Prepared for the Australian Government Department of Health

A literature review and background analysis to support the review of accessory products listed under Group 9 of the Stoma Appliance Scheme Schedule

Prepared for the Australian Government Department of Health

by the Centre for Health Services Research,

University of Tasmania

May 2014

ACKNOWLEDGEMENTS

This project is funded by the Australian Government Department of Health. The information and opinions contained in it do not necessarily reflect the views or policy of the Australian Government or the Department of Health.

Disclosures: Dr Kelly Shaw and Dr Paul Woodhouse are senior consultants with KP Health.

CITATION

Roberts A, Shaw K, Woodhouse P. A literature review and background analysis to support the review of accessory products listed under Group 9 of the Stoma Appliance Scheme Schedule: a report prepared for the Australian Government by the Centre for Health Services Research, University of Tasmania. May 2014.

Centre for Health Services Research

School of Medicine

University of Tasmania

Level 1, Medical Science 1

17 Liverpool Street

Hobart TAS Australia

T +61 3 6226 4757

F +61 3 6226 4816

W

TABLE OF CONTENTS

Executive Summary

Key findings

Conclusions

Introduction

This project

This report

The context for stoma accessory use

Use of accessories in stoma management

Project methods

Project results

The effectiveness of Group 9 accessories

The cost-effectiveness of Group 9 accessories

Discussion

Appendix 1 - A systematic review of the peer-reviewed and 'grey' literature

Criteria for considering publications for inclusion

Databases searched

Criteria for inclusion and exclusion of studies

Critical appraisal and data extraction

Assimilation and interpretation of the body of evidence

Evidence statements for peer-reviewed studies

Part A: Results from the peer-reviewed literature

Level of evidence of included references

Systematic reviews identified in the peer-reviewed literature

Other publications identified in the peer-reviewed literature

1. Skin care and protection accessories

2. Stoma support garments

3. Cleansers and adhesive removal accessories

4. Deodorisers and gas suppressants

5. Skin fillers and adhesive products

Summary of the main results from the peer-reviewed literature

Overall completeness and applicability of the evidence

Quality of the evidence

Potential biases in the systematic review process

Conclusions

Part B - Results from the 'grey' literature

'Grey' literature database searches

Position papers

Guidelines and best practice manuals

International stoma schemes

Conclusions

Attachment 1 (Appendix 1): Characteristics of excluded publications

Attachment 2 (Appendix 1): Included 'grey' literature

Attachment 3 (Appendix 1): References from peer-reviewed literature review

Appendix 2 - Analysis of available financial information regarding Group 9 products

Introduction

Sub-group price comparison

Financial studies identified in searches of peer-reviewed literature

Executive Summary

The Stoma Appliance Scheme (SAS) is an Australian Government program that assists eligible people with stomas to better manage their condition by providing subsidised access to a range of different stoma-related products.

The Department engaged the Centre for Health Services Research, University of Tasmania, to perform a literature review and background analysis to support the SAS Schedule Group 9 - Accessories Review. Group 9 of the Schedule is a collection of miscellaneous products used to support the clinical management of both paediatric and adult patients with a stoma.

Evidence about Group 9 SAS products was compiled from all identifiable information sources in order to describe the clinical appropriateness and relevanceof these products for any described outcome in patients with a stoma. The project methods comprised:

• A systematic review of the peer-reviewed literature;
• A systematic review of the 'grey' literature; and
• An analysis of available financial information regarding Group 9 products.

Key findings

We identified a small, methodologically limited body of evidence regarding the effectiveness of stoma accessories. As a result, firm conclusions about the effectiveness and cost-effectiveness of Group 9 products cannot be drawn from the available literature.

Our comprehensive search of the peer-reviewed literature identified 13 references. Accessories for which outcomes information was available included skin care and protection accessories (five studies), stoma support garments (one study), cleansers and adhesive removal accessories (three studies), deodorisers (one study) and skin fillers and adhesive products (five studies). Some publications provided information regarding more than one class of accessory. The effectiveness of all sub-groups of accessories within Group 9 of the Schedule was unable to be determined from the available studies.

The level of evidence of included studies was generally low and the quality of included studies was poor. One study was a systematic review that included randomised controlled trials (RCTs); however this study did not identify RCTs that were relevant to Group 9 accessories in spite of searching for relevant RCTs. In addition, we identified one RCT, one nested diagnostic study conducted within a cohort study and one case series. All other studies were not able to be rated against the National Health and Medical Research Council's levels of evidence.

Our search of the 'grey' literature identified 27 materials of broad relevance to stoma accessories. Of these, 11 publications were documentation from international stoma schemes, nine publications related to accessory product pricing, threepublications were guidelines / best practice manuals, two publications were consensus statements and two publications were position papers. These materials provided information regarding stoma schemes in other countries including product costs, limits in quantities of Group 9 accessory products supplied to consumers in other countries and guidelines that are in place in other countries to inform use of Group 9 accessories.

Guideline developers internationally confirm the results of our systematic review and have also noted a paucity of published studies of the effectiveness of stoma accessories. Published guidelines are based largely on the opinions of clinicians in the stoma field rather than on empirical evidence. Further, industry sponsorship of panel members involved in developing guidelines is common and introduces a significant risk of bias in the guideline development process.

