Selasa, 30 April 2013

KEK-KISM PTPN III


12-Mar-2013
KEBIJAKAN DAN PRASYARAT KEBERHASILAN PENGEMBANGAN LNDUSTRI HILIR KELAPA SAWIT

MAKSI

Gagasan pembentukan klaster industri kelapa sawit, faktanya telah didukung oleh berbagai kebijakan pemerintah. Sebagai salah satu prasyarat berhasilnya pengembangan hilir sawit.

Guna memudahkan dan mendorong pengembangan industri hilir yang terintegrasi, terutama industri oleokimia. Beberapa kebijakan dan peraturan pemerintah yang mendukung pengembangan industri hilir kelapa sawit diantaranya adalah sebagai berikut, pertama, kebijakan pemerintah mengenai pembangunan klaster industri kelapa sawit melalui Keputusan Menteri Perindustrin (KMP No. 13/M-IND/PER/I/2010), yang menetapkan tiga wilayah sebagai lokasi pendirian klaster industri kelapa sawit, yakni di Sei Mangkei (Sumatera Utara), Kuala Enok (Riau), serta Maloy (Kalimantan Timur). Terwujudnya klaster industri kelapa sawit diharapkan mampu meningkatkan daya saing dan nilai tambah industri kelapa sawit Indonesia.

Lantas kedua, kebijakan Energi Nasional dan Instruksi Presiden (Inpres) Nomor 1 Tahun 2006 tentang Penyediaan dan Pemanfaatan Bahan Bakar Nabati (biofuel), dengan target memacu tumbuhnya sektor industri biodiesel berbasis minyak sawit. Bahkan rencana tersebut juga didukung oleh UU Energi No 30 Tahun  2007 yang mencakup penyediaan dan pemanfataan energi baru dan energi terbarukan yang bersifat wajib ditingkatkan oleh pemerintah.

Ketiga, Peraturan Presiden Republik Indonesia Nomor 16 Tahun 2012 tentang Rencana Umum Penanaman Modal. Kebijakan di atas memberikan dukungan terkait pengembangan industri turunan kelapa sawit melalui klaster industri dan peningkatan produktivitas perkebunannya, termasuk diantaranya adalah mengubah produk primer menjadi produk olahan untuk ekspor.

Keempat, Peraturan Bersama Menristek dan Mendagri No 3 dan 36 tahun 2012 tentang Penguatan Sistem Inovasi Nasional (Sinas) dan Sistem Inovasi Daerah (Sida), yang dapat memperkuat kinerja lembaga penelitian dan pengembangan kelapa sawit untuk lebih giat menciptakan beragam inovasi produk yang akan memperkuat industri hilir kelapa sawit.

Kelima, Peraturan Menteri Energi Sumber Daya Mineral (ESDM) No 4 Tahun 2012, seharusnya juga memacu pengembangan teknologi hilir pemanfaatan cangkang kelapa sawit sebagai sumber energi listrik Pembangunan PLTU berkapasitas 2x15 watt di kawasan industri Sei Mangkei merupakan salah satu contoh cerdas penggunaan cangkang sawit sebagai bahan pembangkit listrik berbasis biomassa.

Keenam, PP 94/2010 tentang penghitungan penghasilan kena pajak dan pelunasan PPh dalam tahun berjalan. Ini menjadi dasar hukum Menteri Keuangan untuk mengeluarkan fasilitas pembebasan PPh atau sering disebut Tax Holiday untuk industri-industri khusus (pionir) termasuk diantaranya industri kelapa sawit.
Ketujuh, Kementerian Koordinator Perekonomian (Kemenko) telah menyiapkan beberapa kebijakan dan langkah penting guna memperbaiki infrastruktur perhubungan di Indonesia. Kebijakan yang dimaksud antara lain menjalankan Perpres No.26 Tahun 2012 tentang Cetak Biru Pengembangan Sistem Logistik Nasional (Sislognas).

