I congratulate the authors for their cost-effectiveness analysis.
Nevertheless, I believe that their work will need at least three
clarifications.
Compared to LNG the UPA's superiority in efficacy reaches statistical
significance only after a process of adjustment of data. Raw data does not
indicate statistically significant superiority of UPA for any temporal
interval of administration (1).
I think the authors should have...
I congratulate the authors for their cost-effectiveness analysis.
Nevertheless, I believe that their work will need at least three
clarifications.
Compared to LNG the UPA's superiority in efficacy reaches statistical
significance only after a process of adjustment of data. Raw data does not
indicate statistically significant superiority of UPA for any temporal
interval of administration (1).
I think the authors should have an extra caution in designing economic
savings from UPA after the entire medical literature indicates the absence
of detectable effects of post-coital LNG in reducing unwanted pregnancies
and abortions at a population level (2).
Finally, although this is not at all the first paper on the subject I am
not sure a cost-saving analysis is suitable to unplanned pregnancies.
Albeit mistimed, unintended or even unwanted embryos and fetuses are not
infectious agents; no disease classification include pregnancy whatever
its level of planning. Although probably more disadvantaged and
problematic, children born after an unplanned pregnancy are not only
burdens, they are also resources for society. Steve Jobs was one of them.
Whoever will celebrate Christmas next week will not deny that his joy has
to do with the unplanned pregnancy by the Holy Mary.
References:
1) Glasier AF, Cameron ST, Fine PM, Logan SJ, Casale W, Van Horn J, Sogor
L, Blithe DL, Scherrer B, Mathe H, Jaspart A, Ulmann A, Gainer E.
Ulipristal acetate versus levonorgestrel for emergency contraception: a
randomised non-inferiority trial and meta-analysis. Lancet. 2010;
375(9714): 555-62.
2) Rodriguez MI, Curtis KM, Gaffield ML, Jackson E, Kapp N. Advance supply
of emergency contraception: a systematic review. Contraception. 2013;
87(5) :590-601.
Dear Editor,
We would like to comment several limitations of the work of Gomez-Perreta.
The work is merely a re-analysis of the data already published in 2001
(Navarro EA 2001)
(http://www.emrpolicy.org/science/research/docs/navarro_ebm_2003.pdf). The
data was obtained in a small city in Spain, called La ?ora, located in
Murcia with an estimated population of 20.000 people. Both publications
have from the same bias. The d...
Dear Editor,
We would like to comment several limitations of the work of Gomez-Perreta.
The work is merely a re-analysis of the data already published in 2001
(Navarro EA 2001)
(http://www.emrpolicy.org/science/research/docs/navarro_ebm_2003.pdf). The
data was obtained in a small city in Spain, called La ?ora, located in
Murcia with an estimated population of 20.000 people. Both publications
have from the same bias. The data used was obtained after a survey carried
out from the data of only 88 responders out 215 questionnaires, which only
represents 0,42% of the total population of La ?ora. The main issue is
that the population asked to participate in the study was not blinded to
the objectives to the study, with the high risk of bias due to the
participation.
Authors only took into account microwave exposure at home,
specifically measured in the bedroom; but neither microwave exposure at
work nor at sites of leisure time, was considered as additional and
eventually more relevant potential sources of microwave exposures.
The authors point out some possible confounders, in particular
persons who believed in the damage of exposure (reached by phone in
February 2012), the use of the computer and the use of the mobile.
However, the authors have not taken into account many other relevant
possible confounders. Among them, personal circumstances (life events)
that may affect their physical/psychological situations, causing also
anxiety, depression, irritability, sleep disorders, etc., such as recent
unemployment or loss of a closed-relatives, previous health problems and
current pharmacological treatment. Moreover, the variables analyzed in the
study (anxiety, troubles of sleep, irritability) are closely related
between them.
In addition to the above high risk of bias, the authors have used the
called Santini survey (http://www.ncbi.nlm.nih.gov/pubmed/12168254), a non
-validated questionnaire that was just been translated into Spanish.
Moreover the analysis was based on isolated variables included in the
survey but not on a specific value assigned to the so-called microwave
syndrome, according to Santini survey. We unsuccessfully tried to find in
Internet any kind of validation of the mentioned questionnaire. It would
be useful to get any further information from the authors in this respect.
Finally, prevalence is most appropriate than incidence to describe
the results in this study.
