Correspondence with the National Institute for Health and Clinical Excellence

This page lists correspondence with the National Institute for Health and Clinical Excellence. On 3 December 2012 BMJ editor in chief Dr Fiona Godlee wrote to NICE's chair, Professor Sir Michael Rawlins. In her letter she says: "Now that serious doubts have been raised about the evidence behind claims for oseltamivir’s effectiveness and safety, I am asking you to withdraw approval for oseltamivir until NICE has received and reviewed the full clinical trial data and those anonymised data are available for independent scrutiny."

 

All rapid responses

Rapid responses are electronic letters to the editor. They enable our users to debate issues raised in articles published on bmj.com. Although a selection of rapid responses will be included as edited readers' letters in the weekly print issue of the BMJ, their first appearance online means that they are published articles. If you need the url (web address) of an individual response, perhaps for citation purposes, simply click on the response headline and copy the url from the browser window.

Hello Everyone.

I discovered a simple solution to treating root causes of disease, by understanding all the main causes and ruling them out one by one we can hone in on the potential cause.

The secret is in looking at the actual blood pressure reading and heart rate and using the numbers and what they represent to pinpoint the general cause of the hypertension. From there you can perform a detailed analysis of the patient's lifestyle, medicines and medical care. You need to consider other conditions and follow a generalist root cause analysis treatment model akin to the Functional Medicine approach used in America. From this I have successfully managed cases of resistant hypertension. Sometimes it is the other medicines a person is on, sometimes dietary and lifestyle choices which predispose to raised blood pressure and sometimes its the systolic drive or the blood volume and electrolyte/sodium intake.

Id like to discuss this with Prof Williams or anyone who is willing to listen. I sent him an email but havent had response.

Many thanks

Ben McEwan, Pharmacist and researcher

Competing interests: No competing interests

26 January 2015
Benjamin R McEwan
Pharmacist at McEwan Healthcare
McEwan Healthcare
Motherwell, ML1 2BB
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A systematic review concluded that patients with lower health literacy level were less likely to have cancer screening tests (Oldach & Katz, 2014), which further lead to cancer disparities. If we consider patients’ health literacy as a contributing factor in the cancer screening guidelines, it might help to have clear communication between doctors and patients. To do so, doctors also need to improve communication skills then address health literacy (Green, Gonzaga, Cohen, & Spagnoletti, 2014).

Patients’ health literacy refers to the ability to find, understand, appraise and apply information on health, especially in disease prevention and health promotion. They then make the correct decision on which test, number of tests (sometimes need more than one test), time, technique, and guideline to follow and collaborate well with doctors. Thus, test results will be more precise, and doctors’ decision will be more accurate. Therefore, beside new screening technology, new treatment, and interventions to reduce overdiagnosis, patient’s health literacy together with doctors’ clear communication skills will reduce the rate of overdiagnosis.

References

Green, J. A., Gonzaga, A. M., Cohen, E. D., & Spagnoletti, C. L. (2014). Addressing health literacy through clear health communication: A training program for internal medicine residents. Patient Education and Counseling, 95(1), 76-82. doi: http://dx.doi.org/10.1016/j.pec.2014.01.004

Oldach, B. R., & Katz, M. L. (2014). Health literacy and cancer screening: A systematic review. Patient Educ Couns, 94(2), 149-157. doi: http://dx.doi.org/10.1016/j.pec.2013.10.001

Competing interests: No competing interests

26 January 2015
Van Tuyen Duong
Scientific Researcher
Taipei Medical University
No 250, Wuxing Street, Taipei City, Taiwan, 110
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Scores of dubious private medical college openly auction their seats in crores & pass them from their own private universities by taking crores again. People of India have every right to know if these graduates possess basic medical skills before allowing them to play with their life. Exit exam in medicine is an established practice world over. Earlier health minister of BJP has already proposed it. When will the current health minister implement it?

Kindly visit NATIONAL EXIT EXAM FOR MBBS GRADUATES INDIA. Not to block any one in life is its stated official policy. SIGN THE PETITION FOR BETTER MEDI CARE TOMORROW:

https://www.change.org/p/2009230?just_created=true

Competing interests: No competing interests

26 January 2015
RAKESH MITTAL
engineer
govt
gujrat
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High quality systematic reviews are regarded as the highest quality evidence (Harbour and Miller, 2001), which means that we have enough confidence about the validity of results. This systematic review indicated that individuals were likely to increase alcohol use for long working hours (OR=1.12, 95%CI: 1.04-1.20, P=0.96, I2=0%). Although, Virtanen et al tried to use systematic review, the most rigorous method, to answer the PICO question, there was still some bias. For example, they didn’t assesse the risk of bias of the included studies. Therefore, how much could we trust the results? In the GRADE approach, if relevant evidence is supported by the studies with high risk of bias, the quality of evidence could be rated down (Guyatt et al., 2011a). Hence, we used GRADE to rate the quality of evidence of this systematic review to verify the certainty of the results.

