An aristocrat, a precocious child and a sacred cow.

Developing General Practice Clinical Computer Systems: A collaboration between general practitioners, system suppliers and the NHS Executive - Lessons from the PRODIGY Methodology

1 Dr Ian Purves, 2 Mike Sowerby, 1 Robin Beaumont, 1 Bob Sugden

1 Sowerby Unit for Primary Care Informatics, Newcastle University

2 NHS Executive Primary Care PC1 (Prescribing Branch), Quarry House, Leeds

Abstract

This paper describes the methodology of a large NHS IT R&D project in general practice: Prodigy. This description of the Prodigy methodology is contrasted with the PRINCE methodology and the real life methodology of NHS IT projects. The lessons from Prodigy, the PRINCE manuals and a discussion of the usage of PRINCE in real projects are highlighted. The paper aims to open a debate on NHS IT project management, user involvement, supplier involvement and evaluation.

Introduction: Prodigy (Prescribing RatiOnally with Decision-support In General-practice studY)

The Prodigy trial is a Research and Development project involving 137 GP practices in England. The purpose of this trial is to develop and test the concept of computerised decision support systems to aid GP prescribing in the UK. The system provides decision support to a GP immediately he has made the initial diagnosis, with clinical advice and therapeutic recommendations that presents a choice of three or more drug treatments; it can also present non-drug treatments and patient information leaflets. If a GP selects the therapeutic choice of a drug, the system provides information on appropriate dosage, and checks for allergies, contra-indications and interactions, then goes on to print the prescription and update the patient record. The system does not override GPs' clinical freedom to prescribe as they see fit. The use of the system is at the discretion of the GP, and there will be no imposition of its use. Providing the GP with the ability to edit the clinical recommendations and the drug choice maintains these clinical freedoms.

In order to provide a credible test of the concept of computerised decision support, the first requirement was the development of approximately 600 prescribing recommen-dations, each of which contains appropriate drug choices. They were developed by a small professional group from sources including the British National Formulary, the Drug and Therapeutics Bulletin, and existing guidelines. To ensure that the clinical advice and therapeutic recommendations have professional credibility, an expert group nominated by the RCGP, RCP, GMSC and RPS was established to validate them. The advice and recommendations will be further developed, primarily in the way they are structured on screen, during the trial in response to feedback from the doctors participating.

The second requirement was to develop software packages which could be integrated into existing UK 'host' computer systems. Five software companies agreed to collaborate with this trial, producing software suitable for seven of the systems commonly used by GPs. Again, this software will be developed in the light of comments from participating GPs as the trial proceeds. If the trial is successful, one of the outputs will be a system specification which could be included in future versions of the Requirements for Accreditation (RFA) for NHS GP computer systems.

The project consists effectively of three successive cycles of development, testing and evaluation (see below). Each phase of the project will assess (i) how far the system and clinical recommendations are acceptable to GPs and patients at the point of consultation, and (ii) the impact on their prescribing decisions. The timescale for this phase of the project is too short to test health outcomes. However, the clinical recommendations are, wherever possible, evidence-based (or where true evidence-based guidelines are not available they are based on a consensus of expert opinion). They will be further developed by the GPs in the trial: it is therefore likely that modification of prescribing behaviour, in the direction of the recommendations, will result in better health outcomes.

NHS IM&T Projects

The NHS is one of most computerised health systems in the world; it is particularly strong in clinical computing. More than 95% of general practitioners are now computerised with a central NHS expenditure of £100 million which makes up 50% of general practice computing expenditure. There is an increasing growth of computing requirements in the secondary sector with a current annual expenditure of £220 million, or 1.8% of revenue. However the more ambitious hospitals are spending 4% and it is predicted most hospitals will move towards this figure. Further, only 50% of hospitals are experimenting with clinical computing as opposed to administrative support and this is embryonic. On average, 20% of hospital expenditure on IT comes from central sources, the rest from local budgets.

Much of this dynamic activity is being driven by central strategic projects. However, despite being dynamic there are a lot of complaints being floated about:-

In the process of writing this paper we decided to poll people's views. We presented some common statements about IT projects to the Internet listserver GP-UK and asked for responses. We have appended these responses as an appendix as we are anxious not to over-present this background information. However, we will use it in discussion later.

The problems highlighted in the bullet points above have meant that often individuals have been picked out within the press as 'scapegoats' or the 'responsible manager'. However, in the clinical community there are a lot of complaints about the quality of deliverables, the running of projects, and the preponderance of management consultants. PRINCE is the Project Management Standard for government IT departments and it is PRINCE which is often criticised. However, PRINCE methodology is for project management not for system development. This distinction is often lost, and some of the confusion seems to emanate from the PRINCE documentation, in that although it is a project management method it puts forward core components of products and activities. These components are obviously appropriate but are not a detailed part of PRINCE.

"In PRINCE, a project is regarded as having a defined and unique set of products, a corresponding set of activities to construct the products, appropriate resources to undertake the activities, a finite life-span and an organisational structure with defined responsibilities.

A project is divided into a number of stages, each forming a distinct unit for management purposes. Like the project, a stage has a defined set of products and activities, a finite life-span and an organisational structure. The production of these products, to the agreed quality standards, marks the completion of a stage.

PRINCE defines the organisational structure of the project and its stages, the structure and content of the project plans, and a set of controls which ensure that the project is working to plan. These three, together with the products of the project and the activities which produce them, comprise the PRINCE components."

