R EGOLAMENTO DELLA GIURIA
DICHIARAZIONE DI POTENZIALE CONFLITTO DI INTERESSI
Si riconosce che gli esperti coinvolti nella Conferenza di consenso possono essere coinvolti a vario titolo in attività scientifiche, professionali o economiche, oppure possedere interessi accademici, scientifici o finanziari tali da poter creare potenziale conflitto di interessi con la partecipazione ai gruppi di lavoro e alla giuria della conferenza di consenso. Si ritiene pertanto opportuno che:
1. i componenti della giuria accettino di limitare l’espressione delle proprie valutazioni su argomenti per i quali si configurino condizioni di potenziale conflitto di interessi, secondo quanto indicato più avanti (vedasi Rivelazione di potenziale conflitto di interessi);
2. i componenti dei gruppi di lavoro siano esenti da conflitto di interessi, secondo quanto indicato più avanti (vedasi: Esempi di situazioni nelle quali può sussistere conflitto di interessi e Rivelazione di potenziale conflitto di interessi).
Le condizioni di potenziale conflitto di interessi dei componenti della giuria e dei gruppi di lavoro dovranno essere autocertificate.
Ricordando che ciascun esperto è stato identificato come esperto indipendente e non come rappresentante di una istituzione, di seguito sono richiamate alcune regole generali alle quali si deve attenere ciascun componente dei gruppi di lavoro o della giuria:
1. l’intera attività preparatoria alla Conferenza di consenso deve essere considerata confidenziale. Si deve evitare di diffondere i documenti preparatori della Conferenza nella fase di lavoro preliminare
2. ciascun esperto deve firmare una dichiarazione sul conflitto di interessi e deve astenersi dalla partecipazione a quegli aspetti della Conferenza nella quale si può configurare eventuale conflitto di interessi.
Esempi di situazioni nelle quali può sussistere conflitto di interessi Un conflitto di interessi può esistere se un esperto:
1. ha rapporti stabili di lavoro (esempio: dipendenza, consulenza) con industrie farmaceutiche o biomedicali le cui attività riguardino le problematiche oggetto della Conferenza di consenso 2. ha interessi finanziari, diretti o indiretti, in comune con industrie farmaceutiche o biomedicali le
cui attività riguardino le problematiche oggetto della Conferenza di consenso
3. partecipa ad attività di ricerca/valutazione nelle aree attinenti alle problematiche che saranno oggetto della Conferenza di consenso
4. svolge attività di divulgazione e informazione per conto di industrie farmaceutiche o biomedicali le cui attività riguardino le problematiche che saranno oggetto della Conferenza di consenso
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5. appartiene ad associazioni professionali o gruppi (associazioni, ecc.) che ricevono finanziamenti da industrie farmaceutiche o biomedicali le cui attività riguardino le problematiche che saranno oggetto della Conferenza di consenso.
Rivelazione di potenziale conflitto di interessi
Per i componenti dei gruppi di lavoro: se esistono potenziali conflitti di interesse, l’esperto non potrà partecipare alle attività dei gruppi di lavoro. Per i componenti della giuria: solamente la condizione al punto 1 (rapporti stabili di lavoro) rappresenta condizione di incompatibilità; per le altre condizioni l’esperto dovrà sottoscrivere una dettagliata auto-dichiarazione che verrà resa pubblica unitamente agli atti della Conferenza di Consenso. Se un esperto ha dubbi riguardo all’esistenza del potenziale conflitto di interessi deve informare il Presidente della Giuria e il Comitato Promotore
Attuazione
Operativamente, ogni esperto invitato a partecipare ai gruppi di lavoro o alla giuria della Conferenza di consenso sottoscrive la dichiarazione in Appendice A2 e, se non esistono condizioni di incompatibilità, partecipa a tutte le attività previste dalla Conferenza di consenso. Se esistono condizioni di incompatibilità non assoluta l’esperto ha facoltà - nel corso dei lavori - di dichiarare specifici potenziali conflitti di interessi e di astenersi da valutazioni nelle relative documentazioni.
