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Objective: To assess the tolerability of multimodal therapy in soft tissue sarcoma patients, particularly with regard to their quality of life and level of distress. Materials and methods: A retrospective cohort study enrolled individuals receiving sarcoma therapy at the sarcoma center of the University of Tuebingen between 2017 and 2022. Participants completed an online survey that included the EORTC's questionnaire (QLQ-C30), coupled with the distress thermometer and demographic inquiries. The primary emphasis was on comparing three distinct modalities: Radiation, Chemotherapy and Surgery. The data were analysed performing one-way ANOVA. Results: A total of 237 patients were included in the study. There was a significant difference (p < 0.001) in quality of life according to the EORTC scores (high score = high quality of life) between the different treatments: chemotherapy (mean: 26.8 [standard deviation: 19.5]), radiotherapy (51.0 [21.5]), and surgery (46.9 [28.3]). Similarly, a statistically significant discrepancy (p < 0.001) was found in average distress levels (high score = high level of distress) corresponding to each treatment type: radiation (5.0 [2.7]), surgery (6.0 [2.9]), and chemotherapy (7.4 [2.4]). The rates of patients willing to undergo the same treatment varied across groups, with the highest percentage observed in the surgery group (94.2%), followed by radiation (87.4%), and chemotherapy (73.5%). Conclusion: Patients receiving multimodal therapy for soft tissue often find chemotherapy particularly demanding. Impairment of both quality of life and physical well-being is more likely and tends to be more severe compared with radiation or surgery. These observations should be taken into consideration when consenting patients and offering treatment plans. [ABSTRACT FROM AUTHOR]

Abstract Purpose This study aims to investigate the potential impact of positive mental well-being on responses of patient-reported outcome measures (PROMs), such as EQ-5D-5L. Methods This study utilized the data collected in a cross-sectional study in a sample consisted of individuals with different health conditions. Spearman's rank correlations were employed to investigate the relationship between the responses to the dimensions of EQ-5D-5L and the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS). A binary logistic regression analysis and ordered logistic multivariable regression were utilized to examine how SWEMWBS scores could impact the responses to EQ-5D-5L dimensions, while controlling for variables such as age, gender, education level, health conditions, caring experience, and data collection methods. The effects of SWEMWBS on EQ-VAS and utility values were also examined. Results One thousand nine individuals participated in the survey. Spearman's rank correlation revealed that all dimensions of EQ-5D-5L, except for the anxiety/depression dimension, exhibited weak correlations with all dimensions of SWEMWBS. Binary logistic regression and ordered logistic multivariable regression indicated that age, SWEMWBS scores, gender, health conditions, data collection methods, and caring experience significantly influenced the likelihood of reporting problems in EQ-5D-5L responses. Notably, better SWEMWBS outcomes increased the likelihood of reporting no or fewer problems across all EQ-5D-5L dimensions. Spearman's rank correlation suggested a moderate or strong positive correlation between SWEMWBS scores and EQ-5D-5L utility values and EQ-VAS. The results of multiple linear regression analysis revealed that SWEMWBS scores, health conditions, caring experience, and data collection methods were significantly associated with EQ-5D utility values and EQ-VAS. Conclusions Individuals with better positive mental well-being results are more likely to report better results in PROMs like EQ-5D-5L. Future study is needed to understand the thought process and to explore strategies to cope with the response heterogeneity that led by the status of mental well-being.

Purpose: This study aims to investigate the potential impact of positive mental well-being on responses of patient-reported outcome measures (PROMs), such as EQ-5D-5L. Methods: This study utilized the data collected in a cross-sectional study in a sample consisted of individuals with different health conditions. Spearman's rank correlations were employed to investigate the relationship between the responses to the dimensions of EQ-5D-5L and the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS). A binary logistic regression analysis and ordered logistic multivariable regression were utilized to examine how SWEMWBS scores could impact the responses to EQ-5D-5L dimensions, while controlling for variables such as age, gender, education level, health conditions, caring experience, and data collection methods. The effects of SWEMWBS on EQ-VAS and utility values were also examined. Results: One thousand nine individuals participated in the survey. Spearman's rank correlation revealed that all dimensions of EQ-5D-5L, except for the anxiety/depression dimension, exhibited weak correlations with all dimensions of SWEMWBS. Binary logistic regression and ordered logistic multivariable regression indicated that age, SWEMWBS scores, gender, health conditions, data collection methods, and caring experience significantly influenced the likelihood of reporting problems in EQ-5D-5L responses. Notably, better SWEMWBS outcomes increased the likelihood of reporting no or fewer problems across all EQ-5D-5L dimensions. Spearman's rank correlation suggested a moderate or strong positive correlation between SWEMWBS scores and EQ-5D-5L utility values and EQ-VAS. The results of multiple linear regression analysis revealed that SWEMWBS scores, health conditions, caring experience, and data collection methods were significantly associated with EQ-5D utility values and EQ-VAS. Conclusions: Individuals with better positive mental well-being results are more likely to report better results in PROMs like EQ-5D-5L. Future study is needed to understand the thought process and to explore strategies to cope with the response heterogeneity that led by the status of mental well-being. [ABSTRACT FROM AUTHOR]

As the treatment for cancer improves and advances are made, the clinical focus is often on treatment response and survival. However, these are not the only factors which are important to patients. More patients are living longer after cancer treatment and therefore it is important that we can describe not only the treatment to patients but also what their life will be like during and after treatment. Patient reported outcomes (PROs) allow us to describe these. Although there are a range of patient reported outcome measures (PROMs) available to the clinician to assess these, the use of them in many areas of brachytherapy lags behind ideal levels. Brachytherapy has many features that differ to external beam radiotherapy (EBRT) yet the assessment of quality of life during and after treatment is much more scarce than EBRT. Brachytherapy is often used in the setting of organ preservation or in place of radical surgery, yet there is a paucity of quality of life data comparing the different treatment modalities. This review article will aim to elaborate on the evidence that exists in the use of specific PROMs within prostate, breast and gynaecologic cancers and describe the development of a novel PROMs approach in rectal brachytherapy which aims to identify and resolve symptoms at an early stage.

Background: Despite widespread usage of the SRS-22r questionnaire (Scoliosis Research Society Questionnaire-22r), the English version has only sparingly been subjected to analysis using modern psychometric techniques for patients with adolescent idiopathic scoliosis (AIS). The study purpose was to improve interpretation and clinical utility of the SRS-22r for adolescents with AIS by generating additional robust evidence, using modern statistical techniques. Questions about (1) Structure and (2) Item and Scale Functioning are addressed and interpreted for clinicians and researchers. Methods: This retrospective case review analyzed SRS-22r data collected from 1823 patients (mean age 14.9±2.2years) with a primary diagnosis of AIS who clinically completed an SRS-22r questionnaire.Individual SRS-22r questions and domain scores were retrieved through data queries. Patient information collected through chart review included diagnosis, age at assessment, sex, race and radiographic parameters. From 6044 SRS-22r assessments, 1 assessment per patient was randomly selected. Exploratory structural equation modeling (ESEM) and item response theory (IRT) techniques were used for data modeling, item calibration, and reliability assessment. Results: ESEM demonstrated acceptable fit to the data: χ2 (130)=343.73, p0.80) reliability. Conclusions: Modern psychometric assessment of the SRS-22r, in adolescent patients with AIS, are presented and interpreted to assist clinicians and researchers in understanding its strengths and limitations. Overall, the SRS-22r demonstrated good psychometric properties in all domains except function. Cautious interpretation of the total score is suggested, as it does not reflect a single HRQoL construct.

Objectives: To investigate the impact of reducing Clinical Target Volume (CTV) to Planning Target Volume (PTV) margins on delivered radiation therapy (RT) dose and patient reported quality-of -life (QOL) for patients with localized prostate cancer. Methods: Twenty patients were included in a single institution IRB-approved prospective study. Nine were planned with reduced margins (4 mm at prostate/rectum interface, 5 mm elsewhere), and 11 with standard margins (6/10 mm). Cumulative delivered dose was calculated using deformable dose accumulation. Each daily CBCT dataset was deformed to the planning CT (pCT), dose was computed, and accumulated on the resampled pCT using a parameter-optimized, B-spline algorithm (Elastix, ITK/VTK). EPIC-26 patient reported QOL was prospectively collected pre-treatment, post-treatment, and at 2-, 6-, 12-, 18-, 24-, 36-, 48-, and 60-month follow-ups. Post -RT QOL scores were baseline corrected and standardized to a [0--100] scale using EPIC-26 methodology. Correlations between QOL scores and dosimetric parameters were investigated, and the overall QOL differences between the two groups (QOLMargin-reduced-QOLcontrol) were calculated. Results: The median QOL follow-up length for the 20 patients was 48 months. Difference between delivered dose and planned dose did not reach statistical significance (p > 0.1) for both targets and organs at risk between the two groups.At 4 years post-RT, standardized mean QOLMargin-reduced-QOLcontrol were improved for Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, and Sexual EPIC domains by 3.5, 14.8, 10.2, and 16.1, respectively (higher values better). The control group showed larger PTV/rectum and PTV/bladder intersection volumes (7.2 ± 5.8, 18.2 ± 8.1 cc) than the margin-reduced group (2.6 ± 1.8, 12.5 ± 8.3 cc), though the dose to these intersection volumes did not reach statistical significance (p > 0.1) between the groups. PTV/rectum intersection volume showed a moderate correlation (r = -0.56, p < 0.05) to Bowel EPIC domain. Conclusions: Results of this prospective study showed that margin-reduced group exhibited clinically meaningful improvement of QOL without compromising the target dose coverage. [ABSTRACT FROM AUTHOR]

Purpose: The added value of measuring patient-reported outcomes (PROs) for delivering patient-centered care and assessment of healthcare quality is increasingly evident. However, healthcare system wide data collection initiatives are hampered by the proliferation of patient-reported outcome measures (PROMs) and conflicting data collection standards. As part of a national initiative of the Dutch Ministry of Health, Welfare and Sport we developed a consensus-based standard set of generic PROs and PROMs to be implemented across Dutch medical specialist care. Methods: A working group of mandated representatives of umbrella organizations involved in Dutch medical specialist care, together with PROM experts and patient organizations worked through a structured, consensus-driven co-creation process. This included literature reviews, online expert and working group meetings, and feedback from national patient- and umbrella organizations. The 'PROM-cycle' methodology was used to select feasible, valid, and reliable PROMs to obtain domain scores for each of the PROs included in the set. Results: Eight PROs across different domains of health were ultimately endorsed: symptoms (pain & fatigue), functioning (physical, social/participation, mental [anxiety & depression]), and overarching (quality of life & perceived overall health). A limited number of generic PROMs was endorsed. PROMIS short forms were selected as the preferred instruments for all PROs. Several recommendations were formulated to facilitate healthcare system level adoption and implementation of the standard set. Conclusions: We developed a consensus-based standard set of Generic PROMs and a set of recommendations to facilitate healthcare system wide implementation across Dutch medical specialist care. [ABSTRACT FROM AUTHOR]

Purpose of review: To review the current literature on patient centered goals for the treatment of pelvic floor disorders (PFDs). Recent findings: Patients have a poor understanding of their PFDs, regardless if they had prior PFD treatments or received counseling, emphasizing the need for improved education from healthcare providers. Understanding the patient perspective provides insights into identifying patient goals, which facilitates communication and allows for tailored counseling, management of expectations, and assessment of treatment response. Functional outcomes are consistently important to patients, often listed as their main treatment goals. The achievement of these goals is fundamental to satisfaction. IMPACT and PROMIS are examples of PCO measures that can be utilized in both research and clinical settings. Finally, telemedicine has emerged as a viable alternative to clinic visits that offers improved access to care with no increase in adverse events or dissatisfaction, in order to aid in monitoring and meeting patient treatment goals. Summary: Patient involvement is fundamental to providing value-based care. Provider understanding of the patient perspective is necessary to guide counseling and treatment. Patient-centered goals offer a way to engage patients, facilitate communication, and improve patient satisfaction. Although there are multiple validated PCO tools, further development and research involving patient input is needed. [ABSTRACT FROM AUTHOR]

Randomised controlled trials (RCTs) have long been considered the gold standard of medical evidence. In relation to cannabis based medicinal products (CBMPs), this focus on RCTs has led to very restrictive guidelines in the UK, which are limiting patient access. There is general agreement that RCT evidence in relation to CBPMs is insufficient at present. As well as commercial reasons, a major problem is that RCTs do not lend themselves well to the study of whole plant medicines. One solution to this challenge is the use of real world evidence (RWE) with patient reported outcomes (PROs) to widen the evidence base. Such data increasingly highlights the positive impact medical cannabis can have on patients' lives. This paper outlines the value of this approach which involves the study of interventions and patients longitudinally under medical care. In relation to CBMPs, RWE has a broad range of advantages. These include the study of larger groups of patients, the use of a broader range and ratio of components of CBMPs, and the inclusion of more and rarer medical conditions. Importantly, and in contrast to RCTs, patients with significant comorbidities-and from a wider demographic profile-can also be studied, so providing higher ecological validity and increasing patient numbers, whilst offering significant cost savings. We conclude by outlining 12 key recommendations of the value of RWE in relation to medical cannabis. We hope that this paper will help policymakers and prescribers understand the importance of RWE in relation to medical cannabis and help them develop approaches to overcome the current situation which is detrimental to patients. [ABSTRACT FROM AUTHOR]

Randomised controlled trials (RCTs) have long been considered the gold standard of medical evidence. In relation to cannabis based medicinal products (CBMPs), this focus on RCTs has led to very restrictive guidelines in the UK, which are limiting patient access. There is general agreement that RCT evidence in relation to CBPMs is insufficient at present. As well as commercial reasons, a major problem is that RCTs do not lend themselves well to the study of whole plant medicines. One solution to this challenge is the use of real world evidence (RWE) with patient reported outcomes (PROs) to widen the evidence base. Such data increasingly highlights the positive impact medical cannabis can have on patients’ lives. This paper outlines the value of this approach which involves the study of interventions and patients longitudinally under medical care. In relation to CBMPs, RWE has a broad range of advantages. These include the study of larger groups of patients, the use of a broader range and ratio of components of CBMPs, and the inclusion of more and rarer medical conditions. Importantly, and in contrast to RCTs, patients with significant comorbidities–and from a wider demographic profile–can also be studied, so providing higher ecological validity and increasing patient numbers, whilst offering significant cost savings. We conclude by outlining 12 key recommendations of the value of RWE in relation to medical cannabis. We hope that this paper will help policymakers and prescribers understand the importance of RWE in relation to medical cannabis and help them develop approaches to overcome the current situation which is detrimental to patients.

Purpose: (1) To investigate intra-articular damage in the hip joint associated with subspine impingement (SSI); (2) to evaluate clinical outcomes of arthroscopic treatment of hips with SSI; and (3) to compare the findings and outcomes to a control group without SSI.Methods: Eligible patients had arthroscopic treatment for femoroacetabular impingement (FAI) concurrent with SSI between January 2015 and December 2017. Inclusion criteria consisted of preoperative and minimum 2-year patient-reported outcomes and preoperative measurements for Tönnis, lateral center edge angle, and alpha angle. Included patients were propensity-matched in a 1:3 ratio to patients who had FAI without SSI. Patient-reported outcomes were compared between groups. Minimal clinically important difference was calculated for modified Harris Hip Score (mHHS) and Hip Outcome Score-Sports Specific Subscale (HOS-SSS).Results: Fifty SSI cases were matched to 150 patients who had FAI without SSI. A greater proportion of the SSI cohort required labral reconstruction (P = .010). The size and locations for labral tears and chondral defects were comparable between groups (P > .05). Both groups demonstrated similar minimum 2-year outcomes for mHHS (P = .103), Nonarthritic Hip Score (P = .200), HOS-SSS (P = .119), visual analog scale (P = .231), international Hip Outcome Tool-12 (P =.300), Short Form-12 Mental (P = .426), Short Form-12 Physical (P = .328), Veterans RAND 12-Item Health Survey, Mental (P = .419), and Veterans RAND 12-Item Health Survey, Physical (P = .316). The percentage of patients achieving minimal clinically important difference for mHHS and HOS-SSS was similar (P > .05). Survivorship was 96.0% and 98.7% for the SSI and control cohorts at 2 years, respectively.Conclusions: Arthroscopic treatment of hips with SSI with subspine decompression and concomitant treatment of labral tears and FAI yielded significant improvement in patients' outcomes, which compared favorably with the control group. SSI may correlate with more complex labral tears, not amenable to repair, and complete tears of the ligamentum teres. Other findings, such as location and size of intra-articular damage, were similar between the cohorts.Level Of Evidence: III, case-control study. [ABSTRACT FROM AUTHOR]

Abstract Background Patient reported outcomes (PROs) provide information on a patient’s health status coming directly from the patient. Measuring PROs with patient reported outcome measures (PROMs) has gained wide interest in clinical practice for individual patient care, as well as in quality improvement, and for providing transparency of outcomes to stakeholders through public reporting. However, current knowledge of selecting and implementing PROMs for these purposes is scattered, and not readily available for clinicians and quality managers in healthcare organizations. The objective of this study is to develop a framework with tools to support the systematic selection, implementation and evaluation of PROs and PROMs in individual patient care, for quality improvement and public reporting. Methods We developed the framework in a national project in the Netherlands following a user-centered design. The development process of the framework contained five iterative components: (a) identification of existing tools, (b) identification of user requirements and designing steps for selection and implementation of PROs and PROMs, (c) discussing a prototype of the framework during a national workshop, (d) developing a web version, (e) pre-testing of the framework. A total of 40 users with different perspectives (clinicians, patient representatives, quality managers, purchasers, researchers) have been consulted. Results The final framework is presented as the PROM-cycle that consists of eight steps in four phases: (1) goal setting, (2) selecting PROs and PROMs, (3) developing and testing of quality indicator(s), (4) implementing and evaluating the PROM(s) and indicator(s). Users emphasized that the first step is the key element in which the why, for whom and setting of the PROM has to be defined. This information is decisive for the following steps. For each step the PROM-cycle provides guidance and tools, with instruments, checklists, methods, handbooks, and standards supporting the process. Conclusion We developed a framework to support the selection and implementation of PROs and PROMs. Each step provides guidance and tools to support the process. The PROM-cycle and its tools are publicly available and can be used by clinicians, quality managers, patient representatives and other experts involved in using PROMS. Through periodic evaluation and updates, tools will be added for national and international use of the PROM-cycle.

Nadeeka R Dias,* Amanda R Howley,* Rinah Yamamoto, Susan M Dallabrida Department of Clinical Science and Consulting, eResearch Technology (ERT), Boston, MA, USA*These authors contributed equally to this workCorrespondence: Amanda R HowleyDepartment of Clinical Science and Consulting, ERT, 500 Rutherford Ave, Boston, MA 02129, USATel +1 617 9731703Email Amanda.Howley@ert.comObjectives: The majority of subjects do not understand how to accurately report PRO data due to conceptual misunderstandings. This study demonstrates how even a short 2-sentence instruction can improve subject understanding.Methods: For this study, 613 subjects completed an online survey, in which they were asked to provide responses to commonly seen PRO questions from various therapeutic areas. Demographic data were also collected.Results: Subjects were provided with scenarios relating to pain severity, the definition of a rescue laxative, reporting stool counts, reporting a bleeding event, and itch severity. After subjects provided an initial response to the question, they were provided with minimal training information consisting of 1–2 sentences and asked to provide a response again to the same question. A 16% increase in mean response accuracy was found amongst all 5 questions evaluated by subjects.Conclusion: Patient understanding of PRO items often seen as key endpoints in clinical trials was shown to increase with minimal training thus increasing the accuracy of data collected.Keywords: patient-reported outcomes PROs, subject training, data accuracy

Abstract The rapid development of immuno-oncology (I-O) therapies for multiple types of cancer has transformed the cancer treatment landscape and brightened the long-term outlook for many patients with advanced cancer. Responding to ongoing efforts to generate value assessments for novel therapies, multiple stakeholders have been considering the question of “What makes I-O transformative?” Evaluating the distinct features and attributes of these therapies, and better characterizing how patients experience them, will inform such assessments. This paper defines ways in which treatment with I-O is different from other therapies. It also proposes key aspects and attributes of I-O therapies that should be considered in any assessment of their value and seeks to address evidence gaps in existing value frameworks given the unique properties of patient outcomes with I-O therapy. The paper concludes with a “data needs catalogue” (DNC) predicated on the belief that multiple key, unique elements that are necessary to fully characterize the value of I-O therapies are not routinely or robustly measured in current clinical practice or reimbursement databases and are infrequently captured in existing research studies. A better characterization of the benefit of I-O treatment will allow a more thorough assessment of its benefits and provide a template for the design and prioritization of future clinical trials and a roadmap for healthcare insurers to optimize coverage for patients with cancers eligible for I-O therapy.

Purpose: Uncertainties exist in how respondents interpret response options in patient-reported outcome measures (PROMs), particularly across different domains and for different scale labels. The current study assessed how respondents quantitatively interpret common response options. Methods: Members of the general public were recruited to this study via an online panel, stratified by age, gender, and having English as a first language. Participants completed background questions and were randomised to answer questions on one of three domains (i.e. loneliness (negatively phrased), happiness or activities (positively phrased)). Participants were asked to provide quantitative interpretations of response options (e.g. how many times per week is equal to "often") and to order several common response options (e.g. occasionally, sometimes) on a 0–100 slider scale. Chi-squared tests and regression analyses were used to assess whether response options were interpreted consistently across domains and respondent characteristics. Results: Data from 1377 participants were analysed. There was general consistency in quantifying the number of times over the last 7 days to which each response option referred. Response options were consistently assigned a lower value in the loneliness than happiness and activities domains. Individual differences, such as age and English as a second language, explained some significant variation in responses, but less than domain. Conclusion: Members of the public quantify common response options in a similar way, but their quantification is not equivalent across domains or every type of respondent. Recommendations for the use of certain scale labels over others in PROM development are provided. [ABSTRACT FROM AUTHOR]

To objectively evaluate the effect different management strategies have on the following post-surgical outcomes. The PubMed, Embase and Cochrane Library databases were reviewed for articles published between January 1st, 2000 to September 18, 2019 that reported on studies comparing techniques for handling the capsule during hip arthroscopy. After applying the inclusion and exclusion criteria, our final analysis included 10 studies. In total, these articles included 1556 hips. The following capsular management strategies were implemented: complete repair (n = 444; 28.53%), partial repair (n = 32; 2.06%), plication (n = 223; 14.33%) and release/no-repair (n = 857; 55.08%). A meta-analysis was performed on outcomes presented in three or more studies using sufficient pooled statistical analysis data. Our meta-analysis demonstrated an improvement in the HOS-SS with capsular repair without being statistically significant (95%CI [-6.71, 8.21], p = 0.06). However, a significant improvement in the mHHS was detected with capsular repair (95%CI [-1.37, 9.39], p = 0.03). Of the Four studies evaluating HOS-ADL, two reported improved outcomes with capsular repair (p < 0.05 for both) while the other two reported no significant difference. While mixed results were demonstrated for reoperation rates, no difference was found across capsular management strategies regarding radiological outcomes, NAHS (all p -values >0.05) pain (p > 0.05), flexion (p > 0.05), and patient satisfaction (p > 0.05). Capsular repair has the potential to improve patient reported outcomes after hip arthroscopy. While there was no consensus in literature, studies consistently reported similar or superior outcomes in the capsular repair cohorts compared to capsular release. Further randomized controlled studies need to be conducted for better evaluation of outcomes. [ABSTRACT FROM AUTHOR]

To screen for depression and assess its frequency in rheumatoid arthritis (RA) patients and to study its relation to clinical parameters, patient-reported outcomes (PROs) and disease activity. This study included 200 consecutive adult RA patients. Clinical and laboratory investigations were performed. PROs including tender and swollen joint count, patient's estimated pain, patient global assessment (PGA), validated Arabic version of the health assessment questionnaire (HAQ-A) as well as physician global assessment were considered. The disease activity score (DAS28) and simplified erosion narrowing score (SENS) were calculated. Patient health questionnaire-9 (PHQ-9) was used to detect depression. The patients' mean age was 41.3 ± 11.9 years and disease duration 6.6 ± 4.9 years, 79% were females and 21% males (F:M 3.8:1). Their mean DAS28 was 6 ± 1.7 and HAQ-A 1.9 ± 0.9. The mean PHQ-9 score was 7.6 ± 9.3. 45% of patients had depression; mild (3%), moderate (13%), moderate/severe (13%) and severe (16%) degrees. PHQ-9 significantly correlated with age, disease duration, morning stiffness, joint deformity, C-reactive protein, erythrocyte sedimentation rate and rheumatoid factor and negatively with disease modifying anti-rheumatic drugs usage (p = 0.002). All PROs and DAS28 significantly correlated with PHQ-9 (p < 0.0001). Logistic regression analysis showed that joint surgery (p = 0.004), steroid usage (p = 0.005), functional status (p < 0.0001) and joint damage (p < 0.0001) independently significantly increased the probability of depression occurrence. Depression is common among rheumatoid arthritis patients. Periodic routine screening for depression in RA should be included in clinical practice to prevent poor outcomes and to adapt therapies to the specific situation of individual patients. [ABSTRACT FROM AUTHOR]

Abstract Background eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is an internet based system for patients to self-report symptoms and side effects (adverse events or AE) of cancer treatments. eRAPID allows AE reporting from home and patient reported data is accessible via Electronic Patient Records (EPR) for use in routine care. The system can generate alerts to clinical teams for severe AE and provides patient advice on managing mild AEs. The overall aims of eRAPID are to improve the safe delivery of cancer treatments, enhance patient care and standardise AE documentation. Methods The trial is a prospective randomised two-arm parallel group design study with repeated measures and mixed methods. Participants (adult patients with breast cancer on neo-adjuvant or adjuvant chemotherapy, colorectal and gynaecological cancer receiving chemotherapy) are randomised to receive the eRAPID intervention or usual care over 18 weeks of treatment. Participants in the intervention arm receive training in using the eRAPID system to provide routine weekly adverse event reports from home. Hospital staff can access eRAPID reports via the EPR and use the information during consultations or phone calls with patients. Prior to commencing the full trial an internal pilot phase was conducted (N = 87 participants) to assess recruitment procedures, consent and attrition rates, the integrity of the intervention information technology and establish procedures for collecting outcome data. The overall target sample for the trial is N = 504. The primary outcome of the trial is quality of life (FACT-G) with secondary outcomes including health economics (costs to patients and the NHS), process of care (e.g. contacts with the hospital, number of admissions, clinic appointments and changes to treatment/medications) and patient self-efficacy. Outcome data is collected at baseline, 6, 12, 18 weeks and 12 months. The intervention is also being evaluated via end of study interviews with patient participants and clinical staff. Discussion The pilot phase was completed in February 2016 and recruitment and attrition rates met criteria for continuing to the full trial. Recruitment recommenced in May 2016 and is planned to continue until December 2017. Overall findings will determine the value of the eRAPID intervention for supporting the care of patients receiving systemic cancer treatment. Trial registration Current Controlled Trials ISRCTN88520246 . Registered 11 September 2014.

This study explored the integration of technology in healthcare consultations between healthcare professionals (HCPs) and cancer survivors. The research aimed to understand how technological tools influence the dynamics and environment of cancer survivor rehabilitation consultations. The study used Actor-Network Theory (ANT) to analyze the effects of new technological actors in consultations and Invisible Work Theory to uncover hidden workflows associated with technology implementation. The study combined observations and in-depth interviews with HCPs and cancer survivors conducted in March to May 2022, and a follow-up group interview in November 2023. The study revealed that technology's presence notably impacts the relationship between HCPs and cancer survivors, with HCPs expressing concerns that technology disrupts the consultation and challenges the relation. Over time, HCPs gradually began to use laptops during consultations to varying degrees, although the resistance to fully embracing technology persisted. This resistance is attributed to perceived pressure from management and a mismatch with established practices. The findings address the challenges in digital literacy and confidence among HCPs to facilitate the effective incorporation of technology and enhance the patient-clinician relationship. This research contributes to a deeper understanding of the interplay between digital health tools and patient-clinician relationships, highlighting the complexities and opportunities in digitizing healthcare consultations.

Background: Patient reported outcomes (PROs) provide information on a patient's health status coming directly from the patient. Measuring PROs with patient reported outcome measures (PROMs) has gained wide interest in clinical practice for individual patient care, as well as in quality improvement, and for providing transparency of outcomes to stakeholders through public reporting. However, current knowledge of selecting and implementing PROMs for these purposes is scattered, and not readily available for clinicians and quality managers in healthcare organizations. The objective of this study is to develop a framework with tools to support the systematic selection, implementation and evaluation of PROs and PROMs in individual patient care, for quality improvement and public reporting. Methods: We developed the framework in a national project in the Netherlands following a user-centered design. The development process of the framework contained five iterative components: (a) identification of existing tools, (b) identification of user requirements and designing steps for selection and implementation of PROs and PROMs, (c) discussing a prototype of the framework during a national workshop, (d) developing a web version, (e) pre-testing of the framework. A total of 40 users with different perspectives (clinicians, patient representatives, quality managers, purchasers, researchers) have been consulted. Results: The final framework is presented as the PROM-cycle that consists of eight steps in four phases: (1) goal setting, (2) selecting PROs and PROMs, (3) developing and testing of quality indicator(s), (4) implementing and evaluating the PROM(s) and indicator(s). Users emphasized that the first step is the key element in which the why, for whom and setting of the PROM has to be defined. This information is decisive for the following steps. For each step the PROM-cycle provides guidance and tools, with instruments, checklists, methods, handbooks, and standards supporting the process. Conclusion: We developed a framework to support the selection and implementation of PROs and PROMs. Each step provides guidance and tools to support the process. The PROM-cycle and its tools are publicly available and can be used by clinicians, quality managers, patient representatives and other experts involved in using PROMS. Through periodic evaluation and updates, tools will be added for national and international use of the PROM-cycle. [ABSTRACT FROM AUTHOR]

The rapid development of immuno-oncology (I-O) therapies for multiple types of cancer has transformed the cancer treatment landscape and brightened the long-term outlook for many patients with advanced cancer. Responding to ongoing efforts to generate value assessments for novel therapies, multiple stakeholders have been considering the question of "What makes I-O transformative?" Evaluating the distinct features and attributes of these therapies, and better characterizing how patients experience them, will inform such assessments. This paper defines ways in which treatment with I-O is different from other therapies. It also proposes key aspects and attributes of I-O therapies that should be considered in any assessment of their value and seeks to address evidence gaps in existing value frameworks given the unique properties of patient outcomes with I-O therapy. The paper concludes with a "data needs catalogue" (DNC) predicated on the belief that multiple key, unique elements that are necessary to fully characterize the value of I-O therapies are not routinely or robustly measured in current clinical practice or reimbursement databases and are infrequently captured in existing research studies. A better characterization of the benefit of I-O treatment will allow a more thorough assessment of its benefits and provide a template for the design and prioritization of future clinical trials and a roadmap for healthcare insurers to optimize coverage for patients with cancers eligible for I-O therapy. [ABSTRACT FROM AUTHOR]

Majid Moshirfar,1,2 Tirth J Shah,3 David Franklin Skanchy,4 Steven H Linn,1 Paul Kang,3 Daniel S Durrie5 1HDR Research Center, Hoopes Vision, Salt Lake City, UT, 2Department of Ophthalmology and Visual Sciences, John A Moran Eye Center, University of Utah School of Medicine, Salt Lake City, UT, 3University of Arizona College of Medicine – Phoenix, Phoenix, AZ, 4McGovern Medical School, The University of Texas Health Science Center at Houston, TX, 5Durrie Vision, Kansas City, KS, USA Purpose: To compare and analyze the differences in visual outcomes between Visx iDesign Advanced WaveScan Studio™ System, Alcon Wavelight Allegro Topolyzer and Nidek EC-5000 using Final Fit™ Custom Ablation Treatment Software from the submitted summary of safety and effectiveness of the US Food and Drug Administration (FDA) data.Methods: In this retrospective comparative study, 334 eyes from Visx iDesign, 212 eyes from Alcon Contour, and 135 eyes from Nidek CATz platforms were analyzed for primary and secondary visual outcomes. These outcomes were compared via side-by-side graphical and tabular representation of the FDA data. Statistical significance was calculated when appropriate to assess differences. A P-value

Objective: To evaluate patient-reported determinants of treatment effectiveness and tolerability amongst persons with major depressive or bipolar disorders.Methods: The Depression and Bipolar Support Alliance (DBSA) conducted an online survey February 2016-April 2016 asking participants about which outcomes are most important in determining subjective treatment effectiveness and tolerability.Results: In total, 896 participants completed the survey [49.9% unipolar depression (n = 447) and 50.1% bipolar depression (n = 449)]. Survey respondents reported several previous medication trials with the minority (25% of depression and 29% of bipolar group) of respondents reporting that their current treatment plan was completely effective. When asked how they know that the treatment is working, for both groups, the highest rated response was, "I don't feel overly anxious, agitated or irritable." Weight gain was the adverse effect that most commonly led respondents to discontinue a medication. Lethargy, emotional blunting, shaking/trembling and anxiety were also identified as common treatment-emergent experiences leading to medication discontinuation in greater than one-third of respondents. The bipolar group more frequently identified several signs that suggested treatment was working (e.g., improved neurocognitive function, improved sleep), as well as more frequently reported several reasons to discontinue medications (e.g., weight gain, trembling).Conclusion: Numerous factors emerged as important to patients when evaluating treatment effectiveness and tolerability. Some of these factors are inadequately assessed by current standard clinical trial outcome measures. Considering these important patient-centred outcomes in future clinical trials, treatment guidelines and direct patient care may serve to improve patient satisfaction, quality of life and the therapeutic alliance. [ABSTRACT FROM AUTHOR]

The latest United Kingdom (UK) strategy for rare diseases emphasises the need to empower affected populations to improve diagnosis, intervention, and coordination of care. Families who have a child with a rare chromosome disorder (RCD) are a challenging group to include. We report the findings of 2 large‐scale surveys, undertaken by the UK RCD Support Group Unique, of these families' experiences over a 10‐year period. Seven stages of the patient journey were examined. From pre‐testing, through diagnosis, genetics consultation, clinical follow‐up and peer support. Overall, 1158 families replied; 36.4% response rate (2003) and 53.6% (2013). Analysis of responses identifies significant differences (P < .001) over time with a decrease in results reported face to face (76%‐62%), doubling by telephone (12%‐22%), improved explanation of chromosome disorder (57%‐75%), and increased signposting to peer support group (34%‐62%). However, conduct of the consultation raises a number of important questions. Overall, 28 aspects of the patient journey are recognised as requiring improvement; only 12/28 are currently incorporated in UK service specifications. Involvement of RCD families has identified key service improvements. This approach can empower those affected by such extremely rare disorders, and also enable professionals to design improved services in partnership with “expert families.” Further surveys are planned. [ABSTRACT FROM AUTHOR]

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Background: eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is an internet based system for patients to self-report symptoms and side effects (adverse events or AE) of cancer treatments. eRAPID allows AE reporting from home and patient reported data is accessible via Electronic Patient Records (EPR) for use in routine care. The system can generate alerts to clinical teams for severe AE and provides patient advice on managing mild AEs. The overall aims of eRAPID are to improve the safe delivery of cancer treatments, enhance patient care and standardise AE documentation.Methods: The trial is a prospective randomised two-arm parallel group design study with repeated measures and mixed methods. Participants (adult patients with breast cancer on neo-adjuvant or adjuvant chemotherapy, colorectal and gynaecological cancer receiving chemotherapy) are randomised to receive the eRAPID intervention or usual care over 18 weeks of treatment. Participants in the intervention arm receive training in using the eRAPID system to provide routine weekly adverse event reports from home. Hospital staff can access eRAPID reports via the EPR and use the information during consultations or phone calls with patients. Prior to commencing the full trial an internal pilot phase was conducted (N = 87 participants) to assess recruitment procedures, consent and attrition rates, the integrity of the intervention information technology and establish procedures for collecting outcome data. The overall target sample for the trial is N = 504. The primary outcome of the trial is quality of life (FACT-G) with secondary outcomes including health economics (costs to patients and the NHS), process of care (e.g. contacts with the hospital, number of admissions, clinic appointments and changes to treatment/medications) and patient self-efficacy. Outcome data is collected at baseline, 6, 12, 18 weeks and 12 months. The intervention is also being evaluated via end of study interviews with patient participants and clinical staff.Discussion: The pilot phase was completed in February 2016 and recruitment and attrition rates met criteria for continuing to the full trial. Recruitment recommenced in May 2016 and is planned to continue until December 2017. Overall findings will determine the value of the eRAPID intervention for supporting the care of patients receiving systemic cancer treatment.Trial Registration: Current Controlled Trials ISRCTN88520246 . Registered 11 September 2014. [ABSTRACT FROM AUTHOR]

Background: The Egyptian government introduced the first directly acting antivirals (DAAs) into Egypt through the government funded National Treatment Program. As yet, there has been no investigation into the effects of these new DAAs therapies on patient reported outcomes (PROs). This study aimed to (1) assess the PROs (health-related quality of life (HRQoL), mental health and perceived social support) of HCV patients receiving DAAs therapy prior, during and at the end of therapy; (2) evaluate PROs of Interferon-free (dual) users versus Interferon-containing (triple) users cross the three different time periods; and (3) identify the predictors of HRQoL of DAAs therapy users cross the three different time periods.Methods: A prospective observational design was used. Patients with chronic HCV undergoing treatment following the Egyptian National Guidelines at one of the national treatment centers were approached. Data collection occurred in the period from February to October 2015. Data was collected at three time points: (1) baseline (time 0: T0), before initiating therapy); (2) 5/6 weeks after initiation of therapy (time 1 of therapy: T1) and at the end of the therapy (Time 2: T2). Four PROs questionnaires were utilized for data collection: (1) Multidimensional Scale of Perceived Social Support (MSPSS), (2) The Depression Anxiety Stress Scales (DASS-21), (3) the Liver Disease Symptom Index-2.0 (LDSI-2.0) for testing disease specific HRQoL and (4) the Center for Adherence Support Evaluation (CASE) Index, alongside the background data sheet.Results: Sixty-two patients participated. There was a change in HRQoL, symptom experience and mental health across the three different time periods. HRQoL was impaired more after starting the course of therapy (T1) than at baseline (T0) and end of therapy (T2), z ≥ -2.04, p ≤ .04. Also, symptom experience deteriorated more during the treatment period than at the baseline, Z ≥ -1.97, p ≤ .04. Anxiety and stress were significantly higher during the treatment period than at the end of treatment. Perceived social support was significantly higher during the treatment period than at baseline and end of therapy, Z ≥ -2.27, p ≤ .023. During the course of therapy, triple users were more likely to report poorer HRQoL and anxiety than dual users (p ≤ .04). By the end of therapy, the two arms of therapy had no significant differences in any of the PROs. At baseline, the predictor model significantly (p = .000) explained 37.5% of the variation in the HRQoL prior to therapy. Depression was the main variable that contributed to (41.3%) predicting change in HRQoL prior to therapy. During therapy, the model significantly (p = .000) explained 76% of the variation in the HRQoL-T1. Stress-T1, body mass index (BMI)-T1 and HRQoL-T0 significantly and respectively predicted 44.4, 46.5 and 31.1% of the variation in HRQoL-T1. At the end of therapy, the model significantly (p = .000) predicted 80.5% of the variation in the HRQoL-T2. HRQoL-T1 and anxiety-T2 significantly predicted 72.3 and 61.6% of the variation in HRQoL-T2.Conclusions: Baseline HRQoL, depression and BMI should be systematically assessed before starting the antiviral therapy for early detection and the improvement of the impairment before the initiation of therapy. Anxiety should be frequently assessed and followed up through the course of antiviral therapy. The triple group required more nursing and practitioner attention due to increased anxiety levels and impaired HRQoL during the treatment therapy. [ABSTRACT FROM AUTHOR]

Esophageal cancer (EC) patients are living longer due to enhanced screening and novel therapeutics, however, the post-esophagectomy long-term management remains challenging for patients, caregivers, and providers. Patients experience significant morbidity and have difficulty managing symptoms. Providers struggle to manage symptoms, affecting patients' quality of life and complicating care coordination between surgical teams and primary care providers. To address these patient unique needs and create a standardized method for evaluating patient reported long-term outcomes after esophagectomy for EC, our team developed the Upper Digestive Disease Assessment tool, which evolved to become a mobile application. This mobile application is designed to monitor symptom burden, direct assessment, and quantify data for patient outcome analysis after foregut (upper digestive) surgery, including esophagectomy. It is available to the public and enables virtual and remote access to survivorship care. Patients using the Upper Digestive Disease Application (UDD App) must consent to enroll, agree to terms of use, and acknowledge use of health-related information prior to gaining access to the UDD App. The results of patients scores can be utilized for triage and assessment. Care pathways can guide management of severe symptoms in a scalable and standardized method. Here we describe the history, process, and methodology for developing a patient-centric remote monitoring program to improve survivorship after EC. Programs like this that facilitate patient-centered survivorship should be an integral part of comprehensive cancer patient care., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-22-1343/coif). SHB has a patent for an anastomotic esophageal stent. She has a clinical trial on lung ablation funded by Medtronic and a clinical trial on cryo ablation mesothelioma funded by Steris. She has been compensated as a consultant for Medtronic. She has released all profit from the UDD AppTM. LLC serves as a committee member in the Society of Critical Care Medicine PADIS Guidelines and the American Thoracic Society Planning and Evaluation. The other authors have no conflicts of interest to declare., (2023 Journal of Thoracic Disease. All rights reserved.)

The PaTH (University of Pittsburgh/UPMC, Penn State College of Medicine, Temple University Hospital, and Johns Hopkins University) clinical data research network initiative is a collaborative effort among four academic health centers in the Mid-Atlantic region. PaTH will provide robust infrastructure to conduct research, explore clinical outcomes, link with biospecimens, and improve methods for sharing and analyzing data across our diverse populations. Our disease foci are idiopathic pulmonary fibrosis, atrial fibrillation, and obesity. The four network sites have extensive experience in using data from electronic health records and have devised robust methods for patient outreach and recruitment. The network will adopt best practices by using the open-source data-sharing tool, Informatics for Integrating Biology and the Bedside (i2b2), at each site to enhance data sharing using centrally defined common data elements, and will use the Shared Health Research Information Network (SHRINE) for distributed queries across the network. [ABSTRACT FROM AUTHOR]

Abstract: The manner in which a communication disorder affects health-related quality of life (QOL) in children is not known. Unfortunately, collection of quality of life data via traditional paper measures is labor intensive and has several other limitations, which hinder the investigation of pediatric quality of life in children. Currently, there is not sufficient research regarding the use of electronic devices to collect pediatric patient reported outcomes in order to address such limitations. Thus, we used a cross-over design to compare responses to a pediatric health quality of life instrument (PedsQL 4.0) delivered using a handheld electronic device to those from a traditional paper form. Respondents were children with (n =9) and without (n =10) a speech or voice disorder. For paper versus the electronic format, we examined time to completion, number of incomplete or inaccurate question responses, intra-rater reliability, ease of use, and child and parent preference. There were no significant differences between children''s scores, time to complete the measure, or ratings related to ease of answering questions. The percentage of children who made answering errors or omissions with paper and pencil was significantly greater than the percentage of children who made such errors using the device. This preliminary study demonstrated that use of an electronic device to collect QOL or patient-reported outcomes (PRO) data from children is more efficient than and just as feasible, reliable, and acceptable as using paper forms. The development of hardware and software applications for the collection of QOL and/or PRO data in children with speech disorders is likely warranted. Learning outcomes: The reader will be able to understand: (1) The potential benefits of using electronic data capture via handheld devices for collecting pediatric patient reported outcomes; (2) The Pediatric Quality of Life Inventory 4.0 is a measure of the perception of general health quality that has distinguished between healthy children and those with chronic health conditions; (3) Past research in communication disorders indicates that voice and speech disorders may impact quality of life in children; (4) Based on preliminary data, electronic collection of patient reported outcomes in children with and without speech/voice disorders is more efficient and equally feasible, reliable, and acceptable when compared to paper forms. [Copyright &y& Elsevier]

Background In previous studies, patient-reported outcomes (PROs) have been shown to improve survival in cancer patients. The aim of the present study was to assess symptoms potentially related to adverse events experienced by cancer outpatients treated by oral anticancer agents (OAAs) using PROs. Methods Between September 2018 and May 2019, outpatients starting OAAs were included in a 12-week follow-up to assess 15 symptoms listed in the National Cancer Institute PRO Common Terminology Criteria for Adverse Events, using a 5-point scale of severity or frequency. Patients were requested to alert a referral nurse or pharmacist when they self-assessed high-level (level 3 or 4) symptoms. Results 407 questionnaires were completed by 63 patients in which 2333 symptoms were reported. Almost three-quarters (74.6%) reported at least one high-level symptom. The symptoms that were most commonly experienced were fatigue (>9 in 10 patients; 13.2% of symptoms declared), various psychological disorders (>9 in 10 patients; 28.6% of symptoms declared) and general pain (>8 in 10 patients; 9.4% of symptoms declared). Conclusion PROs are appropriate to detect potential adverse events in cancer outpatients treated by OAAs. This study is the first step for integrating the patient's perspective in a digital e-health device in routine oncology care.

Knowledge about the therapeutic potential of medical cannabis has greatly improved over the past decade, with an ever-increasing range of developments in human clinical applications. A growing body of scientific evidence supports the use of medical cannabis products for some therapeutic indications, whilst for others, the evidence base remains disputed. For this narrative review, we incorporate areas where the current evidence base is substantial, such as intractable childhood epilepsy and multiple sclerosis, as well as areas where the evidence is still controversial, such as PTSD and anxiety. We provide a high-level summary of current developments using findings from recent major reviews, as well as real world evidence (RWE), including global database registries and other patient reported outcomes (PROs). On the one hand, our strongest empirical data supports the use of cannabis-based medicinal products (CBMPs) for conditions with relatively small patient numbers. Yet on the other hand, the conditions, where the highest patient numbers present, often have debatable clinical evidence but good RWE, incorporating PROs of 1000s of patients. The discord between PROs and the respective strength of the evidence from randomised controlled trials (RCTs) highlights the urgent need for further research. The scientific literature examining the efficacy of medical cannabis for many conditions is still developing, whilst large numbers of patients globally have been successfully using medical cannabis to treat a broad range of conditions. We conclude on the importance of systematically developing RWE databases to supplement RCTs and to bridge the current evidence gaps. • Improved knowledge about cannabis based medicinal products (CBMPs) is widening the range of human clinical applications. • Some of the conditions for which CBMPs are used are well established by now, while other areas remain controversial. • The strongest empirical data supports the use of CBMPs for conditions with relatively small patient numbers. • The conditions with the highest patient numbers often have debatable clinical evidence but good Real World Evidence (RWE). • Discords between RWE and the strength of evidence from randomised controlled trials (RCTs) highlight the need for further research. [ABSTRACT FROM AUTHOR]

Patient reported outcomes (PROs) fulfill a crucial and unique niche in patient management, providing health-care providers a glimpse into their patients' health experience. This is of utmost importance in patients with benign and malignant disorders of esophagus requiring surgery, which carries significant morbidity, in part due to a high burden of symptoms affecting health-related quality of life (HRQOL). There are a variety of generic and disease-specific patient reported outcome measures (PROMs) available for use in esophageal surgery. This article provides a broad overview of commonly used HRQOL instruments in esophageal surgery, including their utility in comparative effectiveness research, prognostication and shared decision-making for patients undergoing surgery for benign and malignant disorders of the esophagus., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/jtd.2020.03.58). The series “Patient reported Outcomes in Thoracic Surgery: A new Frontier” was commissioned by the editorial office without any funding or sponsorship. The authors have no other conflicts of interest to declare., (2020 Journal of Thoracic Disease. All rights reserved.)

Esophagectomy for esophageal malignancies remains an operation with significant potential morbidity and mortality. However, surgical outcomes continue to improve over time and focus has shifted toward not just good outcomes, but quality of life post operatively. Patient reported outcomes (PROs) focus of quality of life measures via validated patient surveys has increasingly become a significant focus. While PROs do have their limitations, they represent a glimpse into the symptomatology, quality of life, and well-being of a patient undergoing a procedure with inherent morbidity. Working to improve outcomes from the perspective of the patient is not a new concept, but has becoming increasingly relevant as surgical quality for all procedures improves. The optimal approach to esophagectomy is controversial. Minimally invasive approaches attempt to avoid laparotomy and thoracotomy with the thought of improving post-operative quality of life by mitigating complications related to those open surgical approaches. The data in favor of laparoscopy and thoracoscopy is quite strong and multiple randomized controlled trials exist in this realm supporting minimally invasive approaches with regards to quality of life outcomes and more rapid return to patient's preoperative baseline. The data in favor of a robotic approach for esophagectomy is not quite as robust, but more studies show that these approaches mirror the benefits of the laparoscopic and thoracoscopic approaches without robotic assistance., Competing Interests: Conflicts of Interest: The authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/jtd-2019-pro-09). The series “Patient reported Outcomes in Thoracic Surgery: A new Frontier” was commissioned by the editorial office without any funding or sponsorship. Dr. JDL reports and owns stock in: Intuitive Surgical, Inc., Cigna Corp, and Proctor and Gamble. ISS serves as an unpaid editorial board member of Journal of Thoracic Disease from Sept 2018 to Aug 2020. Dr. ISS reports honoraria and/or grants for research/education/training, and/or consulting for Intuitive Surgical, Inc., On Target Laboratories, Cambridge Medical Robotics, and Auris Medical, all outside the scope of the submitted work. The authors have no other conflicts of interest to declare., (2020 Journal of Thoracic Disease. All rights reserved.)

Patient reported outcome measures (PROMs) provide a valuable means of measuring outcomes subjectively from a patient's perspective, facilitating the assessment of service quality across healthcare providers, and assisting patients and clinicians in shared decision making. The primary aim of this systematic review was to critically appraise all historic studies evaluating patient reported quality of life, in adult patients undergoing laparoscopic cholecystectomy for symptomatic gallstones. The secondary aim was to perform a quality assessment of cholecystectomy-specific PROM-validation studies. A literature review was performed in PubMed, Google Scholar TM , the Cochrane Library, Medline, CINAHL, EMBASE and PsychINFO databases up to September 2017. Study characteristics, PROM-specific details and a bias assessment were summarised for non-validation studies. A COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) analysis was performed to assess the methodological quality of identified PROM-validation studies. Fifty one studies were found to evaluate health-related quality of life (HRQoL) after laparoscopic cholecystectomy. Although 94.1% of these studies included PROMs as a primary outcome measure, <20% provided level 1 evidence through randomised controlled trials (RCTs). There was significant variation in the selection and reporting of PROMs, with no studies declaring patient involvement in PROM selection, and 88.2% of studies failing to document the management of missing data points, or non-returned surveys (33.3%). In the 6 PROM-validation studies identified, only 5 psychometric properties were evaluated, the findings of which were limited due to the small number of studies. This systematic review identifies a lack in consistency of study design and PRO reporting in clinical trials. Whilst an increasing number of studies are being performed to evaluate PROs, a lack of adherence to existing PRO administration and reporting guidelines is continuing to negatively affect study quality. We recommend that future clinical trials utilizing PROs should adhere to established comprehensive guidelines as described., Competing Interests: Conflicts of Interest: SL Parsons is a company director for EIDO Healthcare Limited. The other authors have no conflicts of interest to declare.

Patients with advanced illnesses, especially near the end of life, often experience multiple complex symptoms which may have profound impact on the quality of life of not only the patients but also their family members. Early and prompt recognition of such clinical challenges is linked with better end of life care for the dying patients, their caregivers and family members. In this narrative, which is not meant to be an in-depth systematic review, we attempt to provide an overview of some commonly used outcome measurement tools available for bedside clinical assessment of the different dimensions of suffering, especially near the time of death. We also mention need for recognition of conditions, like delirium and other personal, environmental and social factors, to draw the readers' attention towards the importance of such assessments, as these may influence interpretation of patient responses on the tools being used to measure outcomes.

Background: Patient reported outcomes and length of hospital stay (LOS) are being used as a proxy for hospital care. An extra day of hospitalization costs thousands of health care dollars. The choice of intraoperative pain medications has been associated with decreased pain scores in other surgical subspecialties. However, the effects of immediate post-operative patient-controlled analgesics (PCA)/intravenous (IV) pain medication on patient care are not well understood in spine surgery. The aim of this study is to determine the effects of different immediate post-operative pain medications on post-operative complications profile, LOS, and patient reported outcomes (PROs) after elective spine surgery., Methods: The medical records of 230 patients (morphine: n=98, fentanyl: n=61, hydromorphone: n=71) undergoing elective spine surgery at a major academic medical center were reviewed. Patients were categorized by the immediate post-operative pain medication they were on, with the most common medications being PCA/IV morphine, fentanyl, and hydromorphone. Patient demographics, comorbidities, and post-operative complication rates were collected. All patients had retrospectively collected outcomes measures and a minimum of 6-month follow up. Patient reported outcomes instruments [Oswestry Disability Index (ODI), SF-36 and Neck/Back/Leg-Pain Visual Analog Scale (VAS-NP/BP/LP)] were completed before surgery, then at 3- and 6-month after surgery., Results: Baseline characteristics were similar in all cohorts. Operative variables were also similar in all cohorts, with no difference in operative time, estimated blood loss (EBL), or fusion levels. Complication rates were similar between cohorts, with the fentanyl-cohort having an increased percentage of urinary tract infection (UTI) than the morphine and hydromorphone cohorts (16.39% vs. 5.15% vs. 5.63%, P=0.0277). The morphine-cohort had a decreased LOS than the fentanyl and hydromorphone cohorts (4.18 vs. 5.56 vs. 5.69 days, P=0.0376). There was a significant difference in the number of feet first ambulated by the patient post-operatively for the morphine and hydromorphone cohorts than the fentanyl-cohort (morphine: 118.44±18.15 vs. fentanyl: 59.26±20.78 vs. hydromorphone: 125.91±19.85, P=0.0420). There was no significant differences in 30-day hospital readmission rates between the cohorts, morphine-cohort did trend lower than the other cohorts (morphine: 5.10 vs. fentanyl: 11.48 vs. hydromorphone: 11.27, P=0.2492). There were no significant differences in PROs between the two cohorts in ODI, SF-36, and VAS-NP/BP/LP at baseline, 3- and 6-month., Conclusions: Our study demonstrates that the choice of immediate post-operative pain medication can make a difference in the hospital course for patients. Identifying these types of factors might help increase patient care and reduce health care costs., Competing Interests: Conflicts of Interest: The authors have no conflicts of interest to declare.

Background: Assessing incisional hernia recurrence typically requires a clinical encounter. We sought to determine if patient-reported outcomes (PROs) could detect long-term recurrence., Methods: Adult patients 1 to 5 years after incisional hernia repair were prospectively asked about recurrence, bulge, and pain at the original repair site. Using dynamic abdominal sonography for hernia to detect recurrence, performance of each PRO was determined. Multivariable regression was used to evaluate PRO association with recurrence., Results: Fifty-two patients enrolled with follow-up time 46 ± 13 months. A patient-reported bulge was 85% sensitive, and 81% specific to detect recurrence. Patients reporting no bulge and no pain had 0% chance of recurrence. In multivariable analysis, patients reporting a bulge were 18 times more likely to have a recurrence than those without (95% confidence interval, 3.7 to 90.0; P < .001)., Conclusions: This preliminary study demonstrates that PROs offer a promising means of detecting long-term recurrence after incisional hernia repair, which can help facilitate quality improvement and research efforts., (Copyright © 2015 Elsevier Inc. All rights reserved.)