Larangan Ibu Hamil

Ada sejumlah  Larangan Ibu Hamil yang perlu untuk diperhatikan. Meliputi makanan yang tidak boleh dilakukan, hingga aktifitas yang perlu dihindari. Hal ini bertujuan untuk menjaga kesehatan ibu sendiri, dan juga untuk kesehatan bayi di dalam kandungan.  Berikut adalah hal-hal yang merupakan larangan ibu hamil.




1. Minum alkohol
Alkohol adalah jelas tidak baik dikonsumsi, bahkan sekalipun tidak

Kesehatan Untuk Ibu Hamil

Kesehatan Untuk Ibu Hamil memerlukan perhatian yang khusus, lebih dari biasanya saat tidak sedang hamil. Hal ini penting untuk menjaga agar ibu dan bayi yang dikandungnya tetap sehat dan bisa tumbuh dan berkembang dengan baik. Untuk itu, ada beberapa hal seputar kesehatan untuk ibu hamil yang harus dihindari selama kehamilan. Apa saja itu? berikut diantaranya:




1. Terlalu keras dalam

Kandungan Gizi Ikan Laut dan Ikan Air Tawar

Kandungan Gizi Ikan Laut dan beberapa Air
Tawar yang tinggi menjadi daya tarik setiap orang untuk lebih rajin
mengkonsumsinya. Gizi pada beberapa Ikan tersebut juga sangat baik bagi IbuHamil dan Menyusui, serta orang yang sedang dalam masa penyembuhan dari
penyakit. Adapun kandungan gizi dari beberapa jenis Ikan tersebut kami
tampilkan berdasarkan tabel seperti berikut:








Jenis

Penggunaan Alat Kontrasepsi Spiral Agar Aman

Alat
Kontrasepsi Spiral atau IUD saat ini dianggap sebagai metode pencegahan
kehamilan yang paling ideal resiko efek samping yang lebih sedikit. Namun
ternyata banyak ibu yang menggunakan KB Spiral yang mengaku tidak nyaman dalam
penggunaannya. Keluhan yang paling sering dialami adalah rasa perih pada perut
bagian bawah. Hal tersebut biasanya disebabkan karena pemasangan spiral yang
tidak pas

Cara Mengatasi Rambut Rontok Secara Alami

Jika Anda mencari cara mengatasi rambut rontok di mesin pencari seperti Google, maka Anda akan menemukan banyak sekali cara untuk mengatasi kerontokan rambut. Namun dari sekian banyak cara yang ada, kami hanya akan memberikan cara mengatasi rambut rontok secara alami dan aman.

Terkadang ada cara mengatasi rambut rontok yang memang sukses menghentikan kerontokan rambut Anda, namun memberikan efek samping lainnya seperti misalnya mudah beruban, rambut yang susah diatur bahkan sampai rambut yang berubah warna menjadi pirang.

Cara Mengatasi Rambut Rontok Secara Aman dan Alami

Hindari mengikat rambut apapun yang terjadi.

Mengikat rambut hanya akan membuat akar rambut Anda terangkat sehingga mudah lemah dan rambut pun mudah sekali rontok.

 Gunakan minyak zaitun

 Perawatan alami yang terbukti ampuh adalah dengan menggunakan minyak zaitun. Jika tidak ada, Anda bisa menggantinya dengan minyak kelapa atau di daerah jawa dan sunda dikenal dengan nama minyak kletik.

Kompres dengan es

Kepala yang terlalu panas sangat tidak baik untuk pertumbuhan rambut Anda. Gunakanlah air es yang tidak terlalu dingin untuk membilas rambut baik saat memakai shampoo ataupun tidak.

Gunakan jus bawang putih
Gosok kulit kepala dengan jus bawang putih. Jika tidak suka dengan baunya, Anda bisa menambahkan ekstrak bunga atau wewangian lainnya.