It is within this context that we started the Prodigy project.

The purpose of this paper

As a final part of the Introduction, we would like to comment that the purpose of this paper is not to hit at sacred cows (PRINCE (?)). Nor are we presenting a new NHS IT project methodology for general practice. What we have to say relates to lessons we have learned while running a large NHS IT project which has delivered its products in a novel way (for the NHS). In the process of running this project we have had a lot of favourable comments from those we respect with regard to our methodology and have had a lot of negative comments on PRINCE. We feel that we are in a position to put a balanced view on this 'debate'. We hope to leave you and those that commission NHS IM&T projects with a fresh perspective and hopefully a new debate on the way forward.

The Prodigy Methodology

From the outset we firmly believed that if we were to deliver the same product using several suppliers and deliver something that was usable, we would need both the suppliers and users at the centre of the project methodology. We also had very tight schedules, and having had experience of PRINCE projects, we decided not to follow the normal NHS IT project route. Of course this flexibility was possible because Prodigy is a Research and Development project. However, retrospective analysis shows that we still used the PRINCE structure but adapted it to suit our means. It has also become clear where some of the conceptual problems have arisen using PRINCE in the past. To enable people to see the issues and lessons we have learned we are deliberately going to use the headings of PRINCE components to present the Prodigy methodology. The PRINCE components are as follows:-

In the following sections of this paper we present PRINCE in italics and the PRODIGY methodology within the same context in plain text.

Organisation

The management style of the project has been a mixture of formal and informal reactive communication. Its aim has been to be pragmatic and bottom-up while having a top-down resource control. The management of timescales and risks has been equally pragmatic and very effective. The project started with extremely tight schedules and despite being complex has managed to deliver with very little slippage. The organisational structure is shown in Figure 1:

Figure 1: The Prodigy Management Structure



Project Management Group (Project Board)

PRINCE: The Project Board has overall control of a PRINCE project and has at least the below members:-

PRODIGY: The project management group has met formally roughly bi-annually. However the project manager has informally updated each member of this group on an 'as required' basis. The group consists of the following members:-

PRODIGY Tasks: Project Management Group

Project Manager

PRINCE: Assumes day-to-day responsibility for management of the project throughout its stages.

PRODIGY: The project manager (MS) has taken responsibility for day-to-day decision making and documentation of those decisions, supported by his NHS Executive support team and members within the project team. Communication between the project manager and the project team has been on a daily basis by telephone and internet email. The email communication has also consisted of attached files. The project manager and project team have a two-weekly face-to-face meeting. The project manager also took the responsibility of negotiating with the suppliers to come to an agreement on work to be performed, time-scales and payment. These agreements were monitored by the GP practices and the project team and were reported to the project manager if difficulties were not resolved by simple negotiation. Any problems arising were managed by the project manager.

PRODIGY Tasks: Project Manager

Project Team Leader (Stage Manager)

PRINCE: Has technical responsibility of ensuring that stage products are produced on schedule, to high quality standards, and within budget. The project manager and stage manager may be the same person.

PRODIGY: The project team is overall led by a project team leader (IP) who is directly responsible to the project manager and is the individual most in contact on a day-to-day basis with the project manager.

Project Team (Stage Team(s))

PRINCE: The stage team are responsible for conducting the activities and producing the products of the stage.

PRODIGY: The work within the project team is managed by two individuals: one (RB) from the evaluation side of the project and the other (BS) from software specification side and project team budgets. However the team is a horizontally managed structure and communicates frequently via email and includes all team members in communications. The team also meets on a weekly basis to monitor progress and problems. Clearly ad hoc meetings occur on a daily basis as individuals share rooms and the same building.

The great strength of this project management style is that those who are developing and using the prototype system are in control of the deliverables. The methods of communicating with these groups will be mentioned in the activities section below but it is worth re-phrasing them:-

GP Practices (n=137)
  • dissemination day
  • questionnaires
  • monthly focus groups (of fewer than 8 individuals)
  • posted or faxed "Guideline Comment Forms"
  • telephone (all) and email (n=14) communication with the contact GP
  • site visits by members of the Prodigy Team
  • newsletters from Prodigy Team
  • future: feedback day and reports
GP Suppliers (n=5)
  • dissemination day
  • as required telephone (all) and e-mail (n=4) contact with supplier project manager
  • monthly technical meetings
  • newsletter from Prodigy Team
  • reports

The GP practices also have an algorithm to help them decide how they should respond to any problems (see Figure 2). This algorithm gives the GP practices access to the supplier, the Project Team and the Project Manager (MS).

Figure 2: The Prodigy practice communication algorithm


To date the project methodology has worked very well. The only exception to this is that we underestimated the required resources needed to communicate with 137 GP practices. This led to the practices not being as informed as they should have been. We have now corrected this fault by adding a full-time communications officer to the project team whose task is to ensure effective production of newsletters, regular telephone (or email where available) contact with GP Practices and suppliers and site visits.

PRODIGY Tasks: Project Team

PRODIGY Tasks: System Suppliers

PRODIGY Tasks: GP Practices

Project Assurance Team

PRINCE: Maintains the continuity of project development activities and product integrity.

PRODIGY: We have developed an innovative way of dealing with quality assurance that stems from being a heavily bottom-weighted project.

