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1.  Prescriptions for medical research. I--Management within the Medical Research Council. 
BMJ : British Medical Journal  1993;306(6893):1668-1672.
In their submission to the government in advance of the white paper on science policy in the United Kingdom the Medical Research Council commends the MRC's own approach to managing directly funded research. But a series of semi-structured interviews with the directors of some of the MRC's units suggests a gap between the MRC's model of managed research and the reality. Although such units are theoretically managed from MRC head office (and units are charged an overhead for this), in practice each unit runs its own affairs. Between major reviews average contact time with the head office contact person is seven hours a year. The first paper argues that a purchaser-provider split would recognise the benefits of decentralisation and allow units to bid for research funds from several sources, the successful ones guaranteeing their survival through a rolling series of research programmes. The second paper criticises the MRC's cumbersome peer review system. Reliance on outside experts atrophies the scientific skills of head office staff and builds delays into decision making. A purchaser-provider model would allow the head office scientific staff to act like commercial research and development managers, commissioning research, and using the outcome, rather than peer review, as a criterion for continued funding.
PMCID: PMC1678049  PMID: 8324441
2.  Multipoint incremental motor unit number estimation versus amyotrophic lateral sclerosis functional rating scale and the medical research council sum score as an outcome measure in amyotrophic lateral sclerosis 
Introduction:
Monitoring the disease progression in amyotrophic lateral sclerosis (ALS) is a challenge due to different rates of progression between patients. Besides clinical methods to monitor disease progression, such as the ALS functional rating scale (ALSFRS) and the medical research council (MRC) sum score, quantitative methods like motor unit number estimation (MUNE) are of interest.
Objective:
The objective of the present study is to evaluate the rate of progression in ALS using multipoint incremental MUNE and to compare MUNE, ALSFRS and MRC sum score at baseline and at 6 months for progression of the disease.
Materials and Methods:
Multipoint incremental MUNE using median nerve, ALS-FRS and MRC sum score was carried out in 29 ALS patients at baseline and then at 6 months.
Results:
Of the 29 ALS patients studied, the mean MUNE at baseline was 21.80 (standard deviation [SD]: 19.46, range 4-73), 15.9 in the spinal onset group (SD: 14.60) and 30.16 (SD: 22.89) in the bulbar onset group. Spinal onset patients had 74.02% of baseline MUNE value while bulbar onset patients had only 24.74% baseline value MUNE at 6 months follow-up (Unpaired t-test, P = 0.001). ALSFRS and MRC sum score showed statistically significant decline (P < 0.001) at 6 months follow-up. MUNE had the highest sensitivity for progression of the disease when compared to the ALS FRS and MRC sum score.
Conclusion:
Multipoint incremental MUNE is a valuable tool for outcome measure in ALS and other diseases characterized by motor unit loss. The rate of decline of multipoint incremental MUNE is more sensitive than that of MRC sum score and ALSFRS-R, when expressed as the percentage change from baseline.
doi:10.4103/0972-2327.138522
PMCID: PMC4162024  PMID: 25221407
Amyotrophic lateral sclerosis functional rating scale; amyotrophic lateral sclerosis; compound muscle action potential; medical research council sum score; motor unit estimation; single motor unit action potential amplitude
3.  Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: Results of a survey 
Trials  2012;13:9.
Background
We aimed to establish levels of consumer involvement in randomised controlled trials (RCTs), meta-analyses and other studies carried out by the UK Medical Research Council (MRC) Clinical Trials Unit across the range of research programs, predominantly in cancer and HIV.
Methods
Staff responsible for studies that were included in a Unit Progress Report (MRC CTU, April 2009) were asked to complete a semi-structured questionnaire survey regarding consumer involvement. This was defined as active involvement of consumers as partners in the research process and not as subjects of that research. The electronic questionnaires combined open and closed questions, intended to capture quantitative and qualitative information on whether studies had involved consumers; types of activities undertaken; recruitment and support; advantages and disadvantages of involvement and its perceived impact on aspects of the research.
Results
Between October 2009 and April 2010, 138 completed questionnaires (86%) were returned. Studies had been conducted over a 20 year period from 1989, and around half were in cancer; 30% in HIV and 20% were in other disease areas including arthritis, tuberculosis and blood transfusion medicine. Forty-three studies (31%) had some consumer involvement, most commonly as members of trial management groups (TMG) [88%]. A number of positive impacts on both the research and the researcher were identified. Researchers generally felt involvement was worthwhile and some felt that consumer involvement had improved the credibility of the research. Benefits in design and quality, trial recruitment, dissemination and decision making were also perceived. Researchers felt they learned from consumer involvement, albeit that there were some barriers.
Conclusions
Whilst most researchers identified benefits of involving consumers, most of studies included in the survey had no involvement. Information from this survey will inform the development of a unit policy on consumer involvement, to guide future research conducted within the MRC Clinical Trials Unit and beyond.
doi:10.1186/1745-6215-13-9
PMCID: PMC3398265  PMID: 22243649
Public and patient involvement; consumer involvement; clinical trials; systematic reviews; RCTs
4.  The Research Council System and the Politics of Medical and Agricultural Research for the British Colonial Empire, 1940–52 
Medical History  2013;57(3):338-358.
Historical accounts of colonial science and medicine have failed to engage with the Colonial Office’s shift in focus towards the support of research after 1940. A large new fund was created in 1940 to expand activities in the colonies described as fundamental research. With this new funding came a qualitative shift in the type of personnel and activity sought for colonial development and, as a result, a diverse group of medical and technical officers existed in Britain’s colonies by the 1950s. The fact that such variety existed amongst British officers in terms of their qualifications, institutional locations and also their relationships with colonial and metropolitan governments makes the use of the term ‘expert’ in much existing historical scholarship on scientific and medical aspects of empire problematic. This article will consider how the Colonial Office achieved this expansion of research activities and personnel after 1940. Specifically, it will focus on the reasons officials sought to engage individuals drawn from the British research councils to administer this work and the consequences of their involvement for the new apparatus established for colonial research after 1940. An understanding of the implications of the application of the research council system to the Colonial Empire requires engagement with the ideology promoted by the Agricultural Research Council (ARC) and Medical Research Council (MRC) which placed emphasis on the distinct and higher status of fundamental research and which privileged freedom for researchers.
doi:10.1017/mdh.2013.17
PMCID: PMC3865944  PMID: 24069883
Medical Research Council; Agricultural Research Council; Colonial Office; 1940 CDW Act; Colonial Medical Research Council; East Africa
5.  The modified Medical Research Council scale for the assessment of dyspnea in daily living in obesity: a pilot study 
Background
Dyspnea is very frequent in obese subjects. However, its assessment is complex in clinical practice. The modified Medical Research Council scale (mMRC scale) is largely used in the assessment of dyspnea in chronic respiratory diseases, but has not been validated in obesity. The objectives of this study were to evaluate the use of the mMRC scale in the assessment of dyspnea in obese subjects and to analyze its relationships with the 6-minute walk test (6MWT), lung function and biological parameters.
