Displaying 11-20 letters out of 261 published
Bone Cement Implantation syndrome is more common than
We read Rutter et al.'s excellent BMJ Open paper on Bone Cement Implantation Syndrome (BCIS) prevalence with considerable interest, but fear that fatal BCIS may be more prevalent than the 1:2900 figure reported .
The recently published Anaesthesia Sprint Audit of Practice report, involving the prospective (and accurate) audit of 11 000 UK patients over 3 months in 2013 conducted in conjunction with the NHFD but published after revision of Rutter et al.'s paper, indicates that the prevalence of Grade 2 and 3 BCIS may be nearer 2.7% and 0.5% respectively, presenting a somewhat greater public health problem than suggested by the authors .
Furthermore, our recent analysis of 65 535 hip fracture operations found that mortality within 24 hours after surgery was significantly higher among patients receiving cemented compared to uncemented hemiarthroplasty (1.6% vs 1.2%, p=0.030), suggesting excess early mortality related to BCIS equivalent to a fatal BCIS 24-hour prevalence in the region of 0.36%, or 1:270, or ~75 patients per annum in the UK (although we accept that there may be other factors affecting mortality after cemented prosthesis) . We note that this is a similar risk to that quoted in the recent Norwegian study of 11 210 hip fracture operations quoted by Rutter et al., 1:116 .
We are currently waiting for the Confidentiality Advisory Group of the Health Research Authority to re-release the ASAP data linked to outcome, so that we can analyse further whether an occurrence of BCIS resulted in death.
We accept that the use of cement is beneficial for patients in the long term, but agree with the authors that clinicians must take great care to minimise the prevalence of BCIS with reference to the 2009 National Patient Safety Alert .
The Hip Fracture Perioperative Network is currently looking at whether a pre-cement 'time-out' is of benefit in reducing BCIS prevalence.
Dr. Stuart White, Brighton
Dr. Richard Griffiths, Peterborough
Professor Iain Moppett, Nottingham
1. Rutter PD, Panesar SS, Darzi A, Donaldson LJ. What is the risk of death or severe harm due to bone cement implantation syndrome among patients undergoing hip hemiarthroplasty for fractured neck of femur? A patient safety surveillance study. BMJ Open 2014 4:e004853; doi:10.1136/bmjopen-2014-004853.
2. National Hip Fracture Database. Anaesthesia Sprint Audit of Practice (ASAP). 2014. http://www.nhfd.co.uk/20/hipfractureR.nsf/welcome?readform (accessed 1 Jul 2014).
3. White SM, Moppett IK, Griffiths R. Outcome by mode of anaesthesia for hip fracture surgery. An observational audit of 65, 535 patients in a national dataset. Anaesthesia 2014; 69: 224-30.
4.Talsnes O, Vinje T, Gjertsen JE, et al. Perioperative mortality in hip fracture patients treated with cemented and uncemented hemiprosthesis: a register study of 11?210 patients. Int Orthop 2013;37:1135-40.
5.National Patient Safety Agency. Mitigating surgical risk in patients undergoing hip arthroplasty for fractures of the proximal femur. National Patient Safety Report; 2009, NPSA/2009/RRR001. http://www.nrls.npsa.nhs.uk/resources/?EntryId45=59867 (accessed 1 Jul 2014).
Conflict of Interest:
SW is a member of the Association of Anaesthetists of Great Britain and Ireland (AAGBI) Hip Fracture Guidelines Working Party, is a Council member of the Age Anaesthesia Association whom he represents at the National Hip Fracture Database, is national research co-ordinator for the Hip Fracture Perioperative Network, and is an Editor of Anaesthesia. This manuscript has therefore undergone additional external review. RG chaired the AAGBI Hip Fracture Guidelines Working Party and founded the Hip Fracture Perioperative Network. He is also Honorary Secretary of the AAGBI. IM is a member of the NICE topic expert group for Quality Standards for hip fracture, a member of the National Institute of Academic Anaesthesia (NIAA) Research Council and holds grants from the National Institute for Health Research and the NIAA for trials in hip fracture.
Re:Is dietary advice alone responsible for metabolic improvements among type 2 diabetes patients ?
In response to Devi et al we have the following comments.
