Studies using the SF-36

The Short Form – 36 is a generic health survey that provides QoL information and is designed for self-completion (Ware & Sherbourne, 1992). It is possibly the most widely evaluated tool and has proven validity and reliability (Garratt et al, 2002). Completion produces a range of scores across eight domains with lower scores indicating more limited functioning in that area; in contrast to the scoring range of the NHP. Five of the selected studies used the SF-36 in order to evaluate the QoL of their participants with CVLU (Charles, 1995; Chase et al, 2000; Franks et al, 2003; Jull et al, 2004; Faria et al, 2011). The studies range over a period of 16 years (1995 – 2011) and include a total sample size of 829 participants. Two studies (Franks et al, 2003; Jull et al, 2004) utilised a control group in order to demonstrate comparisons, whereas the remaining three studies used Age Equivalent Norms (AEN) of various origins (other studies, gender or country specific). A meta- analysis of three studies has been possible (Charles, 1995; Franks et al, 2003; Jull et al, 2004).

Scores are recorded in table 6 overleaf. The range of control and AEN scores show considerable variation but still serve to demonstrate the consistently lower scores, and hence compromised QoL, across all domains for the participants with CVLU. In some of the more recent studies composite scores were calculated to indicate overall physical and mental component scoring (PCS and MCS), however since these were not available for four of the selected studies they have not been utilised.

Two of the studies (Charles, 1995; Franks et al, 2003) recoded SF-36 scores at entry to the study and after 12 weeks in order to observe for improvements over time and with healing. The remaining three studies applied the SF-36 on a single occasion.

Table 6: SF-36 Mean domain scores.

Charles (1995) Chase et al

(2000)

Franks et al (2003) Jull et al (2004) Faria et al (2011)

SF-36 Domains Entry Exit AEN Study AEN Entry Exit Control Study Control Study Control

Physical function 44.3 45.1 59.0 56.2 84.2 29.1 31.1 50.7 49.5 75.7 48.68 80.06 Role-physical 35.4 38.5 54.0 67.9 81.0 41.8 40.3 63.0 43.2 72.7 22.5 75.31 Bodily pain 45.0 61.8 60.0 75.5 75.2 53.9 56.0 65.5 55.3 72.9 57.81 72.29 General Health 61.9 61.4 58.0 72.7 72.0 55.3 54.4 58.2 59.2 73.5 66.18 73.13 Vitality 44.8 49.4 60.0 50.0 69.9 45.9 45.9 48.7 53.2 67.6 59.37 70.75 Social functioning 49.7 59.8 76.0 83.9 83.3 57.3 55.6 78.6 69.9 87.6 56.25 81.60 Role-emotional 44.6 52.3 73.0 81.0 81.3 58.1 59.5 84.9 68.9 85.3 41.61 80.34 Mental health 62.5 68.1 68.0 80.0 74.1 69.1 67.5 73.2 76.2 82.2 64.9 71.94

Physical functioning explored limitations to performing physical activities such as washing and dressing and was limited across all five of the included studies, with mean scores being consistently below their comparators; this was also the case where scoring had been repeated at 12 weeks and even in the event of healing (Charles, 1995; Franks et al, 2003). The role-physical domain refers to problems working or with other daily activities due to physical health and was diminished across all

studies. Bodily pain refers to extremely debilitating pain and was significant for all participants across four of the five studies, with the exception of Chase et al (2000).

Where the study was conducted over 12 weeks, improvements in bodily pain were demonstrated irrespective of healing. General health was the least compromised of the eight health domains; indeed Charles (1995) and Chase et al (2000) demonstrated improved scores for their participants when compared with the AENs selected. General health was most compromised for the participants of Jull et al’s (2004) study, which demonstrated a mean 14 points below their selected AEN. The vitality score represents energy levels for the respondents. Vitality was compromised for participants in all studies, to varying degrees, which reflects consistently reduced energy reserves for this client group.

Social functioning reflects health interfering with the participant’s ability to socialise as they would like and was reduced for the participants of four of the studies. Chase et al (2000) was the only study that demonstrated higher scores for their respondents in the social functioning domain than their AEN. Role-emotional scores explore limitations to daily physical functioning due to the emotional effects of their illness and were compromised for all; again with Chase et al (2000) demonstrating the least compromised compared to their AEN. The final domain, mental health, explores feelings of nervousness and depression and in four of the five studies was compromised, with Chase et al (2000) again being the exception. Charles (1995) demonstrated an improvement in mental health over the 12 weeks of her study with the final score being above her AEN. In contrast, Franks et al (2003) demonstrated a reduction in the mental health score indicating deteriorating function over the 12 weeks of their study.

Overall, all five studies demonstrate reduced functioning across all eight domains and thus compromised QoL for those patients with CVLU. Improved care delivery and even healing did not consistently improve functioning that reflects the recurring and debilitating nature of this condition. Jull et al (2004) proposed that CVLU compromised health states in all areas by approximately 10%, effectively reflecting their compromised health state with this condition (Faria et al, 2011).

3.9.1.1

A meta-analysis refers to a statistical ‘pooling’ of data to allow for scores from a number of studies to be compared and contrasted in order to ascertain similarities or differences (Booth et al, 2012). In order for a meta-analysis to be undertaken, the studies need to be homogenous in terms of population, exposure, comparator and outcome (PECO) (NCCMT, 2012). For the quantitative studies reviewed here, only three demonstrated sufficient similarity in the reporting of data to be included in a meta-analysis (Charles, 1995; Franks et al, 2003; Jull et al, 2004). Review Manager 5.2, a computer package developed by the Cochrane Collaboration was utilised to undertake the meta-analysis (RevMan, 2012), with the output demonstrated in figure 7 overleaf.

Figure 7: Forest plot for SF36 Physical Functioning and Mental Health scores.

3.9.1.2 SF-36 QoL – Physical Functioning.

There were three studies in this analysis. The pooled mean difference for QoL physical functioning was -21.59 (95% CI: -27.96 to -15.22; p <0.00001). Therefore, QoL physical functioning was 21.59 lower in people with CVLU than those without and this effect was statistically significant at the p<0.05 level. There was moderate heterogeneity between the studies (I2 _{= 46%; p 0.16). All three}

studies had a lower mean QoL physical functioning in the CVLU patients than in those without ulcers, but the magnitude of this effect varied between studies.

3.9.1.3 SF-36 QoL – Mental Health.

There were three studies in this analysis. The pooled mean difference for QoL mental health was -5.42 (95% CI: -8.26 to -2.57; p 0.0002). Therefore, QoL mental health was 5.42 lower in people with CVLU than those without and this effect was statistically significant at the p<0.05 level. There was

low heterogeneity between the studies (I2 _{= 0%; p 0.85). All three studies had a lower mean QoL}

mental health in the CVLU patients than in those without ulcers, but the magnitude of this effect varied between studies.

3.9.1.4 Meta-analysis results overall.

Taking two outcomes for these three studies, demonstrated that the pooled mean difference for QoL in these areas was -12.72 (95% CI: -20.34 to -5.09; p 0.001). Therefore, both QoL physical functioning and mental health was 12.72 lower in people with CVLU than those without and this effect was statistically significant at the p<0.05 level. Overall, when these two outcomes were combined, there was high heterogeneity between the studies (I2 _{= 88%; p <0.000001), however all}

three studies had lower mean QoL physical functioning and mental health scores in the CVLU patients than in those without ulcers, but the magnitude of this effect varied between studies.

This meta-analysis demonstrates a consistently lower mean score, and thus diminished QoL, for patients with CVLU when compared to those without ulceration on review of SF36 completion (Ware & Sherbourne, 1992) across these three studies (Charles, 1995; Franks et al, 2003; Jull et al, 2004). Such meta-analysis strengthens individual study results and represents the combined responses of 779 participants.