The role of BAC and TAC are within one member of the project team (BS); however the quality assurance takes place by tightly negotiated contracts with payment on delivery, monitoring of timescales by the Project Manager and technical overseeing by the suppliers and NHS Executive IMC. We believe that the BAC and TAC should be one person as it is easier to understand the separate roles. We also believe that they should be part of the project team with BAC and TAC being part of their role to ensure that this activity is core and continual. Of course adequate control and monitoring should be in place.

The UAC is again a member of the project team (RB); however the quality assurance is undertaken by the users involved in the project.

Clearly the Prodigy Team synthesises the opinions and views of the suppliers and GP practices into a digestible form. This synthesis protects confidentiality of those involved in the study as well pooling information. However information is fed back to the suppliers and GP practices and over time project deliverables will be scrutinised, therefore it is important for all to realise that opinions and views should be faithfully reported. It is therefore inherent in the project method that we have Quality Assurance group which is also the driving force behind the project direction. The size of these groups means that any bias is diluted to become irrelevant and that we have a truly bottom-up directed and quality assured project. It is also vital to understand that the inherent involvement within the project of the suppliers and users means that quality assurance is a major part of the project rather than 'cursory' reading of reports and meeting with individuals with 'day jobs' and otherwise little involvement with the project.

Project Support Office

PRINCE: A central Project Support Office within a department may provide staff for the Project Assurance Team, and other support services for projects.

PRODIGY: The project team takes on the role of the support office although some tasks are delegated to the NHS Executive, to the Project Manager's support team.

Plans

Technical Planning

PRINCE: Technical plans are concerned with the products to be delivered and with the activities necessary to ensure that the products emerge on time and to the required quality standards.

PRODIGY: Plans were generated and monitored on Microsoft Project.

Resource Planning

PRINCE: Resource plans are concerned with managing the finances and resources of the project. They are derived from the corresponding Technical Plan.

PRODIGY: Resource plans were created in Microsoft Excel and monitored against budget headings.

Quality Planning

PRINCE: Action must be taken at the planning stage to ensure that the project can deliver products of the desired quality. Testable quality must be defined, agreed and recorded on the relevant Product Descriptions, and a testing strategy adopted; quality review procedures must be established and review activities must be defined and resourced.

PRODIGY: The project bottom-based structure ensures quality assurance as mentioned under PAT. The Software Requirement Specification had within it appropriate metrics. Interestingly it has been felt that the Software Requirement Specification has stifled some innovation in the suppliers and we have the interesting problem of writing the phase 2 specifications in a less concrete way but still enable evaluation of deliverables to specification (perhaps a future paper). The details of the plans are contained in this paper, the important issue is that quality assurance is bottom-based, at the heart of the project and co-ordinated by funded daily activity.

Exception Planning

PRINCE: The Project Board sets tolerances for Project Plans and Stage Plans. These tolerances define the limits and cost within which the project can operate without further reference to the Project Board or to the IT Executive Committee.

PRODIGY: The Project Manager sets tolerances for Project Plans.

Controls

PRINCE: Regular and formal monitoring of actual progress against plan is essential to ensure the timeliness, cost control and quality of the system under development.

PRODIGY: As PRINCE.

Management Controls

PRINCE: Controls are provided to be applied throughout the project. These controls cover all aspects of project activity and, at the highest level, allow senior management to assess project status prior to committing further expenditure. Controls are applied via meetings of project management and project staff, with each meeting producing a set of pre-defined documents.

PRODIGY: As PRINCE.

Product Controls

PRINCE: Quality and technical controls are applied to specific products rather than to the overall output of a stage or project. The aim is to identify and correct errors as early as possible in the development process.

PRODIGY: We monitored products at the end of each task. Those products produced by the project team were also monitored on an ongoing basis. However we quality-assured the computer suppliers' products at the end of the development cycle. In retrospect this should have been on an ongoing basis with both project team and experimental practice sites, as some suppliers had difficulties and others felt the Software Requirement Specification limited their implementation. Future plans are to have a looser specification, early 'story-boarding', focus groups of users and suppliers, regular meetings, and conformance testing in both user sites and in the 'laboratory'.

Products

PRINCE: Identifies a distinction between Management Products (in the form of plans, reports and other control documents) and Technical Products which are required by the end user and are defined at the start of the project by the Project Board.

PRODIGY: The management products have already been discussed; we took the approach that these took up minimal time (approximately 5-10%). The main thrust of the project methodologies are to deliver the technical products; as follows:-


Activities

PRINCE: Again identifies a split between Management Activity and Technical Activity which relate to delivering their respective products, PRINCE highlights that a standard development method, such as SSADM, is used as they contain structured breakdown of activities and products.

PRODIGY: Management Activity: The method used is very similar to PRINCE and has been highlighted in detail in the above sections.

LITERATURE: Technical Activity: The development of software systems has changed over the years. Mumford1 described the different types of participation philosophies:-

An analysis of these philosophies highlighted a preferred method of representative participation. In order to engage and inform the users so they could participate, the method of rapid prototyping and joint requirement planning (JRD) with joint application development (JAD) sessions were introduced2. Others including Alavi & Wetherbe3 highlighted a need for the use of a mixture of prototyping and modelling. Modelling has itself developed a lot since SSADM and object methods such as Rumbaugh4. OMT are now leading the field. Connell & Shafer5 have linked rapid prototyping with object modelling techniques. Clearly there is also the important issues of identifying user requirements and analysing whether or not the prototypes are delivering what is required; the field of Human-Computer Interaction is rapidly developing and the book by Preece et al6 gives a good summary.

