Jens Foell

Risks of the unregulated market in human breast milk

Urgent need for regulation

More than a lucrative liquid: the risks for adult consumers of human breast milk bought from the online market

Sarah Steele, Jens Foell, Jeanine Martyn and Andreas Freitag Global Health, Policy and Innovation Unit, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AB, UK Richford Gate Medical Practice, Richford Street, London W67HY, UK Lifespan, 167 Point Street, Providence, Rhode Island 02903, USA National Clinical Guideline Centre, Royal College of Physicians, London NW1 4LE, UK Corresponding author: Sarah Steele. Email: s.steele@qmul.ac.uk

An exploration of opioid medication management for non-malignant pain in primary care

The present study aimed to explore how prescription of opioid medication for chronic non-malignant pain (CNMP) is managed in primary care. We used audit as a research tool, and one general practitioner (GP) practice in West London acted as an exemplar. Of the practice population with CNMP, 1% had repeat prescription of at least 12 months duration for opioid analgesics at the time of data collection. These 1% are on highly controlled opioids. Our study showed the following: (1) long-term opioid prescription appears to follow a fluctuating course as opposed to staying the same; (2) we found that medication reviews were done in most cases (85.7%), but the quality of the process is difficult to assess and ascertain; and (3) we identified two incidences where opioid contract was implemented. In both cases, contracts were used as a last chance warning for patients who were already problematic, suggesting that opioid contracts served as a disciplinary tool rather than a preventative measure. Our findings highlight a need for a more structured and specific review of analgesic medication, and a need for a simple and effective way to identify patients at high risk of developing problematic use, to ensure better monitoring and early presentations.

Unmasking quality: exploring meanings of health by doing art

BackgroundQuality in healthcare has many potential meanings and interpretations. The case has been made for conceptualisations of quality that place more emphasis on describing quality and less on measuring it through structured, vertically oriented metrics. Through discussion of an interdisciplinary community arts project we explore and challenge the dominant reductionist meanings of quality in healthcare.DiscussionThe model for structured participatory arts workshops such as ours is ‘art as conversation’. In creating textile art works, women involved in the sewing workshops engaged at a personal level, developing confidence through sharing ideas, experiences and humour. Group discussions built on the self-assurance gained from doing craft work together and talking in a relaxed way with a common purpose, exploring the health themes which were the focus of the art. For example, working on a textile about vitamin D created a framework which stimulated the emergence of a common discourse about different cultural practices around ‘going out in the sun’. These conversations have value as ‘bridging work’, between the culture of medicine, with its current emphasis on lifestyle change to prevent illness, and patients’ life worlds. Such bridges allow for innovation and flexibility to reflect local public health needs and community concerns. They also enable us to view care from a horizontally oriented perspective, so that the interface in which social worlds and the biomedical model meet and interpenetrate is made visible.SummaryThrough this interdisciplinary art project involving academics, health professionals and the local community we have become more sensitised to conceptualising one aspect of health care quality as ensuring a ‘space for the story’ in health care encounters. This space gives precedence to the patient narratives, but acknowledges the importance of enabling clinicians to have time to share stories about care.

Acupuncture is superior to sham for painful conditions

Commentary on: Vickers AJ, Cronin AM, Maschino AC, et al. Acupuncture Trialists’ Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med 2012;172:1444–53.[OpenUrl][1][CrossRef][2][PubMed][3][Web of Science][4] Acupuncture is controversial. Even if one assumes its overall effectiveness, common explanations for its causal impact are biologically implausible. Hence acupuncture is often dismissed as ‘no more than a placebo’, and this allegation is difficult to disprove as placebo-controlled trials are problematic. ‘Placebo’ needles stimulate sensory nerves and are possibly a less active treatment, ‘sham’ rather than ‘placebo’.1 Small differences between treatments require large sample sizes, as achieved by meta-analysis. Previous meta-analyses concentrated on finding all trials, but poor quality limited the conclusions. This is a systematic review of randomised controlled trials (RCTs) of chronic headache and musculoskeletal conditions that had unambiguous allocation concealment and were assessed … [1]: {openurl}?query=rft.jtitle%253DArch%2BIntern%2BMed%26rft.volume%253D172%26rft.spage%253D1444%26rft_id%253Dinfo%253Adoi%252F10.1001%252Farchinternmed.2012.3654%26rft_id%253Dinfo%253Apmid%252F22965186%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/external-ref?access_num=10.1001/archinternmed.2012.3654&link_type=DOI [3]: /lookup/external-ref?access_num=22965186&link_type=MED&atom=%2Febmed%2F18%2F6%2Fe56.atom [4]: /lookup/external-ref?access_num=000310070200003&link_type=ISI

Opioid prescribing for chronic musculoskeletal pain in UK primary care: results from a cohort analysis of the COPERS trial.

