Validated Quality Of Life Instruments Research Articles

Quality-of-Life Instruments and Nutrition Screening Tools

Background Quality of life (QoL) is critical for healthy aging—both for older adults and for healthcare providers/health systems. Eating and nutritious food are essential for older adults to remain healthy/independent and maintain good nutrition status and also provide pleasure and enhance QoL. However, research on nutrition and QoL is limited, including for building understanding of the relationship between nutrition and QoL and of the instruments and tools used to help develop a research framework and evaluate the impact of United States community nutrition programs/services on QoL. Objectives The first objective is to review overlaps/gaps in previously identified/validated QoL instruments and nutrition screening tools used in research with community-living older adults and then, second, to use these findings to suggest opportunities for further research and implications for developing US health and nutrition policies/programs supporting healthy aging. Methods Twenty validated QoL instruments were reviewed to determine if they included nutrition-related items that corresponded to 8 QoL domains (physical health, emotional state, mental health, social connection, environment, personhood, autonomy, and spiritual feeling). Sixteen validated nutrition screening tools were reviewed to determine if any of their nutrition items corresponded with these same 8 QoL domains. Results Of the 20 QoL instruments reviewed, 75% included at least 1 nutrition-related item, most commonly fitting into the autonomy (n = 11), physical health (n = 7), social connection (n = 3), environment (n = 3), emotional state (n = 2), mental health (n = 2), and personhood (n = 1) domains, with none in the spiritual feeling domain. All 16 nutrition screening tools included at least 1 nutrition-related item corresponding to a QoL domain, most commonly the physical health (n = 16) domain. Other QoL domains represented by nutrition items in nutrition screening tools were autonomy (n = 9), emotional state (n = 5), social connection (n = 5), environment (n = 4), and mental health (n = 3). Commonalities existed between QoL instruments and nutrition screening tools in types of nutrition-related items included, but there were many inconsistencies/gaps. Conclusions Nutrition items corresponding to different QoL domains are found inconsistently among validated QoL instruments and nutrition screening tools. Nutrition can be potentially modified to benefit healthy aging and QoL outcomes; findings present opportunities for further research to help increase understanding of the relationship between QoL and nutrition and the effectiveness of nutrition interventions, as well as to help advance US policy development and programs supporting healthy aging.

Meta-Analysis of Validated Quality of Life Outcomes Following Voice Feminization in Transwomen.

For transwomen undergoing voice feminization interventions, fundamental frequency (F 0 ; vocal pitch) is a commonly reported functional outcome measure in the literature. However, F 0 may not correlate well with improvement in quality of life (QoL). Several validated voice-related QoL instruments have been used to assess QoL improvement in these patients, yet there is no consensus on the most appropriate instrument. This systematic review and meta-analysis aimed to assess the relationship between change in F 0 and QoL improvement following voice feminization, and to compare validated QoL instruments commonly used in this population. PubMed, Cochrane, and Embase. A systematic review was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Primary studies of transwomen undergoing voice feminization, reporting validated QoL outcomes were included. Meta-analyses for associations between mean change in QoL score and mean change in F 0 , as well as variations in mean change in QoL score by QoL instrument, were performed using a multilevel mixed effects model. No statistically significant correlation was found between change in F 0 and QoL score improvement post-intervention. Different validated instruments showed statistically significant variation in QoL score change, with the Trans Women Voice Questionnaire (TWVQ) capturing a greater improvement in QoL score relative to other instruments. Lack of correlation between changes in F 0 and QoL improvement further supports that F 0 alone is insufficient to assess the efficacy of voice feminizing interventions. Validated QoL measures are useful adjuncts. Of these, the TWVQ appears to be the most sensitive for measurement of QoL improvement following voice feminization.

Research is still limited on nutrition and quality of life among older adults.

Globally, the number of older adults is growing exponentially. Yet, while living longer, people are not necessarily healthier. Nutrition can positively impact healthy aging and quality of life (QoL). Two decades ago, nutrition and diet were rarely viewed as key QoL domains, were not part of QoL screening, and QoL studies frequently used unvalidated tools. It is unclear how the nutrition and QoL research area may have since evolved. A scoping review was conducted in Pubmed of research with community-living older adults (aged ≥65) from developed economies that included 1 of 29 common, valid QoL instruments, nutrition indices, and was published between 1/2000-12/2022. The review followed published methodology guidance and used the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) flow diagram to document identified studies and record number of included/excluded studies (based on scoping review's pre-specified criteria). Of 258 studies identified initially, 37 fully met scoping review inclusion criteria; only 2 were QoL studies, 30 focused on nutrition, 3 on measurement tool validation/testing, and 2 were other study types. Most studies (n = 32) were among populations outside of North America; majority were conducted in Europe (n = 22) where the EuroQol 5 Dimension (Eq5D) was used in >1/2 the studies. Of 5 North American studies, the 36-Item Short Form Survey (SF-36) was most frequently used (n = 4). Myriad nutrition indices described various aspects of eating, dietary intake, and nutrition status, making comparability between studies difficult. Studies included several different nutrition questionnaires; Mini Nutritional Assessment (MNA) (n = 8) or Mini Nutritional Assessment Short Form (MNA-SF) (n = 5) were used most frequently. The most frequent anthropometric measure reported was Body Mass Index (BMI) (n = 28). Nutrition-related biochemical indices were reported infrequently (n = 8). The paucity of studies over the last two decades suggests research on nutrition and QoL among community-living older adults remains underdeveloped. Valid QoL instruments and nutrition indices are now available. To ensure greater comparability among studies it is important to develop consensus on core indices of QoL and particularly nutrition. Greater agreement on these indices will advance further research to support healthy aging and improve QoL for community-dwelling older adults.

