Patient-reported Outcomes Research Articles

Electronic Health in the Palliative Care Pathway for Patients With Head and Neck Cancer

ImportanceThe Expert Center of Palliative Care for head and neck cancer offers structural attention to patients’ complex physical and psychosocial care needs. Patients are offered remote care, including digital monitoring using patient-reported outcome measures, to enable them to stay as long as possible in their trusted home environment. There is limited literature on qualitative feedback and patient-reported experiences with palliative head and neck cancer care, especially for remote care. To provide optimal palliative care, more information on this is needed.ObjectiveTo provide insight into the experiences of patients with head and neck cancer and their next of kin with a hybrid palliative care pathway.Design, Setting, and ParticipantsA mixed-methods quality improvement study was conducted at a tertiary cancer center. The experiences of patients with head and neck cancer in the palliative phase as of June 2022 and next of kin of patients who had died between June 2021 and March 2022 were evaluated using a patient-reported experience measure that included open-ended questions.ExposuresHybrid palliative care pathway.Main Outcomes and MeasuresExperiences of patients and next of kin.ResultsOf 105 included participants, 54 (51.4%) were male, and the mean (SD) age was 67.2 (12.7) years. A total of 56 participants were patients and 49 were next of kin. The face-to-face consultations on the day of the palliative diagnosis were positively experienced by most patients and next of kin. A total of 42 of 102 participants (41%) and 24 of 79 participants (30%) missed at least 1 topic during consultations with their physician and oncology nurse, respectively, such as discussing life expectancy. During the remote follow-up, 71 of 92 (77%) felt safe with this care: they were able to sufficiently clarify their problems, and if necessary, timely action was taken. However, 17 of 48 patients (35%) and 21 of 46 next of kin (46%) considered the provided psychosocial support to be insufficient.Conclusions and RelevanceIn this quality improvement study, patients and next of kin were satisfied with most aspects of the hybrid palliative care pathway, and remote care seemed to be a promising means of delivery. Key areas needing attention are discussing life expectancy and providing psychosocial support. These insights represent the initial steps toward gaining a deeper understanding of patients’ needs during specific moments in a hybrid palliative trajectory. They may support health care professionals in optimizing personalized and value-based palliative care delivery.

Patient-Reported Outcomes in RLBP1 Retinal Dystrophy: Longitudinal Assessment in a Prospective Natural History Study

Patient-Reported Outcomes in <i>RLBP1</i> Retinal Dystrophy: Longitudinal Assessment in a Prospective Natural History Study

Impact of structured checklist-based preoperative counseling versus standard counseling on postoperative patient-reported outcomes after elective surgery

Impact of structured checklist-based preoperative counseling versus standard counseling on postoperative patient-reported outcomes after elective surgery

BN SO58 - Patient Reported Outcome Measures in Hiatal Surgery: A Feasibility Study

Abstract Background Hiatal surgery is predominantly a quality-of-life procedure rather than a lifesaving intervention. Whilst procedural complications are well understood, they do not necessarily reflect the patient experience. Traditional indicators of patient care are insufficient. Patient Reported Outcome Measures (PROM) are robust indicators of care quality (1) and are being used across surgical specialities to benchmark success and identify areas for improvement (2). We present a three-year review of our PROM data to demonstrate feasibility of data collection. Method Patient reported outcome measure data were collected from the National Hiatal Surgery Registry (3) for our benign centre over a three-year period (November 2021-January 2024). Consent was obtained from all patients for research purposes. Surgical procedures included: anti-reflux surgery, hiatus hernia repair and cardiomyotomy. All patients were asked to complete pre-operative quality of life surveys. Patients are automatically contacted through the registry at 6months, 1 year and then annually for five years and prompted to complete quality of life surveys. Ekhardt score is used in achalasia. GORD-QoL score was used for anti-reflux procedures, with the Hernia-QoL score for hiatal hernia. Results Data were collected for 20 patients. Mean BMI was 28.2. All completed preoperative surveys. At six months there was attrition of one patient, who has since completed 1-year and 2-year data. At the time of writing, six patients have completed 6month data, 5 patients have completed 1-year data and 3 patients have completed 2-year data. Mean Ekhardt score was 9.25 preoperatively; at six months mean score was 0. Five patients underwent LINX, eleven underwent fundoplication; one Dor, ten Toupet. Mean pre-operative quality of life score was 31.1; at six months mean score was 15.5. At one year this was 4. Conclusion The National Hiatal Surgery Registry facilitates easy acquisition of surgeon specific PROM data over a short- and long-term period. Patient attrition is low, demonstrating acceptability. Our data demonstrate significantly improved patient reported quality of life postoperatively for all hiatal surgery.