1. Use of four day food diaries
Food diaries are commonly employed to examine the effects of dietary interventions, and use of 3-day [1, 2], 5-day  and 7-day  diaries have been reported. Four day diaries are used to collect dietary data in the UK's National Diet and Nutrition Survey rolling programme and are deemed to provide data of suitable quality, whilst ensuring participant burden is not too onerous . This allows us to compare our results to a representative national sample. The limitations of self-reported dietary data are acknowledged in our paper. It should be noted that completing food diaries over a longer period of time (e.g., 7-days) may reduce the effects of day-to-day variation in nutrient intake; however a limitation of this approach is a loss of accuracy due to increased participant burden .
As stated in our paper, one of the strengths of the Early ACTID intervention was that, in the first 6 months of the trial, ethical approval was granted to make no changes to medications. The analysis presented explores the associations between change in dietary habits and change in metabolic outcomes and was corrected for medication use. As medication use did not change, it is not appropriate to conduct a subgroup analysis.
3. A high LDL and high HDL
In our paper we found that women had higher HDL and LDL than men. A similar pattern was described in the UKPDS with women having higher fasting plasma total cholesterol, LDL cholesterol, and HDL cholesterol. This sex differences in the lipid profiles remained when the data were adjusted for age, BMI, and fasting plasma glucose. In this study womens' total cholesterol, LDL cholesterol, and HDL cholesterol were all seen to rise with age . Many other studies have described a similar pattern.
4. Nutrient analysis
Participants reported a total reduction in energy intake between baseline and 6 months. They achieved this by reducing the absolute amount (in grammes) of all macronutrients. However, the macronutrient composition (ie the ratio of carbohydrate:fat:protein) did not change to any meaningful extent. Participants did not report an increase in energy obtained from total sugar or total carbohydrate, and there was no change in percentage energy obtained from sugar in men or women. We reported a statistically significant, but quite small, increase in the percentage of energy obtained from total carbohydrates (a rise from 42.4% to 43.8%) by men and a very small association between an increase in total carbohydrate and reduction in HbA1c in men. It is important to emphasise that this association is not clinically meaningful, as increasing the percentage energy from carbohydrate to around 70%, which would involve considerable dietary change for a UK population, would only change HbA1c by 0.09%. Furthermore, we cannot be certain from this exploratory analysis that even this modest estimated benefit in HbA1c would accrue at this potentially very high and unachievable level of carbohydrate intake.
We have only reported the results for the changes in macronutrients showing some evidence of association with metabolic variables. We did not find any associations with changes in percentage energy from sugar or polyunsaturated fats; we do, however, acknowledge that our study was underpowered for these particular comparisons. It would certainly be of interest to see other studies reporting on associations between changes in macronutrients and changes in metabolic outcomes in people with type 2 diabetes. However, current evidence indicates that dietary treatment for type 2 diabetes should focus primarily on weight reduction and maintenance of weight loss, and suggests that a range of different dietary approaches are appropriate .
1. Krebs, J., et al., The Diabetes Excess Weight Loss (DEWL) Trial: a randomised controlled trial of high-protein versus high-carbohydrate diets over 2 years in type 2 diabetes. Diabetologia, 2012. 55(4): p. 905-914. 2. Esposito, K., et al., The Effects of a Mediterranean Diet on Need for Diabetes Drugs and Remission of Newly Diagnosed Type 2 Diabetes: Follow-up of a Randomized Trial. Diabetes Care, 2014. 3. Larsen, R., et al., The effect of high-protein, low-carbohydrate diets in the treatment of type 2 diabetes: a 12 month randomised controlled trial. Diabetologia, 2011. 54(4): p. 731-740. 4. Jenkins, D.J., et al., Effect of a low-glycemic index or a high-cereal fiber diet on type 2 diabetes: a randomized trial. JAMA, 2008. 300(23): p. 2742-53. 5. Department of Health. National Diet and Nutrition Survey: Headline results from Years 1 and 2 (combined) of the rolling programme 2008/9 - 2009/10. 2011 21/01/2013]; Available from: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsStatistics/DH_128166. 6. Trabulsi, J. and D.A. Schoeller, Evaluation of dietary assessment instruments against doubly labeled water, a biomarker of habitual energy intake. American Journal of Physiology-Endocrinology and Metabolism, 2001. 281(5): p. E891-E899.
