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Studies comparing surgical treatments for cervical spondylotic myelopathy (CSM) are heterogeneous, using a variety of different quality of life (QOL) outcomes and myelopathy-specific measures. This study sought to evaluate the relationship of these measures to each other, and to better understand their use in evaluating patients with CSM. A retrospective study was performed in all patients with CSM who underwent either ventral or dorsal cervical spine surgery at a single tertiary-care institution between January 2008 and July 2013. Severity of myelopathy was assessed pre- and postoperatively using both the Nurick scale and the modified Japanese Orthopaedic Association (mJOA) classification of disability. Prospectively collected QOL outcomes data included Pain Disability Questionnaire (PDQ), Patient Health Questionnaire-9 (PHQ-9), and EQ-5D. Spearman rank correlations were calculated to assess the construct convergent validity for each pair of health status measures (HSMs). To assess each HSM's ability to discriminate favorable EQ-5D index, we performed receiver operating characteristic (ROC) curve analysis and assessed the area under the curve (AUC). A total of 119 patients were included. The PDQ total score had the highest correlation with EQ-5D index (Spearman's rho = -0.82). Neither of the myelopathy scales (mJOA or Nurick) had strong correlations between themselves (0.41) or with the other QOL measures (absolute value range 0.13-0.49). In contrast, the QOL measures correlated relatively well with each other (absolute value range 0.68-0.97). For predicting favorable EQ-5D outcomes, PDQ total score had an AUC of 0.909. The AUCs were significantly greater for the QOL measures in comparison with the myelopathy measures (AUCs were 0.677 and 0.607 for mJOA and Nurick scale scores, respectively). The authors found that all included measures of QOL and CSM-specific (mJOA or Nurick scale) measures were valid and responsive. The PDQ was the most predictive of positive QOL after surgery (as measured by the EQ-5D index) for patients with CSM. The substantially lower correlation between myelopathy and QOL outcomes, compared with the various QOL measures themselves, suggests that these questionnaires are measuring different aspects of the patient experience. Solely assessing the myelopathy or disease-specific signs and symptoms is likely insufficient to fully understand and appreciate clinical outcome in its totality. These questionnaire types should be used together to best evaluate patients pre- and postoperatively.

Development of National Research and Clinical Agendas for Patient-Reported Outcomes in IR: Proceedings from a Multidisciplinary Consensus Panel

Introduction Patient-reported outcome measures (PROMs), including patient-reported outcomes (PROs), are one of two primary sources of data about patients on dialysis (1); the other is biologically based patient data. The Food and Drug Administration definition of a PRO is “any report coming from patients about a health condition and its treatment, without interpretation of the patient’s response by a clinician or anyone else” (2). We argue that this definition fits PROMs more generally and that PROs are a subset of that. Like other fields of medicine, in dialysis, PROMs are used as quality assessment and performance measures. Incorporating PROMs into clinical practice across medicine improves outcomes, such as patients’ survival (3). In a meta-analysis, 65% of studies provided evidence that PROMs improved processes of care (e.g., patient education and diagnoses), 47% of studies provided evidence that PROMs improved the outcomes of care (e.g., functional status), and 42% of studies provided evidence that PROMs improved satisfaction with care (4). Because the Centers for Medicare and Medicaid Services (CMS) pays for the cost of dialysis for the vast majority of patients with ESRD, they have a significant stake in understanding the quality of that care and its outcomes. The CMS is particularly interested in patient experience with care and health-related quality of life (HRQOL) and has codified recommendations or requirements that these PROMs be collected on all patients on dialysis. This paper outlines the major methodologic recommendations around use of PROMs in dialysis that we generated in a white paper commissioned by the Kidney Care Quality Alliance (KCQA). These recommendations were generated through a systematic review of the PROM literature and include (1) continue the use of the Kidney Disease Quality of Life 36-item version (KDQOL-36) for dialysis centers’ internal quality improvement activities and the In-Center Hemodialysis Consumer Assessment of Health Care Providers and Systems (ICH-CAHPS) measures for public dialysis center performance monitoring but promote efforts to modify these instruments by incorporating Patient Reported Outcomes Measurement Information System (PROMIS) general health items (KDQOL-36) and reducing the length of the ICH-CAHPS, (2) adopt a PROM of whether patients on dialysis have been informed about their option for transplant and all dialysis options, (3) evaluate equivalence between electronic and paper versions of PROMs before widespread use of electronic administration, (4) explore reimbursement of costs of PROM administration and training, and (5) continue development of provider trainings in PROM administration and interpretation (Table 1). These recommendations were made to the KCQA on the basis of our review and research into methodologic challenges around the use of PROMs in dialysis. Table 1. - Recommendations for use of patient-reported outcome measures in dialysis centers Category Recommendations Selection of PROMs Continue the use of the KDQOL-36 for dialysis centers’ internal quality improvement activities and the ICH-CAHPS for public dialysis center performance monitoring but promote efforts to modify these instruments by incorporating PROMIS general health items (KDQOL-36) and reducing the length of the ICH-CAHPS Adopt a PROM of whether patients have been informed about their option for transplant and all dialysis options Mode of administration Evaluate equivalence between electronic and paper versions of PROMs before widespread use of electronic administration Support for PROM use Explore reimbursement of costs and support for training for PROM administration from the CMS, the ESRD Networks, or professional societies Continue development of provider trainings in PROM administration and interpretation PROM, patient-reported OUTCOME measure; KDQOL-36, Kidney Disease Quality of Life 36-item version; ICH-CAHPS, In-Center Hemodialysis Consumer Assessment of Health Care Providers and Systems; PROMIS, Patient Reported Outcomes Measurement Information System; CMS, Centers for Medicare and Medicaid Services. Recommendation 1 Two of the most commonly used PROM instruments in dialysis facilities are the KDQOL-36 (5) and the ICH-CAHPS (6). The KDQOL-36 is the measure of choice for the CMS’s requirement of annual HRQOL assessment among all patients on dialysis. The ICH-CAHPS is mandated to be assessed twice annually by all patients on dialysis and is included as a clinical measure in the payment year 2019 Quality Improvement Program (QIP). Both of these instruments were developed with extensive patient and expert input, helping ensure that they represent the views and experiences of patients on dialysis and providers (5,6). In addition, support for the reliability (e.g., internal consistency reliability ≥0.80) and validity of the KDQOL-36 has been evidenced (7). Support for the reliability and validity of the ICH-CAHPS has also been presented (6). Finally, both of these measures have been administered to thousands of patients on dialysis, making possible clinically meaningful comparisons of individual patients with national and state norms and key clinical subgroups. As noted above, the ICH-CAHPS is administered as part of the CMS’s QIP. The KDQOL-36 is often administered to help meet the CMS’s requirement for annual quality of life assessment by vendors, like the Medical Education Institute, which administer the KDQOL-36 to thousands of patients on dialysis yearly. Considering these advantages, we recommend the continued use of the KDQOL-36 instrument with patients on dialysis for the purposes of dialysis centers’ internal quality improvement and the continued use of the ICH-CAHPS for the CMS’s dialysis center performance monitoring. There are opportunities to improve both of these measures. The KDQOL-36 incorporates the Medical Outcomes Study 12 Item Short Form Health Survey (SF-12) as its generic HRQOL core. However, the National Institutes of Health PROMIS measures are the state of the science in generic HRQOL measurement (8) and suitable as a replacement for the SF-12. In head to head comparisons, the PROMIS measures have shown better reliability than legacy measures, like the SF-12. The ICH-CAHPS composites could be made more parsimonious by using an approach similar to that used for the Consumer Assessment of Health Care Providers and Systems clinician and group survey, resulting in shorter surveys (9). Recommendation 2 In addition to HRQOL and patient experience, there are many other PROMs that provide relevant information about patients on dialysis. The decision making of patients with ESRD about their treatment is one domain where the use of PROMs in dialysis centers should be expanded. Patients with ESRD have multiple types of dialysis from which they may choose. In addition to dialysis, they may choose to pursue a living or deceased donor kidney transplant. All of these treatment options vary in the length and quality of additional life-years that they offer to patients (10). The importance of providing information about transplants to patients is evidenced by the fact that it increases the likelihood that they will pursue and receive transplants (11). For this reason, the CMS’s 2008 Conditions for Coverage for dialysis facilities require that information about the option for kidney transplant be provided to each patient on dialysis. However, patients on dialysis report having received information about transplant less than their providers report giving transplant information, indicating that provider reports may not be as accurate for this purpose (12). Additionally, there is evidence that alternative dialysis options may improve patients’ survival and HRQOL (10). It has been argued recently that, when patients on dialysis are not given access to information about the risks and benefits of all their treatment options, they cannot make informed consent for their dialysis treatment (13). We contend