This document gives some detail on the purpose of the British Committee for Standards in Haematology and the procedure to be followed when writing BCSH Guidelines. The British Committee for Standards in Haematology is a subcommittee of the British Society of Haematology and its terms of reference are shown in appendix 1. The procedures for guideline approval and development are outlined as algorithms followed by some brief guidance for writing groups. As an aide memoire brief ‘job descriptions’ for each person involved in the BCSH process are shown in appendix 2. Finally in order to make this document as complete as possible appendices 3 to 5 contain an expenses policy and claim form, a guideline template and the classification of evidence levels and grades of recommendations used in the guidelines..
(3) Major vs. minor changes: it is at the discretion of Task Force Chair and the BCSH chair to decide if the draft needs to be re-circulated.
(4) A PDF of the document is placed on the website once and only once it has been approved for publication in a journal. Guidelines that have either been rejected or have not been submitted for publication in a journal must be approved by the BCSH Chair for publication on the website.
The guideline process will receive support as necessary from the BSH (See appendix 3 for BSH expenses policy). Secretarial expenses may also be claimed if appropriate (ask the BCSH administrator for a claim form). Sponsorship from the pharmaceutical industry for any aspect of the writing process must be refused.
Declaration of interest forms will be issued by the BCSH administrator when the guideline is commissioned and must be returned as soon as possible; these will be reviewed by the BCSH Chair and Task Force Chair and if appropriate by the BCSH. Any potential for conflict of interest of writing group members will need to be addressed and the guideline should have a statement at the end declaring any potential conflict (see B: Guideline Layout below for more information).
This is decided between the Task Force and the Chair of the Writing Group to ensure that all relevant professional groups are involved where appropriate. Where it is not feasible to involve all relevant professionals in the writing group there should be an adequate process of consultation at a later stage. Each writing group must include a member of the Task Force whose role is to ensure that the guideline process is followed and the guideline layout is consistent with the suggestions made in Section B (next section). The Task Force member should also liaise with the BCSH administrator to ensure that declaration of interest forms are submitted as soon as work commences on the guideline. The guideline should contain explanation of the representation of individual writing group members. Patient involvement should be considered in the writing process. The exact nature of the involvement will vary according to the topic but possible methods are involvement of patient societies or support groups, either in the writing group itself or the consultation process. If appropriate, a guideline for patients’ use should be devised
To facilitate review of guidelines all documents should be written in Microsoft Word; the change tracking facility of this programme is particularly useful.
If the Task Force decides to pursue paper publication the final version should be submitted by the Writing Group Chair for publication to a Wiley (previously Blackwells) Journal unless there are compelling reasons otherwise i.e. British Journal of Haematology, Clinical and Laboratory Haematology, Transfusion Medicine, Haemophilia or the Journal of Thrombosis and Haemostasis. This will enable the PDF file to be obtained easily for loading on to the website and will also enable a link to the full text version online. If there is likely to be undue delay before the publication of the guideline in a journal a PDF version of the document may be uploaded as in interim measure.
When the Task Force has finally approved a draft guideline this should be distributed to a Sounding Board of haematologists for comment. This would normally be done by the BCSH Administrator who maintains sounding board e-mail address lists for each Task Force. When a guideline is sent to the Sounding Board for comment the covering e-mail would need to give a deadline for return of comments (normally within three to four weeks) and should remind Sounding Board members that the draft guidelines are confidential; while they can be shared with appropriate local colleagues they should not be passed on to third parties (e.g. representatives of the pharmaceutical industry). Comments would normally be returned to the Task Force Secretary whose e-mail address should be given. The BCSH administrator should use the standard Sounding Board letter as shown below.
Writing groups should follow the layout illustrated in Appendix 4 when submitting guidelines for publication. The BCSH administrator will provide the lead writer with a guideline template and ensure that the correct layout is followed.
1. Font and size
Arial font (12 point) should be used to facilitate on screen viewing.
This recognises the authors, Task Force and BCSH. It also provides a permanent correspondence address, legal disclaimer and date for review. The exact template should be followed to provide a continuity of appearance for all BCSH guidelines.
