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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 Our recent Cochrane review highlighted the existence of unpublished data (which often contains negative data) for newer oral anticoagulant drugs, which has net been assessed, and there are reports of several side effects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inhibitors and factor Xa inhibitors for atrial fibrillation: a systematic review and meta-analysis incorporating unpublished clinical study reports.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.

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Mysimba® (naltrexone-bupropion) in the management of overweight and obesity: a systematic review and meta-analysis of unpublished clinical study reports

Igho Onakpoya , Elizabeth Spencer, Beth Stuart, Jeffrey Aronson, Kamal R Mahtani, Carl Heneghan.

Lay summary 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

Lay summary 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

Lay summary 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

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

Lay summary

Protocol

 

 

3.8  Benefits and harms of pregabalin in the management of neuropathic pain: a rapid review and meta-analysis of randomized clinical trials.


 

3.9  Heneghan C, Aronson JK, Spencer E et al. Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis [version 1; referees: 2 approved]. F1000Research 2018, 7:1725

Link to publication

 

3.10 Clinical practice guidelines recommendations for the process of initiating dialysis in patients with chronic kidney disease: systematic review         

Karla Salas, Igho Onakpoya, Jorge Antonio Coronado Daza, Carl Heneghan

Protocol

 

3.11 Reduced Salt Intake for Heart Failure: A Systematic Review

Kamal R. Mahtani, Carl Heneghan, Igho Onakpoya, Stephanie Tierney, Jeffrey K. Aronson, Nia Roberts, F. D. Richard Hobbs, David Nunan.

Link to publication

Workstream Outputs

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.

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