Category: HRB

Reducing drinking in illicit drug users: an impact story @COMETinitiative

Research impact is often hard to prove. It takes years before our findings change the world and the change is often small.  This new abstract published in the Trials journal summarizes a poster presentation from the conference of the Core Outcome Measures in Trials (COMET) Initiative.  This year the conference was in Calgary, Canada, on May 20-21.


One out of three people who receive methadone in primary care drink in excess of the recommended limits. This poses significant risk to their health, especially to their liver; it complicates their care and increases risk of relapse.  
We wanted to inform addiction treatment in primary care with respect to psychosocial interventions to reduce drinking in concurrent problem alcohol and illicit drug users, by: exploring the experience of (and evidence for) psychosocial interventions, developing and evaluating a complex intervention to improve implementation. Evaluation of the intervention tested core feasibility and acceptability outcomes for patients and providers.  
Our Cochrane review found only four studies. Having inconclusive evidence, we interviewed 28 patients, 38 physicians and nurses. Patient interviews informed development of a national clinical practice guideline, as well as design and outcomes of the evaluation project. Feasibility outcome measures included recruitment, retention, completion and follow-up rates, as well as satisfaction with the intervention. Secondary outcome was proportion of patients with problem alcohol use at the follow up, as measured by Alcohol Use Disorders Identification Test.  
Information from the Cochrane review and the qualitative interviews informed an expert panel consultation which developed clinical guidelines for primary care.  The guideline became part of a complex intervention to support the uptake of psychosocial interventions by family physicians; the intervention is currently evaluated in a pilot controlled trial. Two new alcohol education programmes were created as a response of the community to the problem and a lack of specialist support services for patients with dual dependencies. Both Coolmine Therapeutic Community and the Community Response Agency run a 10-week group that specifically seeks to include people with dual dependencies, from methadone programmes. 

Cite this article as: Klimas et al.: Reducing drinking in concurrent
problem alcohol and illicit drug users: an impact story. Trials 2015
16(Suppl 3):P11. doi:10.1186/1745-6215-16-S3-P11

Black fish: how whales and researchers form groups

The eight of us met on Monday, December 2 for a second attempt to create a research group in primary care at University of Limerick. Our discussions brought us to whales and we found ourselves surprised about how they form groups – similar to ours.
Whales form natural groups and families. If you put them together in captivity and expect them to act as a group, they won’t. It’s not natural. What we learned from today’s meeting of the primary mental healthcare research group is that researchers are not so different than whales. If you put them together in a room and expect them to act as a team, they won’t. Social psychology teaches us that people need to have a vision to identify with. Group cohesion can be strengthened by promoting common goals, something that all can identify with. Organizers of the st patrick’s parade in Belfast know it well. They give a tricolored ribbon to all paraders. The ribbon makes them feel part of the parade.
After brief introductions of group members and a lunch with our PI, we went on with finding out how we can help to improve primary care. Our key research question: “what is the role of primary care in managing mental and substance use disorders?” is addressed by the current projects:

Towards early intervention for youth mental health in primary care: a mixed methods study from two perspectives
PINTA – Psychosocial interventions for problem alcohol use among problem drug users: controlled feasibility study in primary care
SPIRIT – Supporting practice integration with research and integration with information technology
EMMES – Establishing minimum medical education support standards
OPTIMIST – Towards optimum mental disorders treatment: a mixed methods study in general practice

For these questions, we use key methodological approaches:
  • Health services research
  • Epidemiology
  • Qualitative and mixed methods
  • Systematic and non-systematic reviews of literature
  • Training and education

Researching primary health in worsening economic situation is becoming increasingly difficult. Through pooling our resources we can make it easier and more effective.

Interested in knowing more about how whales form groups in nature compared to captivity?
check out:

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.


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.

Fidelity questions

Clinical trials use elaborate methods to make sure that everybody does the exact thing as they planned. Measuring treatment fidelity is checking the agreement between study plan and practice. Some health problems require complex changes. How to measure fidelity in trials of complex interventions? Here are some ideas for fidelity checking.

The National Institutes of Health established a workgroup for treatment fidelity, as part of their behaviour change consortium (1999). They surveyed each centre in the consortium to find out which fidelity measures they use in trials. The workgroup recommendations span five areas: study design, training providers, delivery of treatment, receipt of treatment and enactment of treatment skills. They are useful for investigators who want to measure and improve their treatment fidelity. The key areas for our study are design, training, delivery and receipt.

Fidelity in our PINTA study

Our feasibility study has several aims. The first is to estimate parameters for a fully powered clinical trial. Secondly, we also want to know whether our intervention works. As a complex intervention, it targets multiple levels – doctor and patient level. We hope to improve doctors’ practices and patients’ health behaviour. Intervention fidelity in a multi-level study means adhering to different guidelines and processes. Our trainers must deliver uniform training to all learners groups. The doctors must provide consistent interventions to all patients in the intervention group.

Availability of personal portable audio recorders, e.g. smartphones, provides new and exciting opportunities for fidelity checking, but it raises some ethical issues. Doctors and other interventionists can easily record their consultations with patients and email them to researchers for fidelity checking, but email is not safe.

To avoid the potential confidentiality breach, the researchers can ring the doctors, give them a one-sentence brief and ask them what would they respond should this patient appear in their next appointment. Recording such phone calls is not a technical or ethical problem; it is not without limitations, though. Telephonic consultation with researcher in the role of patient does not reflect real life consultations and, as such, cannot be an accurate skills check. Doctors may not want to be called and recorded for quality assurance purposes, even if it’s anonymous and does not affect their income or professional standing.

When designing measures to improve treatment fidelity in our study, we have to consider how they will be perceived by our participants and providers. These are the strategies for monitoring and improving treatment fidelity that we plan to use:


  • Guidelines for primary care providers to manage problem alcohol use among problem drug users
  • Scripted curriculum for the group training of providers


  • Booster session (practice visits) to prevent drift in provider skills
  • Access of providers to research staff for questions about the intervention

  • Instructional video of patient–doctor interaction to standardize the delivery
  • Cards with examples of standard drinks and scripted responses – to standardize the delivery
  • Question about patient scenario in follow-up questionnaires (telephone contact)

  • SBIRT checklist for providers (process measure)
  • Pre- and post training test (knowledge measure)
  • Patient follow-up questionnaire will check whether each component of the intervention was delivered

Measuring fidelity in trials of complex interventions is important. It is not technically demanding. Ultimately this becomes a question of personal development and credibility – willingness to have one’s skills analysed and improved is the basis of reflective practice.

Helping agonist patients with alcohol problems: A NEW guide for primary care staff

What should doctors do differently when screening for alcohol use and delivering brief interventions for agonist patients in primary care? General principles remain the same like for other people, but:
  1. the screening and treatment processes should be more systematic and proactive in all problem drug users, especially in those with concurrent chronic illnesses or psychiatric co-morbidity,
  2. lower thresholds should be applied for both identification and intervention of problem alcohol use and referral to specialist services,
  3. special skills and specialist supervision is required if managing persistent/dependent alcohol use in primary care.