In March 2017, the Royal Free Hospital, London, UK was opened as an additional site for recruitment. Hôpitaux Universitairede Genève, Geneva, Switzerland has been screening since the trial opened on March 2015. By January 2017, this site had screened 71 patients and failed to recruit any patients. At the Trial Steering Committee held in January 2017, it was decided to withdraw this site, with mutual consent of the principle investigator, from the trial. The screening data will be reported, as part of the CONSORT diagram, when recruitment is completed and the trial closed. As the primary outcome is cost effectiveness, the Trial Steering Committee has agreed that the data analysis plan is still valid with at least 17 patients to be recruited per country. The removal of Hôpitaux Universitairede Genève, Geneva, Switzerland as a site will not impact on the planned data reporting and the number needed to recruit has not been changed.
Sites currently screening and recruiting to the trial are:
Guys and St Thomas NHS Foundation Trust
Leeds University Hospital
Royal Brompton and Harefield NHS Foundation Trust
The Royal Free Hospital
Centre Hospitalier Universitaire de Grenoble
Chu-Hôpitaux De Rouen
There is no mention of nurses ordering take out and all hours of the day and those choices. Plus many bring in food items from home to share with others. How often does that happen and what is brought .
Blaming the food service is a quick and easy way to blame others versus choices made by nurses.
As point of Dr. Atif A Baig, this should not be ethical issue but a legal one. After suitable statement of conflict of interest, it is must be no issue. However, Dr. Atif A Baig's conclusion may be obtained without understanding the regulations in China's National Natural Science Foundation (NNSF).
The newest China's NNSF funded project funding regulation, see http://www.nsfc.gov.cn/publish/portal0/tab229/info48335.htm, has been taken effect in 2015 and now is running. There are clear rules for usage of left over funding in its article 28. First, the left over funding should be returned to NNSF of China in 2 years after the project has been closed. Second, the left over funding can only be used in direct expenditure of basic research. Moreover, article 37 also said that misappropriation of funding is illegal.
As point of Dr. Atif A Baig, this should not be ethical issue but a legal one. After suitable statement of conflict of interest, it is must be no issue. However, Dr. Atif A Baig's conclusion may be obtained without understanding the regulations in China's National Natural Science Foundation (NNSF).
The newest China's NNSF funded project funding regulation, see http://www.nsfc.gov.cn/publish/portal0/tab229/info48335.htm, has been taken effect in 2015 and now is running. There are clear rules for usage of left over funding in its article 28. First, the left over funding should be returned to NNSF of China in 2 years after the project has been closed. Second, the left over funding can only be used in direct expenditure of basic research. Moreover, article 37 also said that misappropriation of funding is illegal.
The content of e015983 has claimed itself as an applied research project clearly because it said "This study presents a new approach based on comparative effectiveness research to distinguish the curative effects of three CPMs that are often used in stroke convalescence to determine the ideal medicine for the treatment of each symptom." in its abstract.
For the first 2 project, 81202849 and 30600834, if they are funding article e015983 and ChiCTR-IOR-1701039 after they were closed, they have violated Article 28 in China's NNSF regulation. If the 3rd project, 81603659, is funding article e015983 and ChiCTR-IOR-1701039, it has violated Article 37. As the same time, article e015983 and ChiCTR-IOR-1701039 are facing the same issues.
Despite the legitimacy investigation exceeded scope of ethical, even from an ethical point of view, author of article e015983 should explain the real fund source of this project as soon as possible. These explanations are critical for readers and editors to clarify whether there are any improper issues in this article.
Dear Dr Peter,
Thank you so much for your interest and comment.
The study population consisted of both new pregnant women and those on follow-up of antenatal care clinic (ANC). Yes, it appears that new pregnant women attended ANC in random order. However, pregnant women who were on ANC follow-up visited the clinic on their schedule date. Thus, we assumed there was some pattern to their attendance of the clinic. In order to increase the chance of including women from different schedule dates and avoid clustered selection, we preferred to use a systematic random sampling than convenient sampling.