Objective To establish the level of opioid prescribing for patients with chronic musculoskeletal pain in a sample of patients from primary care and to estimate prescription costs. Design Secondary data analyses from a two-arm pragmatic randomised controlled trial (COPERS) testing the effectiveness of group self-management course and usual care against relaxation and usual care for patients with chronic musculoskeletal pain (ISRCTN 24426731). Setting 25 general practices and two community musculoskeletal services in the UK (London and Midlands). Participants 703 chronic pain participants; 81% white, 67% female, enrolled in the COPERS trial. Main outcome measures Anonymised prescribing data over 12 months extracted from GP electronic records. Results Of the 703 trial participants with chronic musculoskeletal pain, 413 (59%) patients were prescribed opioids. Among those prescribed an opioid, the number of opioid prescriptions varied from 1 to 52 per year. A total of 3319 opioid prescriptions were issued over the study period, of which 53% (1768/3319) were for strong opioids (tramadol, buprenorphine, morphine, oxycodone, fentanyl and tapentadol). The mean number of opioid prescriptions per patient prescribed any opioid was 8.0 (SD=7.9). A third of patients on opioids were prescribed more than one type of opioid; the most frequent combinations were: codeine plus tramadol and codeine plus morphine. The cost of opioid prescriptions per patient per year varied from £3 to £4844. The average annual prescription cost was £24 (SD=29) for patients prescribed weak opioids and £174 (SD=421) for patients prescribed strong opioids. Approximately 40% of patients received >3 prescriptions of strong opioids per year, with an annual cost of £236 per person. Conclusions Long-term prescribing of opioids for chronic musculoskeletal pain is common in primary care. For over a quarter of patients receiving strong opioids, these drugs may have been overprescribed according to national guidelines. Trial registration number ISRCTN24426731; Post-results.

Manual medicine: Out of touch with contemporary medicine?

Out of touch with the contemporary landscape of healthcare? Is manual medicine an activity of ‘grumpy old men’? And how can this branch of medical practice adapt to changing healthcare arenas? One speaker at the International Academy of Manual/ Musculoskeletal Medicine meeting at Bratislava, 2012, suggested that the difference between manual medicine and manual therapy was the number of treatments – one or two in the former, unlimited in the latter; and that this was enabled by the holistic approach in the former, together with an understanding of psychosocial issues and co-morbidities. But if the former has usually less time in consultation, and much of the ‘extras’ can be covered by advanced training, we question why some consider that one approach is specific to one health discipline. Theme of the first session was manual therapy in infants. The spectrum of treated disorders changed from torticollis to feeding and behavioural problems. The speaker, Heiner Biedermann, theorized that functional disturbances of the atlanto-occipital region associated with birth trauma generate a nociceptive barrage which affects feeding and makes the infant irritable as awhole. Someaspects of hismanagement generated controversy, for example, routine use of X-rays in infants. Other aspects are linked to the activity of manual therapists: it is impossible to unpick in a complex intervention what the active treatment components are and how they interact. What one believes the dominant method of action is, may not be what actually works. These uncertainties, the tension between externally validated knowledge and how knowledge is locally enacted, remained a theme throughout the conference. As much as musculoskeletal medicine strives to position itself in the positivist paradigm of evidencebased medicine it also is clear that there are phenomena which remain unexplained and possibly difficult to pinpoint, measure, and control. Aristotle’s distinction between craftsmanship, theoretical skills, and applied wisdom provided a framework to compartmentalize what therapists do and how it gets taught. It is about distinguishing subtle differences in tissue texture. How reproducible is this? This is one of the core questions of hands-on medicine. How can it be measured? And do skilled practitioners agree on their observations? One experiment consisted of comparing palpation of the painful side in a blinded situation. Two experienced therapists in France compared their accuracy in detecting the painful side in patients who complained of unilateral neck pain and back pain. The sad outcome was that there was very little accuracy in detecting the ‘correct’ side. The success rate ranged between 53 and 70% and none of the therapists was happy with the results. Is this something one should expect, as individuals differ in their judgment? Is this something to expect because a dialogue is needed to negotiate differing sources of information? A group in Germany used different textures of pads, hidden under a surface, to test accuracy in detecting the orientation of the hidden but palpable lines. It emerged that this task can be trained and also that there was not much difference between the teachers and disciples in the school of touch. An American group obtained a lot of funding from the Veterans Administration agency, aimed at improving the traumatized brains of war veterans who were exposed to physical and emotional trauma. So they could buy some gadgets to measure forces acting on soft tissues: no, not the initial forces resulting in tissue trauma, the therapeutic physical forces acting on the body of the traumatized veteran. This group of osteopaths theorizes that interventions aimed at improving cerebrospinal fluid flow may improve cerebral function and as a result the lives of veterans. And they set out to measure contact forces between their manipulating hands and the head of Correspondence to: Jens Foell, Blizard Institute, Centre for Primary Care and Public Health, Queen Mary University of London, Barts and the London School of Medicine and Dentistry, Yvonne Carter Building, 58 Turner Street, London E12AT, UK. Email: j.foell@qmul.ac.uk