Firstly, we used the AHRQ Cross-Sectional/Prevalence Study Quality Checklists (Rostom et al., 2004) and Newcastle-Ottawa Scale (NOS) for Cohort Studies (Wells et al., 2010) to assess the risk of bias of cross-sectional studies and cohort studies respectively. However, when reviewing the 63 studies included (except for 4 studies without full-texts), we found that 18 studies didn’t report the data on working hours and alcohol consumption simultaneously. Moreover, Virtanen et al reported that there were 15 studies of which the main topics were not the association between long working hours and alcohol consumption. Meanwhile, Virtanen et al didn’t report whether they contacted the authors to collect the data of primary studies if it could not be abstracted from full-texts. Furthermore, different definitions about the exposure and outcome were found in included studies. Owing to the potential deviation between the total pooled data and the true value, Virtanen et al conducted a subgroup analyses for the six studies (Liu et al., 2002; Nash et al., 2010; Au et al., 2013; Gibb et al., 2012; Holtermann et al., 2010; Cheng et al., 2012) which strictly defined the exposure and outcome. Similarly, it showed that long working hours could affect the alcohol consumption (OR=1.14, 95%CI: 0.89-1.47, P=0.007, I2=68.6%). Therefore, in order to avoid other bias, we only rated the quality of evidence from these six studies.

The downgrading factors

Risk of bias. All of the six studies were cross-sectional studies. Thus, the AHRQ Cross-Sectional/Prevalence Study Quality Checklists was applied to assess the risk of bias (see appendix). Most studies had high risk of bias in each item except for item 1, 3 and 10. And it should be noted that all the six studies were found with high risk of bias in item 5, 8 and 9, which indicated that the research didn’t control the results and other confounding well in primary studies, and would influence the confidence of results. Thus, we considered that there was serious risk of bias.

Indirectness. We did not downgrade the evidence for indirectness, because the exposure and outcome in the six studies and this systematic review were similar.

Inconsistency. In figure 3 of the systematic review, we found differences in direction, little overlap and large I2 among the six studies. Thus, we considered that there was serious bias in inconsistency.

Imprecision. The 95% confidence intervals include the odds ratio of 1. Thus, we considered that there was serious bias in imprecision.

Publication bias. Virtanen et al conducted a systematic search and the estimates in Egger’s test indicated no evidence for publication bias. Thus, we decided not to downgrade for publication bias.
The upgrading factors

Large magnitude of effect. The effect size was not large (OR=1.14) enough to rate up the evidence.

Dose-response gradient. In figure 7 of this systematic review, the alcohol consumption would increase with prolonging working hours. Thus, we considered rating up the evidence for dose-response gradient.

Plausible confounding can increase confidence in estimated effects. The strict definitions of the exposure and outcome in the six studies was a plausible confounding that might decrease the confidence of estimated effect. However, the effect size of the six studies was larger than that of total effect size. Thus, we considered to rate up the evidence for this factor.

Cross-sectional studies belong to the observational study group. And in GRADE, observational studies (except for diagnostic accuracy tests studies) are regarded as low quality evidence at the beginning (Guyatt et al., 2011a). When observational studies are methodologically rigorous and the evidence body meets the criteria, we will consider rating up the quality of evidence (Guyatt et al., 2011b).

In conclusion, although the quality of evidence might be rated up for dose-response gradient and plausible confounding, there was a high risk of bias in the method of the six studies. Therefore, we could not consider rating up the quality of evidence. Finally, we downgraded the quality of evidence from low to very low.

In summary, although the systematic review indicated that individuals whose working hours exceeded standard recommendations were more likely to increase their alcohol consumption, we had little confidence about this conclusion.

