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Keywords:

  • database;
  • incontinence;
  • outcomes;
  • prolapse;
  • surgery

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Concept
  5. Current usage, access and security
  6. Data ownership
  7. Facilities
  8. Inherent challenges
  9. The way forward
  10. References

Key content

  • The British Society of Urogynaecology allows members to enter and access pre-, intra- and postoperative data relating to any anti-incontinence and/or prolapse procedure onto the database.
  • Treatment of patient identifiable data within the database fulfils the Caldicott Guardian principles.
  • The database allows users to create reports based on their own outcomes and complications following surgery.
  • The database is a useful tool for audit, clinical governance, personal development and appraisal.

Learning objectives

  • To understand how to access the database.
  • To understand the benefits of the database.
  • To appreciate that the benefits of the database depends on the quality of data entered.

Ethical issues

  • The issues of data protection and patient consent.
  • Who should have access to publish various outcomes using the data from the database?

Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Concept
  5. Current usage, access and security
  6. Data ownership
  7. Facilities
  8. Inherent challenges
  9. The way forward
  10. References

The British Society of Urogynaecology (BSUG) was formed in 2001 at the request of the Royal College of Obstetricians and Gynaecologists (RCOG) to set and raise the profile of urogynaecology. It continues to do this by providing guidelines, setting standards for training, encouraging study and research into female pelvic floor dysfunction and providing a network of support for clinicians through meetings, forums and more recently the BSUG website (http://bsug.org.uk). In 2002, one of the authors of this review (PM) had been working on setting up a database for urinary incontinence surgery and was approached by the chair of the newly established BSUG Audit Committee to assess the potential for developing a national audit tool. Over the next 5 years, several versions of a workable database (initially in a Microsoft Access format) were tried and tested with varying success, but limited uptake. In 2007, BSUG launched BSUG.NET, the first online urogynaecology database of its kind. This launch was boosted by support from NICE in its guidance on urinary incontinence[1] and subsequently in its guidance on any new urogynaecological interventions/procedures, particularly those involving graft insertions. Since 2007, further modifications have been made, ultimately resulting in a powerful, easily accessible audit tool that can be readily interrogated to produce useful local and national audit data.

Concept

  1. Top of page
  2. Abstract
  3. Introduction
  4. Concept
  5. Current usage, access and security
  6. Data ownership
  7. Facilities
  8. Inherent challenges
  9. The way forward
  10. References

The BSUG audit database offers a user friendly, secure, online interface that allows the user to collect pre-, intra- and postoperative data relating to any anti-incontinence and prolapse procedures they perform. As a result, the database collects data from centres throughout the UK and provides a large dataset on procedure numbers, complications and outcomes using validated measures. The information contained within one's own dataset has proven invaluable to the authors with respect to personal development and appraisal and achieving expected clinical governance targets, such as monitoring the introduction into practice of new mesh procedures. It has also proved a useful adjunct in documenting data relating to a trainee's surgical performance as well as the training offered to trainees by that clinician. Utilisation of the database also forms an almost integral part of the process of formal ‘unit accreditation’ in urogynaecology that BSUG established in 2009. In the future, it is envisaged that keeping a personal dataset will prove invaluable for the revalidation process.

Current usage, access and security

  1. Top of page
  2. Abstract
  3. Introduction
  4. Concept
  5. Current usage, access and security
  6. Data ownership
  7. Facilities
  8. Inherent challenges
  9. The way forward
  10. References

As it became apparent that the database was increasingly being utilised and supported by organisations such as NICE, BSUG established a subsidiary company, BSUG Database Limited, so that the software intellectual property rights could be protected. This also enabled BSUG to enter into formal contracts with our associated IT company (ICE ICT). Over the past 9 years, BSUG has spent in excess of £50,000 developing the database. Currently, the database is free to BSUG members. A change in the constitution of BSUG (in November 2010) allows any consultant or associate specialist/subspecialty trainee who performs anti-incontinence and/or prolapse surgery to join the society and hence gain access to the database. The majority of this type of surgery is still performed by the generalist and the hope is to encourage as many users as possible to join BSUG and utilise this facility. In the future, it is envisaged that access to the database for UK consultants who are not BSUG members will be granted by paying a small annual maintenance fee.

Currently there are 142 registered centres in the UK, with 68 active centres keeping data on over 30 000 procedures. District general hospitals comprise 44 out of the 68 centres (65%). There has been an exponential increase in data being entered on the database since its introduction (Figure 1).

