Disease-specific Quality Of Life Tool Research Articles

Quality of life in Hidradenitis Suppurativa (Acne Inversa): A scoping review.

Hidradenitis Suppurativa (HS) is a chronic, relapsing, inflammatory skin condition which is physically, psychologically and socially disabling and often affects a patient's quality of life (QOL). There are numerous QOL tools used in dermatology. However, assessment of QOL in patients with HS is difficult due to the inability of generic QOL tools to specifically capture QOL in patients with HS. Numerous HS-specific QOL tools have been developed in recent years. It is important to identify evidence on full psychometric evaluation of these tools. There has been a gradual increase in the use of generic and disease-specific QOL tools in the last few decades. The aim of this scoping review (SR) is to evaluate the most widely used generic QOL tools and HS-specific QOL tools to identify the psychometric evaluation of such tools. Design: An SR guided by Joanna Briggs Institute manual and Arskey O'Malley framework guidelines. Data extraction included the studies available on full psychometric evaluation of the most widely used dermatology generic QOL tools in HS and HS-specific QOL tools. Ten papers were included in the review, eight papers demonstrated HS-specific QOL assessment tools. The psychometric properties of these tools were underpinned by reliability, validity and sensitivity measurement. Six disease-specific tools were identified in this SR. However, they all lack full psychometric evaluation. This review indicates that an extensive research in the field of QOL tools for HS is much needed. It is crucial to develop user-friendly and validate disease-specific tools to measure the real impact of disease on patients QOL. QOL instruments can evaluate the impact on life of an HS patient, thus helping improve intervention and management of disease. There is a necessity for more research into existing HS-specific QOL tools and they should be widely tested and fully validated.

Rhinosinusitis and its impact on quality of life in children.

Rhinitis and rhinosinusitis are common conditions which have a significant burden on healthcare services and can lead to reduced productivity in patients across the entire age spectrum. Three disease-specific quality of life tools were analysed in hospital and community settings to explore prevalence, disease characteristics and financial costs to sufferers, and to compare these aspects between cohorts (young children, young adult and adults). These tools were Modified Sino-Nasal Outcome Test-20 (MSNOT-20) questionnaire for adults, MSNOT-20 Young Persons Questionnaire (MSYPQ) for 11-16-year-olds and Sami's Rhinosinusitis Diagnosis and Impact questionnaire for 5-10-year-olds. One of the top three symptoms in children aged 5-10 years was cough, which is a much less common symptom in adults. These validated, disease-specific, quality of life questionnaires provide a fuller illustration of the patient experience, allowing comprehensive comparative analysis across the ages.

Effect of Pegcetacoplan on Quality of Life in Patients with Paroxysmal Nocturnal Hemoglobinuria from the Pegasus Phase 3 Trial Comparing Pegcetacoplan to Eculizumab

Effect of Pegcetacoplan on Quality of Life in Patients with Paroxysmal Nocturnal Hemoglobinuria from the Pegasus Phase 3 Trial Comparing Pegcetacoplan to Eculizumab

Design and development of a disease-specific quality of life tool for patients with aplastic anaemia and/or paroxysmal nocturnal haemoglobinuria (QLQ-AA/PNH)\u2014a report on phase III

