General

Guideline Title

Adjunctive colposcopy technologies for examination of the uterine cervix – DySIS and the Niris Imaging System.

Bibliographic Source(s)

  • National Institute for Health and Care Excellence (NICE). Adjunctive colposcopy technologies for examination of the uterine cervix – DySIS and the Niris Imaging System. London (UK): National Institute for Health and Care Excellence (NICE); 2012 Aug. 34 p. (Diagnostics guidance; no. 4).

Guideline Status

This is the current release of the guideline.

This guideline meets NGC’s 2013 (revised) inclusion criteria.

Recommendations

Major Recommendations

DySIS is a clinically and cost-effective option, compared with standard colposcopy, for examining the uterine cervix in women referred for colposcopy, and should be considered in procurement plans for colposcopy equipment.

Current evidence is insufficient to determine whether the Niris Imaging System is a cost-effective option for use as a colposcopic adjunct for examining the uterine cervix in women referred for colposcopy.

Clinical Algorithm(s)

None provided

Scope

Disease/Condition(s)

  • Cervical cancer
  • Low-grade cervical intraepithelial neoplasia (CIN 1)
  • High-grade CIN (CIN 2/3)
  • Human papillomavirus (HPV) infection

Guideline Category

  • Diagnosis
  • Evaluation
  • Prevention
  • Technology Assessment

Clinical Specialty

  • Internal Medicine
  • Obstetrics and Gynecology
  • Oncology
  • Pathology
  • Radiology

Intended Users

  • Advanced Practice Nurses
  • Nurses
  • Physician Assistants
  • Physicians

Guideline Objective(s)

To determine whether, in conjunction with current decision-making protocols, using adjunctive colposcopy technologies cost-effectively improves health outcomes and quality of life in women referred for colposcopy compared with using conventional colposcopy

Target Population

Women referred for colposcopy through the National Health Service (NHS) Cervical Screening Programme

Interventions and Practices Considered

Adjunctive colposcopy technologies for uterine cervix examination: DySIS and the Niris Imaging System

Major Outcomes Considered

  • Diagnostic test accuracy outcomes (sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio)
  • Adverse effects
  • Patient satisfaction
  • Morbidity and mortality from cancer
  • Cost-effectiveness

Methodology

Methods Used to Collect/Select the Evidence

  • Hand-searches of Published Literature (Primary Sources)
  • Hand-searches of Published Literature (Secondary Sources)
  • Searches of Electronic Databases
  • Searches of Unpublished Data

Description of Methods Used to Collect/Select the Evidence

Note from the National Guideline Clearinghouse (NGC) : The National Institute for Health and Care Excellence (NICE) commissioned an External Review Group to perform a systematic literature review on the technology considered in this diagnostics guidance and prepare a Diagnostics Assessment Report (DAR). The DAR for this guidance was prepared by the Centre for Reviews and Dissemination/Centre for Health Economics (CRD/CHE) Technology Assessment Group, University of York (see the “Availability of Companion Documents” field).

Systematic Review of Clinical Effectiveness

Methods for Reviewing Clinical Effectiveness

Search Strategy

The literature search aimed to systematically identify research related to the clinical and cost-effectiveness of adjunctive colposcopy technologies.

The base search strategy was constructed using MEDLINE and then adapted to the other resources searched. The search included the following components:

  1. Terms for cervix AND
  2. Terms for colposcopy (including both general colposcopy terms as well as specific technologies).

Searches of major bibliographic databases were limited by date (2000 to date) reflecting the date of development of the new technologies. No language, study design or other limits were applied. Reference lists of all included studies were hand-searched to identify further relevant studies. Where necessary, authors of eligible studies were contacted for further information.

Search strategies were developed by an information specialist with input from the project team. The search strategy was checked by a second information specialist. Sources of information were identified by an information specialist with input from the project team.

Since the technologies involved are relatively new, particular attention was given to identifying sources for ongoing trials and conference reports (by searching specialist sources such as Inside Conferences and ClinicalTrials.gov). Details of the search strategies are presented in Appendix 1 in the DAR.