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Figure 1. A figure showing the cumulative operations entered into the database from January 2004 to January 2011

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Access to the database is through the BSUG secretariat that is based at the RCOG. Further details, including BSUG membership forms can be found on the newly re-launched BSUG website. The new user will be allocated a user name and password. Passwords are required to be changed every 90 days. The user's hospital or centre will be allocated a centre number. All clinicians using the database within a single hospital or acute trust can set up the system so that all their department's data are visible to all of the clinicians in that department (with any patient identifiable data removed from other clinicians' patients) or can simply view their own patients' data. The BSUG database website is http://www.bsug.net and this can be typed into the address bar and saved into the list of favourites as one would for any website. At present, the BSUG database is in the process of being moved from a secure external server onto the even more secure NHS N3 network (intranet).

Access to the database is via HTTPS which is 128 bit SSL encryption and following the move to N3, the database will be in an ISO27001, IGSoC (Connecting for Health [Cfh] Information governance certified) data centre. Currently, access to the database is via individual username and password and the ‘acceptable usage policy’ must be accepted by each user before being allowed onto the system. Users can register on the system but are only activated once they have been verified by the BSUG secretary. All the data are backed up online to a mirrored data centre at a diverse location. A copy of the source code is stored by the secretariat of BSUG and is kept at the RCOG. ICE ICT Support limited has access to the database for management purposes, which involves updates, testing and a managed service.

Once logged on to the system, various menus are outlined in the blue bar (Figure 2) and this enables the user to access a range of options. The creation of a new record is detailed below. ‘Search’ functions exist both for locating individual records of specific patients and for identifying episodes. The episode feature is particularly useful; here, any procedure or groups of procedure can be searched within any set time frame. The data set requested could then be displayed in a variety of formats and time order, which helps particularly when looking for patients who are still to be followed up. A download section is included and allows access to the various forms, publications, letters and validated international consultation on incontinence questionnaires (ICIQ) (including the scoring systems). The download section also has a link to the new BSUG website. It is recommended by BSUG that prior to using the database individuals should inform their local Caldicott Guardian, clinical director and Clinical Governance Committee. It is not a requirement that one obtains trust R&D Ethics Committee approval but signed patient consent is required and a specific downloadable consent form and patient information sheet have been designed.

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Figure 2. Homepage showing the available options along the blue bar

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It is very important to understand that users are only able to access data and perform reports on their own patients. Patient identifiable data (PID) are only visible to that patient's clinician or his/her deputy. At a national level, all PID as well as user/centre data are stripped from reports to create national reports that are anonymous, with respect to patients, users and centres. The management of PID within the BSUG database fulfils Caldicott Guardian principles.[2]

Data ownership

  1. Top of page
  2. Abstract
  3. Introduction
  4. Concept
  5. Current usage, access and security
  6. Data ownership
  7. Facilities
  8. Inherent challenges
  9. The way forward
  10. References

Data that are not anonymous, that is to say patient identifiable, are the property of the inputting clinician and their relevant hospital. The individual does not need the input or permission of BSUG to use the data for an audit or study on their own or their unit's dataset. The anonymous national dataset belongs to BSUG. It is very important to realise that all users have access to this dataset for analysis, audit, presentation and/or publication. A formalised process for application to the BSUG audit committee for access to the national dataset has been established. This involves the written submission of a planned audit or project to the audit committee who will assess the application with respect to its quality and feasibility as well as to avoid duplicity.

Facilities

  1. Top of page
  2. Abstract
  3. Introduction
  4. Concept
  5. Current usage, access and security
  6. Data ownership
  7. Facilities
  8. Inherent challenges
  9. The way forward
  10. References

Creating a new record (episode)

Each patient undergoing surgery completes the relevant ICIQ forms at pre-assessment and signs the BSUG consent form at the same time as the operative consent form; both are then filed in the patient's notes. Some units have added the BSUG consent to their routine consent forms thereby ensuring the patient does not have to sign a separate consent form. To enter a new patient into the system, the user should log on and click the ‘add new patient’ option. A basic level of PID is then entered to enable data retrieval at later date. PID in the context of this database is limited to name, date of birth and hospital number. Following this, a series of pages are brought up for completion. These include pre-, intra- and postoperative fields for data entry (Figures 3-5) as well as the optional field for the electronic personal assessment questionnaire (EPAQ). In the author's experience it is most efficient to simply enter the pre- and intraoperative data at the end of each surgical procedure while in the operating theatre. This takes approximately 3–4 minutes, leaving only the follow-up page to be completed at a later stage. Patients who are already on the system having had previous surgery are archived within the system so that PID does not need to be entered for each surgical episode. A user can simply search for the patient's record and add a new episode. In this way, the same patient can have multiple episodes of care. This, of course, is not unusual in urogynaecology.

