Prevalence of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in three regions of England: a repeated cross-sectional study in primary care.

BACKGROUND: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) or chronic fatigue syndrome (CFS) has been used to name a range of chronic conditions characterized by extreme fatigue and other disabling symptoms. Attempts to estimate the burden of disease have been limited by selection bias, and by lack of diagnostic biomarkers and of agreed reproducible case definitions. We estimated the prevalence and incidence of ME/CFS in three regions in England, and discussed the implications of frequency statistics and the use of different case definitions for health and social care planning and for research. METHODS: We compared the clinical presentation, prevalence and incidence of ME/CFS based on a sample of 143,000 individuals aged 18 to 64 years, covered by primary care services in three regions of England. Case ascertainment involved: 1) electronic search for chronic fatigue cases; 2) direct questioning of general practitioners (GPs) on cases not previously identified by the search; and 3) clinical review of identified cases according to CDC-1994, Canadian and Epidemiological Case (ECD) Definitions. This enabled the identification of cases with high validity. RESULTS: The estimated minimum prevalence rate of ME/CFS was 0.2% for cases meeting any of the study case definitions, 0.19% for the CDC-1994 definition, 0.11% for the Canadian definition and 0.03% for the ECD. The overall estimated minimal yearly incidence was 0.015%. The highest rates were found in London and the lowest in East Yorkshire. All but one of the cases conforming to the Canadian criteria also met the CDC-1994 criteria, however presented higher prevalence and severity of symptoms. CONCLUSIONS: ME/CFS is not uncommon in England and represents a significant burden to patients and society. The number of people with chronic fatigue who do not meet specific criteria for ME/CFS is higher still. Both groups have high levels of need for service provision, including health and social care. We suggest combining the use of both the CDC-1994 and Canadian criteria for ascertainment of ME/CFS cases, alongside careful clinical phenotyping of study participants. This combination if used systematically will enable international comparisons, minimization of bias, and the identification and investigation of distinct sub-groups of patients with possibly distinct aetiologies and pathophysiologies, standing a better chance of translation into effective specific treatments.

Social support needs for equity in health and social care: a thematic analysis of experiences of people with chronic fatigue syndrome/myalgic encephalomyelitis.

BACKGROUND: Needs-based resource allocation is fundamental to equitable care provision, which can meet the often-complex, fluctuating needs of people with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). This has posed challenges both for those providing and those seeking support providers, in building shared understanding of the condition and of actions to address it. This qualitative study reports on needs for equity in health and social care expressed by adults living with CFS/ME. METHODS: The participants were 35 adults with CFS/ME in England, purposively selected to provide variation in clinical presentations, social backgrounds and illness experiences. Accounts of experienced needs and needs-related encounters with health and social services were obtained through a focus group (n = 6) and semi-structured interviews (n = 35). These were transcribed and needs related topics identified through data-led thematic analysis. FINDINGS: Participants emphasised needs for personalised, timely and sustained support to alleviate CFS/ME impacts and regain life control, in three thematic areas: (1) Illness symptoms, functional limitations and illness management; (2) practical support and social care; (3) financial support. Access of people with CFS/ME to support from health and social services was seen to be constrained by barriers stemming from social, cultural, organisational and professional norms and practices, further heightened for disadvantaged groups including some ethnic minorities. These reduced opportunities for their illness to be explained or associated functional limitations and social disadvantages to be addressed through social support. Participants sought more understanding of bio-psycho-social aspects of CFS/ME, of felt needs of people with CFS/ME and of human rights and disability rights, for providing person-centred, equitable care. CONCLUSIONS: Changes in attitudes of health practitioners, policy makers and general public and more flexibly organised health and social care provision are needed to address equity issues in support needs expressed by people with CFS/ME, to be underpinned by research-based knowledge and communication, for public and professional education. Policy development should include shared decision-making and coordinated action across organizations working for people with CFS/ME, human rights and disadvantaged groups. Experiences of people with CFS/ME can usefully inform an understanding of equity in their health and social care.

The functional status and well being of people with myalgic encephalomyelitis/chronic fatigue syndrome and their carers.

