Category: Primary care

Beg, steel or borrow: getting physicians to recruit patients in clinical trials

Leaflets, adverts and phone calls have all been used to recruit patients in clinical trials with some results. Still, the personal contact remains the most reliable method, if you can get the recruiter to do it. In this post, I explore some of the barriers of clinicians’ recruitment activity in randomised controlled trials.

Lack of time, specialist staff and patient motivation are the most frequently reported barriers that prevent clinicians to recruit their patients into clinical trials. Even though the physician signs up for the study and is informed about what is involved, they often do not complete the job. Some are distracted by competing clinical priorities, while others cannot get a positive answer from their patients. Regardless of the reason, the research suffers because of low participation numbers and prolonged study set-up.
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Researchers from the University Of Birmingham, UK, looked at all ways that improve the clinicians’ recruitment activity. Their systematic reviewof scientific literature compared the impact of different recruitment strategies and underlying clinician attitudes. To recruit successfully, the clinicians should be incentivised or supported in some way. Unfortunately, many researchers use supports that don’t work. What’s more worrying is that nobody knows how to boost clinicians’ recruitment rates. The study authors recommend that each clinical trial uses qualitative methods to ask clinicians what would work for them and use their suggestions. Another issue was what clinicians think of clinical trials. Misconceptions about trials methods still prevail and clinicians do not see the positives of trials; nor do their patients. Improved education and communication from researchers to physicians can overcome these issues.

Paying research participants for taking part can increase the number of people who agree to take part in the study, the so-called consent rate. It has become a norm in the Western world studies. Still, some studies and countries are unable to provide financial incentives to patients who volunteer for research. Direct payments may also be viewed as introducing unwanted bias into research results. Some may think that people who get paid for research would not participate if they did not get anything. Human motivation is a mysterious subject and money is part of it. It is the currency of modern society.

Is it ethical?

The healing relationship between the patient and doctor can be viewed as unsuitable for recruiting patients into clinical trials. Patients may feel obliged to agree, without making a fully informed decision. Ideally, the recruitment should be done by someone who isn’t involved in patients’ care; however, this is often not feasible in the real life. On one hand, the participants should make an informed decision about their participation and decide voluntarily. On the other hand, the researchers should not surprise patients who attend medical services for non-research purposes. The way to overcome this problem is through a two-stage recruitment process, as used in our study. The first step is to give information. The care provider gives a leaflet with information about the study to potential participants. The person goes home and reads the leaflet at their leisure. When they come to see their doctor next time, they can ask questions about the study, and decide to take, or not to take, part in the study.

Recruitment to randomised trials will probably always remain an issue for science. With an open mind, the investigators and clinicians can seek better solutions for creating trials that would attract human participants and help advance science for the benefit of all.

Cited articles:
Ben Fletcher, Adrian Gheorghe, David Moore, Sue Wilson, Sarah Damery: Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open 2012;2:1 e000496 doi:10.1136/bmjopen-2011-000496

Klimas J, Anderson R, Bourke M, Bury G, Field CA, Kaner E, Keane R, Keenan E, Meagher D, Murphy B, O’Gorman CSM, O’Toole TP, Saunders J, Smyth BP, Dunne C, Cullen W: Psychosocial Interventions for Alcohol Use Among Problem Drug Users: Protocol for a Feasibility Study in Primary Care. JMIR Res Protocols 2013;2(2):e26
doi: 10.2196/resprot.2678

AUDGPI 2014: Addiction research at the 17th Annual Scientific Meeting of the Association of Departments of General Practice in Ireland

What is the role of primary care in addiction treatment? How can be addiction treatment better integrated in the general medical settings? These and other puzzles were discussed during the addiction talks at the meeting of the primary care academics in Ireland. University College Cork hosted this year’s meeting attended by approximately 80 delegates.


The drug-related research was scattered in the 12 parallel sessions from 10.30-16.30, one of which was specifically focused on drugs in primary care. North Dublin City general practices (GP) training presented two decades of experiences with GP placements in Dublin low-threshold services for people without home or with addiction (see www.primarycaresafetynet.ie). Students in the final year of 4-year GP training benefited from the experiences greatly; it was different though. They provided mainly social medicine and had to adjust to a different culture of people living on the brink of our society. To prevent burnout and emotional detachment, the administrators introduced Mindfulness for trainees.

From the same environment, a survey followed-up physical and mental health of people without home in 1997, 2005 and again in 2013. The situation of mental disorders hasn’t changed – it remains bleak, but the baseline data is important for service organisation and delivery. The study now compares Dublin and Limerick.

Among the 39 conference posters, addiction was represented by my poster was (no 15) shown in Figure 2.

Figure 2 Poster by Klimas et al (Cork, March 7, 2014)
Research priorities of general practitioners were explored by the PRIMary healthcarE research group at University of Limerick. They organised a novel World café – a self-facilitated focus group with coffee for participants – 4 key questions prepared by organizers (www.theworldcafe.com). Music & flowers on the tables helped to break ice. Tablecloths served as writing paper. The researchers took the tablecloths with them and put participants’ notes in the computer; Visio programme facilitated mind maps. The doctors and community members prioritized the bigger picture: they wanted more accessible and responsive primary care.