Il Comitato Promotore della Conferenza di Consenso Ufficio Relazioni Esterne, Istituto Superiore di Sanità, Roma AUSL 2 dell’Umbria, Centro Residenziale per i Disturbi del Comportamento Alimentare e del peso, Todi
IS T I T U T O SUPERIORE DI SANITÀ e AUSL N.2 UMBRIA Con il patrocinio del Ministero della Salute
C o n f e r e n za n a zi o n a l e d i c o n s e n s o D i s t u r b i d e l c o m p o r t a m e n t o a l i m e n t a r e
DICHIARAZIONE DI POTENZIALE CONFLITTO DI INTERESSI
Il sottoscritto__________________________________________________________________ conferma di aver letto il documento sulla dichiarazione di potenziale conflitto di interessi per la Conferenza di consenso e dichiara di (barrare la casella ed eventualmente specificare):
/__/ non avere un potenziale conflitto di interessi, come sopra descritto
/__/ avere le seguenti condizioni che comportano un potenziale conflitto di interessi:
_____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________
Firma________________________________ Data_______________
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A3. Checklist utilizzate per la selezione degli studi Appraisal of guidelines for research & evaluation II
Titolo della linea guida:
Domain 1. Scope and Purpose 1 2 3 4 5 6 7
1. The overall objective(s) of the guideline is (are) specifically described. 2. The health question(s) covered by the guideline is (are) specifically
described
3. The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described.
Domain 2. Stakeholder Involvement 1 2 3 4 5 6 7
4. The guideline development group includes individuals from all relevant professional groups.
5. The views and preferences of the target population (patients, public, etc.) have been sought.
6. The target users of the guideline are clearly defined.
Domain 3. Rigour of Development 1 2 3 4 5 6 7
7. Systematic methods were used to search for evidence. 8. The criteria for selecting the evidence are clearly described. 9. The strengths and limitations of the body of evidence are clearly
described.
10. The methods for formulating the recommendations are clearly described.
11. The health benefits, side effects, and risks have been considered in formulating the recommendations.
12. There is an explicit link between the recommendations and the supporting evidence.
13. The guideline has been externally reviewed by experts prior to its publication.
14. A procedure for updating the guideline is provided
Domain 4. Clarity of Presentation 1 2 3 4 5 6 7
15. The recommendations are specific and unambiguous.
16. The different options for management of the condition or health issue are clearly presented.
17. Key recommendations are easily identifiable.
Domain 5. Applicability 1 2 3 4 5 6 7
18. The guideline describes facilitators and barriers to its application. 19. The guideline provides advice and/or tools on how the
recommendations can be put into practice.
20. The potential resource implications of applying the recommendations have been considered.
21. The guideline presents monitoring and/or auditing criteria.
Domain 6. Editorial Independence 1 2 3 4 5 6 7
22. The views of the funding body have not influenced the content of the guideline.
23. Competing interests of guideline development group members have been recorded and addressed.
Overall Guideline Assessment 1 2 3 4 5 6 7
1. Rate the overall quality of this guideline. 2. I would recommend this guideline for use.
AMSTAR for systematic reviews
Titolo dello studio:
1. Was an ‘a priori’ design provided?
The research question and inclusion criteria should be established before the conduct of the review.
Yes No
Can’t answer Not applicable 2. Was there duplicate study selection and data extraction?
There should be at least two independent data extractors and a consensus procedure for disagreements should be in place.
Yes No
Can’t answer Not applicable 3. Was a comprehensive literature search performed?
At least two electronic sources should be searched. The report must include years and databases used (e.g. Central, EMBASE, and MEDLINE). Key words and/or MESH terms must be stated and where feasible the search strategy should be provided. All searches should be supplemented by consulting current contents, reviews, textbooks, specialized registers, or experts in the particular field of study, and by reviewing the references in the studies found
Yes No
Can’t answer Not applicable
4. Was the status of publication (i.e. grey literature) used as an inclusion criterion? The authors should state that they searched for reports regardless of their
publication type. The authors should state whether or not they excluded any reports (from the systematic review), based on their publication status, language etc.
