Quality of life assessment in clinical trials—guidelines and a checklist for protocol writers: the U.K. Medical Research Council experience

doi:10.1016/S0959-8049(96)00412-1

European Journal of Cancer

Volume 33, Issue 1, January 1997, Pages 20-28

https://doi.org/10.1016/S0959-8049(96)00412-1 Get rights and content

Abstract

Many clinical trials groups now routinely consider including Quality of Life (QoL) assessment in trials. Indeed, several have policies stating that QoL should be considered as a potential endpoint in all new trials and that if it is not to be evaluated the applicants should justify not doing so. However, inclusion of QoL in clinical trials presents a number of difficult organisational issues, and serious problems in compliance have frequently been reported. Thus, in multicentre clinical trials many of the expected QoL questionnaires fail to be successfully completed and returned, although a few groups have claimed high success rates. However, it is well recognised that if questionnaires are missing, there may be bias in the interpretation of trial results, and the estimates of treatment differences and the overall level of QoL may be inaccurate and misleading. Hence it is important to seek methods of improving compliance, at the level of both the participating institution and the patient. We describe a number of methods for addressing these issues, which we suggest should be considered by all those writing clinical trial protocols involving QoL assessment. These are based upon over a decade of experience with assessing QoL in Medical Research Council (MRC) cancer clinical trials. In particular, we provide a checklist for points that should be covered in protocols. Examples are given from a range of current MRC Cancer Trials Office protocols, which it is proposed might act as templates when writing new protocols.

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Special paperQuality of life assessment in clinical trials—guidelines and a checklist for protocol writers: the U.K. Medical Research Council experience

Abstract

Ann Oncol

Eur J Cancer

Eur J Cancer

Eur J Cancer

Eur J Cancer

J Clin Epidemiol

J Clin Epidemiol

Editorial (unsigned): Quality of life and clinical trials

Lancet

Measuring and analysing quality of life in cancer clinical trials: a review

Stat Med

Survival, adverse reactions and quality of life during combination chemotherapy compared with selective palliative treatment for small-cell lung cancer. Report to the Medical Research Council by its Lung Cancer Working Party

Respir Med

Controlled trial of twelve versus six courses of chemotherapy in the treatment of small-cell lung cancer. Report to the Medical Research Council by its Lung Cancer Working Party

Br J Cancer

Assessment of quality of life in small-cell lung cancer using a Daily Diary Card developed by the Medical Research Council Lung Cancer Working Party

Br J Cancer

Inoperable non-small-cell lung cancer (NSCLC): a Medical Research Council randomised trial of palliative radiotherapy with two fractions or ten fractions. Report to the Medical Research Council by its Lung Cancer Working Party

Br J Cancer

A Medical Research Council (MRC) randomized trial of palliative radiotherapy with 2 fractions or a single fraction in patients with inoperable non-small-cell lung-cancer (NSCLC) and poor performance status

Br J Cancer

A randomised trial of three or six courses of etoposide, cyclophosphamide, methotrexate and vincristine or six courses of etoposide and ifosfamide in small cell lung cancer (SCLC). II: Quality of life

Br J Cancer

Randomised trial of four-drug vs less intensive two-drug chemotherapy in the palliative treatment of patients with small-cell lung cancer (SCLC) and poor prognosis

Br J Cancer

Randomized trial of palliative two-fraction versus more intensive 13-fraction radiotherapy for patients with inoperable nonsmall cell lung cancer and good performance status

Clin Oncol

MRC Quality of life studies using a Daily Diary Card—practical lessons learned from cancer trials

Qual Life Res

Measuring psychological and physical distress in cancer patients: structure and application of the Rotterdam Symptom Checklist

Br J Cancer

The Hospital Anxiety and Depression Scale

Acta Psychiatr Scand

The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology

J Natl Cancer Inst

Survey of the administration of quality of life (QL) questionnaires in three multicentre randomised trials in cancer

Special paper
Quality of life assessment in clinical trials—guidelines and a checklist for protocol writers: the U.K. Medical Research Council experience