Category: PINTA

PINTA was a cluster randomized controlled trial focused on Psychosocial Interventions for Alcohol Use Among Problem Drug Users in Primary Care.

Please cite as:

Klimas J, Anderson R, Bourke M, Bury G, Field CA, Kaner E, Keane R, Keenan E, Meagher D, Murphy B, O’Gorman CS, 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 Protoc 2013;2(2):e26

DOI: 10.2196/resprot.2678

PMID: 23939340

PMCID: PMC3744386

  • Other PINTA related publications

  • McCombe G, Swan D, O’Connor E, Avramovic G, Vickerman P, Ward Z, Surey J, Macías J, Lambert JS, Cullen W. Integrated Hepatitis C Care for People Who Inject Drugs (Heplink): Protocol for a Feasibility Study in Primary Care. JMIR Research Protocols 2018;7(6):e149
    CrossRef
  • Murtagh R, Swan D, O’Connor E, McCombe G, Lambert JS, Avramovic G, Cullen W. Hepatitis C Prevalence and Management Among Patients Receiving Opioid Substitution Treatment in General Practice in Ireland: Baseline Data from a Feasibility Study. Interactive Journal of Medical Research 2018;7(2):e10313
    CrossRef
  • McCombe G, Henihan AM, Leahy D, Klimas J, Lambert JS, Cullen W. Commentary on Zeremski et al. (2016). Journal of Addiction Medicine 2016;10(5):363
    CrossRef
  • Henihan AM, McCombe G, Klimas J, Swan D, Leahy D, Anderson R, Bury G, Dunne CP, Keenan E, Lambert JS, Meagher D, O’Gorman C, O’Toole TP, Saunders J, Shorter GW, Smyth BP, Kaner E, Cullen W. Feasibility of alcohol screening among patients receiving opioid treatment in primary care. BMC Family Practice 2016;17(1)
    CrossRef
  • McCombe G, Henihan AM, Klimas J, Swan D, Leahy D, Anderson R, Bury G, Dunne C, Keenan E, Meagher D, O’Gorman C, O’Toole T, Saunders J, Smyth BP, Lambert JS, Kaner E, Cullen W. Enhancing alcohol screening and brief intervention among people receiving opioid agonist treatment: qualitative study in primary care. Drugs and Alcohol Today 2016;16(4):247
    CrossRef
  • Klimas J, Cullen W. Addressing a Training Gap Through Addiction Research Education for Medical Students: Letter to the Editor. Substance Abuse 2015;36(1):3
    CrossRef
  • Klimas J, Henihan A, McCombe G, Swan D, Anderson R, Bury G, Dunne C, Keenan E, Saunders J, Shorter GW, Smyth BP, Cullen W. Psychosocial Interventions for Problem Alcohol Use in Primary Care Settings (PINTA): Baseline Feasibility Data. Journal of Dual Diagnosis 2015;11(2):97
    CrossRef
  • Klimas J, Tobin H, Field C, O’Gorman CS, Glynn LG, Keenan E, Saunders J, Bury G, Dunne C, Cullen W. Psychosocial interventions to reduce alcohol consumption in concurrent problem alcohol and illicit drug users. Cochrane Database of Systematic Reviews 2014;
    CrossRef

Hepatitis C unchanged, but drinking soared

NEW PAPER OUT NOW 

What is the study about?

           We wanted to find out how many people receiving treatment for opioid addiction (methadone) have Hepatitis C and other blood borne viruses
           And whether anything changed between the years 2006 and 2013

QUICK FACT:

Over a third of people who receive methadone in primary care and who drink excessively test positive for Hepatitis C
 

asam.org

How was the study done?

           In 2013, we have done a secondary analysis of data collected during a feasibility study of an alcohol brief intervention for people attending primary care for methadone treatment
           We looked at two studies done in 2006 and 2013 and compared them

What did the study find?

