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Thread: Difference between medical research and patient care

  1. #1

    Difference between medical research and patient care

    I have been involved in a discussion about medical mal-practice caps. I chose to start a new topic, as the original topic got lost. After reading the thread over and over I have come to the conclusion that there are 2 schools of thought. I see the need for a researcher to work freely and not have limitations put on their research. They must experiment with new ideas and therapies. They begin on animals and then it moves to human trials. This kind of medicine must operate under risk in order to be successful. The other school of thought involves the treating physician. The treating physician is not a researcher and doesn't usually work with unproven therapies. The two professions are different. One is experimental and the other is implementing the approved treatments. I can see where a researcher would want to use trial and error, and not have someone looking over his or her shoulder,and not have to act like a robot, but in the hospital we should not be treated like mice, and excuse doctors for not giving us the proper treatment so they wouldn't feel restrained. I think we have a problem when we group these to fields of medicine into one.

  2. #2
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    Well put, bigbob.

    Obviously I agree.

  3. #3
    bigbob - There are several fields involved in this topic: Pure research, clinical research and clinical practice, that is based on known standards of care. Physicians who choose to work in research may do their studies in a laboratory setting or in a clinical research setting. All research is held to and must meet high standards; clinical research (uses human subjects) must meet Food and Drug Administration (FDA) approval before it advances to the clinical setting. Persons who are subjects in a clinical research study must sign a statement of approval to participate. When one signs such a statement, they acknowledge that they understand and agree to the treatment protocol.

    Most patients in a clinical setting are not the subjects of clinical research. Each treating institution has protocol for the treatment and management of a patient with a particular diagnosis or health need. If a patient has inappropriate care, it is not the result of someone deciding to use a particular patient as a research subject without that person's knowledge. There are laws that protect people from this. There are many checks and balances within a clinical setting that strive to assure correct treatment. Errors, negligence and malpractice do occur, but these situations are unrelated to the field of research.

    It might be helpful to read the following research information:

    Craig Hospital - Research

    UAB - Research CRF

  4. #4
    I think my point was missed. I have great faith in Doctors. I believe they do wonderful work. I was not as effective and articulate as you, but actually I was trying to say what you just said.
    Thanks

  5. #5
    bob, thanks for your thoughtful post. The situation is more complex. Medical practice is always evolving, just as standards and clinical practice are always evolving. When I went to medical school at Stanford in the 1970's, the practice of medicine was called an "art". In the past two decade or so, there has been a strong move to make the practice of medicine more "evidence-based". Clinicians participate in clinical trials which are designed to provide that evidence. However, most medical practices still do not have a solid evidence base. Most practice guidelines are based on fragmentary evidence and anecdotal information.

    Insurance companies and professional societies are pushing hard for evidence-based guidelines. This movement for evidence-based medical practice has had three serious consequences. First, non-evidence-based standards or practice guidelines are being discarded. Rather retaining them as clinical guidelines or standards, practices that do not have randomized clinical trial (RCT) data support are deemed optional or even discouraged if they are risky or costly. Second, absence of RCT data may be used by insurance companies to withhold insurance coverage. Third, "off-label" use of drugs based on anecdotal experience is being discouraged by the FDA and insurance companies.

    This situation has been devastating for rare diseases and conditions. Clinical trials are very difficult to carry out when the condition happens so rarely that no single center can collect a large series. Also, clinicians have little experience with rare conditions and are unlikely to understand the disease/condition well enough to design good clinical trials. Finally, funding is not often not available for clinical trials of such rare conditions. Without reliable evidence, standards or practice guidelines are often incomplete or wrong.

    Let me give you an example of how much evidence is required to establish a standard of care. In 1990, the Second National Acute Spinal Cord Injury Study (NASCIS) published a paper reporting the high-dose methylprednisolone is effective for spinal cord injury. Published in the New England Journal of Medicine, one of the most rigorously peer-reviewed journals in medicine, this was the first large-scale (487 patients) randomized clinical trial to show that a therapy has significant beneficial effects in acute spinal cord injury. Although several additional multicenter randomized clinical trials have shown the beneficial effects of methylprednisolone for acute spinal cord injury, neurosurgeons have still *not* deemed high-dose methylprednisolone treatment to be a standard for treating acute spinal cord injury in 2000.