Conflict of Interest:
Re:Statin trial and cardiovascular outcome
We thank our colleagues Reeta Devi and Maulana Azad for their comment and welcome the discussion on the representativeness of clinical statin trials for real-world diabetes care.
The health system in Finland has universal coverage, i.e. all persons (regardless of their socioeconomic status) have access to free care and subsidized prescription drugs. Finnish register system is also exceptional, because it has legislative cover of total population since the 1960s and records can be deterministically linked using the personal identification codes. Our data captures all individuals with diabetes identifiable from the Finnish nationwide administrative registers, i.e. all who have purchased anti-diabetic medications or have had hospital visit with recorded diabetes diagnosis. We acknowledge that people with undiagnosed diabetes or treated with diet only in outpatient primary care may remain unidentified, but our data represent the closest thing to the unselected real-world population of statin initiators (among medically treated diabetes) that is feasible to obtain.
Our goal for presenting outcome data after statin initiation was simply to depict the level of event rates among real-world patients in comparison with trial populations. These rates are affected by the baseline cardiovascular risk of statin initiators and effects of statins consumed by them during the follow-up. In other words, these rates are descriptive facts for the studied real-world population, but must not in any circumstances to be interpreted as results on statin effectiveness in the real world.
Our study aimed to investigate whether there is a significant selection between trial populations and real-world population. We have recently also published more detailed data on the use of statins among people with newly diagnosed diabetes (Vehko et al. 2013). In conclusion, we believe that these kinds of results on real-world populations are a step towards the understanding of patterns of statin usage, and will eventually help the clinicians and policy makers to promote more rational statin use in diabetes, but we agree that more research on the actual benefits and harms of statins in different population groups is required.
On behalf of all authors, P Ruokoniemi, MD, Corresponding author
Additional references: Vehko T, Sund R, Arffman M, Manderbacka K, Ilanne-Parikka P, Keskimaki I. Monitoring the use of lipid-lowering medication among persons with newly diagnosed diabetes: a nationwide register-based study. BMJ Open. 2013 Nov 4;3(11):e003414. doi: 10.1136/bmjopen-2013-003414. PubMed PMID: 24189078; PubMed Central PMCID: PMC3822306.
Conflict of Interest:
Please refer to the original article.
Factors influencing access to health care in Andhra Pradesh and Maharashtra, India
The present study gives an overview of the difference in the differences in access to health care facility in both Andhra Pradesh and Maharashtra, two neighbouring states in India. The study design is robust and appropriate in assessing the desired outcomes. However, we would like to highlight few factors which might have contributed to the differences in the observations.
The study used a tool which included questions on a health insurance scheme "Aarogyashri" in Andhra Pradesh whereas questions on "Rashtriya Swasthya Bima Yojana", a similar health insurance scheme in Mahashtra has not been included in the study tool. This might lead to differential response among the respondents in the two states.
The study has not accounted for the changes in the inflation from 2004 to 2012 while calculating changes in the health expenditures. The observed increased expenses could be related to inflation and devaluation of Indian rupee over the study period.
There are geographical differences between the two states compared in the study. Availability of health centres and health manpower are other factors that can contribute to health care seeking behaviour of the participants in the study. A comparison of the average distance of availability of health facility and also on the available health manpower should have been included in the study. In addition , the availability of medicines, equipments and quality of care in the health facilities, which influences health seeking behaviour of the people should have been included in the study. Relying solely on the basis of "Aarogyshri" in Andhra Pradesh led to better access and health seeking in the study sounds unreasonable.
Conflict of Interest:
Statin trial and cardiovascular outcome
The present study has shown under representation of statin users in the population with real diabetes mellitus patients. It has tried to capture data from the available registries which may not depict a true picture of the real patients of diabetes mellitus. As highlighted by the authors, many of the cases may be unreported and may not be taking medications. Such cases were excluded from the study. One of the major factors that may affect the study results is the use of different doses of statin in the estimation of association with cardiovascular outcomes. Varying doses may make the results in comparable across different age groups, sex and also socioeconomic variables which are not discussed in the study.
In addition, the controversy over the use of statin in diabetes mellitus is still unresolved. Studies mention about the role of statin initiating diabetes mellitus in the long term causes much concern to the use of statin for preventing cardiovascular diseases. There is a need to revisit the recommendations on the use of statin for prevention of cardiovascular events.
