A Methodology for Successfully Producing Global Translations of Patient Reported Outcome Measures for Use in Multiple Countries

The production of accurate and culturally relevant translations of patient reported outcome (PRO) measures is essential for the success of international clinical trials. Although there are many reports in publication regarding the translation of PRO measures, the techniques used to produce single translations for use in multiple countries (global translations) are not well documented. This article addresses this apparent lack of documentation and presents the methodology used to create global translations of the Chronic Liver Disease Questionnaire—Hepatitis C Virus (CLDQ-HCV). The challenges of creating a translation for use in multiple countries are discussed, and the criteria for a global translation project explained. Based on a thorough translation and linguistic validation methodology including a concept elaboration, multiple forward translations, two back translations, reviews by in-country clinicians and the instrument developer, pilot testing in each target country and multiple sets of proofreading, the key concept of the global translation methodology is consistent international harmonization, achieved through the involvement of linguists from each target country at every stage of the process. This methodology enabled the successful resolution of the translation issues encountered, and resulted in consistent translations of the CLDQ-HCV that were linguistically and culturally appropriate for all target countries.     

Ischaemic strokes: management in first six hours.

Cerebrovascular disease (CVD) or stroke is one of the foremost causes of high morbidity and mortality for many nations of the world, posing a major socio-economic challenge in the occupational and neuro-rehabilitational programmes of the 'stroke-survivors'. For example, in USA alone it has been estimated that a sum of 3261 million dollars is spent as direct cost for treatment, in addition to 4104 million dollars as indirect costs, consequent on economic losses of 'stroke victims'. Thus, the new concept in stroke pathophysiology and strategies for stroke prevention have assumed global importance. Among all risk factors for strokes, hypertension is one of the most important and treatable factor. Community screening surveys, by well defined WHO protocol, have shown that nearly 15% of urban population is hypertensive (160/95 mm Hg or more). Though high blood pressure has the highest attributable risk for stroke, there are many other reasons such as patient's compliance in taking medicine and poor followup in clinical practice that may lead to failure in reducing stroke mortality. In subjects, who have transient ischaemic attacks (TIAs), regular use of antiplatelet agents like aspirin is well established in prevention of stroke. It is also mandatory to prohibit tobacco use and adjust dietary habits to control body weight. Associated conditions like diabetes mellitus etc. should also be treated. It is advisable to initiate community screening surveys on well defined populations for early detection of hypertension and TIAs. Primary health care centres should be the base stations for these surveys, because data gathered from urban hospitals will not truly reflect the crude prevalence rates for the community to design practical prevention programmes.     

Obesity surgery makes patients healthier and more functional: real world results from the United Kingdom National Bariatric Surgery Registry

Background

The National Bariatric Surgery Registry (NBSR) is the largest bespoke database in the field in the United Kingdom.

Monitoring for and Characterizing Crizotinib Progression: A Chart Review of <Emphasis Type="Italic">ALK</Emphasis>-Positive Non-Small Cell Lung Cancer Patients

Introduction

Crizotinib is recommended as first-line therapy for ALK-positive non-small cell lung cancer (NSCLC), but within a year of treatment initiation many patients develop resistance. With the recent approval of second-generation ALK inhibitors, this study assessed how physicians monitor for and diagnose progression and how they alter treatment following progression on crizotinib.

Methods

A panel of oncologists from the United States were surveyed regarding their monitoring practices and criteria for diagnosing progression on crizotinib. The physicians also retrospectively provided data (March–June 2016) from the medical charts of their adult patients with locally advanced or metastatic ALK-positive NSCLC who progressed on crizotinib after the approval (April 2014) of the first second-generation ALK inhibitor, ceritinib.

Results

A total of 28 physicians responded to the survey. Data was abstracted on 74 patients. In the physician survey, most physicians (71%) reported monitoring for radiographic progression every 3–4 months. When new lesions were detected, physician response varied. Following a symptomatic isolated lesion, most physicians (75%) would add local therapy and resume crizotinib. Following multiple symptomatic lesions, 96% and 64% of physicians would switch to a new therapy depending on whether the lesions were extracranial or isolated to the brain, respectively. For the patient cohort, physician-defined progression on crizotinib was diagnosed after a median of 10 months, and within 30 days of diagnosis, 86% of patients discontinued crizotinib. Among all patients who discontinued crizotinib, 77% switched to ceritinib, 14% to chemotherapy, and 1% to alectinib. The remaining 7% did not receive additional systemic antineoplastic therapy.

Conclusion

The findings from this physician survey and retrospective chart review study suggest that physician response to the development of new lesions in crizotinib-treated ALK-positive NSCLC patients varies with location and extent of the lesions. Once patients were considered to have progressed, most of them were immediately switched to ceritinib.

Funding

Novartis Pharmaceuticals Corporation.