TThe guideline should include a brief summary of the key recommendations. This should be prominent and preferably near the beginning of the document. The layout will depend on the topic and will usually be presented as a series of ‘bullet points’. A table or algorithm may be even better.
The reasons for developing the guideline should be stated together with a discussion of the aims of the guideline. If the guideline concerns patient management, the population should be defined as accurately as possible both in terms of demographics and the diseases to be considered. If relevant, there should be explanation of the circumstances in which the guideline may not be appropriate to individual patients and how patient preferences should be taken into account.
The appropriate method depends on the evidence base and the resources available to the drafting group. As a minimum, the guidelines should be ‘evidence based’ and where possible risk/benefit and pharmaco-economic analysis should be included, thus producing an ‘evaluative’ guideline. However, if adequate evidence is lacking a consensus guideline may be all that is possible. Writing groups are encouraged to apply the ‘AGREE’ instrument for assessment of guidelines (downloadable from www.agreecollaboration.org).
The precise strategy of the literature search must be stated and should include details of the subject headings, databases searched, period of search, literature types and whether limited to English, etc. Internet search details should include the search words and search engines used. If appropriate, details should also be given on how the results were assessed and the criteria for choosing evidence for further study. There should be a statement covering how the evidence was appraised and categorised and which classification system has been used. From late 2009 all BCSH guidelines are using the GRADE nomenclature for the assessment of evidence and the strength of recommendations (see appendix 5). Prior to this the classification devised by the US Agency for Health Care Policy and Research was used.
The guideline should discuss the relevant evidence and provide clear conclusions showing grades of recommendations and levels of evidence (see appendix 5). Recommendations should stand out clearly at the end of the relevant discussion by putting them in bold or into a table.
The guideline should suggest standards or targets, which could be used as topics for audit.
All guidelines should have a review date, which should be established at the time the Task Force approved draft is distributed.
- The British Committee for Standards in Haematology (BCSH) is established under Articles 36 and 40 (a) of the Memorandum and Articles of Association of the British Society for Haematology (BSH) as a sub-committee of BSH, as follows:-
In particular but without limiting the foregoing the Committee shall establish and maintain as a Sub-Committee of the Committee the British Committee for Standards in Haematology (BCSH) and the appropriate Task Forces of that Committee for the purpose of developing and publishing standards in haematology provided that these standards may only be published when they have been approved by the Committee. Wherever the Committee considers it appropriate the Committee may invite other learned societies to nominate representatives whom the Committee may (pursuant to Article 36 (b) co-opt to be members of BCSH and its Task Forces.
- The Officers responsible for the administration of BCSH will be a Chairman and Secretary, who will be appointed by the BSH Committee. The Chairman will be appointed by the BSH committee and will normally have experience of BCSH as a Task Force Chair or Secretary or as BCSH secretary. The appointment will be for a period of 3 years, renewable once only. His/her alternate will be the current President or Vice-President. The Secretary of the BCSH will be appointed for a period of three years and shall be eligible for re-appointment, but shall not normally hold office for more than six consecutive years.
- The Chairman of BCSH is responsible for the strategy and performance of BCSH in conjunction with the Society's Committee and for liaison with NICE and other NHSE/DoH bodies in consultation with Task Force Chairmen as appropriate.
The BCSH Secretary is responsible for (i) the co-ordination of guideline production by providing clear guidance to Task Force Secretaries; (ii) liaison with Blackwells on the guidelines website; and (iii) compilation of agenda and minutes of BCSH meetings and liaison with the Administrator(s) to ensure due process and deadlines are always observed.
- In addition to the Chairman and Secretary, BCSH shall consist of:-
The Scientific Secretary of the BSH and the Chairman of each Task Force (for whom the Task Force Secretary may deputise) and two Ordinary Members of the Society. The Treasurer of the BSH is an ex-officio member.
- The BCSH will establish, with the approval of the BSH Committee, expert Task Forces of no more than eight members (excluding invited nominees of other organisations) to give it advice. At present there are four Task Forces - General Haematology, Haemato-Oncology, Blood Transfusion and Haemostasis and Thrombosis.
