Meta-analysis provides evidence-based interpretation guidelines for the clinical significance of mean differences for the FACT-G, a cancer-specific quality of life questionnaire

In this paper we present a new research paradigm for alternative, complementary, and holistic medicine — a low-cost, effective, and scientifically valid design for evidence-based medicine. Our aim is to find the simplest, cheapest, and most practical way to collect data of sufficient quality and validity to determine: (1) which kinds of treatment give a clinically relevant improvement to quality of life, health, and/or functionality; (2) which groups of patients can be aided by alternative, complementary, or holistic medicine; and (3) which therapists have the competence to achieve the clinically relevant improvements. Our solution to the problem is that a positive change in quality of life must be immediate to be taken as caused by an intervention. We define “immediate” as within 1 month of the intervention. If we can demonstrate a positive result with a group of chronic patients (20 or more patients who have had their disease or state of suffering for 1 year or more), who can be significantly helped within 1 month, and the situation is still improved 1 year after, we find it scientifically evidenced that this cure or intervention has helped the patients. We call this characteristic curve a “square curve”. If a global, generic, quality-of-life questionnaire like QOL5 or, even better, a QOL-Health-Ability questionnaire (a quality-of-life questionnaire combined with a self-evaluated health and ability to function questionnaire) is administered to the patients before and after the intervention, it is possible to document the effect of an intervention to a cost of only a few thousand Euros/USD. A general acceptance of this new research design will solve the problem that there is not enough money in alternative, complementary, and holistic medicine to pay the normal cost of a biomedical Cochrane study. As financial problems must not hinder the vital research in nonbiomedical medicine, we ask the scientific community to accept this new research standard.

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Evidence-Based Guidelines for Determination of Sample Size and Interpretation of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30

Journal of Clinical Oncology ◽

10.1200/jco.2010.28.0107 ◽

2011 ◽

Vol 29 (1) ◽

pp. 89-96 ◽

Cited By ~ 276

Author(s):

Kim Cocks ◽

Madeleine T. King ◽

Galina Velikova ◽

Marrissa Martyn St-James ◽

Peter M. Fayers ◽

...

Keyword(s):

Quality Of Life ◽

Sample Size ◽

Clinical Relevance ◽

Meta Analysis ◽

Performance Status ◽

Age Groups ◽

Life Questionnaire ◽

Quality Of Life Questionnaire ◽

European Organisation

Purpose To use published literature to estimate large, medium, and small differences in quality of life (QOL) data from the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Methods An innovative method combining systematic review of published studies, expert opinions, and meta-analysis was used to estimate large, medium, and small differences for QLQ-C30 scores. Published mean data were identified from the literature. Differences (contrasts) between groups (eg, between treatment groups, age groups, and performance status groups) were reviewed by 34 experts in QOL measurement and cancer treatment. The experts, blinded to actual QOL results, were asked to predict these differences. A large difference was defined as one representing unequivocal clinical relevance. A medium difference was defined as likely to be clinically relevant but to a lesser extent. A small difference was one believed to be subtle but nevertheless clinically relevant. A trivial difference was used to describe circumstances unlikely to have any clinical relevance. Actual QOL results were combined using meta-analytic techniques to estimate differences corresponding to small, medium, or large effects. Results Nine hundred eleven articles were identified, leading to 152 relevant articles (2,217 contrasts) being reviewed by at least two experts. Resulting estimates from the meta-analysis varied depending on the subscale. Thus, the recommended minimum to detect medium differences ranges from 9 (cognitive functioning) to 19 points (role functioning). Conclusion Guidelines for the size of effects are provided for the QLQ-C30 subscales. These guidelines can be used for sample size calculations for clinical trials and can also be used to aid interpretation of differences in QLQ-C30 scores.

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Adult carers quality of life questionnaire (AC-QoL): development of an evidence-based tool

Mental Health Review Journal ◽

10.1108/13619321211270380 ◽

2012 ◽

Vol 17 (2) ◽

pp. 57-69 ◽

Cited By ~ 17

Author(s):

Stephen Joseph ◽

Saul Becker ◽

Hannah Elwick ◽

Richard Silburn

Keyword(s):

Quality Of Life ◽

Evidence Based ◽

Life Questionnaire ◽

Quality Of Life Questionnaire

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Evidence-based guidelines for interpreting change scores for the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30

European Journal of Cancer ◽

10.1016/j.ejca.2012.02.059 ◽

2012 ◽

Vol 48 (11) ◽

pp. 1713-1721 ◽

Cited By ~ 164

Author(s):

K. Cocks ◽

M.T. King ◽

G. Velikova ◽

G. de Castro ◽

M. Martyn St-James ◽

...

Keyword(s):

Quality Of Life ◽

Evidence Based ◽

Life Questionnaire ◽

Change Scores ◽

Quality Of Life Questionnaire ◽

European Organisation ◽

Evidence Based Guidelines

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Magnitude of effect of asthma treatments on Asthma Quality of Life Questionnaire and Asthma Control Questionnaire scores: Systematic review and network meta-analysis

Journal of Allergy and Clinical Immunology ◽

10.1016/j.jaci.2015.03.023 ◽

2015 ◽

Vol 136 (4) ◽

pp. 914-922 ◽

Cited By ~ 36

Author(s):

Eric D. Bateman ◽

Dirk Esser ◽

Costel Chirila ◽

Maria Fernandez ◽

Andy Fowler ◽

...

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Asthma Control ◽

Meta Analysis ◽

Life Questionnaire ◽

Asthma Control Questionnaire ◽

Quality Of Life Questionnaire

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Alexithyme Patientenmerkmale und Lebensqualität – Eine Querschnittsstudie an 79 ambulanten Patienten mit Angststörungen

Zeitschrift für Psychiatrie Psychologie und Psychotherapie ◽

10.1024/1661-4747/a000136 ◽

2013 ◽

Vol 61 (1) ◽

pp. 17-26 ◽

Cited By ~ 2

Author(s):

Katrin Leenen ◽

Michael Rufer ◽

Hanspeter Moergeli ◽

Hans-Jörgen Grabe ◽

Josef Jenewein ◽

...

Keyword(s):

Quality Of Life ◽

World Health ◽

Life Questionnaire ◽

World Health Organization Quality ◽

Fand Sich ◽

Quality Of Life Questionnaire ◽

Organization Quality ◽

Health Organization ◽

Tas 20

Aus Untersuchungen in der Normalbevölkerung ist bekannt, dass Menschen mit erhöhten Alexithymiewerten eine verminderte Lebensqualität (LQ) aufweisen. Für Patienten mit psychischen Störungen wurde dieser Zusammenhang jedoch kaum untersucht. Ziel dieser Studie war es, den möglichen Zusammenhang zwischen alexithymen Patientenmerkmalen und der LQ bei Patienten mit Angststörungen zu überprüfen. Bei 79 ambulanten Patienten mit Angststörungen wurden alexithyme Charakteristika mit der Toronto Alexithymia Scale (TAS-20), die LQ mit der Kurzversion des World Health Organization Quality of Life Questionnaire 100 (WHOQOL-BREF) erfasst. Darüber hinaus fand eine Erhebung der psychischen Symptombelastung (SCL-90-R) und depressiven Symptomatik (MADRS) statt. Mittels hierarchischer Regressionsanalysen wurde der Zusammenhang zwischen der alexithymen Charakteristika und den unterschiedlichen LQ-Domänen berechnet. Die Patienten zeigten eine im Vergleich zur Normalbevölkerung deutlich verminderte LQ. Als Hauptergebnis fand sich, auch nach Kontrolle von Depression, Ängstlichkeit und Geschlecht, ein signifikanter Zusammenhang zwischen den beiden TAS-20 Subskalen Schwierigkeiten, Gefühle zu identifizieren und zu beschreiben und vor allem der psychischen LQ. Unsere Ergebnisse sprechen dafür, bei der Diagnostik und Therapieplanung von Patienten mit Angststörungen alexithyme Merkmale einzubeziehen. Im Falle von ausgeprägten alexithymen Merkmalen sollten psychotherapeutische Interventionen zur Verbesserung der Schwierigkeiten Gefühle wahrzunehmen und zu kommunizieren in Betracht gezogen werden.

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