the normalisation of scabies and impetigo: a cross ...€¦ · 190 impetigo and scabies are common...
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The normalisation of scabies and impetigo: A cross-sectional 1
comparative study of hospitalised children in northern 2
Australia assessing clinical recognition and treatment of 3
skin disease 4
5
Dr Daniel Kheng Choong Yeoh 6
MBBS, DTM&H (Liverpool) 7
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This thesis is presented for the degree of Master of Child Health Research of The University 18 of Western Australia 19
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Faculty of Medicine, Dentistry and Health Sciences 21
2017 22
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THESIS DECLARATION 24
I, Daniel Yeoh certify that: 25
This thesis has been substantially accomplished during enrolment in the degree. This thesis 26 does not contain material which has been accepted for the award of any other degree or 27 diploma in my name, in any university or other tertiary institution. No part of this work will, 28 in the future, be used in a submission in my name, for any other degree or diploma in any 29 university or other tertiary institution without the prior approval of The University of 30 Western Australia and where applicable, any partner institution responsible for the joint-31 award of this degree. 32
This thesis does not contain any material previously published or written by another person, 33 except where due reference has been made in the text. The work(s) are not in any way a 34 violation or infringement of any copyright, trademark, patent, or other rights whatsoever of 35 any person. The research involving human data reported in this thesis was assessed and 36 approved by The University of Western Australia Human Research Ethics Committee. 37 Approval No. RA/4/1/7759 – external approval), the Western Australian Country Health 38 Service Human Research and Ethics Committee (Approval No. 2015-17) and the Western 39 Australian Aboriginal Health Ethics Committee (HREC Reference No. 635).Written patient 40 consent has been received and archived for the research involving patient data reported in 41 this thesis. The work described in this thesis received in kind funding from the Princess 42 Margaret Hospital Foundation. This thesis contains published work and/or work prepared 43 for publication, some of which has been co-authored. 44
Signature: 45 46 PRESENTATIONS, PUBLICATIONS AND PRIZES 47
- Australian Society for Infectious Diseases ASM (Launceston, Tas) – April 2016 (Poster) 48 - Telethon Early Mid-Career Researcher (EMCR) Poster Morning Tea (Perth, WA) - May 2016 49 (Poster – best poster) 50 - International Congress on Tropical Medicine and Malaria (Brisbane, QLD) - Sept 2016 51 (Oral presentation – selected from abstract) 52 - Wesfarmers Centre for Vaccine and Infectious Diseases Research: Inspired by Infectious 53 Diseases Breakfast Presentation (Perth, WA) – Oct 2016 54 - Princess Margaret Hospital (PMH) Research Symposium Finalist (Perth, WA) – Nov 2016 55 - PMH Department of General Paediatrics Meeting (Perth, WA) – Feb 2017 56 - 5th Rural Dermatology Meeting (Broome, WA) – August 2017 (abstract submitted) 57 - Broome Hospital Journal Club – Aleisha Anderson (Broome, WA) – August 2016 58 - Kimberley Aboriginal Health Planning Forum – Asha Bowen (Broome, WA) - Feb 2017 59 60 - Yeoh DK, Bowen AC, Carapetis JR. Impetigo and Scabies – Disease burden and modern 61 treatment strategies. J Infect. 2016 Jul 5;72 Suppl:S61-7. 62 - Yeoh DK,Anderson A, Cleland G, Bowen AC. Are scabies and impetigo "normalised"? A 63 cross-sectional comparative study of hospitalised children in northern Australia assessing 64 clinical recognition and treatment of skin infections PloS Negl Trop Dis 11(7); e0005726. 65 https://doi.org/10.1371/journal.pntd.0005726 66
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AUTHORSHIP DECLARATION: CO-AUTHORED PUBLICATIONS 67 68 This thesis contains work that has been prepared for publication 69 70 Details of the work: SCAB Heal Study Manuscript
Location in thesis: page 23-42
Student contribution to work: Completed study protocol, ethics applications, data collection at one site, co-ordination of data collection, data entry and analysis, completed manuscript first draft.
Co-author signatures and dates:
GC G Cleland 12/4/17
AA
AB
71 Details of the work: Literature Review – Impetigo and Scabies – Disease burden and modern treatment strategies.
Location in thesis: page 9-21
Student contribution to work: Completed literature review and completed manuscript.
Co-author signatures and dates:
AB
JC
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Student signature: Date: 6/4/17
I, Asha Bowen certify that the student statements regarding their contribution to each of the works listed above are correct
Coordinating supervisor signature: Date: 6/4/17
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ABSTRACT 75
Background: 76
Complications of scabies and impetigo such as glomerulonephritis and invasive bacterial 77
infection in Australian Aboriginal children remain significant problems despite the 78
availability of effective treatment. We hypothesised that one factor contributing to this high 79
burden is that skin disease is under-recognised and hence under-treated, in settings where 80
prevalence is high. 81
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Methods: 83
We conducted a literature review to summarise the epidemiology of and current diagnostic 84
and treatment strategies for scabies and impetigo. We subsequently conducted a 85
prospective, cross-sectional study to assess the burden of scabies, impetigo, tinea and 86
pediculosis in children admitted to two regional Australian hospitals from October 2015 to 87
January 2016. A retrospective chart review of patients admitted in November 2014 (mid-88
point of the prospective data collection in the preceding year) was performed. Prevalence 89
of documented skin disease was compared in the prospective and retrospective population 90
to assess clinician recognition and treatment of skin infections. 91
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Results: 93
One hundred and fifty-eight patients with median age 3.6 years, 74% Aboriginal, were 94
prospectively recruited. 77 patient records were retrospectively reviewed. Scabies (8.2% vs 95
0.0%, OR N/A, p=0.006) and impetigo (49.4% vs 19.5%, OR 4.0 (95% confidence interval [CI 96
2.1– 7.7) were more prevalent in the prospective analysis. Skin examination was only 97
documented in 45.5% of cases in the retrospective review. Patients in the prospective 98
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analysis were more likely to be prescribed specific treatment for skin disease compared with 99
those in the retrospective review (31.6% vs 5.2%, OR 8.5 (95% CI 2.9-24.4). 100
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Conclusions: 102
Scabies and impetigo infections are under-recognised and hence under-treated by clinicians. 103
Improving the recognition and treatment of skin infections by clinicians is a priority to 104
reduce the high burden of skin infection and subsequent sequelae in paediatric populations 105
where skin disease is endemic. 106
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TABLE OF CONTENTS 108
1) General Introduction .................................................................................................... 9 109
2) Literature Review: Impetigo and scabies – Disease burden and modern treatment 110
strategies 111
- Introduction ................................................................................................................ 10 112
- Impetigo ...................................................................................................................... 11 113
- Background .............................................................................................................. 11 114
- Clinical Manifestations, Complications and Diagnosis ............................................... 12 115
- Treatment ................................................................................................................ 14 116
- Scabies ........................................................................................................................ 17 117
- Background .............................................................................................................. 17 118
- Clinical Manifestations, Complications and Diagnosis ............................................... 18 119
- Treatment ................................................................................................................ 20 120
- Conclusions ................................................................................................................. 22 121
3) SCAB Heal Study 122
- Introduction ................................................................................................................ 25 123
- Methods………………………………………………………………………………………………………………………27 124
- Study Design ............................................................................................................ 27 125
- Study Population and Setting ................................................................................... 27 126
- Data Collection and Management............................................................................. 28 127
- Definitions ............................................................................................................... 29 128
- Statistical Analysis .................................................................................................... 30 129
- Consent and Ethics Approval .................................................................................... 31 130
- Results ........................................................................................................................ 32 131
- Study Population ...................................................................................................... 32 132
- Table 1 – Baseline Characteristics – prospective vs retrospective .............................. 32 133
- Prevalence, Recognition and Treatment of Skin Disease............................................ 33 134
- Table 2 – Prevalence of Skin Disease – prospective vs retrospective .......................... 34 135
- Table 3 – Treatment of Skin Disease prospective vs retrospective ............................. 35 136
- Risk Factors and Associations ................................................................................... 36 137
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- Table 4 – Risk Factors for Skin Disease (Prospective only, univariate logistic analysis) 37 138
- Table 5 – Prevalence by Age Group (Prospective)……………………………………………………37 139
- Table 6 - Prevalence by Admission Reason (Prospective)………………………………………….37 140
- Microbiology of Skin Diseases .................................................................................. 38 141
- Figure 1 – Impetigo Microbiology ............................................................................. 39 142
- Conclusion ................................................................................................................... 44 143
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4) General Discussion………..……………….………..……..………..………..………..………..………………...45 145
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References...…………………………………………………………………………………………………………………..47 147
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Appendix A – SCAB Heal Study Protocol…………………………..…………………………....................53 149
Appendix B – Case Report Form (Prospective) ………………………………….…………...................58 150
Appendix C – Case Report Form (Retrospective) ……………………………….……………................60 151
Appendix D – Consent Form……………………………………….………………………………....................61 152
Appendix E – Patient / Carer Information Sheet……………………………………………..................62 153
Appendix F – WACHS HREC Approcal Letter…….……………………………………………..................64 154
Appendix G – WAAHEC Ethics Approval Letter………………………………………………..................66 155
Appendix H – Journal of Infection – Disease Burden and Modern Treatment Strategies….68 156
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Acknowledgements 165
I would like to acknowledge Dr Anita Banks from WACHS Pilbara, Professor Jeanette Ward 166
and the Kimberley Health Planning Forum Committee, the Kimberley Aboriginal Medical 167
Services Council, the Broome Regional Aboriginal Medical Service and Natasha Bear for their 168
support of this project. 169
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I would also like to acknowledge my supervisors and collaborators Dr Aleisha Anderson, Dr 171
Chris Blyth, Dr Gavin Cleland and especially Dr Asha Bowen for their hard work, support, 172
guidance and constant encouragement throughout. 173
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Finally, I would like to thank my wife and our little man Charlie for their patience, 175
encouragement and love throughout the last 2 years. 176
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Abbreviations: APSGN: Acute post streptococcal glomerulonephritis, ARF: acute rheumatic 185
fever; ATSI: Aboriginal and Torres Strait Islander, GAS: Group A streptococcus; MSSA: 186
methicillin-susceptible Staphylococcus aureus, MRSA: methicillin-resistant Staphylococcus 187
aureus, SSTI: skin and soft tissue infection; 188
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GENERAL INTRODUCTION 189