The following resources were searched for relevant clinical and cost-effectiveness research:

  • AMED: Allied and Complementary Medicine (via OvidSP, using the segment 1985 to September 2011, searched on 22 September 2011)
  • Biosis Previews (via Dialog, using the segment 1993-2011/October week 2, searched on 19 October 2011)
  • CDSR: Cochrane Database of Systematic Reviews (via Wiley Cochrane Library website, Issue 9 of 12, September 2011, searched on 22 September 2011)
  • CENTRAL: Cochrane Central Register of Controlled Trials (via Wiley Cochrane Library website, Issue 3 of 4, July 2011, searched on 22 September 2011)
  • CINAHL Cumulative Index to Nursing & Allied Health (via EBSCO, using the segment 1981 to 20110916, searched on 22 September 2011)
  • ClinicalTrials.gov (via website www.clinicaltrials.gov/, using the segment to September 2011, searched on 28 September 2011)
  • Current Controlled Trials (using the segment to September 2011, searched on 28 September 2011)
  • DARE: Database of Abstracts of Reviews of Effects (via Wiley Cochrane Library website Issue 3 of 4, Jul 2011, searched on 22 September 2011)
  • EMBASE (via OvidSP, using the segment 1996 to 2011 week 37, searched on 22 September 2011)
  • HMIC: Health Management Information Consortium (via OvidSP, using the segment 1985 to September 2011, searched on 22 September 2011)
  • HTA: Health Technology Assessment Database (via Wiley Cochrane Library website Issue 3 of 4, Jul 2011, searched on 22 September 2011)
  • INSPEC (via OvidSP, using the segment 1969-2011 week 36, searched on 22 September 2011)
  • Inside Conferences (via Dialog, using the segment 1993-2011/Oct 18, searched on 19 October 2011)
  • MEDLINE (via OvidSP, using the segment 1948 to September week 2 2011, searched on 22 September 2011)
  • NHS-EED: NHS Economic Evaluations Database (via Wiley Cochrane Library website Issue 3 of 4, Jul 2011, searched on 22 September 2011)
  • PASCAL (via Dialog, using the segment 1973-2011/Oct w2, searched on 19 October 2011)
  • SCI Expanded: Science Citation Index (via Web of Knowledge, using the segment 2000 - 2011-09-22, searched on 23 September 2011)
  • SCI – Conference Proceedings (via Web of Knowledge, using the segment 1990 - 2011-09-22, searched on 23 September 2011)

Additional searches were conducted to identify systematic reviews of colposcopy, in an attempt to ascertain the diagnostic accuracy of colposcopy:

  • CDSR: Cochrane Database of Systematic Reviews (via Wiley Cochrane Library website Issue 10 of 12, October 2011, searched on 25 October 2011)
  • DARE: Database of Abstracts of Reviews of Effects (via CRD admin database, using the segment to 25/10/2011, searched on 25 October 2011)
  • DARE: Database of Abstracts of Reviews of Effects (via Wiley Cochrane Library website Issue 4 of 4, Oct 2011, searched on 25 October 2011)

The following websites were searched for guidelines and care pathways:

Inclusion and Exclusion Criteria

Two reviewers independently screened all titles and abstracts. Full paper manuscripts of any titles/abstracts that appeared to be relevant were obtained where possible and the relevance of each study independently assessed by two reviewers according to the inclusion and exclusion criteria below. Studies that did not meet all of the criteria were excluded and their bibliographic details listed with reasons for exclusion. Any discrepancies were resolved through consensus, with involvement of a third reviewer when necessary.

The original scope for the assessment also included the APX 100 device. Since this technology was removed from the assessment in December 2011, after the inclusion screening stage of the assessment, inclusion criteria refer to the APX 100 device.

Study Design

Comparative studies, including diagnostic test accuracy studies and controlled trials, were included in the evaluation of clinical effectiveness, since this study design allows a comparison to be made between the new technology and current practice, which is essential for the economic model.

Intervention

Studies assessing DySIS, LuViva Advanced Cervical Scan, Niris Imaging System, or APX 100, alone or alongside colposcopy, were included in the evaluation of clinical effectiveness.