Switching treatment to cipaglucosidase alfa plus miglustat positively affects patient-reported outcome measures in patients with late-onset Pompe disease

Abstract Background Late-onset Pompe disease (LOPD), a rare autosomal recessive multisystemic disorder, substantially impacts patients’ day-to-day activities, outcomes, and health-related quality of life (HRQoL). The PROPEL trial compared cipaglucosidase alfa plus miglustat (cipa+mig) with alglucosidase alfa plus placebo (alg+pbo) in adult patients with LOPD over 52 weeks and showed improved motor and respiratory function in patients switching treatment from standard-of-care enzyme replacement therapy (ERT) to cipa+mig at baseline. This study evaluated the impact of cipa+mig on patient-reported outcomes (PROs), including HRQoL in ERT-experienced patients, using data from PROPEL. Methods PROs evaluated included the Subject’s Global Impression of Change (SGIC), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 20a, PROMIS Fatigue Short Form 8a, Rasch-built Pompe-specific Activity (R-PAct), and European Quality of Life-5 Dimensions 5 Response Levels (EQ-5D-5L). The proportions of responders in the cipa+mig arm and the alg+pbo arm were compared via chi-squared or Fisher’s exact test (patient-level responder analysis), and least squares (LS) mean differences were calculated for change from baseline at Week 52 of the PRO measures (group-level analysis). Results At Week 52, patient-level SGIC responder and group-level SGIC analyses favored cipa+mig compared with alg+pbo across all SGIC domains (e.g. 90 vs. 59% responders in the cipa+mig vs. the alg+pbo group for SGIC ability to move around; P = 0.0005; and LS mean difference 0.385; P = 0.02). Similarly, PROMIS Physical Function and Fatigue domains numerically favored cipa+mig in both analyses (e.g. 50 vs. 40% responders in the cipa+mig vs. alg+pbo arm for PROMIS Physical Function; P = 0.37; and LS mean difference 3.1; P = 0.11). R-PAct for both treatment groups was similar in the patient-level responder analysis, but numerically favored alg+pbo in the group-level analysis (35% responders in both arms; P = 0.95; and LS mean difference −0.8; P = 0.48). Self-care, usual activities, and depression/anxiety domains of EQ-5D-5L numerically favored cipa+mig in both analyses (e.g. 20 vs. 12% responders in the cipa+mig vs. alg+pbo arm for EQ-5D-5L self-care; P = 0.54; and LS mean difference −0.108; P = 0.52). Conclusions Overall, switching treatment from alglucosidase alfa to cipa+mig positively impacted PRO measurements during the double-blind period of PROPEL. Trial registration NCT03729362; Registration date: November 1, 2018; https://clinicaltrials.gov/study/NCT03729362

LeAf Trauma- an intersectoral prospective multicenter study assessing quality of life and return to work after majortrauma–study protocol

With increasing survival rates, the functional outcome and quality of life of trauma patients are gaining more importance. Survivors suffer from chronic pain, psychosomatic disorders, and unemployment as well as increased post-traumatic morbidity, which can lead to an impaired quality of life. So far, the TraumaRegister DGU® records patient data during in-hospital treatment. In this study severely injured patients after major trauma are assessed when discharged from hospital, as well as 6, 12 and 18 months after trauma. The aim is to document cross-sector patient pathways and to identify and quantify the factors influencing the health-related quality of life (hrQoL) and the return to work (RTW), using patient-reported experience measures (PREM) and patient reported outcome measures (PROM). Patients are recruited in certified trauma centers of the German Society for Trauma Surgery (DGU). This study protocol describes the methodology of the prospective multicentre study of LeAf Trauma. Translation of the results will be implemented by using the network structures of the German Society for Trauma Surgery (DGU) for the treatment of patients with major trauma.