The drugs-focused parallel session brought 3 presentations from Galway, Limerick and Dublin. Field et al., studied the management of problem alcohol use among problem drug users in primary care; Henderson et al., analysed key performance indicators for mental health and substance use disorders, and Whiston et al., pilot-tested brief interventions for illicit drug and alcohol use in methadone-maintained patients in 4 methadone maintenance treatment clinics in Dublin.

Irish Network of Medical Educators (#INMED2014): The 7th Annual Scientific Meeting

A network of volunteers for all interested in medical education on the island of Ireland met in Belfast yesterday. The network’s aim is to improve education. Network’s vision:

“The Network seeks to enhance medical education on the island of Ireland by bringing together individuals and organisations with an interest in and responsibilities in medical and healthcare education in a National Medical Education Network.”

The 2014 conference theme was creating supportive learning environments. See figure 1 below.

This year, the programme extended over two half-days and a full day between them.
The Wednesday half day offered five pre-conference workshops: Maximising clinical education opportunities, Researching clinical workplaces, Identifying trainees in difficulty, Overcoming obstacles to reflective practice, and Mixed methods research. As of Tuesday, February 18 (8am), there were 152 names on the delegate list. Of those, 7 were marked as judges, 4 as chairs, and 4 as chair/judge – a transparent practice rather unusual at conferences.

Thursday was the main day of the conference. It started with the usual welcomes and opening addresses in a packed room. In fact, delegates who came late stood in the back of the room, because there were no free seats left.

Two keynotes attracted most delegates, Prof Billet from Australia and Prof McAvoy from Britain. Prof Billet’s lecture was pre-recorded and projected on a large screen, because he was in Geneva at the time of conference. He explained meaning of important education terms, such as curriculum or apprenticeship. In simple words, he talked about learning by doing, but his theory-heavy talk with big words was difficult to follow in some places, as reported by delegates. The organizers helped the audience by pausing the video, interacting with the audience, and letting 20 seconds of silence for free-flow thinking

Doctors in difficulty and the re-mediators were discussed by Prof McAvoy (shown in Figure 2). Her talk reminded us that doctors are people too. Most are motivated, they’re not burned out. The reasons for their underperformance are subject of McAvoy’s research: professional, personal, physical health (e.g., high blood pressure), or mental health problems; the group identified 18% of cognitive problems among doctors, and in one case recommended psychiatric assessment which ended doctor’s career. Comprehensive assessment of underperforming doctors is critical – if you’re not getting the diagnosis right, the treatment won’t be effective. Following the assessment, absolute clarity of feedback is paramount for performance improvement.

Figure 2. Professor McAvoy

An hour and a half before the lunch, the delegates viewed 77 research and education posters. Judges assessed the posters allowing 3 minutes for presenters’ speech plus a couple of question.

Lunchtime provided opportunities for meeting the experts. After lunch, the delegates scattered into 5 workshops: i. student narratives (n= 6), ii. clinical ethics (n= 15), iii. emotional intelligence (n= 12), iv. organizational culture (n= 13), and v. emotions (n= 16). The numbers of delegates who attended workshops but did not put their names on the list are not included. Students led the mental health session from 4-5PM. The day finished with traditional AGM, drinks and dinner.

Friday half day concluded the conference with four sessions including research presentations, keynote speech by Prof Dornan from Netherlands, and hot topics in medical education. Read more about the conference here: www.inmed.ie

The mystery of change (-ing others): article in the Irish Psychologist

How may I help you– change you?* 

“Change is the Law of Life. And those who look only to the past or present are certain to miss the future.” – John F. Kennedy


Trying to help somebody to change their bad habits is an admirable act of kindness. It shows our compassion and care for the less fortunate. The best is when it comes from the person’s own initiative. Motivated helpers are assumed to be good helpers. Some of us help others pro bono, while others do it as part of their job description. But what if the professional helper doesn’t want to help? How do you help the helper with change in others?

