Displaying 11-19 letters out of 275 published
Interaction of doctors with pharmaceutical companies
Dear Editor of the BMJ,
We read with interest the systematic review on 'Legislative, educational, policy and other interventions targeting physicians' interaction with pharmacetical companies' by Alkhaled and colleagues. In 2012, the Irish medical council provided ethical guidelines on the interaction of doctors with pharmaceutical companies. These guidelines stated that doctors should not accept gifts or hospitality, directly from pharmaceutical companies. In 2013, we surveyed 126 Irish doctors at our large university hospital to assess if they were following the medical council guidelines and to further assess their perception of the influence of pharmaceutical companies on their prescription choice using an online questionnaire. 99% (125/126) of respondents admitted to having received something (sandwich, pen, free dinner, educational trip) from a pharmaceutical company at some point in their career. Nine months after publication of the medical council guidelines on interaction with pharmaceutical companies, 35% (41/117) of doctors were unaware of the new guidelines. Of those who said that they were in accordance with the new guidelines, 89% (48/52) had received gifts or hospitality from a pharmaceutical company since the introduction of the guidelines. 58% (69/118) of respondents felt that pharmaceutical company involvement with health care workers created a professional conflict of interest, and half of respondents (56/105) would prefer if pharmaceutical company representatives did not contact them while they were at work. 81% (95/115) of respondents felt that hospitals should have policies on the interactions between doctors and pharmaceutical company representatives. Only 12% (14/120) of the doctors surveyed had been given guidance on interaction with pharmaceutical company representatives or interpretation of information provided by pharmaceutical companies while at university. 84% (97/116) would have liked to have had more guidance as an undergraduate student.
In our study many doctors were keen to have policies on interaction with pharmaceutical company representatives in place in their hospital. Junior doctors expressed a wish to have received guidance on interaction with pharmaceutical companies, their representatives and associated literature while at university. The three observational studies reviewed in the paper by Alkhaled and colleagues demonstrated that introduction of policies can have a positive effect on the interaction between doctors and pharmaceutical companies and subsequent prescribing. The majority of doctors in our study have expressed a wish for hospitals to implement policies on the presence of pharmaceutical company representatives on campus. Now is the time for change.
Kind regards, Dr Susan Byrne Dr Tudor Montaneau Dr Janice Redmond
Department of Neurology, St.James Hospital, James Street, Dublin 8, Ireland.
1. Alkhaled, L., et al., Legislative, educational, policy and other interventions targeting physicians' interaction with pharmaceutical companies: a systematic review. BMJ Open, 2014. 4(7): p. e004880.
Conflict of Interest:
Susan Byrne received 6,298 pens, 467 sandwiches, and a travel grant from pharmaeutical companies between 2005 and 2010. Susan Byrne has not received anything from pharmaceutical companies since 2011. Tudor Montaneau reports no conflicts of interest. Janice Redmond accepted research funding from Merck-Serono in 2009.
Addendum to 'Functionality and feedback: a protocol for a realist synthesis of the collation, interpretation and utilisation of PROMs data to improve patient care'. 2014-005601
The authors would like to add the following sentence to the 'Ethics and Dissemination': We will also submit a final report to the National Institute for Health Research (NIHR) that will be published in the NIHR journals library.
Conflict of Interest:
Correction to the corresponding author for the article 'Functionality and feedback: a protocol for a realist synthesis of the collation, interpretation and utilisation of PROMs data to improve patient care'.
The authors of this paper would like to state that there was an editing error in the final published article. The corresponding author should be stated as Joanne Greenhalgh (first author), email address: firstname.lastname@example.org
Please could all correspondence regarding this article be sent to Joanne Greenhalgh.
Conflict of Interest:
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 (email@example.com) 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.