Best,
Techalew
I was reading it all and I assume that many times the issues can’t be ethical but are still legal. Being a neutral moiety, I assume just based on a fact to get justification from author or anyone sending a response is not enough for such serious ethical concerns. There is a serious need to look into the legal implications of use of funding. As per usual practice, the report of all grants are submitted to the funding bodies and if the “authors” have explained and mentioned the use of this all funding or “left over funding” in specific time to be used later as per rules and regulations, there must be no issue as far as no “conflict of interest “ is there between the authors and the funding agency. Seems it’s a very minor issue but for me it’s a new issue of its type and thank you for a very positive attitude from BMJ Open editor for facilitating science and honesty not in science but the concern minor issues.
This study of 36 practices used a particular system, eCONsult, cannot be taken as indicative of online consultations in general. It is all about how the system works, both the software and within the operational system of the practice.
The average of 0.9 per practice per day is clearly too low to have significant impact, and that was probably to increase costs.
One of the practices involved, Concord Medical Practice, changed to askmyGP the following year and increased its uptake by a factor of 15 to around 60 per day (reported at SAPC, July 2017). Others have a similar level. Then the wider impact becomes measurable. Independent study is urgently needed as a £45m fund has been created to fund this technology, while published evidence says it will be wasted.
he role of Neutrophil Extracellular Traps (NETs) in effectively trapping and destroying bacteria during a bacterial infections is a recent discovery. But certain bacterias, eg. Streptococcus Pneumoniae can escape traps by degrading chromatin fibers of NETs by surface exposed receptors and thus results in promoting bacterial spreading through the airway and into the bloodstream. Furthermore, Wartha and colleagues showed that S. pneumoniae evades NETs by a positive charge on its surface as a result of capsule expression and lipoteichoic acid d-alanylation. However, the mechanisms related to S. pneumoniae-induced NET formation remain unclear beside its degradation. The exact molecular mechanism of escaping NETs by S. pneumoniae is needed to be studied as per basic structural component degradation of NETs towards the pathogenesis and immunogenic response of S. pneumoniae against host defense mechanisms. Studying the exact molecular effect on the quantification and structure of NETs in infected neutrophils is expected to define specific pathogenic induction and destruction of NETs under the effect of specific genes in comparison with their mutants as live controls. The resultant mutants are also expected to give high immune response beside helping in understanding the basic mechanism of NETs in respect to specific genes. This could help in targeting the innate immune response at a more broader level beside multivalency of the vaccine will never be an issue.
The text: Our primary objectives are: i) evaluate the impact of maternal dietary CML intake on maternal and infant complex lipid status by comparing outcomes of product A with product B and a reference group and; ii) investigate the benefits of the fortified maternal milk products (containing CML) on maternal health and nutritional status, and general infant health and neurodevelopment.
Should have read: Our primary objectives are: i) evaluate the impact of maternal dietary CML intake on maternal complex lipid status by comparing outcomes of product A with product B and a reference group and; ii) investigate the benefits of the fortified maternal milk products (containing CML) on maternal health and nutritional status. Secondary outcomes include the effects of the products on infant complex lipid status, and on general infant health and neurodevelopment.
We would be most grateful if an erratum/correction could be published on line
It was disappointing to read the recent report on vaginal breech delivery in Cameroon.1 Pelvic assessment was performed clinically. Surely the Faculty of Medicine and Biomedical Science at the University of Yaounde 1 has access to radiological facilities for an erect lateral pelvic X-ray?
Perhaps the academic debate on pelvimetry in more developed countries has clouded the issue for those in Cameroon. If this is so then the developed world has done little for poorer countries in this area of medicine.
Joyce et al,2 found that for failed vaginal breech delivery there was a linear relation between the Obstetric conjugate dimension and the fetal size.
A flat sacrum is important especially if the mid-pelvic AP diameter is narrower than the Obstetric conjugate and the Obstetric conjugate is less than 11.7cms.
Potter et al.3 studied cases of infants who died of intracranial injury after vaginal breech delivery. In 13 cases maternal pelvic radiographs were available in seven and there was diminished pelvic capacity in all. Beischer4 reviewed the outcome of term breech delivery in 64 patients with pelvic contractions as documented by radiographs. Thirteen patients were delivered by caesarean and all infants survived. In the 51 infants vaginally delivered there were four deaths, three of which were due to tentorial tears. Collea et al.5 performed a study of term frank breech delivery. They randomized patients to vaginal or caesarean delivery...