Encouraging professional helpers to address excessive drinking is a complex problem. It’s so complex and resistant to change, that their unwillingness to adopt these new practices can be viewed as a bad habit. Many experts called for complex strategies to persuade their clinician colleagues to address alcohol. But complex strategies did not help.
Professors Anderson, Laurant, Kaner, Wensing and Grol reviewed available scientific evidence and claimed it was possible to increase the engagement of doctors in screening and advice-giving for excessive drinking. They saw a potential in programs which were specifically focussed on alcohol and that were multi-component. Later, some of the original team tested this theory by doing a clinical trial, which is a type of study considered as a golden-standard by many experts. Their Swedish experiment “failed to show an effect and proved difficult to implement”. Are the Swedish too stubborn to embrace change? Let’s not be harsh by accepting this cultural stereotype as a plausible explanation for their negative findings, before we look at more perplexing findings from other countries.
When scientists ask doctors and other professional helpers about what’s so difficult in talking alcohol with their patients, they give the same reasons all over the world. The World Health Organisation (WHO) commissioned a multi-state study, at the beginning of the millennium, which documented all of these reasons – the myths about alcohol care. The myths were lack of time, inadequate training, a view that alcohol is not a matter that needs to be addressed by medical doctors, conviction that doctors’ advice won’t work and fear of talking about such sensitive issue. It seems that the next twist in the story of change brings us to helpers’ beliefs.
Recent research at the University of Michigan, cardiovascular centre demonstrated how doctors’ confidence in their ability to advise patients on diet and exercise correspond with their own personal health and fitness levels. Could this apply to alcohol too? Would it help if we use some evidence-based strategy to boost their confidence or ambivalence about drinking behaviours?
Motivational enhancement therapy (MET) is an evidence-based treatment which targets person’s ambivalence about unwanted behaviours including their attitudes and beliefs. A team supervised by Professors Hettema and Sorensen used this Swiss-army knife of addiction counselling to help doctors-to-be to resolve their ambivalence around managing alcohol and drug problems. They’ve put a group of nine medical residents through a brief MET therapy before they learned more about alcohol consulting and advice-giving. Five weeks later, their consulting and advice-giving went up, but due to the small numbers, the researchers called for caution with interpretation of their results.
Resident education was combined with a team-based approach to systems change in the Richmond clinic – a busy family practice in the south-east Portland, Oregon. Dr Muench led his team to change the way they deal with drinking issues – from receptionists, through medical assistants to physicians.
Dr Muench is a slim, middle-aged physician with a passion for teaching young doctors and helping patients from difficult backgrounds. Explaining their approach to practice change, he points out, ‘we’ve strengthened our practice systems, but the system leaks at three points. They are at the front desk, in the consultation room and in the teaching modules.’ In making these comments, Dr Muench argues that while their project led to many improvements, there are things that can be improved. Ultimately, Muench conveys a positive message about systems change being possible, although not without some obstacles. In the Richmond team-based approach, the receptionists should give patients alcohol check-ups while they wait for the consultation, but they often forget because the PC fails to remind them of this. When the receptionist doesn’t forget to hand out the form, and the patient brings it to a medical assistant, she frequently forgets to complete the full assessment. It is no surprise then that the next ‘cog in the machine’ – the doctors – ‘forget’ to discuss alcohol with patients.
What science tells us about implementing change is reassuringly similar to the traditional knowledge of common folk. If you can’t change others, change yourself. “We must become the change we want to see”, said Gandhi. Richmond truly became the change they wanted to see in others. And yet, the project’s 75% yardstick of engaging patients into alcohol discussions wasn’t met. Why was Richmond below targets? Embracing change in healthcare requires system changes and education on several levels – multi-level changes.

*This is a shortened version of my article published in the Irish Psychologist, Volume 40, Issue 2/3. Dennis McCarty, PhD gave me feedback on drafts of this blog post.

Citation for the full version of this article:

Klimas, J. (2013). The mystery of change(ing) others. Irish Psychologist, 40(2-3), 78-79. http://www.psihq.ie/irish-psychologist-journal-of-psychology

Recruitment shock

3.6% response rate? Shocking! For our new feasibility study, we sent over 200 invitations to primary care doctors in Ireland and the invitees sent us back a very strong signal. “We are not interested”, or “we are too busy”, or “we don’t have enough eligible patients”? Whatever the reason, the message remained the same: No, thanks.

The primary objective of our study, as for most feasibility studies, is to estimate numbers needed for a definitive trial. We want to know how many people should be invited into the study; of those, how many should be randomized; of those, how many will stay until the end. Right from the beginning, we were faced with a question whether we can recruit enough people for a fully-powered experiment.

Statistical power

Power in research experiments is about finding the truth. Experimenters want to know whether their drugs or treatments work. If the drug or treatment works and they give it to a group of people, some of them will improve, some won’t. There’s a lot of chance and uncertainty in any drug or treatment administration. If we want to know the truth beyond the effects of chance, we need to give the drug or treatment to the right number of people. There’s a formula for it, known to most statisticians. It depends on many things, like the size of the improvement that you want to observe in the treated group, or other confounding factors. The higher power in a study, the more likely it says true (see, e.g., Dr Paul D Ellis’, PhD site here).
A rule of thumb says that the more people are in the study, the higher the chances of finding a meaningful impact of the intervention. Common sense also tells us that the more people in the trial, the more representative they are of the whole population – the more confidence you can be that your results apply to all; except for Martians – unless you really want to study Martian citizenship.

Solution

The easiest would be to call some friends, doctors, and ask for a favor. This should work, but it’s not really scientific. Or you can shut down the study and conclude that it’s not feasible. Or you can do the study with the small number of interested participants. Or you can send another mailshot, a reminder, to all – sometimes that can help.