Impetigo and scabies are common infections with high prevalence in developing countries and 190
amongst disadvantaged populations in developed nations (1, 2). Although often considered trivial or 191
minor infections, both scabies and impetigo can lead to serious complications and the global burden 192
of disease is considerable (3, 4). Specific to the Australian setting, the high incidence of invasive 193
bacterial infection due to Staphylococcus aureus and Streptococcus pyogenes, and the prevalence of 194
both chronic renal disease and rheumatic heart disease amongst our Aboriginal population speak to 195
the significant local burden of complications of skin infection (5-12). 196
197
There are a number of effective treatment strategies for both scabies and impetigo, yet the burden 198
of complications persists. In recent years, there have been a small number of comparative clinical 199
trials demonstrating the efficacy of novel strategies for the treatment of impetigo and scabies 200
respectively(13, 14). Moreover, the translation of these findings and those from previous trials relies 201
in part on the accurate and timely diagnosis by medical staff in the clinical setting. Indeed, there are 202
some observational data to suggest that clinicians can fail to diagnose impetigo and scabies(15-17). 203
Clinician recognition of skin infection has not been assessed in paediatric populations or in the 204
Australian setting previously. 205
206
The first paper of this thesis seeks to summarise the current disease burden, diagnostic strategies 207
and treatment options for scabies and impetigo. The second paper outlines a novel study designed 208
to test the hypothesis that clinician under-recognition and ‘normalisation’ of scabies and impetigo 209
contribute to perpetuating the burden of complications in endemic settings. 210
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LITERATURE REVIEW 211
Impetigo and scabies – Disease burden and modern treatment strategies 212
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Authors: Yeoh DK (MBBS)1,2,3; Bowen AC (MBBS, FRACP, PhD)1,2,4,5; Carapetis JR (MBBS, 214
FRACP, PhD) 1,4,5 215
216
1. Department of Infectious Diseases, Princess Margaret Hospital for Children, Perth, 217
Western Australia 218
2. School of Paediatrics and Child Health, University of Western Australia, Perth, 219
Western Australia 220
3. Western Australia Country Health Service Kimberley Region, Broome, Western 221
Australia. 222
4. Telethon Kids Institute, University of Western Australia, Perth, Western Australia 223
5. Menzies School of Health Research, Charles Darwin University, Darwin, Northern 224
Territory 225
226
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Introduction 227
Both scabies and impetigo are common infections of the skin with a large global burden(1, 228
2) In the industrialised world, significant complications from scabies and impetigo are rare 229
whilst in resource-poor settings and certain marginalised communities, their collective 230
impact is much greater. There are several effective options for the treatment of both 231
scabies and impetigo. Despite this, challenges remain in addressing the burden of disease on 232
a community level in regions where infection is endemic. The under-recognition of skin 233
diseases in the health care setting may contribute to this. It is likely that health professionals 234
normalise skin disease in endemic settings, and as such fail to recommend treatment unless 235
specifically requested. 236
237
Impetigo 238
Background 239
Impetigo is a common superficial skin infection which predominantly affects young 240
children(18, 19). It is estimated that more than 162 million children are suffering from 241
impetigo at any one time(1). The burden of disease is highest in low-income countries and 242
within marginalised populations in developed nations(1). Infection is caused by invasion of 243
the epidermis by bacteria colonising the skin following minor trauma. Autoinoculation is 244
common and the infection is highly transmissible. Hot and humid climatic conditions, poor 245
access to water and possibly overcrowding are factors which play a role in frequent 246
impetigo transmission in endemic areas(19). 247
248
There is limited data of the prevalence of skin disease in the paediatric population in rural 249
and remote Western Australia. A study of the effect of swimming pools on the skin health of 250
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children in 2 remote aboriginal communities in the Pilbara estimated the prevalence of 251
impetigo at 62-70%(20). Studies from primary health care centres in the Northern Territory 252
and Far North Queensland give a similar picture of a high burden of disease (21-23). 253
Estimates of the prevalence of impetigo from colleagues working in the Kimberley region 254
range from 20-40%. 255
The bacterial aetiology of impetigo varies according to region and continues to change over 256
time. In tropical climates Streptococcus pyogenes (Group A Streptococcus or GAS) remains 257
the major pathogen(18, 19) and co-infection with Staphylococcus aureus is common(24). In 258
temperate climates S. aureus has largely replaced S. pyogenes as the predominant pathogen 259
in impetigo(25) and community acquired methicillin resistant S. aureus (CA-MRSA) is of 260
increasing importance worldwide(25-27). 261
Clinical Manifestations, Complications and Diagnosis 262
Impetigo can present as bullous lesions or non-bullous, papular lesions that go on to form a 263
crust. Bullous impetigo is caused by S. aureus whilst non-bullous lesions are associated with 264
both S. pyogenes and S. aureus as described above. Ecthyma is a deep form of impetigo in 265
which ulceration extends into the dermis. In the developed world impetigo is a common 266
reason for presentations to primary health care providers but it is generally a self-limiting 267
condition in this setting(28). In resource-limited settings severe disease and complications 268
of impetigo remain problematic(14, 18, 19) 269
Invasive infections such as erysipelas (involving the dermis and lymphatics), cellulitis 270
(involving subcutaneous tissue), osteomyelitis, septic arthritis and bacteraemia can all 271
complicate impetigo. S. pyogenes bacteraemia and streptococcal toxic shock syndrome are 272
commonly preceded by skin and soft tissue infection(6). S. aureus bacteraemia carries a high 273
13
mortality and skin infection is an important risk factor in settings where impetigo is 274
common(5, 27). 275
Where S. pyogenes is the predominant pathogen, impetigo can also lead to significant 276
immune-mediated complications. In endemic settings most cases of acute post 277
streptococcal glomerulonephritis (APSGN) are preceded by impetigo(7, 10). Individuals with 278
a history of APSGN in childhood are at increased risk of developing ongoing albuminuria and 279
chronic kidney disease in later life(8, 9). There is also a plausible link between S. pyogenes 280
skin infection and acute rheumatic fever(11). This hypothesis is supported by the presence 281
of endemic rates of rheumatic fever and rheumatic heart disease in aboriginal populations 282
in Australia wherein impetigo is pervasive and S. pyogenes throat infection is 283
uncommon(12). 284
The diagnosis of impetigo is generally made clinically. The use of clinical algorithms may aid 285
in the identification and treatment of impetigo in resource-limited settings. For example, 286
the WHO Integrated Management of Childhood Illness (IMCI) skin algorithm has been 287
assessed in Fiji and demonstrated improvement in the clinical recognition of impetigo (17). 288
Elsewhere, flipcharts using high quality photographs and clinical descriptions are used to 289
train health care workers in diagnosing impetigo(29). Gram stain and culture of skin swabs 290
to confirm the aetiological agent are often recommended(30) but adequate laboratory 291
resources are not always available in resource-limited settings. Nonetheless, in the current 292
milieu of increasing antimicrobial resistance(25), regional data on causative bacteriological 293
agents and their antibiotic sensitivity profiles remains vital(19). 294
295
There is limited data assessing clinical recognition of impetigo by health professionals. 296
Although the persistence of high-rates of impetigo in Northern Australia and other endemic 297
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settings is clearly due to a number of factors, it is likely that the recognition and treatment 298
of skin sores in the health care setting is an area where improvements could be made. As 299
will be discussed later with regards to scabies diagnosis, there is evidence to suggest that 300
skin infections are neglected by both patients and health professionals in communities 301
where they are common(15). 302
303
Treatment 304
When determining impetigo treatment, there are several important factors including the 305
extent of disease, community wide prevalence, likely adherence to treatment and known 306
antimicrobial resistance. Most of the trials for impetigo treatment relate to limited or 307
uncomplicated impetigo defined as fewer than 5 lesions. Where, impetigo is extensive 308
(greater than 5 lesions) or community prevalence is high, refer to the treatment section on 309
extensive impetigo. 310
Limited OR Uncomplicated impetigo 311
Topical antibiotics are the most effective treatment for limited impetigo(31). In this 312
systematic review which included 68 randomised control trials representing 5578 313
participants(31), mupirocin, fusidic acid and retapamulin were all shown to be superior to 314
placebo and there was no difference demonstrated between the most commonly studied 315
topical agents: mupirocin and fusidic acid. In addition, there was no significant difference 316
found in 7-day cure rates between topical and oral antibiotics (excluding erythromycin 317
which is inferior to topical mupirocin) and topical antibiotic use was associated with fewer 318
adverse events(31). The review also cited a lack of supportive evidence for the use of 319
disinfectant solutions in the treatment of impetigo(31). 320
15
There are several factors to consider when selecting a topical antibiotic. Resistance to 321
mupirocin and fusidic acid is increasing in association with increased use of these agents(25, 322
32). Although retapamulin has demonstrated good in vitro activity against methicillin 323
resistant S. aureus (MRSA), its efficacy in clinical trials against MRSA infections has been 324
variable(33, 34) and it is not approved for the treatment of MRSA infections. Moreover, S. 325
aureus isolates with elevated minimum inhibitory concentrations (MICs) to retapamulin 326
have been described although the clinical significance of this is uncertain(35). There are calls 327
to restrict the use of topical fusidic acid in order to preserve the oral formulation as a useful 328
agent (used in combination with rifampicin) for difficult-to-treat MRSA infections(32). 329
Topical fusidic acid is not available for use in the USA and this is reflected in the Infectious 330
Diseases Society of America (IDSA) guidelines for skin and soft tissue infection which 331
recommend topical retapamulin or mupirocin for uncomplicated impetigo(30). 332
Extensive impetigo 333
Determining the optimal treatment of extensive impetigo, particularly in resource-limited 334
settings where the burden of disease is highest, remains a challenge(19). It is generally 335
accepted that the use of systemic antibiotics for extensive disease is practical and 336
appropriate, yet there is limited data comparing therapies for this indication(19) and this is 337
a clear limitation of the systematic review on treatment of impetigo(31). Furthermore the 338
demonstrated frequency of co-infection of S. pyogenes with S. aureus and the emergence of 339
CA-MRSA present additional challenges in selecting appropriate therapy(24, 25). Individual 340
antibiotic treatment leads to resolution of impetigo lesions which likely reduce 341
transmission. Studies to date have not explored the effect of antibiotics on rarer endpoints 342
such as invasive infection or APSGN due to the large sample size required. Further work is 343
needed to understand the full benefits of treatment of extensive impetigo. 344
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The available systemic treatment options for impetigo have respective limitations. 345
Benzathine penicillin G (BPG) has been widely used however it is poorly tolerated due to its 346
intramuscular (IM) route of administration and its efficacy has been questioned with the 347
emergence of S. aureus as a pathogen in impetigo(19). Empiric therapy with S. aureus cover 348
is recommended for extensive impetigo however oxacillins and first generation 349
cephalosporins lack activity against MRSA and may not be appropriate in settings where 350
methicillin-resistance is common(30). Amongst oral agents with activity against MRSA, 351
tetracyclines are contraindicated for use in children and liquid formulations of lincosamides 352
are unpalatable for this age group. Co-trimoxazole (TMP-SMX) is an attractive option in that 353
it is cheap, licenced for use in children and is available in a palatable liquid formulation. 354
Although the conventional wisdom is that TMP-SMX lacks activity against S. pyogenes there 355
is both in vitro (25) and in vivo (8, + Miller et al NEJM 2015) data to challenge this 356
perception(36). 357
A recent large clinical trial demonstrated non-inferiority of oral co-trimoxazole compared to 358
IM BPG in the treatment of impetigo in indigenous children in Northern Australia(14). The 359
