Category: Meta-analysis

European Working Group on Drugs Oriented Research Conference: One size does not fit all

“We all need something to help us unwind at the end of the day. You might have a glass of wine, or a joint, or a big delicious blob of heroin, to silence your silly brainbox of its witterings, but there has to be some form of punctuation, or life just seems utterly relentless.”

― Russell Brand, My Booky Wook 
The 15thInternational EWODOR Symposium, on May 22-23, 2014, was hosted by Coolmine therapeutic community (T.C.) at Trinity College Dublin, Ireland. The conference was capped to 100 attendees, 20 more than usual. This post brings a flavour of four key notes (out of 14).

Irish Addiction Treatment vs MacDonald’s

Was Coolmine TC like McDonald’s? Did it stifle it’s openness to change? Did it hinder adaptation to change? 

Through archival sources, meetings, correspondence, interviews with clients, current and former staff, past staff, Prof Butler researched sociological history of the first therapeutic community in Ireland – the Coolmine. The driving force behind Coolmine was Paddy Rossmore who had 2 recovering users from UK to start Coolmine. A complete reordering of Coolmine happened when Sam Anglin from Daytop, New York rejigged Coolmine, quite like a cult. No one opposed it openly – How do you like if your students were critical with you? But the question is “Was it the Daytop-isation or MacDonalds-isation?”
Sociologist, George Ritzer coined the fast food metaphor which has been researched for the past 20 years. It has been used for many problems since then. “Eat it and beat it” philosophy captures the main dimensions of MacDonaldisation – efficiency, calculability, predictability and control. Is this system dehumanising? To answer this question, we would have to answer a bigger question “Are people predictable, controllable, efficient and calculable?” No, but the answers divide helping professionals into 2 camps: one which clearly says “No”, and the second that says “No, but some behaviours can be predicted, controlled, calculated and changed.” Similar to the dichotomy of the left and right side of brain,  the true answer lies probably somewhere in the middle. No one wants to eat like McDonald’s, but addiction treatment can learn a lot from its business model.
What Prof Butler’s presentation showed us was that sticking rigidly to a foreign TC model may be worse than adapting flexibly to changes in society. Universal approach – one-size-fits-all – does not fit the addiction treatment. His presentation, however, did not answer the Gawande’s question modified for the drugs field: “Food chains have managed to combine quality control, cost control, and innovation. Can addiction treatment?” 
 

L-R: Butler, Yates and Pearce

Drug relationships: I love you and heroin

What is a drug relationship? 

DrMayock answered this question through narratives and interviews with women – drug users. It’s a struggle – Suffering on one hand and intimacy on the other hand. Exchange, power and control are the key characters in such relationship. Half of the interviewed women started using drugs in the relationship. Women were often reliant on the partner to administer heroin. They used threats and rewards – leave temporarily or sex for drugs and protection. Women in drugs economies played a supportive role. However, drugs were not the only connection between partners: “but I love him”, said one of the interviewees. Significance of the relationship beyond drugs was clear even after the end of the relationship. What is the true identity of a female drug user – an abused victim or a tender lover? They are both true.

There’s too much morals around women’s drug use, creating stigma and dismissal. Simmons writes that we need a more complex and nuanced understanding of drug-using couples – “drug treatment providers should:
  • establish policies which recognize the existence and importance of interpersonal dynamics between drug users, and
  • work with them to coordinate detoxification and treatment for both partners, and
  • provide additional integrated couples-oriented services”(Simmons& Singer, 2006).  

Can we do clinical trials of TCs? Or why there is a lack of robust evidence on TCs

What is a TC? What are the critical components and active ingredients?