that patient reports of receiving information about their treatment options may be better indicators of whether informed decision making and consent around treatment choices actually occur among patients on dialysis compared with provider reports. Therefore, we recommend that the CMS adopt a PROM of whether patients on dialysis have been informed about their option for transplant and all of their dialysis options. Recommendation 3 A major methodologic challenge faced by dialysis facilities is implementing the best mode of survey administration. The International Society of Quality of Life Research reviewed the resources needed and tradeoffs associated with different modes of administration of PROMs (14), including self-, interviewer-, and computer-administered surveys given in the clinic, by mail, over the telephone, and electronically via the web. All of these options involve a balance of advantages, disadvantages, and resource inputs, each of which is detailed in our full manuscript (J.D. Peipert, R.D. Hays, unpublished manuscript). However, one mode of administration with expanding potential, electronically based PROM surveys, deserves special attention. Electronic administration, either on a computer or portable technologies like tablets, may offer attractive efficiencies over the other modes. One particularly attractive benefit of web-based surveys is the ability to input data into a database directly, avoiding potential problems with data entry. Many PROM instruments were originally developed to be administered in a paper/pencil format. Although these instruments likely do not need to be redeveloped for electronic administration, additional testing for equivalence should be conducted to determine if smaller modifications are required (e.g., updates to instructions and formatting or minor wording changes). Therefore, we recommend that new studies evaluate equivalence between electronic and paper versions of PROMs before widespread use of electronic administration. Additionally, inquiries into the challenges of this mode of administration for older adults, the frail, and those without high levels of technology literacy should be made before large-scale rollout. Recommendation 4 Another major challenge facing dialysis facilities around administering PROMs regards their financial and human resource costs. Administering PROMs requires significant staff time and expertise as well as material costs. Many dialysis staff, who are primarily responsible for administering PROMs to patients, already have a high workload. Along with data entry, interpretation of PROMs’ results and incorporation of these results into clinical intervention are expensive and difficult to accomplish without significant discretionary spending and resource investment (1). Therefore, we recommend that efforts be undertaken to explore reimbursement of costs and support for training for PROM administration from the CMS, the ESRD Networks, or professional societies. Recommendation 5 Related to recommendation 4, an important practical challenge faced in administering standardized PROM instruments in dialysis clinics regards the expertise required to properly administer them. The dialysis providers and staff administering PROMs in face to face or telephonic interviews require a special skill set, including the abilities to gather accurate responses, help patients with their questions and concerns without biasing their responses, execute complex skip patterns, and detect when patients may be giving untruthful responses. PROMs implemented through self-administered surveys (e.g., mailed to the patients) also require expertise, including the ability to execute standardized data entry protocols. These skills are not likely part of the training of many dialysis providers and staff, and therefore, additional training is often required. We recommend the continued development of provider trainings in PROM administration and interpretation to help dialysis providers build these skills. These trainings should target dialysis organizations to help their dialysis providers (e.g., nephrologists) and staff members (e.g., nurses and social workers) sharpen their ability to administer PROMs in clinic. In conclusion, dialysis payers, administrators, providers, and staff deserve recognition for their considerable efforts and successes in incorporating PROMs into routine care. However, there are still many challenges facing dialysis facilities around administering PROMs to their patients. We have identified multiple practical specific recommendations to assist in facing these challenges. These recommendations are intended to help dialysis care decision makers, clinicians, and applied researchers continue to improve the excellent track record of PROM use. Disclosures The authors were compensated by the Kidney Care Quality Alliance (KCQA) to prepare a white paper on methodologic issues around using patient-reported measures in dialysis. The recommendations presented in this manuscript represent the results of the authors’ research but do not necessarily represent the views of the KCQA. R.D.H. was among the team of investigators who originally developed Kidney Disease Quality of Life 36-item version and the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems. Neither investigator benefits financially from the use of these measures.