In the domain of health care computing relating to decision support, Heathfield & Wyatt7 have published a recent outline of important issues to be considered while developing systems such as Prodigy. These issues are listed:-

  1. Establish and clarify the need through rapid prototyping
  2. Use a coherent methodology for modelling the problem
  3. Use appropriate methods, mechanisms and tools
  4. Evaluate
  5. Professional approach to implementation, maintenance and support

More recently Lock8 has lamented the need for evaluation of systems:

"Recent thinking suggests that this is insufficient, and that a more comprehensive assessment should consider whether information technology supports the commercial and strategic objectives of the organisation. For the NHS, the impact of computer systems on patient care as well as on the 'business' objectives of hospitals should be considered."

Donaldson9, in his editorial to Lock's paper, emphasised these sentiments:

"Formal evaluation of major information technology investments in the public sector, including the NHS, has tended to focus on criticism of the implementation process - factors such as lack of design planning, poor project management, inadequate staffing, and cost overruns - rather than on health care benefits or their absence."

It is with this background that Prodigy designed its technical activity.

PRODIGY Technical Activity: The methodology used a combination of standard health service research and software development methodologies. It is a 'user participative iterative design methodology', with an ongoing dialogue between users and the development team leading to a series of successively refined prototypes. We have constructed the project to actively involve medical practitioners at all stages, while patient responses are also being highly valued, and will be incorporated in the final results. The project clearly benefits from having stimulated this user-driven aspect. We employ a wide variety of quantitative and qualitative evaluation techniques. Although it has proved to be very successful in other sectors, this methodology is unique in UK health care computing. Figure 3 shows the methodology used, with the shaded ellipses identifying our current stage:

Figure 3: The Prodigy iterative methodology


The Prodigy sites were generally selected using a purposively sampling method with the following criteria:-

Inclusion Criteria

Exclusion Criteria

However, one supplier gave a full user list and the 30 sites were selected by randomised mailings; we needed to mail 500 users to get the required number of users and then had to use a follow-up purposively sampling method to get adequate stratification (discussed later).

The comprehensive range of evaluation methodologies employed by the team is listed below:-

The experiences of the above methods will the subject of future papers.

Comparative Expenditure

Project budgets follow surprisingly different patterns; the classification of expenditure is equally variable to the extent that our chosen classification proved impossible to map to other projects. However one classification entity is generally mappable: that is, project management. In two other large, current, general practice IT projects, the percentage expenditure is 50% of the total budget - all of this is consumed by management consultants! Generally other projects spend very little on involvement of users and suppliers; furthermore they do very little prototyping and evaluation.

The relative expenditure in the Prodigy project is presented below in table 1.

Table 1: The Prodigy relative expenditure

Project management 4.1%
Knowledge base development and maintenance 2.9%
Software Requirement Specification and modelling 2.2%
Involvement of users 6.7%
User hardware upgrades 17.7%
Involvement of suppliers
  • Iterative software prototyping
  • Software support & training
  • Installation
  • Suppliers' project management

22.1%

11.0%

8.3%

2.8%

Conformance testing 0.4%
Rigorous evaluation 19.7%

The first thing of note is that project management ran to 6.9% of the budget, clearly nearer the accepted standard of 10% than most NHS IT projects. The highest expenditures, both roughly 20%, were 'iterative software prototyping' and 'rigorous evaluation'. As important runners-up came 'User hardware upgrades', 'Software support & training' and 'Involvement of users'. In this pilot phase 'Knowledge base development and maintenance' was a low expenditure but would be clearly the major expense if Prodigy proved a worthwhile product to the users.

Lessons

It might be said that all we have done is apply commonly-used project management and software development in practice. So what are the lessons? Given the context of the current environment and the fact we are unusual in the NHS domain we felt able to comment from this perspective.

One major issue is: What is the aim of the project? We suggest that most projects in the initial phase could use the following outline:-

Other lessons are now listed under their own headings.

Iterative development with prototyping and modelling

Over the years IT projects have learnt that products should be iteratively developed using both rapid prototyping and modelling. Modelling has moved on from SSADM, and object modelling predominates; we prefer to use Rumbaugh with a CASE tool - System Architect. However we have learned that the suppliers find penetrating object models very difficult and therefore we have created simpler "non-standard" ways of diagramatically presenting models for them.

Involvement of users and suppliers

It is clear that involving users and suppliers in IT projects ensures that project delivers a product which is required and iteratively developed by the suppliers who will be putting the system into the clinical workplace. The lesson we have learned is that this is practical (in large numbers) and welcomed by almost everyone.

