4. Collyar DE. The value of clinical trials from a patient perspective. Breast J 2000;6(5):310-
Download abstract at: http://www3.interscience.wiley.com/journal/121444134/abstract
Background
Clinical trials are essential in developing new treatments, care, and prevention for people with cancer. Unfortunately U.S. accrual rates for adult cancers are approximately 2–3%, partly due to the way the clinical trial system operates. The Clinical Trials Information Project (CTIP), a non-profit organisation established by patients and family members, has introduced a new approach through the CTIP Breast Cancer Kit.
Perceived barriers patients
- Physician attitude.
- Knowledge of clinical trials.
- Access to clinical trial care.
- Clinical procedures.
- Trial design (randomization, etc.).
- Insurance coverage.
- Informed consent.
Recommendations:
Clear information that helps people understand the value of research studies must also be presented in caring ways that reinforce the support people seek during crisis. Working together, cancer patient advocates and cancer researchers can provide this kind of useful information.
5. Lara PN, Jr, Paterniti DA, Chiechi C, Turrell C, Morain C, Horan N, Montell L, Gonzalez J, Davis S, Umutyan A, Martel CL, Gandara DR, Wun T, Beckett LA, Chen MS,Jr. Evaluation of factors affecting awareness of and willingness to participate in cancer clinical trials. J Clin Oncol 2005 Dec 20;23(36):9282-9.
Download Full text at: http://www.jco.ascopubs.org/cgi/reprint/23/36/9282
Background and aim
Annually, only 3% of patients participate in cancer clinical trials (CCTs).
Barriers to accrual include lack of CCT awareness and uncertain third-party payer coverage. In January 2002, a California law (Senate Bill 37 [SB37]) required all third-party payers to reimburse patient care costs related to CCTs. This paper evaluates the level of awareness of patients and/or their family members/friends regarding CCTs and SB37.
Findings
The results support the hypothesis that improving CCT awareness and SB37 knowledge especially among lower income, less educated, and minority patients, may potentially overcome barriers to participation and subsequently increase accrual in California.
6. Ellis P. Attitudes towards and participation in randomised clinical trials in oncology: A review of the literature. Annals of Oncology 2000;11(8):939-45.
Download Full text at: http://annonc.oxfordjournals.org/cgi/reprint/11/8/939
Aim
This article provides a broad review of the issues pertinent to physician and patient participation in randomised clinical trials.
Findings
There are a variety of physician and patient characteristics which have previously been shown to influence participation in randomised clinical trials. Additionally, ethical concerns about randomised trials in general and the additional requirements of informed consent for clinical trials, may impact on recruitment. Whilst there is some research examining strategies to improve patient understanding about clinical trials and promote patient involvement in clinical decision-making, there are deficiencies in these areas. In particular there is a paucity of research examining the association between knowledge about clinical trials, anxiety associated with a new cancer diagnosis and willingness to participate in randomised clinical trials. Further research also is needed to evaluate strategies to better inform patients about clinical trials.
7. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials A systematic review. J Clin Epidemiol 1999;52(12):1143-56.
Download at: http://linkinghub.elsevier.com/retrieve/pii/S0895435699001419
Aim
This paper gives a literature review on barriers to recruitment of clinicians and patients to randomised controlled trials.
Clinician barriers included
- Time constraints.
- Lack of staff and training.
- Worry about the impact on the doctor-patient relationship.
- Concern for patients.
- Loss of professional autonomy.
- Difficulty with the consent procedure.
- Lack of rewards and recognition.
- Insufficiently interesting question.
Patient barriers included
- Additional demands of the trial.
- Patient preferences.
- Worry caused by uncertainty.
- Concerns about information and consent.
Recommendations to overcome barriers to clinician recruitment
- The trial should address an important research question.
- The protocol and data collection should be as straightforward as possible.
- The demands on clinicians and patients should be kept to a minimum.
- Dedicated research staff may be required to support clinical staff and patients.
- The recruitment aspects of a randomised controlled trial should be carefully planned and piloted. Further work is needed to quantify the extent of problems associated with clinician and patient participation and proper evaluation is required of strategies to overcome barriers.
8. Williams B, Entwistle V, Haddow G, Wells M. Promoting research participation: Why not advertise altruism? Soc Sci Med 2008 Apr;66(7):1451-6.
Summary
Participation rates have a major impact on the quality, cost and timeliness of health research. There is growing evidence that participation rates may be falling and that new research governance structures and procedures may be increasing the likelihood of recruitment bias. It may be possible to encourage public re?ection about research participation and enhance recruitment by providing information about the potential bene?ts of research to others as well as to research participants and by stimulating debate and in?uencing social expectations about involvement. Publicly funded and charitable bodies use various forms of advertising to encourage altruistic behaviour and generate social expectations about donating money, blood and organs for the bene?t of others. Consideration should be given to the use of similar persuasive communications to promote wider participation in health research generally.
9. O’Connell D, Mosconi P. An active role for patients in clinical research? Drug Dev Res 2006;67(3):188.
Download Abstract at: http://www3.interscience.wiley.com/journal/112696822/abstract?CRETRY=1&SRETRY=0
10. Tosounidis TI, Kontakis GM. Clinical research: The patients’ perspectives. Injury 2008.
11. Kerrison S, Laws S, Cane M, Thompson A. The patient's experience of being a human subject. JRSM 2008;101(8):416.
Aim
The objective of this study was to explore the patients’ perspective on being a subject in a clinical trial. Topics discussed in this article are: informed consent, perceived benefits of participating in a clinical trial and criticisms regarding the trial.
Informed consent
The majority of patients felt that signing an informed consent form was important. It gave a sense of involvement and change of relationship with the clinician.
