Assessing the collection and reporting of patient-reported outcome data in interventional cancer trials: a single institution, retrospective systematic evaluation.

BACKGROUND: To understand our performance with respect to the collection and reporting of patient-reported outcome (PRO) measure (PROM) data, we examined the protocol content, data completeness and publication of PROs from interventional trials conducted at the Royal Marsden NHS Foundation Trust (RM) and explored factors associated with data missingness and PRO publication. DESIGN: From local records, we identified closed, intervention trials sponsored by RM that opened after 1995 and collected PROMs as primary, secondary or exploratory outcomes. Protocol data were extracted by two researchers and scored against the SPIRIT-PRO (PRO protocol content checklist; score 0-100, higher scores indicate better completeness). For studies with locally held datasets, the information team summarized for each study, PRO completion defined as the number of expected (as per protocol) PRO measurements versus the number of actual (i.e. completed) PRO measurements captured in the study data set. Relevant publications were identified by searching three online databases and chief investigator request. Data were extracted and each publication scored against the CONSORT-PRO (PRO manuscript content checklist; scored as SPIRIT-PRO above). Descriptive statistics are presented with exploratory comparisons of point estimates and 95% confidence intervals. RESULTS: Twenty-six of 65 studies were included in the review. Nineteen studies had accessible datasets and 18 studies published at least one article. Fourteen studies published PRO results. Most studies had a clinical (rather than PRO) primary outcome (16/26). Across all studies, responses in respect of 35 of 69 PROMs were published. Trial protocols scored on average 46.7 (range 7.1-92.9) on the SPIRIT-PRO. Among studies with accessible data, half (10/19) had less than 25% missing measurements. Publications scored on average 80.9 (range 36-100%) on the CONSORT-PRO. Studies that published PRO results had somewhat fewer missing measurements (19% [7-32%] vs 60% [- 26 to 146%]). For individual PROMs within studies, missing measurements were lower for those that were published (17% [10-24%] vs 41% [18-63%]). Studies with higher SPIRIT-PRO scores and PROs as primary endpoints (13% [4-22%] vs 39% [10-58%]) had fewer missing measurements. CONCLUSIONS: Missing data may affect publication of PROs. Extent of inclusion of SPIRIT-PRO protocol items and PROs as primary endpoints may improve data completeness. Preliminary evidence from the study suggests a future larger study examining the relationship between PRO completion and publication is warranted.

Clinical experience of linezolid in bone marrow transplantation patients.

Linezolid is an oxazolidinone antibiotic that has been associated with myelosuppression, including leukopenia and thrombocytopenia. Few studies have assessed the use of linezolid in bone marrow transplantation (BMT) patients. The authors evaluated patients who were admitted to the BMT service at their institution from 2001 to 2002 and had undergone ≥3 days of linezolid therapy. These patients (cases) were matched with BMT patients who had not undergone linezolid therapy (controls). Forty-nine patients were evaluated; 25 cases and 24 controls. The authors found no significant differences in the duration of neutropenia or thrombocytopenia, but there was a trend toward a difference in time to engraftment (P = .16). More bleeding episodes were seen and more platelet transfusions were needed in cases than in controls (16% vs 8%; P = .35 and 54.5 ± 55.0 units vs 19.9 ± 20.0 units, respectively). Patients who had undergone linezolid therapy for >10 days (n = 10) had longer thrombocytopenia (102.2 ± 98.0 vs 62.0 ± 61.0 days; P = .27) and time to engraftment (20.5 ± 20.0 vs 10.7 ± 2.0 days; P = .16) and required more platelet transfusions (83.6 ± 76.0 vs 35.1 ± 23.0 units). None of these observations reached statistical significance. The authors conclude that linezolid therapy can be used safely in BMT patients for up to 10 days. However, when therapy is needed for >10 days, monitoring of platelet counts, bleeding time, and time to engraftment are recommended.

Risk factors for infections with multidrug-resistant Pseudomonas aeruginosa in patients with cancer.

BACKGROUND: Pseudomonas aeruginosa is responsible for a wide range of infections. In immunocompromised patients with cancer, the emergence of multidrug resistant P. aeruginosa may have grave consequences. METHODS: Patients with cancer who were infected with multidrug-resistant P. aeruginosa with polyclonal DNA restriction patterns were used as the case group. Two control groups were used: one group of cancer patients who were infected with multidrug-susceptible P. aeruginosa and another group of cancer patients who had the same underlying disease and the same intensive care unit exposure as patients in the case group but who were not infected or colonized by P. aeruginosa. RESULTS: Risk factors that were associated significantly with multidrug-resistant P. aeruginosa infection were the use of carbapenem for > or = 7 days, a history of P. aeruginosa infection during the preceding year, and a history of chronic obstructive pulmonary disease (P < 0.01). CONCLUSIONS: Carbapenems may need to be used more judiciously as first-line empirical therapy for cancer patients with prior pseudomonal infection or chronic obstructive pulmonary disease who require hospitalization, and alternative, antipseudomonal antibiotic regimens may need to be considered, especially in this patient population.