           We found the proportion of patients with problem alcohol use was much higher (46% v 35%) in 2013.
           37% of people who had Hepatitis C also drank excessively
In 2013, number of people who had Hepatitis C was not different from 2006, but more people drank excessively.

Why is the study important?

           Many people who receive treatment for opioid addiction have Hepatitis C
           Treatment of Hepatitis C is expensive
           Because heavy drinking can make the treatment even more expensive, we should help people drink less
Reference: Improvements in HCV-related Knowledge Among Substance Users on Opioid Agonist Therapy After an Educational Intervention. Journal of Addiction Medicine: September/October 2016 – Volume 10 – Issue 5 – p 363–364
(http://journals.lww.com/journaladdictionmedicine/Citation/2016/10000/Commentary_on_Zeremski_et_al___2016___.11.aspx)

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.

credit: trialsjournal.org

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

How to go about getting a postdoc position? Finding funding

There probably isn’t a simple answer to this question. Everybody has a different experience. My path was one of finding my own funding to do what I liked. Other people get postdocs via other routes, but I’d hope that my story bellow illustrates one of the paths people can take.

My mentor helped me identify funding calls and write funding applications. Then, I applied for everything and some of the applications were successful. Keeping up with the current funding calls via Research Newsletters and email alerts, such as Find A Phd, helped me too. I met the collaborators for my projects at conferences and seminars.

 
My experience is from Ireland, although I have a Slovakian PhD in Social Psychology(04/2011).
First, as a Research Assistant, I applied for and was successful with getting a Cochrane Training Fellowship to complete a Cochrane Systematic review over two years – 2 days p/week – from the Health Research Board Ireland (2010-12). The fellowship examined psychosocial interventions to reduce alcohol consumption in concurrent problem alcohol and illicit drug users. The absence of evidence on the subject helped us to identify priorities for research.  To find out more about the Cochrane Systematic reviews of literature, go to: www.cochranecollaboration.org
Towards the end of my two-year Cochrane Fellowship, my Irish supervisors offered me two complementary part-time postdoc positions, both of which I accepted. The first was a three-year position in emergency medical science research. The second was a one-year position developing new projects in primary care settings and supervising medical students (2012-13). From a personal perspective, teaching literature reviews to medical students taught me how to address a training gap through addiction research education for medical students.
At the same time, I applied for two other grants. First was a three-year feasibility study in primary care from Health Research Board Ireland (Co-applicant). Second, an INVEST drug abuse fellowship from the National Institute for Drug Abuse – NIDA (Fellow). The feasibility study was a direct result of our efforts to highlight the problem of alcohol consumption among people receiving methadone treatment. We’ve trained family physicians in psychosocial interventions for concurrent problem and drug use disorders. Hence the title for the PINTA study.
Both were successful. Thanks to the patience and flexibility of my supervisors, I was able to combine and merge all of these opportunities. The INVEST postdoctoral fellowship was a six months job in at Oregon Health and Science Universityin Portland, OR, studying implementation of alcohol SBIRT in primary- versus secondary-care based opioid agonist treatment (2013). Our poster at the Annual Symposium of the Society for the Study of Addiction described qualitative component of the study. Training health care professionals in delivering alcohol SBIRT is feasible and acceptable for implementation among opioid agonist patients; however, it is not sufficient to maintain a sustainable change. After INVEST, I returned back to my composite Irish postdoc.
Eight months after the return back to Ireland, and one year before the end of my three-year Irish postdoc, I received another fellowship from the Irish Research Council. This International Career Development Award is co-funded by a European Union scheme called Marie Sklodowska Curie Actions. To improve the addiction medicine education for doctors (BEAMED), I’ll do an external and independent evaluation of the addiction medicine fellowship and plan a similar training in Ireland (2014-17). To learn more about the Marie Cure awards, go to: http://ec.europa.eu/research/mariecurieactions/