Methods
Forty-five obese subjects (17 M/28 F, BMI: 43 ± 9 kg/m2) were included in this pilot study. Dyspnea in daily living was evaluated by the mMRC scale and exertional dyspnea was evaluated by the Borg scale after 6MWT. Pulmonary function tests included spirometry, plethysmography, diffusing capacity of carbon monoxide and arterial blood gases. Fasting blood glucose, total cholesterol, triglyceride, N-terminal pro brain natriuretic peptide, C-reactive protein and hemoglobin levels were analyzed.
Results
Eighty-four percent of patients had a mMRC ≥ 1 and 40% a mMRC ≥ 2. Compared to subjects with no dyspnea (mMRC = 0), a mMRC ≥ 1 was associated with a higher BMI (44 ± 9 vs 36 ± 5 kg/m2, p = 0.01), and a lower expiratory reserve volume (ERV) (50 ± 31 vs 91 ± 32%, p = 0.004), forced expiratory volume in one second (FEV1) (86 ± 17 vs 101 ± 16%, p = 0.04) and distance covered in 6MWT (401 ± 107 vs 524 ± 72 m, p = 0.007). A mMRC ≥ 2 was associated with a higher Borg score after the 6MWT (4.7 ± 2.5 vs 6.5 ± 1.5, p < 0.05).
Conclusion
This study confirms that dyspnea is very frequent in obese subjects. The differences between the “dyspneic” and the “non dyspneic” groups assessed by the mMRC scale for BMI, ERV, FEV1 and distance covered in 6MWT suggests that the mMRC scale might be an useful and easy-to-use tool to assess dyspnea in daily living in obese subjects.
doi:10.1186/1471-2466-12-61
PMCID: PMC3515513  PMID: 23025326
Dyspnea; Obesity; Modified Medical Research Council scale; Six-minute walk test; Lung function
6.  Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease 
Thorax  1999;54(7):581-586.
BACKGROUND—Methods of classifying chronic obstructive pulmonary disease (COPD) depend largely upon spirometric measurements but disability is only weakly related to measurements of lung function. With the increased use of pulmonary rehabilitation, a need has been identified for a simple and standardised method of categorising disability in COPD. This study examined the validity of the Medical Research Council (MRC) dyspnoea scale for this purpose.
METHODS—One hundred patients with COPD were recruited from an outpatient pulmonary rehabilitation programme. Assessments included the MRC dyspnoea scale, spirometric tests, blood gas tensions, a shuttle walking test, and Borg scores for perceived breathlessness before and after exercise. Health status was assessed using the St George's Respiratory Questionnaire (SGRQ) and Chronic Respiratory Questionnaire (CRQ). The Nottingham Extended Activities of Daily Living (EADL) score and Hospital Anxiety and Depression (HAD) score were also measured.
RESULTS—Of the patients studied, 32 were classified as having MRC grade 3 dyspnoea, 34 MRC grade 4 dyspnoea, and 34 MRC grade 5 dyspnoea. Patients with MRC grades 1 and 2 dyspnoea were not included in the study. There was a significant association between MRC grade and shuttle distance, SGRQ and CRQ scores, mood state and EADL. Forced expiratory volume in one second (FEV1) was not associated with MRC grade. Multiple logistic regression showed that the determinants of disability appeared to vary with the level of disability. Between MRC grades 3 and 4 the significant covariates were exercise performance, SGRQ and depression score, whilst between grades 4 and 5 exercise performance and age were the major determinants.
CONCLUSIONS—The MRC dyspnoea scale is a simple and valid method of categorising patients with COPD in terms of their disability that could be used to complement FEV1 in the classification of COPD severity.


PMCID: PMC1745516  PMID: 10377201
7.  Epidemiological Pathology of Dementia: Attributable-Risks at Death in the Medical Research Council Cognitive Function and Ageing Study 
PLoS Medicine  2009;6(11):e1000180.
Researchers from the Medical Research Council Cognitive Function and Ageing Neuropathology Study carry out an analysis of brain pathologies contributing to dementia, within a cohort of elderly individuals in the UK who agreed to brain donation.
Background
Dementia drug development aims to modulate pathological processes that cause clinical syndromes. Population data (epidemiological neuropathology) will help to model and predict the potential impact of such therapies on dementia burden in older people. Presently this can only be explored through post mortem findings. We report the attributable risks (ARs) for dementia at death for common age-related degenerative and vascular pathologies, and other factors, in the MRC Cognitive Function and Ageing Study (MRC CFAS).
Methods and Findings
A multicentre, prospective, longitudinal study of older people in the UK was linked to a brain donation programme. Neuropathology of 456 consecutive brain donations assessed degenerative and vascular pathologies. Logistic regression modelling, with bootstrapping and sensitivity analyses, was used to estimate AR at death for dementia for specific pathologies and other factors. The main contributors to AR at death for dementia in MRC CFAS were age (18%), small brain (12%), neocortical neuritic plaques (8%) and neurofibrillary tangles (11%), small vessel disease (12%), multiple vascular pathologies (9%), and hippocampal atrophy (10%). Other significant factors include cerebral amyloid angiopathy (7%) and Lewy bodies (3%).
Conclusions
Such AR estimates cannot be derived from the living population; rather they estimate the relative contribution of specific pathologies to dementia at death. We found that multiple pathologies determine the overall burden of dementia. The impact of therapy targeted to a specific pathology may be profound when the dementia is relatively “pure,” but may be less impressive for the majority with mixed disease, and in terms of the population. These data justify a range of strategies, and combination therapies, to combat the degenerative and vascular determinants of cognitive decline and dementia.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Losing one's belongings and forgetting people's names is often a normal part of aging. But increasing forgetfulness can also be a sign of dementia, a group of symptoms caused by several disorders that affect the structure of the brain. The commonest form of dementia is Alzheimer disease. In this, protein clumps called plaques and neurofibrillary tangles form in the brain and cause its degeneration. Vascular dementia, in which problems with blood circulation deprive parts of the brain of oxygen, is also common. People with dementia have problems with two or more “cognitive” functions—thinking, language, memory, understanding, and judgment. As the disease progresses, they gradually lose their ability to deal with normal daily activities until they need total care, their personality often changes, and they may become agitated or aggressive. Dementia is rare before the age of 65 years but about a quarter of people over 85 years old have dementia. Because more people live to a ripe old age these days, the number of people with dementia is increasing. According to the latest estimates, about 35 million people now have dementia and by 2050, 115 million may have the disorder.