Yes No
Can’t answer Not applicable 5. Was a list of studies (included and excluded) provided?
A list of included and excluded studies should be provided. Yes No Can’t answer Not applicable 6. Were the characteristics of the included studies provided?
In an aggregated form such as a table, data from the original studies should be provided on the participants, interventions and outcomes. The ranges of characteristics in all the studies analyzed e.g. age, race, sex, relevant
socioeconomic data, disease status, duration, severity, or other diseases should be reported
Yes No
Can’t answer Not applicable 7. Was the scientific quality of the included studies assessed and documented?
‘A priori’ methods of assessment should be provided (e.g., for effectiveness studies if the author(s) chose to include only randomized, double-blind, placebo controlled studies, or allocation concealment as inclusion criteria); for other types of studies alternative items will be relevant.
Yes No
Can’t answer Not applicable 8. Was the scientific quality of the included studies used appropriately in formulating
conclusions?
The results of the methodological rigor and scientific quality should be considered in the analysis and the conclusions of the review, and explicitly stated in formulating recommendations.
Yes No
Can’t answer Not applicable 9. Were the methods used to combine the findings of studies appropriate?
For the pooled results, a test should be done to ensure the studies were combinable, to assess their homogeneity (i.e. Chi- squared test for homogeneity, I2). If heterogeneity exists a random effects model should be used and/or the clinical appropriateness of combining should be taken into consideration (i.e. is it sensible to combine?).
Yes No
Can’t answer Not applicable 10. Was the likelihood of publication bias assessed?
An assessment of publication bias should include a combination of graphical aids (e.g., funnel plot, other available tests) and/or statistical tests (e.g., Egger regression test). Yes No Can’t answer Not applicable segue
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11. Was the conflict of interest stated?
Potential sources of support should be clearly acknowledged in both the systematic review and the included studies.
Yes No
Can’t answer Not applicable
From: http://www.biomedcentral.com/1471-2288/7/10 (ultima consultazione 31 gennaio 2013)
Criterio di inclusione: almeno il 75% di risposte “Yes”
PRISMA 2009 Checklist systematic reviews
Section/topic # Checklist item Reported
on page # Title
Title 1 Identify the report as a systematic review, meta-analysis, or both. Abstract
Structured
summary 2 Provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number.
Introduction
Rationale 3 Describe the rationale for the review in the context of what is already known.
Objectives 4 Provide an explicit statement of questions being addressed with reference to participants, interventions, comparisons, outcomes, and study design (PICOS).
Methods Protocol and
registration 5 Indicate if a review protocol exists, if and where it can be accessed (e.g., Web address), and, if available, provide registration information including registration number.
Eligibility
criteria 6 Specify study characteristics (e.g., PICOS, length of follow‐up) and report characteristics (e.g., years considered, language, publication status) used as criteria for eligibility, giving rationale. Information
sources 7 Describe all information sources (e.g., databases with dates of coverage, contact with study authors to identify additional studies) in the search and date last searched.
Search 8 Present full electronic search strategy for at least one database, including any limits used, such that it could be repeated.
Study selection 9 State the process for selecting studies (i.e., screening, eligibility, included in systematic review, and, if applicable, included in the meta‐analysis).
Data collection
process 10 Describe method of data extraction from reports (e.g., piloted forms, independently, in duplicate) and any processes for obtaining and confirming data from investigators.
Data items 11 List and define all variables for which data were sought (e.g., PICOS, funding sources) and any assumptions and simplifications made.
Risk of bias in individual studies
12 Describe methods used for assessing risk of bias of individual studies (including specification of whether this was done at the study or outcome level), and how this information is to be used in any data synthesis.