Each Task Force will have a Chairman and Secretary who will be nominated by the BCSH. Task Force members should ordinarily be members of BSH unless they represent another society or interest. The appointment of Task Force members shall be for a term of three years and shall be renewable once. The Chairman and Secretary shall likewise be appointed for a term of three years which shall be renewable once. This shall be in addition to any term that they may have served as a Task Force member. The Chairman and Secretary of BCSH are ex-officio members of each Task Force.
Scheme Organisers of NEQAS may normally be expected to be members of the appropriate Task Forces.
Task Force and Writing Group members shall be approved by the BCSH and BSH committee.
- The Task Force Chairmen may establish working parties and set strategies for their Task Forces and are responsible for monitoring their performance as well as liaising with NICE on specific issues, in consultation with the BCSH Secretary.
The Secretary will circulate the Agenda at least two weeks in advance of meetings. The Secretary will also circulate information to the members at regular intervals. The Chairman or Secretary will present an Annual Report to the BSH.
- The office address of BCSH shall be the address of BSH or such other address as stipulated by the BSH.
- Publication by Task Forces shall be approved by the BCSH and BSH Committee. When it is appropriate the document may show the Societies and Organisations endorsing it. Correspondence should be addressed to the Secretary of the BCSH at the official address.
- Members of Societies and Organisations invited to join a Task Force shall have their expenses incurred on Task Force business reimbursed by the BSH.
Appendix 2
BCSH ‘JOB DESCRIPTIONS’
This document describes the roles and responsibilities of different contributors to the BCSH process. Everybody should be familiar with the procedure for guidelines commissioned by the BCSH as shown on the BCSH website (http://www.bcshguidelines.com/process1.asp). This can also be accessed by clicking on the BCSH process link from the side menu on the home page and then on the ‘procedure for guidelines commissioned by BCSH’ link in the text. All BCSH officers need to fulfil their roles as described in that process and in addition have specific responsibilities as described below:
BCSH Chair
- To define the overall strategy of BCSH in conjunction with the BSH Committee.
- To chair BCSH meetings and attend BSH Committee meetings.
BCSH Secretary
- To convene BCSH meetings and submit minutes to the BSH Administrator.
- To assist Task Force Secretaries / Chairs in development of guidelines.
- To maintain the BCSH website and deal with correspondence generated from this.
- To co-ordinate responses to NICE from the BCSH.
Ordinary BCSH Member
- To oversee the work of the BCSH and ensure it is responsive to the needs of BSH members.
Task Force Chair
- To define the strategy for the Task Force in conjunction with the BCSH.
- To initiate development of guidelines.
- To chair Task Force meetings.
- To decide working group membership.
- To nominate ‘experts’ for NICE consultations.
- To ensure guideline development is proceeding in a timely manner.
Task Force Secretaries
- To convene Task Force meetings and submit minutes to the BCSH Secretary.
- To ensure the BCSH process is followed for every guideline in development.
- To submit final versions of guidelines for publication (if not done by the writing group chair).
- Allocate reference numbers to guidelines.
- Inform the BCSH secretary when guidelines need to be archived.
- Send information on work in progress to the BCSH administrator.
Task Force Members
- To attend Task Force meetings and comment on draft guidelines.
- To chair or participate in Writing Groups. When doing so the purpose is to ensure that guidelines are developed in accordance with procedure for guidelines commissioned by BCSH as shown on the BCSH website.
Writing Group Chair
- To ensure that guidelines are developed in accordance with procedure for guidelines commissioned by BCSH as shown on the BCSH website.
- To decide, in conjunction with the Task Force Chair / Secretary the composition of the Writing Group to involve all relevant stakeholders. Note that work should not start until the participation of any member has been agreed.
- To convene meetings of the Working Group or agree on other means of communication.
- To delegate sections of the guideline to Writing Group members.
- To ensure the initial draft is submitted within the agreed time scale to the Task Force.
- To receive comments from the Task Force or Sounding Board and modify the draft accordingly.