BACKGROUND: Diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome or ME/CFS is largely based on clinical history, and exclusion of identifiable causes of chronic fatigue. Characterization of cases and the impact of interventions have been limited due to clinical heterogeneity and a lack of reliable biomarkers for diagnosis and outcome measures. People with ME/CFS (PWME) often report high levels of disability, which are difficult to measure objectively. The well being of family members and those who care for PWME are also likely to be affected. This study aimed to investigate the functional status and well being of PWME and their lay carers, and to compare them with people with other chronic conditions. METHODS: We used a cross sectional design to study 170 people aged between 18 and 64 years with well characterized ME/CFS, and 44 carers, using SF-36 v2™. Mean physical and mental domains scores (scales and component summaries) were calculated and compared internally and externally with reference standards for the general population and for population groups with 10 chronic diseases. RESULTS: SF-36 scores in PWME were significantly reduced, especially within the physical domain (mean norm-based Physical Component Summary (PCS) score = 26.8), but also within the mental domain (mean norm-based score for Mental Component Summary (MCS) = 34.1). The lowest and highest scale scores were for "Role-Physical" (mean = 25.4) and "Mental Health" (mean = 36.7) respectively. All scores were in general lower than those for the general population and diseased-specific norms for other diseases. Carers of those with ME/CFS tended to have low scores in relation to population norms, particularly within the mental domain (mean = 45.4). CONCLUSIONS: ME/CFS is disabling and has a greater impact on functional status and well being than other chronic diseases such as cancer. The emotional burden of ME/CFS is felt by lay carers as well as by people with ME/CFS. We suggest the use of generic instruments such as SF-36, in combination of other objective outcome measurements, to describe patients and assess treatments.

Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in adults: a qualitative study of perspectives from professional practice.

BACKGROUND: Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) can cause profound and prolonged illness and disability, and poses significant problems of uncertainty for healthcare professionals in its diagnosis and management. The aim of this qualitative study was to explore the nature of professional 'best practice' in working with people with CFS/ME. METHODS: The views and experiences of health care practitioners (HCPs) were sought, who had been judged by people with CFS/ME themselves to have been particularly helpful and effective. Qualitative semi-structured interviews following a topic guide were carried out with six health care practitioners. Interviews were audio-recorded, transcribed and subject to thematic analysis. RESULTS: Five main themes were developed: 1) Diagnosis; 2) Professional perspectives on living with CFS/ME; 3) Interventions for treatment and management; 4) Professional values and support for people with CFS/ME and their families; 5) Health professional roles and working practices. Key findings related to: the diagnostic process, especially the degree of uncertainty which may be shared by primary care physicians and patients alike; the continued denial in some quarters of the existence of CFS/ME as a condition; the variability, complexity, and serious impact of the condition on life and living; the onus on the person with CFS/ME to manage their condition, supported by HCPs; the wealth of often conflicting and confusing information on the condition and options for treatment; and the vital role of extended listening and trustful relationships with patients. CONCLUSIONS: While professional frustrations were clearly expressed about the variability of services both in primary and specialist care and continuing equivocal attitudes to CFS/ME as a condition, there were also strong positive messages for people with CFS/ME where the right services are in place. Many of the findings from these practitioners seen by their patients as helping them more effectively, accord with the existing literature identifying the particular importance of listening skills, respect and trust for establishing a therapeutic relationship which recognises key features of the patient trajectory and promotes effective person-centred management of this complex condition. These findings indicate the need to build such skills and knowledge more systematically into professional training informed by the experience of specialist services and those living with the condition.

The expressed needs of people with chronic fatigue syndrome/myalgic encephalomyelitis: a systematic review.

BACKGROUND: We aimed to review systematically the needs for support in managing illness and maintaining social inclusion expressed by people with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) METHODS: We carried out a systematic review of primary research and personal ('own') stories expressing the needs of people with CFS/ME. Structured searches were carried out on Medline, AMED, CINAHL, EMBASE, ASSIA, CENTRAL, and other health, social and legal databases from inception to November 2007. Study inclusion, data extraction and risk of bias were assessed independently in duplicate. Expressed needs were tabulated and a conceptual framework developed through an iterative process. RESULTS: Thirty two quantitative and qualitative studies, including the views of over 2500 people with CFS/ME with mainly moderate or severe illness severity, met the inclusion criteria. The following major support needs emerged: 1) The need to make sense of symptoms and gain diagnosis, 2) for respect and empathy from service providers, 3) for positive attitudes and support from family and friends, 4) for information on CFS/ME, 5) to adjust views and priorities, 6) to develop strategies to manage impairments and activity limitations, and 7) to develop strategies to maintain/regain social participation. CONCLUSIONS: Although the studies were heterogeneous, there was consistent evidence that substantial support is needed to rebuild lives. Gaining support depends - most importantly - on the ability of providers of health and social care, colleagues, friends and relatives, and those providing educational and leisure services, to understand and respond to those needs.

