Sensitivity to change of health status measures in a randomized controlled trial: comparison of the COOP charts and the SF-36

Abstract

This study compared the sensitivity to change of comparable dimensions of a multi-item multi-dimensional health status measure (the SF-36) with the equivalent single item domains on the Dartmouth COOP charts. One hundred and twenty nine patients were randomized to either day case laparoscopic surgery (n = 60) or open inguinal hernia repair (n = 69). Respondents completed the SF-36 and COOP charts at baseline (prior to surgery) and at follow up at 10 days and 6 weeks. Equivalent dimensions of physical functioning, mental health/emotional condition, social activities, pain and overall condition/general health on the two questionnaires were compared. Despite slightly different pictures of change provided by the physical functioning and 'overall condition/general health' dimensions the general picture of change provided by the two instruments was similar. At 10 days, patients who underwent open surgery reported far greater levels of dysfunction than those who underwent laparoscopic surgery on both questionnaires. At 6 weeks the pain dimension of both questionnaires indicated a large improvement from baseline, whilst no other domain on either questionnaire for either group indicated such improvement. The general picture of change provided by the two measures was similar. The results suggest that both the SF-36 and the COOP charts may prove suitable for the assessment of health perception outcomes in surgical clinical trials. Differences on certain domains were caused in large measure by the nature of the questions posed. The study once again highlights the importance of checking item content to determine the suitability of any particular measure for a given study.

Health-related quality of life in patients with chronic hepatitis C and advanced fibrosis

“…The SF-36 has demonstrated consistently high reliability and validity in a variety of patient populations [24,[26][27][28][29]. SF-36 scales have been used to evaluate change in health-status over time in several studies [30][31][32][33], including therapeutic trials of chronic hepatitis C [7,12,13,15,17,18,[34][35][36][37][38][39].…”

Health-related quality-of-life changes after laparoscopic and open incisional hernia repair

“…Study patients were evaluated 16 months (range, [12][13][14][15][16][17][18][19][20][21][22][23][24][25] after LHR and 28 months (range, 18-52) after OHR, respectively (p < 0.05; Table 1). In addition to being matched for age and gender, LHR and OHR patients were comparable with regard to BMI, ASA classification, incidence of diabetes and chronic obstructive lung disease, defect size, obstruction ileus, operation time, hernia recurrence, and length of hospital stay.…”

Comparison of a single global item and an index of a multi-item health status measure among persons with and without diabetes in the US

“…Following standard convention that is used in formulating summary measures of health status that are based on a preference-based conceptual model [19,34], NHEFS-HUI scores are scaled along a continuum from death (0) to optimal health (10). In this study the NHEFS-HUI scores ranged from )0.17 to 1.0.…”

“…These correlations have been interpreted as being sufficient [8] to suggest to some investigators [9][10][11][12] that the single global item can, under certain circumstances, be an adequate substitute for a multi-item assessment. The most obvious benefit of such a substitution would be a significant reduction in 'respondent burden'.…”