- To submit the final draft guideline to the Task Force Secretary – or by agreement with the Task Force Secretary submit directly for publication.
Writing Group Member
- To return a Declaration of Interest form before starting work.
- To develop draft guidelines as agreed with the Writing Group Chair.
- To be aware of the BCSH process as shown on the BCSH website.
Sounding Board Members
- To inform the BCSH Administrator of any change of e-mail address.
- To return comments on draft guidelines within the timescale given (usually 3 – 4 weeks). Sounding board members should ideally make some comment on every guideline. As a minimum this need only be an acknowledgement that the guideline is satisfactory e.g. ‘looks fine’ or ‘no problems’. If a Sounding Board member does not make any response to three successive requests for comments then they may be removed from the Sounding Board list.
- To treat all documents as confidential. Sounding Board members may discuss guidelines with colleagues e.g. other Haematologists, trainees or scientific / technical / nursing staff to obtain opinions as appropriate but the feed back to the Task Force Secretary should be given by the Sounding Board member. The draft documents should not be discussed in detail or passed on to non NHS / university staff, for example representatives of the pharmaceutical industry.
BCSH Administrator
- To assist the BCSH Chair and Secretary, the Task Force Chairs and Secretaries, and the Writing Group Chairs as requested.
- To arrange and minute all BCSH Executive and Task Force meetings.
- To ensure draft guidelines have been correctly laid out in accordance with the ‘Guideline Layout’ section of this procedure for guidelines commissioned by BCSH.
- To ensure Declaration of Interest forms are completed by all writing group members and to process and retain these forms.
- Maintain the work in progress section of the BCSH website.
- To maintain e-mail lists for the sounding boards and to distribute draft guidelines to the sounding boards.
- Receive and process claims for expenses.
- Maintain BCSH appendices for BSH meetings.
- To respond to outside enquiries.
- To ensure experts are nominated for NICE consultations and to ensure all relevant forms and submissions are returned within deadlines.
Appendix 3
EXPENSES POLICY
Contents
- Introduction
- Administration
- Travel Expenses
- General
- Use of alternative forms of transport for people with disabilities
- Rail travel
- Travel by privately owned car
- Travel by taxi
- Air travel
- Entertaining expenses
- Accommodation and Subsistence
- Overnight accommodation
- Personal incidental expenses
- Meals and subsistence
- Other Expenses
- Expenses and Tax
- General
- Drivers and tax (including mileage rates)
- Contact Details
1 INTRODUCTION
It is the policy of the British Society for Haematology to offer claimants full reimbursement of out-of-pocket expenses incurred on the Society's behalf, providing that the nature of these expenses has been agreed in advance.
All claims must be submitted within three months of the expenditure being incurred.
Consideration must always be given to using the most cost-effective method of travel. As the BSH is a charity, claimants are expected to keep expenses to a minimum.
The BSH will only make reimbursement for actual expenses necessarily incurred and if supported by a receipt where appropriate. The BSH does not pay ‘flat rate' expenses; paying round-sum amounts unsupported by actual expenditure receipts may result in an individual becoming liable to tax on the payments and may put the benefits they receive at risk. The BSH will hold receipts for all claims for at least six years as required by the Inland Revenue.
The BSH will pay the following out-of-pocket expenses:
- petrol/mileage costs incurred whilst on BSH business
- travel from home to and from the place of a meeting and any additional travel necessary in the course of work on behalf of the BSH
- postage, phone calls and stationery costs necessary to the work of the BSH
- meals taken while on BSH business, subject to a minimum time commitment, an upper limit of payment and arrangements for the provision of meals during the BSH business
- accommodation costs if overnight stays are necessary to the activity undertaken on behalf of the BSH.
It is not acceptable to claim sums above the level of out-of-pocket expenses. Claims for travel not actually taken or food not actually consumed is fraudulent and defrauding the BSH.
Travel costs between home and the normal place of work can never be claimed. Costs incurred by travelling companions not engaged in official BSH business may not be claimed.
