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There is good evidence that trial reports in academic journals represent an incomplete picture of the data collected, and are an unsatisfactory source of information. Our recent Cochrane review highlighted the existence of unpublished data (which often contains negative data) for newer oral anticoagulant drugs, which has net been assessed, and there are reports of several side effects related to GLP-1 analogues and newer anti-obesity drugs that have not yet been reviewed. We are therefore planning a series of complex systematic reviews that include regulatory documents and Clinical study reports to evaluate new drugs and some technologies in widespread use where there is uncertainty about the benefit and harms profiles.

Planned Reviews

3.1 What are the benefits and harms of cholesterol lowering drugs to prevent CVD based on clinical study reports and summary of regulatory comments? (Stage 1 review)

3.2 Direct thrombin inhibitors and factor Xa inhibitors for atrial fibrillation: a systematic review and meta-analysis incorporating unpublished clinical study reports.

Kamal R. Mahtani, Carl Heneghan, Igho Onakpoya, David Nunan, Nia Roberts, Beth Stuart.

(Link to Protocol)

3.3 What are the benefits and harms of Glucagon-like peptide-1 (GLP-1) [1] analogues in the summary of regulatory comments)

3.4 Benefits and harms of Mysimba® (naltrexone-bupropion) in the management of overweight and obesity: a systematic review and meta-analysis of unpublished clinical study reports

Onakpoya I , Spencer E, Stuart B, Aronson J, Mahtani K, Heneghan C

(Link to Protocol)

3.5 What is the role of genetics in primary care?

3.5.1 Genetic profiling to inform therapeutic decisions in primary care – a qualitative meta-synthesis of barriers and enablers

Ralph Akyea, Laura Condon, Nadeem Qureshi, Lorna Duncan, Rupert Payne, Kamal R. Mahtani, Joe Kai

(Link to Protocol)

3.5.2 Genetic profiling to inform therapeutic decisions in primary care – a systematic review of relevant drugs

Lorna Duncan, Rupert Payne, Sam Merriel, Ralph Akyea, Nadeem Qureshi, Kamal R. Mahtani, Nia Roberts

(Link to Protocol)

3.6 Using pedometers and accelerometers to increase physical activity and improve health in patients with diabetes, obesity and cardiovascular disease: a systematic review and meta-analysis

Alex Hodkinson, Maria Panagioti, Evangelos Kontopantelis, Peter Bower, Harm Van Marwijk, Charles Adeniji

(Link to Protocol

Additional review outputs

3.7 Factors and variation driving inappropriate opioid analgesic prescribing in the community: a systematic review

Georgia Richards, Carl Heneghan, Kamal Mahtani, Ben Goldacre

(Link to Protocol)

 

Workstream Outputs

 

Publications

 A word about evidence: 'rapid reviews' or 'restricted reviews'?

Aronson JK, Heneghan C, Mahtani KR, Plüddemann A.

BMJ Evid Based Med. 2018 Jun 29. pii: bmjebm-2018-111025. doi: 10.1136/bmjebm-2018-111025.

 Redefining rapid reviews: a flexible framework for restricted systematic reviews.

Plüddemann A, Aronson JK, Onakpoya I, Heneghan C, Mahtani KR.

BMJ Evid Based Med. 2018 Jun 27. pii: bmjebm-2018-110990. doi: 10.1136/bmjebm-2018-110990.

 What is a 'complex systematic review'? Criteria, definition, and examples.

Mahtani KR, Jefferson T, Heneghan C, Nunan D, Aronson JK.

BMJ Evid Based Med. 2018 Aug;23(4):127-130. doi: 10.1136/bmjebm-2018-110965. Epub 2018 May 19.

 Transvaginal mesh failure: lessons for regulation of implantable devices.

Heneghan C, Aronson JK, Goldacre B, Mahtani KR, Plüddemann A, Onakpoya I.

BMJ. 2017 Dec 7;359:j5515. doi: 10.1136/bmj.j5515.

 Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process.

Heneghan CJ, Goldacre B, Onakpoya I, Aronson JK, Jefferson T, Pluddemann A, Mahtani KR.

BMJ Open. 2017 Dec 6;7(12):e017125. doi: 10.1136/bmjopen-2017-017125

 Dissemination:

 BMJ Opinion: Kamal R Mahtani, Tom Jefferson, and Carl Heneghan: What makes a systematic review “complex”? December 12, 2017