ASK QUESTIONS

"Four questions to which readers want answers when reading reports of research:

Why did you start?

What did you do?

What answer did you get?

And what does it mean anyway?"

[Austin Bradford Hill 1965]

Ask the following questions when reading media reports of treatment 'breakthroughs':

• Are the findings preliminary or inconclusive?

• Do the findings differ markedly from previous studies?

• Do these findings appear to contradict mainstream scientific opinion?

• Are these findings based on small or unrepresentative samples?

• Do these conclusions generalise to humans from animal studies?*

From 'Guidelines on Science & Health Communication', Social Issues Research Centre

Click link to SIRC in right panel for full text.

* If the media have based their report on primary animal research (many such reports do) then questions to ask are: What evidence is there for making such claims? What systematic reviews of the animal studies have been carried out? Which journal has the newspaper used as a resource for it's report. Is the report based solely on data from animal studies? Has the research been carried out prior to, alongside or after the human studies? Has the research been duplicated elsewhere? Are the experimental designs of the animal studies scientifically sound in the first place?

Write letters to newspapers, journals and any other relevant sources asking them to provide you with answers to these questions. Many false hopes are raised from poor reporting based on animal studies. Animal research is intended to inform human research and clinical researchers should ask the key question 'Does the animal research have relevance for human medicine'. The public can and should address these same questions to medical research charities before offering donations. Ask what their policy is on animal research and if they seek evidence from systematic reviews of animal studies before funding animal research.

GET INVOLVED IN RESEARCH

You may have a medical condition that is not being treated in the way you would like it to be or you are worried that there is no effective treatment. You may feel that the treatment you are offered is inadequate or irrelevant or it does not tackle the symptoms you experience, or maybe the treatment only tackles symptoms when you really want a cure. If you would like to get actively involved in the search for treatments that are more relevant to people's needs and concerns, more reliable, more effective and safer then join the search for better treatments by becoming actively involved in research. Identify questions about the effects of treatments that are important to you. Use the National Library for Health (www.library.nhs.uk) to see if there is reliable information from the up-to-date systematic reviews.

If you can’t find the information you need, ask NHS Direct to help you (www.nhsdirect.nhs.uk); Tel 0845 46 47 (England and Wales); 0845 24 24 24 (Scotland). Their experts may be able to find it for you. If there is no reliable information to answer your question, ask NHS Direct whether anyone is currently preparing a systematic review of existing evidence, or whether there are any potentially relevant ongoing controlled trials.

RESEARCH VOLUNTEERS

If there is a relevant ongoing trial, consult www.controlled-trials.com or the specific trial website to see if you may wish to participate in it, and with whom you can discuss your options.

Agree to participate in a clinical trial only on condition (i) that the study protocol has been registered publicly on www.controlled-trials.com; (ii) that the protocol refers to the systematic reviews of existing evidence showing that the trial is justified; and (iii) that you receive written assurance that the full study results will be published and sent to all participants who indicate that they wish to receive them. N.B. In PHASE 1 clinical research trials volunteers should also ask to see evidence of risk and safety from the relevant animal studies. Detailed information about the animal studies used to assess the clinical research should be included in the research protocol which should be made available to all Phase 1 volunteers participating in research. The design of the relevant animal studies should be experimentally sound and the results systematically reviewed and set in context to other relevant animal and human research. If these requirements are not evident or not available to you then DO NOT PARTICIPATE and report the trial to the MHRA and or Controlled Clinical Trials and the Clinical Trials Unit.

WHAT TO DO IF YOU CANNOT FIND ANSWERS

If no-one seems to be taking an interest in your inadequately answered questions about the effects of treatments, submit them for consideration to the NHS Health Technology Assessment (HTA) Programme (www.ncchta.org), the National Institute for Health and Clinical Excellence (NICE). Learn to recognise uncertainty; ask questions; seek honest answers.Let your doctors know if you want to discuss evidence on the effects of treatments, and what uncertainties there are about them. You may find the information at www.ohri.ca/DecisionAid helpful. Encourage wider education about the effects of biases and the play of chance, and lobby your MP and others about including this in the curriculum, beginning at primary school. Be a healthy sceptic about unfounded claims and media reports of treatment ‘breakthroughs’; ask pertinent questions; discuss with your friends. Challenge treatments offered to you or your family on the basis of beliefs and dogmas, but unsubstantiated by reliable evidence. Encourage and work with doctors, researchers, research funders, and others who are trying to promote research addressing inadequately answered questions about the effects of treatment which you regard as important. See James Lind Alliance.

ADDITIONAL RESOURCES

James Lind Library

www.jameslindlibrary.org

James Lind Alliance

Promotes working partnerships between patients and clinicians to identify and prioritise important uncertainties about the effects of treatments

www.lindalliance.org

Database of Uncertainties about the Effects of Treatments (DUETs): A resource to help prioritise new research

www.duets.nhs.uk

MRC Clinical Trials Unit

www.ctu.mrc.ac.uk/Trialinfo.asp

NHS National Library for Health

 www.library.nhs.uk/trials

UK Clinical Research Collaboration

A guide – Understanding Clinical Trials – is available at www.ukcrc.org

Critical Appraisal Skills Programme

Organises workshops and provides online and other resources to help individuals to develop the skills to find and make sense of research evidence

www.phru.nhs/casp/casp.htm

Clinical Evidence

An online publication from the BMJ Publishing Group wich can be accessed free of charge in England, Wales and Scotland through the National Library of Health at

www.library.nhs.uk

The Cochrane Library

An online resource which includes The Cochrane Database of Systematic Reviews. It can be accessed free of charge throughout the British Isles at

www.thecochranelibrary.com

Informed Health Online

And evidence-based website for consumers, produced in English and German by the German Institute for Quality and Efficiency in Health Care

www.informedhealthonline.org

Cochrane Consumer Network

Promotes patient input to systematic reviews of treatments prepared by The Cochrane Collaboration www.cochrane.org/consumers/homepage.htm

NHS Health Technology Assessment Programme

Actively involves service-users in all stages of its work.

www.ncchta.org/consumers/index.htm

UK Clinical Research Network

Keen to involve patients in prioritising and helping to design clinical trial

www.ukcrn.org.uk

Current Controlled Trials

An open-access meta-register containing information about ongoing controlled trials

www.controlled-trials.com

INVOLVE (formerly Consumers in NHS Research)

Promotes public involvement in research in health and social care

www.invo.org.uk

Adapted from the book:

‘TESTING TREATMENTS: BETTER RESEARCH FOR BETTER HEALTHCARE’ by Imogen Evans, Hazel Thornton & Iain Chalmers