Why Was This Study Done?
There is no cure for dementia but many drugs designed to modulate specific abnormal (pathological) changes in the brain that can cause the symptoms of dementia are being developed. To assess the likely impact of these potentially expensive new therapies, experts need to know what proportion of dementia is associated with each type of brain pathology. Although some brain changes can be detected in living brains with techniques such as computed tomography brain scans, most brain changes can only be studied in brains taken from people after death (post mortem brains). In this study, which is part of the UK Medical Research Council Cognitive Function and Ageing Study (MRC CFAS), the researchers look for associations between dementia in elderly people and pathological changes in their post mortem brains and estimate the attributable-risk (AR) for dementia at death associated with specific pathological features in the brain. That is, they estimate the proportion of dementia directly attributable to each type of pathology.
What Did the Researchers Do and Find?
Nearly 20 years ago, the MRC CFAS interviewed more than 18,000 people aged 65 years or older recruited at six sites in England and Wales to determine their cognitive function and their ability to deal with daily activities. 20% of the participants, which included people with and without cognitive impairment, were then assessed in more detail and invited to donate their brains for post mortem examination. As of 2004, 456 individuals had donated their brains. The dementia status of these donors was established using data from their assessment interviews and death certificates, and from interviews with relatives and carers, and their brains were carefully examined for abnormal changes. The researchers then used statistical methods to estimate the AR for dementia at death associated with various abnormal brain changes. The main contributors to AR for dementia at death included age (18% of dementia at death was attributable to this factor), plaques (8%), and neurofibrillary tangles (11%) in a brain region called the neocortex, small blood vessel disease (12%), and multiple abnormal changes in blood vessels (9%).
What Do These Findings Mean?
These findings suggest that multiple abnormal brain changes determine the overall burden of dementia. Importantly, they also suggest that dementia is often associated with mixed pathological changes—many people with dementia had brain changes consistent with both Alzheimer disease and vascular dementia. Because people with dementia live for variable lengths of time during which the abnormal changes in their brain are likely to alter, it may be difficult to extrapolate these findings to living populations of elderly people. Furthermore, only a small percentage of the MRC CFAS participants have donated their brains so the findings of this study may not apply to the general population. Nevertheless, these findings suggest that the new therapies currently under development may do little to reduce the overall burden of dementia because most people's dementia involves multiple pathologies. Consequently, it may be necessary to develop a range of strategies and combination therapies to deal with the ongoing dementia epidemic.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000180.
The US National Institute on Aging provides information for patients and carers about forgetfulness and about Alzheimer disease (in English and Spanish)
The US National Institute of Neurological Disorders and Stroke provides information about dementia (in English and Spanish)
The UK National Health Service Choices Web site also provides detailed information for patients and their carers about dementia and about Alzheimer disease
MedlinePlus provides links to additional resources about dementia and Alzheimer disease (in English and Spanish)
More information about the UK Medical Research Council Cognitive Function and Ageing Study (MRC CFAS) is available
doi:10.1371/journal.pmed.1000180
PMCID: PMC2765638  PMID: 19901977
8.  Differences in classification of COPD group using COPD assessment test (CAT) or modified Medical Research Council (mMRC) dyspnea scores: a cross-sectional analyses 
Background
The GOLD 2011 document proposed a new classification system for COPD combining symptom assessment by COPD assessment test (CAT) or modified Medical Research Council (mMRC) dyspnea scores, and exacerbation risk. We postulated that classification of COPD would be different by the symptom scale; CAT vs mMRC.
Methods
Outpatients with COPD were enrolled from January to June in 2012. The patients were categorized into A, B, C, and D according to the GOLD 2011; patients were categorized twice with mMRC and CAT score for symptom assessment, respectively. Additionally, correlations between mMRC scores and each item of CAT scores were analyzed.
Results
Classification of 257 patients using the CAT score vs mMRC scale was as follows. By using CAT score, 60 (23.3%) patients were assigned to group A, 55 (21.4%) to group B, 21 (8.2%) to group C, and 121 (47.1%) to group D. On the basis of the mMRC scale, 97 (37.7%) patients were assigned to group A, 18 (7.0%) to group B, 62 (24.1%) to group C, and 80 (31.1%) to group D. The kappa of agreement for the GOLD groups classified by CAT and mMRC was 0.510. The mMRC score displayed a wide range of correlation with each CAT item (r = 0.290 for sputum item to r = 0.731 for dyspnea item, p < 0.001).
Conclusions
The classification of COPD produced by the mMRC or CAT score was not identical. Care should be taken when stratifying COPD patients with one symptom scale versus another according to the GOLD 2011 document.
doi:10.1186/1471-2466-13-35
PMCID: PMC3680333  PMID: 23731868
COPD; CAT; mMRC scores
9.  Why the Medical Research Council refused Robert Edwards and Patrick Steptoe support for research on human conception in 1971 
Human Reproduction (Oxford, England)  2010;25(9):2157-2174.
BACKGROUND
In 1971, Cambridge physiologist Robert Edwards and Oldham gynaecologist Patrick Steptoe applied to the UK Medical Research Council (MRC) for long-term support for a programme of scientific and clinical ‘Studies on Human Reproduction’. The MRC, then the major British funder of medical research, declined support on ethical grounds and maintained this policy throughout the 1970s. The work continued with private money, leading to the birth of Louise Brown in 1978 and transforming research in obstetrics, gynaecology and human embryology.
METHODS
The MRC decision has been criticized, but the processes by which it was reached have yet to be explored. Here, we present an archive-based analysis of the MRC decision.
RESULTS
We find evidence of initial support for Edwards and Steptoe, including from within the MRC, which invited the applicants to join its new directly funded Clinical Research Centre at Northwick Park Hospital. They declined the offer, preferring long-term grant support at the University of Cambridge, and so exposed the project to competitive funding mode. Referees and the Clinical Research Board saw the institutional set-up in Cambridge as problematic with respect to clinical facilities and patient management; gave infertility a low priority compared with population control; assessed interventions as purely experimental rather than potential treatments, and so set the bar for safety high; feared fatal abnormalities and so wanted primate experiments first; and were antagonized by the applicants’ high media profile. The rejection set MRC policy on IVF for 8 years, until, after the birth of just two healthy babies, the Council rapidly converted to enthusiastic support.
CONCLUSIONS
This analysis enriches our view of a crucial decision, highlights institutional opportunities and constraints and provides insight into the then dominant attitudes of reproductive scientists and clinicians towards human conception research.
doi:10.1093/humrep/deq155
PMCID: PMC2922998  PMID: 20657027
Robert Edwards; funding; history; human conception; IVF; Medical Research Council; Patrick Steptoe
10.  Long-term follow-up of the United Kingdom Medical Research Council protocols for childhood acute Lymphoblastic leukaemia, 1980–2001 
Leukemia  2009;24(2):406-418.