Everything matters – Instructional workshop in reproducibility studies, London 2011

Third time lucky – the first two attempts to launch the course in research methodology for assessing the quality of manual test procedures failed to attract the interest of enough musculoskeletal practitioners. But as a joint venture between British Institute of Musculoskeletal Medicine (BIMM), International Academy of Manual/ Musculoskeletal Medicine (IAMMM), and the British School of Osteopathy it was possible to run a full course of 20 participants. It was a truly interprofessional and international course with delegates from as far as New Zealand, Japan, France, and Norway. The course helped the participants to deal with the methodological challenges of exploring the tools used in daily musculoskeletal practice. All the phases of a research project which can be run in low-tech, low-funding environments were visited: the logbook as hub of the project, the agreement phase, the test phase, the publication phase. Abduction of the shoulder served as a practical task for the group to exemplify the challenges of the methodology. Two experienced musculoskeletal educators as observers writing down their assessment of this basic test – this should not be a problem? However, the first phase of running the test and interpreting the test result yielded a rate of only 40% interrater agreement. Attention to detail, to the hand position, to the instructions of the interpretation, to what is called ‘positive’ or ‘negative’, to the underlying hypothesis and the minutiae of the procedure were the topics of further exploration. This was underpinned by the statistical steps of establishing the prevalence of the condition, which in this case is not a disease or a painful state; it is the distribution of observations in the test sample. The observations needed to be dichotomized for the sake of the statistical procedure. We created contingency tables for the observation results. We discussed the agreements for classification for kappa-values and agreement between observers. The difference between acceptance levels in the field of mental health sciences such as psychology and psychiatry and the medical field generated curious interest. Where is the link between reproducibility studies and validity studies? How do we need to set up research to accept or reject a test? How can we prove the value of segmental mobility testing? How can we prove the effect of manual interventions on tissues in the region where we believe a mechanical effect takes place? These were the questions explored in practical work in the afternoon. Jacob Patijn shared his experience of years in musculoskeletal method research with the audience. A piece of work looking at tests used to detect hypomobility of the SI joint was his starting point. This work could not prove high correlations between the tests and also the three observers. ‘One observer got depressed, one became insecure, one became enthusiastic – guess who am I?’ The participants became temporary passengers in this journey of enthusiastic research into the mundane details of musculoskeletal practice: size matters, for example, the size of the hands of the observers, may it be a size 6 or size 8.5 hand. Position matters. Force matters. Everything matters. The course was an encounter between an experienced enthusiastic researcher in the field of musculoskeletal test methodology and a heterogeneous group of interested practitioners. Where does the knowledge gained in this encounter, where do the skills gathered on this day, where do conversations with fellow practitioners from all over the world change daily practice? The background of the day was our wish to make sense of the observed and perceived effects of our therapies. How tissue specific are the interventions, can they reduce peripheral nociception? What are we doing? How do we think about what we are doing? How do our beliefs and models influence – or cloud? – our judgements? Such questions formed the background of the day. Looking at the link between the hands and the practical questions of the physical interactions between caregiver and patient was the foreground of the day. The journey goes on....

Response to Professor Lewit's letter ‘Fibromyalgia and palpation’