On a practical level, Dr Pearce summarised the scientific literature on TCs. Therapeutic communities are a popular treatment for the rehabilitation of drug users. This Cochrane systematic review showed that “there is little evidence that TCs offer significant benefits in comparison with other residential treatment, or that one type of TC is better than another”, while another review concluded that “TCs can promote change regarding various outcome categories”. The critics of the Cochrane review for only including randomized trials, “while random group allocation appeared to be either not feasible (i.e., significantly higher drop-out among controls), or advisable (i.e., motivation and self-selection are considered to be crucial ingredients of the treatment process), in several studies.”
Pearce’s TACIT trial, unlike many other TCs, studies a day (outpatient) TC for personality disorders in Britain. Its Primary outcome measure is the Number of days in outpatient psychiatric treatment – total hospital days. TACIT faced typical technical problems: you can’t blind people; you can’t conceal people, difficult to standardize the treatment. Blinding is an issue for all psychosocial treatments. There’s a lack of standardisation and quality control in TCs. The staff is not bothered about clinical trials – they really believe in what they are doing. The TC is a complex intervention – all of the technical problems were taken from, and addressed in, the MRC framework, same like diabetes management or parenting. The logical positivist approach is embedded in the RCT approach – control is central. However, TC can be seen as a safe container for other therapeutic interventions. To respect the principles of safety and deep consent, TACIT asked the TCs themselves whether they want to opt out from the study – none of them did so. Inadequate treatment standardisation can be overcome by using a Model for adherence – Community of Communities – peer-opinion-based accreditation. All in all, it’s possible to do it [RCT] and we should do it.
Opposing the RCT evaluations, Dr Yates argued that we know TCs work, “we’ve done them for 50 years and we know it”. The time is now to study how they work and what the basic principles are. Study TCs for new groups: young runaways, trafficked women and children, self-harmers, recidivist, asylum-seekers, survivors of child abuse, etc. In seeing TCs as learning environments – we could use that stuff in other “schools” for other “students”. For better learning, he helped to setup a Drugslibrary.stir.ac.uk.

On a more fundamental level, Dr Yates asserted that TC is one of the few interventions that systematically address all of the components of Zinberg’s “drug, set and setting” model. The main principles: community as method and whole person disorder. Retention in TCs is poor, but that’s the same for all chronic diseases – you find very poor retention, same as addiction treatment. An audience questioned TC as a very safe environment for recovery – does that necessitate residential? It requires level of intensity: You can’t fund a 6 month programme and expect 12 months outcomes.

Cited work:
Gawande, A. (2013) Big Med. New Yorker, August 13th
Smith LA, Gates S, Foxcroft D. Therapeutic communities for substance related disorder. Cochrane Database of Systematic Reviews 2006, Issue 1. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD005338.pub2/full
Wouter Vanderplasschen, Kathy Colpaert, Mieke Autrique, et al., “Therapeutic Communities for Addictions: A Review of Their Effectiveness from a Recovery-Oriented Perspective,” The Scientific World Journal, vol. 2013, Article ID 427817 
Simmons, J., & Singer, M. (2006). I love you… and heroin: care and collusion among drug-using couples. Substance abuse treatment, prevention, and policy, 1, 7. doi: 1747-597X-1-7 
Zinberg, N. E. (1986). Drug, Set and Setting: The Basis for Controlled Intoxicant Use. New Haven, CT: Yale University Press.

Clinical trials are about human dynamics: RCT course in Belfast, May 7-8

As a trialist, the pressure of working on a trial is much bigger than being in a small group educational session. Challenges of implementing a trial are multiple, mainly influenced by the values of outcomes for different people. Whose question is the trial answering? If you’ve ever found yourself puzzled by these issues, you may find some solace in reading my notes from a courseon clinical trials. 


7 instructors and 21 participants – all from Northern Ireland (except 2 Dubliners), 2 medics, three 1-st year PhD students and some professors – talked about clinical trials for two days last week at Queens University Belfast. The aim of the course wasn’t to learn everything, but to think laterally about trials. Professor Clarkecovered the basics of starting trials: formulating a clear research question, deciding on comparisons and placebos and dealing with confounding factors. The 7 main ways of dealing with confounding are:
  1. Matching
  2. Exclusion
  3. Stratified sampling
  4. Standardisation
  5. Multivariate modelling
  6. Randomisation

The pleasures and terrors of trial recruitment were described by Dr Maguire. Everybody struggling with meeting the recruitment targets should read the top 10 tipsfor recruiting into trials at the All-Ireland Hub for Trials Methodology Research website. Trialists should plan for what they’re going to do if things don’t go the way they planned. Recruiters can also become tired and it’s good to think ahead about what would possibly prevent them from recruiting. Even small rewards to recruiters, such as cream eggs, can increase their satisfaction. Satisfaction=Retention. Research networks for General Practitioners can facilitate recruitment.

