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Validation of two complementary oral-health related quality of life indicators (OIDP and OSS 0-10) in two qualitatively distinct samples of the Spanish population
Background:
Oral health-related quality of life can be assessed positively, by measuring satisfaction with mouth, or negatively, by measuring oral impact on the performance of daily activities. The study objective was to validate two complementary indicators, i.e., the OIDP (Oral Impacts on Daily Performances) and Oral Satisfaction 0-10 Scale (OSS), in two qualitatively different socio-demographic samples of the Spanish adult population, and to analyse the factors affecting both perspectives of well-being.
Methods:
A cross-sectional study was performed, recruiting a Validation Sample from randomly selected Health Centres in Granada (Spain), representing the general population (n=253), and a Working Sample (n=561) randomly selected from active Regional Government staff, i.e., representing the more privileged end of the socio-demographic spectrum of this reference population. All participants were examined according to WHO methodology and completed an in-person interview on their oral impacts and oral satisfaction using the OIDP and OSS 0-10 respectively. The reliability and validity of the two indicators were assessed. An alternative method of describing the causes of oral impacts is presented.
Results:
The reliability coefficient (Cronbach's alpha) of the OIDP was above the recommended 0.7 threshold in both Validation and Occupational samples (0.79 and 0.71 respectively). Test-retest analysis confirmed the external reliability of the OSS (Intraclass Correlation Coefficient, 0.89; p< 0.001) Some subjective factors (perceived need for dental treatment, complaints about mouth and intermediate impacts) were strongly associated with both indicators, supporting their construct and criterion validity. The main cause of oral impact was dental pain. Several socio-demographic, behavioural and clinical variables were identified as modulating factors.
Conclusions:
OIDP and OSS are valid and reliable subjective measures of oral impacts and oral satisfaction, respectively, in an adult Spanish population. Exploring simultaneously these issues may provide useful insights into how satisfaction and impact on well-being are constructed.
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Fatigue characteristics in multiple sclerosis: the North American Research Committee on Multiple Sclerosis (NARCOMS) survey
Background:
Fatigue is a common disabling symptom of multiple sclerosis (MS) and has a significantly negative impact on quality of life. Persons with MS enrolled in the North American Research Committee on Multiple Sclerosis (NARCOMS) Patient Registry are invited to complete follow-up surveys every six months to update their original registration information. One of these surveys was designed to focus on the severity and impact of fatigue, and its association with other clinical parameters of MS such as physical disability.
Methods:
In addition to the usual data collected in Registry update surveys such as demographic characteristics, MS-related medical history, disability and handicap, immunomodulatory and symptomatic therapies taken, and healthcare services used, the survey for this study included two validated self-report fatigue scales, the Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS) and questions about the use of symptomatic management for fatigue, both pharmacologic and non-pharmacologic treatments. This Registry update survey was mailed to all NARCOMS registrants (n= 18,595) in November 2002. Information provided by registry participants was approved for research purposes by the Yale University Institutional Review Board.
Results:
The response rate for the survey was 49.5% (9205/18,595). Severe fatigue as measured with the FSS using the developer's recommended severity cutpoint of >=36 was reported by 6691 (74%) of evaluable respondents (n=9077). A higher prevalence of severe fatigue was observed in relapsing-worsening MS compared with relapsing-stable and primary progressive MS. A distinct pattern of fatigue was observed across the disability levels of the Patient-Determined Disease Steps (PDDS). Although there were no differences in the severity or impact of fatigue by immunomodulatory agents (IMA), respondents who recalled therapy changes in the prior six months reported different patterns of change in fatigue with lower fatigue levels reported after changing from interferon-beta to glatiramer acetate than after changing from glatiramer acetate to interferon-beta. Concomitant therapy for fatigue was used by 47.2% of the 5799 survey respondents receiving IMA.
Conclusions:
Characterizing MS symptoms like fatigue can increase awareness about their impact on persons with MS and suggest recommendations for a care plan.
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The responsiveness of the uterine fibroid symptom and health-related quality of life questionnaire (UFS-QOL)
Background:
A number of noninvasive alternatives to hysterectomy have become available as treatments for uterine fibroids. These alternative therapies, however, may not relieve all symptoms. Consequently, the need for patient-reported outcomes to assess symptom reduction of uterine fibroids has become increasingly important to evaluate the clinical success of patients who choose these alternative therapies. The purpose of the study was to examine the responsiveness of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) with treatment of uterine fibroids.