Patient‐reported outcomes post prophylactic risk‐reducing mastectomy: improved breast and psychosocial satisfaction yet poorer physical well‐being

Few studies have investigated patient-reported outcomes (PROs) for patients with high breast cancer risk undergoing elective risk reduction mastectomy and reconstruction. These patients incur operative risk in the absence of active cancer, which renders their treatment experience unique. This study aimed to identify longer-term quality of life (QoL) issues that persist in this patient cohort. A cross-sectional cohort study assessed PROs in 48 women with high breast cancer risk who attended the Royal Melbourne Hospital Risk Management Clinic, at least 12 months post-mastectomy and reconstruction, with surgery between 2011 and 2020, using the BREAST-Q© Likert surveys. The BREAST-Q© internationally validated QoL instrument scales survey data from 0 (worst) to 100 (best) in 14 domains addressing satisfaction and psychosocial issues. There was higher overall breast and psychosocial satisfaction, with scores of 11 and four, respectively, yet lower chest, abdomen and sexual well-being scores with 14, three and four, respectively, in contrast to normative BREAST-Q© data from >1000 women without prior breast cancer or breast operations. High average scores >90 were found for patient satisfaction with surgical, medical and office staff. Twenty-one patients had an average score of 63 for satisfaction with breast implants, while 27 patients post-DIEP had average scores >72 for abdominal well-being, appearance and overall outcomes. Higher mean QoL outcomes were found with DIEP flap in all domains, compared with breast implant reconstruction. QoL assessment with PROs 12 months post-risk reduction mastectomy and reconstruction demonstrated higher psychosocial well-being, yet highlights physical implications, with patients experiencing reduced chest, abdomen and sexual well-being, compared with normative BREAST-Q© control data. Higher mean QoL outcomes were found with DIEP flap compared with breast implant reconstruction. PROs studies can identify unmet needs and facilitate change in service provision.

Early Experience and Patient Characteristics from Opera: A Real-World Study of Pegcetacoplan Treatment