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Figure 3. Preoperative entry field of the database

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Figure 4. Intraoperative entry field of the database

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Figure 5. Postoperative entry field of the database

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Creating reports

The ability to generate one's own reports forms the most rewarding aspect of the database. The quality of reports produced relies heavily on the quantity and quality of data that are inserted. Basic reports include tables of procedure numbers within set time frames as well as complication tables (Figures 6-8). Several matrix reports are already built into the system to allow the interrogator to generate outcome reports by combining a variety of fields. This allows a range of outcomes to be produced from a simple subset, from, for example, outcome for all mid-urethral tapes within a 1-year period (Figure 9), to more complex reports, such as, outcome of redo retropubic tapes for mixed urodynamic stress incontinence/detrusor overactivity (USI/DOA) stratified against body mass index (BMI).

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Figure 6. Complication data for a sacrocolpopexy (57 cases) performed at the Worcestershire Royal Hospital

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Figure 7. A database field showing the global impression outcome in the form of a histogram for patients having mid-urethral retropubic tapes (509 cases)

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Figure 8. A database field showing the global impression outcome for prolapse in the form of a histogram for patients having a vaginal hysterectomy and anterior repair (219 cases)

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Figure 9. Database field showing a request for data in a specified date range for retropubic mid urethral slings-transvaginal tape

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In addition, a recently introduced feature now allows users to simply generate a spreadsheet of all their data relating to one or more procedures over a set time frame. In this way, users can audit any aspect of the data that they have generated without being limited to the built-in basic reporting functions of the database. The database allows users to collect objective, validated outcome measures in the form of a ‘patient's global improvement score’, as well as utilising the range of ICIQs.[3-5] The latter includes ICIQ-urinary incontinence, ICIQ-sexual matters and ICIQ-vaginal symptoms. More recently the ICIQ-overactive bladder and a tab to include the domain scores for EPAQ have been added. Finally, mesh complications data within our patient population are often poorly collected. To address this, the International Urogynecological Association (IUGA) and International Continence Society (ICS) have designed a new mesh complications classification which comes complete with an online calculator (www.ics-office.org/complication).[6] This new system has recently been added to the next version of the database and contains a direct link to the online calculator.

Audit and analyses

The national dataset is beginning to produce interesting and clinically useful audit data. Three recent examples are illustrated. The first analysis looked at BMI and retropubic tapes for urodynamic stress incontinence. This analysis revealed that following continence surgery, patients with a BMI of >40 kg/m[2] had similar good outcomes regarding stress urinary incontinence symptoms compared with other BMI groups. However, the global impression score of improvement in incontinence showed that obese patients were less satisfied with their outcome, mainly secondary to persistence or deterioration in pre-existing urgency symptoms.

Another analysis looked at the types of operation used for stress incontinence surgery and the intraoperative complications that occurred. These data formed the basis of an abstract accepted at the 2010 Joint Annual IUGA/ICS meeting in Toronto, Canada.[7, 8] Such analyses can prove useful in counselling patients and also allows clinicians to compare their own data with the national dataset.

A third analysis looked at the types of continence procedure by the grade of surgeons. It gives a good overview of the surgical training received by the urogynaecology trainees in the UK. The higher rate of bladder perforation during retropubic tapes performed by trainees can be clearly seen.

Inherent challenges

  1. Top of page
  2. Abstract
  3. Introduction
  4. Concept
  5. Current usage, access and security
  6. Data ownership
  7. Facilities
  8. Inherent challenges
  9. The way forward
  10. References

The database does, however, have some shortcomings. It relies on self-reporting of data. In an ideal setting, an independent unbiased observer would be responsible for collating an individual's or unit's data. Although objective validated questionnaires are employed, data input relies heavily on the integrity of the clinician and consecutive case reporting. In turn, this requires consistency and a degree of time input that can be impractical in the middle of a busy job. In addition, BSUG are trying to establish a standardised follow-up interval of 6 months. Currently, inconsistent follow-up intervals make postoperative comparison difficult. More recently, some clinicians are not being allowed any follow up at all. This must be resisted if we are to fulfil our obligations to the clinical governance process, NICE guidance and ultimately to reduce patient dissatisfaction and potential litigation. Alternatively one can look at following up patients by other means. This may include options such as postal follow-up using questionnaires, telephone or online follow-up, or, in some cases, employing a nurse to do the follow-up.

Collecting validated objective data through PGI and the ICIQ modular questionnaires is key given the potential criticism of bias, because surgeons are self-reporting. In this way, Trusts should have no choice but to support the routine collection of validated post-operative data even if this is through postal and/or telephone ‘consultations’.

Unfortunately, not many established registries exist outside the UK to compare with the BSUG database. Within the UK there is the British Society for Gynaecological Endoscopy (BSGE) database, which uses a similar template as the BSUG database. Another database is the Hospital Episode Statistics (HES) which looks at all hospital admissions to English NHS Trusts. The HES has a higher number of contributing trusts mainly because there is a financial requirement as opposed to the voluntary BSUG database. The BSUG database has the advantage of being able to report the results using more objective examination and investigative results and is certainly more useful clinically.