majority of participants (72%) had extensive disease and S. pyogenes and S.aureus were 360
isolated from 90% and 81% of participants respectively. Clearance of S. pyogenes (but not S. 361
aureus) was associated with clinical resolution of sores highlighting the primary role of 362
S.pyogenes in impetigo pathogenesis in this setting(14). The only other study that has clear 363
findings for this context compared oral amoxicillin with oral erythromycin for treatment of 364
impetigo. Treatment success was achieved in 89% of both groups, although microbiology 365
was not available(37). Presumably the high success rate seen in this study was also due to 366
the dominance of S. pyogenes in the microbiology of impetigo. 367
Community treatment and Prevention 368
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Community based drug administration in certain scenarios may reduce the burden of 369
disease associated with impetigo particularly in the setting of APSGN outbreaks and in 370
communities where scabies infestation is widespread. A review of observational studies of 371
such outbreaks in Northern Australia concluded that targeted treatment of children with 372
skin sores and household contacts of cases using BPG was warranted(38). In communities 373
where scabies is endemic targeted or mass community treatment of scabies has also been 374
shown to reduce the prevalence of impetigo(39, 40). 375
It is clear that the greatest burden of impetigo and its complications is borne by resource-376
limited populations and focus on disease prevention in these settings is key. There is 377
ongoing work in the development of a vaccine against GAS which could offer a cost-effective 378
and practical avenue for disease prevention(41). There are, however, barriers around 379
vaccine safety and efficacy and so far the advent of a GAS vaccine is not imminent(41). In 380
the interim, advocacy to improve access to health services, sanitation and housing and to 381
reduce overcrowding in areas where impetigo is highly prevalent should be a major focus in 382
disease prevention. There is some evidence that greater access to water in the form of 383
swimming pools(20, 42) or a combination of hand-washing and daily bathing(43) can reduce 384
the burden of impetigo. On a broader scale, as evidenced in the industrialisation of Asian 385
countries such as Singapore, complications such as APSGN can be virtually eliminated in the 386
setting of improved socioeconomic status, housing and health services(44). 387
388
389
Scabies 390
Background 391
18
Scabies is an infection of the skin caused by the mite Sarcoptes scabiei var hominis. The 392
adult mites burrow into the epidermis and reproduce. In the epidermis, the mites and their 393
excreta produce a delayed hypersensitivity reaction which is responsible for the rash and 394
pruritus associated with scabies infestation. Transmission is predominantly via prolonged 395
skin-to-skin contact and most commonly occurs between members of a household(3). 396
Unsurprisingly scabies infection is associated with overcrowding and socioeconomic 397
disadvantage (3, 19, 45) and children carry the highest burden of disease(2). The prevalence 398
of scabies was found to range from 0.2% to 71.4% in a recent systematic review of 399
population based studies(2). The highest prevalence is seen in tropical regions, such as 400
Central America, the Pacific islands and Northern Australia (2). In developed countries 401
prevalence is generally low but outbreaks amongst populations in institutionalised care are 402
well described (45). As with impetigo, there is limited data on the prevalence of scabies 403
specific to Western Australia but studies involving indigenous populations in other parts of 404
Northern Australia demonstrate a high burden of disease(21, 22). 405
Clinical Manifestations, Complications and Diagnosis 406
During primary infection, the appearance of symptoms is delayed until 4 weeks following 407
initial contact (3). Patients present with a papular or vesicular eruption which is intensely 408
pruritic, usually worse at night. The mites are most often found in web spaces of the fingers, 409
on the wrists, in the axillae, around the umbilicus and in the groin or the popliteal fossa. 410
Other family members may also have pruritus. The distribution of infestation is different in 411
infants with involvement of the palms, soles and scalp(46). 412
Scabies infestation is associated with significant complications related to secondary 413
infection with bacteria. Bacterial infection, particularly with S. pyogenes and S. aureus, is a 414
well-recognised complication of scabies infestation(5, 19, 24, 47). The presence of scabies is 415
19
associated with complications of impetigo including invasive bacterial infection and post-416
streptococcal glomerulonephritis (5-7). As discussed earlier, in endemic settings the 417
treatment of scabies at a community level has been shown to reduce the prevalence and 418
severity of skin sores(39) and haematuria(40). 419
Crusted Scabies is a severe form of scabies where the host immune system fails to control 420
the number of mites(48). It is characterised by crusted, hyperkeratotic lesions with mite 421
numbers reaching millions in some patients(48). Cases classically occur in 422
immunosuppressed patients and those in institutional care although, in particular 423
communities, patients with no underlying risk factors are also affected(48). Because of the 424
high mite burden, contacts of patients with crusted scabies are at high risk of infestation 425
themselves(49) and this may drive community outbreaks. 426
Diagnosis of scabies is predominantly based on the clinical findings of intense pruritus and a 427
typical distribution of papules. Skin scrapings occasionally reveal mites, ova or faeces, 428
however microscopy is time consuming, of low-yield and may be impractical in resource-429
limited settings (3, 50). While dermatoscopy is a potentially useful diagnostic tool, the cost 430
of equipment and the reliance on appropriate training are limitations (50, 51). As with 431
impetigo, clinical algorithms designed for use in resource-limited settings have shown 432
promise in increasing case identification and warrant further evaluation(17). Certainly 433
comparison between studies examining prevalence and treatment outcomes is hindered by 434
the lack of consensus criteria for the diagnosis of scabies (2, 46). Further research in 435
designing simple and accurate diagnostic tests for scabies is ongoing. 436
437
There is evidence that scabies is under-recognised by health professionals in both resource-438
limited(15) and industrialised(16) settings. In a cross-sectional study of a population 439
20
dwelling in a slum in Brazil only 28 of 54 patients with scabies sought specific treatment at 440
the adjacent primary health care centre(15). Although the community prevalence of scabies 441
was estimated at 8.8%, doctors at the health care centre failed to diagnose any cases of 442
scabies amongst the 260 patients who presented for other reasons during the study 443
period(15). These results suggest that scabies may be ‘normalised’ by both patients and 444
health professionals in endemic settings. Hong et al demonstrated that time constraints and 445
ED overcrowding were potential factors contributing to the missed diagnosis of scabies in 446
patients admitted to a tertiary hospital in Taiwan where the diagnosis was missed by the ED 447
physician in 65% (72 of 111) of cases(16). 448
449
Treatment 450
Individual treatment 451
There are various topical therapies utilised in the treatment of scabies. In a Cochrane 452
review of randomised control trials comparing scabies therapies, permethrin was found to 453
be the most effective topical therapy (superior to lindane and crotamiton)(46). Benzyl 454
benzoate is another effective topical therapy that is preferred in some resource-limited 455
settings due to the relatively high cost of permethrin (3, 52). The application of topical 456
scabies therapies can result in skin reactions and tolerability may be poorer in humid 457
tropical climates(46). 458
Ivermectin is an oral scabicide which was previously reserved for cases of scabies refractory 459
to topical therapy but is increasingly seen as a useful agent in individual and community 460
based treatment(53). As ivermectin is not ovicidal a second dose is recommended 8 to 15 461
days following the initial dose to prevent recrudescence(45). The efficacy of oral ivermectin 462
is superior to placebo and topical lindane whilst trials comparing oral ivermectin to topical 463
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benzyl benzoate have demonstrated mixed results(46, 52). In the Cochrane review of 464
scabies therapies, topical permethrin was found to be superior to oral ivermectin although 465
the length of follow up in included trials ranged from 1-2 weeks only(46). 466
Although ivermectin is an effective and well-tolerated agent in the treatment of scabies 467
there remain some limitations to its use. Resistance is a potential concern particularly in 468
endemic communities (54). Also, there is limited data demonstrating safety and tolerability 469
of ivermectin in infants(55) and it is not yet licensed for the treatment of uncomplicated 470
scabies in many regions. 471
Community Treatment and Prevention 472
The treatment of the close contacts of patients with scabies is recommended in order to 473
prevent re-infection and further transmission although there is limited data supporting this 474
strategy (53). Topical permethrin is considered first-line therapy (45), however poor 475
compliance amongst contacts has been identified as a barrier to the efficacy of this 476
approach (56). Oral ivermectin is an alternative agent for the treatment of contacts which 477
may prove effective and more acceptable than topical therapies but this has yet to be 478
assessed in comparative trials (3, 45). There is a clear need for further research in this area 479
with a recent Cochrane review failing to identify any well-designed randomised trials 480
assessing prophylactic measures to prevent the transmission of scabies (57). 481
Mass drug administration (MDA) may be an alternative approach to scabies control in 482
settings where scabies is endemic (3, 53). This strategy has been explored as a control 483
measure using permethrin(13, 58) and ivermectin (13, 40, 59) respectively with promising 484
results. Notably, a recently published randomised trial assessing the effectiveness of scabies 485
MDA in Fiji compared ivermectin MDA and permethrin MDA with standard care (i.e. 486
permethrin treatment of cases and contacts) in three separate island communities (13). 487
22
There was a significant and sustained reduction in scabies and impetigo in all three groups 488
with the most marked effect in the ivermectin group followed by the permethrin MDA 489
group. A significant reduction in the community prevalence of scabies has previously been 490
demonstrated following the implementation of an ivermectin MDA program for the 491
treatment of lymphatic filiariasis in Tanzania(60). This study highlights the potential for 492
collaborative research in assessing the effects of MDA programmes on a number of 493
neglected tropical diseases including scabies (61). 494
As with impetigo, the long-term control of scabies in endemic settings is greatly dependent 495
on addressing the social determinants of health within these populations. 496
497
Crusted Scabies Treatment 498
It is recommended that patients with crusted scabies be treated with a combination of 499
topical permethrin and oral ivermectin (45, 49). Keratolytic agents should also be applied to 500
skin crusts to increase the efficacy of the topical scabicide (45, 49). As yet there are no 501
randomised control trials comparing treatment regimens for patients with crusted scabies. 502
With regards to community control, active case identification and treatment of core 503
transmitters with crusted scabies within a population is a potential adjuvant approach in 504
endemic settings (49). 505
506
Conclusions 507
The significant impact of scabies and impetigo on the health of people in resource-limited 508
settings has in the past been under-recognised. Promisingly, there is growing interest and 509
advocacy concerning scabies and skin sores as demonstrated by the recent formation of the 510
23
International Alliance for the Control of Scabies (53) and the inclusion of scabies on the 511
WHO list of neglected tropical diseases in 2013. There is advocacy for impetigo to be 512
included on this list as well(1). 513
There are safe and efficacious treatments available for these common skin infections, yet in 514
many areas where disease burden is highest, little has changed with regards to control. 515
Ongoing research exploring risk factors and aetiology, improved methods for diagnosis and 516
approaches to both individual and community based treatment is required. Addressing the 517
environmental and socioeconomic factors which serve to perpetuate the high rates of skin 518
disease in certain communities is of chief importance. In addition to this, particularly in 519
regions where scabies and impetigo are endemic, improved recognition of these infections 520
in the health care setting and the opportunistic implementation of appropriate therapy 521
would contribute significantly to addressing the burden of disease. 522
523
24
SCAB HEAL STUDY 524
Are scabies and impetigo “normalised”? A cross-sectional comparative study of 525