12084 Background: Limited data exist on the impact of social determinants of health on neurocognitive, psychological, and quality of life (QOL) outcomes in adult childhood cancer survivors. Methods: We examined patient-reported outcomes (PROs) of neurocognitive function, psychological symptoms, and QOL in association with the Area Deprivation Index (ADI) and neighborhood ambient air quality in 5,131 survivors (52.1% female, mean [SD] age 29.9 [7.1], mean [SD] age at diagnosis 7.9 [6.2], 81.5% White, and 42.3% leukemia) from the Childhood Cancer Survivor Study. The ADI, which reflects neighborhood socioeconomic deprivation, was coded using survivors’ residential 9-digit ZIP codes; neighborhood ambient air quality was coded by the NASA Satellite-based pollution measures PM2.5 and NO2 by ZIP codes. Impairment on PROs was identified from scores on the Neurocognitive Questionnaire (≤10th%ile), the Brief Symptoms Inventory (BSI; ≥90th%ile), the pain survey (yes vs. no), and the Medical Outcomes Study Short Form-36 ( < 16th%ile). Multivariable logistic regression assessed associations between social determinants and PROs with odds ratios (OR) and 95% confidence intervals (CI), adjusting for demographic and treatment (chemotherapy and radiation) factors. Results: Among survivors, impaired neurocognitive function was reported in 26.5% for task efficiency, 25.4% memory, 15.4% emotional regulation, and 11.6% organization. For the BSI and pain survey, 56.7%, 11.3%, 8.3%, and 7.3% reported total pain, depression, somatization, and anxiety, respectively. Poor physical and mental domains of QOL were reported by 10.9% and 17.0% of survivors, respectively. Survivors with an ADI in the top deprived 20% neighborhoods (compared to the bottom 80% neighborhoods) reported worse neurocognitive function (task efficiency, OR 1.89, 95% CI 1.45-2.46; emotional regulation, OR 1.74, 95% CI 1.30-2.34; and memory, OR 1.67, 95% CI 1.29-2.17), more severe symptoms (pain, OR 1.34, 95% CI 1.05-1.70; somatization, OR 1.55, 95% CI 1.05-2.28; and depression, OR 1.70, 95% CI 1.19-2.44), and poorer QOL (physical, OR 1.75, 95% CI 1.28-2.38; mental, OR 1.79, 95% CI 1.35-2.36), controlling for treatment factors. Survivors from the 20% most deprived neighborhoods showed worse task efficiency (OR 1.50, 95% CI 1.03-2.17), adjusting for all confounders. PM2.5 and NO2 levels were not associated with impairment on PROs, adjusting for all confounders. Conclusions: Social determinants, particularly living in the top deprived neighborhoods, are adversely associated with neurocognitive, psychological, and QOL outcomes in adult childhood cancer survivors. These findings indicate the critical need of evaluating childhood cancer survivors’ area-level deprivation and tailoring support and interventions for survivors based on their social and structural contexts.

Emergency laparotomy is a life-saving intervention for acute abdominal conditions, yet its impact on patients' long-term quality of life (QOL) remains poorly understood. This systematic review synthesizes evidence on QOL outcomes following emergency laparotomy, with a focus on emergency medicine perspectives, including recovery trajectories, influencing factors, and implications for clinical practice. A comprehensive search of PubMed/Medline, Embase, Web of Science, and Scopus was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. In total, 11 studies were included, encompassing prospectiveand retrospective cohorts, cross-sectional surveys, and one randomized controlled trial. The risk of bias was assessed using the Newcastle-Ottawa Scale and the Cochrane Risk of Bias tool. Narrative synthesis was performed due to heterogeneity in QOL measures. Key findings revealed significant variability in QOL recovery. Survivors of peritonitis without malignancy reported acceptable QOL, while cancer and advanced age predicted worse outcomes. Chronic pain affected 19-45% of patients, particularly after small bowel obstruction surgery, and was linked to long-term functional impairment. Laparoscopy improved QOL in elderly patients compared to laparotomy. Frailty and prolonged hospitalization were associated with declines in physical and social functioning. Patient-reported outcome measures were feasible in emergency settings but highlighted unmet needs in psychological and social recovery. Emergency laparotomy significantly impacts QOL, with recovery shaped by surgical approach, comorbidities, and postoperative pain. Standardized QOL assessment, integrated multidisciplinary care, and targeted rehabilitation are needed to optimize long-term outcomes. Future research should prioritize prospective studies with uniform QOL metrics to guide patient-centered interventions.

A Summary of the Meetings of the Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) International Multidisciplinary Consensus

Under Reporting of Patient Reported Outcomes (PROs) in Myeloproliferative Neoplasm (MPN) Clinical Trials

Introduction / Background: The goals of heart transplantation (HT) are to improve symptoms, restore quality of life, and extend survival. Clinical trials in HT recipients have largely focused on objective outcomes such as measures of cardiac function and survival; however, a paucity of data exists regarding the use of patient reported outcome measures (PROMs) as outcomes in these studies. Aims: We aimed to characterize the use of PROMs in registered clinical trials of HT recipients. Methods: All clinical studies of adult HT recipients were queried from ClinicalTrials.gov, and studies were stratified by inclusion of PROMs. Studies reporting PROMs were identified via specific search terms using the “outcomes measures” field. Summary statistics compared characteristics of studies that did versus did not report PROMs. Results/Data: Between November 1999 and August 2022, 227 studies of HT recipients were registered on ClinicalTrials.gov. At least one PROM was reported in 11% (n=24/227) of registered studies. Studies reporting PROMs were more likely to be conducted outside of the United States (91.7% vs 54.2%, p<0.001) and report a greater number of total primary/secondary outcomes (PROMs: median 7 [IQR: 4, 9] vs. No PROMs: median 3 [IQR: 2, 6]; p<0.001). The majority of studies reporting PROMs (58.3%) were initiated after 2020. Twenty-one distinct PROM tools/domains were reported as outcome measures, with the Short Form Health Survey 36 being most frequently used (n=10/24). Thirteen of the 21 PROMs included questions assessing mental health, whereas only three PROM tools were cardiac-specific (Figure). Conclusions: Only about one in ten registered clinical trials of HT recipients include PROMs, and mental health was the most commonly assessed domain when a PROM was included. Development and validation of PROM tools is needed to assess the multifaceted nature of health-related quality of life in HT recipients.

Simple SummaryReconstructive surgery is critical to restore form and function after treatment for head and neck cancer (HNC). The aim of this cross-sectional study was to describe long-term quality of life (QoL) and functional outcomes among patients with a history of HNC who underwent reconstruction of the mandible and/or maxilla. Patients who had radiotherapy either before or after their index reconstruction reported significantly worse functional and QoL outcomes, including speech, swallowing, eating and drinking, appearance, smiling, and satisfaction with information. Swallowing, salivation, oral competence, and satisfaction with information worsened with increasing time since surgery. Women and younger patients also reported worse functional and QoL outcomes, especially speech and facial aesthetics. Understanding long-term outcomes of jaw reconstruction is important for both patients and clinicians to make evidence-based decisions about treatment options. We have identified several groups at risk of poorer outcomes that may benefit from enhanced pre-operative counselling and post-operative monitoring.Long-term health-related quality of life (HRQOL) and functional outcomes following mandibular and maxillary reconstruction are lacking. To determine these outcomes, a cross-sectional study of patients with a history of cancer who underwent jaw reconstruction was undertaken. Participants were identified from a database of jaw reconstruction procedures at the Chris O’Brien Lifehouse (Sydney, Australia). Eligible patients had at least one month follow-up, were aged ≥18 years at surgery, and had history of malignancy. HRQOL was measured using the FACE-Q Head and Neck Cancer Module (FACE-Q H&N). Functional outcomes were measured using the FACE-Q H&N, MD Anderson Dysphagia Inventory (MDADI) and Speech Handicap Index (SHI). Ninety-seven questionnaires were completed (62% response rate). Mean age of respondents was 63.7 years, 61% were male, and 64% underwent radiotherapy. Treatment with radiotherapy was associated with worse outcomes across 10/14 FACE-Q H&N scales, three MDADI subscales and one composite score, and the SHI. Mean differences in scores between irradiated and non-irradiated patients exceeded clinically meaningful differences for the MDADI and SHI. Issues with oral competence, saliva, speaking, and swallowing worsened with increasing time since surgery. Younger patients reported greater concerns with appearance, smiling, speaking, and cancer worry. Women reported greater concerns regarding appearance and associated distress. History of radiotherapy substantially impacts HRQOL and function after jaw reconstruction. Age at surgery and gender were also predictors of outcomes and associated distress. Pre-treatment counselling of patients requiring jaw reconstruction may lead to improved survivorship for patients with head and neck cancer.

The aim of this study was to review all the articles that have implemented patient-reported outcome measures (PROMs) to evaluate the quality of life (QoL) in corneal transplantation and discuss quality assessments of the PROMs. An extensive literature review was undertaken to identify all the studies that used PROMs to assess the QoL in corneal transplantation. Non-original or review articles, articles on other subject area and articles on cost-effectiveness/utility without PROM data/results were excluded. Each PROM was assessed against the following criteria: content development (item identification and item selection), psychometric properties, validity, reliability, and responsiveness. 425 articles were identified of which 35 articles were included in the final review. PROMs in corneal transplantation were used to (a) evaluate the QoL after surgery, (b) compare the QoL scores between different surgical techniques and (c) determine the relationship between QoL and objective measures such as visual acuity, visual field and stereoacuity. A total of 17 PROMs were used to assess QoL in corneal transplantation. Whilst this search did not produce any PROMs that were specifically designed to assess corneal transplantation, most studies were found to have employed the National Eye Institute Visual Function Questionnaire 25 (NEI VFQ 25). The Visual Function Index 14 (VF 14) performed better in the present quality assessment criteria compared to other PROMs, however, the NEI VFQ 25 and the VF 14 PROMs were not specifically developed for corneal transplantation and therefore the QoL assessment made using these PROMs may be incomplete. As improvements in various forms of lamellar transplantation surgery techniques such as UT-DSAEK and FT-DSAEK have resulted in better visual outcomes, improved graft survival and reduced complications, a corneal transplantation specific PROM will be useful in clinical settings to compare the outcomes of different surgical techniques from the patient perspective.

Amyotrophic lateral sclerosis (ALS) is the most common motor neuron disease in adults. There are many patient-reported outcome measures (PROMs) for measuring quality of life (QoL) and health-related QoL (HRQoL) within this population; however, there is limited consensus regardingwhich are most valid, reliable, responsive, and interpretable. This systematic review assesses the psychometric properties and interpretability of QoL and HRQoL PROMs for individuals with ALS. This review was conducted following the Consensus-based Standards for the selection of health Measurement Instruments(COSMIN) methodology for systematic reviews of PROMs. MEDLINE, EMBASE, and CINAHL databases were searched. Studies were included if their aim was to evaluate one or more psychometric properties or the interpretability of QoL or HRQoL PROMs in individuals with ALS. We screened 2713 abstracts, reviewed 60 full-text articles, and included 37 articles. Fifteen PROMs were evaluated including generic HRQoL (e.g., SF-36), ALS-specific HRQoL (e.g., ALSAQ-40), and individualized QoL (e.g., SEIQoL) measures. Evidence for internal consistency and test-retest reliability were acceptable. For convergent validity, 84% of hypotheses were met. For known-groups validity, outcomes were able to distinguish between healthy cohorts and other conditions. Responsiveness results ranged from low to high correlations with other measures over 3-24months. Evidence for content validity, structural validity, measurement error, and divergent validity was limited. This review identified evidence in support of the ALSAQ-40 or ALSAQ-5 for individuals with ALS. These findings canguide healthcare practitioners when selecting evidence-based QoL and HRQoL PROMs for patients and provide researchers withinsight into gaps in the literature.

To assess the impact of benign and malignant sinonasal tumors and their management on patients' Quality of Life (QOL) as measured by Patient Reported Outcome Measures (PROMS). Although there is a growing consensus that endoscopic surgical management in carefully selected patients with sinonasal tumors is at least as (and probably more) effective than open resection, it is not clear to what extent this translates to better QOL outcomes. Earlier studies reported better outcomes in the emotional and physical function domains after endoscopic resection, and it seems that postsurgical morbidity is less in endoscopic compared to open approaches. QoL after endoscopic surgery for sinonasal and anterior skull base tumors seems to improve within several months of surgery in both benign and malignant tumor groups. However, patients with benign sinonasal tumors have a higher QOL pre and post operatively compared to those with malignancy mainly due to absence of (neo) - adjuvant radiotherapy and/or chemotherapy. Factors that seem to be associated with worse QoL include > 60 years, less than 6 months from surgery, prior and adjuvant chemo and radiotherapy, smoking history, advanced staging and malignancy. There is not a universally accepted PROM for use in patients with sinonasal benign and malignant tumors: A variety of different PROMs have been used with different degrees of effectiveness. Most likely a combination of disease-specific (such as SNOT 22 and anterior skull base questionnaire) and generic (such as Short Form health survey questionnaire (SF-36) and Karnofsky Performance Status) health outcome measures provide the most insight into QOL of patients with sinonasal tumors. QOL of these patients appears to undergo a bimodal impact with patients experiencing an initial dip in QOL after surgical treatment followed by a slow improvement over time. However, while patients with benign tumors' return to their status quo ante QOL, this is not the case for patients with malignant tumors who stabilize at a lower than initially QOL. To a large extent this seems to be the effect of (neo) adjuvant chemo radiotherapy.

Patient Reported Outcome Measures (PROMs) are used widely to collect patient perspectives on their Health-Related Quality of Life (HRQoL) after stroke. Existing reviews on PROMs typically report the psychometric properties but rarely focus on the content validity. We performed a structured review of the content of items of stroke-specific HRQoL outcomes. We searched four databases using a combination of terms (Stroke, HRQoL, PROMs) to choose the three most frequently used stroke-specific HRQoL-related PROMs. Two raters independently linked the items of the Stroke Impact Scale, Stroke Specific Quality of Life and the Stroke and Aphasia Quality of Life to the International Classification of Functioning, Disability and Health (ICF) and Item Perspective Classification (IPC). We compared the ICF codes to the ICF Core Sets for Stroke and calculated ICF linkage indicators. More than 75% of the content for all three PROMs is represented in the Comprehensive Stroke Core Set, indicating the universality and validity of the content of these PROMs. All three PROMs represent the content of the ICF Core Sets for Stroke to a similar extent. Most items use an Intensity response option and have a Descriptive perspective. On the IPC framework, most items have a Rational appraisal type and represent the Biological domain. Clinicians and researchers should use patient goals as a reference to choose the appropriate PROM. A deeper understanding of the content of PROMs can help clinicians and researchers make informed decisions on which HRQoL outcomes to use among people following stroke.

Apart from whether a health technology is safe and (cost)effective, it is important to assess the patient's burden of living with the health condition of interest and experience with the current health technology. In this thesis, patient-reported outcomes measures will be used to measure the burden of living with stage III NSCLC and the impact of PCI on the patients' quality of life. A patient reported outcome is any report of the status of a patient's health condition (e.g. quality of life, symptoms, treatment effects, functioning) elicited directly from the patient, without interpretation of the patient's response by a clinician or anyone else. 37 It is important to measure patient reported outcomes, as some outcomes can only be reported by patients, and for some outcomes the patient view may differ from the view of others, such as clinicians. In the NVALT-11/DLCRG-02 study 24 for example, both patient and physicianreported adverse events were measured and except for vomiting, all adverse events were under-reported by the physician. The tools used (mostly questionnaires and survey's) to capture information about patient reported outcomes are called patient reported outcome measures. 37 Different types of patient reported outcome measures exist. An important distinction can be made between generic and disease-specific patient reported outcome measures. Disease-specific measures have the advantage that they are more sensitive to small, but important differences between health conditions, whereas generic measures can easily be compared between many types of diseases, health care interventions and populations. 38 Furthermore, patient-reported outcome measures can be either descriptive or preference-based. Preference-based patient reported outcome measures take into account the relative importance of the domains or questions. Patient reported outcomes measures are often used to measure quality of life. There are many definitions of quality of life, but the World Health Organisation defined it as an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. 39 The most commonly used generic preference-based quality of life measure is the EuroQol-5 dimensions-5 levels (EQ-5D-5L), which is a questionnaire consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises 5 levels ranging from no problems to severe problems, and thus, a total of 3,125 health states are possible. To each of these health states a utility value can be assigned, which ranges from below 0 (worse than death), though 0 (death) to 1 (perfect health). 40 This utility value reflects the population preference for a health state. Utilities can be used to calculate quality-adjusted life years (QALYs). QALYs include both the quality (utility value) and quantity of life (life year gains), and are calculated by multiplying the utility score by the number of life years spent in that health state. apter 1

Objective: To evaluate the impact of osteoporosis-related fractures on health-related quality of life (HRQoL).Methods: Data were obtained from the 2016 Adelphi US Osteoporosis Disease Specific Programme™, a cross-sectional survey of physicians and their male and female patients with osteoporosis. Patient-reported outcomes (PRO) measures included the European Quality of Life 5 Domains (EQ-5D), European Quality of Life Visual Analog Scale (EQ-VAS), and Osteoporosis Assessment Questionnaire short-version (OPAQ-SV; physical, emotional, and symptom domains). Associations between PRO scores and the number and site of fractures were evaluated using ANOVA. Multivariate analyses were conducted using linear regression.Results: Physicians provided records for 1848 patients with osteoporosis. Of these, 981 (53.1%) completed the patient survey, data for the number of fractures were available for 935/981 (95.3%), and 185/935 (19.8%) had a history of fracture. Experiencing fractures significantly influenced scores on all PRO measures (p < .0001). Hip and spine fractures were associated with the greatest reduction in most PRO scores. The number of fractures, age, body mass index, and Charlson Comorbidity Index (CCI) were significantly associated with PRO measures (p < .05) in multivariate analyses. In patients with a fracture, fracture site, CCI, gender (EQ-5D and EQ-VAS), and age (OPAQ-SV physical only) were significantly associated with PRO measures.Conclusions: In patients with osteoporosis, fractures are associated with lower HRQoL and lower overall health status. Fracture history, fracture site, age, and comorbidity burden significantly influence HRQoL in individuals with osteoporosis. These data suggest the need for interventions to reduce the risk of fractures in patients with osteoporosis.