Between 1980 and 2001, the United Kingdom Medical Research Council Childhood Leukemia Working Party has conducted 4 clinical trial in acute lymphoblastic leukemia, which have recruited a total of 6516 patients. UKALL VIII examined the role of daunorubicin in induction chemotherapy, and UKALL X examined the role of post-induction intensification. Both resulted in major improvement in the outcomes. UKALL XI examined the efficacy of different methods of CNS-directed therapy and the effects of an additional intensification. ALL97, which was initially based on the UKALL X D template (two intensification phases), examined the role of different steroids in induction and different thiopurines through continuing chemotherapy. A reappraisal of results from UKALL XI compared to other cooperative group results led to a redesign in 1999, which subsequently resulted in a major improvement in outcomes. Additionally, ALL97 and 97/99 demonstrated a significant advantage for the use of dexamethasone rather than prednisolone; although the use of 6-thioguanine resulted in fewer relapses, this advantage was offset by an increased incidence of deaths in remission. Over the era encompassed by these four trials there has been a major improvement in both event-free and overall survival for children in the UK with ALL.
doi:10.1038/leu.2009.256
PMCID: PMC2820452  PMID: 20010621
acute leukemia; therapy; clinical trial
11.  What happens to clinical training fellows? A retrospective study of the 20 years outcome of a Medical Research Council UK cohort 
BMJ Open  2012;2(4):e001792.
Objectives
The Clinical Research Training Fellowship (CRTF) allows up to 3 years support for clinically qualified candidates to undertake specialised or further research training in biomedical sciences. CRTFs are perceived as a crucial step in the career development and progression of Clinical Academics but there are no published data to support this notion. We conducted an electronic survey of a large cohort of Medical Research Council (MRC) CRTFs followed for up to 20 years.
Design
Retrospective analysis of CRTF outcome data held with the MRC, UK.
Participants
Two cohorts comprising 40 CRFTs awarded by the MRC in the year 1991 and 299 MRC CRTFs who were awarded a fellowship between 1993 and 2003.
Results
The MRC CRTF scheme built capacity in clinical academia across the UK with 40% of CRTFs progressing to a University professorship. Importantly, the CRTF scheme is also providing NHS consultants who remain research active.
Conclusions
This is the first analysis of outcome of CRTFs in the UK and provides robust evidence of the importance of this capacity building mode of funding to underpin research excellence at the University–NHS interface.
doi:10.1136/bmjopen-2012-001792
PMCID: PMC3432844  PMID: 22936819
12.  Three Decades of Research on Computer Applications in Health Care 
The Agency for Healthcare Research and Quality and its predecessor organizations—collectively referred to here as AHRQ—have a productive history of funding research and development in the field of medical informatics, with grant investments since 1968 totaling $107 million. Many computerized interventions that are commonplace today, such as drug interaction alerts, had their genesis in early AHRQ initiatives.
This review provides a historical perspective on AHRQ investment in medical informatics research. It shows that grants provided by AHRQ resulted in achievements that include advancing automation in the clinical laboratory and radiology, assisting in technology development (computer languages, software, and hardware), evaluating the effectiveness of computer-based medical information systems, facilitating the evolution of computer-aided decision making, promoting computer-initiated quality assurance programs, backing the formation and application of comprehensive data banks, enhancing the management of specific conditions such as HIV infection, and supporting health data coding and standards initiatives.
Other federal agencies and private organizations have also supported research in medical informatics, some earlier and to a greater degree than AHRQ. The results and relative roles of these related efforts are beyond the scope of this review.
doi:10.1197/jamia.M0867
PMCID: PMC344572  PMID: 11861630
13.  An investigation of whether factors associated with short-term attrition change or persist over ten years: data from the Medical Research Council Cognitive Function and Ageing Study (MRC CFAS) 
BMC Public Health  2006;6:185.
Background
Factors associated with the loss of participants in long-term longitudinal studies of ageing, due to refusal or moves, have been discussed less than those with short term follow-up.
Methods
In a population-based study of cognition and ageing (the Medical Research Council Cognitive Function and Ageing Study (MRC CFAS)), factors associated with dropout due to refusal and moving in the first follow-up period (over two years) are compared with factors associated with dropout over ten years. Participants at 10-year follow-up are compared with their age-standardised baseline contemporaries.
Results
Some consistent trends are found over the longer term. Refusers tended to have poorer cognition, less years of education, not have a family history of dementia and be women. Characteristics of people who moved differed between waves, but the oldest and people in worse health moved more. When surviving and responding individuals at ten years are compared with those of the same age at baseline many differences are found. Individuals of lower social class, education, cognitive ability, in residential care, with sight/hearing problems and poor/fair self-reported health are less likely to be seen after 10 years of follow-up. Individuals report more health problems when they participate in multiple interviews.
Conclusion
The characteristics of refusers in the longer term are similar to those refusing to participate over the shorter term. Long-term follow-up studies will under represent the disadvantaged and disabled but represent full health status of participating individuals better. There are advantages and disadvantages to both short-term and long-term follow-up.
doi:10.1186/1471-2458-6-185
PMCID: PMC1538586  PMID: 16848886
14.  Study protocol: delayed intervention randomised controlled trial within the Medical Research Council (MRC) Framework to assess the effectiveness of a new palliative care service 
Background
Palliative care has been proposed to help meet the needs of patients who suffer progressive non-cancer conditions but there have been few evaluations of service development initiatives. We report here a novel protocol for the evaluation of a new palliative care service in this context.
Methods/Design
Using the MRC Framework for the Evaluation of Complex Interventions we modelled a new palliative care and neurology service for patients severely affected by Multiple Sclerosis (MS). We conducted qualitative interviews with patients, families and staff, plus a literature review to model and pilot the service. Then we designed a delayed intervention randomised controlled trial to test its effectiveness as part of phase II of the MRC framework. Inclusion criteria for the trial were patients identified by referring clinicians as having unresolved symptoms or psychological concerns. Referrers were advised to use a score of greater than 8 on the Expanded Disability Scale was a benchmark. Consenting patients newly referred to the new service were randomised to either receive the palliative care service immediately (fast-track) or after a 12-week wait (standard best practice). Face to face interviews were conducted at baseline (before intervention), and at 4–6, 10–12 (before intervention for the standard-practice group), 16–18 and 22–24 weeks with patients and their carers using standard questionnaires to assess symptoms, palliative care outcomes, function, service use and open comments. Ethics committee approval was granted separately for the qualitative phase and then for the trial.
