Summary of Findings tables

Transcription

1 Cochrane Pain, Palliative & Supportive Care Review Group Pain Research Unit The Churchill Hospital Headington, Oxford, OX3 7LE, UK Tel: +44 (0) Fax: +44 (0) PaPaS Summary of Findings tables for Pain, Palliative, Supportive Care (PaPaS) Review Group A Summary of findings (SoF) table is intended to provide key information concerning quality of, magnitude of of s examined, sum of available data on all important s for a given comparison in a Cochrane (or or) review. SoF tables are typically constructed to satisfy s a limited in a large population, predominantly in prophylactic rapy settings in which re is a generalised initial risk for population, but whereby no means all would suffer out treatment (aspirin or statin to prevent heart attack would be examples). Pain, palliative, supportive care are different, because in almost all circumstances every single patient has a problem initially (, for example), rapy removes or at least decreases in some who are treated; initial risk is one in one, or 100%. Moreover, developments in understing what patients want from treatment, what clinical trials tell us, has moved decisively towards a description of response where response is variably described, but usually a major change in an like brings it concomitant improvements in or areas, like sleep, fatigue, depression, functioning, quality of life. The hbook advises that we consider GRADE system, GRADEpro for production of Summary of Findings Tables. We are working GRADE working Group on an innovations fund project in 2012 to 2013 to consider how GRADE can evolve to take account of many of issues pertinent to PaPaS reviews. We recognize that Methodological expectations of Cochrane Intervention Reviews (MECIR) process is also reviewing all aspects of methods guidance, is likely to influence future PaPaS stards. In meantime, we recognize importance of SoF have developed outline tables that capture essence of communicating complex results readily by focussing on important s of benefit harm. Version Control This is version 1.0 of this document was agreed as correct on September 1 st It is scheduled for review in August Version Last updated January 2012

2 Summary of findings table - proforma Patients or population: Setting: Intervention: Comparison: At least 50% At least 30% Proportion below 30/100 mm on VAS Patient global impression very good life measure event drawals Serious adverse Death Note that not all se s may be available in every review. For some reviews, where an may have been tested in different ful, it may be appropriate for one or more efficacy s to be presented for each condition. Version Last updated January 2012

3 Assessing quality of across studies for an (notes) Systematic reviews typically assess quality validity according to individual studies. For summary of findings table, an assessment of overall quality is required for each chosen for inclusion in summary of findings table. This aide memoir is designed to help in making those assessments. The table is limited to seven s for one comparison, but can be changed in terms of number of s number of comparisons, consistent requirements of Cochrane Review Group (CRG). The following notes are intended to help guide completion of form. Notes: 1. studies : number reporting particular s is likely to vary. Results from only a limited number of studies might tend to be more subject to bias. 2. : an event is a beneficial or harmful in one patient; fewer than 50, rom-s can be very high, over 200 rom-s will be limited. 3. Quality score: studies an Oxford Quality Score of 3/5 or above have been shown to be unbiased. The score includes items describing romisation, blinding drawal, ir appropriateness. Where all studies have scores of three or more, likelihood of bias is minimal. 4. Appropriate study duration: chronic studies are known to demonstrate less efficacy over longer periods. Studies of two weeks or less are likely to confer bias; this will be less in those of two to six weeks, minimal in those of eight weeks or more. In or circumstances authors will need to be sure that s are reported appropriately for acute migraine, for example, are adverse collected over 10 days for an acute attack relevant appropriate? 5. Imputation method appropriate: this section includes issues over intention to treat (ITT), how missing data points are dealt. Completer analyses are not ITT, tend to overestimate treatment s. Last observation carried forward (LOCF) produces more favourable results than baseline observation carried forward (BOCF). Might se be factors for any? 6. Potential threat from publication bias: this is a function of size magnitude of result for any. Have you performed a publication bias threat for (see Guidelines on Reviews in Pain document)? 7. Or limitations: are re any or limitations affecting for? 8. Overall assessment of quality of : here you have to make an overall assessment, based on questions already answered. For simplicity please use high, medium, or low. Version Last updated January 2012

4 Assessing quality of across studies for an (table) Comparison: Quality assessment (please complete for each individual ) studies Quality score (3/5 or more on Oxford Scale) Appropriate study duration Imputation methods appropriate Potential threat from publication bias Or limitations Overall assessment of quality of

5 Summary of findings table pregabalin chronic example Patients or population: Posrpetic neuralgia moderate or severe Setting: Outpatient Intervention: Pregabalin 600 mg daily Comparison: placebo At least 50% At least 30% Proportion below 30/100 mm on VAS Patient global impression much or very much improved life measure event drawals Serious adverse Death 410 in in (3.1 to 5.1) 620 in in (2.2 to 3.2) No data Inadequate data No data 190 in in 1000 Risk ratio 3.7 (2.3 to 6.0) 37 in in 1000 Risk ratio 1.2 (0.7 to 1.8) No data for deaths Note LOCF imputation method probably overestimates efficacy Note LOCF imputation method probably overestimates efficacy All combined Note that not all se s may be available in every review. For some reviews, where an may have been tested in different ful, it may be appropriate for one or more efficacy s to be presented for each condition.

6 Summary of findings table aspirin for acute migraine example Patients or population: Migraine (IHS), moderate to severe intensity, adults Setting: Outpatient Intervention: Aspirin 900/1000 mg Comparison: Placebo Pain-free at 2 h Headache relief at 2 h Sustained -free at 24 h Sustained headache relief at 24 h Relief of associated symptoms at 2 h (nausea) Use of rescue medication in 24 h At least one AE AE drawals 240 in in (6.4 to 11) 520 in in (4.1 to 6.2) No data 390 in in (4.9 to 10) 560 in in (5.6 to 22) 420 in in 1000 p 4.8 (3.9 to 6.0) 120 in in 1000 NNH 34 (18 to 340) Insufficient data - uncommon 6 studies, studies, studies, studies, studies, studies, Moderate?

7 Summary of findings table ibuprofen in acute example Patients or population: Acute postoperative Setting: In patient/out patient Intervention: Ibuprofen 400 mg, oral Comparison: Placebo At least 50% over 4 to 6 h Use of rescue medication in 6 h Median time to use of rescue medication (h) event drawals Serious adverse Death 540 in in (2.4 to 2.6) 42 in in 1000 p 2.7 (2.5 to 3.0) Not calculated 170 in in 1000 RR 0.92 (0.82 to 1.04) Inadequate data - uncommon Inadequate data - uncommon None 61 studies, studies, studies, studies, Moderate. s significantly better for dental. significantly better for. Data mostly over 4 to 8 h Note that not all se s may be available in every review. For some reviews, where an may have been tested in different ful, it may be appropriate for one or more efficacy s to be presented for each condition.