Rigorous evaluation

At each stage of iteratively developing the prototypical system there is a need to evaluate whether the system is achieving its aims. The evaluation needs are different at different stages. In the early stages the following questions should be answered:-

Method: Focus groups / Questionnaires

Method: Focus groups / Questionnaires

Method: Story-boarding focus groups / Laboratory tests / Video ethnographic observation (pre/post)

Method: System log files / external process indicators (pre/post) - these measures are strengthened by using time series methodologies with population controls

General Methodological Note: The ideal is that initially the study population is randomised; even if large numbers of users elect not to participate the bias is still reduced. It should also be recognised that purposively sampling may still be necessary to include the correct stratification within the user base. If purposively sampling is undertaken then clear inclusion and exclusion criteria are required. We used the two approaches of purposively sampling and randomisation. For one supplier we sent out a questionnaire to identify inclusion and exclusion criteria and to offer the practice to be involved. We sent out 300 mails to randomly selected practices and got 30 responses but we then had to go on to purposively sampling. It is not clear how pragmatic randomisation is at the moment for these types of studies but it is still to be preferred until more data is available on the cost benefit of the strategy. If purposively sampling is undertaken a questionnaire should be used to identify relevant bias within the study group (other papers from Prodigy will identify these potential biases). These kinds of interventions can not be blinded at the user level but evaluators should be blinded as to suppliers and user sites until after the analysis. A positive Hawthorn effect will clearly be present in the user sites; nothing can be done about this in this sort of study design and should be recognised in reports. However, if controls are used for external process indicators using controlled time series analysis then blinding the control group will stop any potential negative Hawthorn effect.

Once the product has finished its prototype stages and become a delivered product, then it is appropriate to study the intervention in a much more rigorous way, probably with patient health outcomes and cost utility analyses. There is a political (small and potentially large "p") and professional issue on whether general usage of the product should now take place with a parallel effectiveness trial, or an effectiveness trial should take place before general usage. The preceding development methodologies do not give rigorous answers to the effectiveness question but it may be felt to be 'politically' and professionally imprudent not to put a system in general usage; in this situation those making the decision should be aware that later effectiveness studies may be either positive or negative. Whatever decision is made we propose a system similar to the CSM black triangle system is used for newly- designed clinical computer interventions and they should be evaluated further.

General Methodological Note: Effectiveness studies require that the study population should be randomised. Potential confounders should be stratified (e.g. system suppliers). Again these kinds of interventions cannot be blinded but evaluators should be blinded as to suppliers and user sites until after the analysis. The positive Hawthorn effect will clearly be present. Using methods such as balanced incomplete block designs can equalise and minimise for the Hawthorn effect.

Think of training from the start

We decided to evaluate and monitor training delivered by the system suppliers. This was a useful lesson as we found a wide variability in quality. For future stages we intend to design the training and evaluate its effectiveness in collaboration with the suppliers. This gives the added advantage that should the prototypes become a usable product then the training has been developed and iteratively improved along with the system.

Think knowledge base maintenance from the start (should the system need one)

We are at a pivotal point in implementing evidence-based practice / decision support. As such there are lots of lessons to learn for the future. Specifics of the technicalities of knowledge base change control will be covered in future papers. Generally speaking modelling comes into its element here - a good model is vital. One of the biggest lessons is that the interactions between the knowledge authors and the system specifiers need to be very close and interactive. Furthermore the team should always be looking to the future and to mechanisms for continual development and maintenance should the system become a practical product. Clearly in the earlier stages of the project informal consensus methods10 are appropriate but more rigorous methods11 should be used if the product becomes more generally available.

Management with a PRINCE-like method

In review we have found PRINCE to be very similar to our management methodology. The only difference is in the way we have performed our quality assurance. We feel that the PAT is probably one of the weakest points of PRINCE as it generally uses a consensus or consultative participation method rather than the representative participation method we used (see above). However one point that is regularly made is that most problems with PRINCE relate to important issues:-

  1. Training is required and personalities need to be chosen carefully for the chairperson of the Project Board, the Project Manager and the Stage Manager
  2. PRINCE is only the management component! The real and important part of IT projects is the activities and products, which need to use another methodology


Project Communication

Projects such as Prodigy are dependent on constant and free communication which is mainly informal. Formal communication and documentation have a role but it should be secondary to general informal communication. Asynchronous techniques such as email are vital in busy lives and all projects should depend on freely copied email.

Quality Assurance

Quality assurance should be a core activity to any project. A common problem with Project Assurance Teams are that they are poorly funded and the individuals involved end up have large piles of papers dumped on their desk some weeks before a PAT meeting. The quality of their assurance is the best that can be achieved in these situations. We feel that by having quality assurance co-ordination as a key part of the project team's work and a large user and supplier project base is to be recommended. It means that quality is daily activity, it is adequately funded and the quality assurance is being done by those who will be using the system rather than their representatives. The risk of self-interest within the project team is minimised by the size of the quality assurance and the fact those who are quality assuring the project are also participants. As can seen in the Appendix, PATs can be used in heavily managed PRINCE projects to keep things on the rails and deliver 'high quality' products; which in reality should have been stopped or need reworking before implementation.

Conformance testing

In the first iteration of Prodigy we had a reasonably tight System Requirement Specification. This enabled reasonable bench testing and fairly rigorous conformance testing. For phase 2 we are going to loosen the specification but tighten standards with the hope that this will encourage innovation. Furthermore we discovered that in phase 1 the bench testing was very useful but did not always take into account how the system was used in practice. Therefore the lessons we have learned are that for the future it is going to be harder to bench test the systems in a laboratory so we are to undertake the conformance testing in GP surgeries and in video focus group interaction with the systems in a laboratory. Clearly one man, one day (often a couple of hours), a bit of paper with weak metrics and a computer is worthless for conformance testing.

