EFSPI/PSI working group on data sharing: accessing and working with pharmaceutical clinical trial patient level datasets - a primer for academic researchers.

Background: Access to patient level datasets from clinical trial sponsors continues to be an important topic for the Pharmaceutical Industry as well as academic institutions and researchers. How to make access to patient level data actually happen raises many questions from the perspective of the researcher.

Methods: Patient level data access models of all major pharmaceutical companies were surveyed and recommendations made to guide academic researchers in the most efficient way through the process of requesting and accessing patient level data.

Rate of emergence of cytomegalovirus (CMV) mutations in leukocytes of patients with acquired immunodeficiency syndrome who are receiving valganciclovir as induction and maintenance therapy for CMV retinitis.

The emergence of mutations conferring ganciclovir resistance was evaluated in an open-label randomized clinical trial that compared oral valganciclovir with intravenous ganciclovir as induction therapy, followed by maintenance with valganciclovir, for newly diagnosed cytomegalovirus (CMV) retinitis in 148 patients with acquired immunodeficiency syndrome. The presence of CMV mutations was directly assessed in patient leukocytes by polymerase chain reaction, followed by restriction fragment-length polymorphism (RFLP) for detection of the most common UL97 mutations associated with ganciclovir resistance and by sequencing of the viral UL97 gene. The cumulative percentages of patients with UL97-mutant viruses at 3, 6, 12, and 18 months (based on the number of patients on treatment at each time point) was 2.

Primary resection total knee arthroplasty for complicated fracture of the distal femur with an arthritic knee joint.

Treatment of fractures of the distal end of the femur in an elderly patient is difficult. If the knee joint is arthritic, the problem is even greater. The reports of two patients with rheumatoid arthritis who sustained fractures of the distal end of the femur and underwent unconventional treatment with a resection total knee arthroplasty are presented.

Total ankle arthroplasty. A long-term review of the London Hospital experience.

We report a retrospective study of 62 total ankle arthroplasties performed between 1972 and 1981. Forty-one of these have been reviewed clinically after an average follow-up of five and a half years; only 13 can be described as satisfactory. The complications encountered in all 62 arthroplasties are detailed, the most significant being superficial wound healing problems, talar collapse, and loosening of the components; 13 prosthetic joints have already been removed and arthrodesis attempted.

The management of infected total knee replacements.

A review of patients with an infected resurfacing prosthesis is presented. Eight patients with a loose infected prosthesis were treated by a one-stage exchange arthroplasty; six others with a well-fixed infected prosthesis were treated by drainage and antibiotics. All eight treated by exchange arthroplasty remained free of infection as did five of those treated by drainage.