Dan kedelapan, terkait dengan isu lingkungan, Peraturan Presiden No 61 tahun 2011 tentang Rencana Aksi Nasional Penurunan Emisi Gas Rumah Kaca, seharusnya juga dapat digunakan oleh para pelaku industri kelapa sawit untuk menurunkan emisi gas rumah kaca, dengan mengkonversi gas metana menjadi energi listrik.
Program pengembangan industri hilir kelapa sawit di dalam negeri secara hipotetik menguntungkan karena akan mampu memacu perkembangan perekonomian, terjadinya penganekaragaman produk hilir kelapa sawit, serta peningkatan nilai tambah. Oleh karena itu, kebijakan-kebijakan tersebut di atas diharapkan akan dapat lebih memacu pertumbuhan investasi industri hilir kelapa sawit, sehingga peran dan kontribusinya dalam perekonomian nasional terus meningkat. Namun demikian, industri kelapa sawit adalah sektor bisnis yang unik dan dicirikan dengan adanya rantai bisnis yang kompleks dan terpadu atau saling terkait. Rantai bisnis tersebut sangat  erat hubungannya mulai dari penyiapan lahan, pembibitan, industri penyokong, pengolahan di industri hulu sampai pada maksimasi nilai tambah dalam industri hilir secara terpadu.

Beberapa prasyarat bagi keberhasilan pengembangan industri hilir kelapa sawit adalah sebagai berikut: disokong dengan kuat oleh pemerintah pusat dan daerah, lokasinya harus strategis, memiliki kelimpahan pasokan CPO, PKO dan hasil samping lainnya dengan baik, memiliki dermaga pelabuhan yang dalam, terlindung serta aman dengan akses ke samudera luas yang sangat baik, pengurusan birokrasi yang luwes dan cepat, menggunakan teknologi mutakhir, serta adanya Industri kelapa sawit adalah sektor bisnis yang unik dan dicirikan dengan adanya rantai bisnis yang kompleks dan terpadu atau saling terkait kehadiran perusahaan-perusahaan raksasa dunia yang bekerjasama membentuk perusahaan baru dengan swasta atau BUMN di dalam negeri.

Di lain pihak, pemerintah juga perlu menghilangkan faktor-faktor penghambat iklim investasi dengan melakukan pemberian jaminan kepastian hukum kepada investor dalam dan luar negeri. Mengingat investasi di industri hilir kelapa sawit sangat besar jumlahnya, bukan hanya puluhan atau ratusan juta US dollar, melainkan juga milyar dollar (puluhan trilyun) maka keterlibatan pemodal asing, terutama perusahaan multi nasional akan merupakan prasyarat yang perlu ada lagi. Hal tersebut hanya dapat dicapai dengan dilakukannya harmonisasi kebijakan antara pemerintah pusat, pemerintah daerah, pelaku usaha dan perbankan dalam rangka meningkatkan percepatan realisasi pembangunan industri hilir kelapa sawit, serta penanaman modal dalam perusahaan patungan asing dan nasional. Namun demikian, masuknya investor perusahaan-perusahaaan multi nasional (MNC) dalam industri hilir kelapa sawit, selain menguntungkan dalam segi investasi dan serapan tenaga kerja, sebaliknya juga berpotensi memberikan dampak negatif yang merugikan, yakni tidak akan terbukanya akses kerjasama untuk penelitian dan pengembangan bagi lembaga-lembaga universitas dan lembaga litbang Indonesia.

Ini terjadi mengingat bagi MNC litbang adalah kegiatan rahasia dan sangat penting sebagai strategi dalam memenangkan persaingan, sehingga mereka akan bersikeras untuk mengerjakannya sendiri, dan menafikan peranan universitas dan lembaga litbang di dalam negeri. Hal di atas juga diperparah dengan kenyataan bahwa hampir semua investor MNC, investor asing lainnya, dan juga perusahaan-perusahaan kelapa sawit besar nasional yang melakukan investasi dalam proses hilir kelapa sawit, sebagian besar (bahkan hampir seluruhnya) juga menggunakan teknologi asing, misalnya teknologi LURGI, De-Smet Balistra, Evonik dan lain-lain, sehingga bila ada masalah yang terjadi, maka pemecahan masalahnya otomatis akan dikerjasamakan dengan para industri pemasok teknologi di atas, bukan dengan universitas atau lembaga litbang nasional.

Dengan demikian, proses pembelajaran, pemanfaatan pengalaman secara bersama-sama, apalagi transfer ilmu pengetahuan dan teknologi sangat sulit diharapkan untuk terjadi. Hal terakhir inilah yang sangat meresahkan para peneliti serta kalangan cendekiawan pecinta kelapa sawit di dalam negeri, yang memerlukan solusi yang segera, karena kalau tidak akan menimbulkan apatisme, frustrasi dan bahkan perlawanan moral yang merugikan.