Symptom Monitoring With Patient-Reported Outcomes During Pediatric Cancer Care

Symptom Monitoring With Patient-Reported Outcomes During Pediatric Cancer Care

Oral Semaglutide Use in Type 2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies

Oral Semaglutide Use in Type 2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies

Mental Health of Pediatric Patients with Cystic Fibrosis after 18 Months on Elexacaftor‐Tezacaftor‐Ivacaftor Therapy

ABSTRACTBackgroundResearch studies are conflicting regarding new highly effective modulators and the association with mental health symptoms for adults and adolescents with cystic fibrosis (CF). For younger children, small studies and case reports indicate a wide range of effects, ranging from improvement in mood to the development of neuropsychiatric symptoms. However, a large placebo‐controlled study indicated no causal connection. This study evaluates the frequency and severity of mental health symptoms in children and adolescents while taking elexacaftor/tezacaftor/ivacaftor (ETI).MethodsThe study includes 81 pediatric patients with CF followed at Nationwide Children's Hospital (NCH). Patient Reported Outcomes Measurement Information System (PROMIS)‐Anxiety and Depression, Patient Health Questionnaire 8 (PHQ‐8) and Generalized Anxiety Disorder Questionnaire (GAD‐7) were used to screen for depression and anxiety. Age‐appropriate questionnaires were completed over the first 18 months after initiating ETI.ResultsAt baseline, majority of participants reported mental health symptoms within normal limits (WNL). For participants with elevated baseline measures, depressive and anxiety symptoms significantly decreased throughout the study period. Depending on the metric, patients experiencing depressive and anxiety symptoms dropped to 2−3% (n = 1, on each depressive measure) and 0% (n = 0, on either anxiety measures) respectively by 18 months.ConclusionMost pediatric patients with CF did not endorse symptoms of depression or anxiety disorders at ETI initiation. Over the first 18 months of ETI usage, the percentage of patients with these symptoms decreased, suggesting that the percentage of patients experiencing severe symptoms of depression and anxiety may decrease with ongoing use of ETI.

Cervical Disc Arthroplasty for the Treatment of Adjacent Segment Disease after Anterior Cervical Discectomy and Fusion

Study Design. A retrospective chart review was conducted at a single institution. Objective. The purpose of this study was to investigate clinical outcomes of cervical disc arthroplasty (CDA) used for the treatment of symptomatic adjacent segment disease (ASD) developed after anterior cervical discectomy and fusion (ACDF). Summary of Background Data. A major clinical concern following ACDF is the development of ASD. ASD after ACDF is often treated with an additional fusion, but risks include pseudoarthrosis and further ASD. CDA is a motion preserving alternative that addresses these concerns, and therefore, has been proposed as an alternative treatment for ASD after ACDF. Methods. CDA patients with prior adjacent-level ACDF (n=120) were identified from a consecutive series of CDA patients at one institution. Pre- to post- CDA patient-reported outcome measures were compared using the paired Wilcoxon signed-rank test. Results. A total of 142 devices were implanted – 98 patients underwent a one-level CDA, and 22 patients underwent two-level CDA. The mean follow-up duration after CDA was 32.11 months. Neck pain, arm pain, and Neck Disability Index (NDI) scores significantly improved from the preoperative to postoperative timepoint (respectively: 6.14 to 3.02, 4.42 to 1.61, 44.28 to 28.62, all P&lt;0.001). In total, 7 patients underwent reoperation (5.83%). One of these patients underwent reoperation for pseudarthrosis at the level of ACDF following a hybrid procedure. The indications for index level reoperations (n=3) were foraminal stenosis, osteolysis, and postoperative hematoma. All patients with an adjacent level reoperation (n=3) received surgery at levels adjacent to the prior fusion, not the more recent CDA. Conclusion. The results of this study found CDA was effective for the treatment of ASD following ACDF. CDA appears to be a viable treatment option for ASD after ACDF in appropriately selected patients.