Discussion
We publish the protocol trial here, to allow methods to be reviewed in advance of publication of the results. The MRC Framework for the Evaluation of Complex Interventions was helpful in both the design of the service, methods for evaluation in convincing staff and the ethics committee to accept the trial. The research will provide valuable information on the effects of palliative care among non-cancer patients and a method to evaluate palliative care in this context.
doi:10.1186/1472-684X-5-7
PMCID: PMC1615868  PMID: 17014714
15.  Homeopathy – what are the active ingredients? An exploratory study using the UK Medical Research Council's framework for the evaluation of complex interventions 
Background
Research in homeopathy has traditionally addressed itself to defining the effectiveness of homeopathic potencies in comparison to placebo medication. There is now increasing awareness that the homeopathic consultation is in itself a therapeutic intervention working independently or synergistically with the prescribed remedy. Our objective was to identify and evalute potential "active ingredients" of the homeopathic approach as a whole, in a prospective formal case series, which draws on actual consultation data, and is based on the MRC framework for the evaluation of complex interventions.
Methods
Following on from a theoretical review of how homeopathic care might mediate its effects, 18 patients were prospectively recruited to a case series based at Bristol Homeopathic Hospital. Patients, who lived with one of three index conditions, were interviewed before and after a five visit "package of care". All consultations were recorded and transcribed verbatim. Additional data, including generic and condition-specific questionnaires, artwork and "significant other" reports were collected. Textual data was subject to thematic analysis and triangulated with other sources.
Results
We judged that around one third of patients had experienced a major improvement in their health over the study period, a third had some improvement and a third had no improvement. Putative active ingredients included the patients' "openness to the mind-body connection", consultational empathy, in-depth enquiry into bodily complaints, disclosure, the remedy matching process and, potentially, the homeopathic remedies themselves.
Conclusion
This study has has identified, using primary consultation and other data, a range of factors that might account for the effectiveness of homeopathic care. Some of these, such as empathy, are non-specific. Others, such as the remedy matching process, are specific to homeopathy. These findings counsel against the use of placebo-controlled RCT designs in which both arms would potentially be receiving specific active ingredients. Future research in homeopathy should focus on pragmatic trials and seek to confirm or refute the therapeutic role of constructs such as patient "openness", disclosure and homeopathicity.
doi:10.1186/1472-6882-6-37
PMCID: PMC1676018  PMID: 17101037
16.  Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions 
Trials  2014;15:267.
Background
The Medical Research Councils’ framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable.
Methods
We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions.
Results
Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework.
Conclusions
Incorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex interventions, thereby increasing the likelihood that the intervention will be ultimately effective, sustainable and scalable. We urge researchers developing and evaluating complex interventions to consider using this approach, to evaluate its usefulness and to build an evidence base to further refine the methodology.
Trial registration
Clinical trials.gov: NCT02160249
doi:10.1186/1745-6215-15-267
PMCID: PMC4227087  PMID: 24996765
Complex interventions; Theory of Change; MRC framework for complex interventions
17.  The Registration of Medical Graduates from Eastern European Union Countries with the General Medical Council (GMC) and the Medical Council, Ireland. 
The Ulster Medical Journal  2013;82(2):71-74.
The purpose of this study was to identify the number of medical graduates registered with the General Medical Council (GMC) between 1990 and 2005, whose initial training was in Eastern Europe and who came from universities which have subsequently developed an “English Parallel” course and are now within the European Union (EU). A similar exercise was undertaken with graduates registered with the Medical Council, Ireland.
Between 1990 and 2005 one thousand six hundred and fourteen (1614) doctors, who had trained in the selected universities from Eastern Europe, registered with the General Medical Council (GMC) in the United Kingdom (Table 1). The Register of Medical Practitioners for Ireland as at 1st July 2005 was also scanned manually to identify graduates from these countries who were registered in Ireland. Sixty four such graduates were identified of whom 6 qualified before 1990 and 5 were in their internship year. The study suggests that since 2000 younger graduates who sought training in Central and Eastern Europe are returning to the UK shortly after graduation to register and start clinical training.
PMCID: PMC3756861  PMID: 24082282
18.  Medical Research Council dyspnea scale does not relate to fibroblast foci profusion in IPF 
Diagnostic Pathology  2011;6:28.
Background
In Idiopathic pulmonary fibrosis (IPF) irreversibly progressive fibrosing parenchymal damage, leads to defects in mechanics and gas exchange, manifesting with disabling exertional dyspnea. Previous studies have shown a relationship between fibroblast foci (FF) profusion and severity and survival and a relationship between dyspnea grade and severity and outcome. We hypothesized a relationship between Medical Research Council (MRC) dyspnea scale with FF, and a relationship between FF and functional parameters and survival.
Methods
We retrospectively reviewed 24 histologically documented IPF patients. Profusion of FF was semiquantitatively evaluated by two scores, Brompton and Michigan. Survival analysis was performed by fitting Cox regression models to examine the relationship of the two scores with survival and the non-parametric Spearman correlation coefficient was calculated to describe the relationships of FF scores with dyspnea scores and functional parameters.
Results
No statistically significant correlation between FF scores and the MRC scores was observed (p = 0.96 and p = 0.508 respectively). No significant correlation between FF scores and survival (p = 0.438 and p = 0.861 respectively) or any functional parameter was observed.
Conclusions
The lack of relationship between the MRC dyspnea scale and the FF might relate to the fact that dyspnea in IPF better reflects the overall of lung damage and its related consequences on mechanics and gas exchange whereas FF, one of its histological hallmarks, may not reflect its entire histology derangement also constrained by the geographically limited sampled tissue. This might be also valid for the observed lack of association between FF and survival or functional parameters.
doi:10.1186/1746-1596-6-28
PMCID: PMC3083323  PMID: 21466701
dyspnea; pulmonary fibrosis; fibroblast foci
19.  A Medical Research Council randomized trial of single agent carboplatin versus etoposide and cisplatin for advanced metastatic seminoma 
British Journal of Cancer  2000;83(12):1623-1629.