Comparators

Studies that compared one of the adjunctive colposcopy technologies with standard colposcopy were included in the evaluation of clinical effectiveness.

Participants

The population of interest is women referred for colposcopy through the National Health Service (NHS) Cervical Screening Programme. Therefore, studies of women referred for colposcopy because of an abnormal cytology result were included in the evaluation of clinical effectiveness. Studies that also included women referred for colposcopy because of symptoms indicative of cervical cancer (e.g., post-coital bleeding) or women referred for colposcopy for follow-up of cervical intraepithelial neoplasia (CIN) were also eligible for inclusion; however, studies that only included women referred for symptoms or for follow-up were not eligible for inclusion.

Outcomes

The clinical outcomes of interest were diagnostic test accuracy outcomes (e.g., sensitivity and specificity), adverse effects and patient experience. Where other patient health outcomes were reported (e.g., morbidity and mortality from cancer or treatment), these were also included in the assessment.

Review of Existing Economic Evaluations

Methods

Systematic searches of the literature were conducted to identify potentially relevant studies for inclusion in the assessment of cost-effectiveness (see information on clinical effectiveness searches, above).

Number of Source Documents

Systematic Review of Clinical Effectiveness

A total of 7,835 records were identified from the clinical effectiveness searches and an additional 69 records were identified via hand searching or contact with the manufacturers (via National Institute for Health and Care Excellence [NICE]) (see Figure 4.1 in the Diagnostics Assessment Report [DAR] [see the “Availability of Companion Documents” field]). Seven studies (reported in 31 references) met the inclusion criteria.

  • APX 100 = 1 study (reported in 4 papers/records)
  • DySIS = 2 studies and 2 subgroup assessments (reported in 4 papers/records)
  • LuViva = 1 study and 1 subgroup assessment (reported in 13 papers/records)
  • Niris = 3 studies (reported in 10 papers/records)

Details of studies excluded at the full publication stage are provided in Appendix 4 in the DAR.

On 21 December 2011, after the Assessment Group had finished screening studies for inclusion, they were informed by NICE that the APX 100 device, developed by Zilico Ltd, should be omitted from the assessment (one study, reported in four references). Therefore, six studies (reported in 27 references) were included in the review.

Economic Evaluation

  • The systematic literature search identified no economic evaluation studies of colposcopy or colposcopic adjuncts (DySIS, LuViva Advanced Cervical Scan and Niris Imaging System) that met the inclusion criteria for review.
  • A decision analytic model was submitted.

Methods Used to Assess the Quality and Strength of the Evidence

  • Expert Consensus

Rating Scheme for the Strength of the Evidence

Not applicable

Methods Used to Analyze the Evidence

  • Review of Published Meta-Analyses
  • Systematic Review with Evidence Tables

Description of the Methods Used to Analyze the Evidence

Note from the National Guideline Clearinghouse (NGC) : The National Institute for Health and Care Excellence (NICE) commissioned an External Assessment Group to perform a systematic literature review on the technology considered in this diagnostics guidance and prepare a Diagnostics Assessment Report (DAR). The DAR for this guidance was prepared by the Centre for Reviews and Dissemination/Centre for Health Economics (CRD/CHE) Technology Assessment Group, University of York (see the “Availability of Companion Documents” field).

Systematic Review of Clinical Effectiveness

Methods for Reviewing Clinical Effectiveness

Data Extraction Strategy

Data on study and participant characteristics and outcomes were extracted by one reviewer using a standardised data extraction form and independently checked for accuracy by a second reviewer. Disagreements were resolved through consensus, with involvement of a third reviewer when necessary.

Where sufficient data were available, the following diagnostic accuracy statistics (with 95% confidence intervals) were calculated, for each study, using the Canadian Institute of Health Research’s Knowledge Translation statistics calculator: sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio. Subsequently, accuracy was also calculated (the proportion of true positive and true negative results).