To date, instruments to measure quality of life (QoL) specifically for patients with acquired aplastic anaemia (AA) and paroxysmal nocturnal haemoglobinuria (PNH) are lacking altogether. As a consequence, this issue is either underevaluated or alternatively, instruments originally designed for cancer patients are being used. We therefore started to systematically develop a AA/PNH-specific QoL (QLQ-AA/PNH) instrument in these ultra-rare diseases according to European Organisation for Research and Treatment of Cancer (EORTC) guidelines. While phases I and II of the process have previously been published, we now report on the resulting instrument (phase III of this process). As part of the phase III of the evaluation process, we approached patients through physicians, patient support groups, and patient conferences. After participants completed the preliminary questionnaire and reported socio-demographic data, they were interviewed in person or via phone with a debriefing interview to find out whether the items were relevant, easy to understand, and acceptable to patients and whether there was anything missing in the questionnaire. We hypothesised what items could be combined into a scale and calculated Cronbach’s alpha to define its preliminary internal consistency. After definition of a priori criteria to keep or delete items, a group of six experts met in person, discussed the results, and decided on in- or exclusion. A total of 48 patients were enrolled, 21 of those suffered from AA (44%), 13 from PNH (27%), and 14 from AA/PNH syndrome (29%). The median time to complete the 69 items was 10 min (range 5–20), mean time 11 min. The compliance criterion (> 95% completion) was fulfilled by 57 items. Twenty-three items were mentioned as especially relevant by ≥ 2% of the patients. Cronbach’s alpha of the hypothesised scales ranged from 0.63 (social support) to 0.92 (fear of progression and illness intrusiveness). Finally, 47 items were kept; 16 were deleted, and 5 were changed, while 1 item expanded. This resulted in 54 items in total. As no issues were mentioned to lacking by a minimum of five patients, no items were added to the questionnaire. After completion, the AA/PNH-QoL tool (QLQ-AA/PNH) was translated according to EORTC guidelines into English, French, and Italian. For patients with PNH and AA until now, the standard assessment for QoL was to use the EORTC Quality of Life Questionnaire (QLQ-C30) or the Functional Assessment of Chronic Illness Therapy Fatigue Instrument (FACIT-Fatigue). We herewith present a new instrument aimed to be better tailored to the needs of PNH and AA patients. The anticipated fourth development phase will be performed for psychometric validation; however, we already explored the internal consistency of the hypothesised scales and found the results to be very good. Hence, the new QLQ-AA/PNH with 54 items can be used in trials and clinical studies from now on, according to EORTC strategy even if the scoring algorithm at this point is preliminary and the QLQ-AA/PNH might change slightly after phase IV. This is important, as there are no other disease-specific instruments available for AA/PNH patients right now.

Quality of life, fatigue, anxiety and depression among Egyptian patients with obstructive sleep apnea

Background Sleep disorders have their well-documented deleterious effect on quality of life (QoL). The QoL impairment cannot be detected by polysomnography, which is the gold standard diagnostic tool for diagnosis of obstructive sleep apnea (OSA). Objective This study aimed at the evaluation of QoL, fatigue, depression and anxiety in OSA patients. Relation of QoL to disease severity and sex differences was assessed. Correlation of QoL scores to each other was assessed. Patients and methods We used three disease-specific QoL tools, namely the functional outcome of sleepiness questionnaire-10, the sleep apnea quality of life index, and the OSA patient-oriented severity index. Fatigue, anxiety, and depression were estimated using fatigue severity scale and hospital depression and anxiety scale, respectively. Results A total 170 participants were included; of them, 100 were OSA patients and 70 were non-OSA. OSA patients showed significantly lower QoL and more fatigue, depression, and anxiety symptoms in comparison with the non-OSA group, with more impairment of QoL in severe OSA patients. Female patients with OSA showed more QoL impairment. The highest correlation was observed between the sleep apnea quality of life index and the OSA patient-oriented severity index: r=−0.90, P value less than 0.001. Conclusion This study highlighted the significance of QoL, fatigue, anxiety and depression assessment in OSA patients, especially in those with severe disease.

Reliability and validity of a disease-specific quality of life tool in Nigerian patients with heart failure

Background: Heart failure results in varying limitation in activities of daily living, and consequently on the individual's quality of life. There is a thus a need for a reliable and valid tool to assess HRQoL in Nigerian patients. Aims and Objectives: To determine the health-related quality of life of Nigerian patients with heart failure using the Minnesota Living with Heart Failure Questionnaire (MLHFQ), its validity and reliability, and its relationship between to disease severity as defined by the NYHA class. Materials and Methods: 106 consecutive stable participants diagnosed with HF were recruited and studied. The MLHFQ was self-administered by recruited participants and NYHA class was determined by clinical evaluation. Appropriate descriptive and inferential statistical analysis was subsequently carried out. Results: The mean age (SD) of the subjects was 56.8 (13.4) years. 41.6% of HF subjects had suboptimal HRQoL in varying degrees with a median score of 19. The MLHFQ was found to be reliable exhibiting high internal consistency (Cronbach's alpha reliability coefficient - 0.928), similarly high for each of the subscale domains and there was a significant relationship between the MLHFQ and the NYHA class (rho: 0.7706; P Conclusion: HRQoL evaluation in Nigerian participants with HF using the MLHFQ should be considered in routine practice as it is a reliable and valid assessment with possible significant clinical utility.