Dr McAneney introduced us to the role of social networks in clinical trials. We are all connected.  All the users of Facebook can be linked by 3.74 steps. Networks make the trials work or crash. Networks allow diffusion of innovation. Decisions of participants and researchers are influenced by networks.

Prof McAuleyhelped the participants to write the protocol and funding application for their first trial. Publishing a trial protocol sets the bar pretty high for researchers – transparency and accountability are keyIf it’s not possible to publish the protocol in a peer-reviewed journal, then post it online. Every protocol is changed over time and they should be listed on the first page. The CONSORT diagram is an essential part of a protocol. It’s the only slide that’s projected during meetings of grant reviewers.

Dr Shorterand Prof Buntingcontinued with tips for analysing outcomes. The essence of any research is control. Although power calculations for trials seem difficult, they involve only a short sequence of basic steps. Categorical outcomes require more data and more participants than continuous outcomes. Analysis of clinical trials assumes that our participants are all from the same population. The classical assumption of trials analysis was that individual differences do not matter, they were ignored. Another assumption that things are measured perfectly never holds.

Finally, Dr Dunlopfinished the course presentations with ethics and data storage.

Conference of Cochrane Evidence: Useful, Usable & Used #CE3U

My journey with Cochrane started one summer afternoon in 2010, when I interviewed a Tallaghtdoctor (Tallaght is a rough suburb in Dublin, Ireland) about treatments for drinking problems of people who also use other drugs. I emphasized that brief psychosocial interventions were the treatment of choice for patients who don’t use other drugs and that there’s no reason why this should be different for drug users. He asked me whether I was Swedish, because of my accent, and replied by a single question which kept me awake at night and started my career as an addiction investigator: “Does it work?” I decided to celebrate the four years of trying to find an answer to his question at the Cochrane conference in Manchester, UK.
Wednesday 23rd April 2014
This year’s conference of UK and Irish Cochrane contributors’ swapped plenaries and workshops – Wednesday kicked off with two sessions of developmental workshops. The motto of the priority setting workshop was  “Don’t start a journey that you can’t finish”. Pragmatism is a very important part of priority setting. The value of setting priorities in healthcare is the expected gain from reducing the uncertainty. In another words, to reduce the probability that somebody somewhere is getting a wrong treatment.
Figure 1. Bees were the theme of Cochrane conference
The key question of the public health workshop was How to produce good reviews quickly? Growing number of people are interested in doing reviews under the public health group. Most public health studies are non-randomised. Evidence forms just one part of the complex process of public health policy – timeliness is the big factor. The idea of local context permeates all policies – is this relevant to your local area? All of us, as Cochrane reviewers, give shades of grey and they [policy makers] want black& white answers.
The first afternoon plenary started a faithful member of the Cochrane family, Nicky Cullum. She described how easy reviews were in the past. Her talk inspired 12 new tweets in the first 5 minutes of the plenary (#CE3Useful). The beginning of Cochrane nursing group was accompanied by skepticism “Are RCTs possible in nursing?  Is experimentation at odds with caring?” The explosion of nursing trials in the recent years posed new challenges “How on earth do we help non-academic clinicians to have both clinical and academic career?” Trisha Greenhalghconcluded the first with provocative lecture about boringness of Cochrane reviews. She used the example of young doctor Archie Cochrane in a German camp to demonstrate that the art of rhetoric consists of logos, ethos and pathos. Her other work on how innovations rise and how they spread further supported the rhetoric argument. While a logo is the only thing in scholarship rhetoric, factual knowledge can be rarely separated from ethical or social context. By trying to do so, the Cochrane researchers are stripping away the very thing they need to be exploring – how to change the world through science. The methodological fetishism developed in Cochrane collaboration (linked to control, rationalism and accountability) hinders production of more realist and interesting reviews.
Thursday morning plenaries helped the delegates to confer after the gala dinner last night. Rich Rosenfeld, a Professor and Chairman of Otolaryngology, explained how Cochrane reviewers can help policy makers by rapid reviews – Good is ok, perfect we don’t need [for guidelines]. A health economist, Karl Claxton, continued the discussion on when no more evidence is needed. Research takes long time and evidence that we already have can inform allocation of research funds for new projects. However, we should be cautious about judging the usefulness trials with hindsight, it’s wrong because we don’t know the context. Neal Maskery made the audience “lol” with very entertaining and interactive plenary which focused on what we know about how people make decisions. Our brain is so good at patterns recognition – it wants to do it all the time. This phenomenon is called Base rate neglect – a cognitive bias. Biases such as this one hinder innovation and affect our decisions in all areas from buying a car to prescribing medicines. Al Mulley, an expert on shared decision making, finished morning lectures with a story of how every patient brings their own context by using examples from his research on how bothersome is urinary dysfunction.