Pijat kepala perlahan-lahan
Pijatan di kulit kepala dapat merangsang sirkulasi darah dan membuat akar rambut lebih subur. Selain itu, pemijatan kulit kepala juga sangat ampuh untuk menjaga folikel rambut tetap aktif.

itulah sedikit tips cara mengatasi rambut rontok secara alami, semoga bermanfaat

Presiden Republik Indonesia

Presiden Republik Indonesia merupakan Kepala Negara dan juga Kepala Pemerintahan Indonesia. Presiden Indonesia adalah simbol negara sebagai seorang kepala negara. Presiden memegang kekuasaan eksekutif dibantu wakil dan para menteri sebagai seorang kepala pemerintahan. Masa jabatan presiden adalah lima tahun. Seseorang dapat menjadi presiden maksimal dalam dua periode.



Presiden memiliki kewajiban, wewenang, dan hak antara lain

• Memegang kekuasaan eksekutif pemerintahan sesuai UUD
• Memegang kekuasaan tertinggi atas TNI(Angkatan Udara, Laut, dan Darat)
• Mengusulkan rancangan undang-undang(RUU) kepada DPR. Bersama DPR melakukan pembahasan, persetujuan, dan pengesahan menjadi UU
• Mengangkat dan Memberhentikan pada Menteri
• Menetapkan PERPU
• Menetapkan PP
• Melakukan Perjanjian Internasional dengan Izin DPR
• Mengumumkan keadaan darurat atau bahaya
• Mengangkat Konsul dan Duta Besar dengan memperhatikan saran DPR
• Menerima Duta Besar negara lain terlebih dahulu mempertimbangkan saran DPR
• Memberikan rehabilitasi dan grasi dengan memperhatikan saran MA
• Memberi abolisi dan amnesti terlebih dahulu memperhatikan saran DPR
• Memberikan tanda jasa, tanda kehormatan, dan gelar lainnya.
• Meresmikan anggota BPK
• Menetapkan Hakim Agung
• Menetapkan Hakim Konstitusi

Persyaratan
Berikut syarat untuk menjadi Presiden dan Wakil Presiden sesuai UU No 42/2008 mengenai Pemilu Presiden dan Wapres:

• Bertaqwa pada Tuhan YME
• WNI sejak lahir dan tidak pernah menjadi warga negara lain atas kehendak sendiri
• Mampu secara jasmani dan rohani untuk melaksanakan kewajiban dan tugas sbagai Presiden dan Wapres
• Bertempat tinggal di Kawasan NKRI
• Sudah melaporkan kekayaannya kepada badan atau instansi yang mengurusi pemeriksaan kekayaan penyelenggara negara.
• Tidak sedang mempunyai  hutang  perorangan dan/atau secara badan hukum yg menjadi kewenangannya yang  merugikan keuangan negara
• Berdasarkan putusan pengadilan tidak sedang dinyatakan pailit
• Tidak pernah sekalipun mengerjakan perbuatan tercela
• Terdaftar sebagai Pemilih
• Mempunyai NPWP dan sudah melaksanakan kewajiban perpajakan selama 5 tahun kebelakang yang dibuktikan dengan SPT Tahunan WP OP
• Belum atau tidak pernah menduduki jabatan Presiden/Wakil Presiden selama dua kali massa jabatan dalam posisi jabatan yang sama
• Setia pada Pancasila sebagai dasar negara, UUD 1945, dan juga cita-cita Proklamasi 17-8-1945
• Berdasarkan putusan pengadilan yang mempunyai kekuatan hukum tetap, tidak pernah dijatuhi pidana penjara karena melakukan perbuatan pidana yang diancam dengan sanki pidana penjara lima tahun ataupun lebih
• Memiliki usia minimal 35 tahun
• Memiliki pendidikan setidaknya tamat  Madrasah Aliyah (MA), Sekolah Menengah Atas (SMA), Madrasah Aliyah Kejuruan (MAK), Sekolah Menengah Kejuruan (SMK),  atau yang sederajat
• Bukan termasuk mantan anggota organisasi terlarang PKI, termasuk juga organisasi massanya, atau bukan individu yang terlibat secara langsung dalam tragedi  G.30.S/PKI
• Mempunyai misi, visi, dan program dalam pelaksanakan pemerintahan Indonesia.