Where expenses are incurred in foreign currencies, the amounts should be shown with the currency in question clearly indicated. Reimbursement will be made in sterling at the rate of exchange in force on the date of the claim, as calculated by the Treasurer.
2 ADMINISTRATION
Expenses will usually be reimbursed by cheque. Original receipts (i.e. not photocopies or credit card vouchers) must support all claims and, if VAT has been charged, the receipt should contain the VAT registration number and rate of VAT. In the event of hotel accommodation, please ensure that the receipt is either in the name of ‘the British Society for Haematology' or your own name. Receipts made out in the name of other organisations, such as NHS Trusts, will be returned unpaid.
Expenses should be claimed using the BSH expense claim form, available either on the website (www.b-s-h.org.uk) or from the BSH Manager (telephone: 020 7713 0990 or e-mail: richard.crossick@b-s-h.org.uk).
3 TRAVEL EXPENSES
3.1 General
If you are attending a BSH Committee meeting, a BSH Subcommittee or Forum meeting, a BCSH Committee meeting or BCSH working party/ task force meeting or another meeting as a BSH or BCSH representative, the BSH will reimburse the expenses incurred, subject to the terms of this policy. If you are attending a meeting at the request of, or as a representative of another professional body, association or institution (including BSH Conferences Ltd) then the BSH may require that such costs should be claimed directly from that professional body, association or institution and not from the BSH.
The BSH will reimburse travel expenses from home to and from the place of a meeting. Dates of meetings are often known well in advance, when discounts may be offered by travel companies for advance booking, e.g. by taking advantage of Saver, Supersaver or APEX fares
In order to encourage the booking of tickets in advance, should it subsequently not be possible for you to attend a particular meeting, the BSH will re-imbrues you any non-refundable element of the ticket.
All travel expense claims must be supported with a receipt.
3.2 Use of alternative forms of transport for persons with disabilities
In circumstances where disabled persons are unable to travel by public transport or their own vehicle, taxis may be used, subject to prior approval of either the President or Treasurer.
3.3 Rail travel
For all rail journeys with a scheduled journey time of less than one hour, travel must be arranged on a second (standard) class basis. For rail journeys where the scheduled journey time exceeds one hour, first class APEX (or equivalent) travel will be acceptable. Expense forms must have attached as supporting documentation either the actual train tickets or a receipt from the railway company. If a receipt is required, this should be requested at the time of ticket purchase as these are not routinely supplied.
BSH staff should travel standard class, unless agreed otherwise by the President or Treasurer.
Claimants should ensure that they secure the best price possible by, for example, taking advantage of Senior Railcards (if appropriate), adopting flexible travel arrangements and booking tickets in advance of the day of travel.
3.4 Travel by privately owned car
The driver, not the BSH, is personally liable for any incident. Thus drivers should ensure that their own private motor vehicle insurance policy is comprehensive and permits the use of their own vehicle for the purpose of travel on BSH business.
If an individual's own vehicle is used, a mileage rate will be paid (as detailed in section 6.2 below). Please note that the total claim for any journey made by car (including the mileage rate, parking, toll fees, congestion charges etc) should not exceed the standard-class rail fare. A receipt should support claims for parking or other incidental expenses.
The BSH will not reimburse parking fines, congestion charge fines or fines for other motoring-related offences.
3.5 Travel by taxi
Use of public transport or privately owned vehicle is encouraged and should be used wherever possible. However it is recognised that the use of a taxi may in the following circumstances be the most efficient mode of transport:
- where equipment or heavy baggage is being carried
- when no public transport is available, especially in the early morning or late at night when public transport is either not running or running infrequently
- where the claimant is pregnant
- where the claimant has a temporary or permanent disability
- when it is important to save official time.
Travel by taxi should be kept to a minimum and should definitely not be used for long journeys or between BSH Headquarters and London airports. Claimants should obtain an official receipt from the taxi driver to substantiate their travel expense claim. Where it is expected that the taxi fare will exceed £20, permission to use a taxi must be sought in advance from either the President or Treasurer.