hospitalised children in northern Australia assessing clinical recognition and treatment of 526
skin disease 527
528
Authors: Yeoh DK (MBBS)1,2,3; Anderson A (MBBS)1,3,4; Cleland G (MBBS, FRACP)2,3; Bowen 529
AC (MBBS, FRACP, PhD)1,2,5,6 530
531
6. Department of Infectious Diseases, Princess Margaret Hospital for Children, Perth, 532
Western Australia 533
7. School of Paediatrics and Child Health, University of Western Australia, Perth, 534
Western Australia 535
8. Western Australia Country Health Service Kimberley Region, Broome, Western 536
Australia. 537
9. Hedland Health Campus, Port Hedland, Western Australia 538
10. Wesfarmers Centre for Vaccine and Infectious Diseases, Telethon Kids Institute, 539
University of Western Australia, Perth, Western Australia 540
11. Menzies School of Health Research, Charles Darwin University, Darwin, Northern 541
Territory 542
543 544
25
Introduction 545
Skin infections including scabies, impetigo, tinea and pediculosis are common in children, 546
with high prevalence in developing countries and marginalised populations within 547
developed countries(1, 2, 7, 62). Community based skin infection prevalence studies from 548
Aboriginal populations in northern Australia demonstrate some of the highest prevalence 549
rates in the world(21, 63). 550
551
The high burden of skin infections is challenging in the primary health care setting, whilst 552
the serious sequelae of skin infections predominantly affect hospitalised patients. The 553
burden of these sequelae of skin infections is greatest where the prevalence is high(4, 53, 554
64). Impetigo and secondarily infected scabies lesions may be complicated by invasive 555
bacterial infections including cellulitis, skeletal infection and bacteraemia(6, 27, 65, 66). 556
Immune complications of impetigo are important in tropical regions where Streptococcus 557
pyogenes (Group A Streptococcus or GAS) is the predominant pathogen(4, 7, 67). In 558
endemic settings most cases of acute post streptococcal glomerulonephritis (APSGN) are 559
preceded by impetigo(10) and scabies infestation has been shown to be associated with 560
renal disease(40). There is also a plausible link between S. pyogenes skin infection and acute 561
rheumatic fever (ARF) and rheumatic heart disease(11). 562
563
There are effective and relatively well tolerated treatments for skin infections, yet the 564
burden of disease appears to be increasing or at least stable in endemic settings(14, 46, 68). 565
Translation of these evidence-based treatments depends on the successful recognition and 566
diagnosis of skin infection by clinicians. 567
568
26
We hypothesised that under-recognition due to the ‘normalisation’ of skin disease by 569
clinicians contributes to under-treatment and the perpetuation of skin disease and 570
subsequent sequelae in endemic settings. Normalisation is a term to describe that in 571
contexts of high burden, but not life threatening disease clinicians may not specifically 572
diagnose or treat scabies, impetigo, pediculosis or tinea when a patient presents to a health 573
care provider for a reason other than skin infection. To test this hypothesis, we designed 574
this study to prospectively assess prevalence of skin disease and to assess recognition by 575
comparing this with the documented prevalence in a retrospective case note review.576
27
Methods 577
Study Design 578
We performed a prospective, cross-sectional study to ascertain prevalence of skin disease 579
and compared this with a retrospective, cross-sectional study to assess recognition of skin 580
disease by health professionals. In the prospective arm, patients were opportunistically 581
recruited from two regional hospitals during the period from October 2015 to January 2016. 582
Data for the retrospective review were obtained from the medical records of all patients 583
admitted to the two paediatric wards in November 2014 at both centers. The retrospective 584
data collection was limited to a one-month period that was the mid-point in the prospective 585
data collection period for feasibility. This retrospective data capture provided the same 586
season and likely admission profile as the prospective study. 587
588
Study Population and Setting 589
All children and adolescents (aged <16 years) admitted to Broome Hospital (a 36 bed facility 590
with 8 paediatric inpatient beds) and Hedland Health Campus (a 55 bed facility with 8 591
paediatric inpatient beds) during the study period were eligible for participation in the 592
prospective study. These two hospitals provide the regional paediatric services for the 593
Kimberley and Pilbara regions respectively, covering a total catchment of greater than 900 594
000 km2 in the north of the state of Western Australia. In combination, these units admit 595
around 1500 paediatric patients annually(69) servicing a total paediatric population of over 596
20 000 (70). The study was conducted during the tropical “wet season” when temperatures 597
are on average 33-36oC respectively and rainfall and humidity are high(70). The population 598
of the Kimberley region is 37,000 of whom 40% are Aboriginal(70) The population of the 599
Pilbara is 62,000 of whom 12% are Aboriginal(70). 600
28
601
Patients were recruited by the site coordinator (DY, AA) at the two sites. An attempt to 602
approach all admitted patients was made by the respective site coordinators and 603
individuals were approached to participate regardless of the reason for admission, co-604
morbidities, ethnicity, language spoken, address or gender. Individuals were excluded if the 605
individual or the parent / carer did not assent or consent to participation or if there was no 606
parent / carer available to provide consent. 607
608
Data Collection and Management 609
All participants in the prospective arm of the project underwent assessment including: 610
a) directed history including age, ethnicity, locality of residence, number of 611
household members, primary reason for admission, past history of skin disease, 612
treatment and complications 613
b) a full examination of the skin looking specifically for scabies (including 614
secondarily infected lesions), impetigo (flat/dry, crusted or purulent lesions), 615
tinea corporis, tinea capitis and pediculosis. 616
c) any treatment prescribed for skin disease was recorded and classified as either 617
primarily for skin disease or for another indication but also covering skin disease 618
(e.g. osteomyelitis, septic arthritis as the primary condition under treatment). 619
620
All purulent or crusted skin lesions were swabbed and sent for microscopy, culture and 621
antibiotic susceptibility testing according to standardized methods. All samples were 622
delivered to the local microbiology laboratory and subsequently sent to a tertiary laboratory 623
(over 2500km away) for processing. 624
29
625
In the retrospective review of medical records age, ethnicity, locality of residence, number 626
of household members, primary reason for admission, history of skin disease (including 627
complications and comorbidities), documentation of skin disease on physical examination 628
and treatment recommendations were recorded. Pathology records were reviewed for each 629
patient and microbiology of skin lesions was recorded where applicable. 630
631
All data were initially recorded onto standard case report forms and subsequently entered 632
onto a secure online database (REDCap Software – Version 6.10.12). 633
634
Definitions 635
Ethnicity was self-reported or as recorded in the medical record as Aboriginal and/or Torres 636
Strait Islander (ATSI), Pacific Islander / Maori, Caucasian or other. Locality was assessed and 637
classified for each participant as a local town (resident in Broome or Port Hedland), another 638
regional town (within the region but outside of Broome and Port Hedland) or a remote 639
Aboriginal community. By the Australian Standard Geographical Classification (ASGC) for 640
remoteness, Broome, Port Hedland and Karratha are considered remote and the remainder 641
of the Kimberley and Pilbara are considered very remote(71). Remote Aboriginal 642
communities are defined areas inhabited by Aboriginal people with housing and 643
infrastructure that is managed on a community basis(72). Whilst nearly all are connected to 644
essential services disruptions are commonplace with 38%, 85% and 49% of communities 645
reporting disruptions to water supply, electricity and sewage disposal respectively in 646
2001(72). Access to health services is often limited with 74% of communities 100km or 647
30
further from the nearest hospital and only 12% with a local doctor resident in the 648
community(72). 649
650
Skin disease was defined as scabies, impetigo, tinea corporis, tinea capitis and/or 651
pediculosis. A standard diagnostic guideline with clinical and photographic definitions of 652
each condition was used as a reference tool in the prospective assessment of skin 653
disease(73). Scabies, a parasitic infection of the skin was diagnosed in the presence of 654
pruritic papules in a typical distribution; classically in the web spaces, hands, feet and other 655
moist areas. Impetigo is a bacterial infection of the superficial skin. Clinical detection ranges 656
from active purulent or crusted lesions to resolving flat, dry lesions. Tinea infections were 657
diagnosed based on well-demarcated areas of scale with a raised edge and itch. Pediculosis 658
was diagnosed if either the live lice or nits attached to strands of hair were visualized. 659
Secondary bacterial infection of parasitic or fungal lesions was diagnosed in the presence of 660
pus or a crust. Cellulitis and abscess were not included in this assessment. Each condition 661
was diagnosed clinically by the site’s study coordinator (a paediatric clinician) and treatment 662
was prescribed according to local guidelines(74). 663
664
Statistical Analysis 665
The primary objective was to compare the prevalence of skin disease in the prospective 666
study with the documented prevalence in the retrospective review. The 667
demographic details of patients and microbiology of impetigo lesions were reported for 668
each group using descriptive statistics. Prevalence of each of the skin diseases (scabies, 669
impetigo, tinea, and pediculosis) in the prospective and retrospective cohort was 670
determined. Odds ratios comparing frequency of each skin disease and frequency of 671
31
treatment prescribed in the prospective and retrospective cohorts were calculated using 672
logistic regression. Univariate analysis of associations between skin disease and age, 673
admission reason, overcrowding and ethnicity respectively was performed using logistic 674
regression. Comparison of categorical data was conducted using logistic regression, 675
Pearson’s Chi-square test or Fisher’s exact test (where 0 events occurred in one or more 676
groups). P-values of <0.05 were considered to indicate statistical significance. All statistical 677
analysis was performed using SPSS statistics version 23.0.0.0 (Armonk, NY: IBM Corp.). 678
679
Consent and Ethics Approval 680
Participation in the study was voluntary and verbal and written informed consent was 681
sought from each participant’s parent or appropriate guardian and where appropriate (i.e. 682
in children >7yo) assent was obtained. Ethics approval was granted by the Western 683
Australian Country Health Service Research Ethics Committee (project number 2015:11) and 684
the Western Australian Aboriginal Health Ethics Committee (project number 635). The study 685
protocol was finalised only after consultation with the Kimberley Aboriginal Health Planning 686
Forum Environmental Health and Research subcommittees as well as local Aboriginal 687
Medical Services. 688
689
32
Results 690
Study Population 691
One hundred and fifty-eight patients were included in the prospective assessment; 102 from 692
Broome and 56 from Port Hedland. This was 43.8% of those admitted during the period. No 693
patients who were approached to participate refused to consent. Seventy-seven patient 694
records were reviewed in the retrospective arm; 46 from Broome and 31 from Port 695
Hedland. 696
697
The demographic characteristics including age, gender, ethnicity and area of residence 698
along with the primary reason for admission were similar between the prospective and 699
retrospective cohorts (Table 1). In the prospectively assessed group median age was 3.6 700
years (interquartile range [IQR} 0.9-7.4), 74.1% were of Aboriginal ethnicity and 25.3% were 701
from a remote Aboriginal community. The most common reason for admission was 702
respiratory illness (34.2% prospective, 28.6% retrospective). Conditions that may complicate 703
skin disease including APSGN, ARF, skeletal infections and soft-tissue infections accounted 704
for almost one-quarter of admissions (24.1% prospective, 20.8% retrospective). 705
706
Table 1 – Baseline Characteristics – prospective vs retrospective 707 708
Characteristic Prospective Cases (n=158)
Retrospective Review (n=77)
P-value*
Hospital: Broome n (%) Port Hedland n (%)
102 (64.6 %) 56 (35.4 %)
46 (59.7 %) 31 (40.3 %)
0.473
Age in years: median (IQR)
3.6 (0.9, 7.4)
4.1 (1.4, 9.5)
0.746#
Gender: Male, n (%)
86 (54.4 %)
43 (55.8 %)
0.838
33
Ethnicity: Aboriginal / Torres Strait Islander (ATSI), n (%)
117 (74.1%)^
50 (64.9%)
0.148
Community of residence: local town, n (%) other town, n (%) remote community, n (%)
92 (58.2 %) 26 (16.5 %) 40 (25.3 %)
52 (67.5 %) 9 (11.7 %)
16 (20.8 %)
0.374