To allow consistency when comparing studies, the Assessment Group has reported calculated results, rather than those reported in the study reports. Where data were missing from publications or other study reports, the authors were contacted (via NICE, in the case of the manufacturers of the technologies). Data from multiple publications of the same study were extracted as a single study. The data extraction tables are presented in Appendix 2 in the DAR.

Quality Assessment Strategy

The quality of the included studies was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool for diagnostic studies. As well as adding review-specific questions to domains 2 and 3, three further quality-related questions were assessed (see Appendix 3 in the DAR for details). The assessment was performed by one reviewer, and independently checked by a second. Disagreements were resolved through consensus, with involvement of a third reviewer when necessary. Further details about QUADAS-2 and results of the quality assessment are presented in Section 4.1.3.2 and Appendix 3 in the DAR.

Data Analysis

In view of the heterogeneity between the included studies, in terms of participant characteristics and the different comparator technologies used, formal meta-analysis was not appropriate. Therefore, the studies were grouped according to the adjunctive technology used and a narrative synthesis was presented.

See Section 4.1 in the DAR for more information on clinical effectiveness analysis.

Economic Evaluation

Description of Decision Analytic Model

Overview

A decision analytic model was developed to assess the cost-effectiveness of the three devices (DySIS, LuViva Advanced Cervical Scan, and Niris Imaging System). It compared these to standard colposcopy for examination of the uterine cervix, for the detection of cancerous and precancerous cervical tissue in patients referred for colposcopy through the National Health Service (NHS) Cervical Screening Programme. As a result of the weaknesses in the studies of Niris and LuViva, these devices were excluded in the base case analysis. The analysis adopted the perspective of the UK NHS. The model provides a framework for the synthesis of data from the review of clinical effectiveness and other relevant parameters.

Outcomes in the model are expressed in terms of quality-adjusted life-years (QALYs). Costs are evaluated from the perspective of the NHS and Personal Social Services, expressed in UK £ sterling at 2011 prices. Both costs and outcomes are discounted using an annual discount rate of 3.5%, in line with current methods guidelines. All stages of the work were informed by discussion with a clinical advisor and members of the specialist committee to provide feedback on specific aspects of the analysis such as the modelling approach, data inputs and assumptions.

Modelling Approach

The decision analytic model involved two stages. First, a decision tree to model the diagnostic and treatment pathways for patients referred to colposcopy from the NHS Cervical Screening Programme. Second, a Markov model, which simulates the natural history of patients and captures future cytological screening and referrals to colposcopy, to estimate the outcomes of the initial diagnosis and treatment choices. The decision tree has been developed for this appraisal, whilst the Markov model is based on a revised version of the model, referred to as the Sheffield model (full details of the model are provided in Appendix 5 in the DAR).

Diagnostic and Treatment Decision Tree

The diagnostic and treatment decision tree was developed to model the short-term diagnostic and treatment pathways and the outcomes of patients referred to colposcopy from the NHS Cervical Screening Programme. Patients are referred for colposcopy through the NHS Cervical Screening Programme for a variety of reasons (e.g., moderate or severe cytology). For any given referral reason there is a distribution of the true underlying health states. The diagnostic treatment decision tree first allocates patients to their true underlying health state, with the distribution being dependent on their reason for referral, and then sends them down the diagnostic and treatment pathways dependent on probabilities for diagnostic accuracy, treatment and treatment effectiveness.

The decision tree captures the initial diagnosis of the patient by the colposcopist and any subsequent treatments or screening options based upon their diagnosis at colposcopy and the reason for referral from the NHS Cervical Screening Programme. The effectiveness of any treatment is based upon the true underlying condition of the patient. Treatment and screening options available include:

  1. Return to the NHS Cervical Screening Programme
  2. Refer for re-screen at 6 months: patients can be referred for re-screen with a cytological smear and human papillomavirus (HPV) test, or can be referred for re-screen with colposcopy or adjunct
  3. A diagnostic biopsy
  4. A treatment biopsy
  5. A treatment biopsy followed by cancer treatment

See Sections 4.2-4.7 in the DAR for additional information on the cost-effectiveness analysis.

