Workstream 3: Assessing new drugs and technologies in chronic disease patients using unpublished data sources

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 Our recent Cochrane review highlighted the existence of unpublished data (which often contains negative data) for newer oral anticoagulant drugs, which has net been assessed, and there are reports of several side effects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inhibitors and factor Xa inhibitors for atrial fibrillation: a systematic review and meta-analysis incorporating unpublished clinical study reports.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Mysimba® (naltrexone-bupropion) in the management of overweight and obesity: a systematic review and meta-analysis of unpublished clinical study reports Igho Onakpoya , Elizabeth Spencer, Beth Stuart, Jeffrey Aronson, Kamal R Mahtani, Carl Heneghan.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 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 Lay summary	Protocol 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
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 Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis Heneghan C, Aronson JK, Spencer E et al. h 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
Additional reviews
Optimising a whole-person-centred approach to stopping medicines in older people with multimorbidity and polypharmacy: a realist review within the tailor medication syntheses Geoff Wong, Kamal Mahtani, Amadea Turk, Joanne Reeve, Emma Wallace, Elizabeth Mitchell, Daniel Lasserson, Tom Walley, Edward Ranson, Tom Fahey, Richard Byng, Nia Roberts, Dee Mangin, Janet Krska Link to publication		Protocol