Primary Admission Reason: APSGN, n (%) ARF, n (%) bone / joint infection, n (%) SSTI, n (%) Respiratory, n (%) Gastroenteritis, n (%) UTI/CNS, other infection, n (%) Injury / Immersion, n (%) Surgical / ENT / Dental, n (%) FTT, n (%) Other, n (%)
7 (4.4 %) 4 (2.5 %) 3 (1.9 %)
24 (15.2 %) 54 (34.2 %) 23 (14.6 %)
8 (5.1 %) 9 (5.7 %)
13 (8.2 %) 3 (1.9 %)
10 (6.3 %)
4 (5.2 %) 2 (2.6 %) 1 (1.3 %)
9 (11.7 %) 22 (28.6 %) 13 (16.9 %)
2 (2.6 %) 6 (7.8 %)
8 (10.4 %) 0 (0.0 %)
10 (13.0 %)
0.741
*Pearson’s Chi-square (unless otherwise specified) 709 # Mann Whitney U Test 710 ^compared with overall ATSI population 12% in Pilbara and 40% in Kimberley in 2011 (22) 711
APSGN: Acute post streptococcal glomerulonephritis, ARF: acute rheumatic fever; SSTI: skin 712 and soft tissue infection, ENT: ear nose or throat infection, UTI: urinary tract infection, CNS: 713 central nervous system infection, FTT: failure to thrive 714 715
716
Less than 20% of patients in the prospective analysis reported receiving specific treatment 717
for skin disease in the twelve months prior to admission; 13.9 % of patients had received 718
treatment for scabies, 18.4% for impetigo and 13.9% for pediculosis. 719
720
721
Prevalence, Recognition and Treatment of Skin Disease 722
34
Prevalence of skin disease was high in the prospectively assessed group with 53.2% of 723
patients diagnosed with one or more skin diseases. Scabies was diagnosed in 8.2% (95% CI 724
3.9–12.6). Impetigo was present in 49.4% (95% confidence interval [CI] 41.5–57.3%) of 725
participants, with crusted or purulent lesions identified in 27.8% (95% CI 20.8–34.9%)tinea 726
was identified in in 8.2% (95% CI 3.9–12.6) and pediculosis in 14.6% (95% CI 9.0–20.1). 727
728
The recognition of skin disease was four-fold greater in the prospective assessment 729
compared with the retrospective review; odds ratio (OR) 4.0 (95% CI 2.2-7.5) (Table 2). Skin 730
disease was diagnosed in 22.1% of patients in the retrospective review and notably 54.5% 731
did not have any skin examination findings documented anywhere in the case notes. The 732
prevalence of scabies (8.2% vs 0.0%; OR N/A (p=0.006)), impetigo (49.4% vs 19.5%; OR 4.0 733
(2.1-7.7)) and pediculosis (14.6% vs 1.3%; OR 13.0(1.7-97.8)) respectively were significantly 734
higher in the prospective assessment compared with the retrospective review. Prevalence 735
of tinea was not significantly higher in the prospective assessment (8.2% vs 2.6%; OR 3.4 736
(0.7-15.3)) 737
738
Table 2 – Prevalence of Skin Disease – prospective vs retrospective 739 740
Skin Disease Prospective Cases
(n=156)
Retrospective Review (n=77)
OR (95% CI) p-value
Any skin lesions: Total n (%)
84 (53.2 %)
17 (22.1 %)
4.0 (2.2-7.5)
<0.001*
Scabies: Total n (%)
13 (8.2 %)
0 (0 %)
N/A
0.006*#
Impetigo (total): Total n(%)
78 (49.4 %)
15 (19.5 %)
4.0 (2.1-7.7)
<0.001*
Impetigo (purulent/crusted): Total n (%)
44 (27.8 %)
12 (15.6 %)
2.1 (1.0-4.2)
0.041*
35
Tinea Corporis / Capitis: Total n (%)
13 (8.2 %)
2 (2.6 %)
3.4 (0.7-15.3)
0.117
Pediculosis: Total n (%)
23 (14.6 %)
1 (1.3 %)
13.0 (1.7-97.8)
0.013*
741 #Fisher’s exact test (2-sided) used where 0 events in retrospective arm 742 743
744
Specific treatments for scabies, impetigo, tinea and/or pediculosis were prescribed eight 745
times more frequently in the prospective assessment (31.6% vs 5.2%; OR 8.5 (95% CI 2.9-746
24.4)) (Table 3). Antibiotics were the most commonly prescribed treatment and significantly 747
more patients in the prospective analysis received antibiotics for skin disease (27.8% vs 14.3 748
%; OR 2.3 (1.1-4.8)). No patients received treatment for scabies or tinea in the retrospective 749
group while all patients diagnosed in the prospective assessment received treatment. 750
Environmental health measures were implemented in 8.2% of the prospective cases 751
compared with none in the retrospective review (p=0.006). Although skin infection 752
recognition was higher in the prospective arm, the communication of this finding was poor. 753
In a subsequent review, only 64.6% (31 of 48) of children who received treatment for skin 754
disease in Broome in the prospective study had this documented in the discharge letter. 755
Table 3 – Treatment of Skin Disease prospective vs retrospective 756 757
Treatment Prospective Cases (n=156)
Retrospective Review (n=77)
OR (95% CI) p-value
Treatment recommended (specifically for skin)#: Total n (%)
50 (31.6 %)
4 (5.2 %)
8.5 (2.9-24.4)
<0.001*
Treatment recommended (any covering skin disease)^: Total n (%)
62 (39.2 %)
12 (15.6 %)
3.5 (1.8-7.0)
<0.001*
Treatment Type: IV antibiotics n (%) IM antibiotics n (%)
21 (13.3 %)
6 (3.8 %)
9 (11.7 %) 1 (1.3 %)
1.2 (0.5-2.7)
3.0 (0.4-25.4)
0.730 0.313
36
Oral antibiotics n (%) Any antibiotic n (%) Oral scabicide n (%) Topical scabicide n (%) Oral antifungal n (%) Topical antifungal n (%) Pediculosis treatment n (%)
24 (15.2 %) 44 (27.8 %)a
1 (0.6 %)
14 (8.9 %)b
4 (2.5 %) 10 (6.3 %)c
22 (13.9 %)d
6 (7.8 %) 11 (14.3 %)
0 (0 %) 0 (0 %)
0 (0 %) 0 (0 %)
2 (2.6 %)
2.1 (0.8-5.4) 2.3 (1.1-4.8)
N/A N/A
N/A N/A
6.1 (1.4-26.5)
0.117 0.024*
1.000
0.006*
0.306 0.033*
0.017*
Environmental Health measures**: recommended n (%)
13 (8.2 %)
0 (0 %)
N/A
0.006*
758 # treatment specifically for skin disease (not otherwise indicated) 759 ^treatment for skin disease specifically or for another indication but also treating skin lesion 760 (eg anti-staphylococcal antibiotics for osteomyelitis) 761 **environmental health measures – treatment of household contacts and education around 762 cleaning household linen and clothing 763 IV = intravenous, IM = intramuscular 764 765
766
Risk Factors and Associations 767
Household overcrowding, Aboriginal ethnicity, older age (>5yo) and residence in a remote 768
community were all associated with an increased odds of skin disease in the prospectively 769
assessed group (Table 4). Scabies, impetigo and pediculosis were all significantly associated 770
with Aboriginal ethnicity and household overcrowding. Increased age was associated with 771
increased prevalence of impetigo and pediculosis whilst prevalence of scabies and tinea was 772
similar between age groups (Table 5). Children aged >5y were 3 times more likely to have a 773
condition complicating skin disease (APSGN, ARF, bone and joint infection and soft tissue 774
infection) as the primary admission diagnosis compared with those <5y age; OR 3.2 (95%CI 775
1.5-6.9). 776
777
37
Table 4 – Risk Factors for Skin Disease (Prospective only, univariate logistic analysis) 778 779
Characteristic Any lesions: OR (95 % CI)
Scabies: OR (95 % CI)
Impetigo: OR (95 % CI)
Tinea: OR (95 % CI)
Pediculosis: OR (95 % CI)
Ethnicity: Non-ATSI ATSI
1 (ref)
28.5
(8.3-98.4)
1 (ref)
N/A *
p=0.022
1 (ref)
36.2
(8.3-157.4)
1 (ref)
4.6
(0.6-36.3)
1 (ref)
N/A ** p=0.001
Remoteness: Town Remote community
1 (ref)
7.7
(3.0-19.8)
1 (ref)
1.4
(0.4-4.6)
1 (ref)
9.5
(3.7-24.5)
1 (ref)
2.8
(0.9-8.9)
1 (ref)
1.7
(0.9-5.5)
Household: 5 or less >5 members
1 (ref)
3.9
(1.9-7.9)
1 (ref)
4.0
(1.2-14.0)
1 (ref)
3.4
(1.7-6.8)
1 (ref)
2.2
(0.7-7.0)
1 (ref)
4.2
(1.7-10.8)
780 * no cases of scabies in non-Aboriginal patients (p-value 0.022) (Fisher’s) 781 ** no cases of pediculosis in non-Aboriginal patients (p-value 0.001) (Fisher’s) 782 ATSI - Aboriginal and Torres Strait Islander 783 784 785 Table 5 – Prevalence by Age Group (Prospective) 786 787
Age (n) <1mo (6)
1-5mo (18)
6-12mo (18)
1-4yo (52)
5-10yo (43)
>10yo (21)
p-value^
Any skin lesions: prevalence
0 %
33.3 %
33.3 %
55.8 %
62.8 %
76.2 %
0.002*
Scabies: prevalence
0 %
11.1 %
11.1 %
5.8 %
9.3 %
9.5 %
0.917
Impetigo (total): prevalence
0 %
27.8 %
33.3 %
48.1 %
62.8 %
71.4 %
0.003*
Tinea: prevalence
0 %
5.6 %
5.6 %
9.6 %
9..3 %
9.5 %
0.952
Pediculosis: prevalence
0 %
0 %
5.6 %
9.6 %
32.6 %
14.3 %
0.004*
^ Pearson’s chi-square test 788 789
790
38
Where the reason for admission was a condition associated with or complicating skin 791
disease the prevalence of impetigo was significantly higher compared with admission for 792
other reasons (Table 6). Despite this difference, skin disease was still common amongst 793
those admitted for reasons not directly associated with or complicating skin infection with 794
40.5% (95% CI 31.6–49.4) of these patients having any skin disease: scabies in 6.6% (95% CI 795
2.1–11.1), impetigo in 35.5% (95% CI 26.9–44.2), crusted/purulent impetigo in 13.2% (95% 796
CI 7.1–19.4), tinea capitis / corporis in 5.8% (95% CI 1.6–10.0) and pediculosis in 9.9 % (95% 797
CI 4.5-15.3). 798
799
Table 6 – Prevalence by Admission Reason (Prospective) 800 801
Admission reason SSTI / BJI / ARF / APSGN (37)
Other (121)
OR (95 % CI)
p-value
Any skin lesions: prevalence
35 (94.6 %)
49 (40.5 %)
25.7 (5.9-111.9)
<0.001*
Scabies: prevalence
5 (13.5 %)
8 (6.6 %)
2.2 (0.7-7.2)
0.190
Impetigo (total): prevalence
35 (94.6 %)
43 (35.5 %)
31.7 (7.3-138.5)
<0.001*
Tinea: prevalence
6 (16.2 %)
7 (5.8 %)
3.15 (1.0-10.1)
0.052
Pediculosis: prevalence
11 (29.7 %)
12 (9.9 %)
3.8 (1.5-9.7)
0.004*
802
803
Microbiology of Skin Diseases 804
Bacterial swabs were collected from 41/ 44 (93.2%) participants with crusted and purulent 805
impetigo lesions in the prospective assessment. An organism was isolated in 37/41 (91%). 806
Staphylococcus aureus (30/37, 81% of swabs) and Streptococcus pyogenes (18/41, 44%) 807
were the predominant pathogens and co-infection (15/41, 37%) was common (Figure 1). Of 808
the S. aureus isolates 13 (39%) were methicillin resistant (MRSA). All S. aureus isolates were 809
39
susceptible to co-trimoxazole (SXT). 90% of methicillin susceptible S. aureus (MSSA) and 810
77% of MRSA isolates were susceptible to clindamycin. All S. pyogenes were susceptible to 811
penicillin. Susceptibility of S. pyogenes to SXT is not routinely tested in our laboratory. 812
813
Figure 1 – Impetigo Microbiology 814 815
816 total 41 samples from prospectively assessed patients with crusted or purulent impetigo 817 818
819
820
7.3%
24.4%
24.4%
19.5%
12.2%
2.4%
9.8%
S. pyogenes (GAS)
MSSA
MSSA & GAS
MRSA
MRSA & GAS
other
no growth
40
821
Discussion 822
Our findings demonstrate that under-recognition of skin disease is clearly an important 823
problem; consequentially specific treatment for skin disease is not offered by clinicians. 824
Previous studies have confirmed that under-recognition of scabies occurs in industrialised 825
(16) and resource limited settings (15) due to the absence of diagnostic tests. This is the first 826
comparative study to demonstrate the under-recognition by clinicians of impetigo along 827
with scabies and pediculosis in a region of high skin infection prevalence. 828
829
The implications of under-recognition of skin infection are manifold. The significant 830
individual complications of scabies, pediculosis and impetigo are well documented(4, 7, 11, 831
53, 62, 64, 68). Scabies, impetigo and pediculosis are highly transmissible and the 832
assessment and treatment of household members is recommended as important public 833
health control measures to prevent onward transmission and re-infection(45, 75). In failing 834
to treat children and their family members for skin infections during a hospital admission, 835
clinicians may miss the opportunity to prevent serious individual complications, perpetuate 836
the cycle of ongoing transmission within communities and possibly render other patients at 837
risk by failing to implement appropriate infection control measures. 838
839
The prevalence of skin disease is high in this region as demonstrated in our prospective 840
assessment with over half of all children having at least one form of skin infection. Limited 841
data exists regarding prevalence of skin disease in the Kimberley and Pilbara region 842
although other studies in regional Western and Northern Australia have found similarly high 843
rates(20, 21, 63). This high prevalence in our study supports our hypothesis that the under-844
41
recognition of skin infection is not a product of lack of familiarity with skin infection but 845
rather that clinicians may ‘normalise’ skin infection because it is pervasive. 846
847
S. aureus was the most common pathogen in impetigo lesions in our study with S. pyogenes 848
implicated in less than half of cases. In previous studies S. pyogenes has been demonstrated 849
as the predominant pathogen in impetigo in tropical regions where co-infection with S. 850
aureus is also common(67). The yield of S. pyogenes culture may have been reduced in our 851
study due to the processing of samples which were sent to a tertiary laboratory over 852
2500km away for plating. S. pyogenes requires rigorous temperature and humidity controls 853
to prevent deterioration(76). Our results also reflect the increasing importance of 854
community acquired MRSA as a pathogen in the Australian setting with almost 50% of S. 855
aureus demonstrating methicillin resistance, as has been apparent in recent times(27). 856
857
Clearly other broad factors including the social determinants of health and patient access to 858
health services significantly contribute to the persistent high burden of skin disease and 859
complications in this setting. Overcrowding, poor access to water and poverty have been 860
associated with scabies and impetigo(1, 2, 53, 77), and indeed in our prospective analysis 861
those patients from overcrowded households and remote Aboriginal communities had 862
significantly increased odds of skin disease. As evidenced in the industrialisation of tropical 863
countries such as Singapore, improvements in housing along with better access to quality 864
healthcare can significantly impact on the burden of skin disease complications such as 865
post-streptococcal glomerulonephritis(44). 866
867
42
It is reasonable to conceive that skin disease is also under-recognised outside of the hospital 868