Prof. E' Gumbira Said*) dan Fahmil Qowim**)
*)Profesor Teknologi Industri Pertanian, Fateta; Senior Advisor Program Pascasarjana Manajemen dan Bisnis, SPS-IPB, serta Ketua Umum Masyarakat Perkelapasawitan Indonesia (MAKSI).
**) Magister Teknologi Industri Pertanian, don Pengurus Kerjasama Riset Kelembagaan MAKSI.
sumber : MARET 2013 InfoSAWIT hal 47

Biodiesel


How To Be a 5-Star Scientific Journal Reviewer

"How To Be a 5-Star Scientific Journal Reviewer"
Richard T. Scheife, Pharm.D., FCCP, Editor-in-Chief
Wendy R. Cramer, B.S., FASCP, Associate Editor
Pharmacotherapy
Peer Review
◆ What is the purpose of peer review?
◆ What will it never catch or detect?
Function of Reviewers
Author
Editor
Associate Editor Reader
Editorial Scientific Society
Board Editors
Reviewers New Knowledge
Online Submission and Review (Reviewer Interaction with Manuscript Central)
◆ Invitation to review from the Editor-in-Chief or a Scientific Editor
• Abstract sent to reviewer with invitation letter
◆ Reviewer accepts or declines invitation
◆ New reviewer logs on to Manuscript Central and creates a reviewer account
• Contact information
• Areas of expertise
• Customize availability parameters
◆ Reviewer views or downloads complete manuscript
◆ Reviewer may review manuscript online (piecemeal or all at once), or create the review offline (as a
Word document) and "cut and paste" review into the Manuscript Central "reviewers' comments" section
(do not attach the Word file)
◆ Reviewer has the opportunity to provide both "confidential comments to the editor" and "comments to
be shared with the authors"
◆ Copies of all of the reviewers' comments will be sent to each reviewer when the "accept/reject"
judgment is made. A reviewer's identity is never revealed to authors or other reviewers.
Journal’s Responsibilities to Reviewers
◆ Inform reviewers of what you need
• Examples of reviews
• Review format
• Reviewers’ styles
◆ Time sensitivity
◆ Ongoing teaching by example
◆ Acknowledge and document contribution of reviewer to scientific literature
◆ Three areas of scholarly pursuit
• Original research
• Publication in peer-reviewed journals
• Invitation to serve as an academic reviewer
Reviewer's Responsibilities to Journals
◆ You have responsibilities to both the author and the editor
◆ Pursuit of "truth and beauty"
• Is this good science?
• What is the impact of this paper?
◆ Filter out flawed work and prevent its publication
◆ How can non–fatally flawed papers be made more perfect?
• Evaluate originality, quality, importance of paper
• Identify errors, misinterpretation, overinterpretation, and "crimes of
passion" committed by the authors
• Fill in gaps (missing information)
• Support your comments with appropriate references, if necessary
• Make potential conflicts of interest known to the editor
• Point out areas in which you are not qualified or comfortable to critique
(keep in mind, absence of comments on, for instance, study design or
statistics, infers correctness)
• Inform us if you have previously reviewed this paper for another journal
• In addition to identifying faults, positive comments are encouraged, when
appropriate
◆ Line-by-line comments on grammar are not necessary; a global comment is all that is
needed (e.g., "many spelling errors," "text is very difficult to follow")
◆ Timeliness in the completion of your review is essential
• Kindly extend the courtesy of informing the journal immediately if you cannot
review the manuscript in the allotted time
• Your recommendation of another qualified reviewer is always appreciated
◆ Respect that the manuscript is a privileged communication, is confidential, and for
your eyes only
◆ You may request that all manuscripts sent to you for review have the authors' names
removed (a "blind" review)
Conceptual Approach To Reviewing a Manuscript
If the scientific rigor of this paper were perfect, what would be the scientific and clinical
impact of the data?
None A Little Some A Lot Huge
| ------------------------|--------------- | --------------- | ---------------|
0 25 50 75 100
If the impact of the data were profound, what is the quality of the science (i.e., scientific
rigor)?
Dangerous Questionable Acceptable Very Good Nobel Prize
| ------------------------|--------------- | --------------- | ---------------|
0 25 50 75 100
Sample Reviews
Sample review of a paper with a sufficient number of serious flaws that the reviewer's time
and talent should not be expended at this point
Currently, the paper is so poorly written, from spelling and grammar to poorly presented material, it is painful to even
read through it. There are so many poorly written sections I cannot even spend the time required to give specific
comments. You might send it back to the authors and tell them it is not "finished" enough to be considered. Even if
they had a competent editor make all these corrections, I find it difficult to believe that many readers would take the
time to read through the paper. There is way too much text, and the details they have chosen to include are largely
small, insignificant studies of "special populations." Putting this information into a table would be fine, but including it in
the text just detracts from more relevant information. Also, this will save them the effort of rewriting their poor
descriptions of these studies (see page 29, last paragraph, for a particularly bad passage).
