Evaluation of the quality of the reporting of phase II clinical trials in oncology: a systematic review

Publication date: Available online 10 March 2018
Source:Critical Reviews in Oncology/Hematology
Author(s): Romain Rivoirard, Julien Langrand-Escure, Mathieu Oriol, Fabien Tinquaut, Franck Chauvin, Chloé Rancoule, Nicolas Magné, Aurélie Bourmaud
ObjectiveTo describe the current state of knowledge concerning the quality of reporting in phase II clinical trials in oncology and to describe the various methods published allowing this quality evaluation.Methodsdatabases including MEDLINE and COCHRANE were searched. Reviews and meta-analyses analyzing the quality of the reporting of phase II trials in oncology were included. Descriptive analysis of the results was performed.ResultsThirteen publications were retained. Only 2 publications adopted a systematic approach of evaluation of the quality of reporting by overall scores. The Key Methodological Score (KMS), proposed by Grellety et al., gathering 3 items, seemed adapted for such an evaluation. A score of 3/3 was found in 16.1% of the 156 phase II trials analyzed by this score. The other reviews used a qualitative analysis to evaluate the reporting, via an analysis of a single criterion, generally the statistical plan of the study. This item was considered as having been correctly reported in less than 50% of the analyzed articles.ConclusionThe quality of reporting in phase II trials in oncology is a field that has been investigated very little (13 publications). When it is studied, the estimated level of quality is not satisfactory, whatever the method employed. The use of an overall score of evaluation is a path which should be pursued, in order to get reliable results. It also seems necessary to propose strong recommendations, which would create a consensus for the methodology and the reporting of these studies.



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Evaluation of the quality of the reporting of phase II clinical trials in oncology: a systematic review

Publication date: Available online 10 March 2018
Source:Critical Reviews in Oncology/Hematology
Author(s): Romain Rivoirard, Julien Langrand-Escure, Mathieu Oriol, Fabien Tinquaut, Franck Chauvin, Chloé Rancoule, Nicolas Magné, Aurélie Bourmaud
ObjectiveTo describe the current state of knowledge concerning the quality of reporting in phase II clinical trials in oncology and to describe the various methods published allowing this quality evaluation.Methodsdatabases including MEDLINE and COCHRANE were searched. Reviews and meta-analyses analyzing the quality of the reporting of phase II trials in oncology were included. Descriptive analysis of the results was performed.ResultsThirteen publications were retained. Only 2 publications adopted a systematic approach of evaluation of the quality of reporting by overall scores. The Key Methodological Score (KMS), proposed by Grellety et al., gathering 3 items, seemed adapted for such an evaluation. A score of 3/3 was found in 16.1% of the 156 phase II trials analyzed by this score. The other reviews used a qualitative analysis to evaluate the reporting, via an analysis of a single criterion, generally the statistical plan of the study. This item was considered as having been correctly reported in less than 50% of the analyzed articles.ConclusionThe quality of reporting in phase II trials in oncology is a field that has been investigated very little (13 publications). When it is studied, the estimated level of quality is not satisfactory, whatever the method employed. The use of an overall score of evaluation is a path which should be pursued, in order to get reliable results. It also seems necessary to propose strong recommendations, which would create a consensus for the methodology and the reporting of these studies.



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Risk Stratification for Melanoma: Models Derived and Validated in a Purpose-Designed Prospective Cohort

Abstract

Background

Risk stratification can improve the efficacy and cost-efficiency of screening programs for early detection of cancer. We sought to derive a risk stratification tool for melanoma that was suitable for the general population using only self-reported information.

Methods

We used melanoma risk factor information collected at baseline from QSKIN, a prospective cohort study of Queensland adults age 40 to 69 years at recruitment (n = 41 954). We examined two separate outcomes: 1) invasive melanomas and 2) all melanomas (invasive + in situ) obtained through data linkage to the cancer registry. We used stepwise Cox proportional hazards modeling to derive the risk models in a randomly selected two-thirds sample of the data set and assessed model performance in the remaining one-third validation sample.

Results

After a median follow-up of 3.4 years, 655 (1.6%) participants developed melanoma (257 invasive, 398 in situ). The prediction model for invasive melanoma included seven terms. At baseline, the strongest predictors of invasive melanoma were age, sex, tanning ability, number of moles at age 21 years, and number of skin lesions treated destructively. The model for "all melanomas" (ie, invasive and in situ) included five additional terms. Discrimination in the validation data set was high for both models (C-index = 0.69, 95% confidence interval [CI] = 0.62 to 0.76, and C-index = 0.72, 95% CI = 0.69 to 0.75, respectively), and calibration was acceptable.

Conclusions

Such a tool could be used to target surveillance activities to those at highest predicted risk of developing melanoma over a median duration of 3.4 years.

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Coexistence of chronic myeloid leukemia and diffuse large B-cell lymphoma with antecedent chronic lymphocytic leukemia: a case report and review of the literature

Chronic lymphocytic leukemia and chronic myeloid leukemia are the most common types of adult leukemia. However, it is rare for the same patient to suffer from both. Richter's transformation to diffuse large B-...