Summary
measures 13 State the principal summary measures (e.g., risk ratio, difference in means). Synthesis of
results 14 Describe the methods of handling data and combining results of studies, if done, including measures of consistency (e.g. l2, for each meta-nalysis.)
Risk of bias
across studies 15 Specify any assessment of risk of bias that may affect the cumulative evidence (e.g., publication bias, selective reporting within studies).
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Section/topic # Checklist item Reported
on page # Additional
analyses 16 Describe methods of additional analyses (e.g., sensitivity or subgroup analyses, meta-regression), if done, indicating which were pre-specified.
Results
Study selection 17 Give numbers of studies screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally with a flow diagram.
Study
characteristics 18 For each study, present characteristics for which data were extracted (e.g., study size, PICOS, follow-up period) and provide the citations.
Risk of bias
within studies 19 Present data on risk of bias of each study and, if available, any outcome level assessment (see item 12). Results of
individual studies
20 For all outcomes considered (benefits or harms), present, for each study: (a) simple summary data for each intervention group (b) effect estimates and confidence intervals, ideally with a forest plot. Synthesis of
results 21 Present results of each meta-analysis done, including confidence intervals and measures of consistency. Risk of bias
across studies 22 Present results of any assessment of risk of bias across studies (see Item 15). Additional
analysis 23 Give results of additional analyses, if done (e.g., sensitivity or subgroup analyses, meta-regression [see Item 16]). Discussion
Summary of
evidence 24 Summarize the main findings including the strength of evidence for each main outcome; consider their relevance to key groups (e.g., healthcare providers, users, and policy makers).
Limitations 25 Discuss limitations at study and outcome level (e.g., risk of bias), and at review-level (e.g., incomplete retrieval of identified research, reporting bias).
Conclusions 26 Provide a general interpretation of the results in the context of other evidence, and implications for future research.
Funding
Funding 27 Describe sources of funding for the systematic review and other support (e.g., supply of data); role of funders for the systematic review.
From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group. Preferred reporting items for systematic reviews and
meta-analyses: the PRISMA statement. PLoS Med 2009;6(6):e1000097. Doi:10.1371/journal.pmed1000097 For more information, visit: www.prisma‐statement.org (ultima consultazione31 gennaio 2013)
Criterio di inclusione: almeno il 75% di numeri di pagine riportati
Scala di JADAD per valutare la qualità metodologica degli RCT
From: http://www.csbonlus.org/inc/ALLEGATI/Jadad.pdf (ultima consultazione 31 gennaio 2013)
Titolo dello studio:
Assegnare 1 punto per ogni risposta positiva o 0 punti per ogni risposta negativa
1) Lo studio era descritto come randomizzato? 0
2) Lo studio era descritto come doppio cieco? 0
(solo per le sperimentazioni di farmaci)
3) Lo studio era descritto come cieco? 0
(solo per le sperimentazioni di trattamenti psicologici)
4) Era presente la descrizione dei persi al follow-up? 0
Assegnare 1 punto in più se 5) Randomizzazione appropriata 0 6) Cecità appropriata 0 Togliere 1 punto se 5) Randomizzazione inappropriata 0 6) Cecità inappropriata 0 _________________________________________________________ Punteggio totale (0-5) 0
RCT di non buona qualità <3
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CONSORT 2010 Checklist of information to include when reporting a RCT*
Section/Topic # Checklist item Reported
on page # Title and abstract
Title and abstract 1a Identification as a randomised trial in the title 1b Structured summary of trial design, methods, results, and
conclusions (for specific guidance see CONSORT for abstracts)
Introduction
Background and 2a Scientific background and explanation of rationale objectives 2b Specific objectives or hypotheses
Methods
Trial design 3a Description of trial design (such as parallel, factorial) including
allocation ratio
3b Important changes to methods after trial commencement
(such as eligibility criteria), with reasons Participants 4a Eligibility criteria for participants 4b Settings and locations where the data were collected Interventions 5 The interventions for each group with sufficient details to allow
replication, including how and when they were actually administered
Outcomes 6a Completely defined pre-specified primary and secondary
outcome measures, including how and when they were assessed
6b Any changes to trial outcomes after the trial commenced, with
reasons
Sample size 7a How sample size was determined
7b When applicable, explanation of any interim analyses and