On the other hand, although there are many reviews of atypical antipsychotics right now, none are as practical as they
could be in terms of helping clinicians choose among the available typical and atypical medications. So it would be
useful for you to publish such a practical review. However, this is the worst review I've read so far, and would require
substantial revisions to make it into a practical review.
In case you offer the authors the opportunity to make the major revisions necessary for publication, I've included some
general suggestions for them on a separate page.
Sample Review #1
The paper by XX et al. presents results from a retrospective cohort study based on FY2000 VA data evaluating a
potential beneficial effect of statins and ARBs on 30-day mortality in patients hospitalized with sepsis. The study
addresses a novel question of significant importance, is well written, and uses largely appropriate methodology (see
comments below for an important suggestion regarding the analysis). The results are presented appropriately given
the limitations inherent in the observational nature of the study, but the limitations, specifically a potential healthy user
bias, need to be discussed in more detail.
Major comments:
1) The study presents results for statin-users vs. non-users and ARB-users vs. non-users. However, table 1 compares
statins or ARBs (combined) vs. non-users. Present table 1 for the actual 3 groups (i.e. statin users, ARB users, nonusers)
and add a row to present the percentage of combination users.
2) On page 6 the authors present a sample size calculation. This is not meaningful to me since the study at hand is a
retrospective evaluation of a database containing fiscal year 2000 VA records, originally compiled for a different study.
If at all, a power calculation for a hypothesized effect size or -better- a calculation of the effect size detectable with
90% power, given the parameters of the data, would be informative. However, since the results for both drugs are
significant, the entire section may be omitted.
3) The major limitation of the observational nature of the study is the potential for unmeasured confounders being
responsible for the observed results. While the authors control for a number of potential confounders, including
hospital, classes of medication, and Charlson comorbidity score, unmeasured confounding remains the main concern
with this study. Specifically, the issue with the present study is a potential ‘healthy user bias’ (even after the adjustment
for the aforementioned variables). The fact that medications that largely treat asymptomatic, chronic conditions (e.g.
statins) are underutilized in patients with unrelated comorbidities(1) may lead to a healthier population of users of a
chronic medication. While the authors mention this limitation in the discussion section, they should expand on the
discussion since this potential bias is the key issue with this paper. For example, Glynn et al showed that a relatively
modest association of unmeasured frailty with the exposure to lipid lowering drugs (after propensity score adjustment)
could explain an observed beneficial effect of these medications on mortality.(2) Researchers have addressed this
problem by using a comparison group of users of another chronic medication, instead of a group of non-users of the
drug under study. For example, while Ray et al showed a significant 38% (15-55%) reduction in the risk of hip fractures
among new users of statins compared to non users, this beneficial effect disappeared when the comparison was made
between new statin users and new users of other lipid lowering drugs (RR: 1.42; 0.83-2.43).(3) Similarly, in a study
investigating a hypothezised beneficial effect of statins on the risk of lung, breast, and colorectal cancer, Setoguchi et
al. used a comparison group of new users of glaucoma medication (instead of non-users). Thus, ideally, the authors
may want to consider replicating the analysis with a control group that would have a similar user profile (e.g. patients
on non-statin lipid lowering drugs or glaucoma medication).(4) If the beneficial effects of statins and ARBs remain
significant compared to users of other chronic medications (that don’t have a biologically plausible beneficial effect on
patients with sepsis), the paper would be strengthened considerably, if not, a healthy user bias would be the likely
explanation for the apparent protective effects of both drugs. At the very least, the potential healthy user effect should
be discussed in more detail referencing the previous research.
Minor comment:
For completeness: Start the methods section in the article in a way similar to the abstract methods (i.e. define the
study as a retrospective cohort study)
References
1. Redelmeier DA, Tan SH, Booth GL. The treatment of unrelated disorders in patients with chronic medical diseases.
N Engl J Med. May 21 1998;338(21):1516-1520.
2. Glynn RJ, Schneeweiss S, Wang PS, Levin R, Avorn J. Selective prescribing led to overestimation of the benefits of
lipid-lowering drugs. J Clin Epidemiol. Aug 2006;59(8):819-828.
3. Ray WA, Daugherty JR, Griffin MR. Lipid-lowering agents and the risk of hip fracture in a Medicaid population. Inj
Prev. Dec 2002;8(4):276-279.
4. Setoguchi S, Glynn RJ, Avorn J, Mogun H, Schneeweiss S. Statins and the risk of lung, breast, and colorectal