Methods Used to Formulate the Recommendations

  • Expert Consensus

Description of Methods Used to Formulate the Recommendations

Developing Recommendations

After reviewing the evidence the Diagnostic Advisory Committee (DAC) agrees draft recommendations on the use of the technology in the National Health Service (NHS) in England. When formulating these recommendations, the Committee has discretion to consider those factors it believes are most appropriate to the evaluation. In doing so, the Committee has regard to any relevant provisions of the National Institute for Health and Care Excellence’s (NICE’s) Directions, set out by the Secretary of State for Health, and legislation on human rights, discrimination and equality. In undertaking evaluations of healthcare technologies, NICE takes into account the broad balance of clinical benefits and costs, the degree of clinical need of patients under consideration, any guidance issued to the NHS by the Secretary of State that is specifically drawn to the attention of NICE by the Secretary of State, and any guidance issued by the Secretary of State, and the potential for long-term benefits to the NHS of innovation.

The Committee takes into account advice from NICE on the approach it should take to making scientific and social value judgements. Advice on social value judgements is informed in part by the work of NICE’s Citizens Council.

The Committee takes into account how its judgements have a bearing on distributive justice or legal requirements in relation to human rights, discrimination and equality. Such characteristics include, but are not confined to: race, gender, disability, religion or belief, sexual orientation, gender reassignment and pregnancy or maternity.

The Committee considers the application of other Board-approved NICE methods policies, such as the supplementary guidance on discounting and the end-of-life criteria, if they are relevant to the evaluation.

Because the Programme often evaluates new technologies that have a thin evidence base, in formulating its recommendations the Committee balances the quality and quantity of evidence with the expected value of the technology to the NHS and the public.

The credibility of the guidance produced by NICE depends on the transparency of the DAC’s decision-making process. It is crucial that the DAC’s decisions are explained clearly, and that the contributions of registered stakeholders and the views of members of the public are considered. The reasoning behind the Committee’s recommendations is explained, with reference to the factors that have been taken into account.

The language and style used in the documents produced by the Committee are governed by the following principles:

  • Clarity is essential in explaining how the DAC has come to its conclusions.
  • The text of the documents does not need to reiterate all the factual information that can be found in the information published alongside the guidance. This needs careful judgement so that enough information and justification is given in the recommendations to enable the reader to understand what evidence the DAC considered and, if appropriate, who provided that evidence.

The Committee may take into account factors that may provide benefits to the NHS or the population, such as patient convenience. It may also consider costs and other positive or negative impacts on the NHS that may not be captured in the reference-case cost analysis, such as improved processes.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

DySIS

The base-case analysis compared DySIS colposcopy with standard colposcopy alone for each reason for referral. In all instances, standard colposcopy alone was dominated by DySIS colposcopy (that is, standard colposcopy was more expensive and less effective). For the whole population, based on a weighted average of the results of each reason for referral, DySIS colposcopy provided more quality-adjusted life years (QALYs) (0.01466) at a lesser cost (£59.59). The base case indicates that DySIS colposcopy is a cost-effective form of management, given the assumptions and evidence used.

Extensive sensitivity and scenario analyses were conducted on a variety of measures including the effectiveness of treatment biopsy on cervical intraepithelial neoplasia (CIN 1). In all analyses, DySIS was either dominant or cost effective.

Niris Imaging System

No reliable estimates of the sensitivity and specificity of the Niris Imaging System for CIN 2+ were identified in the assessment, and a full economic analysis was therefore not possible. An indicative analysis of the Niris Imaging System was carried out based on its cost. Assuming the same specificity as DySIS colposcopy, the sensitivity of the Niris Imaging System would have to be 86% to be considered cost effective (compared with DySIS colposcopy). Although the reported sensitivity of the Niris Imaging System was higher in the 1 study examined, that study only biopsied areas considered abnormal by the Niris Imaging System, so the sensitivity is likely to be a significant overestimate.

Considerations

The Committee concluded that the modelling of DySIS colposcopy showed that it is robustly cost-effective (possibly even cost saving) when compared with conventional colposcopy. The Committee concluded that current evidence is not sufficient to determine whether the Niris Imaging System would be cost effective and that additional research on the Niris Imaging System could provide better evidence of its diagnostic accuracy and clinical utility.