In the absence of data regarding the effectiveness of accessories, cost-effectiveness of these products is unable to be assessed. We therefore conducted a comparative analysis of SAS accessory costs compared with other domestic and international product schemes. Our analysis demonstrates that sub-groups of accessories on the SAS Schedule split neatly into two categories in terms of the overall cost of the sub-group and the growth in costs over the past five years. The first category are the sub-groups with a high total cost, high growth and dynamic changes in market share of products within the sub-group (adhesive barriers (a), adhesive removers / cleansers and adhesive removal (d), hernia belts (h), protective films (k) and seals (l)). The second category comprises the sub-groups with lower total cost, low annual growth and stable product mixes.

We identified that new products are more commonly introduced in the high cost, high growth sub-groups and quickly achieve a significant share of the product market. This was in spite of an absence of published studies in the public domain that demonstrate the effectiveness of the new product. Further, there were no studies of comparative effectiveness that indicate substitution of an established product with a newer product is justified by published evidence of improved effectiveness of the newer product.

We found that the SAS price of some high cost products exceeds international comparator product costs. There are five products from sub-group seals (l), three in adhesive barriers (a), one in adhesive removers / cleansers and adhesive removal (d), one in hernia belts.The international comparator cost for these products is $1.9 million less in total than the SAS cost in 2012-13 dollars and suggest that cost savings may be achieved through achieving a purchase price for these products that is equivalent to the product price in comparator schemes.

Limits to the quantity of Group 9 accessories provided to consumers are specified in the SAS Schedule. Some international stoma guideline documents also specify limits to the quantity of stoma products that are provided to consumers. Overall, limits to product quantities specified in the SAS Schedule are consistent with limits in international schemes. No studies were identified that indicated product limits were inappropriate or had any adverse impact on patient outcomes.

Conclusions

We formulated the following conclusions regarding the effectiveness and cost-effectiveness of Group 9 accessories on the SAS Schedule and how these may be determined into the future.

Conclusion 1

Arequirement for level 2 evidence or higher for the listing of new accessory products on the Group 9 SAS Schedule would enable a more detailed assessment of the effectiveness and cost-effectiveness of Group 9 accessories to be performed into the future.

Conclusion 2

A review of current purchasing arrangements for high cost products with a comparator price that is lower than the current SAS price would confirm that the purchasing arrangements for these products are efficient.

Conclusion3

Limits to product quantities specified in the SAS are consistent with limits in international schemes.

Conclusion 4

There is an absence of evidence that Group 9 accessory products are either effective or ineffective, and therefore insufficient information to suggest changes to the range of accessory product types on Group 9 of the SAS based on this review alone.

Introduction

The Stoma Appliance Scheme (SAS) is an Australian Government program that assists eligible people with stomas to better manage their condition by providing subsidised access to a range of different stoma-related products.

The SAS commenced operation in 1975 and is legislated under Section 9A of the National Health Act (1953).

The Australian Government Department of Health('the Department') and the Department of Human Services administer the SAS on behalf of the Australian Government. The Department has overall policy responsibility for the Scheme and manages the SAS Schedule and the product application and assessment process. It also provides secretariat support for the Stoma Product Assessment Panel (SPAP), the Department’s independent technical advice panel.

Subsidised stoma-related products are distributed via 22 regional stoma associations in Australia.

This project

The Department engaged the Centre for Health Services Research, University of Tasmania, to perform a literature review and background analysis to support the SAS Schedule Group 9 - Accessories Review. The objective of the SAS Group 9 Review is to examine the accessories listed under Group 9 of the SAS Schedule to assess their clinical appropriateness, cost effectiveness and relevance to the SAS.

Group 9 of the Schedule is a collection of miscellaneous products used to support the clinical management of both paediatric and adult patients with a stoma. The group can be broadly categorised into the following product types (Table 1):

1

Table 1: Products in Group 9 of the Schedule

Category / Indication / Product type
9a and 9f and 9k / Skin care and protection / Protective sheets
Elastic tape
Strips to picture frame skin barriers
Barrier creams
Conditioning cream
Protective pastes
Emollient creams
Protective barrier wipes
Protective barrier spray
Protective barrier film
9b and 9h / Stoma support garments / Stoma support belts / briefs
Hernia support garments
Stoma and hernia support garments
Abdominal support garments / belts
9c / Clamps & clips / Clamps
Clips
9d / Cleanser & adhesive removal / Wipes
Spray
Lotions
Liquids
9e / Convexity inserts / Convex seal inserts
9g / Deodorisers and gas suppressants / Deodoriser drops
Deodoriser liquids
Lubricating deodorants
Gas suppressant tablets
Gas suppressant liquids
9i / Night drainage / Taps
Drainage outlets
Drainage bags
9j / Skin fillers and adhesive products / Stomadhesive paste
Stomadhesive powder
Skin filling paste
Moisture-absorbing powder
Protective stoma paste
9l / Seals / Stoma seals
Stoma rings
Stoma collars
Cushioning and sealing dressings
Barrier rings
Barrier seals
9m / Miscellaneous / Carbon filters
Absorbent powder
Velcro bands
Thickening agents
Adhesive aerosol spray

1

This report

Evidence about Group 9 SAS products was compiled from all identifiable information sources in order to describe the effectiveness and cost-effectiveness of these products for any described outcome in patients with a stoma. The evidence was identified and critically appraised through:

• A systematic review of the peer-reviewed literature;
• A systematic review of the 'grey' literature; and
• An analysis of available financial information regarding Group 9 products.