References:
Harbour R, Miller J. A new system for grading recommendations in evidence based guidelines. BMJ. 2001 Aug 11;323(7308):334-6.
Guyatt GH, Oxman AD, Vist G, Kunz R, Brozek J, Alonso-Coello P, et al. GRADE guidelines: 4. Rating the quality of evidenced study limitations (risk of bias). J Clin Epidemiol 2011 Apr;64(4):407-15.
Rostom A, Dubé C, Cranney A, et al. Celiac Disease. Rockville (MD): Agency for Healthcare Research and Quality (US); 2004 Sep. (Evidence Reports/Technology Assessments, No. 104.) Appendix D. Quality Assessment Forms. Available from: http://www.ncbi.nlm.nih.gov/books/NBK35156/
GA Wells, B Shea, D O'Connell, J Peterson, V Welch, M Losos, et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses. 2010. Available from: http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp
Liu Y, Tanaka H. Overtime work, insufficient sleep, and risk of non-fatal acute myocardial infarction in Japanese men. Occup Environ Med 2002;59:447-51.
Nash LM, Daly MG, Kelly PJ, van Ekert EH, Walter G, Walton M, et al. Factors associated with psychiatric morbidity and hazardous alcohol use in Australian doctors. Med J Aust 2010;193:161-6.
Au N, Hauck K, Hollingsworth B. Employment, work hours and weight gain among middle-aged women. Int J Obes (Lond) 2013;37:718-24.
Gibb SJ, Fergusson DM, Horwood LJ. Working hours and alcohol problems in early adulthood. Addiction 2012;107:81-8.
Holtermann A, Mortensen OS, Burr H, Sogaard K, Gyntelberg F, Suadicani P. Long work hours and physical fitness: 30-year risk of ischaemic heart disease and all-cause mortality among middle-aged Caucasian men. Heart 2010;96:1638-44.
Cheng WJ, Cheng Y, Huang MC, Chen CJ. Alcohol dependence, consumption of alcoholic energy drinks and associated work characteristics in the Taiwan working population. Alcohol Alcohol 2012;47:372-9.
Guyatt GH, Oxman AD, Sultan S, Glasziou P, Akl EA, Alonso-Coello P, et al. GRADE guidelines: 9. Rating up the quality of evidence. J Clin Epidemiol. 2011 Dec;64(12):1311-6.

Competing interests: No competing interests.

26 January 2015
Dang Wei
master student
Yao-long Chen, Qi Wang, Xiao-qin Wang, Liang Yao, Nan Li, Ke-hu Yang
Key Laboratory of Evidence-based Medicine and Knowledge Translation of Gansu Province; Evidence-based Medicine Center, School of Basic Medical Sciences, Lanzhou University; Chinese GRADE Center, Lanzhou University, Lanzhou 730000, China.
No.222, TianShui Road (south) , ChengGuan District, LanZhou City, GanSu Province, China
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We read with interest the article by Koretz et.al. which questions the assumptions behind widespread screening and treatment of persons at risk for Hepatitis C (1). Besides uncertainties regarding treatment, we have been concerned with the issues related to the CDC and USPHS recommendations to screen all persons born between 1945-1965 (2,3). Although this strategy may identify previously undiagnosed persons who are chronically infected with HCV (who may or may not benefit from treatment), we believe that it will also lead to many persons being falsely diagnosed with past HCV infection.

This concern was part of our rationale when we worked with New York physician groups who opposed a law, ultimately passed by the New York State legislature, mandating that hospital and office physicians and other providers offer Hepatitis C testing to all persons born between 1945-1965. This well-intentioned regulation has affected the practice of physicians across New York, and in our experience, has yielded no unexpected positive tests.

Per a 2003 CDC guideline on HCV testing, the proportion of false-positive HCV antibody test results among immunocompetent populations with anti-HCV prevalence less than 10% averages approximately 35% (range, 15% to 60%). This testing guideline warns that “not relying exclusively on anti-HCV screening-test–positive results to determine whether a person has been infected with HCV is critical” and recommends that all positive screening results be verified with a “supplemental test with high specificity” (4).

The HCV nucleic acid test, which is currently recommended for confirmation, can distinguish between active and past infection but not between true- and false-positive results. The HCV recombinant immunoblot assay (RIBA), which can verify true infection, is unfortunately unavailable in the United States. Although the CDC guideline acknowledges that certain harms (“worry or anxiety while waiting for test results, insurability”) can result from universal screening, it does not address the very real harm of false diagnosis (with implications about past or present risk behaviors), which can occur in one third of persons who test positive.

It seems that screening and treatment of persons with Hepatitis C is a laudable goal, if this will ultimately improve the health and reduce the morbidity and mortality of persons at risk for Hepatitis C. Unfortunately, as Korentz and his colleagues point out, the jury is still out regarding the benefits of treatment. Clearly, the financial costs will be enormous, considering the price tag for the newest medications. We add our concerns regarding the risks of universal screening, especially in a low risk cohort.

