Half standard deviation estimate of the minimally important difference in HRQOL scores?

References

• Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. I Clin. Epi 56, 395–407 (2003).
   Google Scholar
• ••Provides a comprehensive overview of theconcept of clinically meaningful differences in health-related quality of life.
   Google Scholar
• Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR. Clinical Significance Consensus Meeting Group. Methods to explain the clinical significance of health status measures. Mayo Clin. Proc.77, 371–383 (2002).
   Google Scholar
• ••Reviews in detail the various methods that can be used to estimate clinically significant differences.
   Google Scholar
• Norman GR, Sloan JA, Wyrwich KW Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med. Care 41, 582–592 (2003).
   PubMed Web of Science ®Google Scholar
• ••Examines the existing literature andconcludes that the minimally important difference was close to a half standard deviation.
   Google Scholar
• Hays RD, Hadorn D. Responsiveness to change: an aspect of validity, not a separate dimension. Qual. Life Res. 1, 73–75 (1992).
   PubMedGoogle Scholar
• Kosinski M, Zhao SZ, Dedhiya S, Osterhaus JT, Ware JE. Determining the minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis. Arthritis Rheum. 43, 1478–1487 (2000).
   Google Scholar
• ••Uses five different anchors to estimate theminimally important differences for the SF-36 in a clinical trial of people with rheumatoid arthritis.
   Google Scholar
• Beusterien KM, Nissenson AR, Port FK, Kelly M, Steinwald B, Ware JE. The effects of recombinant human erythropoietin on functional health and well being in chronic dialysis patients. j Am. Soc. Neph. 7, 763–773 (1996).
   PubMed Web of Science ®Google Scholar
• Hays RD, Woolley JM. The concept of clinically meaningful difference in health-related quality-of-life research: how meaningful is it? PharmacoEconomics 18, 419–423 (2000).
   PubMed Web of Science ®Google Scholar
• Cohen J. A power primer. Psycho]: Bull. 112,155–159 (1992).
   PubMed Web of Science ®Google Scholar
• Jones PW, Bosh TK. Quality of life changes in COPD patients treated with salmeterol. Am. I Resp. Crit. Care Mea'. 155, 1283–1289 (1997).
   PubMed Web of Science ®Google Scholar
• Bagenstose SE, Bernstein JA. Treatment of chronic rhinitis by an allergy specialist improves quality of life outcomes. Ann. Allergy Asthma Immunol 83,524–528 (1999).
   PubMed Web of Science ®Google Scholar
• Bestall JC, Paul EA, Garrod R, Garnham R, Joes PW, Wedzicha JA. Usefulness of the medical research council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax 54,581–586 (1999).
   PubMed Web of Science ®Google Scholar
• Miller DM, Rudick RA, Cutter G, Baier M, Fischer JS. Clinical significance of the multiple sclerosis functional composite: relationship to patient-reported quality of life. Arch. Neurol 57,1319–1324 (2000).
   Google Scholar
• Singh SJ, Sodergren SC, Hyland ME, Williams J, Morgan MDL. A comparison of three disease-specific and two generic health-status measures to evaluate the outcome of pulmonary rehabilitation in COPD. Resp. Med. 95,71–77(2001).
   Google Scholar
• Talley NJ, Fullerton S, Junghard O, Wiklund I. Quality of life in patients with endoscopy-negative heartburn: reliability and sensitivity of disease-specific instruments. Am. j Gastroenterol 96, 1998–2004 (2001).
   PubMed Web of Science ®Google Scholar
• Cella DF, Bonomi AE, Lloyd SR, Tulsky DS, Kaplan E, Bonomi P. Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument. Lung Canwr12, 199–220 (1995).
   PubMed Web of Science ®Google Scholar
• Cella D, Hahn EA, Dineen K. Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening. Qua]: Life Res. 11,207–221 (2002).
   PubMed Web of Science ®Google Scholar
• Wyrwich KW, Tierney WM, Wolinsky FD. Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J. Clin. Epi. 52,861–873 (1999).
   Google Scholar
• Wyrwich KW, Nienaber NA, Tierney WM, Wolinsky FD. Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. Med. Care 37,469–478 (1999).
   PubMed Web of Science ®Google Scholar
• Redelmeier DA, Bayoumi AM, Goldstein RS, Guyatt GH. Interpreting small differences in functional status: the 6-minute walk test in chronic lung disease patients. Am. j Resp. Crit. Care Med. 155, 1278–1282 (1997).
   Google Scholar
• Badia, X, Podzamczer D, Casado A, Lopez-Lavid C, Garcia M, Spanish MOS-HIV and MQOL-HIV Validation Group. Evaluating changes in health status in HIV-infected patients: Medical Outcomes Study-HIV and Multidimensional Quality of Life-HIV quality of life questionnaires. AIDS14,1439–1447 (2000).
   PubMed Web of Science ®Google Scholar
• Goldstein RS, Gort EH, Stubbing D, Avendano MA, Guyatt GH. Randomised controlled trial of respiratory rehabilitation. Lancet344, 1394–1397 (1994).
   Google Scholar
• Jowett SL, Seal CJ, Barton R, Welfare MR. The short inflammatory bowel disease questionnaire is reliable and responsive to clinically important change in ulcerative colitis. Am.j Gastroenteml 96,2921–2928 (2001).
   PubMed Web of Science ®Google Scholar
• Osman LM, Godden DJ, Friend JAR, Legge JS, Douglas JG. Quality of life and hospital readmission in patients with chronic obstructive pulmonary disease. Thorax52, 67–71 (1997).