3.6 Air travel
All journeys by air travel within the UK must be arranged on an economy class basis. A receipt should be requested at the time of ticket purchase. Claimants should seek to minimise the cost of air travel by booking tickets in advance, taking advantage of early booking discounts where available.
In the case of overseas travel, particularly where the costs are to be funded by the BSH, it is necessary to justify the journey. Please notify either the President or Treasurer before tickets are purchased for agreement as to whether the BSH will reimburse the cost, which will normally be on an economy class basis. The BSH will need to give consideration as to how the journey fits into the BSH's overall strategy and what outcomes are expected to be achieved.
3.7 Entertaining expenses
The BSH will not normally reimburse entertainment expenses. However in the rare case where this may be appropriate, permission must be sought in advance from either the President or Treasurer.
4 ACCOMMODATION AND SUBSISTENCE
4.1 Overnight accommodation
Claimants may stay in 3- or 4-star accommodation, according to local availability. Claimants are reminded of the need to demonstrate value for money and reasonableness of expenditure when selecting accommodation.
For hotel accommodation in Central London, the Royal College of Pathologists has negotiated discounted hotel rates, bookable via the College website. Further details on www.rcpath.org/index.asp?PageID=731.
In all cases, a receipt for the hotel costs should be obtained that is made out either in the name of ‘The British Society for Haematology' or in your own name. Receipts made out in the name of your normal place of work (such as your university or hospital) will be returned to you unpaid. You will then need to contact the hotel for a replacement receipt made out in the BSH's or your own name.
Cost of overnight accommodation and breakfast should not exceed the College accommodation rates as detailed below:
- Central London, £130 per night
- Elsewhere, £90 per night.
When accommodation costs have been saved by staying with friends, relatives or colleagues, an hospitality allowance of up to £25 per 24 hour period may be claimed. You may either give this to your host in cash to cover his/her costs, or use some or all of it to purchase a gift or to take them for a meal. You should claim whatever you have paid to a maximum of £25 per day. Receipts are not required.
4.2 Personal incidental expenses
Persons staying away from home overnight may incur minor incidental expenses of a personal nature such as newspapers, laundry, telephone calls home, etc. These may be claimed up to a daily limit of £3. Please ensure that these amounts are itemised separately on your claim form. The BSH will not reimburse minibar expenses or other hotel leisure costs, such as film or video hire.
4.3 Meals and subsistence
Round-sum subsistence allowances are not paid. A receipt should support all claims for meals or subsistence. Subsistence may not be claimed for absences from home of less than 4 hours duration. As a guide, claims for subsistence away from home are as follows: between 4 and 6 hours, not normally exceeding £5; between 6 and 10 hours, not normally exceeding £15; over 10 hours not normally exceeding £20. These subsistence rates should include all meals in a 24 hour period. Where a meal has been provided at the BSH/BCSH meeting a commensurate reduction in claim/no claim will be expected.
Claims for breakfast will not be reimbursed where already included on a hotel bill or where the claimant is in receipt of a hospitality allowance.
5 OTHER EXPENSES
The BSH will reimburse other out-of-pocket expenses incurred by individual claimants on BSH business such as the cost of postage, phone calls and stationery, subject to a receipt being submitted with the claim.
If you are in doubt about what may be claimed, or wish to claim for items not mentioned in this expenses policy, please contact the BSH Manager or the Treasurer for advice prior to incurring the expenses.
6 EXPENSES AND TAX
6.1 General
It is BSH policy only to reimburse for actual out-of-pocket expenses incurred, for which there is not tax liability. Claimants would only be liable to pay tax if payments were made that either exceeded actual expenditure, or that were not supported by original receipts.
6.2 Drivers and tax
The Inland Revenue sets tax-free mileage rates under the Fixed Profit Car Scheme (FPCS). Please note that these rates apply to your total mileage claimed from any source (your employer, BSH, the College or other association/voluntary body). The BSH reimburses for mileage at the tax-free mileage rate, therefore the Inland Revenue assumes that the claimant has made no profit.