Symptom Screening Linked to Care Pathways for Pediatric Patients With Cancer

ImportancePediatric patients with cancer commonly experience severely bothersome symptoms. The effectiveness of routine symptom screening with symptom feedback and symptom management care pathways is unknown.ObjectiveTo determine whether thrice-weekly symptom screening with symptom feedback and management care pathways, compared with usual care, improves overall self-reported symptom scores measured by the Symptom Screening in Pediatrics Tool (SSPedi) in pediatric patients with cancer.Design, Setting, and ParticipantsThis cluster randomized trial enrolled participants between July 2021 and August 2023 from 20 pediatric cancer centers in the US. Patients newly diagnosed with cancer aged 8 to 18 years receiving any cancer treatment were included. Twenty sites were randomized to provide symptom screening (n = 10) vs usual care (n = 10); 221 participants were enrolled at intervention sites and 224 participants at control sites. The date of final follow-up was October 18, 2023.InterventionSymptom screening included providing thrice-weekly symptom screening prompts to participants, email alerts to the health care team, and locally adapted symptom management care pathway implementation.Main Outcomes and MeasuresThe primary outcome was self-reported total SSPedi score at week 8 (range, 0-60; higher scores indicate more bothersome). Secondary outcomes were Patient-Reported Outcomes Measurement Information System Fatigue score (mean [SD] score, 50 [10]; higher scores indicate more fatigue), Pediatric Quality of Life 3.0 Acute Cancer Module scores (range, 0-100; higher scores indicate better health), symptom documentation and interventions at week 8, and unplanned health care encounters.ResultsA total of 445 participants (median [range] age, 14.8 [8.1-18.9] years; 58.9% males) were enrolled. The mean (SD) 8-week SSPedi score was 7.9 (7.2) in the symptom screening group vs 11.4 (8.7) in the usual care group. Symptom screening was associated with significantly better 8-week total SSPedi scores (adjusted mean difference, −3.8 [95% CI, −6.4 to −1.2]) and less bothersome individual symptoms, with 12 of 15 symptoms being statistically significantly reduced. There was no difference in fatigue or quality of life. The mean (SD) number of emergency department visits was 0.77 (1.12) in the symptom screening group and 0.45 (0.81) in the usual care group. There were significantly more emergency department visits in the symptom screening group (rate ratio, 1.72 [95% CI, 1.03-2.87]).ConclusionsSymptom screening with symptom feedback and symptom management care pathways was associated with improved symptom scores and increased symptom-specific interventions. Future work should integrate symptom screening into routine clinical care.Trial RegistrationClinicalTrials.gov Identifier: NCT04614662

Academic Physician and Trainee Occupational Well-Being by Sexual and Gender Minority Status