It was disappointing to read the recent report on vaginal breech delivery in Cameroon.1 Pelvic assessment was performed clinically. Surely the Faculty of Medicine and Biomedical Science at the University of Yaounde 1 has access to radiological facilities for an erect lateral pelvic X-ray?
Perhaps the academic debate on pelvimetry in more developed countries has clouded the issue for those in Cameroon. If this is so then the developed world has done little for poorer countries in this area of medicine.
Joyce et al,2 found that for failed vaginal breech delivery there was a linear relation between the Obstetric conjugate dimension and the fetal size.
A flat sacrum is important especially if the mid-pelvic AP diameter is narrower than the Obstetric conjugate and the Obstetric conjugate is less than 11.7cms.
Potter et al.3 studied cases of infants who died of intracranial injury after vaginal breech delivery. In 13 cases maternal pelvic radiographs were available in seven and there was diminished pelvic capacity in all. Beischer4 reviewed the outcome of term breech delivery in 64 patients with pelvic contractions as documented by radiographs. Thirteen patients were delivered by caesarean and all infants survived. In the 51 infants vaginally delivered there were four deaths, three of which were due to tentorial tears. Collea et al.5 performed a study of term frank breech delivery. They randomized patients to vaginal or caesarean delivery. They used radiographic pelvimetry as a criterion for selecting patients. Of the 115 patients randomized to vaginal delivery 45% (n=52) had “below normal” pelvic measurements and were delivered by caesarean section. There was only one neonatal death in this study from fatal congenital abnormalities in the caesarean delivered group whereas the postpartum morbidity was significantly higher in this group.
In 1984 Fetal Maternal Medicine 6 quoted: ‘Most authorities agree that radiographic pelvimetry has a place in determining the safest method of delivery for a patient in labour at term with a breech presentation.’6 In 1997, a Lancet Editorial stated: X-ray pelvimetry remains a common procedure. Its aim is to identify those women for whom mechanical difficulties might lead to excess mortality and morbidity due to trauma. Women selected out in this way should have a high chance of successful vaginal breech birth.’7
The Term Breech Trial,8 found significantly higher perinatal morbidity and mortality in the group randomized to vaginal delivery and concluded “planned caesarean delivery is better than planned vaginal birth”. But pelvimetry was performed in less than 10% of those randomized to vaginal delivery. Poor outcome for those allocated to vaginal delivery can hardly be surprising when such an important investigation was so infrequently performed. This fact alone seriously questions both the validity and ethics of this study. This led to the question: Can evidence-based medicine be unscientific?9
Goffinet et al.10 in the Premoda Study, relied heavily on pelvimetry, with 82.5% of patients who were planned to have a vaginal delivery, having this assessment. They found no significant difference in the fetal and neonatal mortality or severe morbidity between the vaginal or caesarean groups.
With improved nutrition, it is argued that there are less pelvic deformities. This may be true in wealthier countries but I doubt that applies to Cameroon!
Can’t we leave a better legacy for the ‘third world’ than this?
References:
1. Dohbit JS, Foumane P, Tochie JN, et al. Maternal and neonatal outcomes of vaginal breech delivery for singleton term pregnancies in a carefully selected Cameroonian population: a cohort study. BMJ Open 2017;7:e017198. doi:10.1136/bmjopen-2017-017198
2. Joyce DN, Giwa-Osagie F, Stevenson GE. Role of pelvimetry in active management of labour. BMJ 1975, 4,505-7.
3. Potter MG, Heaton CH, Douglas GW. Intrinsic fetal risk in breech delivery. Obstet Gynecol. 1960; 15: 158.Beischer NA. Pelvic contraction in breech presentation. J Obstet Gynaecol Br Commonw 1966; 73: 421-7.
4. Beischer NA. Pelvic contraction in breech presentation. J Obstet Gynaecol Br Commonw. 1966; 73: 421-7.
5. Collea JV, Chenin C, Quilligan EJ. The randomized management of term frank breech presentation: a study of 208 cases. Am J Obstet Gynecol 1980; 137:235-44.
6. Bowes WA. Clinical aspects of normal and abnormal labour. In: Creasy RK, Resnik R. Maternal Fetal Medicine Philadelphia: Saunders; 1984; 449-90.