The UK Medical Research Council conducted this trial of carboplatin chemotherapy in advanced seminoma to compare single agent carboplatin with a standard combination of etoposide with cisplatin. The use of single agent carboplatin was expected to be associated with reduced toxicity. A total of 130 patients with advanced seminoma were randomly assigned to treatment with either single agent carboplatin (C) at a dose of 400 mg/m2 to be corrected for glomerular filtration rate outside the range 81–120 ml min–1 and to be administered on day 1 of a 21 day cycle to a total of 4 cycles or to etoposide + platinum (EP). The trial was designed as an equivalence study aiming to exclude a reduction in the 3-year progression-free survival in patients allocated to carboplatin of between 10 and 15%, requiring initially a target accrual of 250 patients (90% power significance level 5% (one-sided)). The trial closed after 130 patients had been randomized following recommendation by an independent data monitoring committee. At a median follow-up time of 4.5 years, 81% of patients had been followed up for at least 3 years and 19 patients have died. The estimated PFS rate (95% Confidence Intervals (CI)) at 3 years was 71% (60–82%) in patients allocated C and 81% (71–90%) in those allocated EP; the 95% CI for the difference in 3 year PFS was – 6% to +19%. The hazard ratio of 0.64 (95% CI 0.32–1.28) favoured EP but the difference was not statistically significant (log rank chi-squared = 1.59 P = 0.21). The 3-year survival rate was 84% (75–92%) in those allocated C, and 89% (81–96%) in those allocated EP. The hazard ratio for survival was 0.85 with 95% CI, 0.35–2.10, log rank chi-squared = 0.12, P = 0.73. The trial has not demonstrated statistically significant differences in the major survival endpoints comparing single agent carboplatin with a combination of etoposide + cisplatin. This cannot be taken as an indication of equivalence since the limited size of this trial rendered it unable to exclude a 19% lower progression-free survival and survival in those treated with single agent carboplatin which would be important clinically. Standard initial chemotherapy for advanced seminoma should be based on cisplatin combinations and the role of carboplatin awaits the outcome of further studies. © 2000 Cancer Research Campaign http://www.bjcancer.com
doi:10.1054/bjoc.2000.1498
PMCID: PMC2363456  PMID: 11104556
seminoma; germ cell tumour; chemotherapy; cisplatin; carboplatin; randomized control trial
20.  The UPBEAT depression and coronary heart disease programme: using the UK medical research council framework to design a nurse-led complex intervention for use in primary care 
BMC Family Practice  2012;13:119.
Background
Depression is common in coronary heart disease (CHD) and increases the incidence of coronary symptoms and death in CHD patients. Interventions feasible for use in primary care are needed to improve both mood and cardiac outcomes. The UPBEAT-UK programme of research has been funded by the NHS National Institute for Health Research (NIHR) to explore the relationship between CHD and depression and to develop a new intervention for use in primary care.
Methods
Using the Medical Research Council (MRC) guidelines for developing and evaluating complex interventions, we conducted a systematic review and qualitative research to develop a primary care-based nurse-led intervention to improve mood and cardiac outcomes in patients with CHD and depression. Iterative literature review was used to synthesise our empirical work and to identify evidence and theory to inform the intervention.
Results
We developed a primary care-based nurse-led personalised care intervention which utilises elements of case management to promote self management. Following biopsychosocial assessment, a personalised care plan is devised. Nurses trained in behaviour change techniques facilitate patients to address the problems important to them. Identification and utilisation of existing resources is promoted. Nurse time is conserved through telephone follow up.
Conclusions
Application of the MRC framework for complex interventions has allowed us to develop an evidence based intervention informed by patient and clinician preferences and established theory. The feasibility and acceptability of this intervention is now being tested further in an exploratory trial.
doi:10.1186/1471-2296-13-119
PMCID: PMC3538052  PMID: 23234253
Complex intervention; Personalised care; Coronary heart disease; Depression; Primary care
21.  Informed palliative care in nursing homes through the interRAI Palliative Care instrument: a study protocol based on the Medical Research Council framework 
BMC Geriatrics  2014;14(1):132.
Background
Nursing homes are important locations for palliative care. Through comprehensive geriatric assessments (CGAs), evaluations can be made of palliative care needs of nursing home residents. The interRAI Palliative Care instrument (interRAI PC) is a CGA that evaluates diverse palliative care needs of adults in all healthcare settings. The evaluation results in Client Assessment Protocols (CAPs: indications of problems that need addressing) and Scales (e.g. Palliative Index for Mortality (PIM)) which can be used to design, evaluate and adjust care plans. This study aims to examine the effect of using the interRAI PC on the quality of palliative care in nursing homes. Additionally, it aims to evaluate the feasibility and validity of the interRAI PC.
Methods
This study covers phases 0, I and II of the Medical Research Council (MRC) framework for designing and evaluating complex interventions, with a longitudinal, quasi-experimental pretest-posttest design and with mixed methods of evaluation. In phase 0, a systematic literature search is conducted. In phase I, the interRAI PC is adapted for use in Belgium and implemented on the BelRAI-website and a practical training is developed. In phase II, the intervention is tested in fifteen nursing homes. Participating nursing homes fill out the interRAI PC during one year for all residents receiving palliative care. Using a pretest-posttest design with quasi-random assignment to the intervention or control group, the effect of the interRAI PC on the quality of palliative care is evaluated with the Palliative care Outcome Scale (POS). Psychometric analysis is conducted to evaluate the predictive validity of the PIM and the convergent validity of the CAP ‘Mood’ of the interRAI PC. Qualitative data regarding the usability and face validity of the instrument are collected through focus groups, interviews and field notes.
Discussion
This is the first study to evaluate the validity and effect of the interRAI PC in nursing homes, following a methodology based on the MRC framework. This approach improves the study design and implementation and will contribute to a higher generalizability of results. The final result will be a psychometrically evaluated CGA for nursing home residents receiving palliative care.
Trial registration
ClinicalTrials.gov NCT02281032. Registered October 30th, 2014.
doi:10.1186/1471-2318-14-132
PMCID: PMC4280705  PMID: 25479633
Palliative care; Nursing homes; Comprehensive geriatric assessment; interRAI Palliative Care instrument; Older adults; Study protocol
22.  Motor grading of elbow flexion – is Medical Research Council grading good enough? 
Restoration of elbow flexion is top priority in reconstruction following brachial plexus injury. Medical Research Council (MRC) Grading is the most commonly used scale to grade muscle power. Though simple to use, it has several limitations. Each grade represents a very wide range and hence precludes accurate assessment of function and outcome following a given procedure. Wide range of Grade 4 is most worrisome. Definitely all grade 4 labeled can not equate to good functional results. With most of the nerve transfer procedures described now claiming grade 4 recoveries in more than 80% of the reported cases a need for more detailed and accurate assessment of this grade is greatly felt. A modified MRC grading system is described which is comprehensive and easy to use.
doi:10.1186/1749-7221-4-3
PMCID: PMC2694805  PMID: 19439090
23.  Insights into the Management of Emerging Infections: Regulating Variant Creutzfeldt-Jakob Disease Transfusion Risk in the UK and the US 
PLoS Medicine  2006;3(10):e342.
Background
Variant Creutzfeldt-Jakob disease (vCJD) is a human prion disease caused by infection with the agent of bovine spongiform encephalopathy. After the recognition of vCJD in the UK in 1996, many nations implemented policies intended to reduce the hypothetical risk of transfusion transmission of vCJD. This was despite the fact that no cases of transfusion transmission had yet been identified. In December 2003, however, the first case of vCJD in a recipient of blood from a vCJD-infected donor was announced. The aim of this study is to ascertain and compare the factors that influenced the motivation for and the design of regulations to prevent transfusion transmission of vCJD in the UK and US prior to the recognition of this case.