cancer in the elderly. Circulation. Jan 2 2007;115(1):27-33.
Sample Review #2
Your manuscript is a MASSIVE work! I cannot fathom how many hours you have invested in tracking down all of these
studies / reports, and compiling them into your paper. Goodness!
I have read this paper several times and submit these recommendations to you:
1. Your manuscript needs to be substantively reconstructed in order to be usable to the Journal's audience.
2. In print, this article's utility will be as a reference for pharmacists dealing with plasmapheresis. Readers will be
seeking to manage one of two scenarios:
* A patient may be considered for plasmapheresis in the setting of acute toxicity, in which case the question is
whether or not PE will contribute substantively to total drug clearance, OR
* A patient will be receiving PE either once or chronically for treatment of an immunologically-mediated condition. In
this case, the pharmacist will be wondering whether replacement doses of chronic medications will be necessary.
Your article MUST address each of these situations in order to be useful to the reader; thus, I strongly encourage the
authors to reformat their submission with the clear intent of addressing these two questions.
3. You are correct in your assertion that the literature on PE is scattered and non-uniform in its reporting of data. You
however, must be our saviour and amend this! Lucky you! What I mean by this is that, in order for your information to
be readable and useful, you must determine a:
* standard format of TYPE of information included, and
* a standard format of MANNER in which it is presented.
For examples: some of these data are presented as "percent of circulating drug removed", some as "percent of total
daily dose removed", some as "fraction eliminated"...etc. You MUST be prepared to do more than just rewrite the data;
you need to offer your own interpretation as to whether or not,
a) Total body removal of drug is substantial enough to warrant use in toxicologic emergencies, and
b) Total body removal of drug is substantial enough to warrant alterations in dosing in patients receiving PE on a
chronic basis. This will need to include the pharmacodynamics of drug response in addition to simply the kinetics of
drug removal. What I mean to say is that, for some drugs, even if the entire last dose is removed, does it really matter
in terms of dynamic response? You'll need to look at half-life (time to reaccumulate), dosing intervals.....lots of things in
order to make this a useful guide to drug dosing in PE patients.
4. Your paper will need to include a substantial introduction that explains several things to the reader:
a.) What is PE, exactly? How does it "work"? In what circumstances is it employed? How frequentlly is it employed?
Do all institutions have access to PE? Is it considered standard of care or is it still controversial?
b.) How is drug removal by PE accomplished? This is huge!!! You MUST distinguish how drug removal by PE is
different from drug removal by hemodialysis. You must discuss both plasma and tissue protein binding. You must
discuss flow rate, run time, redistribution.....the whole potato, in order that your reader truly can understand the
information you will present later. Pharmacists as a whole have no understanding of PE and so you get to be the one
who teaches it.....otherwise, we will not understand the data you present. (Sorry!)
5.) Tighten up your Table 1: For each drug, include the "bottom line" for each of the two questions described in
recommendation # 3a above. Keep terminology standard from item to item or include a brief explanation. Avoid terms
like "circulating drug". This is useless. Use either total body drug or pre and post redistribution concentration change,
or fraction of dose eliminated.....
6.) You'll need to also include a discussion of terms. How are "total body stores" estimated? Is this a reliable
calculation (estimation)? Your reader will not know. Be careful with terms like "fraction eliminated was 10%". Fraction
of what? Total stores? Single dose? Plasma drug concentration? Your readers will need a mini kinetics primer in order
to understand what you are telling them....but it IS doable.
7.) Finally, I recommend that you NOT include a drug-by-drug discussion in the body of your manuscript. Use the body
of your text to discuss the issues clinicians will need to understand in order to make a decision based upon your
information. Put the drug-by-drug information in the table, reference the studies, and be done with them. Yours is a
synthetic and an interpretive function....not a data dump.....please. This article can be hugly informative. Please
consider.
Sample Review #3
Overall this manuscript is a comprehensive and well-written paper concerning adrenal insufficiency. One could argue
that the initial sections dealing with the pathophysiology through the clinical manifestations of adrenal insufficiency (as
well as most of the tables and figures) could be deleted in the interest of journal space considerations since most of
this is basic information that is not specific to the critically ill patient. On the other hand, it makes the paper
comprehensive and more useful to the relatively inexperienced practitioner. The remainder of the paper hits the key
literature with respect to the diagnosis and treatment of adrenal insufficiency in the critically ill patient and provides
