Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire.

نویسندگان

  • Sieta T de Vries
  • Peter G M Mol
  • Dick de Zeeuw
  • Flora M Haaijer-Ruskamp
  • Petra Denig
چکیده

BACKGROUND Direct patient reporting of adverse drug events (ADEs) is relevant for the evaluation of drug safety. To collect such data in clinical trials and postmarketing studies, a valid questionnaire is needed that can measure all possible ADEs experienced by patients. OBJECTIVE Our aim was to develop and test a generic questionnaire to identify ADEs and quantify their nature and causality as reported by patients. METHODS We created a draft list of common ADEs in lay-terms, which were classified in body categories and mapped to the Medical Dictionary for Regulatory Activities (MedDRA(®)) terminology. Questions about the nature and causality were derived from existing questionnaires and causality scales. Content validity was tested through cognitive debriefing, revising the questionnaire in an iterative process. Feasibility and reliability were assessed using a Web-based version of the questionnaire. Patients received the questionnaire twice. Feasibility was assessed by the reported time needed for completion and ease of use. Reliability was calculated using Cohen's kappa and proportion of positive agreement (PPA) on: (1) any ADE at patient level; (2) similar ADEs at MedDRA(®) System Organ Class level; and (3) the same ADE at ADE-specific level. RESULTS In the development phase, 28 patients with type 2 diabetes or asthma/chronic obstructive pulmonary disease (COPD) participated. Questions and answer options were rephrased, layout was improved, and changes were made in the classification of ADEs. The final questionnaire consisted of 252 ADEs organized in 16 body categories, and included 14 questions per reported ADE. A total of 135 patients using a median of five different drugs completed the Web-based questionnaire twice. The median completion time was 15 min for patients not reporting any ADE, and 30 min for patients reporting at least one ADE. Three quarters of the patients found the questionnaire easy to use. Test-retest reliability was acceptable at patient level (κ = 0.50, PPA 0.64) and at MedDRA(®) System Organ Class level (κ = 0.52, PPA 0.54), but was low at ADE-specific level (κ = 0.38, PPA 0.38). CONCLUSION We developed a generic patient-reported ADE questionnaire and confirmed its content validity. The questionnaire was feasible and reliable for reporting any ADE and similar ADEs at MedDRA(®) System Organ Class level. Additional work is, however, needed to reliably quantify specific ADEs reported by patients.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Development and Initial Validation of the Scale of Knowledge, Attitude, Intention and Performance in Drug Abuse in Iranian Elderly Society

Objective: The present study aimed to develop and initially validate the scale of awareness) knowledge(, attitude, intention and performance in elderly with a history of drug substance in Iranian society in 2018. Method: This research was descriptive-correlational of instrument validation type. The statistical population included all elderly addicts referring to the center for rural health soci...

متن کامل

Relationship between Patient Safety Culture and Adverse Events in Hospital: A case study

Abstract Introduction: Patient safety culture is an important factor in reducing hospital's adverse event and improving patient safety. The aim of this study was to evaluate the relationship between patient safety culture and adverse events in hospitals of Hamadan city. Methods: The present study was a descriptive-analytical study which was performed in hospitals of Hamadan in 2018. The stu...

متن کامل

مقایسه روشهای اپیدمیولوژیک در شناسایی سیگنالهای عوارض دارویی ایران

Background and Objectives:To compare three different methods of signal detection applied to the Adverse Drug Reactions registered in the Iranian Pharmacovigilance database from 1998 to 2005. Materials and Methods:All Adverse Drug Reactions (ADRs) reported to Iranian Pharmacovigilance Center from March 1998 through January 2005, were included in the analysis. The data were analyzed based on thre...

متن کامل

طراحی و روش نمونه‌گیری مطالعه آگاهی، نگرش و عملکرد خانوارها و کارکنان بهداشتی در خصوص تغذیه و ریزمغذیها در استانهای پایلوت برنامه

Background and Objectives:To compare three different methods of signal detection applied to the Adverse Drug Reactions registered in the Iranian Pharmacovigilance database from 1998 to 2005. Materials and Methods:All Adverse Drug Reactions (ADRs) reported to Iranian Pharmacovigilance Center from March 1998 through January 2005, were included in the analysis. The data were analyzed based on thr...

متن کامل

Assessing coaching moral competences: Development and initial validation of the Coaching Fairplay Behaviors Inventory

The purpose of the present investigation was to develop and initial validation of a measure for assessing the athletes perceptions of coaches’ behaviors that promote fairplay behaviors. A three-step procedure was undertaken to develop the questionnaire. In the initial step, the literature review provided theoretical and empirical perspectives on how youth sport coaches can influence athletes’ f...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:
  • Drug safety

دوره 36 9  شماره 

صفحات  -

تاریخ انتشار 2013