2 How to Set up an HTA Agency ASERNIP-S.ppt...Royal Australasian College of Surgeons Publications Dawe S, Windsor J, Broeders J, Cregan P, Hewett P, Maddern G. A Systematic Review

ASERNIP-SAustralian Safety & Efficacy Register of New Interventional Procedures -

Surgical

Royal Australasian College of Surgeons

Member of International Network of Agencies for Health

Technology Assessment


Australia

� Population 23 million


Adelaide, South Australia


ASERNIP-S - summary

� Royal Australasian College of Surgeons (RACS) - established 1998

� To inform surgeons, health services, governments, consumers

� Only looks at interventional procedures and devices

� Conducts Systematic Reviews, Rapid Reviews, Horizon Scanning reports,

summary reports, others

� Independent agency – reports to RACS, governments

� ASERNIP-S Advisory Committee at RACS – meets 3 x year, report to,

advises, evaluates work

� Website as part of RACS : http://www.surgeons.org/for-health-professionals/audits-and-surgical-research/asernip-s/


Governance


RACS – RAAS Division & ASERNIP-S


ASERNIP-S Staffing

� Research Manager

� Team Leaders (2) – technical experts

� Senior Research Officers (3) – supervisory

� Research Officers (6)

� Consultants – various HTA

� External Economic Evaluator Group (University of Technology Sydney - CHERE)

� Information Specialist RACS Library


ASERNIP-S

The mission of the Australian Safety and Efficacy Register of New

Interventional Procedures - Surgical (ASERNIP-S) is to provide quality

and timely assessments of new and emerging surgical technologies

and techniques. Services provided include:

�full and rapid systematic reviews, and technology overviews of the

peer-reviewed literature

�the establishment and facilitation of clinical and research audits or

studies

�the assessment of new and emerging techniques and technologies by

horizon scanning

�Our ultimate aim is to improve the quality of healthcare through the

wide dissemination of our evidence-based research to surgeons,

healthcare providers and consumers, both nationally and

internationally.


Peer-reviewed evidence

Clinical input

Consumer input

Methodological expertise

Health

Technology

Research

ASERNIP-S (Australian Safety and Efficacy Register of New Interventional Procedures – Surgical)

Clinician advice

Policy advice

Consumer advice

Our aim is to provide information regarding the safety, effectiveness and cost-effectiveness of new or established interventional procedures.


Current Funding- Commonwealth Department of Health

(Medical Services Advisory Committee & Medical Benefits Schedule)

- State Departments of Health (HPACT – Horizon Scanning)

- Victorian Department of Health

(Evaluation of evidence for effective surgical procedures)

- WHO

(Systematic review on needs for medical devices for older people in WPRO region)

- SA Department of Health – HTAG committee support

- American College of Surgeons (Horizon Scanning)


MSAC


Publications� Dawe S, Windsor J, Broeders J, Cregan P, Hewett P, Maddern G. A Systematic

Review of Surgical Skills Transfer After Simulation-based Training: Laparoscopic Cholecystectomy and Endoscopy. Ann Surg. Forthcoming 2014 (accepted for publication).

� Butler C, Thavaneswaren P, Lee I. Efficacy of the active middle-ear implant in patients with sensorineural hearing loss. The Journal of Laryngology and Otology 2013; 127(Suppl. S2): S8-S16.

� Gallego G, Van Gool K, Casey R, Maddern G. Surgeons’ views of Health Technology Assessment in Australia: online pilot survey” International Journal of Technology and Assessment 2013; 29(3): 309–314.

� Leopardi, D, Thavaneswaran P, Mutimer K, Olbourne N, Maddern G. Autologous fat transfer for breast augmentation: a systematic review. ANZ Journal of Surgery 2013; Epub (ahead of print).

� Thavaneswaran P, Vandepeer, M. Lumbar artificial intervertebral disc replacement: a systematic review. ANZ Journal of Surgery 2013; Epub (ahead of print).

� Gurgacz S, Smith J, Truskett P, Babidge W, Maddern, G. Credentialing of surgeons: a systematic review across a number of jurisdictions. ANZ Journal of Surgery 2012; 82(7-8): 492-498.


Publications� Hailey D, Werkö S, Bakri R, Cameron A, Göhlen B, Myles S, Pwu J, Yothasamut J.

Involvement of consumers in HTA activities by INAHTA agencies. Int J Technol Assess in Health Care 2013;29(1):79–83.

� Kanhere M, Kanhere H, Cameron A, Maddern G. Does patient volume affect clinical outcomes in adult intensive care units? Intensive Care Medicine. 2012; 38(5): 741-751. Epub 5 April 2012.

� Zamora L, Humphreys K, Watt A, Forel D, Cameron A. Systematic review of computer-navigated total knee arthroplasty. ANZ Journal of Surgery 2013;83(1–2):22–30.

� Ahern E, Thavaneswaran P, Babidge W, Maddern G. Consumer perspectives in surgical research and audit.International Journal of Technology Assessment in Healthcare 2011; 27(4): 337-342.

� Sturm L, Cooter R, Mutimer K, Graham J, Maddern G. A systematic review of dermal fillers for age-related lines and wrinkles. ANZ Journal of Surgery 2011; 81(1-

� Perera C, Bridgwater F, Thavaneswaran P, Maddern G. Safety and efficacy of nontherapeutic male circumcision: a systematic review. Annals of Family Medicine 2010; 8(1): 64-72.

� Barber C, Watt A, Pham C, Humphreys K, Penington A, Mutimer K, Edwards M, Maddern G. Influence of bioengineered skin substitutes on diabetic foot ulcer and venous leg ulcer outcomes. Journal of Wound Care 2008; 17(12): 517-527.