In summary, due to the limitations in the design of this study it
cannot be fixed with advanced statistical test. We are of the opinion that
the conclusions according to the authors achieved by the study are not
such conclusive ones. The study merely proposes a hypothesis for future
research works based on well-designed studies, in particular cohort
studies.
The Editor
It is indeed a research which needs to be widely circulated as the
biological science and ancient teachings of mindfulness are on the same
path of helping /alleviating human sufferings. The Indian ancient book
Bhagvad Gita ; the great teaching of Krishna to Arjuna in chapter II
verse 60 talks about how the turbulent senses attack the mind and lead it
astray .
The great wisdom of 'work must be done w...
The Editor
It is indeed a research which needs to be widely circulated as the
biological science and ancient teachings of mindfulness are on the same
path of helping /alleviating human sufferings. The Indian ancient book
Bhagvad Gita ; the great teaching of Krishna to Arjuna in chapter II
verse 60 talks about how the turbulent senses attack the mind and lead it
astray .
The great wisdom of 'work must be done without thought of reward' and 'an
individual may have a tranquil mind even in activity.' The tranquil mind
only be achieved by mindfulness and the rewards of such deeds will never
come into play in decision making thus negating the anxiety of rewards.
Similarly the teachings of Lord Buddha also stresses upon mindfulness.
Brain utilizes some 60% of the utilization of glucose by the whole
body in the resting state but in starvation, ketone bodies generated by
the liver partly replace glucose as fuel for the brain.(1) The brain's
functional connectivity is complex, has high energetic cost, and requires
efficient use of glucose, the brain's main energy source. In an articles
abstract published in which authors concluded that in a rich and
complex visual world the stimuli that are not cognitively accessed are
processed up to levels of perceptual interpretation(3) . The brain is
acting as supercomputer working through out our life , so by calming
down the activity of brain by mind fullness the best optimal utilization
of natures best computer (human brain ) can be achieved .
My sincere thanks to the authors for doing this research. And publishers
for presenting this to the world
(1).Berg JM, Tymoczko JL, Stryer L. Biochemistry. 5th edition. New
York: W H Freeman; 2002. Section 30.2, Each Organ Has a Unique Metabolic
Profile. Available from: http://www.ncbi.nlm.nih.gov/books/NBK22436/
( 2) Proc Natl Acad Sci. 2013;110(33):13642-7
( 3) J Cogn Neurosci. 2013 Nov 27
Umesh Chandra Ojha .MD,DTCD, B Sc., FCCP,FIMSA,FNCCP(I)
Director & Pulmonologist
Institute of Occupational Health & Research .
ESIC Hospital Basaidarapur
New Delhi
Morgan and colleagues elegantly propose the glitch methodology as an
effective means to identify process deviations that could impact on the
quality or speed of surgical procedures (1). We support the authors'
suggestion that the analysis of glitch patterns may facilitate the
development of interventions to improve patient safety in the operating
theatre across a range of domains.
Morgan and colleagues elegantly propose the glitch methodology as an
effective means to identify process deviations that could impact on the
quality or speed of surgical procedures (1). We support the authors'
suggestion that the analysis of glitch patterns may facilitate the
development of interventions to improve patient safety in the operating
theatre across a range of domains.
The development of a common method indeed seems possible. Using a
similar methodology, exclusively in vascular surgery, we have shown
remarkably similar results (2,3). The temporal pattern of glitches
reported in vascular procedures (40% within first quarter, 75% within
first half), reflects our previous data, in which many early intra
operative errors can be attributed to poor preoperative planning- an area
that we are currently assessing through the use of a novel software
application (PREPARE (4)).
Morgan et al.'s laudable efforts in this arena requires two
independent observers to record intraoperative glitches, one with a
background in human factors (HF) and one with surgical experience, with
good agreement between them. Interestingly, the authors identify that the
clinical observer consistently reports more glitches than the HF observer.
We feel that experienced health professionals working 'at the sharp end'
are ideally placed to identify problems with patient safety. For that
reason, we developed a method of identifying intraoperative error that can
be used by operating teams, as well as observers. The Imperial College
Error CAPture record (ICECAP) prompts structured reflection of
intraoperative error during post-operative debriefing sessions with team
members (5), and is being used in our UK multi-centre patient safety study
in vascular surgery (4,6). Similar to the glitch classifications used by
Morgan et al., ICECAP consists of six primary categories of error:
equipment; communication; procedure-independent pressures; technical;
safety awareness; patient-related, with twenty sub-categories used as
prompts. Operating teams have been able to recall 69.9% of all errors
recorded prospectively by a trained observer and nearly 79% of major
errors (5).