Sex Differences in Quality of Life in Patients With Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) predominantly affects women. Clinical phenotype and outcomes in SLE may vary by sex and are further complicated by unique concerns that are dependent upon sex-defined roles. We aimed to describe sex differences in disease-specific quality of life (QoL) assessment scores using the Lupus Patient-Reported Outcome (LupusPRO) tool in a large international study. Cross-sectional data from 1,803 patients with SLE on demographics, self-identified sex status, LupusPRO, and disease activity were analyzed. The LupusPRO tool has 2 constructs: health-related QoL (HRQoL) and non-HRQoL. Disease activity and damage were evaluated using the Safety of Estrogens in Lupus Erythematosus National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index, respectively. Nonparametric tests were used to compare QoL and disease activity by sex. A total of 122 men and 1,681 women with SLE participated. The mean age was similar by sex, but the damage scores were greater among men. Men fared worse on the non-HRQoL social support domain than women (P = 0.02). When comparing disease and QoL among men and women ages ≤45 years, men were found to have greater damage and worse social support than women. However, women fared significantly worse on lupus symptoms, cognition, and procreation domains with trends for worse functioning on physical health and pain-vitality domains. In the largest study of a diverse group of SLE patients, utilizing a disease-specific QoL tool, sex differences in QoL were observed on both HRQoL and non-HRQoL constructs. Although men performed worse in the social support domain, women (especially those in the reproductive age group) fared worse in other domains. These observations may assist physicians in appropriately addressing QoL issues in a sex-focused manner.

Patient factors associated with quality of life in atrial fibrillation

As treatment options for atrial fibrillation (AF) increase, more attention is focused on patients' experiences and quality of life (QoL). However, little is known about the factors associated with these outcomes. The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) is a disease-specific QoL tool for AF, with domain and summary scores ranging from 0 (the worst QoL) to 100. Using multivariable linear regression, we evaluated factors associated with baseline AFEQT Summary and Subscale Scores in ORBIT AF, a large, community-based AF registry. Independent associations were reported as coefficient estimates in scores and 95% confidence intervals (CI). Overall, AFEQT was assessed in 2007 AF outpatients from 99 sites. Median age (IQR) was 76 years (67-82) and 43% were female. The median AFEQT summary score was 82 (67-94). Female sex, younger age, new onset AF, higher heart rate, obstructive sleep apnea, symptomatic heart failure (HF), chronic obstructive pulmonary disease and coronary artery disease were all independently associated with reduced QoL. Female sex [Estimate -7.03, 95% CI (-9.31, -4.75)] and new onset versus permanent AF [Estimate -7.44, 95% CI (-11.03, -3.84)] were independently associated with increased symptoms. NYHA Class III or IV HF [Estimate -14.44, 95% CI (-19.46, -8.76)] and female sex [Estimate -7.91, 95% CI (-9.95, -5.88)] were most independently associated with impaired daily activities. QoL in patients with AF varies widely and is associated with several patient factors. Understanding patient factors independently associated with worse QoL can be a foundation for tailoring treatment.

Emotional Intelligence: A Novel Outcome Associated with Wellbeing and Self-Management in Chronic Obstructive Pulmonary Disease.

Individuals with chronic obstructive pulmonary disease (COPD) often struggle with diminished autonomy and quality of life. Emotional factors play a crucial role in the well-being of patients with COPD; they are independently associated with critical outcomes such as dyspnea, quality of life, and health care use. Emotional intelligence is the capacity to understand and manage personal thoughts and feelings, as well as to positively influence interpersonal communication and social well-being. Emotional intelligence is a trainable skill that is extensively used in corporate business to improve well-being and performance, and it may also be significant in the self-management of emotions in patients with chronic disease. Importantly, research supports the proposition that emotional intelligence may be developed and learned at any time or any age, and training programs have been associated with increased well-being and better emotional regulation in patients with chronic disease. However, to date, no research has been done to investigate its value in patients with COPD. We aimed to investigate the association between emotional intelligence and two meaningful outcomes in COPD: quality of life and self-management abilities. Participants with moderate to severe COPD completed a disease-specific quality of life tool (Chronic Respiratory Questionnaire), the Trait Emotional Intelligence Questionnaire, the Self-Management Abilities Scale, the modified Medical Research Council Dyspnea Scale, and pulmonary function tests, and also provided information about living conditions and self-reported health care use. A total of 310 patients with COPD (mean age, 69 ± 9 yr; 40% female; mean FEV1%, 42.4 ± 15.8) participated in the study. Emotional intelligence was significantly and independently associated with self-management abilities (P < 0.0001) and all domains of quality of life assessed (dyspnea, fatigue, emotions, and mastery; P < 0.0001) after adjusting for age, degree of bronchial obstruction, breathlessness, and other significant confounders. Emotional intelligence may represent an important attribute in COPD, as it is associated with self-management abilities and all domains of quality of life, regardless of age or disease severity. Emotional intelligence can be learned and may complement existing rehabilitation efforts. Attention to it may address the current gap that exists in the treatment of emotional components of COPD responsible for decreased quality of life and increased health care use.