Conflict of Interest:
Dear Dr Jorgensen,
Several things occur to me from your article.
1. This study took place in a Western country. I suggest that the sample with undiagnosed illnesses are more likely to have fallen prey to the Western delusion that we can live on a poor diet, overeat, drink alcohol to excess, do no exercise, not sleep enough, and when our bodies start falling apart, the medical system will be able to return us to 100% health using drugs and surgery. These people's perception that their health is "good", is part of this delusion. I have noticed that Westerners accept a very low state of health as "normal": osteoporosis and arthritis are seen as part of getting old, when in fact they are Western diseases, with diet and lifestyle components; stress incontinence is seen as being part of being a woman, while it is actually much more common in overweight people; a state of permanent mild constipation is mistaken for healthy bowel function. While I don't know about thyroid dysfunction, I believe that diabetes mellitus and hypertension are diseases of Western civilization. So a sample with these diseases is perhaps more likely to comprise people who are well and truly immersed in the above delusion.
2. The Western medical paradigm pays little attention to an individual's ability to maintain good health on a day-to-day basis, using diet, lifestyle, and simple home remedies. Until recently, our health system was authoritarian, with an expectation that "patients" will do what the doctor orders, without question. In this paradigm, a person finding that they have signs of incipient disease is likely to feel helpless. Pharmaceutical companies, which I understand fund a lot of medical research, have no interest in the population realising what can be achieved with simple things like dietary changes. Cultures where traditional medicine is practiced alongside modern medicine, such as China and Germany, may have a different attitude to health and disease.
I may have drawn mistaken conclusions, as I was not able to read and understand your entire article, and my initial impressions were gained from a Reuters news item about your work. Bearing this in mind, my feeling is, the fact that early diagnosis can lead to poor self-rated health, which in turn is tied to a greater risk of death (in a Western country) suggests, not that we should keep people in ignorance, but that we should change our perception of what health is: not merely the absence of those diseases detectable by current Western medical practice.
Conflict of Interest:
Dryad data now available
Data for this article is now available in the Dryad data repository (doi:10.5061/dryad.2hr40) and can be viewed here http://datadryad.org/resource/doi:10.5061/dryad.2hr40
Conflict of Interest:
BMJ Open member of staff
Data is the bridge between different population views
I read with interest the qualitative interview study by Noble et al on accountable care organisations' (ACOs') perceptions of population health. Whilst I agree wholeheartedly with their suggestion that there is a need to define the terms better, there is also an important quantitative element to these terminologies. Both ACOs and public health agencies-in the UK these are clinical commissioning groups (CCGs) and local authorities (LAs)- need to define their responsible populations quantitatively and develop the ability to map linked data back and forth between them, to understand their respective influences.
This is vital to establish meaningful dialogue between them, and to develop the potential synergy between these different views of the data. Dr Noble has already done this in another study where he and his colleagues mapped data from general practice disease registers to produce geospatial maps of resident populations. Building on previous work, we are currently developing for Arthritis Research UK four musculoskeletal (MSK) disease prevalence models which produce estimates at accountable or registered (general practice and CCG) and resident (sub-LA, LA, Electoral Ward and Parliamentary Constituency) levels. This will allow all the agencies able to influence health to understand the size of the problem from their perspective, and to plan what they can do, whether that is increasing physical activity (which is a major risk factor for MSK disease) in a resident population, or referring for joint replacement in an "accountable" one.
The lack of understanding of the overlapping health needs of these two populations is a handicap for both ACOs and the US healthcare system in general, which has led to the development of elaborate methods to try to understand healthcare utilisation, especially regional variations. The survey by Noble et al should help to develop a better approach in future, but coordinated effort by the agencies involved is also needed.
1. Noble DJ, Greenhalgh T, Casalino LP. Improving population health one person at a time? Accountable care organisations: perceptions of population health--a qualitative interview study. BMJ Open 2014;4(4). Link: http://bmjopen.bmj.com/content/4/4/e004665.abstract.
2. Soljak M. Dismantling the signposts to public health? No, satnav has arrived. BMJ 2012;344:1. Link: http://www.bmj.com/content/344/bmj.e4137.