References
1. Koretz RL, Lin KW, Ioannidis JP, Lenzer J. Is widespread screening for hepatitis C justified? BMJ. 2015 Jan 13;350:g7809

2. Smith BD, Morgan RL, Beckett GA, Falck-Ytter Y, Holtzman D, Ward JW. Hepatitis C virus testing of persons born during 1945-1965: recommendations from the Centers for Disease Control and Prevention. Ann Intern Med. 2012;157:817-22.

3. Smith BD, Morgan RL, Beckett GA, Falck-Ytter Y, Holtzman D, Teo CG, et al; Centers for Disease Control and Prevention. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945-1965.MMWR Recomm Rep. 2012;61(RR-4):1-32.

4. Alter MJ, Kuhnert WL, Finelli L; Centers for Disease Control and Prevention. Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2003;52(RR-3): 1-13.

Competing interests: No competing interests

25 January 2015
Ephraim E Back
Clinical Professor of Family and Community Medicine
Mark Josefski
Mid-Hudson Family Medicine Residency Program/ Institute for Family Health
Kingston, NY
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NHS beds have been dwindling for sometime now, from 900 000 to its current 300 000.

There have been closures of community hospitals that prevent convalescent patients staying longer in acute units, leading to delayed discharges. Our ageing population is unable to cope independently at home after being discharged, and support services, especially mental health are failing to provide urgent assessments.

In order to improve this we will have to provide more beds in the community to minimise this strain on acute services.

Competing interests: No competing interests

25 January 2015
Manzarul Haque
Surgeon
WWL Nhs foundation Trust
Wigan WN6 0XL
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Thank you for this insightful article. As a pubic health consultant, I see populations not patients and I think that this viewpoint is enhanced considerably by considering the perspective of the individual. Humans are herd creatures, but homogeneity is not often found.

I am struck by the similarity of this article to Grayson Perry's recent series which considers how we create our identities (http://www.channel4.com/info/press/programme-information/who-are-you-w-t). In the final episode, he works with a group of plus-size ladies who have come together through their struggle for acceptance and support each other to see what is beautiful about their identities as they are. As the author of this article had also experienced, they had tried numerous diet regimes that had failed to work and their mental health was not benefitting from constantly being told that they were wrong because they were fat.

From a public health point of view, reducing obesity levels in the population leads to reduced levels of morbidity and premature mortality from a myriad of causes and is therefore an avenue to be pursued. However, this doesn't mean that achieving this at any cost to people's mental health and self worth is an approach that should gain support. Mindful of time constraints and additional pressures on clinical time, front line health care professionals who are able to take a holistic approach (body and mind) to the person who comes in to their surgery with a swollen ankle should be congratulated.

Competing interests: No competing interests

25 January 2015
Rebecca C Cooper
Public Health Consultant
Oxfordshire
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Crumbled forts on the coasts of England are the residue of a Roman occupation which lasted four centuries. Such a passage of time is appreciated by imagining the width between 1600 and the year 2000. A capacious space for the whims of history. Once settled in Britain, the Romans assumed that they too would encounter invasions and condensed into form a scatter of fortresses along the coastline that faces Europe.

Portchester by the sea has a Roman fort, the "–chester" from "ceastra," which means castle. Dorchester, whose shadows remember Thomas Hardy, has Roman roots, as does the first town of the country, Colchester, on the eastern scapes of England. Cleaved by the twisting steel of the River Severn, the cathedral city of Worcester, in middle England, began as a nest of Mediterraneans called the weogoran (people of the winding river), the "weogoran" and "ceastra" hybridising to yield "Worcester."

All the factors that had given formidability to the Romans faded in the AD 300s and by the 400s the Latin overlay in Britain had shrivelled away. As an empire from southern Europe receded, so flowed onto the island a migration from northern Europe. Wafting in from the mainland, the Angles, Jutes and Saxons settled in those areas that had been Romanised, their inflow sparing Scotland, Wales and the peninsular miles of Cornwall. Hence the Atlantic-ward peripheries of Britain, away from the European side, retained the old Celtic backgrounds. Illustrating these circumstances is the story of the Celtic Welsh, only a few million, living on a western ledge of the island and using a tongue starkly dissimilar to the imported verbals that evolved into English.