Pemilihan
Sesuai amandemen ketiga UUD 1945 pasal 6A, Presiden dan Wapres dipilih dalam pasangan calon secara langsung oleh rakyat melalui mekanisme pemilu presiden dan wakil presiden. Sebelum melalui PILPRES ini Presiden dan juga wakil presiden dipilih oleh MPR.

Pelantikan

Dalam UUD 1945 pasal 9, Presiden dan Wakil Presiden yang terpilih bersumpah sesuai agama/berjanji dengan sungguh-sungguh di depan MPR atau DPR. Jika MPR atau DPR tidak dapat menggelar sidang, maka Presiden dan Wakil Presiden yang terpilih bersumpah sesuai agama atau berjanji dengan sungguh-sungguh di depan pimpinan MPR dengan disaksikan oleh pimpinan MA.

Pemberhentian
Pemakzulan atau  impeachment adalah suatu proses dari  DPR sebagai badan legislatif secara ofisial memberikan dakwaan kepada seorang pejabat tinggi negara. DPR dapat mengusulkan pemberhentian presiden ataupun wakil presiden. Hal ini dapat dilakukan apabila DPR memiliki pendapat bahwa presiden atau wapres telah melakukan pelanggaran hukum atau tidak lagi memenuhi persyaratan menjabat sebagai presiden atau wapres. DPR bisa mengajukan permohonan kepada Mahkamah Konstitusi, apabila memperoleh dukungan sekurang-kurangnya 2/3 dari jumlah anggota yang datang pada sidang paripurna yang dihadiri sekurang-kurangnya 2/3 dari jumlah anggota.
Apabila terbukti menurut UUD 1945 pasal 7A maka DPR dapat mengajukan tuntutan impeachment tersebut kepada Mahkamah Konstitusi RI selanjutnya setelah melaksanakan persidangan dalam amar putusan Mahkamah Konstitusi RI dapat menyatakan membenarkan opini DPR atau menyatakan menolak opini DPR.  dan kemudian MPR-RI kemudian akan menggelar sidang untuk melaksanakan putusan Mahkamah Konstitusi RI.

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Kesehatan Ibu Hamil

Kesehatan Ibu Hamil perlu untuk mendapatkan perhatian khusus. Tidak hanya untuk menjaga kesehatan sang ibu, namun juga demi menjaga agar janin di dalam kandungan tetap sehat. Oleh karena itu, ibu harus memperhatikan hal-hal yang mempengaruhu Kesehatan ibu hamil dan bayinya. Berikut beberapa hal yang perlu diperhatikan oleh ibu hamil.





Makanlah 1 hingga 2 piring lebih banyak makanan yang

Manfaat Susu Kedelai Untuk Ibu Hamil

Susu kedelai untuk ibu hamil memang terbukti sangat bermanfaat dan berkhasit, kenapa bisa gitu yahh?? Jika anda bertanya kok bisa susu kedelai bermanfaat untuk wanita hamil, maka jawabannya karena didalam susu kedelai mengandung beberapa kebutuhan nutrisi yang baik untuk ibu hamil. Nah nutrisi inilah yang menjadikan susu kedelai bermanfaat untuk ibu hamil.

Manfaat Susu Kedelai Untuk Ibu Hamil 

Saat istri kita atau seorang ibu mengandung janin calon bayi, disinilah merupakan suatu momen yang sangat berharga dan ditunggu-tunggu oleh sebuah keluarga, apalagi keluarga ini baru saja dibentuk dan belum pernah punya momongan ( keluarga baru).

Namun momen bahagia ini tak lantas hanya harus bersenang dan berbahagia saja, karena kita juga harus menjaga si kandungan tersebut dengan perawatan, kasih sayang dalam menjaganya agar si janin bisa selamat sehat dan nantinya bisa lahir normal tanpa halangan apapun.

Oleh karenanya jika anda sebagai suami, berikanlah siistri kasih sayang tambahan supaya tidak mudah setress, karena biasanya orang yang hamil muda sering ngambek, katanya siihh hehhe. Dan bagi ibu hamil usahakan berikanlah kecukupan gizi dengan mengkonsumsi makanan dan minuman yang bermanfaat.