Methods and Findings
A document search was conducted to identify US and UK governmental policy statements and guidance, transcripts (or minutes when transcripts were not available) of scientific advisory committee meetings, research articles, and editorials published in medical and scientific journals on the topic of vCJD and blood transfusion transmission between March 1996 and December 2003. In addition, 40 interviews were conducted with individuals familiar with the decision-making process and/or the science involved. All documents and transcripts were coded and analyzed according to the methods and principles of grounded theory. Data showed that while resulting policies were based on the available science, social and historical factors played a major role in the motivation for and the design of regulations to protect against transfusion transmission of vCJD. First, recent experience with and collective guilt resulting from the transfusion-transmitted epidemics of HIV/AIDS in both countries served as a major, historically specific impetus for such policies. This history was brought to bear both by hemophilia activists and those charged with regulating blood products in the US and UK. Second, local specificities, such as the recall of blood products for possible vCJD contamination in the UK, contributed to a greater sense of urgency and a speedier implementation of regulations in that country. Third, while the results of scientific studies played a prominent role in the construction of regulations in both nations, this role was shaped by existing social and professional networks. In the UK, early focus on a European study implicating B-lymphocytes as the carrier of prion infectivity in blood led to the introduction of a policy that requires universal leukoreduction of blood components. In the US, early focus on an American study highlighting the ability of plasma to serve as a reservoir of prion infectivity led the FDA and its advisory panel to eschew similar measures.
Conclusions
The results of this study yield three important theoretical insights that pertain to the global management of emerging infectious diseases. First, because the perception and management of disease may be shaped by previous experience with disease, especially catastrophic experience, there is always the possibility for over-management of some possible routes of transmission and relative neglect of others. Second, local specificities within a given nation may influence the temporality of decision making, which in turn may influence the choice of disease management policies. Third, a preference for science-based risk management among nations will not necessarily lead to homogeneous policies. This is because the exposure to and interpretation of scientific results depends on the existing social and professional networks within a given nation. Together, these theoretical insights provide a framework for analyzing and anticipating potential conflicts in the international management of emerging infectious diseases. In addition, this study illustrates the utility of qualitative methods in investigating research questions that are difficult to assess through quantitative means.
A qualitative study of US and UK governmental policy statements on the topic of vCJD and blood transfusion transmission identified factors responsible for differences in the policies adopted.
Editors' Summary
Background.
In 1996 in the UK, a new type of human prion disease was seen for the first time. This is now known as variant Creutzfeldt-Jakob disease (vCJD). Prion diseases are rare brain diseases passed from individual to individual (or between animals) by a particular type of wrongly folded protein, and they are fatal. It was suspected that vCJD had passed to humans from cattle, and that the agent causing vCJD was the same as that causing bovine spongiform encephalopathy (or “mad cow disease”). Shortly after vCJD was recognized, authorities in many countries became concerned about the possibility that it could be transmitted from one person to another through contaminated blood supplies used for transfusion in hospitals. Even though there wasn't any evidence of actual transmission of the disease through blood before December 2003, authorities in the UK, US, and elsewhere set up regulations designed to reduce the chance of that happening. At this early stage in the epidemic, there was little in the way of scientific information about the transmission properties of the disease. Both the UK and US, however, sought to make decisions in a scientific manner. They made use of evidence as it was being produced, often before it had been published. Despite this, the UK and US decided on very different changes to their respective regulations on blood donation. Both countries chose to prevent certain people (who they thought would be at greater risk of having vCJD) from donating blood. In the UK, however, the decision was made to remove white blood cells from donated blood to reduce the risk of transmitting vCJD, while the US decided that such a step was not merited by the evidence.
Why Was This Study Done?
This researcher wanted to understand more clearly why the UK and US ended up with different policies: what role was played by science, and what role was played by non-scientific factors? She hoped that insights from this investigation would also be relevant to similar challenges in the future—for example, as many countries try to work out how to control the threat of avian flu.
What Did the Researcher Do and Find?
The researcher searched for all relevant official government documents from the US and UK, as well as scientific papers, published between the time vCJD was first identified (March 1996) and the first instance of vCJD carried through blood (December 2003). She also interviewed people who knew about vCJD management in the US and UK—for example, members of government agencies and the relevant advisory committees. From the documents and interviews, the researcher picked out and grouped shared ideas. Although these documents and interviews suggested that policy making was rooted in scientific evidence, many non-scientific factors were also important. The researcher found substantial uncertainty in the scientific evidence available at the time. The document search and interviews showed that policy makers felt guilty about a previous experience in which people had become infected with HIV/AIDS through contaminated blood and were concerned about repeating this experience. Finally, in the UK, the possibility of blood contamination was seen as a much more urgent problem than in the US, because BSE and vCJD were found there first and there were far more cases. This meant that when the UK made its decision about whether to remove white blood cells from donated blood, there was less scientific evidence available. In fact, the main study that was relied on at the time would later be questioned.
What Do These Findings Mean?
These findings show that for this particular case, science was not the only factor affecting government policies. Historical and social factors such as previous experience, sense of urgency, public pressure, and the relative importance of different scientific networks were also very important. The study predicts that in the future, infectious disease–related policy decisions are unlikely to be the same across different countries because the interpretation of scientific evidence depends, to a large extent, on social factors.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030342.
National Creutzfeldt-Jakob Disease Surveillance Unit, Edinburgh, UK
US Centers for Disease Control and Prevention pages about prion diseases
World Health Organization variant Creutzfeldt-Jakob disease fact sheet
US National Institute of Neurological Disorders and Stroke information about prion diseases
doi:10.1371/journal.pmed.0030342
PMCID: PMC1621089  PMID: 17076547
24.  Are medical educators following General Medical Council guidelines on obesity education: if not why not? 
BMC Medical Education  2013;13:53.
Background
Although the United Kingdom’s (UK’s) General Medical Council (GMC) recommends that graduating medical students are competent to discuss obesity and behaviour change with patients, it is difficult to integrate this education into existing curricula, and clinicians report being unprepared to support patients needing obesity management in practice. We therefore aimed to identify factors influencing the integration of obesity management education within medical schools.
Methods
Twenty-seven UK and Irish medical school educators participated in semi-structured interviews. Grounded theory principles informed data collection and analysis. Themes emerging directly from the dataset illustrated key challenges for educators and informed several suggested solutions.