Echoing the Saxons in the south, the zeal of the Angles led to settlements in the middle and north of Britain. The tribe attracted an eminence that resulted in much of the island carrying their name – Angle Lond. England. In the centuries of the Anglo-Saxons, which ended in 1066 when the French Norman conquered England, a major progression was a proto-English mineralising from the imported dialects of German.

From the 400s to 1066, the Anglo-Saxon Age was the dawn of the English nation, a time when Roman overlordship was superseded by a mosaic of several kingdoms. The nomenclature of southern regions, Wessex, Middlesex, Sussex, Essex, is redolent of the Saxon kingdoms from a thousand years ago. The latter names remain in situ though the obscurations of time have covered over the first, Wessex, a place which is fictionalised in the books and literature of Thomas Hardy.

Linguists term the early form of the English language “Old English” (or Anglo-Saxon), a version that in the last century was the special subject of J. R. R. Tolkien, writer and don extraordinaire at Oxford. After the Norman Conquest in 1066, Old English tended toward Middle English, the format called Modern English arriving five centuries ago in 1470, when Caxton installed a printing press in London after studying the ink shops of the Germans.

Old English is flecked through with some of the most scintillating mythology of Britain. In the 800s, its scribes wrote of a warrior king, Arthur, a Celt who battled with his fidelitous sword, Excalibur, against the axe-waving Anglo-Saxons from the mainland. Over time, the storytelling shuffled to offer many grades of the tale, but all spoke of King Arthur and the Knights of the Round Table. Arthur considered his chosen knights his equals, and accordingly the table at which they sat was circular, there being no position for a head. By folklore, Arthur was born at Tintagel by the swirling sea of Cornwall, a Celtic promontory at the end of Britain which in days of yore was notable for its repellency of the Anglo-Saxons.

Conspicuous amongst the first chroniclers of England was a man from the Kingdom of Northumbria. Of Saxon ancestry, this monk has been called “the Venerable Bede” by British historians down the centuries, the publishers of the 1800s issuing finely-printed translations of his Latinate works. Bede lived for sixty years from 672 to 735 and has inestimable significance in the journey of the English language because he was its first substantial scholar and writer.

Freighted with Latin, the Bedan works encompass some of the earliest specimens of Old English. But the book which casts the longest shadow is "Historia ecclesiastica gentis Anglorum" (Ecclesiastical History of the English People), a product of such historical value that scholars have granted the title “father of the English nation” to Bede after filtering through its five handspun volumes. Bede traces Christianity in Britain after the Romans, the handwritten pages, consistently dated, also harbouring asides on medicine. Quilling away in the north of England, where he spent all his life, a monk bent over his desk was adducing Greek theories of health and disease. Such references show by what extent the culture of the ancient Mediterraneans had made its mark on the icy lands of northern Europe.

As the largest literary pyramid of the Anglo-Saxons, the work of Bede was paralleled by the writings of others, most saliently “the Lacnunga” and “Bald’s Leechbook.” Both these medical tomes were didactic, the former a haphazard mix of beliefs, the latter containing explications of various ailments and treatments. Derision may form in the minds of modern physicians as they read of therapies such as a clump of dung to treat bleeding from a limb. But such responses would be misplaced, the result of an ignorance of the conditions in that unimaginably distant age. For it is only in the last two hundred years that disease mechanisms have been understood with any rationality.

Within their superstitious age, the Anglo-Saxons were an enterprising people of history, who attempted their own type of medicine, whilst retaining a distillation of the Greco-Roman ideas that were active in Britain in the centuries before their arrival.

Competing interests: No competing interests

25 January 2015
Jagdeep Singh Gandhi
Consultant Ophthalmic Surgeon
Worcester Royal Eye Unit
Worcestershire Royal Hospital, Worcester, UNITED KINGDOM
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Dear Editor,

I enjoyed very much the article.
It is a very good reminder for us doctors not to forget that the patient sitting opposite us in the office is a human being. So first let's respect the human being and then apply the algorithm.
Thank you.

Competing interests: No competing interests

25 January 2015
Yavor Y Ivanov
physician
University Pulmonary Hospital
7 Pirin Str., ap.7
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I thank MacPherson and colleagues for sharing their information, but I feel rather despondent - had NICE and PHE shared a vision of needing better data, it would have been entirely possible to make prophylaxis an 'only in research' recommendation. At this point - several years on - we would have had far better data, a reduction in uncertainty, and a better ability to share the pros and cons with patients. As it is, decent data seem further away, not nearer.

Competing interests: I wrote the article

25 January 2015
margaret mccartney
gp
94 fulton street
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