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Literature Review of Spinal Cord Glioblastoma

Objectives: This systematic review aims to investigate spinal cord glioblastoma (scGBM) and correlations between patient traits and survival outcome, as well as differences in cohorts administered temozolomide or total resections, through an analysis of published cases reported up to October 2016. Methods: We obtained patient data by querying PubMed and Google Scholar with predetermined search terms and inclusion criteria that enabled the identification of relevant case reports. Survival was compared using Kaplan-Meier curves and log-rank analyses. Results: Of 153 patients with scGBM identified through a literature search, 135 met the predetermined search and inclusion criteria. Median overall survival (OS) for the resulting cohort was 12 (95% CI, 10-14) months. The female sex was found to significantly predict worse outcomes, and a sizable number of patients with long-term disease were found to have afflictions of the thoracic spinal cord. Neither the pediatric, temozolomide nor total resection subgroups had significantly improved survival characteristics, by log-rank analysis, relative to counterparts. Conclusions: These data elucidate the characteristics of patients with scGBM. For more sophisticated and in-depth analyses in the future, it is imperative that time-of-treatment information is recorded in future case reports. In addition, all case reports should be made available to prevent publication bias. J.J.T. and K.Z. contributed equally. Present address: Shiva Gautam, PhD, Department of Biostatistics, University of Florida College of Medicine Jacksonville, Jacksonville, FL. Supported in part by A Reason to Ride research fund. J.J.T.: study concept and design, acquisition of data, analysis and interpretation and critical revision of manuscript for intellectual content. K.Z., J.F., E.L.: acquisition of data, analysis, and interpretation. K.D.S.: analysis and interpretation, and critical revision of manuscript for intellectual content. S.G.: analysis and interpretation. E.T.W.: study concept and design, acquisition of data, analysis and interpretation, study supervision and critical revision of manuscript for intellectual content. E.T.W.: received research support from AstraZeneca, Cephalon, Eli Lilly, Northwest Biotherapeutics, Novartis, Novocure, Pfizer, Plexxicon, and Tocagen. K.D.S.: received research support from Novocure and Tocagen. The remaining authors declare that they have nothing to disclose. Reprints: Eric T. Wong, MD, Brain Tumor Center & Neuro-Oncology Unit, Department of Neurology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215. E-mail: ewong@bidmc.harvard.edu. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.

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Literature Review of Spinal Cord Glioblastoma

Objectives: This systematic review aims to investigate spinal cord glioblastoma (scGBM) and correlations between patient traits and survival outcome, as well as differences in cohorts administered temozolomide or total resections, through an analysis of published cases reported up to October 2016. Methods: We obtained patient data by querying PubMed and Google Scholar with predetermined search terms and inclusion criteria that enabled the identification of relevant case reports. Survival was compared using Kaplan-Meier curves and log-rank analyses. Results: Of 153 patients with scGBM identified through a literature search, 135 met the predetermined search and inclusion criteria. Median overall survival (OS) for the resulting cohort was 12 (95% CI, 10-14) months. The female sex was found to significantly predict worse outcomes, and a sizable number of patients with long-term disease were found to have afflictions of the thoracic spinal cord. Neither the pediatric, temozolomide nor total resection subgroups had significantly improved survival characteristics, by log-rank analysis, relative to counterparts. Conclusions: These data elucidate the characteristics of patients with scGBM. For more sophisticated and in-depth analyses in the future, it is imperative that time-of-treatment information is recorded in future case reports. In addition, all case reports should be made available to prevent publication bias. J.J.T. and K.Z. contributed equally. Present address: Shiva Gautam, PhD, Department of Biostatistics, University of Florida College of Medicine Jacksonville, Jacksonville, FL. Supported in part by A Reason to Ride research fund. J.J.T.: study concept and design, acquisition of data, analysis and interpretation and critical revision of manuscript for intellectual content. K.Z., J.F., E.L.: acquisition of data, analysis, and interpretation. K.D.S.: analysis and interpretation, and critical revision of manuscript for intellectual content. S.G.: analysis and interpretation. E.T.W.: study concept and design, acquisition of data, analysis and interpretation, study supervision and critical revision of manuscript for intellectual content. E.T.W.: received research support from AstraZeneca, Cephalon, Eli Lilly, Northwest Biotherapeutics, Novartis, Novocure, Pfizer, Plexxicon, and Tocagen. K.D.S.: received research support from Novocure and Tocagen. The remaining authors declare that they have nothing to disclose. Reprints: Eric T. Wong, MD, Brain Tumor Center & Neuro-Oncology Unit, Department of Neurology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215. E-mail: ewong@bidmc.harvard.edu. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.

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Assessing Key Stakeholders’ Knowledge, Needs, and Preferences for Head and Neck Cancer Survivorship Care Plans

Abstract

Cancer survivorship care plans (SCPs) are endorsed to support quality care for cancer survivors, but uptake is slow. We assessed knowledge, needs, and preferences for SCP content and delivery from a wide variety of stakeholders. We focused SCP content for head and neck cancer as it is a disease prone to long-term side effects requiring management from multiple providers. We conducted telephone-based, qualitative interviews. We purposively sampled head and neck cancer survivors (n = 4), primary care physicians in the community (n = 5), and providers affiliated with a large academic medical center (n = 5) who treat head and neck cancer, cancer specialists (n = 6), and nurse practitioners/supportive care staff (n = 5). Interviews were recorded, transcribed, and analyzed using direct content analysis. Few participants reported personal experience with SCPs, but most supported the concept. Several key themes emerged: (1) perceived ambiguity regarding roles and responsibilities for SCPs, (2) a need to tailor the content and language based on the intended recipient, (3) documentation process should be as automated and streamlined as possible, (4) concerns about using the SCP to coordinate with outside providers, and (5) that SCPs would have added value as a "living document." We also report SCP-related issues that are unique to serving patients diagnosed with head and neck cancer. Effort is needed to tailor SCPs for different recipients and optimize their potential for successful implementation, impact on care outcomes, and sustainability. Many cancer survivors may not receive a SCP as part of routine care. Survivors could engage their health care team by requesting a SCP.

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