See Sections 5 and 6 in the original guideline document for more information on the cost-effectiveness assessment.

Method of Guideline Validation

  • External Peer Review

Description of Method of Guideline Validation

The National Institute for Health and Care Excellence (NICE) sends the Diagnostics Assessment Report (DAR), with any confidential material removed, to registered stakeholders for comment. Stakeholders have 10 working days to return comments. Models supporting the DAR are made available to registered stakeholders on request during this period.

NICE presents anonymised registered stakeholder comments on the DAR, along with any responses from NICE or the External Assessment Group (EAG), to the Committee and later publishes these comments on its website.

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of evidence supporting the recommendations is not specifically stated.

The Diagnostics Advisory Committee considered clinical and cost-effectiveness evidence from a systematic review of DySIS and the Niris Imaging System performed by an External Assessment Group.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate use of adjunctive colposcopy technologies (DySIS and the Niris Imaging System) for examination of the uterine cervix

Potential Harms

Not stated

Qualifying Statements

Qualifying Statements

  • This guidance represents the view of the National Institute for Health and Care Excellence (NICE), which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
  • Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.

Implementation of the Guideline

Description of Implementation Strategy

The National Institute for Health and Care Excellence (NICE) has developed tools, in association with relevant stakeholders, to help organisations put this guidance into practice (see also the “Availability of Companion Documents” field).

Implementation Tools

  • Mobile Device Resources
  • Patient Resources
  • Resources

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need

  • Getting Better
  • Staying Healthy

IOM Domain

  • Effectiveness
  • Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)

  • National Institute for Health and Care Excellence (NICE). Adjunctive colposcopy technologies for examination of the uterine cervix – DySIS and the Niris Imaging System. London (UK): National Institute for Health and Care Excellence (NICE); 2012 Aug. 34 p. (Diagnostics guidance; no. 4).

Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released

2012 Aug

Guideline Developer(s)

  • National Institute for Health and Care Excellence (NICE) - National Government Agency [Non-U.S.]

Source(s) of Funding

National Institute for Health and Care Excellence (NICE)

Guideline Committee

Diagnostics Advisory Committee

Composition of Group That Authored the Guideline

Standing Committee Members : Professor Ron Akehurst, Professor in Health Economics, School of Health & Related Research (ScHARR), University of Sheffield; Dr Trevor Cole, Consultant Clinical and Cancer Geneticist, Birmingham Women’s Hospital; Dr Paul Collinson, Consultant Chemical Pathologist, St George’s Hospital; Dr Sue Crawford, General Practitioner (GP) Principal, Chillington Health Centre; Professor Ian A Cree, Senior Clinical Advisor, NETSCC, EME; Professor Erika Denton, National Clinical Director for Imaging, Department of Health, Honorary Professor of Radiology, University of East Anglia and Norfolk & Norwich University Hospital; Dr Simon Fleming, Consultant in Clinical Biochemistry and Metabolic Medicine, Royal Cornwall Hospital; Professor Lisa Hall, Professor of Analytical Biotechnology, University of Cambridge; Professor Chris Hyde, Professor of Public Health and Clinical Epidemiology, Peninsula Technology Assessment Group (PenTAG); Professor Noor Kalsheker, Professor of Clinical Chemistry, University of Nottingham; Dr Mark Kroese, Consultant in Public Health Medicine, PHG Foundation, Cambridge and UK Genetic Testing Network; Professor Dietrich Mack, Professor of Medical Microbiology and Infectious Disease, School of Medicine, Swansea University; Professor Adrian Newland ( Chair ); Dr Richard Nicholas, Consultant Neurologist, Heatherwood and Wexham Park Hospitals; Ms Margaret Ogden, Lay representative; Dr Diego Ossa, Director of Market Access Europe, Novartis Molecular Diagnostics; Mr Stuart Saw, Director of Finance, North East London and the City PCTs; Dr Steve Thomas, Consultant Vascular and Cardiac Radiologist at Sheffield Teaching Hospitals Foundation Trust; Mr Paul Weinberger, CEO, DiaSolve Ltd, London; Mr Christopher Wiltsher, Lay representative

