Evaluation of cosmetic outcome following breast‐conserving therapy in trials: panel versus digitalized analysis and the role of PROMs

Cosmetic outcome is an important quality of life‐related end point following breast‐conserving therapy (BCT). To advise on a gold standard, we compare cosmetic outcome evaluated by panel and an objective evaluation (BCCT.core software). Second, patient‐reported outcome measures (PROMs) are compared to cosmetic outcome evaluation by panel and BCCT.core. Sixty‐eight breast cancer patients were included following BCT between 2007 and 2012. Two independent 6‐member panels and two observers using the BCCT.core evaluated cosmetic outcome. First, reproducibility, repeatability, and relatedness of panel and BCCT.core were analyzed using the interclass correlation coefficient (ICC). Second, the association between panel/BCCT.core with PROMs (EORTC‐QLQ‐C30/BR23, EQ‐5D‐5L, and BREAST‐Q) was analyzed with a linear regression and the goodness of fit by the R². Both panel and BCCT.core evaluations showed “excellent” intraobserver agreement (ICC 0.93 [95% CI: 0.83; 0.97] and 0.93 [95% CI: 0.84; 0.97]) for respectively panel 1 and BCCT.core 1 and “excellent” interobserver agreement (ICC 0.94 [95% CI: 0.90; 0.96] and 0.85 [95% CI: 0.77; 0.91]) respectively for panel and BCCT.core. Association between panel and BCCT.core varied, ICC 0.59‐0.69. Only the PROM BREAST‐Q showed a significant association with both panel evaluations and BCCT.core observers (panel 1 and BCCT.core 1; R² of .157 [P = .002] and .178 [P = .001]). Both panel and BCCT.core showed comparable “excellent” intraobserver and interobserver agreement. For future trials evaluating cosmetic outcome following BCT, one of those can be chosen. Solely, the PROM BREAST‐Q showed a significant association with panel and/or BCCT.core evaluation. To enable standardized cosmetic outcome evaluation and corresponding patient satisfaction in future trials, at least the BREAST‐Q should be combined with a panel or BCCT.core evaluation.     

Systematic review of the QoR-15 score,a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia

Background

The QoR-15 is a patient-reported outcome questionnaire that measures the quality of recovery after surgery and anaesthesia. We aimed to perform a systematic review and meta-analysis of the measurement properties of the QoR-15.

Revision of Unicompartmental to Total Knee Arthroplasty: Does the Unicompartmental Implant (Metal-Backed vs All-Polyethylene) Impact the Total Knee Arthroplasty?

Background

The aim of this study is to investigate differences in implant requirement, outcomes, and re-revision when total knee arthroplasty (TKA) was performed following unicompartmental knee arthroplasties (UKAs) with metal-backed (MB) compared to all-polyethylene (AP) tibial components.

老年腹股沟疝手术选择和自我临床报告结果

目的探讨老年腹股沟疝患者的术式选择,比较开放和腹腔镜疝修补≧60岁,小于60岁的患者临床报告结果。方法日期从2015年1月到2016年5月接受腹股沟疝手术患者被纳入本研究,共有137例接受调查,其中72例小于60岁(60组),65例大于等于60岁(≧60组)。在60组,29例患者行腹腔镜疝修补术(TEP)和43例开放式疝修补术。在≧60组,29例患者行腹腔镜疝修补术(TEP)和36例开放式疝修补术。术后6月随访,患者临床报告结果(PROM)包括总体感觉、疼痛、恶心、呕吐、头晕、疲倦和满意度。结果 137例得到术后6个月随访。严重疼痛患者8例,其中6例为60岁组,≧60岁组仅2例出现严重疼痛(P0.05)。≧60 TEP组中只有1例患者中度疼痛,60 TEP组中有3例中度疼痛(P0.05)。绝大多数患者对手术满意程度在所有组患者中满意或非常满意,只有2例病人主诉手术疤痕和术后疼痛。结论 60岁以上腹股沟疝患者的手术,采用TEP术式安全、痛苦少;但比较60岁患者,无论腹腔镜还是开放的腹股沟疝修补术,均未体现更多优势。     

Development and psychometric characteristics of the SCI-QOL Bladder Management Difficulties and Bowel Management Difficulties item banks and short forms and the SCI-QOL Bladder Complications scale

ObjectiveTo describe the development and psychometric properties of the Spinal Cord Injury – Quality of Life (SCI-QOL) Bladder Management Difficulties and Bowel Management Difficulties item banks and Bladder Complications scale.DesignUsing a mixed-methods design, a pool of items assessing bladder and bowel-related concerns were developed using focus groups with individuals with spinal cord injury (SCI) and SCI clinicians, cognitive interviews, and item response theory (IRT) analytic approaches, including tests of model fit and differential item functioning.SettingThirty-eight bladder items and 52 bowel items were tested at the University of Michigan, Kessler Foundation Research Center, the Rehabilitation Institute of Chicago, the University of Washington, Craig Hospital, and the James J. Peters VA Medical Center, Bronx, NY.ParticipantsSeven hundred fifty-seven adults with traumatic SCI.ResultsThe final item banks demonstrated unidimensionality (Bladder Management Difficulties CFI = 0.965; RMSEA = 0.093; Bowel Management Difficulties CFI = 0.955; RMSEA = 0.078) and acceptable fit to a graded response IRT model. The final calibrated Bladder Management Difficulties bank includes 15 items, and the final Bowel Management Difficulties item bank consists of 26 items. Additionally, 5 items related to urinary tract infections (UTI) did not fit with the larger Bladder Management Difficulties item bank but performed relatively well independently (CFI = 0.992, RMSEA = 0.050) and were thus retained as a separate scale.ConclusionThe SCI-QOL Bladder Management Difficulties and Bowel Management Difficulties item banks are psychometrically robust and are available as computer adaptive tests or short forms. The SCI-QOL Bladder Complications scale is a brief, fixed-length outcomes instrument for individuals with a UTI.     