7. Walkinshaw SA. Pelvimetry at term. Lancet 1997; 305:1791.
8. Hannah ME, Hannah WJ, Hewson SA, Hodnet ED, Saigol S, Willan AR. Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial. Lancet. 2000; 356: 1375-83.
9. McMaster-Fay R. Can evidence-based medicine be unscientific? ANZJOG 2004; 44:173-4.
10. Goffinet F, Carayol M, Foidart JM et al. PREMODA Study Group. Is planned vaginal delivery for breech presentation at term still an option? Results of an observational prospective survey in France and Belgium. AJOG 2006; 194:1002-11.
The editorial team of BMJ Open are currently investigating the issues raised by Yuzhen Li in response to this article.
We have asked the authors to respond to the points raised and will investigate the case in line with the principles of the Committee On Publication Ethics (COPE).
In March 2017, the Royal Free Hospital, London, UK was opened as an additional site for recruitment. Hôpitaux Universitairede Genève, Geneva, Switzerland has been screening since the trial opened on March 2015. By January 2017, this site had screened 71 patients and failed to recruit any patients. At the Trial Steering Committee held in January 2017, it was decided to withdraw this site, with mutual consent of the principle investigator, from the trial. The screening data will be reported, as part of the CONSORT diagram, when recruitment is completed and the trial closed. As the primary outcome is cost effectiveness, the Trial Steering Committee has agreed that the data analysis plan is still valid with at least 17 patients to be recruited per country. The removal of Hôpitaux Universitairede Genève, Geneva, Switzerland as a site will not impact on the planned data reporting and the number needed to recruit has not been changed.
Sites currently screening and recruiting to the trial are:
Guys and St Thomas NHS Foundation Trust
Leeds University Hospital
Royal Brompton and Harefield NHS Foundation Trust
The Royal Free Hospital
Centre Hospitalier Universitaire de Grenoble
Chu-Hôpitaux De Rouen
There is no mention of nurses ordering take out and all hours of the day and those choices. Plus many bring in food items from home to share with others. How often does that happen and what is brought .
Blaming the food service is a quick and easy way to blame others versus choices made by nurses.
Dear editor,
As point of Dr. Atif A Baig, this should not be ethical issue but a legal one. After suitable statement of conflict of interest, it is must be no issue. However, Dr. Atif A Baig's conclusion may be obtained without understanding the regulations in China's National Natural Science Foundation (NNSF).
The newest China's NNSF funded project funding regulation, see http://www.nsfc.gov.cn/publish/portal0/tab229/info48335.htm, has been taken effect in 2015 and now is running. There are clear rules for usage of left over funding in its article 28. First, the left over funding should be returned to NNSF of China in 2 years after the project has been closed. Second, the left over funding can only be used in direct expenditure of basic research. Moreover, article 37 also said that misappropriation of funding is illegal.
As common sense of scientific research, there are many differences between basic research and applied research, see 1953's annual report of National Science Foundation of US, https://www.nsf.gov/pubs/1953/annualreports/ar_1953_sec6.pdf. In China, the definition of basic research is similar, see http://www.most.gov.cn/kjgh/kjfzgh/200708/t20070824_52690.htm.
The content of e015983 has cla...
Show MoreDear Dr Peter,
Thank you so much for your interest and comment.
The study population consisted of both new pregnant women and those on follow-up of antenatal care clinic (ANC). Yes, it appears that new pregnant women attended ANC in random order. However, pregnant women who were on ANC follow-up visited the clinic on their schedule date. Thus, we assumed there was some pattern to their attendance of the clinic. In order to increase the chance of including women from different schedule dates and avoid clustered selection, we preferred to use a systematic random sampling than convenient sampling.
Best,
Techalew
Dear Editor of BMJ.
I was reading it all and I assume that many times the issues can’t be ethical but are still legal. Being a neutral moiety, I assume just based on a fact to get justification from author or anyone sending a response is not enough for such serious ethical concerns. There is a serious need to look into the legal implications of use of funding. As per usual practice, the report of all grants are submitted to the funding bodies and if the “authors” have explained and mentioned the use of this all funding or “left over funding” in specific time to be used later as per rules and regulations, there must be no issue as far as no “conflict of interest “ is there between the authors and the funding agency. Seems it’s a very minor issue but for me it’s a new issue of its type and thank you for a very positive attitude from BMJ Open editor for facilitating science and honesty not in science but the concern minor issues.