Methods:
The responsiveness of the UFS-QOL was assessed as a post-hoc analysis of patients treated with MRI-guided focused ultrasound thermal ablation (MRgFUS) for uterine fibroids. The UFS-QOL and SF-36 were completed at baseline and months 1, 3, and 6. Patient perceived overall treatment effect (OTE) was assessed at month 3, while satisfaction with treatment was collected at month 6. The responsiveness of the UFS-QOL was examined using effect sizes and change scores by patient-reported overall treatment effect and satisfaction.
Results:
A total of 102 women with complete UFS-QOL data were included in the analysis; the mean age was 45 years and 79% were Caucasian. From baseline to 6 months, significant improvements were observed in UFS-QOL Symptom Severity and all Health-Related Quality of Life (HRQL) subscale scores (p < 0.0001). When examining change in general health status over the 6-month follow-up period, significant improvements were noted in all 8 SF-36 subscales. The UFS-QOL was highly responsive with subscale effect sizes ranging from 0.74 for Sexual Function to -1.9 for Symptom Severity. Improvements in UFS-QOL subscales were associated with patient perceptions of perceived benefit and treatment satisfaction.
Conclusions:
The UFS-QOL is responsive to treatment for uterine fibroids and is a useful outcome measure for uterine-sparing uterine fibroid treatments.
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Health predicting factors in a general population over an eight-year period in subjects with and without chronic musculoskeletal pain
Background:
Many factors are proposed to be associated with health-related quality of life. Knowledge of health factors associated to development of a good health-related quality of life could be of use in clinical practice and public health work. The aim of this study was to investigate the associations between suggested health factors and health-related quality of life at baseline and in an eight-year follow up in subjects with and without chronic musculoskeletal pain in a cohort from a general population.
Methods:
The study was designed as a longitudinal study in a Swedish general population (N=1 849) with a postal questionnaire at baseline 1995 and at follow up 2003. Subjects were divided into two groups, according to their response about chronic musculoskeletal pain at baseline. Health-related quality of life was assessed by the SF-36 together with suggested health factors. The associations between SF-36 subscales and suggested health factors were estimated by OR and 95 % CI calculated by multivariable logistic regressions, with adjustment for all health factors, age, sex and baseline SF-36 values.
Results:
Although subjects without chronic musculoskeletal pain reported better health-related quality of life than subjects with chronic pain, similar health factors were found to be associated to higher scores in SF-36 at baseline and predicted a better outcome in the eight-year follow up. The most consistent finding was a better health outcome in the eight-year follow up for subjects that were feeling rested after sleep. Other factors that in some aspects predicted a better outcome were belonging to higher socioeconomic group, being a native Swede, having emotional support, having good sleep structure, never being or being a former smoker, and regularly drinking alcohol.
Conclusions:
The most important health factor in subjects with and without chronic musculoskeletal pain was feeling rested after sleep, but also emotional support, sleep structure, smoking and alcoholic habits appears to be important components. These health factors could be important to address in clinical work with painful musculoskeletal disorders. Since several health factors are common in both subjects with and without pain there could be a common strategy to be formed in public health programmes.
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Logistic feasibility of health related quality of life measurement in clinical practice: results of a prospective study in a large population of chronic liver patients
Background:
The objective of the present study was to provide a complete and detailed report of technical and logistical feasibility problems with the implementation of routine computerized HRQoL measurement at a busy outpatient department of Hepatology that can serve as a tool for future researchers interested in the procedure.
Methods:
Practical feasibility was assessed by observing problems encountered during the development of the computer program, observing patients' ability to complete the HRQoL questionnaires, monitoring the number of times that patients completed the HRQoL questionnaires and observing logistics at the outpatient department. Patients' reasons for not completing the HRQoL questionnaires were assessed retrospectively by means of a mailed questionnaire. Physicians' attitudes towards the availability of computerized HRQoL information about their patients were assessed by means semi-structured interviews and by means of checklists administered after each consultation with s study participant.
Results:
All physicians (n=11) and 587 patients agreed to participate in the study. Practical feasibility problems concerned complicated technical aspects of developing a user-friendly computer program and safe data transmission over the Internet, patients' lack of basic computer skills and patients' lack of compliance (completion of questionnaires on only 43% of the occasions). The main reason given for non-compliance was simply forgetting, which seemed to be related to reception employees' passive attitude towards sending patients to the computer. Physicians were generally positive about the instant computerized availability of HRQoL information. They requested the information in 92% of the consultations and found the information useful in 45% of the consultations, especially when it provided them with new information.
Conclusions:
This study was among the first to implement the complete procedure of routine computerized HRQoL measurements in clinical practice and to subsequently describe the feasibility issues encountered. It was shown that the attitudes of physicians were generally positive. Several barriers towards successful implementation of such a procedure were encountered, and subsequently solutions were provided. Most importantly, when implementing routine computerized HRQoL measurements in clinical practice, assistance of an IT professional for the development of a tailor-made computer program, availability of questionnaires in multiple languages and the use of touch-screen computers to optimise patient participation are essential. Also, all staff of the department concerned should approve of the intervention and consider it as part of standard clinical routine if successful implementation is to be obtained.
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Health-related quality of life assessment in Indonesian childhood acute lymphoblastic leukemia
Background:
Most studies on Health-related Quality of Life (HRQOL) in children with cancer were conducted in developed countries. The aims of this study were to assess the HRQOL in childhood acute lymphoblastic leukemia (ALL) patients in Indonesia and to assess the influence of demographic and medical characteristics on HRQOL.
Methods:
After cultural linguistic validation, a cross-sectional study of HRQOL was conducted with childhood ALL patients and their guardians in various phases of treatment using the Pediatric Quality of Life InventoryTM (PedsQLTM) 4.0 Generic Core Scale and the Pediatric Quality of Life InventoryTM (PedsQLTM) 3.0 Cancer Module.
Results:
Ninety-eight guardians and 55 patients participated. The internal consistency of both scales ranged from 0.57 to 0.92. HRQOL of Indonesian patients was comparable with those in developed countries. There were moderate to good correlations between self-reports and proxy-reports, however guardians tended to report worse HRQOL than patients. Children of the 2-5 year-group significantly had more problems in procedural anxiety, treatment anxiety and communication subscales than in older groups (p<0.05). In the non-intensive phase HRQOL was significantly better than in the intensive phase, both in patient self-reports and proxy-reports.
Conclusion:
Younger children had more problems in procedural anxiety, treatment anxiety and communication subscales. Therefore, special care during intervention procedures is needed to promote their normal development. Psychosocial support should be provided to children and their parents to facilitate their coping with disease and its treatment.
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The longitudinal link between visual acuity and health-related quality of life in patients with diabetic retinopathy
Background:
This study characterized the degree of change in health-related quality of life (HRQL) associated with change in visual acuity among patients with diabetic retinopathy.
Methods:
Data are from a randomized, placebo-controlled trial of ruboxistaurin for vision loss in patients with diabetic retinopathy. Visual acuity was quantified as letters on the ETDRS visual acuity chart. HRQL was assessed with the 25-Item Visual Function Questionnaire (VFQ-25) and the SF-36. Patients were categorized into groups based on visual acuity change from baseline to month 18. HRQL change of these groups was compared using general linear models. Regression analyses examined visual acuity change defined continuously.
Results:
Patients (N = 535) were primarily Caucasian (81.9%) and male (64.1%); mean age = 59.3 years. Compared to patients whose visual acuity did not change, the group with > 10 letters vision loss had significantly greater decreases in all VFQ-25 subscales except ocular pain. SF-36 change scores did not correspond as closely to change in vision. Change in visual acuity defined continuously was significantly associated with change in all VFQ-25 scales except ocular pain (p < 0.0001).
Conclusions:
Change in visual acuity was associated with corresponding changes in HRQL among patients with diabetic retinopathy. Previous research has often defined vision loss as a loss of at least 15 letters on the ETDRS visual acuity chart. In the current study, however, a loss of at least 10 letters was associated with substantial declines in HRQL domains such as driving, dependency, role limitations, and mental health. These findings suggest that patients who experience vision loss of at least 10 letters may be appropriate targets of future research and clinical intervention.
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Correspondence between EQ-5D health state classifications and EQ VAS scores
Background:
The EQ-5D health-related quality of life instrument comprises a health state classification followed by a health evaluation using a visual analogue scale (VAS). The EQ-5D has been employed frequently in economic evaluations, yet the relationship between the two parts of the instrument remains ill-understood. In this paper, we examine the correspondence between VAS scores and health state classifications for a large sample, and identify variables which contribute to determining the VAS scores independently of the health states as classified.
Methods:
A UK trial of management of low-grade abnormalities detected on screening for cervical pre-cancer (TOMBOLA) provided EQ-5D data for over 3,000 women. Information on distress and multi-dimensional health locus of control had been collected using other instruments. A linear regression model was fitted, with VAS score as the dependent variable. Independent variables comprised EQ-5D health state classifications, distress, locus of control, and socio-demographic characteristics. Equivalent EQ-5D and distress data, collected at twelve months, were available for over 2,000 of the women, enabling us to predict changes in VAS score over time from changes in EQ-5D classification and distress.
Results:
In addition to EQ-5D health state classification, VAS score was influenced by the subject's perceived locus of control, and by her age, educational attainment, ethnic origin and smoking behaviour. Although the EQ-5D classification includes a distress dimension, the independent measure of distress was an additional determinant of VAS score. Changes in VAS score over time were explained by changes in both EQ-5D severities and distress. Women allocated to the experimental management arm of the trial reported an increase in VAS score, independently of any changes in health state and distress.
Conclusions:
In this sample, EQ VAS scores were predictable from the EQ-5D health state classification, although there also existed other group variables which contributed systematically and independently towards determining such scores. These variables comprised psychological disposition, socio-demographic factors such as age and education, clinically-important distress, and the clinical intervention itself.
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Prevalence of stress, anxiety and depression in with Alzheimer caregivers
Background:
Alzheimer's disease presents a social and public health problem affecting millions of Italians. Those affected receive home care from caregivers, subjected to risk of stress.
The present investigation focuses on stress, anxiety and depression in caregivers.
Methods:
Data on 200 caregivers and their patients were collected using a specific form to assess cognitive, behavioural, functional patient (MMSE, and ADL- IAD) and caregiver stress (CBI). The relationship between stress, depression and disease has been assessed by means of a linear regression, logistic analysis which reveals the relationship between anxiety, stress and depression
and cognitive problems, age, the patient's income.
Results:
The caregivers are usually female (64%), mean age of 56.1 years, daughters (70.5%), pensioners and housewives (30%), who care for the sick at home (79%). Of these, 53% had little time for themselves, 55% observed worsening of health, 56% are tired, 51% are not getting enough sleep. Overall, 55% have problems with the patient's family and/or their own family, 57% at work. Furthermore, 29% feel they are failing to cope with the situation as they wish to move away from home. The increase in the degree of anxiety and depression is directly proportional to the severity of the illness, affecting the patient (r = 0.3 stress and depression r = 0.4, related to CBI score). The memory disorders (OR = 8.4), engine problems (OR = 2.6), perception disorders (OR = 1.9) sick of the patient with Alzheimer's disease are predictive of caregiver stress, depression is associated with the presence of other disorders, mainly behavioural (OR = 5.2), low income (OR = 3.4), patients
< 65 years of age (OR = 2.9).
Conclusions:
The quality of life of caregivers is correlated with the severity of behavioural disorders and duration of the Alzheimer's disease. The severity of the disease plays an important role in reorganization of the family environment in families, caring for patients not institutionalised. It is important to promote measures to soften the impact that the patient has on the caregiver, and that, at the same time, improves the quality of life of the patient.
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Onset, persistence and recovery of person-perceived participation restriction in older adults: A 3-year follow-up study in the general population.
Background:
Participation restriction is defined as "problems an individual may experience in involvement in life situations" and refers to the personal and societal consequences of health conditions. There is a growing interest in participation restriction because (i) problems with work or looking after others may be more concerning to individuals than the signs and symptoms of health conditions and (ii) even when poor health persists, participation may still be maintained. The natural history of participation restriction in the general population is unknown and the aim of this report is to describe change in status of person-perceived participation restriction over three years in community-dwelling adults aged 50 years and over. MethodProspective cohort study (baseline and 3-year follow-up) using postal questionnaires mailed to a population-based sample of older adults. Responders were included in this study if they completed all items of the Keele Assessment of Participation, at both baseline and follow-up (n=3709). Onset and persistence of person-perceived participation restriction at 3-year follow-up were calculated for any and for each aspect of life in the sample as a whole, and then by age and gender.
Results:
In the whole sample of 3709 persons, overall participation status at three years was unchanged in 69%, and changed in 31%. Of 2049 persons with no restriction at baseline, 29.2% (n=599) reported restriction in at least one aspect of life at 3-year follow-up. Of 1660 persons who had baseline restriction, 69.2% (n=1149) reported continuing restriction in at least one aspect of life after 3 years. Onset and persistence both increased with age, and were most frequently recorded for restricted mobility outside the home.
Conclusion:
Although most older persons do not change their overall participation status during a three-year period, change does occur which implies that population approaches to improving participation can be sought. Both onset and persistence of person-perceived participation restriction are more common the older the age-group.
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