Background Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired life-threatening disease characterized by complement-mediated hemolysis and thrombosis. Chronic hemolysis leads to anemia, which can result in persistent fatigue and dependance on transfusions, affecting the overall quality of life (QOL) of patients with PNH. Pegcetacoplan (PEG; US brand name Empaveli®) is the first approved C3 inhibitor for US adults with PNH. Although clinical trials have assessed the efficacy of PEG, which include patient-reported outcomes, there is no information on the use of PEG in a real-world setting. Aims To provide the first report of trends in hemoglobin (Hb) values and baseline QOL (measured by patient-reported fatigue and cognitive impairment) from OPERA, a descriptive, observational exploratory outcomes study, presenting the first real-world data describing PEG treatment for adults with PNH post-approval. Methods This single site opt-in study recruited patients in the US, following a valid PEG prescription from a licensed medical professional. Patients ≥18 years of age, diagnosed with PNH and prescribed PEG, were electronically consented and then enrolled to participate in the OPERA study, as approved by the internal review board. OPERA collected information from routine care and did not direct or suggest any medical interventions. In this observational setting, Hb lab values were reported (by the patient/site) at varying timepoints when available. Participants self-reported QOL status from baseline over a 12-month period through monthly phone calls and quarterly online patient-reported outcome measures (PROMs). During monthly phone calls, participants were asked to report their most recent Hb levels (typical normal range: male, 13.6-18 g/dL; female, 12-16 g/dL) if available from their regular primary care visits in the previous month. Online PROMs collected data using validated QOL instruments including the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale (0-52 total score) and the Patient-Reported Outcomes Measurement Information System (PROMIS) scale for Cognitive Abilities (23.27-67.09 t-score). Lower scores on each measure represent greater levels of fatigue or cognitive impairment. Results Participants enrolled in OPERA with a 30-70% monthly range to opt-in. Of 17 participants enrolled with available baseline Hb values, mean (range) age was 45.76 (20-70) years, and 8 were female. No OPERA participants were previously enrolled in a PEG clinical trial. All participants were prescribed and received the label recommended dose of PEG (1080 mg, twice weekly). All participants reported prior treatment with either eculizumab, ravulizumab or both, before starting PEG. Additional dosing information and time since PNH diagnosis can be found in the Table. The mean (SD) baseline Hb levels from 17 OPERA participants was 8.90 (2.19) g/dL, which was similar to the mean (SD) baseline Hb levels (8.69 [1.08] g/dL) for 41 patients in the previously published phase 3 PEGASUS (NCT03500549) trial. Among 4 participants with available data after 1 month of PEG use, mean (SD) Hb levels increased to 11.95 (1.84) g/dL (mean change from baseline +2.83 (1.35) g/dL) which was similar to the mean (SD) Hb levels of 11.55 (1.62) g/dL seen in 40 PEGASUS participants after 1 month of treatment. QOL data was available at baseline in 12 participants and the mean (SD) baseline FACIT-Fatigue score was 30.25 (15.63), which was similar to the mean (SD) baseline FACIT-Fatigue score of 32.2 (11.4) from the PEGASUS trial, but below the reported mean FACIT-Fatigue population norm of 43.6 (Cella, et al. Cancer. 2002). Additionally, the mean (SD) PROMIS-Cognitive Abilities t-score for patients with available QOL data (n=12) was 43.57 (9.11), which is lower than the published population norm of 50 (Saffer, et al. Psychiatry Research 2015). Conclusions This first real-world study of adults with PNH receiving PEG indicates a positive trend in Hb levels in participants after 1 month of use. These early experiences are similar to previously reported changes in Hb levels after PEG treatment in phase 3 clinical trials (Hillmen et al, NEJM 2021). At baseline, participants with PNH report a considerable amount of fatigue and cognitive impairment, indicating poor QOL with previous C5 inhibitor treatment. More research is needed to corroborate the findings of this first analysis. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

MPN-391: A Review of Gender Differences in Quality of Life for Hematologic Malignancies

Context Accumulating data have shown that several factors influence quality of life (QOL) in oncology patients, making this an important clinical endpoint. Such studies have concluded that gender differences exist for QOL symptoms; therefore, these should be incorporated into clinical decision-making to optimize patient management and improve outcomes. Despite this knowledge, there is a paucity of QOL data characterizing gender differences in hematologic malignancies. Health care providers should be cognizant of this data, as gender differences warrant diverse clinical approaches. Objective The aim of this integrative review is to summarize data from published literature encompassing comparisons of QOL outcomes between men and women diagnosed with any hematologic malignancy and identify knowledge gaps with implications for future intervention-based research aimed at improving QOL symptoms based on the gender of the individual. Methods A systematic literature search using appropriate keywords was conducted in PubMed, CINAHL, and PsycINFO databases to identify research published between 2005 and 2021. Eligibility criteria included studies (1) comparing QOL symptoms as an outcome between men and women with any hematologic malignancy; (2) with patients ≥18 years old; (3) using a validated QOL instrument; and (4) published in English. Manuscripts were screened and extracted using Covidence software and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Results Preliminary search strategy from PubMed, CINAHL, and PsycINFO databases yielded 511 studies meeting eligibility criteria. After selective screening for eligibility criteria and excluding duplicates, nine studies remained for detailed analysis. A review of the published research showed that women reported more pain, greater physical impact of disease and treatment, worse fatigue, fatigue severity with interference, and higher symptom burden compared to men. Level of evidence criteria was defined as being strong if two or more high-quality studies resulted in consistent findings. Conclusions The impact of QOL symptoms based on sex as a biological variable in various hematologic malignancies is an important consideration for providing gender-competent care. Data shows that QOL symptoms differ between genders across several hematologic malignancies. However, research is inadequate regarding the clinical recognition or effective management based on gender. The results of this review will provide information to deliver more personalized and gender-centered care.

Assessment of the Validity of the Sinonasal Outcomes Test-22 in Pituitary Surgery: A Multicenter Prospective Trial.