This study of 36 practices used a particular system, eCONsult, cannot be taken as indicative of online consultations in general. It is all about how the system works, both the software and within the operational system of the practice.
The average of 0.9 per practice per day is clearly too low to have significant impact, and that was probably to increase costs.
One of the practices involved, Concord Medical Practice, changed to askmyGP the following year and increased its uptake by a factor of 15 to around 60 per day (reported at SAPC, July 2017). Others have a similar level. Then the wider impact becomes measurable. Independent study is urgently needed as a £45m fund has been created to fund this technology, while published evidence says it will be wasted.
he role of Neutrophil Extracellular Traps (NETs) in effectively trapping and destroying bacteria during a bacterial infections is a recent discovery. But certain bacterias, eg. Streptococcus Pneumoniae can escape traps by degrading chromatin fibers of NETs by surface exposed receptors and thus results in promoting bacterial spreading through the airway and into the bloodstream. Furthermore, Wartha and colleagues showed that S. pneumoniae evades NETs by a positive charge on its surface as a result of capsule expression and lipoteichoic acid d-alanylation. However, the mechanisms related to S. pneumoniae-induced NET formation remain unclear beside its degradation. The exact molecular mechanism of escaping NETs by S. pneumoniae is needed to be studied as per basic structural component degradation of NETs towards the pathogenesis and immunogenic response of S. pneumoniae against host defense mechanisms. Studying the exact molecular effect on the quantification and structure of NETs in infected neutrophils is expected to define specific pathogenic induction and destruction of NETs under the effect of specific genes in comparison with their mutants as live controls. The resultant mutants are also expected to give high immune response beside helping in understanding the basic mechanism of NETs in respect to specific genes. This could help in targeting the innate immune response at a more broader level beside multivalency of the vaccine will never be an issue.
Dear Sir/Madam
We have been alerted to an error in our paper:
The text: Our primary objectives are: i) evaluate the impact of maternal dietary CML intake on maternal and infant complex lipid status by comparing outcomes of product A with product B and a reference group and; ii) investigate the benefits of the fortified maternal milk products (containing CML) on maternal health and nutritional status, and general infant health and neurodevelopment.
Should have read: Our primary objectives are: i) evaluate the impact of maternal dietary CML intake on maternal complex lipid status by comparing outcomes of product A with product B and a reference group and; ii) investigate the benefits of the fortified maternal milk products (containing CML) on maternal health and nutritional status. Secondary outcomes include the effects of the products on infant complex lipid status, and on general infant health and neurodevelopment.
We would be most grateful if an erratum/correction could be published on line
Philip N Baker, on behalf of the CLIMB team
Dear Sir,
It was disappointing to read the recent report on vaginal breech delivery in Cameroon.1 Pelvic assessment was performed clinically. Surely the Faculty of Medicine and Biomedical Science at the University of Yaounde 1 has access to radiological facilities for an erect lateral pelvic X-ray?
Show MorePerhaps the academic debate on pelvimetry in more developed countries has clouded the issue for those in Cameroon. If this is so then the developed world has done little for poorer countries in this area of medicine.
Joyce et al,2 found that for failed vaginal breech delivery there was a linear relation between the Obstetric conjugate dimension and the fetal size.
A flat sacrum is important especially if the mid-pelvic AP diameter is narrower than the Obstetric conjugate and the Obstetric conjugate is less than 11.7cms.
Potter et al.3 studied cases of infants who died of intracranial injury after vaginal breech delivery. In 13 cases maternal pelvic radiographs were available in seven and there was diminished pelvic capacity in all. Beischer4 reviewed the outcome of term breech delivery in 64 patients with pelvic contractions as documented by radiographs. Thirteen patients were delivered by caesarean and all infants survived. In the 51 infants vaginally delivered there were four deaths, three of which were due to tentorial tears. Collea et al.5 performed a study of term frank breech delivery. They randomized patients to vaginal or caesarean delivery...
The editorial team of BMJ Open are currently investigating the issues raised by Yuzhen Li in response to this article.
We have asked the authors to respond to the points raised and will investigate the case in line with the principles of the Committee On Publication Ethics (COPE).
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