The special addition to the conference was presence of Students 4 Best Evidence, some of whom won prizes from UK Cochrane centre, including free travel and conference participation. Read more about their winning entries on prostatecancer, dentalhealth, smoking, and long-term illness.

From a personal perspective, starting a Cochrane review took me on a journey which led from a clinical question (from the Tallaght doctor), to policy development, medical education and further research in a very short time. I still don’t know whether counselling works for drink problems in people who also use other drugs, but I’ve learned how to find an answer using the Cochrane methodology.

Do talking treatments help problem drinkers who also use illicit drugs? We’re still guessing – by Sarah Chapman

19 Nov 2012

Do talking treatments help problem drinkers who also use illicit drugs? We’re still guessing

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Alcohol Awareness Week starts today, with the theme ‘It’s time to talk about drinking’, so I thought we’d kick-start the week in this bit of the woodland by doing just that. Alcohol Concern’s Hair of the Dog campaign poster displays facts which may well achieve their aim of prompting conversation on this subject, including the surprising information that around 200,000 people will have turned up to work with a hangover today (and people who work are more likely to drink alcohol than unemployed people).
Talking treatments were the focus for a new Cochrane review, published last week, which looked at different psychosocial interventions to reduce alcohol consumption in people with problem alcohol and drug use. Four studies with 594 people were included, comparing cognitive-behavioural coping skills training with 12-step facilitation, a brief intervention with treatment as usual, motivational interviewing with hepatitis health promotion and brief motivational interviewing with assessment only.
Here’s what they found:
  • The only study finding a significant difference found that people in the control group receiving ‘treatment as usual’ drank less alcohol at three and nine months than those receiving a brief intervention.
  • The evidence is weak, coming from low quality studies
  • Studies differed too much for their results to be combined
I was rather surprised to read a positive result favouring the control group, until I discovered that the only additional intervention for the intervention group was a single one-hour talking session. Otherwise, everyone in the trial received ‘treatment as usual’ which included a barrage of things including drugs, medical and psychiatric follow-up AND, wait for it, psychosocial interventions…
The reviewers, not surprisingly, said that
 no conclusion can be made because of the paucity of the data and the low quality of the retrieved studies.
So targeting drug and alcohol use together may be a logical approach, given the high rate of these problems occuring together, but one that still lacks an evidence base. If you want to talk about drinking this week, check-out the drinkaware website for some facts about alcohol and you could use the MyDrinkaware feature to track or cut down your drinking. I’m off now to grab a glass of water, something I definitely don’t drink enough.