    Let us review the evidence for use of methylprednisolone in the treatment of transverse myelitis (TM). In 1980, Dowling, et al. reported that high-dose intravenous steroid may be possibly beneficial in a study where they gave intravenous steroids in an open label trial to 5 patients with Guillian-Barre, 3 patients with transverse myelitis, and 7 patients with multiple sclerosis. In 1986, Zerbini, et al. reported recovery of one patient from transverse myelitis due to systemic lupus erythematosus, treated with steroids. Likewise, Kenik, et al. (1987) and Boumpas, et al.. (1990) successfully treated individual patients with transverse myelitis with high dose steroids. Tippett, et al. (1991) treated 3 patients with transverse myelitis with partial or complete recovery. Obara & Tanaka (1991) treated one patient with transverse myelitis. Barile & Lavalle (1992) treated seven patients with methylprednisolone and found that most of the patients recovered walking with partial or total sphincter control. Klaiman & Miller (1994) gave high-dose methylprednisolone to a patient with TM associated with lupus. Many others have reported similar findings, including Sebire, et al, (1997) who reported complete motor recovery in 5 children who developed severe acute transverse myelitis. Lahat, et al. (1998) likewise reported remarkable motor recovery in 10 children treated with high-dose methylprednisolone. Baca, et al. (1999) gave methylprednisolone and cyclophosphamide to 7 children with transverse myelitis associated with lupus and found that all but one recovered.

    Based on so many anecdotal cases, you would think that the data is pretty strong that methylprednisolone should be given to all transverse myelitis cases. However, as more studies appeared, it became clear that the situation and data is not so simple. In 1999, Kalita, et al. did evoked potentials and found pronounced recovery associated with methylprednisolone treatment. But in 2001, the same authors (Kalita & Misra, 2001) published a study in the journal Spinal Cord, asking "Is methylprednisolone useful in acute transverse myelitis?" They examined 21 patients and compared 12 consecutive patients that did not receive the drug versus 9 that did. They found no beneficial effect of methylprednisolone.

    Defresne, et al. (2001) studied 12 children with acute transverse myelitis treated with methylprednisolone, compared against 17 children (historical controls) that did not get the drug. They found that a significantly higher proportion of treated patients walked independently at 1 month and at 1 year, with no difference in complication rates between the two groups. However, Miyazawa, et al. (2003), however, reported in 2003 that age at onset and neruologic features were important for outcome prediction in acute transverse myelitis and that steroid therapy did not associate with better outcome. They reviewed the cases of 50 Japanese children who had acute transverse myelitis between 1987 and 2001.

    This evidence base is not sufficient to justify methylprednisolone treatment as a "standard" of therapy of transverse myelitis. No randomized clinical trials were carried out. The few controlled trials based on historical comparisons suggest conflicting results. The problem is the difficulty and lack of funding of clinical trials to obtain reliable evidence of treatment efficacy. Without such data, the current trend for evidence-based medicine will shackle the ability of doctors to make decisions when evidence is incomplete and standards are not available. I hope that you agree with me that this is not a good situation. Your argument for strict adherence to standards may have resulted in no methylprednisolone treatment for your son even if the diagnosis of transverse myelitis had been made early. That is why I oppose the concept of strict adherence of medical practice to standards or practice guidelines. Doctors must be allowed to use their best judgment because "standards" may be incomplete or even wrong. Yes, there are some bad doctors but please let good doctors be good doctors.

    Wise.


    References

    • Dowling PC, Bosch VV and Cook SD (1980). Possible beneficial effect of high-dose intravenous steroid therapy in acute demyelinating disease and transverse myelitis. Neurology. 30: 33-6. Intravenous steroid followed by oral prednisone was administered to patients with Guillain-Barre syndrome (five), acute transverse myelitis (three), and multiple sclerosis in acute relapse (seven). Preliminary experience with each of these disorders revealed prompt clinical improvement in some patients. The approach used in this uncontrolled study deserves further investigation.

    • Zerbini CA, Fidelix TS and Rabello GD (1986). Recovery from transverse myelitis of systemic lupus erythematosus with steroid therapy. J Neurol. 233: 188-9.

    • Kenik JG, Krohn K, Kelly RB, Bierman M, Hammeke MD and Hurley JA (1987). Transverse myelitis and optic neuritis in systemic lupus erythematosus: a case report with magnetic resonance imaging findings. Arthritis Rheum. 30: 947-50. We describe a patient with systemic lupus erythematosus who developed transverse myelitis and optic neuritis. Magnetic resonance imaging showed the presence of an abnormal signal in a normal-sized spinal cord which corresponded to the patient's neurologic deficit. No abnormality was recognized in either optic nerve. Magnetic resonance may prove to be a useful imaging modality for the diagnosis of a transverse myelopathy in systemic lupus erythematosus.

    • Tippett DS, Fishman PS and Panitch HS (1991). Relapsing transverse myelitis. Neurology. 41: 703-6. Department of Neurology, University of Maryland School of Medicine, Baltimore 21201. Acute transverse myelitis is a monophasic disorder, the recurrence of which raises the question of multiple sclerosis (MS) or other multifocal CNS disease. We now report three patients with a previously undescribed syndrome of relapsing isolated acute transverse myelitis. Each had two to five attacks over periods of 3 to 8 years, characterized by ascending paresthesias, urinary retention, sensory loss with a thoracic or cervical level, paraparesis, hyperreflexia, and bilateral Babinski signs. MRI demonstrated areas of increased signal intensity on T2- and proton density-weighted scans and decreased signal intensity on T1-weighed scans of the cervical or thoracic spinal cord consistent with an inflammatory or demyelinating process. All patients had normal complete myelograms, oligoclonal IgG bands were consistently absent from the cerebrospinal fluid, cranial MRIs were normal, and there was no other clinical or laboratory evidence of MS, collagen-vascular disease, or active viral infection. They were treated with high doses of intravenous corticosteroids, stabilized between episodes, and had partial or complete recovery. The recognition of these three patients at a single medical center in a 1-year period suggests that relapses of acute transverse myelitis may not be rare.

    • Obara K and Tanaka K (1991). [A case of mixed connective tissue disease (MCTD) associated with transverse myelitis responding to pulse therapy]. Rinsho Shinkeigaku. 31: 1197-201. Department of Neurology, Mito Red Cross Hospital. A 42-year-old female was admitted to our hospital on October 1, 1990 because of one week history of back pain, weakness of her right lower extremity and sensory disturbance of her left lower extremity. Physical examination revealed swollen hands, Raynaud's phenomenon, sclerodactyly and heliotrope rash. The body temperature was 37.0 degrees C. Neurological findings included weakness in the right lower extremity, left hypalgesia and thermohypesthesia below Th4, hyperreflexia on the right lower extremity and right extensive plantar response. Laboratory data showed leucopenia (3,700/mm3) and hypergammaglobulinemia. Serological examination revealed antinuclear antibodies with a titer of 1:5120 (speckled pattern) and anti-RNP antibody with a titer of 1:32. Neither anti-DNA antibody nor anti-Sm antibody were detected. Serum C3 and C4 were normal. The cerebrospinal fluid (CSF) contained mononuclear cells of 5/mm3, protein 29 mg/dl and glucose 56 mg/dl. Queckenstedt test was negative. Treatment with prednisolone 60 mg daily was started. On the 8th day of therapy, she complained of a burning sensation in the back, then paraplegia and urinary retention developed. MRI examination showed a high intensity area of the spinal cord at the right Th4 on T2-weighted images. Next day the treatment with 1000-mg intravenous daily pulse of methylprednisolone for 3 days was started, followed by prednisolone 40 mg daily. After this pulse therapy, the CSF contained mononuclear cells of 52/mm3, protein 34 mg/dl, glucose 67 mg/dl and IgG 7.6 mg/dl. Her neurological manifestation gradually improved and at six weeks after the pulse therapy neurological examination revealed no abnormality except for painful tonic spasm. Prednisolone was slowly tapered to 15 mg daily.(ABSTRACT TRUNCATED AT 250 WORDS).

    • Barile L and Lavalle C (1992). Transverse myelitis in systemic lupus erythematosus--the effect of IV pulse methylprednisolone and cyclophosphamide. J Rheumatol. 19: 370-2. Rheumatic Diseases Unit, Hospital de Especialidades, Centro Medico La Raza, IMSS. Mexico City, Mexico. Transverse myelitis is a rare but serious complication of systemic lupus erythematosus (SLE). Standard treatment with medium to high doses of oral prednisone has been inadequate to control neurologic sequelae, and patients remain confined to a wheel chair or even die. We employed aggressive treatment in 7 patients with transverse myelitis complicating SLE with pulse methylprednisolone for acute episodes followed by pulse cyclophosphamide for a mean of 6 months; most of our patients are currently able to walk and have partial or total sphincter control.

    • Klaiman MD and Miller SD (1993). Transverse myelitis complicating systemic lupus erythematosus: treatment including hydroxychloroquine. Case report. Am J Phys Med Rehabil. 72: 158-61. Department of Rehabilitation Medicine, Columbia University, Presbyterian Hospital, City of New York, New York. Transverse myelitis has been cited as a rare and unusual complication of systemic lupus erythematosus (SLE). A review of the literature reveals only 10 cases of transverse myelitis as the initial presentation of SLE, and only one with reported benefits from antimalarial therapy. The case of a 30-year-old woman is reviewed. She presented to the emergency room with complaints of hypogastric and low back pain. The ensuing course was one of frank urinary retention and rapidly progressing quadriparesis. Magnetic resonance imaging of the spine revealed marked edema of the cervical and thoracic spine. A diagnosis of SLE was based on positive antinuclear antibodies and leukopenia. The patient was treated with high dose methylprednisolone, plasmapheresis and pulse cyclophosphamide for 3 months. Subsequently, treatment was begun with hydroxychloroquine, and significant improvement in her neurologic and functional status was achieved after 1 month of therapy. Ten months after her onset of symptoms, the patient suffered an acute exacerbation of paraparesis and urinary retention. Again, she improved clinically after high dose methylprednisolone and pulse cyclophosphamide for 1 month. Hydroxychloroquine was continued throughout the duration of therapy.

    • Lopez Dupla M, Khamashta MA, Sanchez AD, Ingles FP, Uriol PL and Aguado AG (1995). Transverse myelitis as a first manifestation of systemic lupus erythematosus: a case report. Lupus. 4: 239-42. Department of Internal Medicine, Santa Tecla Hospital, Tarragona, Spain. Transverse myelitis as a first manifestation of systemic lupus erythematosus (SLE) is very uncommon. No pathognomonic clinical or biochemical characteristics exist, and therefore an early diagnosis is often difficult. Therapy with intravenous pulses of methylprednisolone and cyclophosphamide has been shown to improve the prognosis. However, morbidity and mortality rates in transverse myelitis are still high due to the fact that complications such as opportunistic infections and pulmonary embolism are still frequent causes of death. We report a woman with relapsing transverse myelitis which was the first manifestation of SLE. A good response to pulse methylprednisolone and cyclophosphamide therapy was obtained but she died later as a result of a pulmonary embolism. We conclude that intravenous pulse methylprednisolone and cyclophosphamide therapy improve the prognosis of transverse myelitis associated with SLE but that a careful follow-up is needed to avoid complications due to the illness itself or secondary to the therapy.

    • Baca V, Sanchez-Vaca G, Martinez-Muniz I, Ramirez-Lacayo M and Lavalle C (1996). Successful treatment of transverse myelitis in a child with systemic lupus erythematosus. Neuropediatrics. 27: 42-4. Department of Rheumatology, Hospital de Pediatria, Centro Medico Nacional Siglo XXI, Mexico, D.F. We describe a 13-year-old female patient with systemic lupus erythematosus (SLE) who presented with acute transverse myelitis (ATM) in the course of SLE. IgG and IgM anticardiolipin antibodies (aCL) were positive at moderate titers. Magnetic resonance imaging (MRI) of the thoracic spine demonstrated decreased signal intensity and diffuse edema of the spinal cord from T2 to T6 on T1-weighted images. Dramatic clinical improvement of the neurologic impairment was noted a few days after high dose intravenous (IV) methylprednisolone (MP) and cyclophosphamide (Cy). Herein we further emphasize the benefit of IV MP and Cy in ATM and the relationship between ATM and antiphospholipid antibodies (aPLA) in SLE.

    • Chan KF and Boey ML (1996). Transverse myelopathy in SLE: clinical features and functional outcomes. Lupus. 5: 294-9. Department of Rehabilitation Medicine, Tan Tock Seng Hospital, Singapore. The objective of the study was to examine the clinical features of lupus patients who present with transverse myelopathy (TM) and ascertain functional outcomes when treated early with high dose corticosteroids and/or cyclophosphamide. Case records of nine patients who developed a total of 14 episodes of TM were retrospectively studied. All the patients were female and their ages ranged from 21 to 59 years. Nine episodes of paraparesis, three of tetraparesis, one of numbness and one of neurogenic bladder were reported early in the diagnosis of SLE (median of two years). Neurogenic bowel and bladder and presence of ANA and ds-DNA were invariable. Urodynamics assessment in six patients showed abnormal detrusor behavior in all. CT scans and myelograms were uninformative and CSF studies were normal. ESR and complement levels were insensitive as markers of disease activity. The treatment regimens included pulses of methylprednisolone and/or cyclophosphamide followed by prednisolone and high dose prednisolone from onset. The functional outcomes were uniformly good-with independent ambulation in all except three (who needed assistive devices) and improvement of motor scores. Acute hospital stays were short (range of three to 45 days) whilst only two were referred for inpatient rehabilitation. Bladder abnormalities persisted despite motor recovery and would require long-term review.

    • Sebire G, Hollenberg H, Meyer L, Huault G, Landrieu P and Tardieu M (1997). High dose methylprednisolone in severe acute transverse myelopathy. Arch Dis Child. 76: 167-8. Department of Paediatrics, Hopital de Bicetre, Le Kremlin-Bicetre, France. No effective treatment has been shown for patients with acute transverse myelopathy. In an open study five children with severe acute transverse myelopathy were treated with intravenous methylprednisolone and compared with a historical group of 10 patients. The results show that in the methylprednisolone treatment group compared with the historical group of 10 patients: the median time to walk independently was significantly reduced (23 v 97 days); the proportion of patients with a full recovery within 12 months was significantly higher (80 v 10%); all patients had complete motor recovery within one year in contrast with only two of 10 patients in the historical group; and serious adverse effects did not occur. This pilot study suggests that high dose methylprednisolone is effective in the treatment of acute transverse myelopathy.

    • Lahat E, Pillar G, Ravid S, Barzilai A, Etzioni A and Shahar E (1998). Rapid recovery from transverse myelopathy in children treated with methylprednisolone. Pediatr Neurol. 19: 279-82. Pediatric Neurology Unit, Assaf Harofeh Medical Center, Zerifin, Israel. Acute transverse myelopathy is an uncommon disease that manifests with gradually developing weakness of the lower extremities associated with bladder or bowel dysfunction, sensory deficits, and pain localized in the back, legs, or abdomen. There are controversies in the literature regarding the role of steroids in the treatment of acute transverse myelopathy. Recently, a pilot open study of five children with acute transverse myelopathy treated with high-dose methylprednisolone demonstrated significant shortening of motor recovery when compared with an historic control group receiving either no treatment or low-dose steroids. The authors add their experience of 10 children with acute transverse myelopathy treated with high-dose methylprednisolone as soon as the diagnosis was confirmed. The median time of motor recovery in the present series was 5.5 compared with 23 days in the other study. No significant side effects were observed after treatment. This study provides further support that this treatment modality is safe and efficient and should be suggested for all children with acute transverse myelopathy after establishing the diagnosis.

    • Baca V, Lavalle C, Garcia R, Catalan T, Sauceda JM, Sanchez G, Martinez I, Ramirez ML, Marquez LM and Rojas JC (1999). Favorable response to intravenous methylprednisolone and cyclophosphamide in children with severe neuropsychiatric lupus. J Rheumatol. 26: 432-9. Department of Immunology and Rheumatology, Hospital de Pediatria Centro Medico Nacional Siglo XXI, IMSS, Mexico City, Mexico. OBJECTIVE: To evaluate the effect of intravenous methylprednisolone (IVMP) and cyclophosphamide (IVCy) in children with severe neuropsychiatric (NP) systemic lupus erythematosus (NPSLE). METHODS: We studied 7 consecutive pediatric patients with severe NPSLE. All patients were treated initially with IVMP and IVCy followed by monthly IVCy for at least 3 months, and then every 2 and/or 3 months according to clinical response. Prednisone was given at 1-2 mg/kg during the first month. Laboratory studies included routine laboratory tests, antinuclear antibodies, anti-dsDNA, antiphospholipid antibodies, and complement components C3 and C4. Neurodiagnostic studies included cerebrospinal fluid, magnetic resonance imaging, computed tomography scanning, single photon emission computed tomography and electroencephalography. RESULTS: Three patients had organic brain syndrome with psychosis, 3 had seizures, 1 stroke, 1 cerebral vasculitis, 1 optic neuritis, and 1 transverse myelitis. In 3 of these cases, nervous system involvement was the initial presentation of SLE. Five patients had 2 or more NP manifestations. Most of them were accompanied by general SLE activity. Anticardiolipin antibodies were positive in 3 patients and none was anticoagulated. All patients improved, 6 patients had a complete recovery and 1 patient recovered with minor neurological deficit. All but one improved significantly within the first week of combined IVMP and IVCy. The mean time of follow-up was 37 months (range 8-55). IVCy was well tolerated with minimal side effects. CONCLUSION: Early aggressive treatment with combined IVMP and IVCy followed by monthly IVCy may be an effective therapy for severe NPSLE in children.

    • Kalita J, Guptar PM and Misra UK (1999). Clinical and evoked potential changes in acute transverse myelitis following methyl prednisolone. Spinal Cord. 37: 658-62. Department of Neurology, Sanjay Gandhi PGI of Medical Sciences, India. Study design: Observational study with sequential follow-up. Objective: To study the role of somatosensory evoked potential (SEP) and motor evoked potential (MEP) in monitoring the effect of methyl prednisolone (MPS) therapy in acute transverse myelitis (ATM). Setting: Tertiary care referral teaching hospital at Lucknow, India. Methods: In the present study, nine patients with ATM whose age ranged between 12 and 42 years and three of whom were females have been included. They were subjected to clinical examination, median and tibial SEP and Central motor conduction time (CMCT) to upper and lower limbs. The clinical and evoked potential studies were repeated after 7 and 90 days of intravenous methyl prednisolone treatment for 5 days. The outcome was defined on the basis of a 3 month Barthel Index (BI) score into poor (BI<12) and good [BI>/=12). Results: All the patients had varying degrees of leg weakness ranging between grade 0 and 4 on the Medical Research Council scale. Upper limbs were weak in four patients. Pinprick and joint position sensations in the lower limb were impaired in all patients. Central motor conduction time to upper limb was abnormal in two patients and to lower limbs in eight patients. Median SEPs were normal in all and tibial in two patients. On the seventh day follow-up, muscle power improved in six which correlated with CMCT-to tibialis anterior in five patients. Joint position sense improved in two patients on the seventh day but there was no further improvement at 3 months. Tibial SEP, however, improved in four patients on the seventh day and six patients at 3 months. Following methyl prednisolone therapy, both sensory and motor functions improved, but the improvement was more pronounced and more frequent at 3 months compared to that on seventh day. At a 3 month follow-up, six patients had good and three poor recovery. Conclusion: Evoked potential studies provide additional objective means for monitoring the effect of therapy in ATM.

    • Kalita J and Misra UK (2001). Is methyl prednisolone useful in acute transverse myelitis? Spinal Cord. 39: 471-6. Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, RaeBareli Road, Lucknow 226 014, India. STUDY DESIGN: Hospital based observational study. OBJECTIVES: To evaluate the role of methyl prednisolone (MPS) in the management of acute transverse myelitis (ATM). METHODS: Twenty-one patients with ATM were included in a prospective hospital based study during 1992-1997. All the patients underwent neurological examination, spinal MRI, somatosensory and motor evoked potentials of both upper and lower limbs and concentric needle EMG study. Twelve consecutive patients did not receive MPS therapy who were managed during 1992-1994 and nine consecutive patients during 1995-1997 received MPS therapy in a dose of 500 mg i.v. for 5 days. The clinical and neurophysiological studies were repeated 3 months later. The outcome was defined on the basis of Barthel index (BI) score at the end of 3 months into good (BI> or =12) and poor (BI<12). RESULTS: The age of MPS group was 25.5 years [range 12-42) and three were females. The age of non MPS group was 33.5 years [range 16-70) and two were females. In the MPS group 33% had poor outcome compared to 67% in the non MPS group. In the MPS group mean admission BI score was 7.3 which improved to 14.6 after MPS therapy. In the non MPS group, the admission BI score was 3.2 which improved to 9.6 at 3 month follow-up. In patients with complete paraplegia, evidence of denervation on EMG and unrecordable central motor conduction time to lower limb and tibial SEP were associated with poor outcome irrespective of MPS treatment. Global test statistics did not suggest a beneficial role of MPS therapy in the outcome of ATM. CONCLUSION: Our results do not suggest a beneficial role of methyl prednisolone on the 3 month outcome of ATM.

    • Defresne P, Meyer L, Tardieu M, Scalais E, Nuttin C, De Bont B, Loftus G, Landrieu P, Kadhim H and Sebire G (2001). Efficacy of high dose steroid therapy in children with severe acute transverse myelitis. J Neurol Neurosurg Psychiatry. 71: 272-4. Service de Neurologie, Departement de Pediatrie, Cliniques Universitaires Saint-Luc, Universite Catholique de Louvain, Avenue Hippocrate 10, 1200 Bruxelles, Belgium. pierre.defresne@freebel.net. No effective treatment has been demonstrated for patients with acute transverse myelopathy. In a multicentre controlled study, 12 children with severe acute transverse myelopathy were treated with intravenous methylprednisolone (IVMP) and compared with a historical group of 17 patients. The treatment had a significant effect on the proportion of patients walking independently at 1 month and on the proportion with full recovery at 1 year, with no differences in the frequency of complications between the two groups.

    • Miyazawa R, Ikeuchi Y, Tomomasa T, Ushiku H, Ogawa T and Morikawa A (2003). Determinants of prognosis of acute transverse myelitis in children. Pediatr Int. 45: 512-6. Department of Pediatrics, Tone Central Hospital, Numata, Gunma University School of Medicine, Maebashi and Saku Central Hospital, Minamisaku, Nagano, Japan. BACKGROUND: Acute transverse myelitis (ATM) is a severe disorder; recovery requires several months and often leaves neurologic residua. To determine what features of patients with acute transverse myelitis significantly influence prognosis, the authors reviewed reports of ATM in Japanese children published in the last 15 years (from 1987 to 2001). METHODS: The authors studied reports of 50 Japanese patients (17 boys, 26 girls, 7 children of unspecified sex; mean age +/- SD, 8.0 +/- 3.8 years). Acute-phase and demographic features including age, increased deep tendon reflexes, Babinski reflex, sex, preceding infection, decreased deep tendon reflexes, time course of peak neurologic impairment, treatment with prednisolone and/or high-dose methylprednisolone, and the day of illness when treatment was started were used as independent variables in a regression analysis. The dependent variable was long-term persistence of neurologic deficits. RESULTS: Younger patients and those without increased deep tendon reflexes or a Babinski reflex were more likely to have residual neurologic deficits such as paraplegia or tetraplegia, sensory loss and sphincter disturbance. No relationship was seen between prognosis and sex, preceding infections, decreased deep tendon reflexes, time course of peak neurologic impairment, treatment with prednisolone or high-dose methylprednisolone, or timing of treatment initiation. CONCLUSIONS: Age at onset and neurologic features were important for outcome prediction in ATM. Steroid therapy did not associate with better outcome.

    [This message was edited by Wise Young on 02-16-04 at 02:47 AM.]

  6. #6
    Wise
    Let me give you an example of how much evidence is required to establish a standard of care. In 1990, the Second National Acute Spinal Cord Injury Study (NASCIS) published a paper reporting the high-dose methylprednisolone is effective for spinal cord injury. Published in the New England Journal of Medicine, one of the most rigorously peer-reviewed journals in medicine, this was the first large-scale (487 patients) randomized clinical trial to show that a therapy has significant beneficial effects in acute spinal cord injury. Although several additional multicenter randomized clinical trials have shown the beneficial effects of methylprednisolone for acute spinal cord injury, neurosurgeons have still *not* deemed high-dose methylprednisolone treatment to be a standard for treating acute spinal cord injury in 2000.
    Wise I thought you already answered this one as noted below

    Wise
    Because it is very easy for lawyers and patients to sue doctors for not giving methylprednisolone, one of the responses of the doctors is not to adopt methylprednisolone as a "standard of care". It is just an "option". This way, it is more difficult to sue doctors for not giving the drug. As a consequence, probably 10-20% of patients in the United States currently do not receive the drug, even though it is the only, best, and safe treatment with a good benefit:risk ratio.

  7. #7
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    Patient Safety: Achieving a New Standard for Care (2003)
    Board on Health Care Services (HCS), Institute of Medicine (IOM)


    Table of Contents

    Front Matter, pp. i-xviii
    Executive Summary, pp. 1-20
    1 Introduction, pp. 21-32

    PART I: BUILDING THE NATIONAL HEALTH INFORMATION INFRASTRUCT..., pp. 33-38
    2 Components of a National Health Information Infrastructure..., pp. 39-70
    3 Federal Leadership and Public-Private Partnerships, pp. 71-92
    4 Health Care Data Standards, pp. 93-122

    PART II: ESTABLISHING COMPREHENSIVE PATIENT SAFETY PROGRAMS, pp. 123-126
    5 Comprehensive Patient Safety Programs in Health Care Setti..., pp. 127-146
    6 Adverse Event Analysis, pp. 147-164 7 Near Miss Analysis, pp. 165-178

    PART III: STREAMLINING PATIENT SAFETY REPORTING, pp. 179-182
    8 Patient Safety Reporting Systems and Applications, pp. 183-202
    9 Standardized Reporting, pp. 203-228

    Appendix A: Biographies of Committee Members, pp. 229-234
    Appendix B: Glossary and Acronym List, pp. 235-246
    Appendix C: Examples of Federal, State, and Private Sector R..., pp. 247-310
    Appendix D: Clinical Domains for Patient Safety, pp. 311-312
    Appendix E: Key Capabilities of an Electronic Health Record ..., pp. 313-348
    Appendix F: Quality Improvement and Proactive Hazard Analysi..., pp. 349-380
    Appendix G: Australian Incident Monitoring System Taxonomy, pp. 381-382



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    Definition of Standards

    Standards are the "generally accepted principles for the best/most appropriate way to provide clinical care for patients with a medical condition(Traw, 1994).

    Standards are the level of clinical practice that is considered as legally and professionally expected to be found in treating an illness. Deviation from this standard is considered as malpractice(Traw, 1994)

    Another definition :

    Standards are the criteria or set of rules that describe the expected levels of clinical and system behavior as well as courses of action based on research and experience (Davis, 1997)


    Dr. Young, you are probably using the second definition.

    *********************************************

    For purposes of a medical malpractice lawsuit, two things have to be established:

    1. There was a deviation from "standard medical practice" as defined in the first bold print.

    2. This deviation from standard medical practice caused the injury


    Given that about 85% of sci patients get methyl-prednisone, this would be considered standard of practice.

    One is required to provide the usual and customary treatment as provided by the majority of health care professionals.

    It is the second requirement (2.)in a medical malpractice case that is often difficult to prove.

  9. #9
    faye, bob, I am on the side of not limiting people if they suspect improper treatment was recieved by their healthcare provider, but in regard to standards, the definitions provided below, are not necessarily different or separate definitions.

    "Standards of clinical practice that is considered as legally and professionally expected to be found in treating an illness." (def.#1)
    can be based upon:
    "the criteria or set of rules that describe the expected levels of clinical and system behavior as well as courses of action based on research and experience." (def.#2)

    If it is known that 85% of SCI pts get methylprednisone, there must have been some scientific method/data collection to determine that. So, the "generally accepted principles for best/most appropriate way to provide clinical care for patients with a medical condition"(Traw,1994), are (usually) the result of and based on research and experience. Also, what is "good/most appropriate" is not based upon just the frequency of a given procedure, WITHOUT the scientific evidence to support it's clinical application for specific medical conditions. Research should show efficacy/effectiveness before being considered "standard" practice.

    Furthermore, because a certain procedure is frequently utilized in a particular region or hospital setting, it does not necessarily mean that that procedure is best for ALL patients/populations. There are individual factors (that aren't necessarily independent of social/environmental factors as well), that may make that procedure more appropriate for pt 1, while inappropriate for pt 2. Even with individual factors being the same, a procedure that is generally used need "principles and guidelines" that establish a set criteria, a standard, that has to come from "research and experience". What is "legally and professionally expected" arise from research.

  10. #10
    I guess point of my last post was-
    Doctors should adhere to standards established by the industry, based upon sound research. However, Dr.s are also constrained by those same standards at times, because standards are being set by Insurance bureaucrats who do not necessarily follow the same research as clinicians. Patients are denied tx against physician recommendations, and physician recommendations as well, are being limited to what insurance will allow (some Dr.s will be hesitant to recommend Tx that they know will not be covered by Pt's insurance, so will not even mention as option).

    Patients are taking a risk whenever they consent to care (being required to sign numerous content forms acknowledging/agreeing to the risks and possible harm involved). This consent should not absolve the hospital or doctors from responsibility for any mistakes or unintended harmful consequence (ie death, chronic disability), especially if this could have been avoided.

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