reasonable recommendations for practice based on this literature.
Unfortunately for the author, the results of a couple of important studies have just been presented within the past few
weeks that need to be added to the paper to stop it from being outdated soon after publication. In particular, the results
of the CORTICUS trial were presented as late breaking sessions at the SCCM February meeting (as well as the ATS
meeting if I’m not mistaken). This multi-center blinded RCT found no significant difference in mortality between lowdose
hydrocortisone and placebo in cortrosyn non-responders, the group thought most likely to benefit from steroids
based on the trial by Annane et al. In fact, the hydrocortisone group tended towards higher mortality, and
hyperglycemic and infectious complications were also more frequent. The lack of even a trend towards benefit in the
steroid group offset the fact that the trial had to be stopped (at 499 analyzable patients) before the anticipated
enrollment of 800 patients. Furthermore, when the lead investigator, Dr. Sprung, presented the findings at SCCM, he
concluded that the results also suggested that routine ACTH testing is not indicated. The CORTICUS trial will clearly
not end the debate concerning the use of steroids in septic shock since there were some differences in the methods
and results of the Sprung and Annane trials (e.g., severity of illness, use of fludrocortisones). Regardless, the initial
results of the CORTICUS trial are likely to be published within the next few months.
Another paper was presented at the SCCM meeting that likely will affect the statements in the last paragraph of the
treatment section of the paper dealing with hyperglycemia. The GLUCONTROL study was another multi-center
investigation comparing tight (80 to 110 mg/dL) vs. moderately tight (140 to 180 mg/dL) glucose control in the ICU. No
differences were found in ICU or hospital mortality or length of stay. Furthermore, more patients in the tight control
group suffered from episodes of hypoglycemia and the death rate in patients with hypoglycemia was higher in the tight
control group. As above, this trial will likely not end the debate concerning tight glucose control.
The author should be able to get the preliminary results of both of these papers from meeting summaries and possibly
the Internet (I think I saw the CORTICUS results on Medscape). Obviously, the paper would be more timely with the
inclusion of these studies, and the author may want to revise some of his conclusions based on these trials.
I have two specific, albeit minor issues for consideration.
Corticosteroids section, second to the last paragraph, third sentence. Since the terms hydrocortisone and cortisol are
used interchangeably, I’m wondering if the author means that 10 mg/day of cortisol in the body is equivalent to 20-30
mg per of hydrocortisone given orally. If not, than another explanation is in order.
Table 6. I have mixed emotions about the need for this table. While it does provide a nice summary of the key tests for
adrenal insufficiency, it repeats what is in the text yet does not provide some of the important qualifiers stated in the
text, particularly for ACTH stimulation (so it’s not really a stand-alone table).
Sample Review #4
The stated objectives of this manuscript are to describe the pharmacokinetics of pegfilgrastim and the ANC profiles
after administration of the drug to patients receiving cancer chemotherapy. Though the information provided in this
manuscript is interesting, the results do not accurately reflect the stated objectives and do not flow from the methods.
The discussion seems to indicate that an objective of the paper was to evaluate the tempo of ANC response to
pegfilgrastim administration in order to address the concerns of clinicians regarding the possibility of achieving
dangerously high white counts. Serious revision of the manuscript is necessary to ensure that the stated objectives are
met and that the methods adequately describe how the results were derived.
Introduction:
The study objectives stated in the last paragraph of the introduction should be identical to those stated in the abstract
(or vice versa). Those stated in the abstract are more in line with the title of the manuscript. That is, to describe the
pharmacokinetics and ANC profiles after pegfilgrastim administration. Please align and clarify the objectives of your
study.
When speaking about drug concentrations, please use the term ‘concentration’ rather than ‘level’.
Methods:
Please be more clear in the text about which studies’ data were used for which aspect of the study (PK vs ANC
profile). For example the sentence that begins ‘No pharmacokinetic data were collected. . ‘ on page 6 should be moved
to the first paragraph.
Please define ‘ANC profile’ and ‘nadir’. In addition, use of the term pharmacokinetics is confusing since no traditional
PK data are presented. Do you mean only to describe the inter-relationship between serum pegfilgrastim
concentrations and ANC? Please use a term other than pharmacokinetics to describe your data or provide
methodology relevant to the determination of pharmacokinetics.
Please provide the number of patients who received each of the 2 dosing strategies. Did either the PK or ANC profiles
differ between these groups?
ANC is more traditionally defined as the neutrophil count plus the band count. Why was this more accepted definition