Does it work? When doctors need evidence

Healthcare professionals can generate important clinical questions for addiction research. Answering such questions by conducting a Cochrane review of evidence is a satisfying learning process and can contribute to drugs policy. This article summarises the experiences of an addiction medicine researcher conducting a Cochrane review, developing and evaluating a researcher-facilitated programme for medical student research activity in general practice.

photo credit: theconversation.net

One summer afternoon in 2010, an interview with a family physician in Dublin opened my eyes about talking therapies for drink problems among people who also used other drugs. “Does counselling work for these people?” the doctor asked.  “Yes”, I was absolutely convinced about it, but I had no evidence for my faith. Surprised by his interest, I sent him the only two studies on the topic that I knew of; never heard back from him.

I searched for more studies without success. Many studies on general population showed up in my internet search, but none for people who also used other drugs.
This made me doubt my beliefs. At that time, a national funding agency announced a call for Cochrane training fellowships. Cochrane collaboration hosts the largest database of systematic reviews to inform healthcare decisions. Cochrane reviews are the jaguars of medical evidence synthesis. The fellowship was a godsend. I could use the funding to learn from Cochrane gurus and answer the Dublin doctor’s question by making the most of all available literature. My supervisor introduced me to a Cochrane author, Dr Liam Glynn, who reviewed self-management strategies for high blood pressure. He agreed to mentor my fellowship. We booked the title for our review with the Cochrane Drug andAlcohol Review Group in Italy and started to work on it when we got the funding.
The review found very few studies, most of which didn’t have a control group or randomised patients without drink problems; we could not give any recommendations to doctors.
The next step in the quest for the answer, we approached patients with dual drug and alcohol problems and fed their ideas back to the experts. Expert consensus recommendations are standard in the absence of scientific studies. The group had to rely on semi-structured interviews with doctors and patients and “B class” evidence from my review. The result of their consensus was a manual for family doctors.
Having developed the manual, we tested its value to answer our original question: “Does it work?” The new pilot trial encourages doctors to ask people who use illicit drugs about alcohol and to help those with mild problems; severe problems are best treated by a specialist.  Sixteen general practices (GPs) in two deprived regions will be randomised to receive the manual-based training or to keep doing what they do. The latter group will be trained later.
When I finished my Cochrane training and review, it was time for me to give back and teach medical students because the fellowships worked on the pay-it-forward model. Equipping the new generation of doctors with critical literature review and appraisal skills was my contribution to the improvement of addiction healthcare delivery. The aim of our teaching project was to create and evaluate a training-through-research programme for medical students, facilitated by a seasoned researcher.
We offered online webinars, methodological advice, mentoring, and one-one interaction. Our medical school emailed all students and we randomly selected a handful needed for our research projects. Collaborators from biostatistics, psychiatry and public health aided the programme. The students presented their work at four conferences and wrote three academic papers for medical journals.
Teaching literature reviews to medical students was a rewarding learning experience. I learned that the quality and commitment of students varies; different expectations led to different work processes and outputs. Some students submitted their work in more finished stage than others; competing priorities precluded achievement of higher standards. The manuscript preparation, submission and publication processes were too long for short student projects, although some students persevered and remained involved until the end.
From a personal perspective, I still don’t know whether counselling works for drink problems in people who also use other drugs, but I’ve learned how to query the literature when doctors need evidence.

This post is based on our presentation at the INMED conference in Belfast, and o recent article in the Substance Abuse journal. References:
  • Klimas, J., & Cullen, W. (2014). Addressing a Training Gap through Addiction Research Education for Medical Students: Letter to editor. Substance Abuse. doi: 10.1080/08897077.2014.939802
  • Klimas, J., & Cullen, W. (2014). Teaching literature reviews: researcher-facilitated programme to support medical student research activity in general practice. Poster presented at the Annual scientific meeting of the Irish Network of Medical Educators, February 21, Belfast, NI.

 

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.