Interpretation of Changes in Health-related Quality of Life: The Remarkable Universality of Half a Standard Deviation

Background. A number of studies have computed the minimally important difference (MID) for health-related quality of life instruments. Objective. To determine whether there is consistency in the magnitude of MID estimates from different instruments. Methods. We conducted a systematic review of the literature to identify studies that computed an MID and contained sufficient information to compute an effect size (ES). Thirty-eight studies fulfilled the criteria, resulting in 62 ESs. Results. For all but 6 studies, the MID estimates were close to one half a SD (mean = 0.495, SD = 0.155). There was no consistent relationship with factors such as disease-specific or generic instrument or the number of response options. Negative changes were not associated with larger ESs. Population-based estimation procedures and brief follow-up were associated with smaller ESs, and acute conditions with larger ESs. An explanation for this consistency is that research in psychology has shown that the limit of people’s ability to discriminate over a wide range of tasks is approximately 1 part in 7, which is very close to half a SD. Conclusion. In most circumstances, the threshold of discrimination for changes in health-related quality of life for chronic diseases appears to be approximately half a SD.

[1]  G. A. Miller THE PSYCHOLOGICAL REVIEW THE MAGICAL NUMBER SEVEN, PLUS OR MINUS TWO: SOME LIMITS ON OUR CAPACITY FOR PROCESSING INFORMATION 1 , 1956 .

[2]  E B Keeler,et al.  Does free care improve adults' health? Results from a randomized controlled trial. , 1983, The New England journal of medicine.

[3]  E. Keeler,et al.  Does free care improve adults' health? , 1984, The New England journal of medicine.

[4]  M. Testa Interpreting quality-of-life clinical trial data for use in the clinical practice of antihypertensive therapy. , 1987, Journal of hypertension. Supplement : official journal of the International Society of Hypertension.

[5]  Lewis E. Kazis,et al.  Effect Sizes for Interpreting Changes in Health Status , 1989, Medical care.

[6]  A. Stewart,et al.  Functional status and well-being of patients with chronic conditions. Results from the Medical Outcomes Study. , 1989, JAMA.

[7]  G. Guyatt,et al.  Measurement of health status. Ascertaining the minimal clinically important difference. , 1989, Controlled clinical trials.

[8]  N. Jacobson,et al.  Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. , 1991, Journal of consulting and clinical psychology.

[9]  S. Ziebland,et al.  Importance of sensitivity to change as a criterion for selecting health status measures. , 1992, Quality in health care : QHC.

[10]  P. Tugwell,et al.  Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. , 1993, The Journal of rheumatology.

[11]  G H Guyatt,et al.  Determining a minimal important change in a disease-specific Quality of Life Questionnaire. , 1994, Journal of clinical epidemiology.

[12]  G. Guyatt,et al.  Randomised controlled trial of respiratory rehabilitation , 1994, The Lancet.

[13]  D. Postma,et al.  Quality of Life in Patients With Chronic Obstructive Pulmonary Disease Improves After Rehabilitation at Home , 1995 .

[14]  D. Postma,et al.  Long term benefits of rehabilitation at home on quality of life and exercise tolerance in patients with chronic obstructive pulmonary disease. , 1995, Thorax.

[15]  D. Tulsky,et al.  Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument. , 1995, Lung cancer.

[16]  G. Guyatt,et al.  Randomized Controlled Trial of Respiratory Rehabilitation , 1995 .

[17]  P. Stratford,et al.  Defining the minimum level of detectable change for the Roland-Morris questionnaire. , 1996, Physical therapy.

[18]  J. Wright,et al.  The minimal important difference: who's to say what is important? , 1996, Journal of clinical epidemiology.

[19]  G. Guyatt,et al.  Assessing the minimal important difference in symptoms: a comparison of two techniques. , 1996, Journal of clinical epidemiology.

[20]  M Johannesson,et al.  Interpretation of change scores in ordinal clinical scales and health status measures: the whole may not equal the sum of the parts. , 1996, Journal of clinical epidemiology.

[21]  D A Redelmeier,et al.  Interpreting small differences in functional status: the Six Minute Walk test in chronic lung disease patients. , 1997, American journal of respiratory and critical care medicine.

[22]  P. Jones,et al.  Quality of life changes in COPD patients treated with salmeterol. , 1997, American journal of respiratory and critical care medicine.

[23]  J. G. Douglas,et al.  Quality of life and hospital re-admission in patients with chronic obstructive pulmonary disease. , 1997, Thorax.

[24]  S. Heald,et al.  The shoulder pain and disability index: the construct validity and responsiveness of a region-specific disability measure. , 1997, Physical therapy.

[25]  J. O'fallon,et al.  Randomized comparison of four tools measuring overall quality of life in patients with advanced cancer. , 1998, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[26]  R. Keller,et al.  Comparative responsiveness of generic versus disease-specific and weighted versus unweighted health status measures in carpal tunnel syndrome. , 1998, Medical care.

[27]  G. Guyatt,et al.  Quality of life in patients with chronic respiratory disease: the Spanish version of the Chronic Respiratory Questionnaire (CRQ) , 1998, The European respiratory journal.

[28]  P. Jones,et al.  Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease , 1999, Thorax.

[29]  J. Bernstein,et al.  Treatment of chronic rhinitis by an allergy specialist improves quality of life outcomes. , 1999, Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology.

[30]  A. Feinstein Indexes of contrast and quantitative significance for comparisons of two groups. , 1999, Statistics in medicine.

[31]  W. Tierney,et al.  Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. , 1999, Journal of clinical epidemiology.

[32]  T. Wagner,et al.  Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL) , 1999, Urology.

[33]  R. Doughty,et al.  Measuring health-related quality of life. , 1999, The New Zealand medical journal.

[34]  J Zhang,et al.  What are minimal important changes for asthma measures in a clinical trial? , 1999, The European respiratory journal.

[35]  W M Tierney,et al.  Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. , 1999, Medical care.

[36]  D. Redelmeier,et al.  Quality of life and utility in irradiated laryngeal cancer patients. , 2000, International journal of radiation oncology, biology, physics.

[37]  M. Decramer,et al.  Short- and long-term effects of outpatient rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. , 2000, The American journal of medicine.

[38]  M. Testa,et al.  Interpretation of quality-of-life outcomes: issues that affect magnitude and meaning. , 2000, Medical care.

[39]  D. Podzamczer,et al.  Evaluating changes in health status in HIV-infected patients: Medical Outcomes Study-HIV and Multidimensional Quality of Life-HIV quality of life questionnaires , 2000, AIDS.

[40]  Deborah M. Miller,et al.  Clinical significance of the multiple sclerosis functional composite: relationship to patient-reported quality of life. , 2000, Archives of neurology.

[41]  J. Ware,et al.  Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis. , 2000, Arthritis and rheumatism.

[42]  C. Seal,et al.  The short inflammatory bowel disease questionnaire is reliable and responsive to clinically important change in ulcerative colitis , 2001, American Journal of Gastroenterology.

[43]  F Angst,et al.  Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. , 2001, Arthritis and rheumatism.

[44]  G. Guyatt,et al.  Relation of Distribution- and Anchor-Based Approaches in Interpretation of Changes in Health-Related Quality of Life , 2001, Medical care.

[45]  C. Bombardier,et al.  Looking for important change/differences in studies of responsiveness. OMERACT MCID Working Group. Outcome Measures in Rheumatology. Minimal Clinically Important Difference. , 2001, The Journal of rheumatology.

[46]  M. Hyland,et al.  A comparison of three disease-specific and two generic health-status measures to evaluate the outcome of pulmonary rehabilitation in COPD. , 2001, Respiratory medicine.

[47]  I. Wiklund,et al.  Quality of life in patients with endoscopy-negative heartburn: reliability and sensitivity of disease-specific instruments , 2001, American Journal of Gastroenterology.

[48]  S. Colletta,et al.  Structured exercise improves physical functioning in women with stages I and II breast cancer: results of a randomized controlled trial. , 2001, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[49]  Gordon H Guyatt,et al.  Methods to explain the clinical significance of health status measures. , 2002, Mayo Clinic proceedings.

[50]  G. Stucki,et al.  Minimal clinically important rehabilitation effects in patients with osteoarthritis of the lower extremities. , 2002, The Journal of rheumatology.

[51]  L. Nail,et al.  Measurement of fatigue: Determining minimally important clinical differences , 2002 .

[52]  P. Jones Interpreting thresholds for a clinically significant change in health status in asthma and COPD , 2002, European Respiratory Journal.

[53]  Tara Symonds,et al.  Assessing clinical significance in measuring oncology patient quality of life: introduction to the symposium, content overview, and definition of terms. , 2002, Mayo Clinic proceedings.

[54]  D. Cella,et al.  What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592. , 2002, Journal of clinical epidemiology.

[55]  D. Cella,et al.  Meaningful change in cancer-specific quality of life scores: Differences between improvement and worsening , 2002, Quality of Life Research.

[56]  G. Guyatt,et al.  Measuring quality of life in children with asthma , 1996, Quality of Life Research.

[57]  R. Epstein,et al.  Interpretation of quality of life changes , 1993, Quality of Life Research.

[58]  W. Tierney,et al.  Using the standard error of measurement to identify important changes on the Asthma Quality of Life Questionnaire , 2002, Quality of Life Research.

[59]  C. McHorney,et al.  Individual-patient monitoring in clinical practice: are available health status surveys adequate? , 1995, Quality of Life Research.