not utilized? In addition, the word ‘cells’ is usually inserted into the units for ANC; i.e. 1.0 x 10^3 cells/mL.
Mention of filgrastim as the ‘comparator’ drug on page 7 is confusing as no comparisons are made in this study.
On page 7 it is stated that the ‘Average time course of ANCs was similar between cycle 2 and subsequent cycles”.
How was this determined?
In the last sentence of the Methods section, it is stated that Pearson’s correlation coefficients were calculated for ANC.
What was the second variable in this correlation? Which time points after pegfilgrastim administration were assessed?
Please indicate that patients who experienced high ANCs following pegfilgrasitm administration were specifically
identified.
Results:
Please use all abbreviations in full the first time they are used in the manuscript.
It would be helpful if the results were presented in the same order as the relevant methods.
Please present data relevant to clearance and other pharmacokinetic parameters.
Please describe the methods relevant to the development of the biomathematical model used to determine the lowest
pegfilgrastim concentration able to elicit meaningful granulopoiesis. This information should be included in the Methods
section. Please also more fully explain the concept of EC values in the Methods.
Please give the actual number of patients as well as % who experienced a postnadir ANC ≥ 30 x 10^3 cells/mL.
Similarly, please provide correlation coefficients and p values in the text.
Discussion:
The first paragraph of this section provides important information required by the reader. However, its message would
be clearer if the sentences were presented in a different order.
Tables
Please explain all abbreviations used in the tables in a legend for each table.
Figures:
Please refer to each figure in the text.
Figure 1: Are these graphs not concentration/count vs time graphs positioned to allow easy comparison rather than
correlations? The figure title labels them as correlations.
Sample Review #5
This is an interesting case, but one which may have a flawed (and potentially dangerous) conclusion. It would greatly
benefit this case, and its readers, if the authors discussed the different scenarios and controversies that might better
explain their results (discussed below).
First, some general comments:
1. A graphic detailing the timeline of drug initiation, rash progression, eosinophilia, and concurrent medication use
would significantly complement this case scenario. An example of such a graphic is Lynch J, Wong-Beringer A.
Caspofungin: a potential cause of reversible severe thrombocytopenia. Pharmacotherapy 2004;24:1408-11.
2. On page 5, 1st paragraph. Believe you meant to say “In our report, the negativity of the skin test with amoxicillin and
MEROPENEM….”
Comments about case:
1. Significantly more discussion is needed regarding the type of allergic reaction that the patient developed from the
imipenem-cilastatin. This is crucial in order to convey safe, accurate information to readers. The implications are
important: true anaphylactic hypersensitivity, which we presume is what the authors are implicating in this case, is IgE
mediated, often immediate, and presents with urticaria, laryngeal edema, bronchospasm, hypotension, and/or local
swelling. These are the reactions that are of most concern to clinicians, especially concerning cross-reactivity between
antimicrobial agents of the same class. When it comes to skin testing, only penicillin skin testing (using major and
minor immunogenic determinants) has been shown to be accurate for the identification of IgE-mediated
hypersensitivity. A “positive” skin test from pure imipenem-cilastatin compound might not be due to IgE. This is an
important distinction in this case, because the “erythematous macular morbiloform rash” that this patient developed
after 5 days of imipenem-cilastatin is more consistent with a delayed-type hypersensitivity reaction, which is mediated
through T cells, not IgE. (see Gruchalla RS, Pirmohamed M. Antibiotic allergy. NEJM 2006;354:601-9). This is NOT an
anaphylactic reaction, and correlations regarding cross-reactivity concerning these reactions have not been made (see
Brackett CC, Singh H, Block JH. Likelihood and mechanisms of cross-allergenicity between sulfonamide antibiotics
and other drugs containing a sulfonamide functional group. Pharmacotherapy 2004;24:856-70). Presumably, the
development of a 5mm wheal after a skin test with imipenem-cilastatin could be mediated by T cells (as in PPD skin
tests). As such, the case as described now would confuse clinicians without significant knowledge of the types of
allergic reactions, and perhaps could lead to meropenem use in patients with true IgE-mediated hypersensitivity to
imipenem-cilastatin. This is a very dangerous scenario. The authors are correct that the Bauer reference (J Allergy Clin
Immunol) does appear to reflect a case of true IgE hypersensitivity (large erythematous maculopapular rash
developing within 48 hours, and possibly most important, with areas of urticaria). However, the present case might not
reflect a similar situation, and in order for the authors to draw any conclusions, they must expound upon the scenarios
presented above. Another point that is interesting is the eosinophilia in this case. It would be prudent for the authors to