setting. This is compounded by the poor communication of diagnosis and treatment of skin 869
infections documented by hospital staff on discharge back to primary care providers. 870
Despite the high prevalence of skin disease in our population, few children had received 871
specific treatment for impetigo in the preceding twelve months. This speaks to the likely 872
‘normalisation’ of skin sores amongst patients and families as well as under-treatment of 873
skin disease in primary health care and community clinics. Strategies to improve recognition 874
of and awareness of the complications of skin disease and the importance of treatment 875
should consider primary health care workers, community workers, teachers, environmental 876
health providers as well as children and their families. 877
878
This study has several limitations. Firstly, we were not able to recruit all of the eligible 879
patients during the study period due to the availability of study staff and clinical 880
commitments at other sites. Although recruitment was opportunistic, all children admitted 881
to the ward were approached to participate when the study site doctor was present in order 882
to achieve a representative sample. Secondly, in the prospective assessment, the diagnosis 883
of skin disease was made clinically. In order to limit possible bias due to the reliance on 884
clinical judgement, a diagnostic guide with clear clinical definitions was used as a reference 885
tool in all cases(73). Finally, by virtue of the study design the assessment of clinician 886
recognition of skin disease was performed retrospectively. Although it is plausible that 887
clinicians did in fact recognise skin disease but did not document this, specific treatment for 888
skin disease was prescribed far less frequently in the retrospective analysis supporting the 889
finding of clinician under-recognition. Notwithstanding the limitations of this study the 890
findings have significant implications for policy and future research. 891
43
892
As the diagnosis of skin infections in endemic settings remains predominantly clinical, 893
training of health care providers is vital in improving recognition. Specific training of health 894
workers has been shown to improve recognition and treatment of skin disease in resource-895
poor settings(78). The use of integrated algorithms for the management of skin disease in 896
health clinics has also demonstrated promise as a strategy to improve diagnosis of skin 897
disease(17, 79). Future policy in regions with high prevalence of skin infection should direct 898
the training of clinicians in the recognition and treatment of skin disease as well as the 899
implementation of local diagnostic and therapeutic guidelines. The use of mass drug 900
administration to target scabies has shown promise in populations with endemic disease; 901
this strategy may allow circumvention of some of the challenges around clinical under-902
recognition and normalisation of skin disease in selected settings(13). 903
904
Other factors outside of lack of skills and training likely contribute to the under-recognition 905
of skin disease and warrant further investigation. Identifying barriers to clinician diagnosis 906
and treatment of skin disease and exploring reasons for the ‘normalisation’ of skin disease 907
through well-designed qualitative research is vital. Measuring potential under-recognition of 908
skin disease at a patient and community level and exploring factors that contribute should 909
be a focus of future studies. Moreover, ongoing efforts to address the social determinants 910
which lead to the disproportionate load borne by people of Aboriginal ethnicity, particularly 911
those living in remote communities, remain of great importance. 912
913
914
915
44
Conclusion 916
Skin infections are under-recognised by clinicians and this leads to suboptimal treatment 917
and likely contributes to the significant ongoing burden of sequelae. There are many factors 918
which contribute to the challenge of addressing the problem of skin disease and improving 919
clinician recognition and treatment of skin disease is a priority. 920
921
922
45
GENERAL DISCUSSION 923
Scabies and impetigo remain highly prevalent in paediatric populations in the developing world as 924
well as in Aboriginal populations in northern Australia. The complications of these skin infections 925
contribute to a significant overall burden of disease. Despite the availability of tolerable and 926
efficacious individual therapies, recognition of these conditions remains reliant predominantly on 927
clinical diagnosis. Hence, the failure of clinicians to diagnose and subsequently prescribe 928
appropriate therapy persists as a barrier to preventing complications in individual patients and 929
onward transmission in the community setting. The under-recognition of scabies and impetigo by 930
clinicians in an endemic setting, as demonstrated by this body of research, suggests that skin 931
infections are normalised where they are common, that is to say in regions where appropriate 932
treatment is most important. 933
934
The logical focus of research leading on from this data should include the identification of barriers to 935
clinician recognition and treatment, the exploration of interventions to improve clinician diagnosis 936
and the further evaluation of alternative strategies to individual case management such as mass-937
drug administration. Further qualitative evaluation of reasons for under-recognition of scabies and 938
impetigo amongst hospital clinicians in northern Australia could marry with similar studies at 939
regional and remote health centres to inform strategies to improve diagnosis and education of 940
health workers in general. Assessing specific strategies to improve clinician recognition and 941
treatment of skin infections such as educational resources, clinical algorithms and / or standing 942
orders and standardized protocols in regional clinics will help inform policy on the best approach to 943
optimising diagnosis and treatment. With the recent evidence of the efficacy of mass drug 944
administration for the treatment of scabies, further assessment is warranted including exploring the 945
applicability of this strategy in the Australian setting. It is feasible that impetigo could also be 946
targeted by mass drug administration in communities where prevalence is very high although in any 947
such trial monitoring of adverse events and the emergence of drug-resistance would be essential. 948
46
949
Significant challenges persist for policy makers in addressing the burden of scabies and impetigo in 950
endemic settings. Clearly, efforts to educate clinicians at all levels of health care are vital to improve 951
recognition and treatment of skin infection. Furthermore, focus to improve public and 952
environmental health with access to basic amenities such as clean water and appropriate housing 953
should have significant impacts on skin health. In addition, where access to health services or the 954
number of trained health workers may be limited, particularly in areas where scabies is highly 955
prevalent, mass drug administration should be considered as an option. Elsewhere, access to 956
suitable health care facilities and community education and engagement remain vital in minimising 957
the impact of skin disease on the health of communities. 958
959
Overall, there has been much recent progress in addressing scabies and impetigo with increasing 960
recognition of the breadth of the problem, yet many challenges remain. Importantly, as diagnosis of 961
these conditions remain largely dependent on clinician recognition, as demonstrated in this data, 962
the under-recognition of skin disease by clinicians leads to under-treatment of skin infections in 963
hospitalized children. There is potentially much to be gained by improving clinical recognition of 964
scabies and impetigo in regions with high burden of disease such as Northern Australia and this 965
should be a priority for researchers and policy-makers. 966
967
47
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45. Currie BJ, McCarthy JS. Permethrin and ivermectin for scabies. The New England 1105 journal of medicine. 2010;362(8):717-25. 1106 46. Strong M, Johnstone P. Interventions for treating scabies. The Cochrane database of 1107 systematic reviews. 2007(3):Cd000320. 1108 47. Romani L, Koroivueta J, Steer AC, Kama M, Kaldor JM, Wand H, et al. Scabies and 1109 impetigo prevalence and risk factors in fiji: a national survey. PLoS neglected tropical 1110 diseases. 2015;9(3):e0003452. 1111 48. Roberts LJ, Huffam SE, Walton SF, Currie BJ. Crusted scabies: clinical and 1112 immunological findings in seventy-eight patients and a review of the literature. The Journal 1113 of infection. 2005;50(5):375-81. 1114 49. Lokuge B, Kopczynski A, Woltmann A, Alvoen F, Connors C, Guyula T, et al. Crusted 1115 scabies in remote Australia, a new way forward: lessons and outcomes from the East 1116 Arnhem Scabies Control Program. The Medical journal of Australia. 2014;200(11):644-8. 1117 50. Walton SF, Currie BJ. Problems in diagnosing scabies, a global disease in human and 1118 animal populations. Clinical microbiology reviews. 2007;20(2):268-79. 1119 51. Walter B, Heukelbach J, Fengler G, Worth C, Hengge U, Feldmeier H. Comparison of 1120 dermoscopy, skin scraping, and the adhesive tape test for the diagnosis of scabies in a 1121 resource-poor setting. Archives of dermatology. 2011;147(4):468-73. 1122 52. Ly F, Caumes E, Ndaw CA, Ndiaye B, Mahe A. Ivermectin versus benzyl benzoate 1123 applied once or twice to treat human scabies in Dakar, Senegal: a randomized controlled 1124 trial. Bulletin of the World Health Organization. 2009;87(6):424-30. 1125 53. Engelman D, Kiang K, Chosidow O, McCarthy J, Fuller C, Lammie P, et al. Toward the 1126 global control of human scabies: introducing the International Alliance for the Control of 1127 Scabies. PLoS neglected tropical diseases. 2013;7(8):e2167. 1128 54. Mounsey KE, Holt DC, McCarthy JS, Currie BJ, Walton SF. Longitudinal evidence of 1129 increasing in vitro tolerance of scabies mites to ivermectin in scabies-endemic communities. 1130 Archives of dermatology. 2009;145(7):840-1. 1131 55. Becourt C, Marguet C, Balguerie X, Joly P. Treatment of scabies with oral ivermectin 1132 in 15 infants: a retrospective study on tolerance and efficacy. The British journal of 1133 dermatology. 2013;169(4):931-3. 1134 56. La Vincente S, Kearns T, Connors C, Cameron S, Carapetis J, Andrews R. Community 1135 management of endemic scabies in remote aboriginal communities of northern Australia: 1136 low treatment uptake and high ongoing acquisition. PLoS neglected tropical diseases. 1137 2009;3(5):e444. 1138 57. FitzGerald D, Grainger RJ, Reid A. Interventions for preventing the spread of 1139 infestation in close contacts of people with scabies. The Cochrane database of systematic 1140 reviews. 2014;2:Cd009943. 1141 58. Andrews RM, Kearns T, Connors C, Parker C, Carville K, Currie BJ, et al. A regional 1142 initiative to reduce skin infections amongst aboriginal children living in remote communities 1143 of the Northern Territory, Australia. PLoS neglected tropical diseases. 2009;3(11):e554. 1144 59. Haar K, Romani L, Filimone R, Kishore K, Tuicakau M, Koroivueta J, et al. Scabies 1145 community prevalence and mass drug administration in two Fijian villages. International 1146 journal of dermatology. 2014;53(6):739-45. 1147 60. Mohammed KA, Deb RM, Stanton MC, Molyneux DH. Soil transmitted helminths and 1148 scabies in Zanzibar, Tanzania following mass drug administration for lymphatic filariasis--a 1149 rapid assessment methodology to assess impact. Parasites & vectors. 2012;5:299. 1150
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78. Mahe A, Faye O, N'Diaye HT, Konare HD, Coulibaly I, Keita S, et al. Integration of 1196 basic dermatological care into primary health care services in Mali. Bulletin of the World 1197 Health Organization. 2005;83(12):935-41. 1198 79. Mahe A, Faye O, N'Diaye HT, Ly F, Konare H, Keita S, et al. Definition of an algorithm 1199 for the management of common skin diseases at primary health care level in sub-Saharan 1200 Africa. Transactions of the Royal Society of Tropical Medicine and Hygiene. 2005;99(1):39-1201 47. 1202 1203 1204
53
APPENDIX A – STUDY PROTOCOL 1205
1206 1207
Protocol Version/Date: SCAB Heal Project Version 3 (17/8/15) Page 1 of 5
Study Protocol – SCAB Heal Project
1. PROJECT DETAILS
1.1 Project Details.
Protocol/Research
Project Title:
Skin Care Assessment in Broome & Port Hedland (SCAB Heal) Project
Protocol Number (Version and Date):
Protocol 1 Version 4 (August 2016)
Amendment
(Number and Date):
Project Start Date: August 2015 Project Finish Date: June 2016
Coordinating Principal
Investigator Name: Dr Daniel Yeoh
Coordinating Principal
Investigator Contact
Details:
Princess Margaret Hospital Roberts Road, SUBIACO 6008
[email protected] Phone: 0423520575
Sponsor Name (if
applicable): N/A
Laboratory Name (if
applicable): N/A
1.2 Project Summary
A prospective cross-sectional study to assess the prevalence of skin sores, scabies and other skin
diseases in children presenting to Broome & Port Hedland Hospitals requiring paediatric review / admission. A retrospective medical record review of a cohort of children previously presenting to
Broome & Port Hedland hospitals to assess the recognition of skin disease in this population. The
documentation of skin disease in the retrospective and prospective cohorts will be compared.
2. RATIONALE / BACKGROUND
In northern Australia the complications of skin disease continue to present a significant challenge. This is
despite the availability of tolerable and effective therapies for impetigo, scabies and tinea(1). It is clear that
improvements need to be made in the recognition and treatment of these conditions by health professionals(1). It is likely that health professionals normalise skin disease, and as such fail to recommend
treatment unless specifically requested. This study seeks to understand, by comparing the documentation of skin disease in a retrospective cohort and a prospective cohort, whether this hypothesis is true.
Streptococcus pyogenes (GAS) is the key pathogen in most cases of impetigo in Northern Australia although
co-infection with Staphylococcus aureus is common(2). Skin infection with GAS is associated with a number
of serious sequelae including acute rheumatic fever, rheumatic heart disease, glomerulonephritis and invasive GAS infection(3, 4). GAS skin disease is strongly associated with infection with scabies and
treatment of scabies is thought to decrease the risk of the complications associated with GAS(2, 5).
Over the last 24 months there has been an ongoing outbreak of post-streptococcal glomerulonephritis in the
north west of Western Australia. This has put a significant strain on local health services faced with the challenge of managing individual cases and mounting a public health response. In addition to this, acute
rheumatic fever and invasive bacterial infections are ongoing problems in this region. This all emphasises the need to continue to address skin disease both at the community level and in the
health care setting. Greater recognition of the breadth of this problem along with the significant benefit to patients of better treatment of skin disease must begin with health care professionals.
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There is limited data of the prevalence of skin disease in the paediatric population in rural and remote
Western Australia. A study of the effect of swimming pools on the skin health of children in 2 remote aboriginal communities in the Pilbara estimated the prevalence of impetigo at 62-70%(6). Studies from
primary health care centres in the Northern Territory and Far North Queensland give a similar picture of a
high burden of disease (7, 8). Estimates of the prevalence of impetigo from colleagues working in the Kimberley region range from 20-40%. There is no local data assessing clinical recognition of skin sores/skin
disease by health professionals.
By describing the prevalence of skin sores in children presenting to Broome & Port Hedland Hospitals and potentially demonstrating the under-recognition of skin sores clinically, we hope to draw further attention to
the significant burden of skin disease in these regions. The flow on effect from this will be increased clinical
awareness leading to improved treatment of skin sores in hospitals and primary health care clinics locally and also abroad.
3. PROJECT OBJECTIVES / HYPOTHESES
3.1 Objectives:
To describe the prevalence of skin diseases in a population of paediatric patients presenting to
Broome Hospital and Port Hedland Hospital. To assess the clinical recognition of skin diseases in a population of paediatric patients by health
professionals at Broome Hospital & Port Hedland Hospital. To trial the SCAB proforma as a possible tool for data collection of skin diseases in paediatric populations
3.2 Hypotheses:
We hypothesise that the burden of skin disease is high in this population and that there is under-recognition of skin sores in the health care setting. This will be reflected in a higher prevalence of all
skin diseases when documented prospectively as compared to the documentation of skin diseases in the retrospective chart review
4. PROJECT DESIGN
The scientific integrity of the project and the credibility of the project data depend substantially on the project design and methodology.
4.1 Project Type:
Quantitative Prospective Cross-Sectional Study (to ascertain prevalence of skin disease) and a Retrospective Cross-sectional Study (to assess recognition of skin disease by health professionals in
this population)
4.2 Study Population:
Participants will be opportunistically recruited from the population of all children and adolescents (aged <16 years) presenting to Broome hospital & Port Hedland hospital requiring paediatric review
over a 3-4 month period in the latter half of 2015 with an aim to recruit 100 patients at each site. A
retrospective review of case notes from patients admitted over a 4 week period prior to August 2015 will also be conducted.
4.3 Inclusion Criteria:
All children presenting to Broome hospital & Port Hedland hospital requiring review by the paediatric team during the recruiting period will be eligible to participate.
4.4 Exclusion Criteria: Individuals will be excluded if the individual and/or the parent/carer do not give assent/consent.
4.5 Participant Withdrawal:
Participants are free to withdraw from the trial voluntarily at any stage. The data collected in these
participants prior to withdrawal will be destroyed.
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4.6 Measures taken to minimise/avoid bias: Individuals will be approached to participate regardless of the reason for admission / review, co-
morbidities, ethnicity, language spoken, address or gender.
The retrospective review of cases will include all patients presenting to Broome Hospital & Port Hedland Hospital requiring paediatric review during the designated time period, and will record the
frequency, severity and treatment of any skin diseases documented. This study design is necessary to assess for “normalisation’ of skin health, as it is not ethical to
provide a prospective data collection tool and then expect clinicians to fail to use this.
4.7 Communication with participants and families:
In cases where cultural and linguistic diversity may be a barrier to effective communication, professional interpreters will be utilised. In cases where an on-site interpreter is not available
professional telephone interpreters will be used (via the National Translator Interpreter Service/On Call Interpreters). Family members will not be used to translate to avoid breaches in confidentiality or
inaccuracies due to misunderstanding of medical terminology.
4.8 Community and agency support:
Advice and support for this project have been sought from the Kimberley Public Health Unit, Kimberley Aboriginal Medical Services Council the Port Hedland Hospital Paediatric Team and the
Broome Hospital Paediatric Team.
4.9 Data Collection:
All participants in the prospective arm of the project will undergo an assessment including: a) A directed history including past history of skin disease, treatment and complications
b) A full examination of the skin looking specifically for impetigo (flat/dry, crusted or purulent lesions and total number of lesions), scabies (including infected lesions), tinea corporis, tinea
capitis and tinea unguium, pediculosis and other skin diseases.
c) A microbiological swab if any purulent or crusted lesions are present This information will be recorded on the Case Report Form (see Appendix A).
The retrospective review of medical records will record the documented history of skin disease (including complications and comorbidities) and any skin diseases seen and documented on physical examination (see Appendix E). The retrospective review will be performed by the site’s primary investigator. Patient medical records of children presenting to Broome Hospital & Port Hedland
Hospial requiring paediatric review in October 2014 will be re-called from the medical records
department at respective hospitals in order to collect this data.
Data will be drawn from the prospective assessment to assess prevalence of skin disease in the study population. Comparison will be made with the proportion of patients with skin disease documented in
their case records from the retrospective review.
“Data will be collected from the discharge summary of all patients with skin disease recruited at
Broome Hospital to assess whether the findings and management plan were communicated to the appropriate primary health care provider”
4.10 Data Analysis:
Descriptive statistics will be used to analyse the data using SPSS. Guidance will be provided by a
PMH biostatistician as required. The prevalence of each of the skin diseases (impetigo, scabies, tinea, and pediculosis) in the prospective and retrospective cohort will be determined and 95%
confidence intervals calculated, to determine if there is a difference in the documentation of skin diseases.
4.11 Project Duration: The expected duration of the data collection for this project is 3-4 months.
5. TREATMENT OF PARTICIPANTS
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This project does not include the assessment of treatment outcomes in participants. All skin diseases
recognised during assessment will be treated according to local guidelines (see link below and appendix D). Participation in the study will have no bearing on treatment decisions. The principal site
investigator will follow up any swab results and contact the family of the patient and implement any
necessary changes in therapy’ http://resources.kamsc.org.au/downloads/oth_skin.pdf
6. ASSESSMENT OF EFFICACY
Not applicable
7. ASSESSMENT OF SAFETY
All three components of the assessment of participants in this study (history, physical examination and
microbiological swabs of purulent/crusted lesions) are a part of the usual assessment of paediatric patients admitted to Broome Hospital. There is no additional risk of harm attributable to participation in
this study.
Treatment recommendations are a part of the data collection however treatment decisions will not be
affected by participation in the study. Treatment will be implemented according to local protocols in accordance with best clinical practice (Appendix D)
All information documented on research forms will be securely managed to ensure participant confidentiality is maintained throughout (as outlined below).
8. DATA MANAGEMENT AND RECORD KEEPING
Safeguards will be put in place to maintain patient confidentiality and anonymity of participants. All
paper-based forms (including consent forms and CRFs) will be stored in a locked filing cabinet in the
locked medical officer’s office at Broome & Port Hedland Hospitals. All electronic data documents will be password-protected and saved on the W-drive of the WA Health Information Network System.
This system is secured by user names and passwords and protected from external access by firewalls. Only the research team will have access to the paper-based and electronic data.
Any patient medical records re-called for the retrospective arm of the study will be stored securely in a locked filing cabinet in the locked medical officer’s office at the two study sites. Once data has been
collected, individual records will be returned to the medical records departments. Only the primary site
investigator will have access to these medical records during the data collection. All the data generated by this project will be retained for a minimum of 7 years following the date of
publication, as per the National Health and Medical Research Council guidelines.
9. MONITORING / AUDIT
The project investigators will permit project-related monitoring, audits, and regulatory inspections,
providing direct access to source data/documents. This may include, but not limited to, review by external sponsors, Human Research Ethics Committees and institutional governance review bodies.
10. QUALITY CONTROL AND QUALITY ASSURANCE
10.1 This project will be conducted in compliance with the protocol, Good Clinical Practice and the
application regulatory requirements.
10.2 All assessments in the prospective and the retrospective arms of this study will be performed by the
chief investigator. Cases of scabies, impetigo and tinea will be diagnosed based on clinical case definitions in concordance with available clinical resources (Appendix F).
11. ETHICS
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Informed Consent and Assent Participation in this study will be entirely voluntary and verbal and written informed consent will be sought
(Appendix C). As all participants will be under the age of 16, consent will be sought from a parent or
appropriate guardian for the child to participate in the study. Where appropriate (ie in children >7yo) assent will also be sought from the child.
Information will be presented in a written format (Appendix B) and also offered verbally by the recruiting clinician. Where there may be linguistic barriers to adequate communication, an interpreter will be employed
as outlined above.
12. FINANCING
All costs for this project will be covered through the salary of the chief investigator who is the recipient of a
PMH Foundation Fellowship for the year 2015. This full time fellowship combines clinical duties (80% allowance) with allocated time for research activities (20%).
13. PUBLICATION
The results of this study will be disseminated through publication in peer-reviewed journals and through
presentation at local and/or international conferences.
14. REFERENCES
1. Andrews RM, McCarthy J, Carapetis JR, Currie BJ. Skin disorders, including pyoderma, scabies,
and tinea infections. Pediatric clinics of North America. 2009;56(6):1421-40.
2. Bowen AC, Tong S, Chatfield MD, Carapetis JR. The microbiology of impetigo in Indigenous
children: associations between Streptococcus pyogenes , Staphylococcus aureus, scabies, and nasal carriage.
BMC infectious diseases. 2014;14(1):3854.
3. Carapetis JR, Steer AC, Mulholland EK, Weber M. The global burden of group A streptococcal
diseases. The Lancet Infectious Diseases. 2005;5(11):685-94.