   Google Scholar
• Bessette L, Sangha O, Kuntz K et al Comparative responsiveness of generic versus disease-specific and weighted versus unweighted health status measures in carpal tunnel syndrome. Med. Care. 36,491–502 (1998).
   PubMed Web of Science ®Google Scholar
• van Doorslaer E, Jones AM. Inequalities in self-reported health: validation of a new approach to measurement. I Health Econ. 22,61–87 (2003).
   PubMed Web of Science ®Google Scholar
• Drummond M. Introducing economic and quality of life measurements into clinical studies. Ann. Med. 33(5), 344–349 (2001).
   PubMed Web of Science ®Google Scholar
• Fryback DG, Lawrence WF, Martin PA, Klein R, Klein BEK. Predicting Quality of Well-being scores from the SF-36: results from the Beaver Dam Health Outcomes Study. Med. Dec. Making / 7(1), 1–9 (1997).
   Google Scholar
• Kaplan RM. The minimally clinically important difference in generic utility-based measures. Prepared for the workshop on minimally clinically important differences in COPD. Bel Harbor, FL, USA. January 11–13 (2004).
   Google Scholar
• Pyne JM, Sullivan G, Kaplan R, Williams DK. Comparing the sensitivity of generic effectiveness measures with symptom improvement in persons with schizophrenia. Med. Cam 41 (2), 208–217 (2003).
   Google Scholar
• Walters SJ, Brazier JE. What is the relationship between the minimally important difference and health state utility values? The case of the SP-6D. Health Qua]: Life Outcomes1(1), 4(2003).
   Google Scholar
• King M, Dobson A. Estimating the responsiveness of an instrument using more than two repeated measures. Biometrics 56, 1197–1203 (2000).
   PubMed Web of Science ®Google Scholar
• Efron B. Bootstrap methods: another look at the jackknife. Ann. Stat. 7,1–26 (1979).
   Web of Science ®Google Scholar
• Kazis LE, Anderson JJ, Meenan RE Effect sizes for changes in health status. Med. Cam 27, S178—S189 (1989).
   Google Scholar
• Fitzpatrick R, Ziebland S, Jenkinson C, Mowat A, Mowat A. Importance of sensitivity to change as a criterion for selecting health status measures. Qua]: Health Cam 1,89–93 (1992).
   Google Scholar
• Wells GA, Tugwell P, Kraag GR, Baker PRA, Groh J, Redelmeier DA. Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. j Rheumatol 20,557–566 (1997).
   Google Scholar
• Juniper EF, Guyatt GH, Feeny DH, Ferrie PJ, Griffith LE, Townsend M. Measuring quality of life in children with asthma. Qual Life Res. 5,35–46 (1996).
   PubMed Web of Science ®Google Scholar
• Wijkstra PJ, Ten Vergert EM, van Altena R etal. Long-term benefits of rehabilitation at home on quality of life and exercise tolerance in patients with chronic obstructive pulmonary disease. Thorax 50, 824–828 (1995).
   PubMed Web of Science ®Google Scholar
• Juniper EF, Guyatt GH, Willan A, Griffith LE. Determining a minimal important change in a disease-specific quality of life questionnaire. j Clin. Epidemiol 47, 81–87 (1994).
   PubMed Web of Science ®Google Scholar
• Guell R, Casan P, Sangenis M, Morante F, Belda J, Guyatt GH. Quality of life in patients with chronic respiratory disease: the Spanish version of the chronic respiratory questionnaire. Eur. Respir.J11, 55–60 (1998).
   PubMed Web of Science ®Google Scholar
• Patrick DL, Martin ML, Bushnell DM, Yalcin L, Wagner TH, Buesching DR Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I- Q O L) . Urology 53,71–76 (1999).
   PubMed Web of Science ®Google Scholar
• Samsa G, Edelman D, Rothman ML, Williams GR, Lipscomb J, Matchar D. Determining clinically important differences in health status measures: a general approach with illustration to the health utilities index mark II. PharmacoEconomics 15,141–155 (1999).
   PubMed Web of Science ®Google Scholar
• Santanello NC, Zhang J, Seidenber B, Reiss TF, Barber BL. What are minimal important changes for asthma measures in a clinical trial? Eur. Resp. J 14,23–27 (1999).
   Google Scholar
• Troosters T, Gosselink R, Decramer M. Short- and long-term effects of outpatient rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Am. J Med. 109, 207–212 (2000).
   Google Scholar
• Angst F, Aeschlimann A, Stucki G. Smallest detectable and minimally 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. Arthritis Care Res. 45,384-391 (2001).
   Google Scholar
• Segal R, Evans W, Johnson D et al. Structured exercise improves physical functioning in women with states I and II breast cancer: results of a randomized controlled trial. J Clih. Oncol. 19, 657–665 (2001).
   PubMed Web of Science ®Google Scholar
• Cella D, Eton DT, Fairclough DL et al. What is a clinically meaningful change on the functional assessment of cancer therapy-lung (FACT-L) questionnaire? results from eastern co-operative oncology group (ECOG) study 5592. J Clin. Epidemiol. 37, 469–478 (2002).
   Google Scholar
• Angst F, Aeschlimann A, Michel BA et al. Minimal clinically important rehabilitation effects in patients with osteoarthritis of the lower extremities. J Rheumatol. 29, 131–138 (2002).
   PubMed Web of Science ®Google Scholar
• Wise EA. Methods for analyzing psychotherapy outcomes: a review of clinical significance, reliable change, and recommendations for future directions. J. Pers. Assess. 82,50–59 (2004).
   PubMedGoogle Scholar