ImportanceFew studies have explored the association between sexual and gender minority (SGM) status and occupational well-being among health care workers.ObjectivesTo assess the prevalence of burnout, professional fulfillment, intent to leave, anxiety, and depression by self-reported SGM status.Design, Setting, and ParticipantsThis cross-sectional survey study collected data from October 2019 to July 2021, from 8 academic medical institutions participating in the Healthcare Professional Well-Being Academic Consortium. The survey, including questions on SGM status, was administered to attending physicians and trainees. Statistical analyses were performed from June 1, 2023, to February 29, 2024.ExposureSGM status was determined via self-reported sexual orientation and gender identity.Main Outcomes and MeasuresPrimary outcomes measured were the Professional Fulfillment Index (burnout and professional fulfillment), intent to leave, and self-reported anxiety and depression using the Patient-Reported Outcomes Measurement Information System short-form 4-item measure.ResultsOf 20 541 attendings and 6900 trainees, 8376 attendings and 2564 trainees responded and provided SGM status. Of these respondents, 386 attendings (4.6%) and 212 trainees (8.3%) identified as SGM. Compared with their non-SGM peers, SGM attendings had a lower prevalence of professional fulfillment (133 of 386 [34.5%] vs 3200 of 7922 [40.4%]) and a higher prevalence of burnout (181 of 382 [47.4%] vs 2791 of 7883 [35.4%]) and intent to leave (125 of 376 [33.2%] vs 2433 of 7873 [30.9%]) (all P &amp;amp;lt; .001). Compared with their non-SGM peers, SGM trainees had a lower prevalence of professional fulfillment (63 of 211 [29.9%] vs 833 of 2333 [35.7%]) and a higher prevalence of burnout (108 of 211 [51.2%] vs 954 of 2332 [40.9%]) (both P &amp;amp;lt; .001). After adjusting for age and race and ethnicity, SGM attendings had higher odds of burnout than their non-SGM peers (adjusted odds ratio, 1.57 [95% CI, 1.27-1.94]; P &amp;amp;lt; .001). Results for burnout were similar among the SGM trainees compared with their non-SGM peers (adjusted odds ratio, 1.47 [1.10-1.96]; P = .01).Conclusions and RelevanceIn this cross-sectional survey study of academic physicians and trainees, SGM attendings and trainees had higher levels of burnout and lower levels of professional fulfillment. SGM attendings had greater intent to leave than their non-SGM peers, but trainees did not. These disparities represent an opportunity for further exploration to retain SGM health care workers.

Does Transforaminal Endoscopic Lumbar Discectomy Provide More Value than Microdiscectomy? An Application of the Operative Value Index

BACKGROUND AND OBJECTIVES: A few studies have compared the value (outcomes per dollar spent) provided by transforaminal endoscopic discectomy (TED) vs microdiscectomy (MD) for lumbar disc herniations. Here, we attempt to address this gap using a novel Operative Value Index (OVI), which combines a procedure-specific patient-reported outcome with intraoperative cost data based on time-driven activity-based costing. METHODS: MD (n = 95) and TED (n = 23) performed by neurosurgeons at our institution from 2017 to 2022 were retrospectively identified. Time-driven activity-based costing was applied to identify both direct and indirect costs for all cases. Individual costs were obtained by direct observation, electronic medical records, and through consulting multiple departments (including business operations, sterile processing, plant operations, and pharmacy). Oswestry Disability Index (ODI) scores were prospectively collected at baseline and 3 months after surgery. Our primary outcome of interest was the OVI, defined as the percent change in the ODI per $1000 spent intraoperatively. Generalized linear mixed model regression was performed to assess whether TED was associated with significantly different OVI as compared to MD. Similar analyses were also performed for operative times and length of stay. RESULTS: The average intraoperative cost of a TED was $3698, as compared to $3410 for an MD. For both procedures, this total cost was largely driven by the cost of supplies and personnel. Multivariable regression revealed that MD was associated with significantly higher OVI (β-coefficient: 7.2, P &lt; .05) and lower operative times (β-coefficient: - 34.6 minutes, P &lt; .01) compared with TED, with no significant differences in length of stay (P = .17). CONCLUSION: When performed by surgeons at our institution from 2017 to 2022, MD was associated with a 7% greater improvement in ODI per $1000 spent intraoperatively. Continual assessment of value over time (both for established procedures and new techniques) will become increasingly important with the emergence of value-based care.