Links:

Klimas J, Field CA, Cullen W, O’Gorman CSM, Glynn LG, Keenan E, Saunders J, Bury G, Dunne C. Psychosocial interventions to reduce alcohol consumption in concurrent problem alcohol and illicit drug users. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD009269. DOI: 10.1002/14651858.CD009269.pub2. Cochrane summary 

Sarah Chapman

My name is Sarah Chapman. I have worked on systematic reviews and other types of research in many areas of health for the past 17 years, for the Cochrane Collaboration and for several UK higher education institutions including the University of Oxford and the Royal College of Nursing Institute. I also have a background in nursing and in the study of the History of Medicine.

Read the full article here

Is it easier to recruit participants in space? Ten years of Cochrane and Mike Clarke in Ireland

Tenth annual Cochrane in Ireland conference“From evidence to clinical guidelines” took place on 24 January 2014 at School of Nursing& Human Sciences, Dublin City University.

The 7-hours programme kicked off with a welcome by Professor John Costello, Executive Dean of the Faculty of Science and Health, Dublin City University, followed by the National Clinical Effectiveness Agenda of Dr Kathleen MacLellan, Director National Clinical Effectiveness Committee, Department of Health, Dublin.

Figure 1 Yellow arrow card
Mike Clarke’s (Professor & Director of MRC Methodology Hub, Queen’s University Belfast) random thoughts about randomised trials covered some of the more unusual things people have studied. There are approximately 25000 new randomised trials every year, leading to around 700 000 trials registered in CENTRAL Cochrane database. From this overwhelming amount of evidence, Dr Clarke cherry-picked the most unusual, controversial and interesting trials. His presentation started by distributing yellow-arrow cards to delegates in anticipation of active engagement (See figure 1).

Figure 2 Votes and Mike Clarke
Dr Clarke’s random thoughts started with sweets as tip boosters and continued through gamgee hats to lipsticks, restaurants and vegetables, organ music, citruses, chocolate and space trials – a truly spectacular collection. We all voted on Clarke’s provoking questions about these trials (shown in figure 2): did sweets increase, decrease or unchanged the size of the tip? Does smiley face make more difference in tips size than a hand-written thank you? How beneficial is doodling while working or phone-calling? Mike encouraged us to relate each of these entertaining questions to bigger dilemmas about trials, for example, who is in charge of interpreting whether an intervention works? Or, do we believe something because it was published? Ending on a positive note, Clarke presented trials that were conducted on astronauts in the international space station. The drop-out rate was 0 because they had nowhere to go?

Help, I’m stuck.

After a brief tea and coffee break, the participants dispersed into three parallel sessions (N=25:12:7). Dr Clarke’s session was most popular. Traditionally, Mike uses the power and knowledge of a group of people at his workshops that might have some problems with their Cochrane reviews, but collectively have the knowledge to solve them. The list of participants’ questions that he wrote on the white board at the session start was left with only 2-3 questions unanswered. The group disciplines were mutually helpful – psychology, general practice, nursing or information science, experienced reviewers and Cochrane’s novices.
Two other sessions happened in parallel with Clarke’s workshop. Drs O’Rourke & O’Toole covered practicalities of generating clinical guidelines for cancer treatment in Ireland. Dr Matthews, HRB Cochrane Fellow and Senior Lecturer, School of Nursing & Human Sciences, Dublin City University, helped delegates with issues around starting Cochrane reviews.

Lunch was in the campus canteen – each delegate got a €10 voucher. The atmosphere in the canteen was conducive to contact making; we sat by long tables surrounded by students.

The afternoon programme included 2 lectures by Susan Smith and Anne Matthews, and a conclusion by Dr Teresa Maguire – Head of the population science and health services research at the Health Research Board in Ireland. Dr Matthews corroborated on her experience of doing a review on morning sicknessand being a Cochrane fellow – it’s for life, not just for the 2-year fellowship. Dr Smith is a Professor of general practice at Royal College of Surgeons in Ireland who has done 9 Cochrane reviews. Her rich experiences from these reviews were especially useful for those interested in multimorbidity.