is focused on

making the referral proforma directly accessible online for local general practitioners,

thereby avoiding the need for patients to present to emergency services, as well as

exploring options for national-level engagement regarding breast sepsis through

collaborations with the breast surgery work stream of the GIRFT quality improvement

initiative (6).

Limitations of this clinical study include the retrospective nature of the initial audit,

which may have failed to capture the total number of episodes and details of treatment.

While every effort was made to ensure that all women with mastitis and/or breast

abscess were included during the study phases, cases in which the protocol or pathway

were not used may have been missed and the true denominator remains unknown.

Patient demographic data was not collected to determine the distribution of key

confounding variables such as breast-feeding, smoking or diabetes between the groups.

The number of patients included in this study was modest and the unpredictable nature

of mastitis/abscess presentations made it challenging to ensure parity in the number of

cases between each phase of study. The sample size may also have contributed to the

19

observation of clinically important improvements which failed to reach statistical

significance (type II error, false-negative findings), such as hospital admission rates and

length of in-patient stay.

Financial conflicts of interest

The authors declare that they have no competing interests.

Acknowledgments

Presentation and publication of this work elsewhere:

1) Development of a treatment pathway to improve quality of care in the management

of breast abscess and mastitis. Eshelby S, MacAskill F, Contractor K, Omar A,

Thiruchelvam P, Curtis S, Cunningham D, Al-Mufti R, Hadjiminas D, Leff DR. Presented at

the Association of Breast Surgeons meeting in 2016. Published in abstract form,

European Journal of Surgical Oncology, 2016: 42 (5), S4.

2) A ‘best-practice’ pathway for the acute management of mastitis and breast abscess

enables non-specialists to “get it right first time”. Patani N, MacAskill F, Eshelby S, Omar

A, Kaura A, Contractor K, Thiruchelvam P, Curtis S, Main J, Cunningham D, Hogben K, Al-

Mufti R, Hadjiminas D, Leff D. To be presented at the Association of Breast Surgeons

meeting in 2018.To be published in abstract form, European Journal of Surgical

Oncology.

20

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