UK Medical Cannabis Registry: a cohort study of patients prescribed cannabis-based oils and dried flower for generalised anxiety disorder

ABSTRACT Background Generalized anxiety disorder (GAD) is a common mental health condition. The endocannabinoid system has become a focus for new therapies, increasing interest in cannabis-based medicinal products (CBMPs). This study uses data from the UK Medical Cannabis Registry (UKMCR) to investigate real-world outcomes and safety of different CBMP formulations in GAD patients. Methods This study analyzed patient-reported outcomes from 302 GAD patients prescribed CBMPs (oil-based, dried flower, or a combination). Anxiety (GAD-7), sleep quality (SQS), and quality of life (EQ-5D-5 L) were assessed at 1, 3, 6, and 12 months. Adverse events were recorded. Results All CBMP formulations were associated with improvements in anxiety, sleep, and quality of life over 12 months (p < 0.050). At 12 months, there were no significant differences in outcomes between formulations (p > 0.050). The majority of reported adverse events (n = 707) were mild (n = 343) or moderate (n = 285) in severity, with no life-threatening events observed. Conclusion This study provides real-world evidence supporting the potential of CBMPs for improving GAD symptoms. Patients prescribed both oil-based and dried flower formulations have similar outcomes over 12 months. Further research is needed to determine the optimal CBMP formulation and long-term effects.

Early insights from the routine use of patient reported outcome measures in elective hip and knee arthroplasty at a public teaching hospital in South Australia

Abstract Introduction For advanced osteoarthritis of the knee and hip, the most clinically effective treatment remains total-knee arthroplasty (TKA) and total-hip arthroplasty (THA). Success of these surgeries have traditionally been appraised by economic and volume-based measures. There has been a shift towards the use of patient reported outcome measures (PROMs) to quantify success and guide treatment. The present study provides analysis of three PROMS which have been validated for use in orthopaedic settings; the Oxford Knee Score (OKS), Oxford Hip Score (OHS), Forgotten Joint Score (FJS), and the EuroQol-Visual Analogue Scale (EQ-VAS) - a non-disease specific measure of health. PROMs were completed pre-operatively, 6-weeks, and 1-year after elective TKA and THA undertaken in 2018 in a public teaching hospital in South Australia. Post-operative satisfaction/dissatisfaction was measured using a 5-point Likert scale and was collected at the same 6-week and 1-year points. Results PROMs were collected from 285 eligible elective knee-arthroplasty, and 205 elective hip-arthroplasty patients. There was significant average improvement, greater than minimal clinical important differences between pre-operative and 1-year post-operative scores for all three PROMs tools. Inter-PROM correlation was strongest between FJS and OKS at 1-year post TKA (rs = 0.722), and between FJS and OHS in post-THA at the same interval (rs = 0.609). TKA patients with higher pre-surgical 10-year mortality were weakly associated with lower pre-operative OKS score (rs = 0.169). BMI was weakly negatively associated with pre-operative and 6-week post-operative EQ-VAS scores (rs = -0.291 and rs = -0.149 respectively). Post-TKA satisfaction was 77.2% at 1-year, and THA 88.5% at the same interval. Conclusion This study provides an early insight from the use of the OKS, OHS, the EQ-VAS and the FJS as PROMs in primary TKA and THA at our centre. All PROMs demonstrate significant increase (improvement) at both 6-week and 1-year post-operative intervals, relative to pre-operative scores. The FJS demonstrated good sensitivity. Pre-existing co-morbidities do not appear to have any significant relation with post-operative PROMs collected in this study.

Abstract 4141434: Real-World Improvement of Cardiometabolic Risk Factors by Treating Obesity at Scale

