***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: A prospect i ve study was conducted to assess the prevalence , severity and diagnostic utility of pain in patients with venous leg ulcers . A semi-structured question naire was completed by 140 consecutive patients in two specialist centres caring for patients with leg ulcers . A high proportion ( 64 % ) of the 94 patients with ulcers of purely venous aetiology reported severe pain ; 50 % of these patients were taking either mild analgesia or none at all . In 10 of 72 cases , leg elevation made the pain worse . Venous ulcers are painful . Pain in three distinct locations was reported by patients -within ulcers , around ulcers and elsewhere in the leg . The presence of severe pain does not necessarily indicate arterial disease or infection . Pain is , in general , inadequately controlled in these patients Quality of life may be considerably reduced in patients who are suffering from chronic lower limb venous insufficiency , although existing generic quality of life instruments ( NHP , SF-36 or SIP ) can not completely identify their specific complaints . The Chronic Venous Insufficiency Question naire ( CIVIQ ) has been developed by iterative process . First , a pilot group of 20 patients was used to identify a number of important features of quality of life affected by venous insufficiency , other than physical symptoms of discomfort . A second study involving 2,001 subjects was used to reduce the number of items . Subjects were asked to score both the severity of their problems and the importance they attributed to each problem on a 5-point Likert scale . The importance items found in patients with venous insufficiency were subjected to factorial analyses ( PCA , PAF ) . The final version is a 20-item self-administered question naire which explores four dimensions : psychological , physical and social functioning and pain . Internal consistency of the question naire was vali date d for each dimension ( Cronbach 's alpha > 0.820 for three out of four factors ) . Reproducibility was confirmed in a 60 patient test-retest study . Pearson 's correlation coefficients for both the four dimension subscales and for the global score at 2-week intervals were greater than 0.940 . Finally , the question naire was tested in a r and omized clinical trial of 934 patients in order to assess responsiveness and the convergent validity of the instrument , together with the patient 's own quality of life . This study demonstrated that convergence was valid : Pearson 's correlation coefficients between clinical score differences and quality of life score differences were small ( from 0.199–0.564 ) but were statistically different from 0 ( p<0.001 ) . St and ardized response mean ( SRM ) and effect size ( ES ) were calculated to assess sensitivity to change . SRM and ES both demonstrated considerble responsiveness to change ( > 0.80 ) . Reliability , face , content , construct validity and responsiveness were also determined for this specific quality of life question naire relating to venous insufficiency . Results suggest that this question naire may be used with confidence to assess quality of life in clinical trials on chronic venous insufficiency This study compared the rate of leg ulcer recurrence using two types of compression stockings  and examined the factors underlying Introduction : The effect on quality of life by healing leg ulcers is not known and no vali date d disease-specific tool is available for measuring health-related quality of life ( HRQoL ) for people with venous leg ulcers . The objective of this paper was to compare four generic instruments [ MOS 36-Item Short-Form Health Survey ( SF-36 ) ; EuroQol ( EQ ) ; McGill Short Form Pain Question naire ( SF-MPQ ) and the  Frenchay Activities Index ( FAI ) ] used for measuring HRQoL in people with venous leg ulcers , and to offer guidance on the most appropriate tool for research ers . Methods : Two hundred and thirty-three patients with venous leg ulcers were recruited as part of a r and omised controlled trial of the cost-effectiveness of community leg ulcer clinics . Subjects completed question naires containing the four instruments on three occasions ( initial assessment , 3 and 12 months ) . The discriminative and evaluative properties of the four instruments were compared . Results : All four instruments were acceptable to patients , taking a mean of 19.3 ( SD 6.3 ) min to complete . At initial assessment , the SF-MPQ had poorer discriminative properties than the other three instruments and was not able to distinguish between the different patient groups in relation to age and ulcer duration . The FAI was good at discriminating between the different patient groups ( at initial assessment ) in relation to age , mobility and ulcer size . At the three-month follow-up , the SF-MPQ was more responsive than the other measures and detected changes in HRQoL , whereas the EQ and SF-36 did not . At 12 months , the SF-MPQ still identified differences and the SF-36 and EQ also did at this stage . Conclusion : In the absence of a vali date d condition-specific tool for measuring changes in general health status for patients with venous leg ulcers , we make the following recommendations . For evaluating the outcome of interventions with a short-term follow-up ( three months ) in a clinical study we recommend the SF-MPQ and for 12-month follow-up in a clinical study the SF-36 , with or without the SF-MPQ STUDY OBJECTIVE To observe changes in perceived health in patients during a clinical trial of treatments for venous leg ulceration . DESIGN R and omised prospect i ve factorial trial in patients with venous ulceration . Each patient r and omised  to a b and age , dressing and a drug .  Perceived health assessed at entry and after 24 weeks . SETTING Outpatient departments and patient 's home . PATIENTS Two hundred patients presenting to two vascular services in Falkirk and Edinburgh with chronic ( duration > 2 months ) non-healing venous ulceration . STATISTICAL ANALYSIS AND MAIN RESULTS : Analysis using the Nottingham Health Profile revealed that after 24 weeks there were significant improvements in all subscores ( p < 0.01 ) with the exception of social isolation ( p = 0.081 ) . Patients with healed ulceration had improved in energy , pain , emotion , sleep and mobility compared with those whose ulceration failed to heal ( p < 0.05 ) . Patients r and omised to four layer b and aging had significantly better energy ( diff = 7.9 , 95 % CI 0.2 , 15.6 , p = 0.04 ) and mobility ( diff = 4.5 , 95 % CI 0.0 , 9.0 , p = 0.046 ) . This difference could be explained largely by the improved healing of patients r and omised to this b and age system ( 67/97 vs. 50/103 , OR = 2.37 , 95 % CI 1.31 , 4.27 ) . CONCLUSIONS Improvements in perceived health were significantly greater in patients whose ulcers had completely healed . Methods of treatment which offer improved healing for patients with venous leg ulceration are likely to improve patients ' perceived health status OBJECTIVES To quantify the effect of leg ulceration on health-related quality of life and to estimate a health state value for leg ulceration . DESIGN Population based case-control study . SETTING Two New Zeal and health districts ( population 540,468 people ) . SUBJECTS 241 people with a leg ulcer of any aetiology , and 224 controls r and omly selected from the electoral roll using stratified sampling . MAIN OUTCOME MEASURES health-related quality of life as measured by the eight domains of the Short Form 36 question Health Survey  , adjusted for age , sex and confounding co-morbidities ; the physical component summary and mental component summary scores of the Short Form 36 question Health Survey st and ardised for age and sex ; preference-based health state value derived from the Short Form 36 question Health Survey . RESULTS Completed Short Form 36 question Health Survey question naires were available for 230 cases ( 95 % ) and 218 controls ( 97 % ) . Cases reported significantly lower mean scores than controls across all eight domains of the Short Form 36 question Health Survey ( P < 0.0005 ) . Mean domain scores for cases were also significantly lower than population norms . The mean physical component summary score for cases and controls was 45.2 versus 50.1 ( P < 0.0001 ) and the mean mental component summary score was 48.1 for cases versus 51 for controls ( P < 0.0001 ) . The mean health state values ( adjusted for age and sex ) were 0.80 for cases and 0.89 for controls . CONCLUSION Leg ulcers reduce quality of life to a similar extent as other common chronic conditions , such as arthritis and diabetes Wound pain is a serious problem for elderly patients suffering from chronic leg ulcers , and it may lead to reduced wound healing rates and reduced quality of life . Biatain-Ibu Non-adhesive ( Coloplast A/S ) , a new pain-reducing moist wound healing dressing containing ibuprofen was tested for pain reduction , safety , and efficacy on 10 + 2 patients in a single-blinded crossover study against Biatain Non-adhesive ( Coloplast A/S ) .  Pain was measured with a Numeric Box Scale before , during , and after dressing change . Quality of life was measured using the World Health Organization-5 Well-Being Index . Dressing moist wound healing properties such as absorption capacity and leakage were tested together with assessment of wound exu date and blood plasma content of ibuprofen . Use of the Biatain-Ibu foam dressing correlated with a decrease in pain intensity scores from 7 in the run-in period to approximately 2.5 in the Biatain-Ibu treatment phase . Quality of life measures were improved which together with the reduced pain could contribute to faster wound healing . The moist wound healing properties of Biatain-Ibu were similar to that of the Biatain Non-adhesive and ulcer size was reduced by 24 % during the treatment period . Neither side effects nor systemic plasma concentrations of ibuprofen were observed . These data indicate that Biatain-Ibu could reduce persistent and temporary wound pain , increase Quality of life , was found safe to use , and had excellent moist wound healing properties OBJECTIVE This descriptive phenomenological study explored patients ' experiences of living with a leg ulcer . METHOD Eight participants ( five female and three male ) were recruited from a secondary care leg ulcer clinic in a large UK teaching hospital . All had current venous leg ulceration , lasting between five months and 34 years . Data collection was via in-depth semi-structured interviews . Data categories were : symptoms ; treatment ; perceptions , emotions and coping strategies ; and restrictions . RESULTS Leg ulcers have a significant impact on individuals ' lives . The degree to which this occurs varies between each person . CONCLUSION Patients need consistent treatment that incorporates benchmarking . A support network to address the needs of those living with a leg ulcer should be considered . This study 's findings should be promoted to raise awareness among health-care professionals , enabling them to provide more responsive care OBJECTIVE Health-related quality of life ( HRQOL ) affects outcome in chronic diseases such as inflammatory bowel disease ( IBD ) . The inflammatory bowel disease question naire ( IBDQ ) , a disease-specific HRQOL question naire , can define changes in health status in IBD , but simple instruments are needed for daily application . The present study proposed to develop a short version of the IBDQ , the SIBDQ , for community physicians . METHODS Using data from a clinical trial in 149 patients with Crohn 's disease , 10 items were selected ( by forward stepwise regression ) that best explained the variance of the IBDQ or dimensional scores ( bowel , systemic , social , emotional ) . The validity , reliability , and responsiveness of the SIBDQ were then assessed in 150 different patients with Crohn 's disease and 45 with ulcerative colitis . All scores were reported with a 7-point scale ( 1 = poor HRQOL , 7 = optimum HRQOL ) . RESULTS Mean SIBDQ scores were similar ( p = 0.22 ) in Crohn 's patients among 14 participating centers at study entry . Mean scores were lower in active Crohn 's disease ( range 4.00 - 4.92 ) than inactive disease ( range 4.67 - 5.83 ; p = 0.0015 ) . In active ulcerative colitis , the mean SIBDQ was 4.79 + /- 1.17 compared to 5.90 + /- 0.80 ( p = 0.0006 ) in inactive disease . The SIBDQ explained 92 % and 90 % of the IBDQ variance in Crohn 's disease and ulcerative colitis , respectively . In patients with stable Crohn 's disease , the test-retest reliability coefficient was 0.65 and Crohnbach 's alpha was 0.78 , indicating good reliability . In patients with Crohn 's disease who relapsed during follow-up , the mean SIBDQ decreased by -0.93 + 0.55 ( p = 0.001 ) . CONCLUSION The SIBDQ is valid , reliable , and able to detect meaningful clinical changes in HRQOL that might occur in the office setting AIM To explore the characteristics of venous and arterial leg ulcer pain among people cared for in the community . BACKGROUND There is little information available concerning the different characteristics of pain result ing from venous and arterial leg ulcers . The identification of clear differences in pain experience might aid recognition of arterial deterioration and provide a useful adjunct for existing diagnostic procedures . DESIGN This was a prospect i ve interview-based survey . METHOD Structured interviews were conducted with each of the participants in their home .  Ulcer history , pain ( McGill pain question naire and verbal rating scale ) and factors influencing pain were assessed . RESULTS Fifty-two women and 27 men aged 77.7 
    Output:
    
The disease-specific instruments showed limitations in relation to their applicability to venous ulcer patients because of flaws in design or validation .
The literature on quality of life related to venous ulceration failed to sufficiently distinguish between those with different causes of leg ulceration .
There appeared to be problems with the ability of current quality of life instruments to detect changes in quality of life related to ulcer healing .
There appears to be an opportunity for nurses to develop a health-related quality of life health-related quality of life  instruments to evaluate their impact on patient outcomes .
Such instruments could potentially allow nursing interventions to be assessed more effectively than the recently proposed nursing metrics