Development and psychometric characteristics of the SCI-QOL Pressure Ulcers scale and short form

ObjectiveTo develop a self-reported measure of the subjective impact of pressure ulcers on health-related quality of life (HRQOL) in individuals with spinal cord injury (SCI) as part of the SCI quality of life (SCI-QOL) measurement system.DesignGrounded-theory based qualitative item development methods, large-scale item calibration testing, confirmatory factor analysis (CFA), and item response theory-based psychometric analysis.SettingFive SCI Model System centers and one Department of Veterans Affairs medical center in the United States.ParticipantsAdults with traumatic SCI.Results189 individuals with traumatic SCI who experienced a pressure ulcer within the past 7 days completed 30 items related to pressure ulcers. CFA confirmed a unidimensional pool of items. IRT analyses were conducted. A constrained Graded Response Model with a constant slope parameter was used to estimate item thresholds for the 12 retained items.ConclusionsThe 12-item SCI-QOL Pressure Ulcers scale is unique in that it is specifically targeted to individuals with spinal cord injury and at every stage of development has included input from individuals with SCI. Furthermore, use of CFA and IRT methods provide flexibility and precision of measurement. The scale may be administered in its entirety or as a 7-item “short form” and is available for both research and clinical practice.     

Patient outcomes of genetic counseling: Assessing the impact of different approaches to family history collection

No studies have yet evaluated whether different modalities for the collection of family history data influence patient outcomes of genetic counseling. We retrospectively compared outcomes of genetic counseling between patients whose family history (Fhx) was collected (1) via telephone prior to their appointment (FhxPrior) or (2) during the appointment (FhxDuring). We used a psychiatric genetic counseling clinic database, where information about demographics and Fhx timing is recorded, and patients complete the Genetic Counseling Outcomes Scale (GCOS, measuring empowerment) and Illness Management Self‐Efficacy Scale (IMSES) immediately prior to (T1) and 1 month after their appointment (T2). We used ANCOVA to evaluate the effect of the Fhx method on patient outcomes at T2. Complete data were available for 240 patients and were used for analysis (FhxPrior, n = 206; FhxDuring, n = 34). GCOS and IMSES scores increased from T1 to T2 (P < .0005 and P = .004, respectively). Although there was no difference between groups for GCOS (P = .412), T2 IMSES scores were significantly higher for FhxPrior than FhxDuring after controlling for T1 scores (P = .011). Our data suggest that obtaining Fhx via telephone prior to genetic counseling may lead to greater increases in patients’ self‐efficacy as compared to obtaining Fhx during the genetic counseling appointment.     

UK families with children with rare chromosome disorders: Changing experiences of diagnosis and counselling (2003‐2013)

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.     

Criteria for gauging response to sodium oxybate for narcolepsy

Our objective was to define responder criteria using an anchor‐based approach for frequency of cataplexy attacks and excessive daytime sleepiness in patients with narcolepsy undergoing sodium oxybate treatment. We used pooled data from two randomized, placebo‐controlled, double‐blind, multicentre 4‐ and 8‐week trials of sodium oxybate for narcolepsy with cataplexy and analysed using receiver operator characteristics analysis. The percentage change in frequency of weekly cataplexy attacks and the Epworth Sleepiness Scale outcomes were compared with Clinical Global Impression of Change ratings, used as the anchor to define true response. Participants (n = 336) were 39% male, 89% white, with a mean age of 41.5 (15.3) years, reporting a median of 20.5 cataplexy attacks per week and a mean Epworth Sleepiness score of 17.5 at baseline. A majority (51%) were Much Improved or Very Much Improved based on Clinical Global Impression of Change ratings, considered a true response to treatment. Area under the curve values for % reduction in cataplexy attacks (77%) and % change in sleepiness score (78%) supported response definition thresholds of 46% and 12%, respectively. Classification using either response definition agreed with the anchor for approximately 71% of participants. Cataplexy response definition was more sensitive (cataplexy = 0.77, Epworth Sleepiness Scale = 0.69), while sleepiness was more specific (cataplexy = 0.66, Epworth Sleepiness Scale = 0.75). Both responder definitions showed a dose–response relationship with sodium oxybate, demonstrating their validity using an external criterion. Weekly cataplexy attacks and Epworth Sleepiness Scale can be used to help document clinical response to narcolepsy treatment using criteria of 46% and 12% reductions, respectively.     

Predicting patient reported outcome in total knee arthroplasty using body mass index and limb measurements

Background

Body mass index (BMI) has not been shown to correlate with Patient Reported Outcome Measures (PROMs) following total knee arthroplasty (TKA). We investigated the relationship between weight, BMI, limb morphology, and Oxford Knee Score (OKS). Furthermore, the utility of a novel radiological measurement, the Knee Mass Index (KMI), was investigated.