Sinonasal Outcomes Test-22 (SNOT-22) is used widely as a patient-reported sinonasal quality-of-life (QOL) instrument for endoscopic endonasal pituitary surgery. However, it has never been validated in this population. This study explores the psychometric validity of SNOT-22 to determine if it is a valid scale in patients undergoing endoscopic pituitary surgery. Multicenter prospective trial. Adult patients (n=113) with pituitary tumors undergoing endoscopic surgery were enrolled in a multicenter study. Patient-reported QOL was assessed using SNOT-22 and the Anterior Skull Base Nasal Inventory-12. Face validity, internal consistency, responsiveness to clinical change, test-retest reliability, and concurrent validity were determined using standard statistical methods. Internal consistency using Cronbach's alpha at baseline and 2 weeks postoperatively were 0.911 and 0.922, indicating SNOT-22 performed well as a single construct. Mean QOL scores were significantly worse at 2 weeks than baseline (16.4 ± 15.1 vs. 23.1 ± 16.4, P < .001), indicating the scale is responsive to clinical change. However, only 11/22 items demonstrated significant changes in mean scores at 2 weeks. Correlation between scores at 2 and 3 weeks was high, suggesting good test-retest reliability, r(107)=0.75, P < .001. Factor analysis suggests the five-factor solution proposed for the SNOT-22 in rhinosinusitis patients is not valid in pituitary surgery patients. The SNOT-22 is a valid QOL instrument in patients undergoing endoscopic pituitary surgery. However, because it includes 22 items, can be applied only as a single construct, 50% of the items do not demonstrate changes after surgery, and is not as sensitive to change as other scales, shorter instruments developed specifically for this patient population may be preferable. 2 Laryngoscope, 131:E2757-E2763, 2021.

Integrative review and evaluation of quality of life related instruments in pediatric urology

While most paediatric urologists consider patients' quality of life (QOL) important, few actually measure this outcome. Our goal was to assess instruments used in the pediatric urology QOL literature, specifically looking at whether they captured QOL. We searched MEDLINE and EMBASE for articles with a self-described primary outcome of measuring QOL. All validated QOL instruments in the papers were analyzed by QOL instrument content experts. Instruments were classified as focusing on: Functioning or QOL (Table). The term Functioning focuses on performing activities. QOL captures person's perceptions about their position in life, informed by circumstances, functioning and conditions. QOL instruments were further subdivided into generic QOL, health-related QOL (HRQOL) and disease-specific HRQOL. Only direct patient self-reported QOL instruments were then assessed, since they are the most clinically useful, reliably assessing patients' own perception of their QOL. Forty-three publications met inclusion criteria (published 1999-2019). Most common conditions included urinary incontinence (16, 37.2%) and kidney transplantation (12, 27.9%). Overall, 22 unique instruments purporting to measure QOL were identified. Looking at the concepts measured by each instrument, nine instruments (40.9%) assessed Functioning. Nine instruments (40.9%) measured a combination of Functioning and QOL. Only the remaining 4 instruments (18.2%) assessed strictly QOL. The 13 instruments assessing any QOL focused on generic QOL (n=4), HRQOL (n=3) and disease-specific HRQOL (n=6). Of the subset of four instruments assessing strictly QOL, and not Functioning, all had patient self-reported versions available: two generic QOL instruments (KINDL, KIDSCREEN), one generic HRQOL (DISABKIDS), and one disease-specific HRQOL (QUALAS). Thirteen of 43 studies (30.2%) employed more than one instrument. Thirty-eight studies (88.4%) used an instrument measuring Functioning, with 19 (44.1%) measuring only Functioning, not QOL at all. Twenty-four studies (55.8%) used an instrument measuring actual QOL, although 17 (39.5%) used a combined Functioning/QOL instrument. Only nine (20.9%) used a strictly QOL instrument (strictly HRQOL instruments: 4.7%). We present encouraging evidence of sustained interest in QOL research in pediatric urology and identify areas needing improvement. Selecting appropriate QOL tools requires a working knowledge of their various underlying meanings and purposes. Whether it adequately assess QOL must be considered. We discuss strengths and weaknesses of instruments and a practical approach to QOL instrument selection. Much of pediatric urology is grounded in improving QOL. Unfortunately, most studies published to date focus on Functioning, rather than young people's perception-based QOL. Future QOL studies should ideally employ validated instruments capturing patient-reported QOL.

Survival analysis of a prospective multicenter observational study on surgical palliation among patients receiving treatment for malignant gastric outlet obstruction caused by incurable advanced gastric cancer

We had previously reported that surgical palliation could maintain quality of life (QOL) while improving solid food intake among patients with malignant gastric outlet obstruction (GOO) caused by advanced gastric cancer. The present study aimed to perform a survival analysis according to the patients' QOL to elucidate its impact on survival. Patients with GOO who underwent either palliative gastrectomy or gastrojejunostomy were included in this study. A validated QOL instrument (EQ-5D) was used to assess QOL at baseline and 2weeks, 1month, and 3months following surgical palliation. Postoperative improvement in oral intake was also evaluated using the GOO scoring system (GOOSS). Thereafter, univariate and multivariate survival analyses were performed to determine independent prognostic factors. The median survival time of the 104 patients included herein was 11.30months. Patients who received postoperative chemotherapy, PS 0/1, baseline EQ-5D ≥ 0.75, improved or stable EQ-5D, and improved oral intake expressed as GOOSS = 3 had significantly better survival. Multivariate analysis identified postoperative chemotherapy, a better baseline PS, a better baseline EQ5D, improved or stable EQ5D scores, and improved oral intake 3months after surgical palliation as independent prognostic factors. Apart from preoperative PS and postoperative chemotherapy, the present study identified better baseline QOL, improvement in postoperative QOL, and improvement in oral intake as prognostic factors among patients who underwent palliative surgery for advanced gastric cancer with GOO.

Development of a Patient-Reported Outcome Measure for Mohs Reconstruction.

Objective: There are currently no validated patient-reported outcome measures (PROMs) to specifically evaluate quality-of-life (QOL) outcomes for patients undergoing Mohs micrographic surgery (MMS) reconstruction. Therefore, the objective of this report was to develop a short PROM that can be used to evaluate the outcome after MMS reconstruction from the patient's perspective. Methods: Following established guidelines for PROM development, a comprehensive literature review, concept elicitation interviews (n = 25), and cognitive debriefing interviews (n = 5) were performed. These data were used to develop a preliminary survey to measure patient QOL throughout the MMS reconstruction process. Results: Participants identified many items from existing validated QOL instruments as being irrelevant to their situation, indicating that the sensitivity of existing instruments may be relatively low for patients undergoing MMS. There was significant overlap between what patients frequently identified and what expert physicians believed would be important in terms of factors that affect patient QOL throughout this process. Cognitive debriefing interviews indicated that the survey can be quickly and easily administered. Conclusions: Following accepted standards, we have created a 12-item disease- and treatment-specific QOL PROM for individuals undergoing the MMS reconstruction process. Given the prevalence of MMS, this PROM could be an important tool for clinicians to assess outcomes in future interventional studies aimed at minimizing morbidity and maximizing QOL for these skin cancer patients. Psychometric testing and validation of this newly developed PROM are currently underway.

Development and Validation of the Greek version of the Early Childhood Oral Health Impact Scale (ECOHIS)

Background: The oral health of preschool-age children can affect their quality of life (QoL) as well their families. The Early Childhood Oral Health Impact Scale (ECOHIS) is a reliable instrument that has been used to assess the impact of oral health problems and their treatment on the QoL of preschool-age children and their families’. Objective: To report the development, evaluation and psychometric properties of the Greek version of ECOHIS (Gr-ECOHIS). Methods: Participants of this cross-sectional study were 176 mothers and their young (aged 25-71 months) children, patients of a private pediatric dental practice. During a structured interview, they completed a questionnaire, including a translated, Greek language version of the ECOHIS. Data on children’s oral health were obtained via clinical examinations. The psychometric properties of Gr-ECOHIS evaluated were reliability (internal and test-retest) and construct (convergent and discriminant) validity. Test-retest reliability was determined in an independent sample of 20 mother-child dyads, who completed the Gr-ECOHIS twice within a two-week interval. Results: The scale showed excellent internal consistency (Cronbach’s alpha=0.85) and test-retest reliability (Intraclass Correlation Coefficient= 0.97). Gr-ECOHIS showed a strong correlation with dental caries (Spearman’s rho=0.62, p&lt;0.0005) and dental treatment needs. Gr-ECOHIS was also positively associated with dental knowledge, health literacy and parental oral health-related QoL. Conclusion The Gr-ECOHIS is a psychometrically reliable and valid Greek language QoL instrument, which demonstrated significant associations with clinical and parent-reported measures of early childhood oral health. As such, it can be used to measure oral health-related QoL among preschool-age children in clinical and public health settings.

Validation of the English Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) Questionnaire.

Keratinocyte carcinomas (KC) impact patient quality of life (QoL). There is a need for validated QoL instruments specific to KC. The Basal and Squamous Cell Carcinoma QoL (BaSQoL) questionnaire was developed to comprehensively measure issues of importance to patients with KC. To validate and characterize the BaSQoL questionnaire for QoL measurement after diagnosis and treatment of KC. This was a prospective, observational study. Patients with basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) were asked to fill out BaSQoL, Skin Cancer Index (SCI), and Hospital Anxiety and Depression Scale (HADS) questionnaires. Descriptive statistics and classical test theory were used to assess validity. One hundred eighty-seven subjects enrolled in this study: 122 with BCC and 65 with SCC. One hundred seventy-one subjects (91.4%) completed questionnaires at all 3 time points; 16 patients (8.6%) were lost to follow-up. Overall performance using classical test theory was good, with good internal consistency (Cronbach's α 0.63-0.80). BaSQoL subscales were strongly correlated with subscales of the SCI, demonstrating convergent validity, and weakly correlated with HADS, showing divergent validity. The English language version of BaSQoL has good face, content, and construct validity. This study validates BaSQoL for use in English-speaking patients with BCC and SCC.

Quality of Life in Children with Sensorineural Hearing Loss.

To assess quality of life (QOL) in pediatric patients with sensorineural hearing loss (SNHL) with the Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) and the Hearing Environments and Reflection on Quality of Life 26 (HEAR-QL-26) and HEAR-QL-28 surveys. Prospective longitudinal study. Tertiary care center. Surveys were administered to patients with SNHL (ages 2-18 years) from July 2016 to December 2018 at a multidisciplinary hearing loss clinic. Patients aged >7 years completed the HEAR-QL-26, HEAR-QL-28, and PedsQL 4.0 self-report tool, while parents completed the PedsQL 4.0 parent proxy report for children aged ≤7 years. Previously published data from children with normal hearing were used for controls. The independent t test was used for analysis. In our cohort of 100 patients, the mean age was 7.7 years (SD, 4.5): 62 participants had bilateral SNHL; 63 had mild to moderate SNHL; and 37 had severe to profound SNHL. Sixty-eight patients used a hearing device. Mean (SD) total survey scores for the PedsQL 4.0 (ages 2-7 and 8-18 years), HEAR-QL-26 (ages 7-12 years), and HEAR-QL-28 (ages 13-18 years) were 83.9 (14.0), 79.2 (11.1), 81.2 (9.8), and 77.5 (11.3), respectively. Mean QOL scores for patients with SNHL were significantly lower than those for controls on the basis of previously published normative data (P < .0001). There was no significant difference in QOL between children with unilateral and bilateral SNHL or between children with SNHL who did and did not require a hearing device. Low statistical power due to small subgroup sizes limited our analysis. It is feasible to collect QOL data from children with SNHL in a hearing loss clinic. Children with SNHL had significantly lower scores on validated QOL instruments when compared with peers with normal hearing.

Restricted Speech Recognition in Noise and Quality of Life of Hearing-Impaired Children and Adolescents With Cochlear Implants – Need for Studies Addressing This Topic With Valid Pediatric Quality of Life Instruments

Cochlear implants (CI) support the development of oral language in hearing-impaired children. However, even with CI, speech recognition in noise (SRiN) is limited. This raised the question, whether these restrictions are related to the quality of life (QoL) of children and adolescents with CI and how SRiN and QoL are related to each other. As a result of a systematic literature research only three studies were found, indicating positive moderating effects between SRiN and QoL of young CI users. Thirty studies addressed the quality of life of children and adolescents with CI. Following the criteria of the World Health Organization (WHO) for pediatric health related quality of life HRQoL (1994) only a minority used validated child centered and age appropriate QoL instruments. Moreover, despite the consensus that usually children and adolescents are the most prominent informants of their own QoL (parent-reports complement the information of the children) only a minority of investigators used self-reports. Restricted SRiN may be a burden for the QoL of children and adolescents with CI. Up to now the CI community does not seem to have focused on a possible impairment of QoL in young CI users. Further studies addressing this topic are urgently needed, which is also relevant for parents, clinicians, therapists, teachers, and policy makers. Additionally investigators should use valid pediatric QoL instruments. Most of the young CI users are able to inform about their quality of life themselves.

Sinonasal quality-of-life outcomes after endoscopic endonasal skull base surgery.

There are substantial gaps in our understanding of the influence of the endoscopic endonasal approach (EEA) for endoscopic skull base surgery on sinonasal-specific quality of life (QOL) as well as the instruments available for assessment. Our primary objective in this study was to characterize postoperative changes in sinonasal QOL, specifically using the 22-item Sino-Nasal Outcome Test (SNOT-22), with a secondary objective of delineating weaknesses in our current understanding of patient symptomatology after EEA for skull base surgery. A comprehensive literature review was conducted using PubMed, CINAHL, Cochrane Library, and SCOPUS for studies reporting SNOT-22 data pre- and postoperatively in patients who underwent EEA for skull base pathologies. Studies were limited to patients ≥18 years of age and excluded patients diagnosed with chronic rhinosinusitis (CRS). Nineteen unique studies with 27 separate data sets and a total of 1025 patients were used in this meta-analysis. Overall SNOT-22 scores statistically improved at the 6-month (p = 0.0009) and 1-year (p = 0.002) time-points. Patients with preoperative SNOT-22 scores ≥20 achieved postoperative improvements at 12-week (p < 0.00001), 6-month (p < 0.0001), 1-year (p < 0.00001), and long-term follow-up (p < 0.0001). Patients with preoperative SNOT-22 scores <20 remained stable and did not worsen postoperatively. Patients undergoing EEA for skull base pathologies who have impaired sinonasal QOL preoperatively demonstrated significant postoperative QOL improvements. Those patients with relatively normal preoperative sinonasal QOL remained asymptomatic postoperatively. This study supports the need for development of a contemporary disease- and approach-specific, validated QOL instrument for skull base pathologies.

Reliability and Validity of the Turkish Version of the FACIT-PAL Quality of Life Instrument

ContextThe accurate measurement of quality of life (QoL) among people with chronic and incurable illnesses is essential for evaluating service delivery, understanding the impact of illness and treatment effects, and testing intervention effectiveness. Palliative care interventions are relatively new in Turkey; therefore, it is important that reliable and valid QoL instruments are available to evaluate palliative care effectiveness in Turkish speakers. ObjectivesThe purpose of this study was to translate, linguistically validate, and determine the psychometric properties of the newly translated Functional Assessment of Chronic Illness Therapy–Palliative Care (FACIT-Pal) scale (FACIT-Pal-TR) for Turkish-speaking cancer patients. MethodsWe used standard multilingual translation and validation methods for the initial translation of the FACIT-Pal-TR and then assessed the psychometric properties of reliability and validity of the translated scale. We used the Karnofsky Performance Scale and Edmonton Symptom Assessment Scale to assess concurrent and construct validity. ResultsA convenience sample of 232 cancer patients participated in this study. The Cronbach's alpha coefficient of FACIT-Pal-TR was 0.932 (between 0.732 and 0.860 for subscales). There was a statistically significant relationship between test and retest scores (r = 0.877, P < 0.001). The factor loadings of FACIT-Pal-TR were between 0.205 and 0.815. FACIT-Pal-TR construct validity was acceptable with 45 items and five subscales. There were statistically significant relationships between FACIT-Pal-TR scores and Edmonton Symptom Assessment Scale (P < 0.001) and Karnofsky Performance Scale (r = 0.656; P < 0.001) scores. ConclusionsThe FACIT-Pal-TR demonstrates strong reliability and validity for evaluating palliative care–specific QoL in Turkish cancer patients.

Patient and physician perceptions of disease management in Parkinson's disease: results from a US-based multicenter survey.

Background: Clinical care for patients with Parkinson’s disease (PD) is complex, and disconnect may exist between patient and physician perceptions of treatment, disease awareness, and impact on quality of life (QoL). Relatively few studies have analyzed patient and physician perspectives of disease management concurrently, and even fewer have compared responses between corresponding patients and their physicians. This study aimed to characterize these aspects and identify opportunities to improve alignment.Methods: This cross-sectional study used an online survey and chart review. Participating physicians completed a profiling survey, followed by patient record forms (PRFs) for their next five patients with PD. Patients completed paper questionnaires. PRFs were matched with patient questionnaires, and patient and physician responses compared.Results: Of 107 participating physicians, 70 completed 350 PRFs. Patients completed 71 questionnaires; 66 were matched to PRFs. From a physician perspective, there was alignment between the motor symptoms that were most bothersome for patients and those that were most discussed (physicians felt tremor was most bothersome for most patients [71%]; 77% of physicians included tremor among top three most discussed), but disconnect between the most bothersome and most discussed nonmotor symptoms (physicians felt fatigue was most bothersome for most patients [35%]; cognitive impairment was the most discussed nonmotor symptom, with 52% of physicians including it in top three most discussed). Patients and physicians reported moderate satisfaction with current PD medication. Patients considered form of delivery more important than did physicians. Physicians showed a strong level of awareness of PD’s impact on patient QoL, although validated QoL instruments were not widely used. Physicians were more confident than patients about patients’ awareness of support resources for patients with PD.Conclusion: Nonmotor symptoms, form of medication delivery, and awareness of support services are areas where PD physician and patient alignment could be increased to improve outcomes.

The effect of scalp cooling on CIA-related quality of life in breast cancer patients: a systematic review.

Chemotherapy-induced alopecia (CIA) remains a distressing adverse event of cancer treatment but may be prevented by scalp cooling. The effectiveness of scalp cooling, however, is dependent on the chemotherapy regimen with successful hair preservation (i.e., < 50% hair loss) in 41-59% of women on taxane-based therapies in comparison to 16-36% on anthracycline-based therapies. Despite the potential utility, use of scalp cooling has shown a more equivocal impact on quality of life (QoL). In this review, we aim to evaluate the use of scalp cooling for CIA and quantitative QoL measures. A systematic review of PubMed, Embase, Web of Science, and Cochrane databases for clinical studies on scalp cooling to prevent CIA published before October 29, 2018 was performed. Clinical studies with 5 or more patients that reported on a quantitative QoL measure were included and graded according to a modified five-point scale from the Oxford Centre for Evidence-Based Medicine. Studies meeting inclusion criteria included 4 randomized clinical trials (RCT), 8 cohort studies, and 1 cross-sectional study with 1282 unique patients. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30: 46%) and Breast Cancer Module (QLQ-BR23: 46%) represented the most commonly used QoL assessments. Overall, 4 (31%) of the 13 studies concluded that scalp cooling was associated with significant improvements in QoL measures; 8 (62%) determined that there was either non-significant or no improvements; and 1 (7.7%) provided a mixed conclusion. Although 2 (50%) RCT demonstrated that scalp cooling can effectively prevent CIA depending on the chemotherapy regimen, these studies did not show that successful hair preservation was associated with improved QoL measures. This review demonstrates that scalp cooling is not consistently associated with significant QoL improvements as assessed by EORTC QLQ-C30 and -BR23. Representing a critical limitation, more than one-third of the studies did not subcategorize QoL outcomes for successfully or unsuccessfully scalp-cooled patients but rather reported on QoL measures for all scalp-cooled patients in general. Failure to prevent hair loss in patients undergoing an expensive and potentially uncomfortable treatment likely contributes to decreased well-being, impacting the overall distribution of QoL measures in scalp cooling patients compared to controls. Future studies should incorporate validated QoL instruments specific to hair disease and classify QoL outcomes for scalp-cooled patients based on the degree of hair preservation.

Quality-of-Life Metrics Correlate With Disease Severity in Idiopathic Subglottic Stenosis.

Idiopathic subglottic stenosis (ISGS) can have significant impacts on quality of life (QOL), but it remains unclear how patients' subjective responses correlate with objective measurement of disease severity. Peak expiratory flow percentage (PEF%) has been shown to be an effective measure of disease severity in subglottic stenosis. This study aims to identify the key QOL questions correlated with PEF% and proposes a statistical model for prediction of disease severity. Patients with ISGS presenting to an academic laryngologist were included retrospectively from 2012 to 2016. Peak expiratory flow percentage (age, sex, and height adjusted) was recorded for each visit, along with four validated QOL instruments (European QOL-Five Dimensions; RAND 36-Item Health Survey; Clinical COPD [Chronic Obstructive Pulmonary Disease] Questionnaire; and the Airway, Dyspnea, Voice, and Swallowing Summary Assessment). A stepwise multiple linear regression was used to identify statistically significant independent variables correlated with PEF%, and a model was built with these variables. Thirty-two patients were included, with a total of 271 patient encounters. Overall scores from each of the four QOL instruments were correlated with PEF% values recorded each visit (P < 0.05). Question responses correlating most positively included overall breathlessness, difficulty catching breath, cough within the past week, dyspnea with moderate activity, perception that voice changes are restricting social life, and overall general health (all P < 0.01). A model constructed using six nonoverlapping questions yielded an adjusted R2 of 0.58. Quality of life is correlated to PEF% in ISGS. Using a limited number of QOL questions, clinicians can predict objective worsening or improvement of disease severity, as measured by spirometry. 2b. Laryngoscope, 2017.

Stereotactic body radiotherapy (SBRT) versus high dose rate (HDR) brachytherapy (BT) boost for high-risk (HR) prostate cancer.

12 Background: Declining use of BT has prompted questions regarding the use of SBRT in HR patients. A systematic literature review was conducted to assess toxicity, and biochemical outcomes following SBRT or HDR BT boost in HR patients. Methods: A search was carried out on the PubMed and Embase databases, for studies published between 2007 and 2017, including HR patients treated with SBRT or HDR boost. Results: We identified 11250 articles, with 6 SBRT and 41 HDR boost studies eligible. The median follow-up was 3.5-5.5 and 2.6-10.3 years in SBRT and HDR boost studies, respectively. The five-year bDFS was 41%–96% in HDR and 69%–98% in SBRT boost studies. Toxicity was reported using the Radiation Therapy Oncology Group (RTOG) scale or the Common Terminology Criteria for Adverse Events (CTCAE) scale and/or validated patient reported Quality of Life (QoL) outcomes. Single SBRT and HDR studies reported 1 year IPSS scores &lt; 7, with 2 SBRT reports of excellent outcomes by the EPIC scale. Acute grade 2 (G2) genitourinary (GU) toxicity ranged from 24-46% and 0.4-33% in SBRT and HDR boost studies, respectively. Late G2 GU toxicity occurred in 2.3-25% and 0-22% following SBRT and the HDR boost, respectively. Late grade 3 (G3) GU toxicity was reported in 0-2.3% and 0-10% with SBRT and HDR boost, respectively. Late G3 GU was reported in 0.8% (2/226) and 4% (114/2763) following SBRT and HDR boost, respectively. Acute G2 gastrointestinal (GI) was noted in 8-19% and 0-19% of SBRT and HDR boost studies, respectively. Late G3 GI was reported in 0-10% and 0-4.6% of SBRT and HDR boost studies, respectively. Late G3 GI was reported in 2% (5/226) and 0.6% (18/2829) of SBRT and HDR boost studies, respectively. Conclusions: SBRT boost may be associated with higher acute G2 but lower late G3 GU toxicity but was not shown by QoL reports, and could be due to selection bias, learning curves or other factors. Randomized trials and validated QoL instruments are needed to accurately compare SBRT to HDR boost.