discuss whether this finding is indicative of an IgE mediated reaction, or may occur in other scenarios (for example,
acute interstitial nephritis may present with eosinophilia, but is considered to be a Type II, ie IgG mediated, reaction).
Sample Review #6
1. Did the sponsor which makes atypical antipsychotics) have any role in initiating, desgning, analyses or interpretation
of study? Do any of the study authors work for the sponsor or have consulting or financial ties to any atypical
manufacturers?
2. The title is misleading - the outcome looked at here was just a subset of all cases of pancreatitis - ie hospitalized
diagnosed symptomatic pancreatitis. So the title and abtsrct and methods and discussion need to make this clear.
3. Introduction - the conclusions of Szarfman et al are misrepresented. That study did not report "an increased risk" but
merely found differences in reporting ratios and concluded there may be differences even among atypical agents with
clozapine and olanzapine having the highest reporting ratio. They also found that reporting was highest for individuals
concomittantly using lithium or valproate. The authors need to correctly cite this paper.
The Methods is flawed for several reasons:
4) The total numbers of atypical and conventional users by specific drug (clozapine, olanzapine, risperidone, etc) is not
specified and needs to be
5) It is inapprorpiate to pool all atypical users sicne there are differences among these agents in lipid and pancreatic
effects. Given the lack of power to assess individual atypicals, all that can be concluded is that their sample is too
small to test effects with atypicals. The number of conventional agent users (N=2000) is 10 times higher than the
number of atypical agent users (N=200) giving rise to differences in statistical power as shown in their own highly
variable confidence estimates.
6. There is no information on dose or duration of use. Atypical and conventional antipsychotics are often used for
different populations and so controlling for age and gender alone will not suffice if the primary diagnosis for which they
are given for is not taken into account.
7. The authors provide no data to assure that users of atypical and conventional drugs did not differ in other ways that
would have biased their outcome. I suggest they provide a Table comparing the atypical and conventional users on
age, gender, race, economic status, DSM or ICD psychotic diagnosis, duration of drug use, dose, diabetes, ethanol
use, gall stone disease and use of concomittant lithium and mood stabilizers.
8. How was combination drug use of atypical and convenbtional addressed?
9. Most cases of pancreatitis are asymptomatic and numerous studies have now shown that drugs like clozapine and
olanzapine induce asymtpmatic pancreatitis during dose titration that can only be detected with enzyme testing. These
studies also document reversal of enzymes upon cessation of the drug which suggest causative links. Such
asymptomatic cases would not have been captured in this study.
10. the discussion of the discrepancy between their finding and those of the two prior epidemiological findings should
be discussed more and should conclude with statement that neither their study nor those prior can prove causality.
Only a definite prospective study can. Their abstract should also discuss the discrepancy between their study and two
prior epidemiological studies.
11. Although the authors claim their methodologic validity has been established previously, I suggest they run an
analyses looking at valproic acid, a known pancreatitis agent, as a positive control. If this agent is shown to have a
pancreatitis effect then it adds confidence to their sample.
"How To Be a 5-Star Scientific Journal Reviewer"
Richard T. Scheife, Pharm.D., FCCP, Editor-in-Chief
Wendy R. Cramer, B.S., FASCP, Associate Editor
Pharmacotherapy
LEARNING OBJECTIVES
1. Discuss the purpose of peer review, and outline its advantages and disadvantages.
2. Describe the two general areas on which to focus when reviewing any kind of scientific paper.
SELF-ASSESSMENT QUESTIONS
1. Which of the following components is least useful to the editor for reviewers to include in their
comments to an author?
a. Evaluate originality, quality, and importance of the paper.
b. Support comments with appropriate references, if necessary.
c. Provide positive comments when appropriate.
d. Provide line-byline comments on grammar.
2. All except which of the following are responsibilities that a journal has to its reviewers?
a. Inform reviewers of the review format.
b. Be time sensitive and limit the number of manuscripts sent to each reviewer.
c. Provide to reviewers the names of the other reviewers.
d. Update reviewers' areas of expertise as specifically as possible.
3. All except which of the following are responsibilities that a reviewer has to a journal?
a. Inform the journal if you have previously reviewed the manuscript for another journal.
b. Point out areas in which you are not qualified or comfortable to critique.
c. Make potential conflicts of interest known to the editor.
d. If you are unable to complete the review in the requested time frame, simply ignore the request for
review, as the other reviewers will probably comply.
ANSWERS TO SELF-ASSESSMENT QUESTIONS
1. d
2. c
3. d

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