3. Noble D, Smith D, Mathur R, Robson J, Greenhalgh T. Feasibility study of geospatial mapping of chronic disease risk to inform public health commissioning. BMJ Open 2012;2(1). Link: http://bmjopen.bmj.com/content/2/1/e000711.abstract.
4. Soljak MA, Majeed A. Understanding variation in utilisation: start with health needs. BMJ 2013;346. Link: http://www.bmj.com/content/346/bmj.f1800?etoc=.
Conflict of Interest:
Is dietary advice alone responsible for metabolic improvements among type 2 diabetes patients ?
The study by England et al 1 provides an important information on the effective role of non prescriptive dietary advice and reduction in metabolic parameters among newly diagnosed Type 2 diabetes mellitus patients. The authors have clearly given their limitations in the study. However, we need to consider the followings before accepting the results of the study.
The rationale of using four day food diary is not clear. Whether these four days show usual dietary pattern over a week is not discussed. There could be differences in the dietary intake pattern between these four days and the other three days in which the participants did not maintain a diary.
The baseline information of the study showed that 40% were on oral hypoglycemics, 65% on lipid lowering, more in man and 66% on anti hypertensives. Subgroup analysis is needed for differences in relation to oral medication intake status and find out whether medications had a better effect on glycemic control or not adjusting for other variables in the study.
It has been reported that women had higher lower density lipoprotein, and higher high density lipoprotein. Generally it is observed that there is inverse relationship between LDL and HDL. The reported high LDL and HDL in women needs further probing.
It is noteworthy to see a total reduction in mean fat intake of 5 gms in women, 9 gms in men and in saturated fats by 2 gms. and even polyunsaturated fats by 1 gms. (considered to be good fats). Energy from total sugar increased by 0.2% in women and 0.7% for men despite mean decline in sugar intake by 6 gms. in both women and men. The authors have not discussed these issues in relation to metabolic control. In men, 1% energy increase from carbohydrates was associated with decline in glycated Hb by 0.003%. Thus, it is not clear whether reduction in polyunsaturated fats and energy increase from sugar or carbohydrates after intervention have any role in metabolic control. If these observations are true, then discussion on the role of these factors should have been done by the authors.
England CY, Thompson JL, Jago R, Cooper AR, Andrews RC. Dietary changes and associations with metabolic improvements in adults with type 2 diabetes during a patient -centred dietary intervention: an exploratory analysis. BMJ Open 2014;4:e004953.
Reeta Devi Assistant Professor School of Health Sciences, Indira Gandhi National Open University Maidan Garhi, New Delhi-110068.
Mongjam Meghachandra Singh Professor Department of Community Medicine Maulana Azad Medical College New Delhi-110002.
Bimla Kapoor Ex-Director School of Health Sciences, Indira Gandhi National Open University Maidan Garhi, New Delhi-110068.
Conflict of Interest:
Bias in the study of prevalence of pre-diabetes in England from 2003 to 2011
The present study shows an increase in the prevalence of prediabetes in England since 2003 till 2011. The population based study has strengths in terms of having an appropriate sampling method, with blood samples for glycated haemoglobin level estimation for diagnosis of pre diabetes state. However, some factors need to be considered while analyzing the results.
Firstly, the reported hypertension in the study could be an underestimate since a large number of hypertensives are undetected. The present report may also does not indicate about the relationship before or after onset of the pre diabetes state. Hence, the presence of hypertension as a risk may not absolutely true.
Secondly, the odds ratio for social deprivation does show a statistically increase risk in second and fourth quintile only, not for 3rd and 5th quintiles. Hence, the generalized interpretation of risk of pre-diabetes with increasing social deprivation is not true.
Thirdly, it is surprising that pre-diabetes is prevalent even in those with BMI less than 25 Kg/m2. It indirectly shows that factors other than obesity might have played a role in the onset of pre diabetes among the study population.
Fourthly, generalization about South Asians as a proxy may not give true picture about the actual prevalence among Sout Asians since there are wide variations even among them.
Lastly, as mentioned by the authors to some extent, other potential risk factors have not been studied. Hence, factors such as lifestyle, diet, sedentary work, family history,stress have not been studied and the potential risk factors in this study are not fully indicated.
Conflict of Interest: