Displaying 1-10 letters out of 261 published
Systematic reviews and the risk of diluting evidence
We have read with interest the systematic review by Nagrebetsky et al(1) on Smoking cessation in adults with diabetes.
The authors conclude that there is an absence of evidence of efficacy for more intensive smoking cessation interventions in people with diabetes. However we believe the diverse quality of the studies, and small numbers who stopped smoking in both groups in all of the trials apart from one (which did show a benefit from more intense treatment), reduces the certainty of such conclusions.
There is also a risk with systematic reviews of diluting high quality trials with poorly designed ones. The larger and better rated trials included in the meta-analysis (2, 3) favour the more intensive intervention group while the smaller in size and lower quality studies(4, 5) favour the less intensive intervention group. The high levels of statistical heterogeneity found (I2=76%) should have been explored further using a subgroup analysis or sensitivity analysis removing studies of poor quality; and this should also be more clearly examined in the light of the clinical and methodological heterogeneity that exists in these studies.
Despite these limitations, we welcome the authors recommendations that further research on tailored smoking interventions for diabetic patients should be carried out over a period of at least 1 year and assess impact on glycaemic control. It is however important when reviews of this type are published that the limitations are clearly explained to prevent misunderstanding or misuse by those who might seek to reduce smoking cessation treatment provision for reasons other than a lack of positive evidence
Conflict of Interest:
MD and NC are authors of one of the studies included in the systematic review.
Affiliations for Jann foster
Affiliations for Jann Foster are: School of Nursing and Midwifery, University of Western Sydney/Sydney Nursing School/Sydney Medical School, University of Sydney.
Conflict of Interest:
Our Trusts innovative approach to reduce bone cement risk and improve patient safety.
We read with interest the paper by Rutter et al describing the frequency and severity of bone cement syndrome.(1)
Working in a busy Major Trauma Centre and teaching hospital, we treat a large number of patients with fractured neck of femurs and many of these have cemented hip arthroplasties. Along with most hospitals entering data into the National Hip fracture database (NHFD) we took part in the Anaesthetic Sprint Audit Project (ASAP) from May to July 2013. During this time we had two patients who had significant cardiovascular deterioration and one cardiac arrest thought to be due to Bone Cement Implantation Syndrome. These cases highlighted a number of difficulties with initiating resuscitation in this situation, including: resuscitation in the lateral position and how to manage the open hip.
Together with orthopaedic and theatre staff colleagues we designed and implemented a 'Cement Curfew' with the aim to improve patient safety in our hospital. This incorporates all of the measures advised by the NPSA 2009 alert(2) and adds role designation and description. It is based around the WHO Safer Surgery Checklist.
The aspects of the cement curfew are as follows:
1) Team Brief Patients undergoing cemented arthroplasties are identified. Those that are deemed high risk are recommended to have higher levels of monitoring such as invasive arterial blood pressure measurement. Specific 'Cement Curfew' roles are allocated to team members as part of the Team Brief and their names written on a laminated card clearly displayed in the operating theatre.
2) Time Out The need for 'Cement Curfew' is emphasised and individual roles reiterated.
3) Cement mixing At the point of cement mixing, the cement curfew is verbally instituted and all team members with a role must be present in theatre for this period of increased risk. Distractions are minimised at this time.
4) Cement Insertion Surgical and Anaesthetic factors as described by the NPSA alert are followed.
5) Following prosthesis relocation If cardiovascular stability is maintained the Anaesthetist announces the end of the 'Curfew'.
6) Cardiac Arrest If there is a cardiac arrest, members of the team know what their roles are and the patient can be quickly turned supine while maintaining wound sterility to allow resuscitation to continue.
Before introducing the cement curfew into daily practice we carried out simulated training in the theatre with all team members. This served to both prove the appropriateness of the assigned roles, and to empower staff so they were confident of what would be required of them in this situation. Having experienced another cardiac arrest following the establishment of the cement curfew, all team members commented that resuscitation was commenced swiftly and efficiently and they felt more confident in knowing what was expected of them individually. We believe these simple measures could be incorporated into all trauma lists and should serve to both improve patient care and empower staff to deal with these critical incidents.
1. 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. Mitigating surgical risk in patients undergoing hip arthroplasty for fractures of the proximal femur. www.nrls.npsa.nhs.uk/alerts/?entryid45=59867 14 September 2009
Factors related to hypoglycemia among diabetics
The study reported by Rajendran et al (1) gives an interesting finding on the frequency and temporality of hypoglycemia episodes compared between diabetics on insulin and on suphonylureas in the inpatient setting in UK. The authors reported a higher rate of hypoglycemia among those on sulphonylureas than those on insulin. In contrast, a study from UK has shown that hypoglycemia occurs more often than previously reported in insulin-treated type 2 diabetes and with sufficient frequency to cause significant morbidity. The prevalence of hypoglycemia has been reported to be 70-80% in clinical trials using insulin to achieve good metabolic control in type 2 diabetes (2). Hence, we need to look into other factors that might have led to the risk of hypoglycemia using sulphonylureas.
The study does not mention about the type of diabetes - type 1 or type 2 or both. This is relevant since type 1 patients would be on insulin while the figure would change for type 2 diabetes patients. A separate analysis on this aspect might give the readers a clear picture on the nature of patients shown to be hypoglycemic and the susceptibility of hypoglycemia could differ depending upon the type of diabetes.
The authors have given several valid limitations to the findings. Since the study was based on record analysis, it might not be possible to look into other factors which might have contributed to the frequent occurrence of hypoglycemia during night to morning hours. They have mentioned about lack of bedtime carbohydrate snacks as a possible risk factor. Many risk factors are also reported for hypoglycemia among diabetics. According to Briscoe VJ et al (3) the risk factors of hypoglycemia are: missed or delayed meal, eating less food at a meal than planned, vigorous exercise without carbohydrate compensation, taking too much diabetes medicine (e.g., insulin, insulin secretagogues, and meglitinides), drinking alcohol. Hence, the present study could have gathered information on feeding practices of the hospitals for the patients, habit of alcohol intake, dose of medications given to the patients which have a role to play in hypoglycemia incidence among the patients. The older age group of patients in the study treated with sulphonylureas, having lesser levels of HbA1C had more occurrence of hypoglycemia than younger patients on insulin with higher levels of HbA1C. This is an important variable to be considered while giving sulphonylureas to the older diabetics with better control of blood glucose levels during the past three to four months. Whether there is a need for lowering the dosage of sulphonylureas in this group of patients need to be re-looked and discussed.
Another factor that has not been analyzed in the present study is the differences in the occurrence of hypoglycemia between male and female diabetic patients. We do not know whether the differences in the occurrence of hypoglycemia could be related to biological difference according sex. Such analysis could have provided additional information on the risk factors of hypoglycemia in the present study.
1. Rajendran R,Kerry C, Rayman G, et al. Temporal patterns of hypoglycaemia and burden of sulfonylurea-related hypoglycaemia in UK hospitals: a retrospective multicentre audit of hospitalised patients with diabetes. BMJ Open 2014;4:e005165. doi:10.1136/bmjopen-2014-005165
2. The U.K. Prospective Diabetes Study Group: Intensive blood-glucose control with sulfonylureas or insulin compared with conventional treatment and risk of complication in patients with type 2 diabetes. Lancet 352:837- 853, 1998
3. Briscoe VJ, Davis SN. Hypoglycemia in Type 1 and Type 2 Diabetes: Physiology, Pathophysiology, and Management. Clinical Diabetes 2006;24:114 -121.
Reeta Devi Assistant Professor, School of Health Sciences, Indira Gandhi national Open University, New Delhi.
Mongjam Meghachandra Singh Professor, Department of Community Medicine, Maulana Azad Medical College, New Delhi.
Bimla Kapoor, Former Director and Professor, School of Health Sciences, Indira Gandhi national Open University, New Delhi.
Conflict of Interest:
Fits like a glove
Patient safety is at the forefront of every healthcare worker's mind. Therefore any system or methodology that will improve patient safety should be embraced by every hospital worldwide. The introduction of the Safety Program in the Netherlands has improved awareness on safety issues. This is demonstrated by the study by Van Schoten et al.
Although ideally this percentage should be nearer a 100, the mean Time-out procedure (TOP) compliance was 71,3% during the final year of the Safety Program. As the authors have stated there may have been a selection bias in the surgical procedures on the observation days. With spectators in the OR there also may have been a compliance bias by OR staff which may exaggerate the final outcome. In every day practice the compliance will unfortunately be probably less.
I wonder why the number of participating academic hospitals in this study was deemed low? Since there are only eight academic hospitals in the Netherlands twenty-five percent participated. The poor result of these hospitals, which also act as teaching hospitals, should be seen as a wake- up call rather than misrepresentation.
The Dutch program is called: "Veiligheidsmanagementsysteem" or VMS and should therefore be translated as: Safety Management System. This in my view is probably why the compliance rates will not reach a 'full pull'. The system was implemented top-down. In 2008 the government required hospitals to implement this management system by the end of 2012. And in most if not all operating theaters across the Netherlands you will find a map or card stating the correct TOP. From a governmental point of view the Safety Program was therefore implemented successfully.
The best way to implement this important safety system of course is to involve the persons responsible: physicians. They are the primary caregivers responsible for the safety of their patients. They should intrinsically feel a need of urgency in this matter. TOP's should be as inextricably part of every operation procedure as putting on a pair of sterile gloves. And it should fit like one.
Conflict of Interest:
Living with pulmonary hypertension
We thank Drs Herxheimer and Greenhalgh for their interest in our article. Pulmonary hypertension (PH) is a rare and poorly understood disease (as they point out), and our research is the first to provide in- depth insights into the perspective of the patient. Indeed, health-care providers consider the latter as essential in the management of the disease (Guillevin L et al. Eur Respir Rev. 2013 Dec;22(130):535-42 ; Anderson I et al. BMJ Open. 2012 Apr 18;2(2):e000806. doi: 10.1136/bmjopen -2011-00080). The research was originally supported by Bayer HealthCare as part of their broad commitment to PH in order to better understand the needs of these patients, and was completed in August 2011, before completion of relevant Phase III clinical trials. The decision to publish the data was made by the health-care professionals involved in the research, as we realised that this in-depth analysis of the patient's journey adds value to a global approach to the disease, and as such, should be shared with the scientific community.
The research was conducted to the highest ethical standards by Ipsos MORI, an independent research company that specialises in ethnographic research, and did not set quotas for the type of medication that patients were receiving. The authors participated at all steps of the development of the research and the manuscript. The sponsorship by Bayer HealthCare was clearly stated in the disclosures section of the manuscript. Readers are of course welcome to draw their own conclusions regarding the impact of such sponsorship on the validity of the scientific contribution, however, we are satisfied that the sponsor did not have any undue influence over the collecting or reporting of the data. Needless to say, the leading and senior authors (who are health-care professionals working in the field of PH) fully endorse the content of the manuscript.
Regarding the 'openness' of the data, the unique nature of ethnographic research makes it difficult to provide full access to data collected without compromising patient anonymity. As stated in the data sharing statement, we were required to delete transcripts after 6 months in accordance with Ipsos MORI retention and destruction procedures put in place for compliance with both the Data Protection Act (5th principle), and the international standard for information security, ISO 27001. If a third party wishes to view the patient footage collected, they should contact Barbara Hinzmann (firstname.lastname@example.org) and we will endeavour to make these data available in a way that is acceptable to the patients involved in the study.
Conflict of Interest:
M. Kingman has served on advisory boards and/or steering committees for Actelion Pharmaceuticals, Gilead Sciences, United Therapeutics Corporation, and Bayer HealthCare Pharmaceuticals; and has served as a speaker for Actelion Pharmaceuticals, Gilead Sciences and United Therapeutics Corporation. J.-L. Vachiery has served on advisory boards and/or steering committees for Actelion Pharmaceuticals, United Therapeutics Corporation and GlaxoSmithKline; has received research support from GlaxoSmithKline; and has served as a speaker for Actelion Pharmaceuticals, Bayer HealthCare Pharmaceuticals, GlaxoSmithKline, Eli Lilly and United Therapeutics Corporation.
Re:Factors influencing access to health care in Andhra Pradesh and Maharashtra, India
To the Editor.
We thank Profesor Mongjam Meghachandra Singh, and Dr Reeta Devi for the points they have raised in their letter dated 27 June 2014. Our responses are below.
The questionnaires used in the 2 states were identical except for the additional questions related specifically to the Aarogyasri scheme which were included in the Andhra Pradesh version of the questionnaire and administered in that state. The questions common to the 2 states were used in the difference in differences analysis. We therefore do not believe that there was a risk of differential responses.
In Maharashtra, advice we had received from the state Government and others was that there were some health financing schemes in existence including the RSBY, and we have described all the schemes we were made aware of, in our paper. Despite our best efforts we remained uncertain as to whether we were aware of ALL the schemes which may have existed in Maharashtra. Furthermore, we were advised that the coverage of the schemes we were informed about, was very low and this was confirmed by the published literature and data. We refer the authors of the letter to Figure 2 of a World Bank Working Paper (Bergkvist S, Wagstaff A, Katyal A, Singh P, Samarth A, Rao M. What a Difference a State Makes. Health reform in Andhra Pradesh. Policy Research Working Paper 6883. The World Bank http://www- wds.worldbank.org/external/default/WDSContentServer/IW3P/IB/2014/05/21/000158349_20140521134140/Rendered/PDF/WPS6883.pdf) which we have recently prepared. Trends in coverage of the relevant government sponsored insurance schemes in the 2 states ascertained from administrative data published by the Aarogyasri Trust, Government of Maharashtra and RSBY are shown in the Figure. RSBY coverage was approximately 1% compared with approximately 80% for the Aarogyasri in Andhra Pradesh. A household survey in Maharashtra conducted by Thakur and Ghosh in 2012 found RSBY coverage to be even less at 0.5 percent (Thakur, H. and S. Ghosh (2013). Social Exclusion and Rashtriya Swasthya Bima Yojana (RSBY) in Maharashtra. Mumbai, India School of Health Services Studies, Tata Institute of Social Sciences).
Despite the reported differences in scheme coverage, our aim was to ensure that our questions in the tool used in Maharashtra (as well as in Andhra Pradesh) offered an opportunity for the households to provide information on any form of insurance or health financing scheme they had access to, including the RSBY. So, for example, questions 411-413, 617, 618, 655 and 666 were designed to elicit any information about other health financing options including the RSBY which the household may have availed of, and the field survey staff were trained to collect data on any schemes mentioned by the interviewee. Questions 403-407 offered an additional opportunity to elicit information on hospitals chosen by individuals or households and factors which influenced this decision.
We are therefore confident that the differential response is due to the differences in the scale of coverage and public information about the scheme. These results have been shared with Government of Maharashtra in 2013, and there is acknowledgement that our conclusions are likely to be reasonable. It may also be noted that, because of the uncertainties, we restricted ourselves to comparing the effects of health financing innovations over time between Andhra Pradesh and Maharashtra, but do not infer a causal link between changes in AP and the Aarogyasri scheme.
In relation to accounting for changes in inflation from 2004 to 2012 while calculating changes in the health expenditures, we have highlighted in the section entitled 'Deflation of follow-up expenditure estimates' that all 2012 data were deflated using the consumer price index of the Government of India to reflect 2004 values. It is therefore incorrect to suggest that the analysis did not control for inflation.
In the hierarchy of methodologies, ours is the best possible, in the absence of baseline data. However, we do accept that there are limitations which impact on our findings and conclusions, and these are described in detail in our paper. Our difference-in-differences study design as well as our analysis which adjusted for 9 covariates (these are mentioned in our paper, and we have therefore not listed them again) have nevertheless accounted for the differences between the 2 states as best as possible.
The focus of our study was restricted to inpatient hospital care. For inpatient care, the Aarogyasri scheme is the major innovation in Andhra Pradesh, in terms of the population coverage, numbers of hospitals empanelled, medical conditions included and the appointment of Aarogyamitras and conduct of camps partly to raise awareness and help individuals to navigate their way through the health system. It would therefore be reasonable to suggest that any changes in behaviours related to inpatient treatments in AP may be attributable to the Aarogyasri.
Our study focused on out of pocket expenditure on health and access to hospitalisations in selected households. It was not designed to answer any research questions related to health provider-related issues such as health manpower or facilities. These would be worthwhile aspects of health care to explore in the future.