4. McDonald MI, Towers RJ, Andrews RM, Benger N, Currie BJ, Carapetis JR. Low rates of
streptococcal pharyngitis and high rates of pyoderma in Australian aboriginal communities where acute
rheumatic fever is hyperendemic. Clinical infectious diseases : an official publication of the Infectious
Diseases Society of America. 2006;43(6):683-9.
5. Romani L, Koroivueta J, Steer AC, Kama M, Kaldor JM, Wand H, et al. Scabies and impetigo
prevalence and risk factors in fiji: a national survey. PLoS neglected tropical diseases. 2015;9(3):e0003452.
6. Lehmann D, Tennant MT, Silva DT, McAullay D, Lannigan F, Coates H, et al. Benefits of
swimming pools in two remote Aboriginal communities in Western Australia: intervention study. Bmj.
2003;327(7412):415-9.
7. McMeniman E, Holden L, Kearns T, Clucas DB, Carapetis JR, Currie BJ, et al. Skin disease in the
first two years of life in Aboriginal children in East Arnhem Land. The Australasian journal of dermatology.
2011;52(4):270-3.
8. Valery PC, Wenitong M, Clements V, Sheel M, McMillan D, Stirling J, et al. Skin infections among
Indigenous Australians in an urban setting in far North Queensland. Epidemiology and infection.
2008;136(8):1103-8.
15. APPENDICES
15.1 Appendix A – Case Report Form 15.2 Appendix B – Patient/Carer Information Form
15.3 Appendix C – Patient/Carer Consent Form 15.4 Appendix D – KAMSC Management of Skin Infections Protocol
15.5 Appendix E – Retrospective Case Review Form
15.6 Appendix F - East Arnhem Regional Healthy Skin Project - Recognising and Treating Skin Conditions
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APPENDIX B – CASE REPORT FORM (PROSPECTIVE) 1215
1216
SCAB Heal (Skin Care Assessment in Broome & Port Hedland) Project - Case 1217
Report Form 1218 1219
1) Demographics 1220 1221
Postcode or Community: _______ DOB: ____________ Gender: M 1 F 2 1222 Ethnicity: Aboriginal 1 TSI 2 Caucasian 3 Pacific Islander 4 Other 5__________________ 1223
Unknown 9 [More than one ethnicity is possible] 1224 Number of people living in household: _________ 1225 Number of bedrooms in household:_________ 1226 Does your child attend school? YES 1 NO 0 UNKNOWN 9 1227 What year are they currently in at school? _______ 1228 1229
2) Admission Details 1230
Primary reason for admission:____________________________________________ 1231 Comorbidities (list all): 1232 ______________________________________________________ 1233 1234
3) Significant Past Medical History 1235
Any history of: 1236 ARF or Rheumatic Heart Disease…………… YES 1 NO 0 UNKNOWN 9 1237 Post-streptococcal Glomerulonephritis……….. YES 1 NO 0 UNKNOWN 9 1238 Osteomyelitis/Septic Arthritis….………………... YES 1 NO 0 UNKNOWN 9 1239 Cellulitis (requiring hospital admission)………... YES 1 NO 0 UNKNOWN 9 1240 Recent treatment (within last 6 months) for: 1241 Impetigo……………………………………………. YES 1 NO 0 UNKNOWN 9 1242 Scabies……………………………………………. YES 1 NO 0 UNKNOWN 9 1243 Tinea Corporis …………………………………... YES 1 NO 0 UNKNOWN 9 1244
Tinea Capitis ……………………………..……… YES 1 NO 0 UNKNOWN 9 1245 Tinea Unguium …………………………………... YES 1 NO 0 UNKNOWN 9 1246 Pediculosis ………….……………………………. YES 1 NO 0 UNKNOWN 9 1247 Other (e.g. leprosy, eczema, vitiligo)……………. YES 1 NO 0 1248 --specify _______________________________ 1249 1250 1251 1252 1253 1254 1255 1256 1257 1258 1259 1260 1261 1262 1263 1264 1265 1266
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1267 1268
4) Skin Assessment 1269 1270
1271 Count of total body Impetigo lesions (purulent and/or crusted)_________ 1272 Count of total body Impetigo lesions (flat, dry)__________ 1273 (Code: A.1.3 = 3 purulent impetigo lesions in 1 body area) 1274
5) Microbiology (any child with a crusted or purulent skin sore) 1275
Swab (from the most purulent or crusted lesion): 1276 site number ____ 1277 Group A streptococcus……………. YES 1 NO 0 UNKNOWN 9 1278 MSSA………………………………… YES 1 NO 0 UNKNOWN 9 1279
MRSA………………………………… YES 1 NO 0 UNKNOWN 9 1280 Other………………………………..... YES 1 NO 0 UNKNOWN 9 1281 details ______________________________ 1282
1283 6) Management 1284
Has treatment of skin lesions been recommended? YES 1 NO 0 UNKNOWN 9 1285 If so, list all recommended treatments for skin disease_____________________________________ 1286 Were any environmental health interventions recommended? YES 1 NO 0 UNKNOWN 9 1287 Were skin findings and management communicated in discharge letter YES 1 NO 0 1288 1289
A –impetigo A.1 – purulent A.2 – crusted A.3 – flat and dry
B – scabies
B.1 – not infected B.2 – infected B.3 - crusted
C – tinea C.1 - corporis C.2 - capitis C.3 – unguium
D - pediculosis
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APPENDIX C – CASE REPORT FORM (RETROSPECTIVE) 1290
1291
SCAB Heal (Skin Care Assessment in Broome & Port Hedland) Project – 1292
Retrospective Case Report Form 1293
1294 1) Demographics 1295
Postcode or Community: _______ DOB: ____________ Gender: M 1 F 2 1296 Ethnicity: Aboriginal 1 TSI 2 Caucasian 3 Pacific Islander 4 Other 5__________________ 1297
Unknown 9 1298 Number of people living in household: _________ Not recorded 99 1299 Number of bedrooms in household:____________ Not recorded 99 1300 Level of Education - Year at school: ___________ Not recorded 99 1301 1302
2) Admission Details 1303
Primary reason for admission:____________________________________________ 1304 Comorbidities (list all): 1305 ______________________________________________________ 1306 1307
3) Significant Past Medical History 1308
Any history of: 1309 ARF or Rheumatic Heart Disease…………… YES 1 NO 0 UNKNOWN 9 1310 Post-streptococcal Glomerulonephritis……….. YES 1 NO 0 UNKNOWN 9 1311 Osteomyelitis/Septic Arthritis….………………... YES 1 NO 0 UNKNOWN 9 1312 Cellulitis (requiring hospital admission)………... YES 1 NO 0 UNKNOWN 9 1313 1314
4) Skin Assessment 1315
Any documented physical examination findings of: 1316 Impetigo……………………………………………. YES 1 NO 0 1317 If yes, were microbiological swabs collected? YES 1 NO 0 UNKNOWN 9 1318
Scabies……………………………………………. YES 1 NO 0 1319 Tinea Corporis …………………………………... YES 1 NO 0 1320
Tinea Capitis ……………………………..……… YES 1 NO 0 1321 Tinea Unguium …………………………………... YES 1 NO 0 1322 Pediculosis ………….……………………………. YES 1 NO 0 1323 Other (e.g. leprosy, eczema, vitiligo)……………. YES 1 NO 0 1324 --specify _______________________________ 1325 1326
5) Microbiology (if available from skin swabs collected) 1327
Site(s) taken from ________________ 1328 Group A streptococcus…………….. YES 1 NO 0 UNKNOWN 9 1329 MSSA………………………………… YES 1 NO 0 UNKNOWN 9 1330
MRSA………………………………… YES 1 NO 0 UNKNOWN 9 1331 Other………………………………..... YES 1 NO 0 UNKNOWN 9 1332 details ______________________________ 1333
1334 6) Management 1335
Has treatment of skin lesions been recommended? YES 1 NO 0 UNKNOWN 9 1336 If so, list all recommended treatments for skin disease_____________________________________ 1337 Were any environmental health interventions recommended? YES 1 NO 0 UNKNOWN 9 1338
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APPENDIX D – CONSENT FORM 1339
1340
SCAB Heal (Skin Care Assessment in Broome Port Hedland) Project Consent 1341
Form 1342
Signing this form means that you agree to take part in the study. 1343 You do not have to join the study and can say No. 1344
If you have any complaints please contact the WACHS HREC mobile 0417 068 594 1345 Patient/Carer Consent 1346 1347 I _________________ consent for _________________to participate in this project. 1348 (parent/carer’s name) (child’s name) 1349 I ___________________aged___ assent to participate in this project (if older than 7) 1350 (child’s name) 1351 I have received and read a copy of the carer & patient information sheet. I understand all of 1352 the information provided and have had any questions about this information answered. 1353 1354 I consent to: 1355 answering questions……………………………. YES NO 1356 recording skin problems…..…………………… YES NO 1357
skin swabs………………………………………. YES NO 1358 1359 1360 Parent/Carer Signature: ___________________________________________ 1361 1362 Child’s Signature: ________________________________________________ 1363 1364 Clinician’s Signature ____________________________ Initials:____________ 1365 1366 Date: ______________ 1367 ___________________________________________________________________ 1368 1369 Interpreter’s Name / Job Number (if required): __________________________ 1370 1371
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APPENDIX E – PATIENT / CARER INFORMATION SHEET 1372
1373
SCAB Heal (Skin Care Assessment in Broome & Port 1374
Hedland) Project - Patient & Parent Information 1375
1376 Background 1377 This project includes children less than 16 years of age seen by the paediatric teams at 1378 Broome and Port Hedland Hospitals for any reason to look at how common skin infections 1379 are in these children. 1380 We think that skin problems are not recognised and treated as often as they should be. We 1381 are doing this study to find out if this is true. 1382 We know that early treatment of skin problems can prevent later complications. 1383 Complications of untreated skin infections include kidney and heart disease. 1384 If we find skin infections that need to be treated, your child will receive treatment while 1385 they are at the hospital. 1386 1387 What does participating in the study involve? 1388 The study has three parts: 1389 - We will ask a few questions about your child 1390 - We will look at your child’s skin and record any skin infections 1391 - We will swab any skin sores that have pus or a crust 1392 We will record this information on a research form as well as in the medical record. 1393 1394 Do I have to participate in the study? 1395 Being a part of the study is entirely up to you. Participation is voluntary. You do not have to 1396 sign up. Not signing up will not have any effect on your (or your child’s) hospital care. 1397 1398 What are the benefits to participating in the study? 1399 By participating in the study you will be helping us to better understand how common skin 1400 problems are in kids. With this information we hope to improve awareness of skin health 1401 and improve the management of skin problems in kids in Western Australia and beyond. 1402 1403 What will happen to my information once it is collected? 1404 All of your child’s information will be kept confidential and there will be no information on 1405 the form to identify your child. A separate, secure spreadsheet including the unit record 1406 number will allow us to follow up swab results later on in the week. 1407 All information collected will be stored securely in a locked cabinet and all electronic 1408 databases will be password protected. Data sheets and databases will be stored for a 1409 minimum of 7 years in keeping with the National Health and Medical Research Council 1410 guidelines 1411 Once we have enough patients in the study we will compare our results with what has 1412 happened in the past to see how we are doing with the recognition of skin problems in 1413 children. 1414 Any significant findings will be shared with other health professionals through local 1415 meetings/conferences and also through publication in medical journals. 1416 1417
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Who do I contact if I have any questions or would like to withdraw from the study? 1418 If you have any questions or would like to withdraw from the study please contact me: 1419
Dr Daniel Yeoh 1420 Email: [email protected] 1421 Phone: 9340 8222 / 9194 2222 1422 1423
If you have any complaints about this study please contact: 1424 WACHS Research Ethics Committee 1425 Email: [email protected] 1426 1427 Phone: 9223 8500 / 0417 068 594 1428 1429 1430
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APPENDIX F – WACHS HREC APPROVAL LETTER1431
1432
65
1433
66
APPENDIX G – WAAHEC ETHICS APPROVAL LETTER1434
1435
67
1436
68
1437
69
1438
70
1439
71
1440
72
1441
73
1442
74
1443