As worthwhile comment, Ewan Davies in July 1996 posted the following on the GP-UK listserver:-

"I'm not sure there is a place for the RFA in the future. If there is it needs to limit its scope to three areas - gross functionality, standards and safety:-

Whatever is in the RFA there MUST be a business case that justifies its cost to the NHS and suppliers. You can have any feature you can think of in your system as long as you are willing to pay for it. The consultation process needs to be more transparent. RFA has no place as a wish list. It should not be used as a tool to create homogenous systems: UK GP computing has gain greatly from diversity and competition."

We generally agree with Ewan's sentiments and have presented them as we feel they add to the debate, but there are issues with which we don't fully agree and need further discussion. Clearly we need to discuss the whole role of NHS IT Projects, prioritisation of user requirements, conformance testing, commercialisation, and the Requirements for Accreditation for the future.

Other issues from internet consultation

The above points are the lessons we have learned in Prodigy. As part of writing this paper we consulted widely over the internet about PRINCE and the appendix was the result. The only outstanding issues raised as lessons from the internet discussion which we did not identify within Prodigy, but clearly others have within their projects, are as follows:-


Conclusion

We have presented to you the workings of a precocious child and compared them with those of an aristocrat. As in life the child still needs to develop and the aristocrat is mature but can still learn. Interestingly the sacred cow is not the aristocrat as it has a different spiritual meaning for everyone; in fact it is not clear what the sacred cow really is! We believe that the precocious child will develop into a fuller being than the aristocrat whose role is still there but perhaps better understood with a clearer defined role.

We hope the learning and debate will continue.

References

1 Mumford E. Designing participatively. Wright Ltd, Sandbach, England, 1979

2 Martin J. Design and Construction Vol III (Information Engineering). Prentice Hall, Englewood Cliffs, NJ, 1990

3 Alavi M, Wetherbe JC. Mixing prototyping and data modelling for information system design. IEEE Software 1991 (May):88-91

4 Rumbaugh J, Balaha M, Premerlani W, Eddy F, Lorensen W. Object-Oriented Modeling and Design. Prentice-Hall International Inc, Englewood Cliffs, NJ, 1991

5 Connell J, Shafer L. Object-orientated rapid prototyping. Prentice Hall, Englewood Cliffs, NJ, 1995

6 Preece J, Rogers Y, Benyon D, Holland S, Carey T. Human-Computer Interaction. Addison-Wesley Publishing Company, Wokingham, England, 1994

7 Heathfield HA, Wyatt J. Philosophies for the design and development of clinical decision support systems. Meth Inf Med 1993; 32:1-8

8 Lock C. What value do computers provide to NHS hospitals? Br Med J 1996; 312:1407-1410

9 Donaldson LJ. From black bag to black box: will computers improve the NHS? Br Med J 1996; 312:1371-1372

10 Grimshaw J, Eccles M, Russell IT. Developing clinically valid practice guidelines. J Eval Clin Prac 1995; 1:37-48

11 Eccles M, Clapp Z, Grimshaw J, Adams PC, Higgins B, Purves I, Russell IT. Developing valid guidelines: methodological and procedural issues from the North of England Evidence Based Guideline Development Project. Quality in Health Care 1996; 5:44-50

Acknowledgments

Many individuals helped put this paper together: they all go unrecognised as we were not able to get a reply from them all in time for the deadline. Some were willing to be attributed but as they had not seen the paper, and they were in the minority, we felt it unreasonable to name them. Thanks one and all.

Appendix: Notes on PRINCE

The benefits of PRINCE are (taken from the PRINCE manual):


Internet Consultation on PRINCE

While writing this paper we posted an e-mail to GP-UK explaining what we were doing and asked several questions (those highlighted in bold below). The response to the questions and other comments are listed below. There were 12 respondents.

"Yes, I have seen this all too frequently. Not through lack of will to do the coordination, but through the lack of means and competence. The Health Care Modelling team have been asked to help mitigate this problem (although they can only be part of the solution)."

"I have seen this happen, and it's not a fault of the methodology. The Service is (of necessity and funding) tactically oriented, so when there is a need to be strategically or holistically focused to include a number of inter-related projects, it isn't able to take the wider picture - the classic case being the NHS IM&T national infrastructure projects, which are run separately, although "regular co-ordination meetings take place" ;-))"

"Unfortunately this does tend to happen. The difficulty is that projects can be committed to delivering specific products to external timescales set without due regard to the complexities (a) of building the products (b) of interdependencies. If the PID has been drawn up properly, interdependencies and risks should have been identified at the outset, and appropriate control measures put in place. To be effective, these *must* be monitored and updated, and where they change proper impact analyses done with exception plans to update project plans. A weakness is that changes in risks and interdependencies may not be (perhaps cannot be) allowed to change the delivery timetable."

"Try replacing "suppliers who have to deliver" with "users and clients who separate the project from the dynamic of their business". I have, on many occasions, had to tell Project Boards of ancillary issues which need to be addressed - but as it was all too difficult, and the situation was not addressed, making it difficult for the supplier to deliver. My worry is that it's often seen as them and us - when it should be (and is in the most successful projects) we. An interesting comment made by one Chief Exec to me once was that when suppliers say "we want this to be a partnership", ask them if they're prepared to share the risks, as well as the rewards, which is what a true partnership means - but the client/user also has to meet their end of the bargain, which usually means making a far higher level of commitment than most Health organisations can, or are prepared, to do."