Specialist Committee Members : Dr Karin Denton, Consultant in Cellular Pathology; Mrs Phyllis Dunn, Clinical Lead Nurse; Dr Andrew Fish, Consultant Gynaecological Surgeon; Dr Sadaf Ghaem-Maghami, Clinical Senior Lecturer and Honorary Consultant in Surgical Gynaecological Oncology; Dr Pierre Martin-Hirsch, Consultant Gynaecological Oncologist; Mr Robert Music, Lay representative; Mr Charles Redman, Consultant Gynaecological Oncologist; Dr Miren Turner, GP/Colposcopist

Financial Disclosures/Conflicts of Interest

Committee members are required to submit a declaration of interests on appointment, in every year of their tenure, and at each Committee meeting, in line with the National Institute for Health and Care Excellence’s (NICE’s) code of practice for declaring and dealing with conflicts of interest.

Guideline Status

This is the current release of the guideline.

This guideline meets NGC’s 2013 (revised) inclusion criteria.

Guideline Availability

Electronic copies: Available from the National Institute for Health and Care Excellence (NICE) Web site. Also available for download as a Kindle or EPUB ebook from the NICE Web site.

Availability of Companion Documents

The following are available:

  • Wade R, Spackman E, Corbett M, Walker, S, Light K, Naik R, Sculpher M, Eastwood, A. Adjunctive colposcopy technologies for examination of the uterine cervix – DySIS, LuViva Advanced Cervical Scan and Niris Imaging System. Diagnostics assessment report. York (UK): Centre for Reviews and Dissemination/Centre for Health Economics (CRD/CHE) Technology Assessment Group, University of York; 2012 Feb. 284 p. Electronic copies: Available from the National Institute for Health and Care Excellence (NICE) Web site.
  • Adjunctive colposcopy technologies for examination of the uterine cervix – DySIS, LuViva Advanced Cervical Scan and Niris Imaging System. Diagnostics assessment report. Appendix 5. Sheffield (UK): University of Sheffield; 2010. 59 p. Electronic copies: Available from the NICE Web site.
  • Adjunctive colposcopy technologies for examination of the uterine cervix – DySIS and the Niris Imaging System. Costing template. London (UK): National Institute for Health and Care Excellence (NICE); 2012 Aug. (Diagnostics guidance; no. 4). Electronic copies: Available from the NICE Web site.
  • DySIS and colposcopy. Podcast. London (UK): National Institute for Health and Care Excellence (NICE); 2012 Aug. (Diagnostics guidance; no. 4). Electronic copies: Available from the NICE Web site.
  • Diagnostics Assessment Programme manual. London (UK): National Institute for Health and Care Excellence; 2011 Dec. 130 p. Electronic copies: Available from the NICE Web site.

Patient Resources

The following is available:

  • Adjunctive colposcopy technologies for examination of the uterine cervix - DySIS and the Niris Imaging System. Information for the public. London (UK): National Institute for Health and Care Excellence (NICE); 2012 Aug. (Diagnostics guidance; no. 4). Electronic copies: Available from the National Institute for Health and Care Excellence (NICE) Web site.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline’s content.

NGC Status

This NGC summary was completed by ECRI Institute on January 2, 2015.

The National Institute for Health and Care Excellence (NICE) has granted the National Guideline Clearinghouse (NGC) permission to include summaries of their Diagnostics guidance with the intention of disseminating and facilitating the implementation of that guidance. NICE has not verified this content to confirm that it accurately reflects the original NICE guidance and therefore no guarantees are given by NICE in this regard. All NICE diagnostics guidance is prepared in relation to the National Health Service in England and Wales. NICE has not been involved in the development or adaptation of NICE guidance for use in any other country. The full versions of all NICE guidance can be found at www.nice.org.uk.

This NGC summary is based on the original guideline, which is subject to the guideline developer’s copyright restrictions.

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