Condition-specific Quality Of Life Measure Research Articles

Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial.

To determine whether percutaneous tibial nerve stimulation (PTNS) is superior to sham stimulation for the treatment of fecal incontinence (FI) in women refractory to first-line treatments. Women aged 18 years or older with ≥3 months of moderate-to-severe FI that persisted after a 4-week run-in phase were randomized 2:1 (PTNS:sham stimulation) to 12 weekly 30-minute sessions in this multicenter, single-masked, controlled superiority trial. The primary outcome was change from baseline FI severity measured by St. Mark score after 12 weeks of treatment (range 0-24; minimal important difference, 3-5 points). The secondary outcomes included electronic bowel diary events and quality of life. The groups were compared using an adjusted general linear mixed model. Of 199 women who entered the run-in period, 166 (of 170 eligible) were randomized, (111 in PTNS group and 55 in sham group); the mean (SD) age was 63.6 (11.6) years; baseline St. Mark score was 17.4 (2.7); and recording was 6.6 (5.5) FI episodes per week. There was no difference in improvement from baseline in St. Mark scores in the PTNS group when compared with the sham group (-5.3 vs -3.9 points, adjusted difference [95% confidence interval] -1.3 [-2.8 to 0.2]). The groups did not differ in reduction in weekly FI episodes (-2.1 vs -1.9 episodes, adjusted difference [95% confidence interval] -0.26 [-1.85 to 1.33]). Condition-specific quality of life measures did not indicate a benefit of PTNS over sham stimulation. Serious adverse events occurred in 4% of each group. Although symptom reduction after 12 weeks of PTNS met a threshold of clinical importance, it did not differ from sham stimulation. These data do not support the use of PTNS as conducted for the treatment of FI in women.

Feasibility and Concurrent Validity of Cerebral Palsy Quality of Life for Children (CP QOL-Child) in Thai Version

Background: The Cerebral Palsy Quality of Life for Children (CP QOL-Child) questionnaires are condition-specific QOL measures for children with CP focusing on perspectives of children with CP on their quality of life, not on their physical difficulties. The perspectives of well-being are core concepts of quality of life. The CP QOL-Child has already been translated in Thai and the reliability is excellent. The validity after the translation has not been conducted and is required. therefore, it is needed to examine the validity to ensure the clinical practicality. Objective: To examine feasibility and concurrent validity of the CP QOL-Child (Thai version). Materials and Methods: Eighty-five primary caregivers of 4- to 12-year-old children and 65 children between 9- and 12-years-old, who passed the inclusion criteria, completed three questionnaires including the CP QOL-Child (Thai version), the PedsQL 4.0 Generic Core Scales, and the PedsQL 3.0 CP module (Thai version). Results: For feasibility of the CP QOL-Child, no missing items were found in any items for the child self-report. For parent proxy report, missing items were scattered and from 1.2% to 7.1%. For concurrent validity, according to the total scores of both versions, the self-report and the parent proxy, the correlation coefficients between CP QOL-Child and PedsQL 4.0 Generic Core Scales were 0.23 to 0.25 meaning no or little correlations, at significance level of 0.05. The correlation coefficients between the CP QOL-Child and the PedsQL CP module were 0.38 to 0.49, meaning fair correlations, at significance level of 0.01. Conclusion: The feasibility of the CP QOL-Child (Thai version) was reportedly acceptable. The concurrent validity support that the CP QOL-Child may not measure the quality of life at the same constructs as the PedsQL. The CP QOL-Child asks the client’s perspectives of quality of life (QOL) while both PedsQL modules ask the client’s difficulties that might relate to QOL. Keywords: Health-related quality of life, CP QOL-Child, Cerebral palsy, Feasibility, Validity

Quality of life and communication in orthognathic treatment.

The primary aim was to determine what, if any, relationships exist between communication and quality of life in patients receiving orthognathic treatment since this has not been explored. A secondary aim was to compare the Quality of Life (QoL) of a pre-treatment sample with those at 2 years post-surgery. A cross-sectional questionnaire method was used. Outpatient clinics providing orthognathic treatment at four UK hospital sites. Two separate samples of pre-treatment (n = 73) and 2-year post-surgery (n = 78) patients participated in the study. At clinic appointments, all eligible patients were invited to complete the Orthognathic Quality of Life Questionnaire (OQLQ), a previously validated condition-specific quality of life measure. At the same time, participants at the 2-year post-surgery stage also completed a second short questionnaire, the Communication Assessment Tool-Team (CAT-T), where they rated the quality of communication they had received during treatment. One hundred and fifty-one complete responses were received. The average age was 24.5 years (S.D. 9.77) and the majority (67%) were female in both groups. Statistically significant associations were found between QoL and quality of communication in the treated sample. Findings also showed a comparatively poorer QoL for the pre-treatment participants. This reduced QoL was more pronounced in females than males for all aspects except dentofacial appearance. There was an improvement in QoL for patients at 2 years post-surgery compared to pre-treatment. There is an association between QoL and quality of communication as reported by participants at 2 years post-surgery. These novel findings are similar to outcomes in other patient settings such as oncology, but further investigation is required to establish the direction of cause and effect.

Oral health-related quality of life in surgery-first vs traditional orthognathic approach

The article entitled “Surgery-first orthognathic approach vs traditional orthognathic approach: oral health-related quality of life assessed with 2 questionnaires” published in August 2017 was interesting in the light of contemporary interest in this topic (Pelo S, Gasparini G, Garagiola U, Cordaro M, Di Nardo F, Staderini E, et al. Am J Orthod Dentofacial Orthop 2017;152:250-4). The surgery-first approach reduces the number of treatment phases from 3 to 2 and hence reduces treatment time and patient discomfort. Even so, an evidence-based benefit assessment is still not clear with this new approach.1Huang C.S. Hsu S.S. Chen Y. Systematic review of the surgery-first approach in orthognathic surgery.Biomed J. 2014; 37: 184-190Crossref PubMed Scopus (72) Google Scholar We appreciate the authors for publishing data that will initiate more studies regarding this intangible aspect of orthognathic/orthodontic treatment. Confusion persisting among clinicians regarding the application of generic or condition-specific quality of life measures for othognathic surgery is reflected here also with the use of 2 different measures,2Choi W.S. Lee S. McGrath C. Samman N. Change in quality of life after combined orthodontic-surgical treatment of dentofacial deformities.Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010; 109: 46-51Abstract Full Text Full Text PDF PubMed Scopus (95) Google Scholar even though the use of generic measures in orthodontics is questioned by Marshman and Robinson3Marshman Z. Robinson P.G. Child and adolescent oral health related quality of life.Semin Orthod. 2007; 13: 88-95Abstract Full Text Full Text PDF Scopus (15) Google Scholar and others.4O'Brien C. Benson P.E. Marshman Z. Evaluation of a quality of life measure for children with malocclusion.J Orthod. 2007; 34: 185-193Crossref PubMed Scopus (118) Google Scholar However, this article also has generated some doubts in our mind which, if clarified, will broaden its scope.1.The study design is not clear even though test and control groups were mentioned. Ethics committee approval is not cited (although it was according to the Helsinki Declaration). This is essential in any study involving human participants, and the importance of mentioning the study design cannot be overlooked when considering this study for future systematic review or meta-analysis.2.There is no mention regarding the outcome assessment using morphometric skeletal, occlusal, and soft tissue parameters; this causes us to conclude that the study is ongoing. Quality of life status of the surgery-first group during the postsurgical orthodontic phase is very important, and we doubt that the results were premature to publish.3.Translation and cross-cultural adaptation of these psychometric tools were not mentioned, nor was the existence of such validated tools (OHIP-14 and OQLQ) in the geographic area of study. Administration of questionnaires 1 month before surgery and before bracket placement for the test group does not make sense when the bracket was placed just 3 days before surgery for this group. Clarification of the above doubts will be really appreciated. Surgery-first orthognathic approach vs traditional orthognathic approach: Oral health-related quality of life assessed with 2 questionnairesAmerican Journal of Orthodontics and Dentofacial OrthopedicsVol. 152Issue 2PreviewThe purposes of the study were to investigate and evaluate the differences detected by the patients between the traditional orthognathic approach and the surgery-first one in terms of level of satisfaction and quality of life. Full-Text PDF Authors' responseAmerican Journal of Orthodontics and Dentofacial OrthopedicsVol. 152Issue 6PreviewWe thank Dr Peter et al for their interest in our article and want to respond point by point. Full-Text PDF

Quality of life in children with cerebral palsy: implications for practice.

The ability to assess the quality of life of children with cerebral palsy to inform and evaluate individual care plans, service planning, interventions, and policies is crucial. In this article, the recent evidence on quality of life in children with cerebral palsy is reviewed, with attention to the determinants of quality of life and role of this construct as a practical outcome indicator in clinical trials. Quality of life measurement advances for children with cerebral palsy are discussed with a focus on condition-specific quality of life measures, particularly, the Cerebral Palsy Quality of Life-Child, which is the first condition-specific quality of life measure for children with cerebral palsy. The article presents an overview for clinicians and researchers intending to use quality of life measures on children with cerebral palsy and provides recommendations for future research that will better inform practice in the field.

Item and instrument development to assess sexual function and satisfaction in outcomes research

This article looks at two of the major issues associated with the development of condition-specific quality of life measures. The first issue is the process of conceptualization. The importance of conceptualization to developing sound questions and instruments is evaluated, and the need to utilize multiple perspectives in the conceptualization process is discussed. The second issue addressed is fundamentals of writing survey questions. Questions from a range of sexual function questionnaires are presented and discussed relative to seven basic guidelines associated with question and response category development.

Quality of life in childhood epilepsy: What is the level of agreement between youth and their parents?

Children and parents evaluate the child's quality of life (QOL) from their own perspectives; therefore, responses may differ, especially in abstract domains. We examined differences between self- and proxy-reported QOL of children with epilepsy. Children with active epilepsy (N=375) and their parents (N=378) separately completed the CHEQOL-25, a condition-specific QOL measure. The intraclass correlation coefficient was used to determine interrater agreement. Concordance on the Total CHEQOL-25 was 0.45 (P<0.01). Discrepancies were greatest for the subscales of Secrecy (0.24, P<0.01) and Present Concerns (0.32, P<0.01). School placement correlated with discrepancy in the Intrapersonal/Emotional subscale (r=0.19, P<0.05), and the child's age at testing correlated with discrepancy of the Total measure (r=0.15, P<0.01). This study demonstrates that parent perspectives alone are insufficient to measure their child's QOL. The CHEQOL-25 is a practical tool, with complementary parent and child versions, which can be used to determine health-related quality of life in children with epilepsy.

Quality of life assessment in heart failure interventions: a 10-year (1996–2005) review

The increasing prevalence and poor prognosis associated with heart failure have prompted research to focus on improving quality of life (QoL) for heart failure patients. Research from 1996-2005 was systematically reviewed to identify randomized controlled trials that assessed QoL in heart failure. In 120 studies, 44 were medication trials; 19 surgical/procedural interventions; and 57 patient care/service delivery interventions. Studies were summarized in terms of aim, population, QoL measures used and QoL findings. Studies used 47 different measures of QoL-generic, health-related, condition-specific, domain-specific and utility measures. Most used a single QoL measure. In 87%, a condition specific QoL measure was used, with the Minnesota Living with Heart Failure Questionnaire being the favoured assessment tool. The range of QoL measures in use poses challenges for development of cumulative knowledge. Although comparability across studies is important, this must be informed by the responsiveness of the instrument selected. As carried out in other cardiac groups, comparative evaluations of instrument responsiveness are needed in heart failure.

Development and multi-site validation of a new condition-specific quality of life measure for eating disorders

BackgroundIn eating disorders (EDs) treatment, outcome measurement has traditionally focused on symptom reduction rather than functioning or quality of life (QoL). Generic QoL measures lack sensitivity for some diagnoses and many not be responsive in eating disorder patients. This article describes the development and validation of a condition-specific QoL measure for adolescents and adults with eating disorders – the Eating Disorders Quality of Life Scale (EDQLS).MethodsMulti-source and multi-stage methods were used to develop the EDQLS, with participation of patients with EDs, their family members and ED treatment providers. Sources for domain and item development included 39 articles, 12 patient and 10 treatment provider interviews, and 31 first person narratives from the internet. Four stages of validation and pre-testing involving 17 patients, 10 family members and 18 providers reduced 233 items to 40 items in 12 domains. These items were pilot tested in 41 ED patients.ResultsThe final instrument was then validated in a 12 site sample of 171 individuals aged 14–60 with EDs. All items showed good dispersion. The total raw mean score was 110 out of 200 (SD 27.6) with higher scores indicating better QoL. Internal consistency was excellent (Cronbach's alpha = .96) and subscale internal consistency ranged from alpha .36 to .79 providing evidence for a strong overall construct and some multi-dimensionality. Validity was supported by significant differences in mean EDQLS according to severity levels on the EDI-2 (F = 95.3, p <.001) and the BSI (F = 86.9, p <.001). EDQLS scores were positively associated with time in treatment (F = 4.65, p = .01) suggesting responsiveness. A strong positive association was also found between EDQLS scores and stage of change (F = 15.1 p <.001). Pearson's correlations between the EDQLS and criterion instrument scores were .71 for the SF-12 mental subscale, .61 for the QoLI and .78 for the 16D, supporting construct validity. Exploratory principal components and item response theory analyses identified only a few poor fitting items.ConclusionThe EDQLS has promising psychometric characteristics and may be useful for evaluating ED treatment effectiveness.

A comparison of the discriminatory power of the Inflammatory Bowel Disease Questionnaire and the SF-36 in people with ulcerative colitis

The aim of this study was to compare the discriminatory power of a generic and a condition-specific quality of life measure (the Medical Outcomes Study Short-Form 36 (SF-36) and the Inflammatory Bowel Disease Questionnaire (IBDQ)) with respect to sub-groups defined by disease-related and other factors, in a sample of patients with ulcerative colitis. Disease activity was generally more highly correlated with IBDQ scores than with SF-36 scores. The only significant differences with respect to disease extent were in the SF-36 energy/vitality and social function domains. Age was negatively and weakly to moderately correlated with the physical domains of the SF-36 but positively though weakly correlated with scores on the IBDQ emotional domain and those domains of the SF-36 related to mental well-being. Co-existing chronic illness, even on controlling for age, was associated with significantly poorer scores on the generic measure, but had little influence on IBDQ scores. In conclusion, generic and disease-specific measures of quality of life appear to be complementary rather than interchangeable. We recommend the use of both types of measure in parallel.

Development of a condition-specific quality of life measure for patients with dentofacial deformity: II. Validity and responsiveness testing.

The assessment of quality of life is becoming increasingly important in dentistry. This may be measured using two groups of instruments: generic and condition-specific. This paper describes the processes of validity and responsiveness testing of a condition-specific quality of life measure for patients who present with severe dentofacial deformity requesting orthognathic treatment (the so-called Orthognathic Quality of Life Questionnaire). The development of the instrument is described in a previous paper. The OQLQ was tested for validity using a visual analogue scale and also the Short-Form 36 health survey questionnaire. Responsiveness was tested using longitudinal data obtained before, during and after orthognathic treatment. The OQLQ shows good evidence of validity and responsiveness. This, together with previous evidence of good reliability, suggests that the instrument may prove useful in both clinical trials and in quality assurance.

The IBS-36: a new quality of life measure for irritable bowel syndrome

OBJECTIVE: We aimed to develop and validate a quality of life instrument for patients with irritable bowel syndrome (IBS). METHODS: Using focus groups, existing questionnaires, and literature reviews, five IBS patients and nine gastroenterologists compiled and pilot tested for content validity a 70-item questionnaire. The questionnaire was then administered to 107 IBS patients, and using these data, the 70-item questionnaire was reduced to 36 questions through statistical and consensus methodology. The IBS-36 questionnaire was tested for construct validity, reliability, reproducibility, and responsiveness using a gold standard of structured interviews by three gastroenterologists, the Medical Outcomes Study Short Form Quality of Life Questionnaire, and the Coping Resource Inventory. RESULTS: The IBS-36 consists of 36 questions scored on a 7-point Likert scale. It has a very high internal consistency (Cronbach’s α = 0.95) and a high test-retest reliability (Spearman’s r = 0.92) and correlates as hypothesized with the Medical Outcomes Study Short Form Quality of Life Questionnaire ( p < 0.001), McGill pain scores ( p < 0.001), and IBS patient-reported sleep, symptom, and pain scores ( ps = 0.030, <0.001, and <0.001, respectively). CONCLUSIONS: The IBS-36 addresses all areas of quality of life affected by IBS and is easy to administer and score. The IBS-36 is a well-validated, condition-specific quality of life measure for IBS patients that is sensitive to clinical intervention and highly correlated with established quality of life measures and patient-reported symptom scores.

The IBS-36: a new quality of life measure for irritable bowel syndrome

We aimed to develop and validate a quality of life instrument for patients with irritable bowel syndrome (IBS). Using focus groups, existing questionnaires, and literature reviews, five IBS patients and nine gastroenterologists compiled and pilot tested for content validity a 70-item questionnaire. The questionnaire was then administered to 107 IBS patients, and using these data, the 70-item questionnaire was reduced to 36 questions through statistical and consensus methodology. The IBS-36 questionnaire was tested for construct validity, reliability, reproducibility, and responsiveness using a gold standard of structured interviews by three gastroenterologists, the Medical Outcomes Study Short Form Quality of Life Questionnaire, and the Coping Resource Inventory. The IBS-36 consists of 36 questions scored on a 7-point Likert scale. It has a very high internal consistency (Cronbach's alpha = 0.95) and a high test-retest reliability (Spearman's r = 0.92) and correlates as hypothesized with the Medical Outcomes Study Short Form Quality of Life Questionnaire (p < 0.001), McGill pain scores (p < 0.001), and IBS patient-reported sleep, symptom, and pain scores (ps = 0.030, <0.001, and <0.001, respectively). The IBS-36 addresses all areas of quality of life affected by IBS and is easy to administer and score. The IBS-36 is a well-validated, condition-specific quality of life measure for IBS patients that is sensitive to clinical intervention and highly correlated with established quality of life measures and patient-reported symptom scores.

Measuring change in quality of life in response to Helicobacter pylori eradication in peptic ulcer disease: the QOLRAD.

This study was designed to determine if a new condition-specific quality of life measure, the Quality Of Life in Reflux And Dyspepsia (QOLRAD), was responsive to clinical change over a four-week period when evaluating peptic ulcer disease patients undergoing Helicobacter pylori (Hp) eradication. A secondary aim was to evaluate QOLRAD's psychometric performance. Hp-positive patients with peptic ulcer disease were recruited from primary care and gastroenterology clinics (N = 155). QOLRAD scores improved significantly (P < 0.0001) and mean total score increase was 1.07 points on a 7-point scale among 111 subjects who responded to Hp eradication. Effect sizes were moderate for responders (0.64) and low for nonresponders (0.36). Score changes below 0.60 were associated with the smallest improvement in patient and physician condition rating; scores above 1.2 were associated with the greatest improvement. The QOLRAD demonstrates reliability and validity. Changes in QOLRAD score can be meaningfully related to clinical changes, aiding evaluation of health-related quality of life in peptic ulcer disease.

Spinal cord injury and quality of life measures: a review of instrument psychometric quality.

Quality of life (QOL) is often considered the primary endpoint in research, clinical medicine, and health promotion when impairments are incurable or insufficiently understood. For spinal cord injured (SCI) persons extended life spans and the need for life-long follow-up make it important to expand the outcome parameters of medical care and health services to include QOL measures. Review. The aim of this study was to evaluate QOL research in SCI persons from the perspective of current criteria for instrument psychometric quality developed by Medical Outcomes Trust (MOT). Relevant articles were extracted from the Medline, Cinahl, and PsycLit databases for approximately a recent 30-year period (1966 - 1999). The keyword 'spinal cord injuries' was cross-indexed with 'quality of life', 'personal satisfaction' and 'life satisfaction'. A total of 105 articles were identified and 46 met our inclusion criteria: (a) report of original research; (b) evaluation of QOL by self-report questionnaires or scales; and (c) publication in English. The quality of the research designs varied widely. Most of studies were cross-sectional with limited study populations. The number of instruments or different combinations of instruments nearly equalled the number of studies conducted. Most questionnaires were condition-specific and only used by the developers. The variety of instruments and the diversity of their core content made results difficult to compare, and evaluations and conclusions unpredictable and sometimes contradictory. The low psychometric standard of many instruments used further aggravates the interpretation of results. To improve future research in special populations such as the SCI, the MOT criteria for review of QOL instruments should be further disseminated and applied to reach desirable consensus of a limited number of standardised generic and condition-specific QOL measures.

Development of a condition-specific quality of life measure for patients with dentofacial deformity: I. Reliability of the instrument.

The assessment of quality of life is becoming increasingly important in clinical research. Its importance in dentistry has been realised only relatively recently. Health-related quality of life is concerned with the aspects of quality of life that relate specifically to an individual's health. This may be measured using two groups of instruments: (i) generic measures, which provide a summary of health-related quality of life and sometimes generate a single index measure of health or (ii) condition-specific measures, which focus on a particular condition, disease, population or problem and are potentially more responsive to small, but clinically important, changes in health. The aim of this study was to develop a condition-specific quality of life measure for those patients with severe dentofacial deformity who were requesting orthognathic treatment and to assess the reliability of this instrument. Instrument content was derived through a literature review and interviews with clinicians and patients. The resulting instrument was tested for internal consistency and test-retest reliability. The instrument was found to divide into four clinically meaningful domains. Internal consistency and test-retest reliability were good. Patient acceptance of the questionnaire was also encouraging.

‘Generic’ versus condition-specific quality of life measures in middle to late stage dementia

‘Generic’ versus condition-specific quality of life measures in middle to late stage dementia