I fully agree with Prof. Lewit about the importance of palpation in the musculoskeletal assessment of people presenting with widespread pain in the locomotor system. However, some questions arise. Recently I was at the Primary Care Rheumatology Society conference. I had a chat with a colleague, Mike Hopkins, over a coffee and he mentioned how challenging it is to treat the tender points in people with fibromyalgia. He said that they are sore for days after treatment and how difficult it is to get the job done. He practices positional release, an osteopathic technique using a monitoring finger to assess tissue tension and passive positioning of the articulating body parts to achieve a release phenomenon of the tender area under treatment. Jones’ terminology sees tender points as peripheral pain generators. For him ‘tender points’ are a call for treatment. In rheumatological settings, by contrast, they are pure diagnostic targets to assess generalized allodynia and hyperalgesia. Interestingly enough a topic in the conference itself was fibromyalgia and the updated American College of Rheumatology document was discussed. Palpation and pressure pain tenderness mapping in the form of 18-point ritual has been abandoned in the new preliminary version of the consensus document. The diagnosis relies entirely on the patients’ report of symptom severity in the key domains pain, fatigue, disturbed sleep, depression, and cognitive function. Where does this leave musculoskeletal practitioners? Where does this leave palpation, the modality of touch? Is it a diagnostic modality, an investigation, able to bypass the subjectivity of the patient? Or is palpation the main medium of the caring interaction in the shared intimate space to improve the therapeutic alliance? These questions should be reframed as research questions and answered using appropriate methods. This could include reproducibility studies exploring the interrater reliability in tissue assessment. It could include surveys among musculoskeletal practitioners about the extent of their physical interaction with patients who could be labelled with fibromyalgia and in which organizational context these interactions take place. The general consensus is to conceptualize fibromyalgia as an umbrella term or phenomenological endpoint of different processes starting at various entry points – adverse childhood experiences, viral infections, inflammatory conditions, traumata, and affective disorders. Fibromyalgia is known as a condition with high healthcare resource usage. Reliable subgroup identification could allow wisely targeted resource allocation. The relevance of palpation for diagnosis and therapy within a multimodal approach should be the topic of further studies. Multidisciplinary treatment is advocated in European and American guidelines. My fear is that the current scientific fashion risks treating patients like brains in jars, interacting with them by pharmacotherapy and psychological therapies, possibly missing therapeutic targets in a relevant subgroup of patients. The interaction between the musculoskeletal practitioner as provider and the patient presenting with widespread pain in the locomotor system can be explored from different viewpoints. One area could be the exchange about the diagnosis, prognosis, and management of the condition. Despite the remarkable progress in understanding the pathophysiology of fibromyalgia as one facet of central sensitivity syndromes, the effectiveness of the therapies is not high. We are still not far away from a situation like in Vienna in the beginning of the nineteenth century, where with scientific methods diagnoses could be made, but they did not have consequences for effective management – therapeutic nihilism. The question is, whether medicalizing or normalizing a condition opens more space for the sufferer. This cannot be answered a priori without looking at the social setting in which encounters take place. Wolfe called this debate between social and biological formulations ‘Fibromyalgia wars’. I am aware of the conflict and would like to locate the information derived from palpation alongside information from the patient, his or her living conditions, and the way he or she conceptualizes her illness and the external influences on this

Psychogenic fibromyalgia – dissection of a culturally constructed model

motor system in combinationwithmood disturbances, fatigue and dysfunctions in several organ systems are commonly regarded as difficult.1,2 They may or may not get reported in conjunction. They may or may not get coded as ‘syndrome’, a pattern of symptoms indicative of a unifying underlying disease process.3 Depending on the setting of the consultation and the cultural background of the participants, the formulation for the presented problem may vary.4 ‘Medically unexplained symptoms’, ‘somatisation’ or ‘depression’ may be the diagnostic vignettes for a heterogeneous set of symptoms with affective, visceral, somatic and cognitive components.5 Pikoff highlights the end of one concept commonly used in such encounters – psychogenesis. ‘Psychogenic’ assumes the existence of a ‘psyche’and also a direction and hierarchy of agency, assigning a causative role to a central process. The technological advances in demonstrating neural plasticity, altered signal transmission and transduction networks have generated new ways of conceptualising mind–body interactions.6,7 However, this technological progress in visualising central function can only inform the theoretical model. Speculation remains about what in a given specific clinical scenario, the morphological and functional substrate for the pain experience is. In a biomedical context, the structure of the tissues canbe visualised, but the functionof the different parts of the neuro-axis and their transmission relay stations still remains obscure. The medicolegal and benefitascribing arena is still dominated by a sequential biomedical work-up with psychological influences remaining second order explanations.8 This is in stark contrast to epidemiological concepts which assign psychosocial factors a powerful role in the illness trajectory.9–11 Unfortunately, ‘fear avoidance’ and ‘catastrophising’ are as much epistemiological constructs as ‘soft tissue rheumatism’ or ‘fibrositis’.12 Nevertheless, it has been possible to link measurable pathophysiological changes to psychological processes and vice versa – cognitive behavioural therapy (CBT) can change the attenuation of nociceptor activity in fibromyalgia, cytokine levels correlate with catastrophising in experimental pain, even a short period of post-traumatic dysfunction associated with anterior cruciate ligament (ACL) injury leads to changes in central representations.13–15 The musicians in the orchestra of pain are known. More and more pathways andprocesses of information exchangeonall levels of organisation reaching from molecule to movement and social interaction are known. However, it remains unknown how the orchestra conducts itself. And, at thismoment in time, we are not able to prevent the orchestra from playing the same score again and again and again – the lament of never-ending suffering. As a result of these limitations, it is timely to consider alternative contemporary concepts. There is a need to co-construct a mindful and helpful model which accommodates the interactions of social and biological events in people experiencing wide-spread pain – as narrator, as organism, as part of a bigger community, as social animal. Pikoff’s review of the rise and fall of a psychodynamic formulation for fibromyalgia shows how the psychogenic model has become obsolete. He uses the paradigm change in the understanding and treatment of peptic ulcer after the discovery of Helicobacter pylori infection to draw analogies to the understanding of fibromyalgia. It should be added, that the infection model did not settle the question