Di antara berbagai banyak jenis minuman biasanya orang hamil lebih melirik pada susu. Sebenarnya ada berbagai pilihan susu juga yang tersedia di pasaran dan bagus untuk menjaga kesehatan janin, ada susu kambing etawa, susu khusus untuk ibu hamil, namun yang tak kalah bermanfaatnya adalah susu kedelai.

Susu yang berasal dari kedelai ini ternyata juga patut untuk anda pertimbangkan apalagi jika anda mempunyai penyakit alergi jika mengkonsumsi susu yang mengandung laktosa yang biasa ditemukan pada susu sapi.

Nah setelah diatas udah ngalor ngidul kesana kemari, saatnya saya mengulas pembahasan utama mengenai manfaat susu kedelai untuk ibu hamil. Semoga pembahasan dibawah ini bisa bermanfaat amiiin

Manfaat susu kedelai untuk ibu hamil dari berbagai kandungannya:

• Asam Folat
  Adanya kandungan asam folat yang terkandung pada susu kedelai dapat memberikan nutrisi yang sangat penting bagi ibu hamil. Manfaat asam folat jika dikonsumsi rutin mulai awal kehamilan adalah dapat membantu pertumbuhan sel saraf, sehingga perkembangannya dapat berjalan optimal pada janinnya yang ia kandung. Jika perkembangan sarafnya berjalan optimal maka anak anda insy@ dapat dipastikan akan lahir dengan dibekali kecerdasan.
• Vitamin
  Dalam susu kedelai ternyata juga kaya akan kandungan vitminnya lo,  adapun vitamin2nya yang baik untuk ibu hamil seperti vitamin A, Vitamin B1, dan dan tak ketinggalan pula vitamin E. ketiga kandungan vitamin ini mempu memberikan asupan energy yang cukup untuk menjaga kondisi ibu hamil agar tetap sehat dan bugar.
• Protein
  Didalam susu kedelai juga terdapat kandungan protein, fungsi dari protein ini bermanfaat sekali untuk menjaga kesehatan organ dalam tubuh pada ibu hamil dan dapat membantu mengontrol perkembangan organ calon bayi (janin yang kita kandung) sehingga dapat berkembang secara optimal. Adapun kandungan protein dalam susu kedelai seperti lisin, glisin, isoleusin, arginin, treonin dll.
• Karbohidrat
  Biasanya ibu hamil akan sering mengalami kelelahan, dan tentunya sangat membutuhkan asupan energy tambahan yang berbeda dengan orang yang tidak mengandung. Oleh karenanya susu kedelai bisa memberikan solusi untuk asupan karbohidrat untuk si ibu hamil sehingga energinya dapat terpenuhi.
• Lemak Nabati 
  Jenis lemak yang terkandung pada susu kedelai adalah lemak nabati, lemak jenis ini bermanfaat baik untuk memerangi kolestrol jahat yang ada dalam tubuh, sehingga kolestrolini akan dapat terkontrol. Selain itu lemak ini bemanfaat baik juga untuk perkembangan janin dalam kandungan.

Selain bermanfaat diatas rumor atau banyak isu yang mengatakan bahwa dengan mengkonsumsi susu kedelai sejak awal kehamilan bisa memberikan solusi alternative supaya dapat mempunyai keturunan laki-laki (bagi anda yang menginginkan anak laki-laki) namun ini hanya rumor saja belum tentu kebenarannya, dan hanya tuhan atau allah yang dapat menentukan kebenarannya. Oke sekian dulu semoga bermanfaat.

Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday

At my May 30, 2013 post "Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients ... CEO Cites Defective HHS Paper and Red Herrings As Excuse Why He Knowingly Allows This To Continue" at http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html, I lamented that hospital management felt they could ignore clinicians calling for implementation postponement of what they viewed as bad health IT, dangerous to patients, with impunity.

Finally, medical professionals stand up to imperial hospital management that, in a perhaps criminally negligent fashion (e.g., see my post on the ECRI Deep Dive Study on Health IT harm at this link), ignores its clinicians over too-rapid deployment of health IT.