Involve the patient and pass the MRCGP: investigating shared decision making in a consulting skills examination using a validated instrument.

BACKGROUND: Shared decision making is an important aspect of patient centredness. Lack of this consulting behaviour is a common reason for failure in the Membership of the Royal College of General Practitioners (MRCGP) consulting skills examination. AIM: To investigate candidates' performance in shared decision making and overall performance in the MRCGP consulting skills assessment compared with an independently validated measure, the OPTION ('observing patient involvement') scale. DESIGN: Cross-sectional study. SETTING: MRCGP examination, UK. PARTICIPANTS: Two hundred and fifty-two consultations submitted by 36 GPs submitting seven consultations per videotape. METHOD: A stratified sample of 63 candidates, 21 each from fail, pass and merit selected from candidates in the MRCGP consulting skills examination, were approached for participation. Participants' examination videotapes were independently assessed for shared decision making using the OPTION scale by two non-clinical raters. RESULTS: Thirty-six candidates (of 63; 57%) who participated were no different from non-participants. Candidates who passed the 'sharing management options' in the MRCGP had significantly higher OPTION scores than those who did not (35.4 versus 27.3; mean difference = 8.1, P = 0.044). There was a significant difference between OPTION scores of MRCGP candidates with 'fail' and 'pass' (including pass with merit): 28.6 versus 36.1, 95% confidence interval CI = 1.13 to 13.87. Scores decreased as clinician age increased but were not significantly associated with sex of GP, age or sex of patient or consultation duration. The probability of passing the MRGCP increased as OPTION scores increased. CONCLUSION: This study demonstrated concurrent validity of the MRCGP consulting skills assessment of sharing management options against an independent validated instrument for shared decision making, the OPTION scale. Candidates who performed best in the MRCGP exhibited high scores with OPTION. This study provides the basis for further work to demonstrate evidence for the potential of training for professional assessment to improve consulting competence.

Complex consultations and the 'edge of chaos'.

Complexity theory has attracted considerable attention in recent years, both within medicine and in the wider world. Its themes of uncertainty and non-linearity resonate deeply with the experience of working in general practice. Describing the consultation as a complex, adaptive system provides a coherent theoretical basis for understanding the consultation, which has so far been lacking. Understanding the consultation as a complex, adaptive system offers insights into the consultation of that may prove to be of practical use to clinicians.

A Disease Register for ME/CFS: Report of a Pilot Study.

BACKGROUND: The ME/CFS Disease Register is one of six subprojects within the National ME/CFS Observatory, a research programme funded by the Big Lottery Fund and sponsored by Action for ME. A pilot study in East Anglia, East Yorkshire, and London aimed to address the problem of identifying representative groups of subjects for research, in order to be able to draw conclusions applicable to the whole ME/CFS population.While not aiming for comprehensive population coverage, this pilot register sought to recruit participants with ME/CFS in an unbiased way from a large population base. Those recruited are constituting a cohort for long-term follow-up to shed light on prognosis, and a sampling frame for other studies. FINDINGS: Patients with unidentified chronic fatigue were identified in GP databases using a READ-code based algorithm, and conformity to certain case definitions for ME/CFS determined. 29 practices, covering a population aged 18 to 64 of 143,153, participated.510 patients with unexplained chronic fatigue were identified. 265 of these conformed to one or more case definitions. 216 were invited to join the register; 160 agreed. 96.9% of participants conformed to the CDC 1994 (Fukuda) definition; the Canadian definition defined more precisely a subset of these. The addition of an epidemiological case definition increased case ascertainment by approximately 4%. A small-scale study in a specialist referral service in East Anglia was also undertaken.There was little difference in pattern of conformity to case definitions, age or sex among disease register participants compared with subjects in a parallel epidemiological study who declined to participate.One-year follow-up of 50 subjects showed little change in pain or fatigue scores. There were some changes in conformity to case definitions. CONCLUSIONS: Objective evaluation indicated that the aim of recruiting participants with ME/CFS to a Disease Register had been fulfilled, and confirmed the feasibility of our approach to case identification, data processing, transmission, storage, and analysis. Future developments should include expansion of the ME/CFS Register and its linkage to a tissue sample bank and post mortem tissue archive, to facilitate support for further research studies.