The FPCS rates for 2009-2010 are 40p per mile for the first 10,000 miles in any tax year and 25p per mile thereafter. These rates apply only to travel in your privately owned car and are regardless of engine size.
BCSH Administrator: Richard Crossick; 020 7713 0990; richard.crossick@b-s-h.org.uk or bcsh@b-s-h.org.uk.
Treasurer Graham Jackson 0191 282 5042 graham.jackson@newcastle.ac.uk
Expense Claim Form
Expense Claim Form, available as a PDF (33KB) or contact the BCSH administrator.
Appendix 4
Guideline Template
Guideline layout, available as a Word Document (36KB)
Appendix 5
Evidence levels and grades of recommendations
Guidelines prior to January 2010 used the classification of evidence and grading of recommendations as devised by the US Agency for Health Care Policy and Research (AHCPR). Guidelines published from January 2010 will use the ‘GRADE’ nomenclature.
AHCPR:
CLASSIFICATION OF EVIDENCE LEVELS (AHCPR)
-
a. Evidence obtained from meta-analysis of randomised controlled trials.
b. Evidence obtained from at least one randomised controlled trial
-
a. Evidence obtained from at least one well-designed controlled study without randomisation.
b. Evidence obtained from at least one other type of well-designed quasi-experimental study. *
- Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies and case studies.
- Evidence obtained from expert committee reports or opinions and/or clinical experiences of respected authorities.
CLASSIFICATION OF GRADES OF RECOMMENDATIONS (AHCPR)
- Requires at least one randomised controlled trial as part of a body of literature of overall good quality and consistency addressing specific recommendation.
(Evidence levels Ia, Ib).
- Requires the availability of well conducted clinical studies but no randomised clinical trials on the topic of recommendation.
(Evidence levels IIa, IIb, III).
- Requires evidence obtained from expert committee reports or opinions and/or clinical experiences of respected authorities. Indicates an absence of directly applicable clinical studies of good quality.
(Evidence level IV).
Evidence obtained from the literature searches should be assessed by the drafting group and recommendations formulated from this evidence. As in the summary, the recommendations need to be graded according to the strength of supporting evidence using the AHPCR system. If there are several possible options for management, these should be enumerated and also linked to supporting evidence.
* refers to a situation in which implementation of an intervention is out with the control of the investigators, but an opportunity exists to evaluate its effect.
GRADE:
GRADE stands for: Grading of Recommendations Assessment, Development and Evaluation (GRADE).
From January 2010 BCSH guidelines will adopt the GRADE nomenclature for assessing levels of evidence and providing recommendations in guidelines. For laboratory tests guidance is related specifically to clinical utility (that is the ability of a test to alter clinical outcome). Details of the GRADE system are available at the working group website:
http://www.gradeworkinggroup.org/index.htm
STRENGTH OF RECOMMENDATION
Strong (grade 1): Strong recommendations (grade 1) are made when there is confidence that the benefits do or do not outweigh harm and burden. Grade 1 recommendations can be applied uniformly to most patients. Regard as 'recommend'.
Weak (grade 2) Where the magnitude of benefit or not is less certain a weaker grade 2 recommendation is made. Grade 2 recommendations require judicious application to individual patients. Regard as ‘suggest’.
QUALITY OF EVIDENCE AND DEFINITIONS
The quality of evidence is graded as high (A), moderate (B) or low (C). To put this in context it is useful to consider the uncertainty of knowledge and whether further research could change what we know or our certainty.
(A) High Further research is very unlikely to change confidence in the estimate of effect. Current evidence derived from randomised clinical trials without important limitations.
(B) Moderate Further research may well have an important impact on confidence in the estimate of effect and may change the estimate. Current evidence derived from randomised clinical trials with important limitations (e.g. inconsistent results, imprecision - wide confidence intervals or methodological flaws - e.g. lack of blinding, large losses to follow up, failure to adhere to intention to treat analysis),or very strong evidence from observational studies or case series (e.g. large or very large and consistent estimates of the magnitude of a treatment effect or demonstration of a dose-response gradient).
(C) Low Further research is likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate. Current evidence from observational studies, case series or just opinion.