Also see newspaper article at http://www.cantonrep.com/news/x393137745/Affinity-nurses-seek-delay-on-electronic-records#axzz2WcOMZpvF.

(The hospital management is extolling the safety of the new Cerner system.  What could possibly go wrong?  -- I'd bet the executives, despite their fiduciary duties towards maintaining a safe hospital environment, have no idea about Cerner defects such as at the FDA MAUDE database; see "MAUDE and HIT Risks: What in God's Name is Going on Here?" at http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html or are familiar with "Medical center has more than 6000 'issues' with Cerner CPOE system in four months" at http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html.  Instead, unpaid bloggers do their work for them to protect patients....)

See this:

-----------------------------

For Immediate Release - June 18, 2013

For more information: Michelle Mahon, RN, 234-207-6706 or Liz Jacobs, RN, 510-273-2232

Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday

Affinity Medical Center RNs in Massillon, Ohio are calling on hospital officials to delay the planned June 21 implementation of the Cerner electronic medical records (EMR) system, until the hospital bargains with the nurses and proceeds in a safe manner.

The direct-care RNs, represented by the National Nurses Organizing Committee (NNOC) in Ohio, an affiliate of National Nurses United (NNU), say that nurses, the primary users of the complex system, have had insufficient training, which will put patients at risk. The implementation, which has been done without bargaining with NNOC, reflects yet another violation of federal labor law by Affinity, nurses say.

Nurses have documented their concerns in a detailed letter to hospital officials. Those concerns include woefully inadequate training, short staffing in the first days of the roll out, and the subsequent risk of harm to their patients.  The system, they say, has the potential of violating the Ohio Nursing Practice Act because it doesn’t permit RNs to communicate individualized, potentially life-saving information about their patients.

The letter, which RNs attempted to deliver to hospital officials on Friday, cites nationally recognized experts in health information technology who reinforce the RNs’ concerns. Most notably, the Institute of Medicine (IOM) has concluded that the failure to include RNs in all steps of this transition is one of the most significant barriers to successful, safe implementation of electronic health records systems.

Hospital officials have continued to refuse to meet with nurses, and would not accept the letter.  [Willful ignorance? - ed.] Without bargaining with the union or acknowledging the nurses’ concerns, the hospital added a few more trainings late Friday, but the RNs say that remains far from adequate.

Over the last few years, American healthcare corporations have invested heavily in information technology (IT) systems, which make up a multi-billion dollar market.

“RNs who actually use these systems day in and day out have found that the kind of care they can provide with this new technology is limited,” said NNOC Co-president Cokie Giles, RN. “The programs are often counterintuitive, cumbersome to use, and sometimes simply malfunction. Nurses are finding that the technology is taking time away from patients and fundamentally changing the nature of nursing.”

NNOC/NNU has successfully negotiated clauses in its contracts that allow RNs to play a greater role in reviewing and approving new technologies before they are introduced, and that the new technologies will not supersede RN professional judgment. 

“I have been chosen as a ‘super-user,’ said Amy Pulley, an RN who works in the endoscopy unit of the hospital. “I’m not sure what makes me ‘super’ with the limited training for this complex system that I’ve received. I’m concerned that the manner in which this technology is being implemented may pose serious disruptions in patient care.”

Highlights of RN Concerns on the Implementation of the Cerner Electronic Medical Records System at Affinity Medical Center

Inadequate Staffing

·        Several units will be severely short staffed for the transition, despite the fact that the hospital has been planning on the “go live” date for several months.

·        The entire hospital and all portions of the system will go live at once, referred to as the “big bang” approach, which has a very low rate of success, rather than implementing it in trial, pilot stages.

·        They are utilizing the ‘super-user’ model which will pull nurses from direct-care so they can be available to teach, leaving several units without enough nurses to care for patients.

·        The hospital refuses to decrease the number of elective procedures or provide additional staff during the transition time.

Lack of training

·        Some nurses have received only one day of training.

·        Super-users have received no education or training in the system beyond what is provided to the other users.