Therapeutic effects of magnetic and copper bracelets in osteoarthritis: a randomised placebo-controlled crossover trial.

OBJECTIVES: To test the effectiveness of a typical magnetic wrist strap for reducing pain and stiffness, and for improving physical functioning amongst patients with osteoarthritis. DESIGN: A randomised double-blind placebo-controlled crossover trial. Each participant wore four devices over a 16-week period. SETTING: Forty five patients with osteoarthritis were recruited from general practices in rural and urban areas of Yorkshire. INTERVENTIONS: Experimental device: a commercially available magnetic wrist strap. Control devices: a weak magnetic wrist strap, a demagnetised wrist strap, and a copper bracelet. MAIN OUTCOME MEASURES: The WOMAC Osteoarthritis Index, the McGill Pain Questionnaire-Pain Rating Index (PRI), a pain visual analogue scale (VAS), and medication use. RESULTS: No difference was observed between devices in terms of their effects on pain as measured by the primary outcome measure (WOMAC A), the PRI and the VAS. Similar results were obtained for stiffness (WOMAC B), physical function (WOMAC C), and medication use. Further analyses of the PRI subscales revealed a statistically significant difference between devices (P=0.025), which favoured the experimental device. Participants reported lower sensory pain after wearing the standard magnetic wrist strap, than when wearing control devices. However, no adjustment was made for multiple testing. CONCLUSIONS: Our results indicate that magnetic and copper bracelets are generally ineffective for managing pain, stiffness and physical function in osteoarthritis. Reported therapeutic benefits are most likely attributable to non-specific placebo effects. However such devices have no major adverse effects and may provide hope.

Smuggled tobacco, deprivation and addiction.

OBJECTIVE: To identify the links between smuggled tobacco, deprivation and addiction across one Health Authority in the North East of England and identify the impact on people living in disadvantaged areas. DESIGN: Anonymous postal survey. Sample size 11 443. Multivariate analysis including an 'Ideal Types analysis' examined the probabilities of purchase of smuggled tobacco and associations with population characteristics. SETTING: Sample taken from across the Hull & East Riding Health Authority area in the UK. PARTICIPANTS: Randomly selected from those aged 16 and over, who were registered with a GP in the Health Authority area on the 1 September 2000. RESULTS: The predicted probability of having ever bought smuggled tobacco for a male, employed, heavy smoker living in a deprived area was 0.67. A female with the same characteristics had a probability of 0.49. For the unemployed the probabilities are 0.55 and 0.37 respectively. For respondents living in non-deprived areas the probability of having ever bought smuggled tobacco was much lower. This probability was further reduced for respondents who were unemployed. Respondents living in deprived areas had a 134% higher probability of being heavily addicted to tobacco. Links between addiction and deprivation are confirmed. CONCLUSIONS: This study confirms and extends the findings of previous qualitative studies. The results of this analysis demonstrate that people who have bought smuggled tobacco are heavy smokers with high levels of addiction, living in socially deprived areas, but are more likely to be in employment. They are likely to use smuggled tobacco to save money and sustain their smoking habit.

Achieving multiple topic shifts in primary care medical consultations: a conversation analysis study in UK general practice.

The 'by the way' phenomenon, while commonly described in medical texts on the consultation, has not been systematically explored from an interactional perspective. Starting from a 'noticing' of an example of this phenomenon we studied a collection of over 200 recorded consultations in British general practice. New topics were introduced by both parties, but more commonly by patients, who used two sorts of device to change topic: an announcement, usually at the start of a consultation, but sometimes later, that they had multiple topics, which we have called a 'pre-announcement', and an apparently unexpected sudden change of topic, which we have called an 'in-situ announcement'. These phenomena occurred in about one third of our unselected collection of recorded consultations, drawn from nine doctors, and 27 surgery (office) sessions. We argue that this management of multiple topics is an important and normal part of the consultation, in contrast to its problematic status implied in some medical literature.