Abstract 14332: Factors Associated With Quality of Life in Atrial Fibrillation: Results From the ORBIT-AF Registry

Background: With increasing options for treating atrial fibrillation (AF), it is important to understand and quantify patient symptoms and quality of life (QoL), as improving symptoms and maximizing QoL are primary treatment goals. However, little is known about the factors associated with QoL. Methods: The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) is a disease-specific QoL tool for AF, with domain and summary scores ranging from 0 (the worst health status) to 100. Using hierarchical pseudo-binomial regression, we evaluated factors associated with baseline AFEQT Summary and Subscale scores in the ORBIT AF registry. Adjusted associations were reported as odds ratios (OR) and 95% confidence intervals (CI). Results: AFEQT was assessed in 2,007 AF outpatients from 99 sites. Median age and interquartile range (IQR) was 76 (67-82); 43% were female; and the median CHA2DS2-VASC score was 4 (3-5). Median AFEQT summary score was 82 (67, 94). Median symptom score was 92 (78-100) and daily activity score was 77 (52-94). Female sex, younger age, new onset AF, higher heart rate, obstructive sleep apnea, and CAD were all associated with reduced QoL. (Table) Similar trends were seen for the symptoms subscale: female sex [OR 0.57 CI (0.48, 0.68)], younger age [OR 1.10 CI (1.06, 1.15)], and new onset AF [OR 0.55 CI (0.43, 0.70)] were associated with worse symptoms. Likewise, for the daily activities subscale, Other race [OR 0.54 CI (0.36-0.80)] and higher BMI [OR 0.98 CI (0.98-0.99)] were associated with decreased activity. Conclusions: In the largest community-based assessment of QoL in patients with AF, we found several patient factors to be associated with low QoL, including female sex, new onset AF, younger age, higher heart rate, and certain cardiopulmonary comorbidities. Understanding patient characteristics associated with worse QoL can be a foundation for eradicating disparities and tailoring treatment.

Health-related quality of life in long-term survivors of paediatric liver transplantation.

Long-term survival after paediatric liver transplantation is now the rule rather than the exception. Improving long-term outcomes after transplantation must consider not only the quantity but also the quality of life years restored. To characterize health-related quality of life (HRQOL) of LT recipients ≥15 years after paediatric LT. Recipients of a paediatric LT performed before December 1996 in a single institution with continuous follow-up at either the paediatric or adult partner centre were identified. Patients with severe developmental or neurological impairment were excluded. HRQOL was assessed using the Pediatric Quality of Life Inventory 4.0, the Medical Outcomes Study Short Form-36 version 2 and the Pediatric Liver Transplant Quality of Life Tool. A total of 27 (67% male) subjects (mean age 24.3±6.7 years [median 23.2 years; range 16.6 to 40.3 years]) participated. The median age at transplant was 1.7 years (range 0.5 to 17.0 years). Seven (26%) participants underwent retransplantation. Seventeen (63%) participants were engaged in full-time work/study. Mean Short Form-36 version 2 scores included physical (49.6±11.1) and mental (45.3±12.5) subscale scores. The mean score for the disease-specific quality of life tool for paediatric liver transplant recipients (the Pediatric Liver Transplant Quality of Life Tool) was 64.70±15.2. The physical health of the young adults strongly correlated with level of involvement in work/study (r=0.803; P<0.05). The self-reported HRQOL of participants <18 years of age was comparable with a standardized healthy population. In contrast, participants between 18 and 25 years of age had HRQOL scores that were more similar to a group with chronic illness. Participants engaged in full-time work/study experienced enhanced physical health.

Long-term quality of life and risk factors for recurrence after laparoscopic repair of paraesophageal hernia.