Intro: Obesity is a critical risk factor for cardiometabolic disease. A growing body of clinical trial data shows GLP-1 receptor agonist medications (GLP-1s) are not only effective in treating obesity but also demonstrate significant impact on the reduction of cardiovascular risk. Yet current models of care have not been able to reach the &gt;200 million Americans who meet criteria for obesity treatment. To improve access to evidence-based treatment, we established a virtual metabolic health company to provide medically-supervised obesity treatment at scale. Research Question: This real-world evaluation examines the impact of a virtual health program on weight and related cardiometabolic markers. Methods: Data were analyzed for individuals who completed at least 12 months (mos) in the core program and for a subset who continued to 24 mos. Obesity treatment involved GLP-1s combined with a proprietary intensive lifestyle intervention delivered with virtual coaching. Weights were submitted via cellular connected scale. Waist circumference, metabolic labs, and patient-completed surveys were analyzed at baseline and 12 mos. Results: The cohort included 6,766 patients, a subset with structured lab data from a larger population of 16,098 patients who had completed 12 mos in the commercial program. Average weight loss at 12 mos was -16.5% (n=5,932) and -17.8% at 24 os (n=1,171). Improvement was observed for all collected metabolic markers: waist circumference, AST/ALT, lipids, HbA1c, insulin, hs-CRP. Specifically for cardiovascular labs, 12 mos results showed improvement in HDL in 56.3% (n= 3,090), in LDL for 64.8% (n=3,066), in hs-CRP for 82.9% (n=2,446). Of n=825 with abnormal A1c at baseline, 77.1% achieve A1c &lt;5.7%. Average reduction in waist circumference was -5.9 inches (n=3,682). Positive changes were also seen for patient-reported outcomes (PROs). Discussion: In the context of significant obesity and cardiovascular results for GLP-1s in clinical trials, it is important to gather data on the efficacy of approaches to scale treatment in the real world since factors such as medication shortages, gaps in insurance coverage, and challenges with adherence occur with treatment outside of clinical trials. Results from 6,766 patients in a virtual metabolic health program available in 50 states and DC demonstrate clinically significant and sustained weight loss through 24 mos, with improvement in associated key cardiometabolic risk markers, health behaviors, and PROs.

Gastric Pouch Resizing for Recurrent Weight Gain After Roux-en-Y Gastric Bypass—Does It Have Its Rational?

Abstract Introduction The most effective treatment for obesity and associated comorbidities is metabolic-bariatric surgery (MBS). Nevertheless, recurrent weight gain is reported in up to 40% of patients after Roux-en-Y gastric bypass (RYGB), eventually with a recurrence of obesity-associated comorbidities. Gastric pouch resizing (GPR) is performed as a low-risk secondary surgery to cease weight regain. We herewith analyzed the effect of GPR after primary RYGB on long-term weight loss, course of comorbidities, safety, and patient satisfaction. Methods Forty-eight patients undergoing GPR between 2016 and 2020 at the University Hospital of Zurich were included. Data were collected from a prospective database. GPR was performed laparoscopically and included a resection of the enlarged gastric pouch and a redo of the gastrojejunostomy. Additionally, 37 patients participated in a survey to evaluate PROMs (patient-reported outcome measures). Results GPR followed RYGB after a mean time of 106.2 ± 45.5 months at a mean BMI of 39 ± 5.4 kg/m2. Mean follow-up was 55.9 ± 18.5 months with a mean BMI 1- and 5-years postoperative of 37 ± 5.5 kg/m2 and 35 ± 7.5 kg/m2, respectively. Obesity-associated comorbidities were resolved in 53% of patients at follow-up (p &lt; 0.05). Minor postoperative complications occurred in 12.5% while major complications occurred in 10.4% of patients. The PROMs showed high levels of satisfaction after GPR. Conclusion GPR for recurrent weight gain after primary RYGB is a safe procedure resulting in weight stabilization and resolution of obesity-associated comorbidities. It is thus a valuable surgical option in well-selected patients. Graphical Abstract

Patient-reported outcome measures for life participation in patients with chronic kidney disease: a systematic review

Abstract Background The symptoms, comorbidities and treatment burden associated with chronic kidney disease (CKD) can be debilitating and limit life participation in patients with CKD not requiring kidney replacement therapy (KRT). The aim of this study was to identify the characteristics, content, and psychometric properties of patient-reported outcome measures (PROMs) used to assess life participation in patients with CKD. Methods We searched MEDLINE, Embase, PsycINFO, and CINAHL from database inception to February 2023 for all studies that reported life participation in patients with CKD (Stage 1–5 not requiring kidney replacement therapy). We analyzed the characteristics, dimensions of life participation and psychometric properties of the measures. Results From the 114 studies included, 20 (18%) were randomized trials, 3 (3%) were non-randomized trials, and 91 (80%) were observational studies. Forty-one different measures were used to assess life participation, of which six (15%) were author-developed measures. Twelve (29%) measures assessed life participation specifically, while 29 (71%) measures assessed broader constructs such as quality of life, which included questions relevant to life participation. The 36-Item Short Form Health Survey (SF-36) and Kidney Disease Quality of Life—Short Form (KDQOL-SF) were the most frequently used, in 39 (34%) and 24 (21%) studies, respectively. Many content domains for life participation were assessed including physical activities (walking, running, and sports), social activities, leisure activities, work or study and self-care. None of the measures for life participation were developed specifically for CKD. Four measures (EQ-5D-3 L, FACT-An, SF-6D, and SF-36) had validation data collected in patients with CKD. Conclusion The measures for life participation used in patients with CKD vary in content with few validated in the CKD population. There is a need for a validated measure to assess life participation in a meaningful and consistent way in all patients with CKD worldwide.

Can KOOS-PS be replaced with a simple anchor question in patients after total knee arthroplasty?: an agreement study of 2,478 primary surgeries

Background and purpose: Physical function and pain are the most important outcomes following total knee arthroplasty (TKA). These can be evaluated by patient-reported outcome measures (PROMs), or by an anchor question. The primary aim of the study was to evaluate whether a simple anchor question can replace KOOS-PS in assessing postoperative knee function until 1-year follow-up, evaluated by analyzing the agreement between the 2 methods using the diagnostic odds ratio (DOR). Secondary aims were pain (NRS) at rest and during mobilization.Methods: This is a diagnostic accuracy study with primary TKAs performed between 2010 and 2022. The surgeries were categorized as improved (I) or worsened (W) based on a dichotomized anchor question related to self-perceived change in physical function, and the dichotomized change in KOOS-PS until 1-year follow-up. This led to 4 groups: (II, IW, WI, and WW).Results: Agreement was found with a DOR of 11.3 (CI 7.9–16.2). 2,335 (94%) reported improved function on the anchor question and 143 (6%) worsened function. Among those with improved anchor 2,132 (91%) had improved KOOS-PS, but among those with worsened anchor only 74 (52%) had worsened KOOS-PS. Pain at 1-year follow-up was lower in the groups reporting improved anchor.Conclusion: The KOOS-PS can be replaced with an anchor question to assess change in function until 1 year. However, the KOOS-PS might be a valuable supplement in patients reporting worsened anchor as only half of those had worsened KOOS-PS.

Advancements in breast cancer management: a comprehensive review of ribociclib combined with endocrine therapy

Background: In this review, the complicated landscape of breast cancer management is explored with a focus on the promising synergies between ribociclib and endocrine therapy. Ribociclib mainly acts as a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, which disrupts cell cycle progression necessary for tumor growth. This, in combination with endocrine therapy, aims to produce hormone receptor-positive breast cancers, which is a very relevant subtype with challenging therapeutics. Methods: A comprehensive review was conducted using multiple databases, PubMed, Embase, Scopus, Cochrane Library, and Web of Science, covering the period from January 1990 to May 2024. Results: Pharmacokinetic studies underscore the efficacy and tolerability of ribociclib, thus providing vital information for dose adjustments, particularly among patients with renal and hepatic impairments. Ribociclib’s value in extending progression-free survival and improving overall survival has been shown by clinical trials such as the MONALEESA series. Quality of life considerations and patient-reported outcomes from these trials indicate that ribociclib has a broader effect on the well-being of the patients. However, despite the success experienced by this drug in clinical practice, it still has some side effects, including hematologic toxicity, hepatotoxicity, and thromboembolism associated with it. Ribociclib resistance mechanisms are multifaceted mixtures comprising genetic variations or mutations, compensatory signaling pathways, and epigenomic changes. While overcoming resistance remains challenging, ongoing research seeks to reconcile. Conclusion: Ribociclib combined with endocrine therapy represents a significant advancement in breast cancer treatment, albeit with challenges that necessitate ongoing research and holistic patient care approaches.