Results
Factors influencing obesity management education included: 1) Diverse and opportunistic learning and teaching, 2) Variable support for including obesity education within undergraduate medical programmes, and 3) Student engagement in obesity management education. Findings suggest several practical solutions to identified challenges including clarifying recommended educational agendas; improving access to content-specific guidelines; and implementing student engagement strategies.
Conclusions
Students’ educational experiences differ due to diverse interpretations of GMC guidelines, educators’ perceptions of available support for, and student interest in obesity management education. Findings inform the development of potential solutions to these challenges which may be tested further empirically.
doi:10.1186/1472-6920-13-53
PMCID: PMC3641974  PMID: 23578257
Qualitative; Interviews; UK; Undergraduate education; Curriculum; Obesity
25.  Neglect of Medical Evidence of Torture in Guantánamo Bay: A Case Series 
PLoS Medicine  2011;8(4):e1001027.
Vincent Iacopino and Stephen Xenakis review case records of nine individuals imprisoned at Guantánamo Bay which indicate that medical personnel assigned to the US Department of Defense neglected and/or concealed medical evidence of torture.
Background
In the wake of the September 11, 2001 attacks on the US, the government authorized the use of “enhanced interrogation” techniques that were previously recognized as torture. While the complicity of US health professionals in the design and implementation of US torture practices has been documented, little is known about the role of health providers, assigned to the US Department of Defense (DoD) at the US Naval Station Guantánamo Bay, Cuba (GTMO), who should have been in a position to observe and document physical and psychological evidence of torture and ill treatment.
Methods and Findings
We reviewed GTMO medical records and relevant case files (client affidavits, attorney–client notes and summaries, and legal affidavits of medical experts) of nine individuals for evidence of torture and ill treatment and documentation by medical personnel. In each of the nine cases, GTMO detainees alleged abusive interrogation methods that are consistent with torture as defined by the UN Convention Against Torture as well as the more restrictive US definition of torture that was operational at the time. The medical affidavits in each of the nine cases indicate that the specific allegations of torture and ill treatment are highly consistent with physical and psychological evidence documented in the medical records and evaluations by non-governmental medical experts. However, the medical personnel who treated the detainees at GTMO failed to inquire and/or document causes of the physical injuries and psychological symptoms they observed. Psychological symptoms were commonly attributed to “personality disorders” and “routine stressors of confinement.” Temporary psychotic symptoms and hallucinations did not prompt consideration of abusive treatment. Psychological assessments conducted by non-governmental medical experts revealed diagnostic criteria for current major depression and/or PTSD in all nine cases.
Conclusion
The findings in these nine cases from GTMO indicate that medical doctors and mental health personnel assigned to the DoD neglected and/or concealed medical evidence of intentional harm.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Torture has been used throughout history for interrogation, coercion, and punishment. Ingenious methods have been devised to inflict severe physical or mental pain or suffering intentionally on an individual to obtain a confession or information, or to punish, intimidate, or coerce. Nowadays, torture is prohibited under international law and under the domestic law of most countries, and is considered to be a violation of human rights. Article 5 of the United Nations (UN) Universal Declaration of Human Rights, which was adopted in December 1948, states: “No one should be subjected to torture or to cruel, inhuman or degrading treatment or punishment.” Similarly, signatories of the Geneva Conventions, which provide protection for people who fall into enemy hands during conflicts, have agreed not to torture prisoners. Torture is also prohibited by the UN Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, which came into force in June 1987. Implementation of this Convention by participating states is monitored the UN Committee against Torture.
Why Was This Study Done?
After the September 11, 2001 attacks on the United States, the US government redefined acts such as waterboarding (simulated drowning), sleep deprivation, and prolonged isolation as “safe, legal, ethical, and effective” “enhanced interrogation” techniques (EITs). These EITs were previously recognized as torture by the UN Committee against Torture. US health professionals are known to have been complicit in the design and implementation of EITs. For example, the US Central Intelligence Agency (CIA) and Department of Defense (DoD) designated “non-clinical” health professionals to monitor the use of EITs at the US detainee facility at the US Navy Base at Guantánamo Bay, Cuba (GTMO), and the active role of these individuals during interrogations has been documented. Much less is known, however, about the role of health professionals assigned to the DoD to provide medical and mental health care to the GTMO detainees. Specifically, it is not known whether these health professionals accurately documented physical and psychological evidence of torture and ill treatment among the detainees. In this case series, the researchers review GTMO medical records and case files of nine detainees for evidence of documentation of ill treatment and torture by medical personnel.
What Did the Researchers Do and Find?
The researchers—non-governmental medical experts retained by legal representatives of GTMO detainees alleging torture and ill treatment—reviewed the medical records, client affidavits, attorney–client notes, and legal declarations of medical experts of nine GTMO detainees. In each case, the detainee alleged abusive interrogation methods consistent with torture as defined by the UN Convention against Torture. The researchers report that the medical affidavits for all the cases indicate that the allegations of torture and ill treatment were consistent with physical and psychological evidence of torture and ill treatment documented in the medical records and in evaluations by non-governmental experts. However, the medical personnel responsible for the detainees' routine medical and mental health care failed to inquire about and/or document the causes of the physical injuries and psychological symptoms that they observed. Instead, they attributed psychological symptoms to “personality disorders” and “routine stressors of confinement”. Moreover, psychotic symptoms such as hallucinations did not prompt consideration of abusive treatment. Importantly, psychological assessments conducted by non-governmental experts revealed diagnostic criteria for current major depression and/or post-traumatic stress disorder (PTSD, a common outcome of torture or ill treatment) in all the cases.
What Do These Findings Mean?
These findings indicate that health professionals assigned to the DoD to provide medical and mental health care to GTMO detainees neglected and/or concealed evidence of intentional harm. Because only nine cases are included in this case series, these findings may not be generalizable to other GTMO detainees. The findings are also limited by their reliance on medical records and case files that were sometimes heavily edited and on psychological assessments based on questionnaires rather than on direct examination. Nevertheless, these findings reveal new information about the potential extent of medical complicity in US torture practices, and they highlight the need for a thorough and impartial investigation of all the available information, including relevant classified information.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.pmed.1001027.
This study is further discussed in the April 2011 PLoS Medicine Editorial
Wikipedia has pages on torture, and on the Guantánamo Bay detention camp note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The Office of the UN High Commissioner for Human Rights provides information about the UN Convention against Torture and other Cruel, Inhuman or Degrading Treatment or Punishment and the UN Committee against Torture (in several languages)
Physicians for Human Rights is a non-profit organization that mobilizes health professionals to advance health, dignity and justice, and promotes the right to health for all. Its Campaign against Torture seeks to restore the US commitment against torture
Amnesty International provides information about the Guantánamo Bay detention camp
doi:10.1371/journal.pmed.1001027
PMCID: PMC3084605  PMID: 21559073

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