The way forward

  1. Top of page
  2. Abstract
  3. Introduction
  4. Concept
  5. Current usage, access and security
  6. Data ownership
  7. Facilities
  8. Inherent challenges
  9. The way forward
  10. References

Although it has been a difficult and slow start, the BSUG database should be part of routine practice for surgeons performing anti-incontinence and/or prolapse surgeries. Currently, between 150–250 cases per week are entered into the system. Clinical directors and clinical governance leads should be looking carefully at their departments and assessing compliance with NICE guidance. This is particularly the case when surgeons are performing incontinence surgery or using graft material in prolapse procedures. These surgeons should be encouraged to utilise the database, particularly when one considers its value with respect to audit and governance, appraisal and revalidation and potentially unit accreditation.

Audit is a key part of maintaining a good quality service and at the same time recognising deficiencies in the service. It provides a method of comparing results with recognised standards and in some cases can aid in offering the relevant corrective measures. The database is a useful tool for auditing surgical data locally, regionally and nationally. Several useful audits have already been performed nationally and give a flavour of the kind of information BSUG hopes to provide.7 At a national level, BSUG hopes to be able to produce an annual national report for its members. At an international level, in December 2011, BSUG aided the Australasian Urogynaecology Society in establishing an online database using the same software codes but with the data stored in Australia. It is envisaged that future international data collaboration will then be possible. Discussions with IUGA and some countries (for example, the USA) have also taken place. These have been driven recently by the Food and Drug Administration guidance from the USA recommending prompt and accurate reporting of adverse events, particularly those associated with surgical mesh.[9, 10]

Revalidation

Annual appraisal of clinicians is already in place. The authors have found the database invaluable for this process. BSUG has been involved with the RCOG in establishing a variety of outcome measures that will be assessed as part of this process. The complications and outcome data collected by the database will form part of the measures deemed necessary. Of course, individuals and trusts can choose to collect these data in other ways if they wish.

BSUG accreditation

The main objectives of BSUG accreditation are to monitor the standards and quality of care. In doing so, the unit can compare their results with other units and individual users can identify units that provided a high standard and quality of care. One of the standards recommended for BSUG accreditation of both the unit and surgeon is the need for regular audits. It is recommended that the lead urogynaecologist is responsible for ongoing audits for surgical and conservative managements.

Expanding the use of the database

There is need to expand the use of the database, not only among BSUG members but also among all gynaecologists who perform anti-incontinence and/or prolapse procedures. Trust governance leads should be aware of its existence and usefulness and promote its use within their departments. Trusts will need to support clinicians in being able to collect good quality data pre- and postoperatively.

Disclosure of interests

All authors are members of the BSUG audit committee. PM has received sponsorship from and participated in advisory boards for Ethicon Women's Health and Urology, Atellas, Boston Scientific, American Medical Systems and BARD.

References

  1. Top of page
  2. Abstract
  3. Introduction
  4. Concept
  5. Current usage, access and security
  6. Data ownership
  7. Facilities
  8. Inherent challenges
  9. The way forward
  10. References
  • 1
    NICE. Urinary Incontinence. The Management of Urinary Incontinence in Women. London: NICE; 2006 [http://www.nice.org.uk/cg40].
  • 2
    Department of Health. Protecting and Using Patient Information. A Manual for Caldicott Guardians. London: DH; 1999.
  • 3
    Srikrishna S, Robinson D, Cardozo L. Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J 2010;21:5238.
  • 4
    Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol 2003;189:98101.
  • 5
    Price N, Jackson SR, Avery K, Brookes ST, Abrams P. Development and psychometric evaluation of the ICIQ Vaginal Symptoms Questionnaire: the ICIQ-VS. BJOG 2006;113:70012.
  • 6
    Haylen BT, Freeman RM, Swift SE, Cosson M, Davila GW, Deprest J, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery. Neurourol Urodyn 2011;30:212.
  • 7
    Assassa P, Moran PA, Duckett JB, Bsug B. Stress incontinence surgery in the UK. Pre-operative work up and intra-operative complications. Analysis of the British Society of Urogynaecology database. Int Urogynecol J 2010;21(Suppl 1):S5S6.
  • 8
    Assassa P, Duckett J, Moran PA, Bsug B. Stress incontinence surgery in the UK (2). Post surgery success, follow-up and complications. Analysis of the British Society of Urogynaecology database. Int Urogynecol J 2010;21(Suppl 1):769.
  • 9
    Haylen BT, Sand PK, Swift SE, Maher C, Moran PA, Freeman RM. Transvaginal placement of surgical mesh for pelvic organ prolapse: more FDA concerns–positive reactions are possible. Int Urogynecol J 2012;23:113.
  • 10
    US Food and Drug Administration. FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse. Silver Spring: FDA; 2011 [http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm].