For and against: Clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial FOR AGAINST

Weijer, Charles; Shapiro, Stanley H.; Glass, Kathleen Cranley

doi:10.1136/bmj.321.7263.756

Cited by 155 publications

(97 citation statements)

References 12 publications

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“…The primary reason being that clinical equipoise cannot be met; given the weight of recent evidence the majority of clinicians would now be reluctant to revert to previous treatments for IHs, and therefore cannot ethically choose at random which treatment to provide. 2 An RCT in this situation will have inherent flaws with confounding factors and bias.…”

Section: Sir Reply To Spiteri Cornish and Reddymentioning

confidence: 99%

“…Rarely, MS arises de novo. 2,3 Here, we describe a case of MS presenting de novo with a white anterior chamber infiltrate. …”

mentioning

confidence: 99%

“…Comment MS is rare and often misdiagnosed. 2,3 The incidence of a single MS is 2% in AML, 1 whereas orbital MS accounts for 1 of 250 cases. 4 An anterior chamber infiltrate might be misdiagnosed as retinoblastoma or hypopyon, resulting in delayed or improper treatment.…”

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confidence: 99%

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Anterior chamber infiltrate in 3-month-old: rare presentation of myeloid sarcoma

Dunbar

Hubbard

Wells

2012

Eye

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Sir, Anterior chamber infiltrate in 3-month-old: rare presentation of myeloid sarcoma Myeloid sarcoma (MS) is an extramedullary tumour of immature myeloblasts associated with leukaemias. 1 MS commonly presents after diagnosis of active leukaemia, during a recurrence, or as a blastic transformation of myelodysplastic syndrome. Rarely, MS arises de novo. 2,3 Here, we describe a case of MS presenting de novo with a white anterior chamber infiltrate. Case reportA 3-month-old infant presented to an outside ophthalmologist with a unilateral 'discoloured iris.' He was referred for retinoblastoma vs endophthalmitis. Examination showed a fluffy, white anterior chamber infiltrate and scarce vitreous cell in the right eye. The rest of the ocular exam and peripheral blood studies were unremarkable.Social reasons delayed the exam under anaesthesia and MRI for 12 days. Unexpectedly, he developed bilateral proptosis, lacrimal gland swelling, a larger right anterior chamber infiltrate, and new left anterior chamber infiltrate (Figure 1). MRI of the brain showed infiltrative bone marrow processes with involvement of bilateral globes, lacrimal glands, extraocular muscles, and paranasal sinuses (Figure 2).Lacrimal gland biopsy revealed MS. The H&E stain showed sheets of tumour cells and the lysozyme stain was positive (Figures 3a and b). Work-up of blood and bone marrow showed no evidence of malignancy.After two courses of 10-day cycles of cytarabine, daunorubicin, and etoposide, CNS involvement was seen and additional intrathecal therapy was started. His lesions regressed and anterior segment infiltrates disappeared (Figure 4).Before his fifth course, rare leukaemic blasts were noted in the CSF. These cleared with intrathecal therapy; however, during recovery, leptomeningeal enhancing lesions were noted. He was started on palliative oral VP-16 (etoposide). After multiple relapses despite external radiation and chemotherapy, the decision was CommentMS is rare and often misdiagnosed. 2,3 The incidence of a single MS is 2% in AML, 1 whereas orbital MS accounts for 1 of 250 cases. 4 An anterior chamber infiltrate might be misdiagnosed as retinoblastoma or hypopyon, resulting in delayed or improper treatment. We present this case to emphasize that MS should be considered in patients with white anterior chamber infiltrates even if previously healthy. Conflict of interestThe authors declare no conflict of interest. AcknowledgementsThis study was supported in part by an unrestricted grant from Research to Prevent Blindness, New York, NY.

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Section: Sir Reply To Spiteri Cornish and Reddymentioning

confidence: 99%

“…Rarely, MS arises de novo. 2,3 Here, we describe a case of MS presenting de novo with a white anterior chamber infiltrate. …”

mentioning

confidence: 99%

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Anterior chamber infiltrate in 3-month-old: rare presentation of myeloid sarcoma

Dunbar

Hubbard

Wells

2012

Eye

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“…A surgical RCT may compare two different surgical procedures or may compare surgery with nonsurgical management or with the natural history of the disease being studied. For a surgeon-researcher to enrol patients in an RCT, it is widely accepted that a state of Bclinical equipoise^must exist [12].…”

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confidence: 99%

If it can be done, it should be done,…or not?

Grotenhuis

2016

Acta Neurochir

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“…In this situation, when an alternative treatment is predicted to have about an equal probability of a good outcome, then RTCs are considered the optimal method to establish superiority of one treatment regimen over another. In other words, when the concept of equipoise-similar therapy has similar effects-is present, then it is considered ethical and scientifically reasonable to randomize patients to receive either of two (or more) arms of a trial trying to establish a superior benefit of competing treatments [19]. Accepting that AA is a rare disease, then patients from regions would need to be pooled if there was any hope of having RTCs large enough to find subtle differences in competing treatments.…”

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confidence: 99%

Novel immunotherapy for anaplastic astrocytoma

Yaeger

2012

J Radiat Oncol

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For and against: Clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial FOR AGAINST

Cited by 155 publications

References 12 publications

Anterior chamber infiltrate in 3-month-old: rare presentation of myeloid sarcoma

Anterior chamber infiltrate in 3-month-old: rare presentation of myeloid sarcoma

If it can be done, it should be done,…or not?

Novel immunotherapy for anaplastic astrocytoma

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