Design flaws

·        Placement of the workstations are ill conceived—RNs must turn their back to patients while documenting.

·        During one education session, the system crashed because 17 users at one time overloaded it.

Failure to consult nurses

·        Several concerns were brought to management’s attention which they were unable to answer. One example— how will RNs override the system in the event of an emergency?

Affinity is one of five hospitals in California, Ohio, and West Virginia that are part of one of the nation’s largest for-profit hospital chains, Tennessee-based Community Health Systems where affiliates of NNU are pursuing federal action for significant violations of RN rights.

The National Labor Relations Board held a five-day hearing in May in a complaint filed by the nurses and NNOC over Affinity’s refusal to bargain a first contract and retaliation against RNs for advocating for their patients and their colleagues. A decision by an NLRB administrative law judge is pending. CHS affiliated hospitals in West Virginia and California are facing similar sanction from federal officials. At one of the California hospitals last week, a U.S. District Court judge issued an injunction ordering the hospital to return to negotiations with the RNs.

CHS is the second largest for-profit hospital chain in the United States, and one of the wealthiest. Over the past five years, CHS reported over $1.5 billion in profits to the Securies Exchange Commission.

Michelle Mahon, RN

National Representative

National Nurses United

mmahon@nationalnursesunited.org

234-207-6706

I believe the nurses should strike if their concerns are not heeded.

I once worked in a highly-unionized city Transit Authority; I believe the unions would have shut the Authority down in the face of even a fraction of concerns like this that could impact pubic safety - and their own memberships' careers and lives.

-- SS

6/20/13 addendum:

I note that this EHR medical device (per FDA) is non-FDA approved, nor vetted by any regulatory agency.  Apparently the hospital believes it has the prerequisite skills and expertise to vet this device for safety.  Who, exactly, will take responsibility for bad outcomes?

FDA's Chair of the Center for Device and Radiological Health, Jeffrey Shuren, MD JD, stated explicitly that EHRs were medical devices on Feb. 25, 2010 (see testimony to the HHS Health Information Technology HIT Policy Committee at this PDF) that:

... Under the Federal, Food, Drug, and Cosmetic Act, [that regulates all drug, medical devices, etc. in the United States - ed.] HIT software is a medical device. Currently, the FDA mandates that manufacturers of other types of software devices comply with the laws and regulations that apply to more traditional medical device firms. These products include devices that contain one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor patient activity), as well as devices that are composed solely of software (such as laboratory information management systems)... To date, FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices.

I also note that patient informed consent to its use in their care is likely not being sought.  Should it?  If not, why not?

-- SS

9/2/2013 addendum

The comment by "Anonymous August 20, 2013 at 11:24:00" has many characteristics of a sockpuppet (see http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html) - ignoring everything written in the post and expressing perverse and deranged views.  See it, and my response, in the comment section.  A post about an anti-health IT union dispute such as this is a strong potential sockpuppet magnet.

-- SS

"Computer problems" force docs back to paper charts at Memorial Hospital - From June 11 until at least June 24?

More on the wonders and dependability of commercial health IT, as implemented in hospitals, which are generally an IT backwaters:

Computer problems force docs back to paper charts at Memorial Hospital

Published: June 17, 2013 

BELLEVILLE (Illinois) — Computer problems have caused Memorial Hospital (http://www.memhosp.com/Pages/Home.aspx) staff back to the old days of using paper to chart patients' treatments.

The hospital's computer system, Meditech, went down late on Tuesday, June 11 and is not expected to be fully restored until at least Monday, June 24, according to the hospital. In the meantime, staff will be recording patients' medical records unto traditional paper charts.

"While the duration of this down time is unfortunate, all hospital services continue utilizing the backup process we have in place for occasions such as this," Memorial President Mark Turner said in a prepared statement. "I am extremely proud of the way our employees and medical staff have pulled together to maintain quality care and patient safety."

Once the system is up and running again, the information from the paper charts will be transferred into each patient's electronic medical record. The same standards for patient confidentiality and safety are being met, according to the hospital.

The computer problems are believed to result from upgrades added to the system in preparation for a major upgrade in July.

"The duration of this down time is unfortunate?"  This mission-critical system went down June 11 and won't be fully restored until June 24?  How is this even possible?  What, exactly, were their maximal-uptime, redundancy, disaster recovery and business continuity strategies?  Was there a natural disaster in that area I don't know about?

Regarding the hospital President's statement that:

"I am extremely proud of the way our employees and medical staff have pulled together to maintain quality care and patient safety."

I would translate that to read:

"Our IT incompetence is all on you, clinicians.  You're liable for any patient harm that results in the messy transitions from IT to paper, and back from paper to IT."

-- SS

Addendum - a question I've asked before - if everything is just fine, business as usual, with no safety impediments after reverting to paper due to emergency ... then why spend $100 million+ on EHRs?

Read more here: http://www.bnd.com/2013/06/17/2660472/computer-problems-force-docs-back.html#storylink=cpyA

summer has officially begun and my kiddos are number uno these days....with them being out of school, it's a lot harder for me to sit down and have time to post here....so here's our life according to my iphone.

i hope y'all are having a wonderful summer too....

A Call to Restore the Integrity of Clinical Research - but Will Anyone Heed it?

Concerns about suppression and manipulation of clinical research to serve vested interests have finally gotten a little more mainstream.

Background: Suppression and Manipulation of Clinical Research

For a long time, we have decried and discussed examples of manipulation of clinical research done to increase the likelihood that its results would please vested interests, often drug, device or other corporations that sponsored the research and often exerted considerable control over its design, implementation, analysis, and dissemination.  We have also decried and discussed examples of suppression of research whose results offended such vested interest, sometimes done when manipulation did not succeed in producing such pleasing results.


I wrote about suppression of research in my 2003 paper on health care dysfunction,(1)

The integrity of medical research has been violated by the deliberate suppression of its results.

That assertion was based on several important, although understandably largely anechoic cases.

I first wrote about systematic attempts to manipulate clinical research in 2005, based on Richard Smith's PLoS Medicine commentary which listed specific tactics that vested interests could use to make it more likely that research studies would provide them with favorable results.

Although striking cases of manipulation and suppression appeared more frequently starting in the 1990s, in the last few years it has become more apparent that these are widespread problems.

A Call to Restore Integrity

This week, the British Medical Journal published a special article calling for restoration of suppressed or manipulated clinical trials(2), accompanied by an editorial entitled, "restoring the integrity of the clinical trial evidence base."(3)

The article used slightly different terminology than we do, replacing suppression with invisibility, and manipulation with distortion, thus,

Two basic problems of representation are driving growing concerns about relying on published research to reflect the truth. The first is no representation (invisibility), which occurs when a trial remains unpublished years after completion. The second is distorted representation (distortion), which occurs when publications in medical journals present a biased or misleading description of the design, conduct, or results of a trial.

The article boldly asserted

Both go against the fundamental scientific and ethical responsibility that all research on humans be used to advance knowledge and are symptomatic of a general culture of data secrecy. The end result is that the healthcare, biomedical research, and policy communities may, despite best intentions and best practices, end up drawing scientifically invalid conclusions based on only those parts of the evidence base they can see.

The editorial went further, asserting that

This crisis of hidden or misreported information from clinical trials—and the resulting distortion of the clinical evidence base—is widely recognized and commonly decried. It is one of the leading scientific problems of our time, but few solutions have been put forward.

Furthermore, it concluded with a warning about the immorality of continuing on the current course,

The results of clinical trials are a public, not a private, good. The public interest requires that we have a complete view of previously conducted trials and a mechanism to correct the record for inaccurately or unreported trials. If we do not act on this opportunity to refurbish and restore abandoned trials, the medical research community will be failing its moral pact with research participants, patients, and the public. It is time to move from whether to how, and from words to action.

Thus the notion that suppression and manipulation of clinical research is a systemic, severe problem that confounds health professionals and hurts patients is no longer a concern of only a few fringe dissidents, but a matter for discussion in the foremost mainstream medical journals.