stopping guidelines
Randomisation: 8a Method used to generate the random allocation sequence
Sequence
generation 8b Type of randomisation; details of any restriction (such as blocking and block size)
Allocation
concealment mechanism
9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned
Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions
Blinding 11a If done, who was blinded after assignment to interventions
(for example, participants, care providers, those assessing outcomes) and how
11b If relevant, description of the similarity of interventions Statistical methods 12a Statistical methods used to compare groups for primary and
secondary outcomes
12b Methods for additional analyses, such as subgroup analyses and adjusted analyses
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Section/Topic # Checklist item Reported
on page # Results Participant flow (a diagram is strongly recommended)
13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome
13b For each group, losses and exclusions after randomisation,
together with reasons
Recruitment 14a Dates defining the periods of recruitment and follow up 14b Why the trial ended or was stopped Baseline data 15 A table showing baseline demographic and clinical
characteristics for each group
Numbers analysed 16 For each group, number of participants (denominator)
included in each analysis and whether the analysis was by original assigned groups
Outcomes and
estimation 17a For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)
17b For binary outcomes, presentation of both absolute and
relative effect sizes is recommended Ancillary analyses 18 Results of any other analyses performed, including subgroup
analyses and adjusted analyses, distinguishing pre-specified from exploratory
Harms 19 All important harms or unintended effects in each group (for
specific guidance see CONSORT for harms)
Discussion
Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses
Generalisability 21 Generalisability (external validity, applicability) of the trial
findings
Interpretation 22 Interpretation consistent with results, balancing benefits and
harms, and considering other relevant evidence
Other information
Registration 23 Registration number and name of trial registry Protocol 24 Where the full trial protocol can be accessed, if available Funding 25 Sources of funding and other support (such as supply of
drugs), role of funders
*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this Checklist, see www.consort-statement.org (ultima consultazione 31 gennaio 2013).
Nota: Se un item non è riportato digitare 0 (zero)
Criterio di inclusione: almeno il 75% di numeri di pagine riportati
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TREND Statement Checklist for Non-Randomised Studies (NRS)
Titolo dello studio:
Section/Topic # Descriptor Reported
on page # Title and abstract
Title and abstract 1 Information on how unit were allocated to interventions Structured abstract recommended
Information on target population or study sample Introduction
Background 2 Scientific background and explanation of rationale Theories used in designing behavioral interventions
Methods
Participants 3 Eligibility criteria for participants, including criteria at different levels in recruitment/sampling plan (e.g., cities, clinics, subjects)
Method of recruitment (e.g., referral, self-selection), including
the sampling method if a systematic sampling plan was implemented
Recruitment setting
Settings and locations where the data were collected Interventions 4 Details of the interventions intended for each study condition
and how and when they were actually administered, specifically including:
− Content: what was given?
− Delivery method: how was the content given? − Unit of delivery: how were the subjects grouped during
delivery?
− Deliverer: who delivered the intervention? − Setting: where was the intervention delivered − Exposure quantity and duration: how many sessions or
episodes or events were intended to be delivered? How long were they intended to last?
− Time span: how long was it intended to take to deliver the
intervention to each unit?
− Activities to increase compliance or adherence (e.g.,
incentives)
Objectives 5 Specific objectives and hypotheses
Outcomes 6 Clearly defined primary and secondary outcome measures Methods used to collect data and any methods used to
enhance the quality of measurements
Information on validated instruments such as psychometric and
biometric properties
Sample size 7 How sample size was determined and, when applicable,
explanation of any interim analyses and stopping rules
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Section/Topic # Descriptor Reported
on page # Assignment Method 8 Unit of assignment (the unit being assigned to study condition,
e.g., individual, group, community)
Method used to assign units to study conditions, including details