"Supplier involvement seems to vary enormously. From 'our' side of the fence I would say that suppliers often fail to take into account the goodies that projects are offering and would prefer to go with existing proprietary products that have been slightly tweaked in the direction of the project products."

"This can be due to confusion or lack of definition over what precisely the project is supposed to be delivering. Specification projects (are you perhaps thinking of RFA?) can get bogged down in technical details relating to possible solutions when they should be concentrating on what are the user and business functions to be satisfied. It should be left open to suppliers to propose the most appropriate (and pragmatic) solution that meets those functional requirements. Specific technical standards should only be included where there is a clearly identified reason for doing so."

"CISP and DISS and DISP all produced working systems. Many others produced paper products. Horses for courses."

"If this is the case, then surely caveat emptor applies?"

"Yep"

"In the context of IMG projects this is almost invariably the case. I think this shows up another weakness of PRINCE in this context; it was primarily designed to cope with the design of operational systems. It can be applied effectively to specification projects, but it needs to be closely coupled with a well-defined and well-controlled configuration management system so that once a specification product is baselined it does not change without a proper impact analysis involving input from *all* affected parties being done."

"The CBS development projects, DIS (Data Interchange Standards), Clinical Terms and AR all had (or have) very heavy user involvement. I would say that user input is usually pretty good and is listened to."

"I think the problem is often twofold - the methodology runs the project, instead of being its servant, and the client staff involved have insufficient experience of their role and associated responsibilities. The most successful project I managed had a Board Chairman who said "I'm not interested in the process - that's for the auditors, and the front-line staff; I work on an exception basis, and like to keep things simple, so in our monthly meetings I want five things - are we ahead or behind schedule; are we under or over budget; what are the issues in order of criticality; what do *we* have to do to fix the problems; and I want this documented on one page." This approach provided a very sharp focus, and kept things simple....."

"The problem here is defining the users properly, and defining a proper mechanism for capturing their input. As referred to above, I think there is a tendency to do this by having "user" representatives on project boards. This I think does *not* work because the project board is too senior and not close enough to the detail project work to be able to work with the project effectively. In the case of IMG projects, these tend to be strategic and can be somewhat remote from the real end-users in the NHS, concentrating perhaps more on what the centre would like to see happen rather than on what the people doing the job in the NHS want to happen. This can create a tension in project activity. Users can (and should) play an important part in the QA process as reviewers. An important part of the UAC's role is to ensure that this happens; UACs should be backed up by the user member(s) on the board to ensure that this is done. The PRINCE methodology does not really make adequate provision for user representative panels, partly because of course it's designed for developing operational systems."

"IMG seems unable to escape its dependency on consultancy firms for doing much of its work. Use of consultants has, for senior managers, the personal advantage of distancing themselves from difficult decisions, but in the EDI area it brings some big disadvantages to the service as a whole: the big-firm consultants usually don't understand either the clinical business or the technical issues of EDI very well, but are always very hot on project management-speak.

"So they spend a lot of time with the people in the service who do know, and regurgitate the pickings to the [project] manager. Something is always lost in the listening/regurgitating through, and the report needs correcting. Nevertheless the consultant seems to have (with 2 days' study) a higher credibility than the person who's made the matter a lifetime's work. The net effect of this is to make expertise held within the service invisible to those at the top of it, and blunts the decision-making abilities accordingly. In addition consultants need (to safeguard their position) to interpose themselves between key participants in any project, and sometimes this corrupts the dialogue.

"Some quite big problems have occurred from the activities of consultants in the 'Dataflows for Fundholders' and 'NHS-Wide Networking Projects', and would also have arisen in the 'GP-Provider Links Project' without a concerted effort by most of the Project Board. MIG needs to consider how IMG might escape this destructive pattern of behaviour."

"The methodology is good at forcing exceptions/highlights & reports to appear but awful at telling you what's actually happening in the project. The project leader & board chairman usually run things & everybody else has peripheral involvement only. This means megabucks get spent & the board meets 2-4 times per year to rubber-stamp decisions already made (or at least directions already charted). Too much of the work is left to external consultants who make loadsa money by constantly reinventing the wheel. Very frustrating. PRINCE does not force a strategic perspective with other similar linked projects with the result that there are several overlapping IMG projects I've been involved in - where I seemed to be the only person around who knew about the other projects … So as a mechanism for accountability, reporting & project planning, it's OK, BUT a huge amount of time goes into producing all the different types of reports the methodology requires. PRINCE is not democratic - it allows too much power to the project chairman & leader & lacks any strategic input or influence."

"Those that do the jobs well usually contribute well to successful projects & vice versa (i.e. I suspect that project success varies more with the quality of people assigned to it than with the project management "methodology" adopted)."

"Oddly, I've come to the conclusion that methods are necessary but not in themselves sufficient to rise above the 'personality' factor. A blinkered set of principals makes for a blinkered project etc."

"My view is that the single biggest problem we have is a lack of people with the skills to manage these projects. There are three main things required:

  1. First class project management skills
  2. Intimate understanding of user needs (but not necessarily of the exact user focus - i.e. a practice nurse would have a good enough understanding of GP problems and probably vice versa)
  3. A good general technical grasp - gained from years in the business

No-one can be all three of the above. However, the manager of the project should have 1. plus either 2. or 3. and should be able to liaise very, very well with whoever fulfils the one of 2. or 3. that they don't have."