Will Anyone Heed the Call?

Furthermore, this dire problem formulation suggests the need for a strong solution, as proposed by the article, and seconded by the editorial.  Using the term "abandoned trials" for " unpublished trials for which sponsors are no longer actively working to publish or published trials that are documented as misreported but for which authors do not correct the record using established means such as a correction or retraction (which is an abandonment of responsibility)," Doshi and colleagues wrote,

We call on institutions that funded and investigators who conducted abandoned trials to publish (in the case of unpublished trials) or formally correct or republish (in the case of misreported trials) their studies within the next year.

Starting in 2005, we have repeatedly called for protection of " researchers' rights to speak truth to power," but then noted that "right now, it is more often power that speaks to truth."  The question is whether without some bigger allies, individual clinical researchers will stand up on their own to restore the integrity of clinical research.

The big reason to worry is that most of these researchers work within a context which strongly favors vested interests, rather than scientific truth, or the rights of research subjects.  The researchers who would be most likely to be able to heed the call by Doshi et al are those within academic medicine. Yet clinical research in the academic medical world now functions within a strong and deep web of individual and institutional conflicts of interests, subjects that we also have written about incessantly.

There is evidence suggesting that the majority of medical faculty,(4) and the majority of their academic departmental leaders(5) have important financial ties to the health care corporations most likely to have reason to want to suppress or manipulate research.  Furthermore, most academic medical institutions have stated their interest in increasing "collaboration" with industry, usually giving the rationale that this will lead to "innovations" that will bring better tests or treatment to patients. (See posts here,  here and here for some examples.)  Such collaboration also tends to bring a lot of money to institutional budgets.  Further collaboration with industry is likely favored by academic leaders' own financial ties to the same sorts of corporations discussed above.  Thus it should be no surprise that a study by Mello et al in 2005 suggested that most of the managers of academic medical institutions who control research contracts are willing to give significant control of of research design, implementation, analysis, and dissemination to the sponsors, not the researchers.  (See this post.) (6)


Thus, a researcher who volunteers to restore suppressed or manipulated clinical studies might become suddenly very unpopular with his or her colleagues or supervisors, and perhaps with people who are already paying him or her.

So as long as health care professionals, policy makers, and the public at large are willing to go along with the notion that academic medical institutions' "collaboration" with "industry" is absolutely necessary to foster "innovation" and hence medical progress, it is very unlikely that academic medical researchers will be willing to help restore the integrity of clinical research.  In fact, while we continue on our present course, the integrity of clinical research will probably get even worse.
 
Since questioning the integrity of contemporary clinical research might make those with vested interests who have been willing to suppress or manipulate research very uncomfortable, perhaps it should be no surprise that the paired articles in the British Medical Journal have been relatively anechoic.  For example, while one might think the publication of these simultaneous articles might get at least a little coverage in the "main-stream media," I can find not a single mention of them there.  (So far, only the Chronicle of Higher Education, MedScape the Science Insider blog and The Scientist blog have provided news coverage.)


So I hope the brave people who wrote the article and editorial are also willing to join us in decrying the web of individual and institutional conflicts of interest that have entangled health care professionals and academic medicine.  Individuals and institutions who make medical or health care decisions, or who are involved in medical and health care education and research should reveal all their conflicts of interest, at least in the interests of honesty.  Furthermore, in the interest of patients' and the public's health, clinical research meant to assess medical tests, treatments, and programs should be done completely independently from the corporations that sell them.  


References

1.  Poses RM.  A cautionary tale: the dysfunction of American health care.  Eur J Int Med 2003; 14: 123-130.  Link here..
2.  Doshi P, Dickersin K, Healy D et al.  Restoring invisible and abandoned trials: a call for people to publish the findings.  Br Med J 2003;  BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f2865  Link here.
3.  Loder E, Godlee F, Barbour V et al.  Restoring the integrity of the clinical trial evidence base.  Br Med J 2003;  BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3601  Link here.
4. Campbell EG, Gruen RL, Mountford J et al.  A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Link here.
5. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786.  Link here.
6.  Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352:2202-2210. Link here.

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