Mala Rao (on behalf of all the authors of the paper)
Conflict of Interest:
Passive smoking at home is a risk factor for community-acquired pneumonia in older adults: a population-based case-control study
Dear Prof Pankaj B Shah, Thank you very much for your comments and for the opportunity to clarify the design, the data and the results of the present analysis. The PACAP study was a large population-based case-control study that recruited 1336 cases of CAP and 1326 controls without CAP matched by age and sex (total sample of 2662 subjects). For the purpose of assessing the effect of passive smoking on CAP, only never smokers were selected from the original PACAP sample. Among this original sample, 1003 subjects were never smokers and constitute the subsample for the present analysis. Never smokers were then classified as passive or non-passive smokers at home depending if they reported to be exposed to tobacco consumption at home or not. We hereby present the results for all age groups: 1.- Never smoker(>14 years group) Passive smokers at home:CAP 143;Controls(without CAP) 140 Non-Passive smokers at home: CAP 328; Controls (without CAP) 392 TOTAL: CAP 471; Controls(without CAP) 532
Data from the subgroup of subjects >65 years of age were as follows:
2.- Never smokers(>65 years group) Passive smokers at home:CAP 59;Controls(without CAP)43 Non-Passive smokers at home: CAP 168; Controls (without CAP) 195 TOTAL: CAP 227; Controls(without CAP) 238
On the other hand, as mentioned in the data analysis section in the manuscript two approaches were established to assess the relationship between passive smoking and CAP: a) estimation of incidence of CAP in general >14 years population (for exposed and non-exposed) and the RR, from the prospective phase of the study and b) estimation of OR from the case-control study. In our opinion, presenting the results of both different analyses is of value because both showed very similar and concordant results which reinforce their robustness. Controls were frequency matched by age and sex with cases in the original PACAP sample. However, when selecting only the subgroup of never smokers this matching could be lost. That is beacuse we also present results adjusted for age and sex. Finally, regarding the effect of passive smoking in ?65 years old subjects, with a statistically significant chi square, crude OR (1.59) and RR (1.48) and with and adjusted OR (1.56) just in the limit of significance, we conclude that passive smoking is a risk factor for CAP in this age group.
Conflict of Interest:
Issues before interpretation foo making informed decision making
Dear Sir, at the outset, I would like to congratulate BMJ open and authors for publishing wonderful study. There are certain issues which needs more clarity before an reader can make informed decision. 471 patient mentioned in abstract is missing in the content of the paper. The number of cases and control somehow do not match with the earlier paper cited for the detailed methodology. After preparing 2X2 table, authors should have restricted to either calculation of OR or RR rather than both as the results make interpretations difficult. The authors indicate about frequency matching for age, sex while same is adjusted in logistic regression. It is also indicated that controls are selected from the random sample which is probably difficult as only 1003 participants were never smokers which includes 471 cases. This number 1003 also does not match which the earlier study cited for detail methodology. Passive smoking definition is restricted to only current smokers. CAP can have some risk associated with people living earlier with a smoker but not currently staying. Some of the results are included in data analysis section which could have been avoided. It is indicated that table shows significant result for participants more than age 65 years but adjusted odds ratio is 1.56 (1.00 to 2.45. Since CI has 1 that indicates that there is no significant association. Comparing the same with RR in table 2, it is 1.48 (1.08 to 2.03)which indicates significance. Hence it may be good on authors part to restrict to either OR or RR. If authors believe that this is case control study, then they should have restricted to OR.If the author assumes that since it is population based case control study which can assess incidence and relative risk, they should have avoided OR. If authors believe that this is case control study, then they should have restricted to OR.
All these issues are very important for making informed decision.
Conflict of Interest:
How do we build new evidence on OP neurotoxicity?
The review by Takahashi and Hashizume (1)is a well-written analysis of papers addressing an important public health problem - that of the risk of neurotoxic outcomes associated with workplace Organophosphate (OP) exposure. However, one wonders how it builds new evidence on occupational OP neurotoxicity when two recent systematic reviews in 2012 have already covered the same or similar ground (2,3) and produced largely similar, findings. Neither of these reviews are cited in this paper which also claims, incorrectly, that few epidemiological studies have assessed the relationship between occupational exposure and OP neurotoxicity. These two oversights should alert one to the importance of peer review. I am becoming increasingly concerned that academic publication practice is losing sight of the main objective for research - to advance our understanding of problems in ways that scientific problems can help us solve, rather than producing papers that do not get read, or used to systematically advance scientific understanding.
1. Takahashi N, Hashizume M. A systematic review of the influence of occupational organophosphate pesticides exposure on neurological impairment. BMJ Open 2014;4:e004798
2. Mackenzie Ross, S., McManus, I. C., Harrison, V. & Mason, O. Neurobehavioral problems following low-level exposure to organophosphate pesticides: a systematic and meta-analytic review. Critical Reviews in Toxicology, 2012; 43: 21-44.
3. Ismail AA, Bodner TE, Rohlman DS. Neurobehavioral performance among agricultural workers and pesticide applicators: a meta-analytic study. Occup Environ Med 2012;69:457-464
Conflict of Interest: