Study Of Patient-reported Outcomes Research Articles

Intravesical sodium hyaluronate reduces severity, frequency and improves quality of life in recurrent UTI

PurposeUrinary tract infections (UTI) occur in nearly half of all women at least once, with around 35% experiencing recurrences. Bladder mucosal glycosaminoglycan (GAG) layer damage is postulated to contribute. Sodium hyaluronate (SH) replenishes the GAG layer and is believed to be protective. However, there is limited literature on patient-reported outcomes and quality of life (QoL) after treatment. Our objective was to observe changes in UTI severity and QoL after treatment with intravesical SH.MethodsIn this retrospective, observational patient-reported outcome study, we examined outcomes in UTI patients treated with intravesical SH. SH was instilled weekly for 6 weeks. If symptoms persisted, patients received further instillations on demand. Patients were sent postal questionnaires to score symptoms before and after treatment. Patient-reported UTI occurrences before treatment were compared with recurrences after treatment collected from their primary care providers.ResultsThere were 18 (58.1%) valid replies. The median age was 75. The median duration of illness before treatment was 4.5 (IQR 2.8–7) years. The median number of infections fell from ten per year (IQR 7–10) before treatment to two per year (IQR 0–5) after treatment. Pain improved by 34%, urgency 30%, nocturia 30%, frequency 32%, ‘inability to carry out daily activities due to UTI related ill-health’ 37% and ‘loss of sleep’ by 38%. Patients reported a 76% improvement in ‘UTI-related QoL.’ No adverse events were reported.ConclusionSH is safe and useful for managing patients with recurrent UTI, with improvements in symptoms, QoL, a decrease in the number of UTI episodes and in the best interests of antimicrobial stewardship.

Energy level and fatigue after surgery for thyroid cancer: A population-based study of patient-reported outcomes

IntroductionThe relationship between treatment for differentiated thyroid cancer and patient-report of decreased energy and fatigue remains unclear. MethodsPatients diagnosed with differentiated thyroid cancer from 2014 to 2015 included in the Georgia and Los Angeles, California cancer registries of the Surveillance, Epidemiology, and End Results program were surveyed 2 to 4 years after diagnosis, and responses were linked to data from the Surveillance, Epidemiology, and End Results registry. Multivariable logistic regression analysis determined characteristics associated with the report of worse energy level at 2 to 4 years compared to before treatment and current fatigue severity using adjusted odds ratios with 95% confidence intervals. ResultsOf the 2,584 respondents, 988 (38.2%) reported much worse or somewhat worse energy and 1,310 (50.7%) reported moderate to very severe fatigue. The majority of patients were treated with total thyroidectomy with or without nodal dissection (total thyroidectomy with lymph node removal [49.3%] or total thyroidectomy [38.3%]). Only 12.3% had a thyroid lobectomy. Just over half were treated with radioactive iodine therapy (56.7%) and thyroid hormone suppression (50.2%) after the thyroidectomy. Younger age, history of depression, thyroid hormone suppression (odds ratio 1.48 [confidence interval 1.21–1.82]), and receipt of radioiodine (odds ratio 1.31 [confidence interval 1.10–1.56]) correlated with worse energy. Similarly, correlates of substantial fatigue included younger age, more comorbidities, history of depression, and thyroid hormone suppression (odds ratio 1.63 [confidence interval 1.34–1.99]). The presence of low serum calcium levels for >3 months after thyroidectomy was associated with worse energy (odds ratio 1.26 [confidence interval 1.02–1.54]) and substantial fatigue (odds ratio 1.49 [confidence interval 1.21–1.84]). ConclusionIn addition to accepted risk factors such as depression and comorbidities, receiving radioactive iodine and reporting low calcium after thyroidectomy for differentiated thyroid cancer were associated with reports of worse energy compared to preoperative levels; thyroid hormone suppression was associated with reports of both worse energy and substantial post-treatment fatigue.

Prospective Assessment of Patient-Reported Dry Eye Syndrome after Whole Brain Radiation

Dry eye is not typically considered a toxicity of whole brain radiation (WBRT). We analyzed dry eye syndrome as part of a prospective study of patient-reported outcomes after WBRT. Patients with adequate mental status receiving WBRT (25-40 Gy in 10-20 fractions) for any diagnosis were enrolled on a study with dry mouth as the primary endpoint and dry eye syndrome as a secondary endpoint. Patients received 3-dimensional WBRT using opposed lateral fields. Per standard practice, the lacrimal glands were not prospectively delineated. Patients completed the Subjective Evaluation of Symptom of Dryness (SESoD, scored 0-4, higher representing worse dry eye symptoms) at baseline, immediately after WBRT (EndRT), one month (1M), three months (3M), and six months. Patients with baseline SESoD score of ≥3 (moderate dry eye) were excluded from this analysis. The dry eye endpoints analyzed were ≥1 point and ≥2 point increase in SESoD score at 1M. Lacrimal glands were retrospectively delineated with the aid of fused MRI’s and considered a single structure for dosimetric analysis. 100 patients were enrolled, 70 were eligible for analysis (30 patients were excluded, including 18 with baseline xerostomia, 4 who did not complete WBRT, 5 who did not complete any post-WBRT questionnaires, and 3 with baseline SESoD score of ≥3), and 54 were evaluable at 1M. Median bilateral lacrimal V20Gy was 79%. At 1M, 17 patients (32%) had a ≥1 point increase in SESoD score, and 13 (24%) a ≥2 point increase. At 3M, SESoD score was higher than baseline in 34% of evaluable patients. Lacrimal doses appeared to be associated with an increase in SESoD score at 1M of both ≥1 point (V10Gy: p=0.042, OR 1.09/Gy, V20Gy: p=0.071, OR 1.03/Gy) and ≥2 points (V10Gy: p=0.038, OR 1.15/Gy, V20Gy: p=0.063, OR 1.04/Gy). The proportion with increase in dry eye symptoms at 1M for lacrimal V20Gy ≥79% vs. <79% was 46% vs 15%, respectively, for ≥1 point SESoD increase (p=0.02), and 36% vs 12%, respectively, for ≥2 point SESoD increase (p=0.056). Dry eye syndrome appears to be a previously-unreported acute toxicity of WBRT. These data provide further support for the minimization of dose to secretory organs in patients receiving WBRT.

Establishing Institution-specific Normative Data for the BREAST-Q Reconstruction Module: A Prospective Study

Background Breast satisfaction in general female populations is relatively unknown and prior research populations do not reflect our community. Objectives We sought to assess breast satisfaction in a cohort of female participants utilizing the BREAST-Q and determine the impact of participant-related factors. Methods Females with no history of breast cancer or breast surgery attending gynecology appointments completed preoperative BREAST-Q reconstruction modules and demographic forms in this prospective, single-center, patient-reported outcomes study. We also assessed participant-related factors capable of influencing BREAST-Q scores. Results Three hundred females were included. Increasing body mass index had significant associations with lower Satisfaction with Breasts and Psychosocial Well-being scores. Increasing age was associated with significantly lower Sexual Well-being scores. African Americans had significantly higher scores for Satisfaction with Breasts, Psychosocial Well-being, and Sexual Well-being compared with Caucasians. Bra cup sizes A and C were associated with significantly higher Psychosocial Well-being scores than other sizes. Bra cup sizes A, B, and C were associated with significantly higher Sexual Well-being and Physical Well-being: Chest scores than larger sizes. Bra cup sizes B and C were associated with significantly higher Physical Well-being: Abdomen scores than size DD. Bra cup size A was associated with significantly higher Satisfaction with Breasts scores than sizes DD and >DD. Bra cup size C was associated with significantly higher Satisfaction with Breasts scores than larger sizes. Conclusions Body mass index, age, race, and bra cup sizes significantly impact BREAST-Q scores in our population. Determining normative BREAST-Q scores in female populations could represent important baselines for breast outcomes research. Level of Evidence: 2.

Effectiveness and Patient Satisfaction with Budesonide/Formoterol Easyhaler® Among Patients with Asthma or COPD Switching from Previous Treatment: a Real-World Study of Patient-Reported Outcomes.

IntroductionPersistent symptoms, poor disease control, and reduced quality of life (QoL) are common in patients with asthma and chronic obstructive pulmonary disease (COPD). Current therapies are only partially effective and inhaler misuse contributes to insufficient disease control and poor outcomes. This real-world study aimed to evaluate the effectiveness of budesonide/formoterol fumarate (B/F) Easyhaler® in everyday clinical practice in Hungary.MethodsPost hoc, subgroup analyses of this 12-week, real-world, multicenter, open-label study were conducted in adults diagnosed with asthma or COPD. Endpoints included the change in patient-reported outcome measures; i.e., symptoms and disease control measured by Asthma Control Test or COPD Assessment Test and health-related (HR)QoL measured by mini-Asthma Quality of Life Questionnaire or modified Medical Research Council dyspnea scale. Changes in lung function and patient satisfaction with B/F Easyhaler versus their previous inhaler were also evaluated. Results were stratified by the inhaler device used at visit 1 (baseline, when patients switched device); comparisons were made with B/F Easyhaler use after 12 weeks, assessed at visit 3.ResultsIn total, 398 and 563 patients with asthma and COPD, respectively, were analyzed. Significant improvements (p < 0.0001) in symptoms and disease control, HRQoL, and lung function were reported 12 weeks after switching treatment to B/F Easyhaler from the most commonly used devices (≥ 10% of patients). Significant increases in patient satisfaction were also reported versus comparators.ConclusionsPatients with asthma or COPD who switched to B/F Easyhaler from their previous inhaler due to lack of disease control achieved significant improvements in symptoms and disease control, HRQoL, and lung function within 12 weeks of real-world use with significant increase in patient satisfaction also observed. Such comparative information may reassure clinicians and patients that may be viewed as an appropriate and potentially beneficial treatment option.Trial Registration NumberOGYÉI/13942-5/2016 (National Pharmaceutical Institute of Pharmacy and Nutrition of Hungary).FundingOrion Corporation, Orion Pharma.Plain Language SummaryPlain language summary available for this article.Electronic supplementary materialThe online version of this article (10.1007/s41030-019-0097-7) contains supplementary material, which is available to authorized users.

Prospective Assessment of Patient-Reported Dry Eye Syndrome After Whole Brain Radiation

Dry eye is not typically considered a toxicity of whole brain radiation therapy (WBRT). We analyzed dry eye syndrome as part of a prospective study of patient-reported outcomes after WBRT. Patients receiving WBRT to 25 to 40 Gy were enrolled on a study with dry mouth as the primary endpoint and dry eye syndrome as a secondary endpoint. Patients received 3-dimensional WBRT using opposed lateral fields. Per standard practice, lacrimal glands were not prospectively delineated. Patients completed the Subjective Evaluation of Symptom of Dryness (SESoD, scored 0-4, with higher scores representing worse dry eye symptoms) at baseline, immediately afterWBRT (EndRT), and at 1 month (1M), 3 months, and 6 months. Patients with baselineSESoD ≥3 (moderate dry eye) were excluded. The endpoints analyzed were ≥1-point and ≥2-point increase in SESoD score at 1M. Lacrimal glands were retrospectivelydelineated with fused magnetic resonance imaging scans. One hundred patients were enrolled, 70 were eligible for analysis, and 54 were evaluable at 1M. Median bilateral lacrimal V20Gy was 79%. At 1M, 17 patients (32%) had a ≥1-point increase in SESoD score, and 13 (24%) a ≥2-point increase. Lacrimal doses appeared to be associated with an increase in SESoD score of both ≥1 point (V10Gy: P = .042, odds ratio [OR] 1.09/%; V20Gy: P = .071, OR 1.03/%) and ≥2 points (V10Gy: P = .038, OR 1.15/%; V20Gy: P = .063, OR 1.04/%). The proportion with increase in dry eye symptoms at 1M for lacrimal V20Gy ≥79% versus <79% was 46% versus 15%, respectively, for ≥1 point SESoD increase (P = .02) and 36% versus 12%, respectively, for ≥2 point SESoD increase (P = .056). Dry eye appears to be a relatively common, dose/volume-dependent acute toxicity of WBRT. Minimization of lacrimal gland dose may reduce this toxicity, and patients should be counseled regarding the existence of this potential side effect and treatments for dry eye.

A review of patient reported assessment tools for endometriosis

This article describes the current research status of patient reported assessment tools for endometriosis from the aspects including pain symptoms, satisfaction, quality of life and efficacy based on traditional Chinese medicine in the patients with endometriosis, aiming at providing more efficient assessment tools for the study of patient reported outcomes in endometriosis patients. Key words: Review; Endometriosis; Patient report outcomes; Assessment tool

The burden of non-alcoholic steatohepatitis (NASH) among patients from Europe: A real-world patient-reported outcomes study

Background & AimsData on the economic and humanistic burden of non-alcoholic steatohepatitis (NASH) are scarce. This study assessed the comparative burden of NASH, relative to a representative sample from the general population and a type 2 diabetes mellitus (T2DM) cohort, in terms of health-related quality of life, work productivity and activity impairment (WPAI), and healthcare resource use.MethodsData across 5 European countries came from the 2016 National Health and Wellness Survey, a nationally representative patient-reported outcomes survey. Outcomes included mental (MCS) and physical (PCS) component scores from the Short-Form (SF)-36v2, WPAI scores, self-reported physician diagnosis of sleep difficulties, anxiety, and depression, and healthcare resource use: healthcare professional visits, hospital visits, and emergency room visits in the previous 6 months. Bivariate and multivariable analyses were conducted for each outcome and comparative group.ResultsAfter adjusting for matching criteria and covariates, patients with NASH (n = 184) reported significantly worse health-related quality of life, worse WPAI scores, and more healthcare resource use than the general population (n = 736) (MCS 39.22 vs. 45.16, PCS 42.84 vs. 47.76; overall work impairment 49.15% vs. 30.77%, healthcare professional visits 10.73 vs. 6.01, emergency room visits 0.57 vs. 0.22, hospitalizations 0.47 vs. 0.17, p ≪0.05 for all). Patients with NASH did not differ from patients with T2DM (n = 368) on PCS and WPAI scores, suggesting a similar impairment on work and daily activities, but did report significantly worse mental status (MCS 39.64 vs. 43.64, p ≪0.05) and more healthcare resource use than those with T2DM (healthcare professional visits 10.85 vs. 7.86, emergency room visits 0.65 vs. 0.23, hospitalizations 0.39 vs. 0.19, p ≪0.05 for all).ConclusionsThese findings suggest that the burden of NASH may be underestimated, highlighting the unmet needs of patients with NASH.Lay summaryThese findings show that patients with non-alcoholic steatohepatitis (NASH) experience a significant burden of illness, in terms of health-related quality of life, work productivity and activity impairment, and healthcare resource use. As there is currently no approved treatment for NASH, these findings highlight the unmet medical need of patients with NASH.

A Real-World, Non-interventional Indian Study Evaluating Intensive Plant-Based Butter Moisturizing Cream in Psoriasis.

IntroductionPsoriasis is estimated to affect 0.44–2.8% of the Indian population. Moisturizers are a key adjuvant psoriasis treatment strategy, but data regarding their effectiveness, safety and compliance pattern in an Indian context are lacking. Hence, this real-world study on an intensive plant-based butter moisturizing cream (Venusia ® Max) was conducted among Indian patients with psoriasis.MethodsThis was an observational, patient-reported outcomes (PRO) study in patients with psoriasis aged 18–75 years who were prescribed the cream in routine clinical practice, as per clinician’s discretion, over 4 weeks. The primary outcome measure was improvement from baseline in quality of life assessed using the Dermatology Quality of Life Index (DLQI) at 4 weeks of the study period. The secondary outcome measures were improvement in dryness using the Dry Skin/Ichthyosis Area and Severity Index (DASI) score at 4 weeks, safety and compliance. The DLQI and DASI scores were recorded by the clinicians at baseline and after 2 (optional) and 4 weeks of starting the cream. Safety was assessed throughout the study.ResultsThe study included 400 patients from 9 outpatient dermatology centers across India. Of 400 patients, 384 completed the study. A significant reduction in both the mean DLQI score (66.7%; p < 0.001) and mean DASI score (84.6%; p < 0.001) was observed at week 4 after starting the cream vs. baseline in the overall population. Overall, the cream showed a good safety and compliance profile during the study period. There were no serious adverse events or deaths.ConclusionsThe evidence from the PRO study suggests that use of the intensive plant-based butter moisturizing cream in a real-world scenario has a noticeable impact on improving the quality of life and reducing the skin dryness associated with psoriasis over 4 weeks. The moisturizing cream may serve as a valuable adjuvant treatment option for the management of psoriasis.Trial Registration NumberCTRI/2017/03/008023.FundingDr. Reddy’s Laboratories Ltd.Electronic supplementary materialThe online version of this article (10.1007/s13555-019-0307-0) contains supplementary material, which is available to authorized users.

Beyond HIV prevention: a qualitative study of patient-reported outcomes of PrEP among MSM patients in two public STD clinics in Baltimore

ABSTRACTPre-exposure prophylaxis (PrEP) could have a substantial impact on the HIV epidemic within the US. However, the implementation of PrEP interventions outside of clinical trials has been slow and faces considerable barriers. The aim of the current study was to qualitatively explore PrEP-related patient-reported outcomes (PRO) among MSM patients who enrolled in a PrEP program at two public STD clinics in Baltimore. We conducted in-depth interviews with 18 PrEP patients who self-identified as MSM at two Baltimore City Health Department STD clinics between March and November, 2017. A codebook was developed using an iterative process. During analysis, the study team identified various biomedical and psychosocial PrEP-related PRO among MSM PrEP patients. In addition to HIV prevention, PrEP-related PRO included greater peace of mind, better continuity in care and awareness about health and well-being, relationship solidarity with serodiscordant partners, and access to social services. These findings on PrEP-related PRO can potentially contribute to improving patient-provider communication, leading to increased engagement in care and uptake of PrEP by MSM.

0398 Improvement in Sleep Duration and Maintenance with Ion Powered Continuous Release and Absorption Melatonin in a Cohort of Patients with Chronic Short Sleep Duration: Results from a Patient-Reported Outcomes Study

0398 Improvement in Sleep Duration and Maintenance with Ion Powered Continuous Release and Absorption Melatonin in a Cohort of Patients with Chronic Short Sleep Duration: Results from a Patient-Reported Outcomes Study

Real-World, Non-Interventional, Observational Study of Hydroxyzine Hydrochloride in Chronic Pruritus: a Prospective, Non-Comparative Study.

IntroductionAlthough hydroxyzine is widely used for symptom relief in pruritus, its clinical safety and efficacy data in the Indian setting are scarce. We conducted a study to assess the effectiveness and tolerability of hydroxyzine in the management of Indian patients with chronic pruritus in a real-world setting.MethodsThis was a prospective, observational, patient-reported outcomes (PRO) study in patients with chronic pruritus due to dermatological causes treated with hydroxyzine as per the clinician’s discretion for a period of up to 12 weeks. The primary outcome was improvement in quality of life from baseline, assessed using the 10-point Dermatology Quality of Life Index (DLQI) at week 12 of the study period. Secondary outcomes were improvement in the pruritus scores (5-D itch scale) at 12 weeks, improvements in the DLQI and 5-D itch scores at 2, 4 and 8 weeks and safety.ResultsThe study included 400 patients (179 males, 221 females) from 7 dermatology centres across India. Of the 400 patients recruited, 391 patients completed at least 2 weeks of treatment. There was significant (p < 0.0001) improvement from baseline in the DLQI scores and 5-D itch scores at 2, 4, 8 and 12 weeks; 189/391 (48.34%) patients had symptom relief leading to early termination. Overall, the treatment was well tolerated with a total of 11 mild-to-moderate adverse events reported during the study, which included dizziness, constipation, drowsiness, dry mouth and sedation. All events resolved without any intervention. There were no serious adverse events.ConclusionThis real-world, observational, PRO study demonstrates that hydroxyzine significantly improves symptoms of pruritus and quality of life in patients with chronic pruritus due to dermatological causes over 12 weeks. Despite the sedating potential of the drug, hydroxyzine is well tolerated in real-world settings.Trial RegistrationCTRI/2017/06/008847.FundingDr. Reddy’s Laboratories.Electronic supplementary materialThe online version of this article (10.1007/s13555-019-0293-2) contains supplementary material, which is available to authorized users.

Relationship of Spiritual Wellbeing and Depressive Symptoms for Patients with a Left-Ventricular Assist Device (LVAD)

Purpose Although quality of life (QOL) has been widely reported in patients receiving LVADs, spiritual wellbeing among LVAD recipients is rarely included in these reports. Methods Prospective, multi-site, cross-sectional, descriptive study of patient-reported outcomes. Depressive symptoms were measured by PHQ9 (lower = fewer symptoms). Spiritual wellbeing was measured through two different questionnaires. The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being scale (FACIT-Sp) (12-items) is an established independent measure (possible score 0-48, higher better) with a faith subscale (score 0-16) and a meaning/peace subscale (score 0-32). The QOLVAD Meaning/Spirituality subscale (5-items) is one of five domains for QOL included in the new, valid and reliable Quality of Life with an LVAD (QOLVAD) questionnaire (domain possible score 0-100, higher better). Results There were 186 LVAD patients in the overall sample: 83% male, 77% white, 22% African American, 90% HeartMate II and 3, 50% bridge to transplant, 30% destination therapy, with average age of 58.5±13.8 years. We report preliminary findings from surveys completed at median time (25th, 75th percentile) of 44 weeks (17.5±115.5) post-VAD. Faith affiliation was 69% Protestant, 19% Catholic, 6% Agnostic/Atheist, and 6% other. The mean PHQ9 score was 3.97±4.16 and FACIT-Sp 38.7±8.8. Meaning/Peace and Faith subscale scores were 26.1±5.5 and 13.0±4.0, respectively. The PHQ9 and the faith subscale of the FACIT-Sp had a significant inverse relationship (r = -0.2166, p=0.004), suggesting that patients with higher faith had fewer depressive symptoms. Similarly, scores for the PHQ and the Meaning/Spirituality subscale of the QOLVAD had a significant inverse relationship (r = -0.3121; p Conclusion Spiritual wellbeing is an important facet of assessing patient-reported outcomes in LVAD patients. Given the strong inverse correlation between spiritual wellbeing and depressive symptoms, some patients may benefit from interventions targeted at improving spiritual wellbeing during LVAD support. Findings may suggest a role for institutional support of resources to promote patient spiritual wellbeing.

Looking Back, Moving Forward: A Retrospective Review of Care Trends in an Academic Palliative and Supportive Care Program from 2004 to 2016.

Objective: To examine a rural-serving HBPC program's 12-year experience and historical trends to inform future program direction and expansion. Background: There is limited information about longitudinal trends in mature hospital-based palliative care (HBPC) programs serving racially diverse rural populations. Methods: This is a retrospective cross-sectional study of operational and patient-reported outcomes from the University of Alabama at Birmingham (UAB) Center for Palliative and Supportive Care (CPSC) inpatient (n=11,786) and outpatient (n=315) databases from October 2004 to March 2016. Results: Inpatients were a mean age of 63.7 years, male (50.1%), white (62.3%), general medicine referred (19.5%), primarily for goals of care (84.4%); 47.1% had "do not resuscitate/do not intubate" status and 46.9% were transferred to the Palliative Care and Comfort Unit (PCCU) after consultation. Median time from admission to consultation was three days, median PCCU length of stay (LOS) was four days, and median hospital LOS was nine days. Increased emergency department and cardiology referrals were notable in later years. Outpatients' mean age was 53.02 years, 63.5% were female, 76.8% were white, and 75.6% had a cancer diagnosis. Fatigue, pain, and disturbed sleep were the most common symptoms at the time of the visit; 34.6% reported mild-to-moderate depressive symptoms. Of patients reporting pain (64.8%), one-third had 50% or less relief from pain treatment. Discussion: The CPSC, which serves a racially diverse rural population, has demonstrated robust growth. We are poised to scale and spread our lessons learned to underserved communities.

Temporary Health Impact of Prostate MRI and Transrectal Prostate Biopsy in Active Surveillance Prostate Cancer Patients

PurposeTo assess the temporary health impact of prostate multiparametric MRI (mpMRI) and transrectal prostate biopsy in an active surveillance prostate cancer population. MethodsA two-arm institutional review board–approved HIPAA-compliant prospective observational patient-reported outcomes study was performed from November 2017 to July 2018. Inclusion criteria were men with Gleason 6 prostate cancer in active surveillance undergoing either prostate mpMRI or transrectal prostate biopsy. A survey instrument was constructed using validated metrics in consultation with the local patient- and family-centered care organization. Study subjects were recruited at the time of diagnostic testing and completed the instrument by phone 24 to 72 hours after testing. The primary outcome measure was summary testing-related quality of life (summary utility score), derived from the testing morbidities index (TMI) (scale: 0 = death and 1 = perfect health). TMI is stratified into seven domains, with each domain scored from 1 (no health impact) to 5 (extreme health impact). Testing-related quality-of-life measures in the two cohorts were compared with Mann-Whitney U test. ResultsIn all, 122 subjects were recruited, and 90% (110 of 122 [MRI 55 of 60, biopsy 55 of 62]) successfully completed the survey instrument. The temporary quality-of-life impact of transrectal biopsy was significantly greater than that of prostate mpMRI (0.82, 95% confidence interval [CI] 0.79-0.85, versus 0.95, 95% CI 0.94-0.97; P < .001). The largest mean domain-level difference was for intraprocedural pain (transrectal biopsy 2.6, 95% CI 2.4-2.8, versus mpMRI 1.3, 95% CI 1.1-1.5; P < .001). ConclusionTransrectal prostate biopsy has greater temporary health impact (lower testing-related quality-of-life measure) than prostate mpMRI.

Optimizing DIEP Flap Insetting for Immediate Unilateral Breast Reconstruction: A Prospective Cohort Study of Patient-Reported Aesthetic Outcomes.

To improve the aesthetic outcome of deep inferior epigastric perforator (DIEP) flap breast reconstruction, flaps should be tailored to the patient's characteristics. A single method of DIEP flap insetting will not suffice for all women seeking breast reconstruction. The authors share the outcomes of a prospective longitudinal study on DIEP flap insetting and present an algorithm for reconstruction. Over 4 years, 70 consecutive immediate unilateral DIEP flap breast reconstructions were prospectively evaluated. DIEP insetting was based on the characteristics of the donor site and contralateral breast, according to the authors' algorithm. Baseline and outcome data were collected. Aesthetic outcomes were evaluated by a panel of three independent assessors, and patient-reported outcomes were quantified using the BREAST-Q at 1 year after reconstruction. Seventy women underwent reconstruction. There were no total or partial flap failures, four cases of fat necrosis, and 14 revision operations. Women reported a mean overall BREAST-Q score of 82 of 100, representing excellent satisfaction but poor satisfaction with sexual well-being. BREAST-Q scores were not associated with age or body mass index. Fat necrosis reduced satisfaction with the chest (absolute mean reduction, 13; 95 percent CI, 8 to 18; p = 0.002). Independent assessors scored the outcomes favorably, but there was no agreement between surgeons, nurses, and lay assessors. The authors' algorithm can support surgeons in selecting individually tailored DIEP flap insetting to achieve excellent aesthetic outcomes. Further research is needed as to the relevance of scores from BREAST-Q in relation to interventions. Therapeutic, IV.

Prospective multicentre cohort study of patient-reported outcomes and complications following major abdominal neoplastic surgery (PATRONUS) \u2013 study protocol for a CHIR-Net student-initiated German medical audit study (CHIR-Net SIGMA study)

BackgroundOne of the most important aspects of designing a clinical trial is selecting appropriate outcomes. Patient-reported outcomes (PROs) can provide a personal assessment of the burden and impact of a malignant disease and its treatment. PROs comprise a wide range of outcomes including basic clinical symptom scores and complex metrics such as health-related quality of life (HRQoL). There is limited data on how postoperative complications following cancer surgery affect symptoms and HRQoL. For this reason the primary aim of the PATRONUS study is to investigate how perioperative complications affect cancer-related symptoms and HRQoL in patients undergoing abdominal cancer surgery. The PATRONUS study is designed and will be initiated and conducted by medical students under the direct supervision of clinician scientists based on the concept of inquiry-based learning.MethodsPATRONUS is a non-interventional prospective multicentre cohort study. Patients undergoing elective oncological abdominal surgery will be recruited at regional centres of the clinical network of the German Surgical Society (CHIR-Net) and associated hospitals.A core set of 12 cancer associated symptoms will be assessed via the PRO version of the Common Terminology Criteria for Adverse Events. The cancer-specific HRQoL will be measured via the computerised adaptive testing version of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30. PROs will be measured eight times over a period of six months. The short-term clinical outcome measure is the rate of postoperative complications (grade II to V) within 30 days according to the Clavien-Dindo classification. The long-term clinical outcome is overall survival within six months postoperative.DiscussionPATRONUS will provide essential insights into the patients’ assessment of their well-being and quality of life in direct relation to clinical outcome parameters following abdominal cancer surgery. Furthermore, PATRONUS will investigate the feasibility of multicentre student-led clinical research.Trial registrationGerman Clinical Trials Register: DRKS00013035 (registered on October 26, 2017).Universal Trial Number (UTN): U1111–1202-8863.

Pilot study of iPad-based patient-reported outcomes at the MGH Cancer Center.

190 Background: Patient reported outcomes (PROs) have been shown to improve outcomes in cancer patients in clinical trials and have also been shown to improve the patient experience, provide real-time access to patient reported symptoms and are increasingly used across disciplines. Given the importance of PROs, at the MGH Cancer Center, we implemented a pilot using iPADs to capture patient reported outcomes for patients receiving IV chemotherapy in the breast and lymphoma clinics as well all IV chemotherapy patients at one of the MGH satellite clinics where patients across all disease groups are seen. Methods: 12 measures from the PRO-CTCAE were selected to be applicable to all cancer patients. Working with the technology team and EPIC team at MGH the selected PROs were loaded into iPADs and are automatically assigned to patients receiving IV chemotherapy. Staff and clinicians were trained in the breast, lymphoma and satellite clinic. Patient who were receiving IV chemotherapy were assigned iPADs at check in. Patients completed the questionnaire and in real-time, the data was available in the EPIC chart. The objectives of the pilot were to assess the feasibility of collecting iPAD based PROs at the MGH Cancer Center. Results: In the 4-month pilot, there were 2,304 visit types that were eligible to receive an iPAD for PRO collection, 79% (N = 1,1816) patients were assigned an iPAD. Of the 1,816 patients assigned an iPAD, 65% (N = 1,173) patients completed the PROs, 4% (N = 36) partially completed the PROs. In terms of completion at the main disease specialty clinic vs the satellite, completion rates were higher at the satellite (77% vs 44%). During one week, we asked the front desk to record why patients did not complete the PROs-93 patients were assessed, 45% of patient refused the iPAD, in 28% of these patients the staff did not capture the reason and 22% were not given an iPAD. Conclusions: This pilot demonstrates the feasibility of collecting PROs in an oncology clinic for patients receiving IV chemotherapy. We plan to continue to improve the assignment of PROs to eligible patients, educate staff, providers and patients on the important of PROs and plan to expand to all the clinics at MGH Cancer Center and satellite centers.

Quality-Adjusted Survival in Women with Gynecologic Malignancies Receiving IMRT after Surgery: A Patient Reported Outcome Study of RTOG 1203

Quality-Adjusted Survival in Women with Gynecologic Malignancies Receiving IMRT after Surgery: A Patient Reported Outcome Study of RTOG 1203

356P - A prospective observational study of mobile application-based patient-reported outcomes (PRO) in advanced breast cancer: Interim baseline data from the MADELINE study

356P - A prospective observational study of mobile application-based patient-reported outcomes (PRO) in advanced breast cancer: Interim baseline data from the MADELINE study