Team self-report of error has several benefits over prospective
observation, not least the fact that teams can feedback in real time, but
are also uniquely placed to understand the context of errors that occur
which is important in determining their significance. We believe that our
self-report methodology also helps to foster a culture of openness and
transparency to support patient safety- a key recommendation of the recent
Francis Report on Mid Staffs (7). Indeed the effect of culture may, in
agreement with Morgan et al., explain differences in glitch rates between
hospitals identified in their study.
In the light of our recent systematic review on surgery and
technology operating failures (8), we agree with Morgan et al. that
differences in glitch rates between sites and specialties are likely to be
dependent on differences in personnel, procedures and equipment.
Interestingly, Morgan et al. found that glitch rates varied significantly
in vascular. We have identified significant differences in error rates
between procedural sub-types in vascular (open versus endovascular) (3);
the types of treatment the authors observed may have influenced their
findings.
As Morgan and colleagues state, it is unlikely that we can improve
patient safety by addressing only one category of glitch, but
characterising error patterns and their significance are crucial first
steps in developing the wider surgical safety agenda.
1 Morgan L, et al. Capturing intraoperative process deviations using
a direct observational approach: the glitch method, BMJ Open 2013; 3:
e003519
2 Morbi AHM, et al. Reducing Error and Improving Efficiency during
Vascular Interventional Radiology: Implementation of a Preprocedural Team
Rehearsal. Radiology. 2012:264(2):473-483.
3 Albayati MA, et al. Identification of patient safety improvement
targets in successful vascular and endovascular procedures: analysis of
251 hours of complex arterial surgery. Eur J Vasc Endovasc Surg.
2011;41(6):795-802.
4 Cardiovascular Safety Group Research Programme. Accessed Jan 16,
2014.
http://www1.imperial.ac.uk/medicine/about/institutes/patientsafetyservicequality/research_themes_2/clinical_programmes/surgery/cardiovascular_safety_group/
5 Mason SL, et al. Design and validation of an error capture tool for
quality evaluation in the vascular and endovascular surgical theatre. Eur
J Vasc Endovasc Surg. 2012; 45(3):248-254.
6 UK Clinical Research Network. UK LEAP. Accessed Jan 16, 2014.
http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=12982.
7 Francis R, The Mid Staffordshire NHS Foundation Trust Inquiry,
2013. Accessed Jan 16, 2014. http://www.midstaffspublicinquiry.com/report
8 Weerakkody RA, et al. Surgical technology and operating-room safety
failures: a systematic review of quantitative studies. BMJ Quality and
Safety 2013; 22(9): 710-718.
Thank you very much for your interest in our paper, and for the
interesting comments.
I'd appreciate learning more about the situation of clinical trials in
France. Please, email your reply to me at
giuseppe.ambrosio@ospedale.perugia.it
I congratulate the authors for their cost-effectiveness analysis. Nevertheless, I believe that their work will need at least three clarifications. Compared to LNG the UPA's superiority in efficacy reaches statistical significance only after a process of adjustment of data. Raw data does not indicate statistically significant superiority of UPA for any temporal interval of administration (1). I think the authors should have...
Dear Editor, We would like to comment several limitations of the work of Gomez-Perreta. The work is merely a re-analysis of the data already published in 2001 (Navarro EA 2001) (http://www.emrpolicy.org/science/research/docs/navarro_ebm_2003.pdf). The data was obtained in a small city in Spain, called La ?ora, located in Murcia with an estimated population of 20.000 people. Both publications have from the same bias. The d...
The Editor It is indeed a research which needs to be widely circulated as the biological science and ancient teachings of mindfulness are on the same path of helping /alleviating human sufferings. The Indian ancient book Bhagvad Gita ; the great teaching of Krishna to Arjuna in chapter II verse 60 talks about how the turbulent senses attack the mind and lead it astray . The great wisdom of 'work must be done w...
Morgan and colleagues elegantly propose the glitch methodology as an effective means to identify process deviations that could impact on the quality or speed of surgical procedures (1). We support the authors' suggestion that the analysis of glitch patterns may facilitate the development of interventions to improve patient safety in the operating theatre across a range of domains.
The development of a common...
Dear Dr Silbenair,
Thank you very much for your interest in our paper, and for the interesting comments. I'd appreciate learning more about the situation of clinical trials in France. Please, email your reply to me at giuseppe.ambrosio@ospedale.perugia.it
Thank you
Conflict of Interest:
None declared
Pages