This is the report of the review.

The context for stoma accessory use

A stoma, also known as an ostomy, is a surgically created opening onto the abdominal wall to allow the exit of faeces and / or urine. There are three main types of stomas[1]:

• A colostomy is formed from the colon (large bowel/intestine). The colostomy is often formed in the left iliac fossa. The output is often formed stool and flatus.
• An ileostomy is made from the ileum (small bowel). The ileostomy is generally formed in the right iliac fossa. The faeces will be more liquefied than a colostomy output, which is often described as a porridge consistency—flatus will also be passed.
• Aurostomy (or ileal conduit) is frequently formed in the right iliac fossa. The urostomy is usually formed from the ileum, but is used to pass urine and not faeces.

A stoma can be temporary or permanent. Stomas are required for paediatric or adult patients due to diseases (including cancer and inflammatory bowel disease), injury, birth defects or other causes[2].

People who have a stoma require stoma appliances and accessories for the ongoing care and maintenance of their stoma. In Australia these are largely accessed through a funded national program: the SAS. In 2008-09 there were approximately 37,000 ostomates (people with a stoma) in Australia who received products under the SAS[3].

To be eligible for SAS products, an ostomate must become a member of a stoma association. The volunteer stoma associations purchase stoma related products from suppliers and distribute to their members as required. Total Australian Government Australian Government expenditure on the SAS was $67 million in 2008-09 and $72. million in 2009–10[4].

The stomal care needs of ostomates change over time. In the immediate post-operative period, patients usually wear a clear bag, so that the stoma can be seen. This enables staff and the patient to check for complications that may occur, including necrosis of the bowel used to form the stoma. In the post-operative period the appliance used for a colostomy or ileostomy often does not have a filter. No filter in the appliance allows the nurse and ostomate to see when flatus is passed[5].

Once discharged, the patient enters a maintenance phase in the care of their stoma. Some ostomates continue to use a clear appliance once they are discharged home into the community. Alternatively the ostomate may choose an opaque or patterned appliance. This is supplemented with the use of accessories to facilitate achieving positive outcomes for patients.Stoma accessories are used in conjunction with stomal appliances to maintain peristomal skin integrity and promote pouch reliability, thereby increasing patients' confidence in their stoma management. There are a multitude of stoma accessories that are used in conjunction with stoma appliances, the types of which are described below.

The ideal outcome for patients with a stoma is that they reach the optimal level of rehabilitation and return to their normal day-to-day activities, while being able to manage their stoma without disruption and reliance on excessive routine.

The equipment needs of ostomates vary between patients and according to stoma type. Indicative average use of stoma supplies by an ostomate are provided at Table 2.

Table 2: Average use of stoma supplies[6]

One piece appliance / Two piece appliance
Colostomy / 2 bags a day / 2-3 flanges a week
2 bags a day
Ileostomy / 1 bag a day / 2-3 flanges a week
1 bag a day
Urostomy / 1 bag a day / 2-3 flanges a week
1 bag a day
1 night bag a week
Night bag / 1 bag a week
Accessories (if needed):
Adhesive remover / 2-3 a month
Skin protector / 2-3 a month

Use of accessories in stoma management

A stoma accessory is defined as 'any product used in addition to a stomalappliance'[7].

Ostomatesmay manage independently without needing touse the wide array of accessories availableon the market. However, there are a subgroup ofpatients for whom accessories enable greater independence and improved management of their stoma - an estimated one in three patients has a problematicstoma that requires the use of one or moreaccessories to keep them clean and dry for aperiod of 24 hours[8] and between 39% and 55% of people with astoma will experience problems at some time that necessitate the use of stoma accessories[9].

Clinical decisions regarding the use of accessories are guided by the ability of the individual patient touse them, and alsotake into account[10]:

• the condition of peristomal skin;
• the likelihood of increased skin sensitivityand with it an increased probability of furtherproblems;
• the type of stoma/fistula and the nature of itsoutput; and
• the patient’s ability to use the products.

Indications for the use of accessories vary according to stoma care nurses and patients (Table 3)[11]:

Table 3: Indications for the use of accessories, according to stoma care nurses and patients

Stoma care nurses / Patients
Sore skin
Peristomal moats and dips
Damage to skin
Leakage around the stoma
Pain on removal of appliance / Sore skin
Damage to skin
Enhancing pouch security
Pain on removal of appliance
Odour

Ideally, patients using stoma accessories are assessed intermittently with regard to their ongoing need for accessories because of the financial constraints faced by the health service and the resultant costs associated with the use of accessories on health system budgets[12].

Different categories of stoma accessories have different functions. Broadly, these can be described as products for[13]: