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Life Measures (life + measure)
Selected AbstractsPatient-assessed health outcome measures for diabetes: a structured reviewDIABETIC MEDICINE, Issue 1 2002A. M. Garratt Abstract Aims To identify available disease-specific measures of health-related quality of life (HRQL) for diabetes and to review evidence for the reliability, validity and responsiveness of instruments. Methods Systematic searches were used to identify instruments. Instruments were assessed against predefined inclusion and exclusion criteria. Letters were sent to authors requesting details of further instrument evaluation. Information relating to instrument content, patients, reliability, validity and responsiveness to change was extracted from published papers. Results The search produced 252 references. Nine instruments met the inclusion criteria: Appraisal of Diabetes Scale (ADS), Audit of Diabetes-Dependent Quality of Life (ADDQoL), Diabetes Health Profile (DHP-1, DHP-18), Diabetes Impact Measurement Scales (DIMS), Diabetes Quality of Life Measure (DQOL), Diabetes-Specific Quality of Life Scale (DSQOLS), Questionnaire on Stress in Diabetic Patients-Revised (QSD-R), Diabetes-39 (D-39) and Well-being Enquiry for Diabetics (WED). The shortest instrument (ADS) has seven items and the longest (WED) has 50 items. The ADS and ADDQoL are single-index measures. The seven multidimensional instruments have dimensions covering psychological well-being and social functioning but vary in the remainder of their content. The DHP-1 and DSQOLS are specific to Type 1 diabetes patients. The DHP-18 is specific to Type 2 diabetes patients. The DIMS and DQOL have weaker evidence for reliability and internal construct validity. Patients contributed to the content of the ADDQoL, DHP-1/18, DQOL, DSQOLS, D-39, QSD-R and WED. The authors of the ADDQoL, DHP-1/18, DQOL, DSQOLS gave explicit consideration to content validity. The construct validity of instruments was assessed through comparisons with instruments measuring related constructs and clinical and sociodemographic variables. None of the instruments has been formally assessed for responsiveness to changes in health. Conclusions Five of the diabetes-specific instruments have good evidence for reliability and internal and external construct validity: the ADDQoL, DHP-1/18, DSQOLS, D-39 and QSD-R. Instrument content should be assessed for relevance before application. The instruments should be evaluated concurrently for validity and responsiveness to important changes in health. [source] Prevention of wound complications following salvage laryngectomy using free vascularized tissueHEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 5 2007FRCS(C), Kevin Fung MD Abstract Background. Total laryngectomy following radiation therapy or concurrent chemoradiation therapy is associated with unacceptably high complication rates because of wound healing difficulties. With an ever increasing reliance on organ preservation protocols as primary treatment for advanced laryngeal cancer, the surgeon must develop techniques to minimize postoperative complications in salvage laryngectomy surgery. We have developed an approach using free tissue transfer in an effort to improve tissue vascularity, reinforce the pharyngeal suture line, and minimize complications in this difficult patient population. The purpose of this study was to outline our technique and determine the effectiveness of this new approach. Methods. We conducted a retrospective review of a prospective cohort and compared it with a historical group (surgical patients of Radiation Therapy Oncology Group (RTOG)-91-11 trial). Eligibility criteria for this study included patients undergoing salvage total laryngectomy following failed attempts at organ preservation with either high-dose radiotherapy or concurrent chemo/radiation therapy regimen. Patients were excluded if the surgical defect required a skin paddle for pharyngeal closure. The prospective cohort consisted of 14 consecutive patients (10 males, 4 females; mean age, 58 years) who underwent free tissue reinforcement of the pharyngeal suture line following total laryngectomy. The historical comparison group consisted of 27 patients in the concomitant chemoradiotherapy arm of the RTOG-91-11 trial who met the same eligibility criteria (26 males, 1 female; mean age, 57 years) but did not undergo free tissue transfer or other form of suture line reinforcement. Minimum follow-up in both groups was 12 months. Results. The overall pharyngocutaneous fistula rate was similar between groups,4/14 (29%) in the flap group, compared with 8/27 (30%) in the RTOG-91-11 group. There were no major wound complications in the flap group, compared with 4 (4/27, 14.8%) in the RTOG-91-11 group. There were no major fistulas in the flap group, compared with 3/27 (11.1%) in the RTOG-91-11 group. The rate of pharyngeal stricture requiring dilation was 6/14 (42%) in the flap group, compared with 7/27 (25.9%) in the RTOG-91-11 group. In our patients, the rate of tracheoesophageal speech was 14/14 (100%), and complete oral intake was achieved in 13/14 (93%) patients. Voice-Related Quality of Life Measure (V-RQOL) and Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) scores suggest that speech and swallowing functions are reasonable following free flap reinforcement. Conclusions. Free vascularized tissue reinforcement of primary pharyngeal closure in salvage laryngectomy following failed organ preservation is effective in preventing major wound complications but did not reduce the overall fistula rate. Fistulas that developed following this technique were relatively small, did not result in exposed major vessels, and were effectively treated with outpatient wound care rather than readmission to the hospital or return to operating room. Speech and swallowing results following this technique were comparable to those following total laryngectomy alone. © 2007 Wiley Periodicals, Inc. Head Neck 2007 [source] Application of a Quality of Life Measure, the Life Situation Survey (LSS), to Alcohol-Dependent Subjects in Relapse and RemissionALCOHOLISM, Issue 11 2000J. H. Foster Background: Recent studies have shown that quality of life (QOL) is improved significantly when subjects do not relapse to heavy drinking, and QOL deteriorates significantly on prolonged relapse. This article further investigates these relationships using a QOL index, the Life Situation Survey (LSS). Methods: Eighty-two DSM-IV alcohol-dependent subjects admitted for alcohol detoxification were studied at baseline and 12 week follow-up. Sociodemographic data were collected, and severity of alcohol dependence (SADQ) and General Health Questionnaire (GHQ-12) were baseline indices only. The main outcome measure, the LSS, was administered at both time points. Results: Two subjects were lost to follow-up and one died during the study period. Thus, the relapse/nonrelapse analysis related to 79 subjects. Fifty subjects (63%) had relapsed to heavy drinking at 3 months follow-up. There was a significant correlation between LSS and GHQ-12 scores. Significant changes occurred in total LSS scores as a result of relapse and nonrelapse. The improvement in LSS scores associated with nonrelapse was larger than the deterioration that accompanied relapse. In those subjects who did not relapse to heavy drinking, the mean follow-up score remained in the poor/borderline LSS range. Remission from heavy drinking was accompanied by significant improvements in appetite, sleep, and self-esteem. Relapse to heavy drinking coincided with a significant deterioration in mood/affect, public support, and work/life role scores. Conclusion: QOL as assessed by the LSS in recently detoxified alcoholics is impaired significantly. In the nonrelapse group, there was a significant improvement in LSS scores after 3 months. Relapse was accompanied by a smaller deterioration in LSS scores. The LSS can play an important role in monitoring the clinical care and progress of alcohol-dependent subjects. [source] Is negative affectivity associated with oral quality of life?COMMUNITY DENTISTRY AND ORAL EPIDEMIOLOGY, Issue 6 2001Nancy R. Kressin Abstract ,Objectives: The personality trait of negative affectivity (NA) is associated with reports of worse physical health, more symptoms and worse health-related quality of life but its associations with oral quality of life (OQOL) are unexplored. In this study we examined the association of NA with OQOL. Methods: We drew on data from two samples of older men: The VA Dental Longitudinal Study (DLS; n=177) and the Veterans Health Study (VHS; n=514), which included three measures of oral quality of life: the Oral Health-Related Quality of Life Measure (OHQOL), the Oral Health Impact Profile (OHIP), and the Geriatric Oral Health Assessment Instrument (GOHAI). For each OQOL measure, and the GOHAI and OHIP subscales, two regression models were estimated to examine the marginal change in variance due to NA: the first model included age, number of teeth, and self-rated oral health, and the second added NA. Results: In both bivariate and multivariate analyses, higher NA was consistently associated with worse scores on the OQOL measures. In the regression analyses, NA explained an additional .01 to 18% of the variance in OQOL, explaining the most variance in the OHIP and the least in the OHQOL. The addition of NA explained more variance in the more subjective, psychologically oriented GOHAI and OHIP subscales than it did in the more objective, physical function oriented subscales. Conclusions: Psychosocial factors such as personality are significantly associated with quality of life ratings. Such associations should be taken into account when OQOL measurements are used and interpreted. [source] Assessing Levels of Agreement between Two Commonly Used Oral Health-Related Quality of Life MeasuresJOURNAL OF PUBLIC HEALTH DENTISTRY, Issue 3 2009Eduardo Bernabé MSc Abstract Objective: This study aimed to assess the level of agreement between two commonly used oral health-related quality of life (OHRQoL) measures, the short form of the Oral Health Impact Profile (OHIP14) and the Oral Impacts on Daily Performances (OIDP). Methods: A sample of 1,675 15- to 16-year-old students attending all schools in Bauru (Sao Paulo, Brazil) was selected. The impact of oral conditions on quality of life in the last 6 months was reported using both OHIP14 and OIDP. To allow for comparison with the 100 percent OIDP score, OHIP14 scores were converted to percentages. Then, agreement between the two OHRQoL measures was analyzed using the Bland and Altman method. Results: The mean difference between OHIP14 and OIDP was 6.48 percent [confidence interval95% (6.08; 6.89)], with higher scores reported for OHIP14 than for OIDP. Besides, 95 percent of the differences between the two OHRQoL measures were between ,10.59 and 23.56 percent. Finally, differences between OHIP14 and OIDP increased significantly as the magnitude of their average increased (P < 0.001). Conclusion: There was a moderate level of agreement between OHIP14 and OIDP, which may be partly due to the fact that both OHRQoL measures assess different levels of oral impacts on quality of life in addition to having different scoring systems. [source] Is Depressive Symptomatology Associated with Worse Oral Functioning and Well-being Among Older Adults?JOURNAL OF PUBLIC HEALTH DENTISTRY, Issue 1 2002Nancy R. Kressin PhD; Abstract Objectives: Although depression negatively affects individuals' physical functioning and well-being, its association with oral functioning and well-being has not been examined previously. The objective of this study was to examine the association between depressive symptomatology and oral quality of life. Methods: We utilized data from two samples of older adults: community-dwelling participants who used community primary care physicians in Los Angeles (n=7,653) and individuals who sought ambulatory care through four Department of Veterans Affairs facilities in the Boston metropolitan area (n=212). Depressive symptomatology was measured with the CES-D scale; Oral Quality of Life was measured with the Geriatric Oral Health Assessment Instrument and the Oral Health-related Quality of Life measure. We conducted hierarchical regression analyses to examine the effects of depression on oral quality of life, controlling for self-reported oral health, age, education, income, and marital status. Results: Individuals with more depressive symptoms reported worse oral quality of life, controlling for socio demographic factors and self-reported oral health. This finding persisted across multiple samples and both sexes, and using two measures of oral quality of life. Conclusion: These findings further emphasize the importance of treating depression among older adults, and suggest that both dentists and physicians have a role in recognizing and referring patients for such treatment. [source] Botulinum Toxin Type-A (BOTOX®) in the Treatment of Occipital Neuralgia: A Pilot StudyHEADACHE, Issue 10 2008Martin Taylor DO Objective., To determine the efficacy of occipital nerve blocks using reconstituted botulinum toxin type-A (BTX-A) in providing significant and prolonged pain relief in chronic occipital neuralgia. Background., Occipital neuralgia is a unilateral or bilateral radiating pain with paresthesias commonly manifesting as paroxysmal episodes and involving the occipital and parietal regions. Common causes of occipital neuralgia include irritation or injury to the divisions of the occipital nerve, myofascial spasm, and focal entrapment of the occipital nerve. Treatment options include medication therapy, occipital nerve blocks, and surgical techniques. BTX-A, which has shown promise in relief of other headache types, may prove a viable therapeutic option for occipital neuralgia pain. Methods., Botulinum toxin type-A (reconstituted in 3 cc of saline) was injected into regions traversed by the greater and lesser occipital nerve in 6 subjects diagnosed with occipital neuralgia. Subjects were instructed to report their daily pain level (on a visual analog pain scale), their ability to perform daily activities (on several quality of life instruments) and their daily pain medication usage (based on a self-reported log), 2 weeks prior to the injection therapy and 12 weeks following injection therapy. Data were analyzed for significant variation from baseline values. Results., The dull/aching and pin/needles types of pain reported by the subjects did not show a statistically significant improvement during the trial period. The sharp/shooting type of pain, however, showed improvement during most of the trial period except weeks 3-4 and 5-6. The quality of life measures exhibited some improvement. The headache-specific quality of life measure showed significant improvement by 6 weeks which continued through week 12. The general health- and depression-related measures showed no statistical improvement. No significant reduction in pain medication usage was demonstrated. Conclusions., Our results indicate that BTX-A improved the sharp/shooting type of pain most commonly known to be associated with occipital neuralgia. Additionally, the quality of life measures assessing burden and long-term impact of the headaches, further corroborated improvement seen in daily head pain. [source] A qualitative investigation of school-aged children's answers to items from a generic quality of life measureCHILD: CARE, HEALTH AND DEVELOPMENT, Issue 1 2007J. Cremeens Abstract Background, The development of instruments to measure child self-reported quality of life (QOL) is dependent on whether children can understand the concepts behind items. Researchers need more information on how children are interpreting and answering items. This paper aims to investigate the strategies school-aged children use to answer QOL items. Methods, A generic 30-item QOL measure (the TedQL) was administered to 266 healthy children (5,6, 7,9 years old). Children were asked to ,think aloud' while answering a selection of 10 TedQL items (n = 4 ability, n = 4 social, n = 2 mood items), and their responses were recorded verbatim. Results, The strategies children reported using when answering items were coded into five categories: (1) social comparisons; (2) stable character references; (3) concrete examples; (4) other reasons; or (5) no reason given. Concrete examples were used most frequently by children. Strategy type was dependent on age, with 7,9-year-olds reporting social comparisons and concrete examples more frequently than 5,6-year-olds. Five-to-six-year-olds gave no reasons for their response choices more frequently than 7,9-year-olds. Strategy type also differed by item type, with social comparisons used more frequently for ability items, and stable character references for social items. However, concrete examples were used consistently highly across ability and social items. Conclusions, Children aged 5,9 years most commonly report using concrete examples of specific instances when answering QOL items. However, strategy use varies as a function of age and types of items. Our results highlight the importance of keeping in mind children's developmental age when interpreting responses from child QOL instruments. [source] A randomised controlled trial of clinics in secondary schools for adolescents with asthmaCHILD: CARE, HEALTH AND DEVELOPMENT, Issue 1 2004Cliona Ni Bhrolchain Aim To test the hypothesis that delivery of a programme of asthma care in nurse-led clinics in school would improve access to care and health outcomes compared with care in general practice. Methods Pupils at four secondary schools in Bristol, North Somerset and South Gloucestershire, UK, were included in the randomized controlled trial. Another two schools were included to control for any cross-contamination between school clinic attenders and general practice attenders in the trial schools. Pupils in trial schools were randomly assigned to receive an invitation for an asthma review at school or in general practice. Schools were stratified for deprivation and covered rural, urban and suburban populations. Pupils with asthma were identified using a screening questionnaire and then cross-referenced with practice prescribing records. Four school nurses with additional specialist asthma training ran the school clinics weekly. Consultations concentrated on the needs and interests of adolescents and followed national guidelines for treatment changes. Reviews were arranged at 1 and 6 months, with an additional 3-month review if needed. The pupil's GP was kept informed. General practice care was according to the practice's usual treatment protocols. Primary outcomes were the proportion of pupils who had had an asthma review in 6 months, health-related quality of life and level of symptoms. Secondary outcomes were pupil knowledge and attitude to asthma, inhaler technique, the proportion taking inhaled steroids daily, school absence due to asthma, PEFR and pupil preference for the setting of care. Sample size was calculated to have an 80% chance of showing an increase from 40% to 60% having a review in 6 months and half a standard deviation improvement on the quality of life measure. Analysis was on an intention to treat basis. Results School clinic pupils were more likely to attend (91% vs. 51%). However, symptom control or quality of life were no better. School clinic pupils knew more about asthma, had a more positive attitude and better inhaler technique. Absence and PEFR showed no difference. 63% who attended school clinics preferred this model but, taking both groups together, just over half would prefer to attend their GP for follow-up. Cost of care (including practice, school clinic, hospital and medication) was £32.10 at school, £19.80 at the trial practices and £18.00 at control practices. Conclusions Previous evaluations of nurse-led asthma clinics in practice have also failed to show improvements in outcomes, though process measures do improve. This may be due to the need for nurses to refer patients to doctors for changes in medication, rather than doing this themselves. Some weaknesses in study design that may have affected outcome, but the essential conclusion is that nurse-led asthma clinics in school are not cost effective. The study does suggest that such clinics can reach a high proportion of adolescents, but for asthma at least this does not result in any measurable improvement in outcome. [source] Quality of life for patients with a personality disorder , comparison of patients in two settings: an English special hospital and a Dutch TBS clinicCRIMINAL BEHAVIOUR AND MENTAL HEALTH, Issue 3 2001Dr Mark Swinton Consultant Forensic Psychiatrist Introduction There are differing approaches to the management of people with a severe personality disorder in the UK and The Netherlands. Few comparative studies exist. This study describes the use of an adapted version of the Lancashire Quality of life profile as a patient based-outcome measure. Method A cross-sectional sample of 37 patients was interviewed at each site. Result Patients in the Dutch service reported a significantly higher quality of life which could not be explained by better objective circumstances. Discussion The data collected do not explain why the Dutch patients reported a higher quality of life. It is suggested that this finding was related to more extensive therapeutic activity and greater therapeutic optimism in the Dutch service. There is a need for critical scrutiny of the appropriateness of quality of life measures in offender patients before they are accepted for use as an outcome measure. Copyright © 2001 Whurr Publishers Ltd. [source] Health-related quality of life measures and psychiatric comorbidity in patients with migraineEUROPEAN JOURNAL OF NEUROLOGY, Issue 9 2009M. Mula Background and purpose:, The identification of factors associated to health-related quality of life (HRQoL) measures in patients with migraine has major implications in terms of prognosis and treatment. This study aimed at investigating associations between HRQoL and comorbid mood and anxiety disorders. Methods:, Consecutive adult outpatients with a diagnosis of migraine with or without aura were assessed using the Mini International Neuropsychiatric Interview (M.I.N.I.) Plus version 5.0.0 and the Migraine-Specific Quality-of-Life Questionnaire (MSQ). Results:, Data of 112 patients (82 females), 69 without aura, mean age 41.2 ± 13.3 years were analyzed. According to the M.I.N.I., 50% patients had a lifetime or current DSM-IV diagnosis of mood or anxiety disorder. There was no between-groups difference in MSQ total and subscale scores in relation to the presence/absence of psychiatric comorbidity, independently whether that was current or lifetime. In the group of subjects with psychiatric disorders, age at onset of migraine correlated with MSQ-total (rho = ,0.407 P = 0.002), and subscale scores (Role Function-Restrictive, rho = ,0.397, P = 0.002; Emotional Function, rho = ,0.487, P < 0.001). Conclusions:, Our findings suggest that current and/or lifetime psychiatric comorbidities are not associated with HRQoL measures in patients with migraine. However, patients with migraine and psychiatric comorbidities may represent a specific subgroup deserving particular attention for targeted interventions. [source] A Double-Blind Comparison of OnabotulinumtoxinA (BOTOX®) and Topiramate (TOPAMAX®) for the Prophylactic Treatment of Chronic Migraine: A Pilot StudyHEADACHE, Issue 10 2009Ninan T. Mathew MD Background., There is a need for effective prophylactic therapy for chronic migraine (CM) that has minimal side effects. Objective., To compare the efficacy and safety of onabotulinumtoxinA (BOTOX®, Allergan, Inc., Irvine, CA) and topiramate (TOPAMAX®, Ortho-McNeil, Titusville, NJ) prophylactic treatment in patients with CM. Methods., In this single-center, double-blind trial, patients with CM received either onabotulinumtoxinA, maximum 200 units (U) at baseline and month 3 (100 U fixed-site and 100 U follow-the-pain), plus an oral placebo, or topiramate, 4-week titration to 100 mg/day with option for additional 4-week titration to 200 mg/day, plus placebo saline injections. OnabotulinumtoxinA or placebo saline injection was administered at baseline and month 3 only, while topiramate oral treatment or oral placebo was continued through the end of the study. The primary endpoint was treatment responder rate assessed using Physician Global Assessment 9-point scale (+4 = clearance of signs and symptoms and ,4 = very marked worsening [about 100% worse]). Secondary endpoints included the change from baseline in the number of headache (HA)/migraine days per month (HA diary), and HA disability measured using Headache Impact Test (HIT-6), HA diary, Migraine Disability Assessment (MIDAS) questionnaire, and Migraine Impact Questionnaire (MIQ). The overall study duration was approximately 10.5 months, which included a 4-week screening period and a 2-week optional final safety visit. Follow-up visits for assessments occurred at months 1, 3, 6, and 9. Adverse events (AEs) were documented. Results., Of 60 patients randomized to treatment (mean age, 36.8 ± 10.3 years; 90% female), 36 completed the study at the end of the 9 months of active treatment (onabotulinumtoxinA, 19/30 [63.3%]; topiramate, 17/30 [56.7%]). In the topiramate group, 7/29 (24.1%) discontinued study because of treatment-related AEs vs 2/26 (7.7%) in the onabotulinumtoxinA group. Between 68% and 83% of patients for both onabotulinumtoxinA and topiramate groups reported at least a slight (25%) improvement in migraine; response to treatment was assessed using Physician Global Assessment at months 1, 3, 6, and 9. Most patients in both groups reported moderate to marked improvements at all time points. No significant between-group differences were observed, except for marked improvement at month 9 (onabotulinumtoxinA, 27.3% vs topiramate, 60.9%, P = .0234, chi-square). In both groups, HA/migraine days decreased and MIDAS and HIT-6 scores improved. Patient-reported quality of life measures assessed using MIQ after treatment with onabotulinumtoxinA paralleled those seen after treatment with topiramate in most respects. At month 9, 40.9% and 42.9% of patients in the onabotulinumtoxinA and topiramate groups, respectively, reported ,50% reduction in HA/migraine days. Forty-one treatment-related AEs were reported in 18 onabotulinumtoxinA-treated patients vs 87 in 25 topiramate-treated patients, and 2.7% of patients in the onabotulinumtoxinA group and 24.1% of patients in the topiramate group reported AEs that required permanent discontinuation of study treatment. Conclusions., OnabotulinumtoxinA and topiramate demonstrated similar efficacy in the prophylactic treatment of CM. Patients receiving onabotulinumtoxinA had fewer AEs and discontinuations. [source] Botulinum Toxin Type-A (BOTOX®) in the Treatment of Occipital Neuralgia: A Pilot StudyHEADACHE, Issue 10 2008Martin Taylor DO Objective., To determine the efficacy of occipital nerve blocks using reconstituted botulinum toxin type-A (BTX-A) in providing significant and prolonged pain relief in chronic occipital neuralgia. Background., Occipital neuralgia is a unilateral or bilateral radiating pain with paresthesias commonly manifesting as paroxysmal episodes and involving the occipital and parietal regions. Common causes of occipital neuralgia include irritation or injury to the divisions of the occipital nerve, myofascial spasm, and focal entrapment of the occipital nerve. Treatment options include medication therapy, occipital nerve blocks, and surgical techniques. BTX-A, which has shown promise in relief of other headache types, may prove a viable therapeutic option for occipital neuralgia pain. Methods., Botulinum toxin type-A (reconstituted in 3 cc of saline) was injected into regions traversed by the greater and lesser occipital nerve in 6 subjects diagnosed with occipital neuralgia. Subjects were instructed to report their daily pain level (on a visual analog pain scale), their ability to perform daily activities (on several quality of life instruments) and their daily pain medication usage (based on a self-reported log), 2 weeks prior to the injection therapy and 12 weeks following injection therapy. Data were analyzed for significant variation from baseline values. Results., The dull/aching and pin/needles types of pain reported by the subjects did not show a statistically significant improvement during the trial period. The sharp/shooting type of pain, however, showed improvement during most of the trial period except weeks 3-4 and 5-6. The quality of life measures exhibited some improvement. The headache-specific quality of life measure showed significant improvement by 6 weeks which continued through week 12. The general health- and depression-related measures showed no statistical improvement. No significant reduction in pain medication usage was demonstrated. Conclusions., Our results indicate that BTX-A improved the sharp/shooting type of pain most commonly known to be associated with occipital neuralgia. Additionally, the quality of life measures assessing burden and long-term impact of the headaches, further corroborated improvement seen in daily head pain. [source] Pregabalin for peripheral neuropathic pain: results of a multicenter, non-comparative, open-label study in Indian patientsINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 9 2006LYRICA STUDY GROUP Summary The aim of this study was to evaluate the tolerability, safety and efficacy of pregabalin in Indian patients with peripheral neuropathic pain. In this prospective, multicenter, non-comparative, open-label study, patients with peripheral neuropathic pain (n = 111) received pregabalin in doses ranging from 75 to 300 mg twice daily for 3 weeks. Primary efficacy measures included weekly pain score and the Visual Analogue Scale (VAS) score of the Short-Form McGill Pain Questionnaire (SF-MPQ). Despite a short study duration, a significant reduction was seen in weekly pain score (p < 0.0001), as well as VAS score of SF-MPQ (p < 0.0001). Significant improvements were also seen in other pain-related endpoints, weekly sleep interference score, quality of life measures, and patient and clinician ratings of global improvement. Pregabalin was well tolerated, and the most common adverse events were dizziness and somnolence. The short study duration precluded the assessment of longer term safety issues such as weight gain. This study has demonstrated the safety, tolerability and efficacy of pregabalin for peripheral neuropathic pain in Indian patients. [source] Exploring nursing outcomes for patients with advanced cancer following intervention by Macmillan specialist palliative care nursesJOURNAL OF ADVANCED NURSING, Issue 6 2003Jessica Corner BSc PhD RGN OncCert Background.,Little information exists about the outcomes from nursing interventions, and few studies report new approaches to evaluating the complex web of effects that may result from specialist nursing care. Aims.,The aim of this study was to explore nursing outcomes for patients with advanced cancer that may be identified as resulting from the care of a Macmillan specialist palliative care nurse. Methods/instruments.,Seventy-six patients referred to 12 United Kingdom Macmillan specialist palliative care nursing services participated in a longitudinal study of their care over 28 days. Patients were interviewed and completed the European Organization for Research on Treatment of Cancer Quality of Life Scale and the Palliative Care Outcomes Scale at referral, and 3, 7 and 28 days following referral to a Macmillan specialist palliative care nursing service. A nominated carer was interviewed at baseline and 28 days. Notes recorded by Macmillan specialist palliative care nurses in relation to each patient case were analysed. Findings.,Significant improvements in emotional (P = 0·03) and cognitive functioning (P = 0·03) were identified in changes in patients' European Organization for Research on Treatment of Cancer Quality of Life Scale scores, and in Palliative Care Outcomes Scale patient anxiety scores (P = 0·003), from baseline to day 7. Analysis of case study data indicated that overall positive outcomes of care from Macmillan specialist palliative care nursing intervention were achieved in 42 (55%) cases. Study limitations.,Sample attrition due to patients' deteriorating condition limited the value of data from the quality of life measures. The method developed for evaluating nursing outcomes using data from patient and carer interviews and nursing records was limited by a lack of focus on outcomes of care in these data sources. Conclusions.,A method was developed for evaluating outcomes of nursing care in complex situations such as care of people who are dying. Positive outcomes of care for patients that were directly attributable to the care provided by Macmillan specialist palliative care nurses were found for the majority of patients. For a small number of patients, negative outcomes of care were identified. [source] Current treatment strategies for pulmonary arterial hypertensionJOURNAL OF INTERNAL MEDICINE, Issue 3 2005S. H. LEE Abstract., Lee SH, Rubin LJ (University of California, San Diego, La Jolla, CA, USA). Current treatment strategies for pulmonary arterial hypertension (Review). J Intern Med 2005; 258: 199,215. Pulmonary arterial hypertension (PAH) is a disease characterized by an elevation in pulmonary artery pressure that can lead to right ventricular failure and death. Although there is no cure for PAH, newer medical therapies have been shown to improve a variety of clinically relevant end-points including survival, exercise tolerance, functional class, haemodynamics, echocardiographic parameters and quality of life measures. Since the introduction of continuous intravenous prostacyclin, the treatment armamentarium of approved drugs for PAH has expanded to include prostacyclin analogues with differing routes of administration, a dual endothelin receptor antagonist, and a phosphodiesterase-5 inhibitor. Selective endothelin-A receptor antagonists have shown promise in clinical trials and are likely to be added to the list of options. As the number of medications available for PAH continues to increase, treatment decisions regarding first-line therapy, combination treatments, and add-on strategies are becoming more complex. This article reviews the current treatments strategies for PAH and provides guidelines for its management. [source] Social Support and Quality of Life Among Older People in SpainJOURNAL OF SOCIAL ISSUES, Issue 4 2002Ballesteros, Rocío Fernández Social support is a key concept in social gerontology; there is empirical evidence of its relationships with health, well,being and quality of life in old age. The density of an individual's social relationships, the degree to which he/she interacts with others and how much he/she receives and gives affect, instrumental support, and/or services are all associated with health indicators, subjective well,being, and quality of life measures. This article deals with social support in old age in Spain, its relationships with health indicators, and its role in quality of life. Several descriptive studies dealing with social integration, frequency of social interactions, satisfaction with social relationships, and formal and informal social support are reviewed. Finally, the role attributed by elders to social relationships is an important conditioning factor of quality of life. [source] The use of quality of life measures in oral medicine: a review of the literatureORAL DISEASES, Issue 5 2010R Ni Riordain Oral Diseases (2010) 16, 419,430 Objectives:, To explore the use of patient reported quality of life measures in oral medicine, to highlight the importance of use of these measures in oral medicine practice and to provide guidance for the selection of such measures in the future. Methods:, A detailed literature review was undertaken to investigate the use of quality of life measures in oral medicine. The databases searched were MEDLINE (through PubMed), EMBASE, CINDHL, Web of Science Citation Index and the Cochrane Database of Systematic Reviews and randomised controlled trials. Results:, The initial literature search yielded a total of 5310 citations; however, only 63 of these fulfilled the inclusion criteria. Twenty-two articles were regarding oral mucosal conditions, 14 related to orofacial pain disorders and 27 were regarding salivary gland-related conditions. Conclusions:, The evaluation of quality of life in oral medicine has a broad applicability, providing information in treatment-based studies and population-based studies. A predominance of generic and oral health specific quality of life measures are being used to a limited extent in oral medicine practice. A scarcity of reports of the development, validation or use of disease specific measures is evident. [source] An Open-Label Study of the Lidocaine Patch 5% in Painful Idiopathic Sensory PolyneuropathyPAIN MEDICINE, Issue 5 2005David N. Herrmann MBBCh ABSTRACT Objective., Painful idiopathic distal sensory polyneuropathy is common, but has been largely ignored as a model for the evaluation of neuropathic pain therapies. We have therefore conducted a safety, tolerability, and effectiveness study of the lidocaine patch 5% in painful idiopathic distal sensory polyneuropathy. Design., A prospective open-label, flexible dosing, 3-week study period with a 5-week extension. Setting., Peripheral Neuropathy clinics and Anesthesiology Clinical Research Center at a tertiary care facility. Patients., Twenty subjects with a diagnosis of idiopathic distal sensory polyneuropathy (with or without associated impaired glucose tolerance), with a baseline mean pain daily rating of ,4 on a visual analog scale. Intervention., Lidocaine patch 5%, maximum of four patches daily for 18 hours. Main Outcome Measure., Change from baseline week to week 3 mean daily diary pain ratings. Secondary endpoints included assessments of safety and tolerability as well as quality of life measures. Results., Subjects with idiopathic distal sensory polyneuropathy, both with and without impaired glucose tolerance, showed significant improvements in pain and quality of life outcome measures over a 3-week treatment period. These improvements were maintained in a subgroup of patients treated for an additional 5 weeks and permitted a taper of concomitant analgesics in 25% of subjects. The lidocaine patch 5% was well tolerated. Conclusions., The lidocaine patch 5% appeared well tolerated and potentially effective in the management of painful idiopathic distal sensory polyneuropathy. Idiopathic distal sensory polyneuropathy is an appropriate patient population for the conduct of clinical trials of neuropathic pain therapies. [source] Behavior and quality of life measures after anesthesia for tonsillectomy or ear tube insertion in childrenPEDIATRIC ANESTHESIA, Issue 10 2010KELLY HOWARD BSc (HONS) Summary Background:, Past research examining the psychosocial impact of general anesthesia and day case surgery on children has been hampered by a lack of valid and reliable assessment tools. Aim:, The purpose of the current study was to assess the feasibility of using a well-validated scale (i.e. the Pediatric Quality of Life Inventory Generic Core Scales Version 4.0, PedsQL) in the perioperative setting and to establish changes seen in a sample of children having day case surgery when using this scale. Method:, Eighty-nine children (aged 3,12 years) scheduled for general anesthesia for day case tonsillectomy or ear tube insertions were recruited into a prospective study in Melbourne, Australia. Parents completed the PedsQL and the Post Hospitalization Behavioral Questionnaire (PHBQ), and children completed the PedsQL (child self-report) at baseline (preanesthesia), 7 days following anesthesia and 30 days following anesthesia. Results:, The response rate at day 7 and day 30 was modest but when returned the PedsQL and PHBQ had minimal missing data. On the PedsQL, parents rated children's physical functioning as worse at day 7 than at baseline but psychosocial functioning did not differ significantly from baseline. At 30 days, both physical and psychosocial functioning was rated by parents to be better than baseline levels. From children's perspective, there was little evidence of a change in their physical or psychosocial functioning on the self-report PedsQL at day 7, but by day 30 both physical and psychosocial functioning was above baseline levels. A similar pattern was observed on the PHBQ, with little difference in ratings of behavioral problems between baseline and day 7, but less behavioral problems reported at day 30 compared with baseline. Conclusions:, The PedsQL is feasible for use in the perioperative setting. Future studies should take into account the possibility that deterioration of psychosocial functioning is uncommon at 1 -month postsurgery compared to the preoperative baseline. [source] Health-related quality of life measures in genetic disorders: An outcome variable for consideration in clinical trials,AMERICAN JOURNAL OF MEDICAL GENETICS, Issue 3 2009David A. Stevenson Abstract The field of medical genetics is rapidly advancing, and therapeutic options to treat genetic syndromes are becoming increasingly available. An understanding of the pathophysiology of various genetic disorders has provided researchers the opportunity to propose and test pharmacologic agents in preclinical murine models with hopes of translation to human trials. The development of clinical trials can be costly and time consuming, particularly for rare conditions. Pilot feasibility studies should be performed when designing clinical trials for genetic disorders. The development and selection of appropriate outcome measures are particularly paramount in the implementation of clinical trials. The selection of inappropriate outcome measures can lead to non-measurable differences or clinically insignificant findings. In addition, just as age appropriate measures are needed, some instruments may not apply to populations with specific genetic disorders that have significant cognitive and physical impairment, as the measures may not be sensitive enough to identify clinically significant changes. In the last decade, health-related quality of life measures (HRQOL) have been increasingly included as an outcome measure in clinical trials. While traditional clinical outcomes are important, these newly developed instruments should be considered along with clinical indicators as measures of effect in clinical trials of interventions in genetic disorders. © 2009 Wiley-Liss, Inc. [source] Standardized versus open-ended assessment of psychosocial and medical concerns among African American breast cancer patientsPSYCHO-ONCOLOGY, Issue 5 2006Rebecca A. Shelby Abstract Standardized quality of life measures have been developed and used primarily with Caucasian and middle-class cancer patients. This study assessed the ability of several widely used standardized measures to capture the concerns and problems of 89 African American breast cancer patients. Concerns and problems were assessed using both an open-ended format and standardized measures. The degree of overlap in responses from these two formats was examined. The most frequently reported problems in the open-ended format included physical (43%), financial (40%), and worry about others (30%). Overall, standardized measures had significant overlap with open-ended concerns and problems. The Cancer Rehabilitation Evaluation System-Short Form subscales/items were associated with corresponding open-ended physical, financial, and social problems (R2 change=0.07,0.16, p's,0.02), the Interpersonal Support Evaluation List-Short Form was associated with open-ended social problems (R2 change=0.11, p=0.004), and the Mental Health Inventory was associated with open-ended psychological distress problems (R2 change=0.08, p=0.01). One category of open-ended problems, worry about others, was not captured by standardized measures. With the exception of associations between open-ended physical problems and psychological distress measures, there were few significant correlations between standardized measures and dissimilar problem categories. These findings suggest that the standardized measures in this study reflected the concerns and problems of African American breast cancer patients. Additional studies are needed to evaluate the utility of other widely used standardized measures that have not been developed or standardized among non-white samples. Copyright © 2005 John Wiley & Sons, Ltd. [source] Development of a disease specific questionnaire to supplement a generic tool for QoL in colorectal cancerPSYCHO-ONCOLOGY, Issue 7 2003J. Davidson-Homewood The need for disease-specific quality of life measures is highlighted in the literature. The psychometric properties of a supplementary disease-specific quality of life questionnaire developed for use with a generic Quality of Life tool in colorectal cancer patients are explored. Originally developed and tested in a German sample, the English translation was tested on a cohort of UK colorectal cancer patients. Relevance and acceptability was previously established in Germany. A rigorous factor analysis ascertained the underlying structure of two factors with a number of single items that were retained as clinically important symptom indicators. In considering validity, four conditions were assessed: Reliability using Cronbach's alpha; Construct validity by comparing patient subgroups; Clinical Validity, by testing the hypothesis that some patient subgroups experience worse quality of life; Construct Reliability using second order factor analysis with the EORTC QOLQ-C30 scales, confirming that the factors retained provide an excellent measure of physical discomfort and a good measure of physical well being. Two other such questionnaires were developed in parallel with this one and reported in the literature (FACT-C and QOLQ-CR38). However, this questionnaire provides a useful alternative tool for use in clinical trials of colorectal cancer treatments alongside a core QoL questionnaire especially when brevity is an important consideration. Copyright © 2003 John Wiley & Sons, Ltd. [source] Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis,ANNALS OF NEUROLOGY, Issue 2 2010Bruce A. C. Cree MD Objective To evaluate the efficacy of 4.5mg nightly naltrexone on the quality of life of multiple sclerosis (MS) patients. Methods This single-center, double-masked, placebo-controlled, crossover study evaluated the efficacy of 8 weeks of treatment with 4.5mg nightly naltrexone (low-dose naltrexone, LDN) on self-reported quality of life of MS patients. Results Eighty subjects with clinically definite MS were enrolled, and 60 subjects completed the trial. Ten withdrew before completing the first trial period: 8 for personal reasons, 1 for a non,MS-related adverse event, and 1 for perceived benefit. Database management errors occurred in 4 other subjects, and quality of life surveys were incomplete in 6 subjects for unknown reasons. The high rate of subject dropout and data management errors substantially reduced the trial's statistical power. LDN was well tolerated, and serious adverse events did not occur. LDN was associated with significant improvement on the following mental health quality of life measures: a 3.3-point improvement on the Mental Component Summary score of the Short Form-36 General Health Survey (p = 0.04), a 6-point improvement on the Mental Health Inventory (p < 0.01), a 1.6-point improvement on the Pain Effects Scale (p =.04), and a 2.4-point improvement on the Perceived Deficits Questionnaire (p = 0.05). Interpretation LDN significantly improved mental health quality of life indices. Further studies with LDN in MS are warranted. ANN NEUROL 2010 [source] Is physical activity influenced by urinary incontinence?BJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 5 2004Beata Stach-Lempinen Objective To evaluate physical activity among urinary incontinent women seeking treatment and to assess the change of physical activity after treatment. Design Part of a prospective observational intervention study to examine the factors influencing the severity of urinary incontinence. Setting Tampere University Hospital,referral unit. Population Eighty-two urinary incontinent women were evaluated in the baseline and 69 (84%) one year (mean 13 months, range 6,21) after treatment. Methods Physical activity was measured by self-report questionnaire and electronic motion sensor: Caltrac accelerometer worn by women for one week. The diagnosis and severity of urinary incontinence was estimated on the basis of urodynamics, pad test, diary and incontinence-specific quality of life measures. Treatment outcome was assessed according to objective parameters and patients satisfaction. Main outcome measures Physical activity at work, leisure and sport expressed in MET (metabolic unit) and kilocalories, change in physical activity after treatment. Results Twenty-one (25.6%) of all women reported exercise of more than three times per week. Incontinent women with the highest leisure time activity ,6 MET (n= 23, above 75th centile) were younger; they had less body mass index and greater urine leakage than others. One year after treatment, there was no change in any parameters of physical activities. Also exercise habits among women who were completely dry (n= 37) after treatment were not changed. Conclusion Urinary incontinent women who seek treatment are as physically active as the normal population. Even after successful incontinence treatment, exercise habits do not change. [source] Randomized cross-over clinical trial of injectable vs. implantable depot testosterone for maintenance of testosterone replacement therapy in androgen deficient menCLINICAL ENDOCRINOLOGY, Issue 1 2010Carolyn Fennell Summary Background, Life-long testosterone replacement therapy (TRT) for younger men with organic androgen deficiency is best provided by depot testosterone (T) products. This study compared directly the two long-acting depot T products, subdermal T implants (TI) and injectable T undecanoate (TU) for maintenance of TRT. Design, setting and participants, Men with organic androgen deficiency (n = 38) undergoing regular TRT at an academic Andrology centre were recruited for a two period, randomized sequence, cross-over clinical trial without intervening wash-out period of TRT maintenance. Outcomes, For both depot T products, their pharmacokinetics and pharmacodynamics were evaluated using a range of androgen sensitive clinical, laboratory and quality of life measures as well as preference for ongoing treatment after experience of both products. Results, The two depot T products had distinct pharmacokinetics and were not bioequivalent. However, there were no consistent clinical differences in a comprehensive range of pharmacodynamic measures reflecting androgen effects on biochemistry and haematology, muscle mass and strength, and quality of life, mood and sexual function. The majority (91%) of participants chose TU over TI at study completion. Conclusion, Despite significant pharmacokinetic differences, the two depot T products are clinically interchangeable allowing for choice dependent on patient and physician delivery preference in practice but most patients preferred the injectable over the implantable form. [source] A pilot study of ultrasound guided Durasphere injection in the treatment of faecal incontinenceCOLORECTAL DISEASE, Issue 9 2010A. D. Beggs Abstract Aim, To assess injection of Durasphere under direct endoanal ultrasound guidance as a treatment for faecal incontinence. Method, A total of 23 patients with varying degrees of persistent faecal leakage and/or soiling were recruited. Durasphere was injected in the intersphincteric plane under direct ultrasound guidance. All patients were given a general anaesthetic. Patients had ano-rectal physiology, endoanal ultrasound, continence scoring and quality of life measures assessed at 0, 1, 3, 6 and 12 months. Results, A total of 21 patients were followed up for at least 12 months, with two being excluded at the follow-up stage. Friedman two-way analysis of variance of the Cleveland Clinic Score, Faecal Incontinence Quality of Life Score and Diary Response Score demonstrated a significant sustained improvement. There was no significant improvement in number of bowel movements. There was a significant difference in anal squeeze pressure after therapy, but no significant difference in anal resting pressure. Six patients reported no improvement after Durasphere therapy. Conclusions, Durasphere gave sustained improvements in quality of life and continence scores in this study group. Strict criteria are needed to ascertain suitability for Durasphere therapy. [source] Validity of two oral health-related quality of life measuresCOMMUNITY DENTISTRY AND ORAL EPIDEMIOLOGY, Issue 2 2003Peter G. Robinson Abstract , Objectives: To assess the validity of the Oral Impacts on Daily Performance (OIDP) and the short form of the Oral Health Impact Profile (OHIP 14) in the UK. Setting: Primary care department at a UK dental hospital. Sample: Consecutive patients. Method: Cross-sectional comparison of impacts using OIDP and OHIP 14 against clinical findings, Global Oral Health Ratings and pain. Results: A total of 179 patients participated (83.2% response rate). OIDP had weak face validity because it contained contingency questions. Both instruments were developed from the same theoretical model and appeared to have reasonable content validity. In regression analyses, the number of impacts detected by each measure and the total score using OHIP 14 were related to the presence of oral disease and inversely related to age. No suitable transformation could be found to allow regression analysis of OIDP total scores. OHIP 14 correlated more closely with Global Oral Health Ratings but both measures correlated similarly to the experience of pain (0.43 < r < 0.47). The correlation between OHIP and OIDP scores was +0.78. The use of a simple additive method for calculating the total OHIP 14 score did not compromise its validity. Conclusion: Both instruments have some validity as measures of Oral Health-Related Quality of Life (OHRQoL) among dental hospital patients. The superior face, criterion and convergent validity and greater amenability to analysis of OHIP 14 render it more suitable for questionnaire-based research and for comparing groups. The additive method may be used to calculate the total score for OHIP 14. 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