"I believe that used properly and applied intelligently PRINCE is a very powerful methodology. I think that it doesn't always work as well as it should partly because the key people involved in PRINCE projects do not always understand their roles, and partly because PRINCE methodology is often perceived as a bureaucratic overhead, that by writing a PID and the odd project manager's report you are somehow magically complying with PRINCE."

"My initial thoughts are that if PRINCE goes wrong, it's because:

(a) someone is using it slavishly, hoping the method alone will be enough, and not paying enough attention to the contents / products of the project:

(b) within IMG, there is little or no effective control above Project Board level, and the business case, if one is prepared, is weak. This is where the relationship between the project and its context should be examined and taken into account. Neither is control usually exercised by the ultimate purchasers/users of the system, because they do not usually fund development (altho' they increasingly do have to fund the implementation).

(c) the initial definition of the project and its products are poor, often because the project is initiated by bureaucrats, not users, who are involved later (sometimes, it seems, only because PRINCE requires it). The 'users' are often also merely people working in the domain, not people committed to using/paying for the product.

(d) quality assurance is not done thoroughly. Not enough time is allowed for it, and QA comments are not really resolved.

(e) the project owners (especially civil servants) are more interested in avoiding failure rather than achieving success. Thus exception conditions are hushed-up or down-played, rather than dealt with honestly. The criteria for 'success' are therefore primarily based on completing the project to time and to budget, rather than on the quality of the products themselves.

(f) yes, the project products are defined in isolation, without sufficient awareness of related work going on or completed elsewhere. This has definitely been true within IMG, but is a general problem - communications within large organisations are difficult, and there may be few / no mechanisms for taking an overall view. That's why generalised business modelling is important - it provides a backdrop for doing this. Also if project owners are mesmerised by budgets and timescales, there is little chance of being able to apply mid-course corrections if they are discovered to be necessary. This was what happened in the AR project.

People have said that the method itself is cumbersome, but I would not agree. Used with a light touch, and without Cecil B de Mille-sized project management staffing, the results can be good, viz AAGP and the CBS COSS study. PRINCE is nothing more than codified common sense. But the documentation about it is largish, and the people who use it often have no specific training in it. So first-time users tend to be in awe of it, and hope that by going through the PRINCE motions, all will be well. It won't."

"The good thing about PRINCE is that it can be tailored to meet your needs, and can be as simple or comprehensive as you need. I guess the single most important question should always be "What are we trying to do here?", and "How will we know we've been successful?", with all that means in terms of its answer."

"Creative ways should be devised to persuade suppliers to write software now and to reduce the subsequent support costs so that the total public expenditure is at least no higher. Inconsistencies already exist. For example the Executive's funding of (a) software development for GP Fundholding (b) GP-FHSA links, (c) Prodigy, and most damaging, (d) EDI for contracting data show that the principle [of not paying the suppliers] has not always been adhered to. A further reason for applying some funding (not necessarily direct to the suppliers) at the time of software development is that it allows a greater lever for professionally-led quality control of the software produced. There is some evidence that the suppliers would welcome this as it is cheaper to rectify problems at an early stage in design/development than when a product is found faulty in its use. Such user-led review would also bring them closer to their customers."

"PRINCE does involve an overhead - a very necessary management overhead. What it can bring is a comprehensive check-list of all the things you have to consider in delivering a successful project, together with procedures for ensuring issues and interdependencies are properly addressed.

It has to be applied intelligently. Full PRINCE procedures (with project boards, PATs, product descriptions, exception reports and the rest) may not be appropriate for very small projects (e.g. with budgets of less than £100K). This doesn't mean there isn't benefit from applying the philosophy of PRINCE though. It doesn't always seem to work very well with "soft" deliverables, where the end-product is (for example) a strategy document or consultative report. An important element of PRINCE is obtaining a clear sign-off of the end products by the "user" against the pre-defined product descriptions. If the project is unclear or vague about who the "users" of the products are, or what the products are intended for, then you have problems in deciding when the project actually ends.

"Related to this is the problem of applying PRINCE methodology to extensive programmes of work, consisting of several complex projects each operating under PRINCE methodology. This tend[s] to manifest itself by inflated project/programme boards with a range of user representatives for the diverse interests involved. To be effective the project board needs to be small enough to take proper executive decisions; if it gets above more than about six in number this can get very difficult. The project board is not the place for user input and consultation; that is more properly done through the PAT. The role of the PAT tends to be understated. The PAT has a very important role in PRINCE; its role is to check finished products against their product descriptions and report to the project board. A weakness is that it if PRINCE is not applied properly it degenerates into an advisory body. Formal QA meetings are an important mechanism at which problems should be formally logged and equally formally signed off as and when resolved.

"Understanding of project roles is important for those taking part in boards and PATs. The board member's role is to direct the project; membership of the board should therefore be restricted to those with direct responsibility for the implementation of the project. The co-ordinator's role is to ensure that all user, technical and business issues affecting the project are brought out. The coordinators are responsible to the project board for ensuring (a) that product descriptions are complete and contain proper quality criteria; and (b) that products are completed to those descriptions in line with the criteria. Co-ordinators should liaise closely with their respective board members over project issues; unfortunately there is a tendency (because of work/travel commitments) for them only to meet at formal board meetings."

"IMG is stuck with its "I've started so I'll finish" attitude. By the way, this is not a flaw of the project management method, but of the people doing the managing. How many IMG projects do you know that have been 'pulled'?"

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