Laparoscopic repair of paraesophageal hernia (PEH) has been shown to result in excellent relief of symptoms and improved quality of life (QOL) despite a relatively high radiographically identified recurrence rate. To assess potential risk factors for recurrence and long-term change in QOL after laparoscopic repair of PEH. This was a prospective study of 111 patients who underwent elective laparoscopic repair of type III PEH with biological mesh buttressed over a primary cruroplasty from April 3, 2009, through July 31, 2014, at the Department of Surgery, Johns Hopkins University of Medicine. We administered a modified version of a validated gastroesophageal reflux disease-specific QOL tool to patients before and at 2, 12, and 36 months after the procedure. Higher QOL scores represent greater severity of symptoms. An upper gastrointestinal tract barium-contrast radiographic examination was performed at 1 year to assess for recurrence. Demographic factors, comorbidities, and preoperative radiographic findings were analyzed as possible indicators for recurrence using logistic regression. Quality of life, measured by the gastroesophageal reflux disease-specific QOL tool, and recurrence, defined as a PEH of greater than 2 cm. Median patient age was 61 years, 63.1% of patients were women, and 81.1% of patients were white. Four patients required reoperation, of which only 1 was for symptomatic recurrent PEH. The mean follow-up time for the 36-month QOL assessment was 43.5 months. The overall preoperative and 2-, 12-, and 36-month QOL scores were 28.50, 10.18, 9.74, and 10.58, respectively (P < .001). Recurrences were found in 19 of the 70 patients (27%) who completed the 1-year radiographic examination. Compared with baseline, all individual symptoms improved significantly except for early satiety (mean [SD] score, 3.18 [1.88] at baseline vs 2.07 [1.70] at the 36-month follow-up; P = .07), nausea (1.69 [1.63] vs 0.77 [1.25]; P = .08), pain with swallowing (1.06 [1.50] vs 0.53 [0.90]; P = .73), and bloating/gas (3.28 [1.71] vs 2.23 [1.72]; P = .05) at the 36-month QOL assessment. Although not statistically significant, preoperative hernias containing most of the stomach were more likely to recur after repair when compared with those involving gastric cardia and fundus (odds ratio, 3.74 [95% CI, 0.93-15.14]; P = .06). Overall, laparoscopic repair of PEH with biological mesh results in excellent long-term QOL. The cause of recurrence is likely multifactorial and individualized to each patient. Further evaluation of novel techniques and unidentified patient factors is needed.

The Multiligament Quality of Life Questionnaire

Background: Existing knee joint–specific outcome questionnaires lack content pertinent to patients with multiligament knee injuries. Purpose: To develop and test the reliability and validity of a novel disease-specific quality of life questionnaire for patients with multiligament knee injuries. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Participants in this study included patients with multiligament knee injuries and clinician experts. Inclusion criteria were (1) patients with multiligament knee injury (age, 18-60 years), (2) ≥6 months after injury, and (3) operative or nonoperative treatment. Exclusion criteria were (1) preexisting osteoarthritis or inflammatory arthritis and (2) intracerebral/spinal cord injury. In phase I of the study, 85 eligible patients were mailed a questionnaire composed of 132 items from 11 existing knee questionnaires. Items were rated with regard to importance and frequency on a 5-point Likert scale. Criteria for inclusion in the first draft of the Multiligament Quality of Life (MLQOL) questionnaire included mean importance rating ≥3.5 and frequency <30% for the response “never experienced.” In phase II, patient focus groups and expert interviews were conducted until no further new content was generated for the MLQOL, and in phase III, 99 eligible patients across 2 centers were mailed a preliminary MLQOL questionnaire along with the Tegner activity scale, Short Form (SF)–36, and anchor questions. Interitem and item-to-total correlations were used to perform item reduction to generate a final MLQOL instrument, which was tested for internal consistency (Cronbach alpha), test-retest reliability (interclass correlation coefficient [ICC]), and construct validity. Results: At the end of phase III, a final MLQOL instrument was developed that was composed of 4 domains (physical impairments [PI], emotional impairments [EI], activity limitations [AL], and societal involvement [SI]) with 52 items in total. The MLQOL had adequate content validity, as none of the domains had any floor or ceiling effects. The Cronbach alpha was .94 (PI), .93 (EI), .94 (AL), and .91 (SI); ICC values were .89 (PI), .86 (EI), .91 (AL), and .88 (SI). Seven of 8 a priori hypotheses were satisfied, indicating good construct validity. Conclusion: The MLQOL instrument is a novel disease-specific quality of life tool that has demonstrated excellent content validity, reliability, and construct validity.

Comparison of disease-specific quality of life tools in patients with chronic venous disease

This work was presented as a poster in the American Venous Forum 25th Annual Meeting; 28 February 2013; Phoenix, Arizona, USA. Quality of life (QoL) is an important outcome measure in the treatment for chronic venous disease. The Aberdeen Varicose Vein Questionnaire (AVVQ) and the ChronIc Venous Insufficiency quality of life Questionnaire (CIVIQ-14) are two validated disease-specific QoL questionnaires in current use. The aim of this study is to evaluate the relationship between the AVVQ and the CIVIQ-14 to enable better comparison between studies and to compare these disease-specific QoL tools with generic QoL and clinician-driven tools. Adults attending our institution for management of their varicose veins completed the AVVQ, CIVIQ-14 and EuroQol-5D (EQ-5D). Clinical data, CEAP classification and the Venous Clinical Severity Score (VCSS) were collected. The relationship between the AVVQ and CIVIQ-14 scores was analysed using Spearman's correlation. The AVVQ and CIVIQ-14 scores were also analysed with a generic QoL tool (EQ-5D) and a clinician-driven tool, the VCSS. One hundred patients, mean age 57.5 (44 males; 56 females), participated in the study. The median AVVQ score was 21.9 (range 0-74) and the median CIVIQ-14 score was 30 (range 0-89). A strong correlation was demonstrated between the AVVQ and CIVIQ-14 scores (r = 0.8; p < 0.0001). Strong correlation was maintained for patients with C1-3 disease (r = 0.7; p < 0.0001) and C4-6 disease (r = 0.8; p < 0.0001). The VCSS correlated strongly with the AVVQ and CIVIQ-14 scores (r = 0.7; p < 0.0001 and r = 0.7; p < 0.0001, respectively). Both the AVVQ and CIVIQ-14 scores correlated well with the EQ-5D score (r = -0.5; p < 0.0001 and r = -0.7; p < 0.0001, respectively). This study demonstrates that there is good correlation between two widely used varicose vein specific QoL tools (AVVQ and CIVIQ-14) across the whole spectrum of disease severity. Strong correlation exists between these disease-specific QoL tools and generic and clinician-driven tools. Our findings confirm valid comparisons between studies using either disease-specific QoL tool.

Correlation between Disease-Specific Quality of Life Tools in Recently Hospitalized Heart Failure Patients

Correlation between Disease-Specific Quality of Life Tools in Recently Hospitalized Heart Failure Patients

Defining recurrence after paraesophageal hernia repair: Correlating symptoms and radiographic findings

Laparoscopic repair of paraesophageal hernia (PEH) has been shown to result in excellent relief of symptoms and improved quality of life (QOL) despite a high radiographically identified recurrence rate. Because there is no uniform definition of PEH recurrence, it is difficult to compare studies reporting on this. This study attempts to introduce consistency to the definition of PEH recurrence based on correlation of symptoms and radiographic findings. This is an analysis of data derived from an ongoing prospective study. From April 2009 to December 2012, we enrolled 101 patients who underwent elective laparoscopic PEH repair with bioprosthesis buttressed over a primary cruroplasty. A validated gastroesophageal reflux disease-specific QOL tool was administered to patients before, and at 2 and 12 months postoperatively. Upper gastrointestinal barium contrast examination (UGI) was performed at 1 year. Of 101 patients, 13 were not available for follow-up, 58 reached the 1-year milestone for interval UGI, and 1 patient required reoperation for symptomatic recurrent PEH. There was no relationship between total QOL score and radiographic recurrent hernia (RRH); however, significant deterioration in many symptoms was seen in RRH > 2 cm. Based on these findings, we defined recurrence as RRH > 2 cm and calculated our recurrence rate as 28% (n = 16). Our analysis of symptom scores after laparoscopic PEH repair suggests that significant worsening occurs with RRH > 2 cm. Given that there is no consistent description of recurrent PEH, we suggest this as a possible standardized definition. Overall, patients with recurrent PEHs continue to experience excellent QOL and rarely require reoperation.

How can we measure endometriosis-associated pelvic pain?

Purpose The aim of our work was to explore which of the most commonly used pain scales is best suited to assess treatment success in endometriosis therapy and, therefore, qualifies best to be used as primary endpoint for clinical studies in this indication. Methods We compared patient's responses on the different pain scales Visual Analog Scale, Biberoglu and Behrman Score, and SF-36 Bodily Pain Subscale with the Clinical Global Impression score. Parametric and non-parametric correlation coefficients and effect sizes were calculated. Results A total of 428 patients with endometriosis-associated pelvic pain from three studies were included in our analyses. Their mean age was 31.4±6.3 years and their mean pain score on the visual analog scale was 58.1±21.9 at baseline. The highest correlation with the Clinical Global Impression score was observed for the visual analog scale followed by the B&amp;B pelvic pain item. The highest effect sizes were found for dysmenorrhea and SF-36 bodily pain subscale followed by the visual analog scale. Conclusions A general measure of endometriosis-related pain can be recommended as primary endpoint in clinical trials to assess painful symptoms of endometriosis. In addition, a disease-specific quality of life tool is recommended to help interpret impact on patients’ daily activities.

Development of a disease-specific measure of quality of life in myelodysplastic syndromes (MDS): The “QUALMS-1”.

6103 Background: Studies assessing the quality of life (QoL) experienced by patients with MDS have almost universally relied upon generic measures; however, disease-specific QoL tools can allow for more sensitive assessments of the impact of changes in disease status. Methods: Using a clinical impact method of instrument development, individual and combined focus groups were conducted with 32 members of our institution’s MDS community (patients, their caregivers, and health care providers) to identify MDS-relevant QoL domains and associated question topics. Participants’ rankings of the importance of the domains and question topics were compared, collapsing patients/caregivers into one group and physicians/other providers into another. A draft scale was constructed taking a greater number of questions from the more highly-ranked domains. Results: “Fatigue” was ranked as the most important domain (see table). None of the 12 domains were ranked significantly differently by patients/caregivers versus providers. The two groups ranked 5 of 60 question topics differently: “Too tired for routine tasks” (providers higher; p= .05); “limited availability of support beyond the family” (providers higher; p= .02); “organizing life around transfusion/MD appointments” (providers higher, p= .03); “bruising” (patients/caregivers higher, p= .05) and “anger over diagnosis” (providers higher, p= .03). Conclusions: A high level of agreement in the rankings of domains and question topics between MDS patients/caregivers and providers suggests that the QoL experience of MDS patients is consistently compromised. The resulting 38-item draft QUALMS-1 tool is now being piloted (cognitive debriefing and behavioral coding) in a new cohort of MDS patients, with the ultimate goal of validation in a multi-institutional setting. [Table: see text]

Quality-of-life changes in patients with thyroid cancer after withdrawal of thyroid hormone therapy.

Quality of life (QOL) is an important consideration as patients survive longer with cancer and is an area of increasing interest in patients with thyroid cancer who undergo long-term cancer surveillance. However, there are few disease-specific QOL tools available to evaluate QOL in patients with thyroid cancer. The purposes of this longitudinal, repeated-measures study were to: (1) test a new instrument, the QOL-Thyroid Scale, during thyroid hormone withdrawal; and (2) to evaluate the impact of thyroid hormone withdrawal on patients' perceived changes in quality of life. The sample included 34 subjects (mean age 40 years) undergoing thyroid hormone withdrawal in preparation for scanning procedures. Subjects completed three instruments (demographic data tool, the QOL-Thyroid, and the FACT-G) at four specific time points in relationship to scanning. The results demonstrated that the QOL-Thyroid tool is a reliable and valid measure of QOL. Cronbach's alpha coefficient of r = .78 between QOL-Thyroid and FACT-G indicated good concurrent validity. Second, the impact of thyroid hormone withdrawal on QOL showed significant changes in physical, psychological, and social well-being across the four testing points. The greatest changes occurred between peak hormone withdrawal and thyroxine (T4) therapy. While it is generally known that patients suffer troublesome physical symptoms relating to thyroid hormone withdrawal, the negative psychological, family, and work sequelae are less apparent. In conclusion, the QOL-Thyroid is a reliable and valid measure for use in evaluating patients undergoing scanning procedures and may be used to identify and target teaching and support for high-risk areas in patients lives that are negatively affected by hormone withdrawal.