Introduction

	SPREAD V Ed.			Introduction

10 years of SPREAD Collaboration

Introduction

The development of the Italian Guidelines on Stroke has been a coordinate process, involving a multidisciplinary working group, denominated "SPREAD Collaboration" (Stroke PREvention and Awareness Diffusion), in which at present thirty-seven different professional organisations and two patients associations are represented. The group was organised in operative subcommittees. Each subcommittee dealt with a different area covered by the guidelines and was composed of 5-10 experts in the specific field. Furthermore, a "scientific task force" and an editorial board were assigned to coordinate and review the texts progressively processed.

Since early 1998, when works officially started, four consecutive versions were released thanks to an intense multidisciplinary cooperation in the processing phase and in the consensus achievement. Most of the work and the communications occurred electronically through the limited-access section of an specifically set-up intranet. Plenary or single area meetings took place at crucial decisional points.

During the consecutive editions of the national forum "Stroke", held annually in Florence, the final versions of the guidelines were officially presented for comments and consensus by experts, nurses, physiotherapists, patients, and regional representatives.

Finally the ultimate versions were submitted for approval to the medical associations involved.

The guideline development was financially supported by an unconditional grant from Bayer Healthcare Italy. None of the participants to the working groups declared conflicts of interest.

In the first two versions of the guidelines (1999, 2001) the classification of the strength of evidence and the grades of recommendations were derived from what stated by the AHCPR (Agency for Health Care Policy and Research, now AHRQ, Agency for Healthcare Research and Quality).

However some critical issues came out in the application of this methodology of weighing the available scientific evidence. The classification of the results from a randomised, controlled study (RCT) only as statistically "strong" or "weak" appeared unsatisfactory for the actual practice. It was necessary to consider the strength of the evidence, the methodological quality of the studies, the external validity, by applying a "considered judgment" on the whole amount of the data.

The direct applicability of the results of a study to the target population addressed by the guidelines was considered as well.

Accordingly a new methodology was developed by integrating the principles of the SIGN (Scottish Intercollegiate Guideline Network) with the statistical considerations on alpha and beta error size suggested by the CEBM (Centre for Evidence-Based Medicine) methodology (Tables 1 and 2). This methodology has been in use and applied since the 3rd and up to the present Edition.

Table 1. Levels of evidence

1++	High quality meta analyses without heterogeneity, systematic reviews of RCTs each with small confidence intervals (CI), or RCTs with very small CI and/or very small alpha and beta
1+	Well conducted meta analyses without clinically relevant heterogeneity, systematic reviews of RCTs, or RCTs with small CI and/or small alpha and beta
1-	Meta analyses with clinically relevant heterogeneity, systematic reviews of RCTs with large CI, or RCTs with large CI and/or alpha or beta
2++	High quality systematic reviews of case-control or cohort or studies High quality case-control or cohort studies with very small CI and/or very small alpha and beta
2+	Well conducted case control or cohort studies with small CI and/or small alpha and beta
2-	Case control or cohort studies with large CI and/or large alpha or beta
3	Non-analytic studies, e.g. case reports, case series
4	Expert opinion
- (minus)	metanalyses with clinically relevant heterogeneity; systematic reviews of trials with large confidence intervals; trials with large confidence intervals and/or large alpha and/or beta

Table 2. Grades of recommendation

A	At least one meta analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or A systematic review of RCTs or a body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results
B	A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+
C	A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++
D	Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+; or Evidences from trials classified as (minus) regardless of the level
Good Practice Point (GPP)	Recommended best practice based on the clinical experience of the guideline development group, without research evidence

The syntheses (S) and recommendations (R) presented in the final draft of 16 February 2007 (as printed on 20 December 2007) are reported hereafter.

S 1-1

The aim of these guidelines is to provide knowledge and recommendations about the best management of acute stroke and the primary and secondary prevention of stroke in the clinical practice.

S 1-2

These guidelines are not only informative but also normative, though in a non-binding way.

S 1-3

The recommendations are judged valid when they:

	explicitly consider all the important steps of the clinical decision-making process and the relevant outcomes;
	identify the best evidence concerning stroke treatment and prevention, and critically evaluate its reliability;
	identify and take into account the preferences of the involved subjects concerning the outcomes of the decisions taken (including benefits, risks and costs).

S 1-4

The recommendations are relevant when they:

	intervene in situations of broad variability in the clinical practice;
	provide new evidence that may have specific impact on a current therapeutic conduct;
	concern the treatment of such a number of subjects that even small changes in the practice could have a strong impact on outcomes and on allocation of resources.

S 1-5

The ethical frame of these guidelines is based on four fundamental principles:

	beneficence;
	non-maleficence;
	autonomy;
	justice;

taking however into account, with equal dignity, the different ethical positions deriving from the unavoidable contrasts between ethics, economy and law, which also affect the model of the patient-doctor relationship.

S 1-6

At present, reliable evaluations of cost-effectiveness of the main treatments and procedures considered in these guidelines are not available in Italy. If such studies are performed it will be advisable also to consider the problems related to the estimation of costs:

	exclusion of important cost factors;
	inclusion of costs that are not surely attributable to the project;
	improper or incorrect cost estimation;
	inadequate actualisation of cost values;
	uncertainty of the estimates (sensitivity analysis);
	improper use of average costs;
	confusion and overlapping between costs and tariffs.

In any case, costs should be classified as direct, indirect or intangible (that compounded constitute the total cost), in relation to the measure of effectiveness and/or of benefit that is defined as appropriate.

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