Benefits of taking part
Most people hoped for therapeutic advance. Other benefits mentioned were increased surveillance by doctors, the ability to obtain information and finally contribution to the scientific process was mentioned. The latter is often considered very important for involvement but this study suggests that participants often expect immediate returns.
What could have been done better?
Participants mentioned a range of inconveniences with regards to practicalities, such as late notice, and not taking in account specific needs. Study methods were also questioned by participants, in particular questionnaires were found to be badly constructed to obtain the right information. A final criticism was the lack of feedback on personal results and research results in general.
Implications for clinicians and policy makers
An important finding of this research was that participants valued the opportunity to have contact with other patients who were in the same trial. When used as a regular part of studies such contact may improve retention. Furthermore patients did not see themselves as passive research subjects but felt they made an active contribution. Some argued that the involvement of patients in the study design will improve the acceptability of questionnaires and other tests of functioning.
12. Lawton J, Fox A, Fox C, Kinmonth AL. Participating in the united kingdom prospective diabetes study (UKPDS): A qualitative study of patients' experiences. The British Journal of General Practice 2003;53(490):394.
Download the full text article at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1314601/pdf/12830569.pdf
Aim
The aim of this discussion paper is to explore patients' motivations for joining the UKPDS and for remaining in the trial.
Findings
The results showed that patients were motivated to join the UKPDS because they believed this would give them the best clinical care and reduce the threat of the disease. However, all of the patients identified unanticipated benefits of trial participation, to which they attributed their strong commitment to the UKPDS. These included the reassurance provided by regular clinical examinations, the personal nature of clinical care, and the welcome discipline imposed by UKPDS professionals. Transition back to primary care at trial closure could be a lonely experience, despite follow-up being seen as competent. Practitioners involved in recruiting patients for clinical trials should be aware that participants may be motivated by the desire for better clinical care, irrespective of randomisation consequences. Those taking back the clinical care of trial participants with chronic disease may wish to consider a 're-entry' interview, to minimise trial bereavement.
Other articles on being a research subject in clinical research; from the patient’s perspective
Donovan J.L. et al. Capturing users' experiences of participating in cancer trials, European Journal of Cancer Care (2002); 11(3), pages 210-214.
Download Abstract at: http://www3.interscience.wiley.com/journal/118957332/abstract
Aim
In this article, authors examine whether users' experiences of participating in cancer trials can be used to assist in the design or conduct of trials.
Conclusion
There are various methods to measure user’s experience. These are often in the form of questionnaire’s that aim to measure aspects of quality of life. However the proportion of cancer trials including even these structured measures is small and there are serious concerns that such measures capture only a small part of users’ experiences. Qualitative research methods may have a role in enabling user views to be collected and used to drive changes to patient information and in?uence the design and conduct of cancer trials.
Stiggelbout A. M. et al. A role for the sick role - Patient preferences regarding information and participation in clinical decision-making, Canadian Medical Association; (1997); 157: pages 383-389.
Download Full text at: http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=9275945
Aim
To assess whether patient preferences regarding information and participation in decision-making about treatment options are related to patient characteristics and the context of the decision.
Conclusion
The lack of strong predictors of a preferred decision-making role implies that clinicians need to assess every patient individually to determine what role he or she prefers. The finding that the patients preferred a more passive role than their companions suggests that the "sick role" influences the preference regarding participation more strongly than the type of decision to be made or the presence of a life-threatening disease. This hypothesized shift in preference among subjects who are sick implies that these patients need encouragement to participate.
Aymé S, Kole A, Groft S. Empowerment of patients: Lessons from the rare diseases community. The Lancet 2008;371(9629):2048-51.
Background
Patient empowerment is a necessity for patients with rare diseases. Because they are ignored by the medical community. In developed countries the first patient organisations were set up in the 1950s. Patient participation is a trend of the last years. Patients participate in the decision-making process through advocacy groups. This is because: This participation requires a sense of community, an organisation capacity, and collective actions. In the US umbrella organisation: National Organization for Rare Disorders (NORD) and the Genetic Alliance are very effective in changing the political agenda. In Europe 1673 organisations are federated by the European Organisation for Rare Diseases ( EURODIS).
This article furthermore gives a good overview of many other patient organisations and how they have influenced awareness, policy making and research. Amongst organisations that have collaborated in research are: Muscular Dystrophy Association, European Research Network for Alternating Hemiplegia and International Prader Willi Syndrome Organization (IPWSO).
Website EURORDIS: http://www.eurordis.org
Website NORD: http://www.rarediseases.org
Baggot R. & Forster R, Health consumer and patients’ organizations in Europe: towards a comparative analysis, Health expectations (2007), 11; pages 85–94
Download Abstract at: http://www.ncbi.nlm.nih.gov/pubmed/18275405
Aim
The workshop reviewed the development of HCPOs in Europe and their role in the policy process in order to establish a platform for further research in this field. In this workshop 22 delegates from 10 European Countries were present.
Findings
It found evidence of an increase in HCPOs across European countries, increased engagement with policy makers and political institutions, and the creation of alliance organizations bringing together HCPOs across the sector. However, variations between countries were observed, relating to different political, cultural and health system contexts. There was no consensus on whether the rise of HCPOs constituted a new social movement. An increase in HCPO activity at the pan-European level was noted, reflecting the increased interest of EU institutions in health policy.
At both domestic and European levels, concerns about the representativeness and legitimacy of HCPOs were raised as well as questions about their independence (notably with regard to the drugs industry). HCPOs face a number of obstacles including: lack of capacity and resources, fragmentation and the power of more established interests within the health-care system. The workshop concluded that further research is needed in this field, in the form of a comparative study of HCPOs in European countries and an analysis of their activities at the pan-European level.