Publications� Windsor J, Sturm L, Cosman P, Cregan P, Hewett P, Maddern G. RE: A systematic

review of skills transfer after surgical simulation training. Annals of Surgery 2008; 248(4): 690-691.

� Watt A, Cameron A, Sturm L, Lathlean T, Babidge W, Blamey S, Facey K, Hailey D, Norderhaugh I, Maddern G. Rapid versus full systematic reviews: validity in clinical practice? ANZ Journal of Surgery 2008; 78: 1037-1040.

� Windsor J, Sturm L, Cosman P, Cregan P, Hewett P, Maddern G. RE: A systematic review of skills transfer after surgical simulation training. Annals of Surgery 2008; 248(4): 901-2.

� Maddern G, Boult M, Ahern E, Babidge W. ASERNIP-S: International trend setting. ANZ Journal of Surgery 2008; 78: 853-858.

� Pham C, Perera C, Watkin S, Maddern G. Laparoscopic ventral hernia repair: a systematic review. Surgery Endoscopy 2008, DOI 10.1007/s00464-008-0182-8.

� Sturm L, Windsor J, Cosman P, Cregan P, Hewett P, Maddern G. A systematic review of skills transfer after surgical simulation training. Annals of Surgery 2008; 248(2): 166-179.

� Della Flora E, Wilson T, Martin I, O'Rourke N, Maddern G J. A review of natural orifice translumenal endoscopic surgeryTM (NOTESTM) for intra-abdominal surgery: applicability to the clinical setting. Annals of Surgery 2008; 247(4): 583-602.


New Emerging Techniques - Surgical� Initiated in 1999, identifies and assesses new medical devices and procedures

(horizon scanning).

� Provides rapidly completed reports on new emerging technologies with the aim of:

� alerting policy makers and clinicians of new/emerging medical devices� assisting regulation and introduction of new technology� preventing unnecessary utilisation of unproven medical devices.

� Currently funded by Australian Departments of Health through the Health Policy Advisory Committee on Technology (HPACT).

� HPACT is one of the largest contributors to the EuroScan database. The International Information Network on New and Emerging Health Technologies (EuroScan International Network) is a collaborative network of member agencies for the exchange of information on important emerging new drugs, devices, procedures, programmes, and settings in health care. Members from Spain, Italy, Canada, France, Germany, Finland, the Netherlands, Australia, Israel, Austria, UK, Norway, Sweden and Switzerland.


New Emerging Techniques - Surgical� HPACT Technology briefs in 2013:

� Ophthalmic high intensity ultrasound (circular cyclo-coagulation) for glaucoma

� Biodegradable stents

� Cardiovascular magnetic resonance and single-photon emission computed tomography for diagnosis of coronary heart disease

� The Margin Probe: to determine surgical margins during breast cancer tumour removal

� Safety and efficacy of antibiotics compared with appendicectomy for treatment of uncomplicated acute appendicitis

� Assay to identify biopsy-negative prostate cancer

� Endoscopic pancreatic stenting for prophylaxis of pancreatic fistula after distal pancreatectomy

� MGuard™: novel mesh-covered bare metal stent

� Posthorax™ and Stern-E-Flex sternum support vests to prevent sternal dehiscence


New Emerging Techniques - Surgical� Technology brief updates in 2013:

� LINX Reflux Management System for the treatment of gastro-oesophageal reflux

� Magnetic resonance thermometry-guided laser interstitial thermal therapy for intracranial neoplasms

� AIGISRx® Antibacterial Envelope for preventing infection in implanted cardiac devices

� Single-incision mini-sling system for female stress urinary incontinence

� IRay® for wet age-related macular degeneration

� RePneu® lung volume reduction coils for patients with advanced emphysema

� Argus II® Retinal Prosthesis System for peripheral retinal degeneration

� Bilateral BAHA implantation for bilateral hearing loss

� High sensitivity troponin for the diagnosis of myocardial infarction

� Inert liquid-to-solid gels for prostate-rectum separation

� Microwave ablation for hepatic tumours

� Multi-catheter interstitial brachytherapy for early stage breast cancer


Horizon Scanning for American

College of Surgeons

Reports for American College of Surgeons (2013):

�Irreversible electroporation for tumour ablation

�Stapled transanal rectal resection for obstruction

�Implantable gastric stimulation devices for glycaemic control

�Extracorporal shock wave therapy for wound healing


Consumer information and editing� ASERNIP-S reports are written and edited for a targeted audience (health

professionals, decision makers, patients).

� Plain English summaries of systematic reviews are prepared by consumer information groups:

� surgeons� consumer representatives� research staff.

� Dissemination:� website� publications (annual report, newsletters)� links with consumer groups.

� Accreditation:� HealthInsite� HONcode.

� Globally:� Health Technology Assessment International.

Courtesy of Mr Randall Sach, surgeon-artist


International Work

� HTAi (Health Technology Assessment International)

- Members of HTAi (since 1999), the global scientific and professional society for all those

who produce, use, or encounter HTA.

- Professor Maddern, current Vice President HTAi

� INAHTA (International Network of Agencies for Health Technology Assessment)

- Members of INAHTA (since 1999),non-profit organization of agencies producing HTAs,

are linked to regional or national government.

- Wendy Babidge current Chair INAHTA

� WHO (World Health Organisation)

- Needs of the elderly for medical devices in the Asia-Pacific region

- Systematic review and survey (2012 – 2013)


Thank you!

� ASERNIP-S – contacts

[email protected]

[email protected]

http://www.surgeons.org/for-health-professionals/audits-and-surgical-research/asernip-s/

Documents

2 How to Set up an HTA Agency ASERNIP-S.ppt...Royal Australasian College of Surgeons Publications Dawe S, Windsor J, Broeders J, Cregan P, Hewett P, Maddern G. A Systematic Review