scholarly journals Patient-Reported Satisfaction Following Radiation of Implant-Based Breast Reconstruction

2019 ◽  
Vol 27 (2) ◽  
pp. 147-155 ◽  
Author(s):  
Eva Thiboutot ◽  
Peter Craighead ◽  
Carmen Webb ◽  
Claire Temple-Oberle

Background: Little is known with regard to patient-reported outcomes (PROs) in the setting of implant-based reconstruction (IBR) with post-mastectomy radiation therapy (PMRT). Methods: We identified patients who underwent immediate IBR from a prospectively compiled database. The Breast Reconstruction Satisfaction Questionnaire (BRECON-31) was scored and compared between patients with and without PMRT. Results: Sixty-four women met the study criteria. Forty-eight did not receive PMRT and 16 did. Nine women had an unanticipated indication for PMRT. The PMRT group was similar to the control group with regard to baseline characteristics (ie, age, marital status, body mass index, tobacco use, and comorbidities). However, treatment and oncologic characteristics (eg, diagnosis, tumour characteristics, systemic therapy use) differed. Of all complications, only capsular contracture rates differed (1.2% vs 13%; P = .01). Of the 9 subscales, 7 showed no difference in satisfaction between the groups. Radiated women scored lower in the arm concerns and breast appearance subscales. Scores were similar whether the indication for PMRT had been anticipated or not. Discussion: Women with immediate IBR scored similarly to their nonradiated counterparts across 7 of 9 domains of satisfaction. Arm concerns and breast appearance scores are lower with PMRT, likely secondarily to more extensive nodal procedures in higher stage patients and to the side effect profile of radiotherapy. Our findings are in line with the few available studies using other PRO tools to evaluate the impact of PMRT on patient satisfaction and studies objectively measuring the effect of PMRT on arm morbidity and cosmetic outcomes.

10.37512/700 ◽  
2020 ◽  

Poor quality complementary foods contribute to undernutrition in children aged 6-23 months. Therefore, there is need to explore foods that will provide adequate nutrients for this age group. This study aimed at determining the impact of a sorghum-amaranth composite flour porridge on nutrient intake of children aged 6-23 months. A randomized controlled trial was conducted at Kiandutu slum, Thika, Kenya. Children in the control group (CG), received a maize-sorghum flour while those in the treatment group (TG) received an amaranth-sorghum flour. The sample size per study group was 73 mother-child pairs. The children in the TG received Kcal 1000 worth of porridge/day while those in the CG received Kcal 266.8/day. Mothers of children in both groups were given nutrition education at baseline, and monthly, for six months. Food intake data was taken at baseline, then monthly for six months. Descriptive statistics were used to describe nutrient intake. Chi square and Mann Whitney U test were was used to compare the baseline characteristics of the two groups and their nutrient intake, respectively. At baseline characteristics of the two groups were similar. On a monthly basis, nutrient intake in the TG was significantly higher for a majority of the nutrients than in the CG. The product can contribute to preventing under-nutrition in children aged 6-23 months.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
J. H. Fisher ◽  
M. Kolb ◽  
M. Algamdi ◽  
J. Morisset ◽  
K. A. Johannson ◽  
...  

Abstract Background The CAnadian REgistry for Pulmonary Fibrosis (CARE-PF) is a multi-center, prospective registry designed to study the natural history of fibrotic interstitial lung disease (ILD) in adults. The aim of this cross-sectional sub-study was to describe the baseline characteristics, risk factors, and comorbidities of patients enrolled in CARE-PF to date. Methods Patients completed study questionnaires and clinical measurements at enrollment and each follow-up visit. Environmental exposures were assessed by patient self-report and comorbidities by the Charlson Comorbidity Index (CCI). Baseline characteristics, exposures, and comorbidities were described for the overall study population and for incident cases, and were compared across ILD subtypes. Results The full cohort included 1285 patients with ILD (961 incident cases (74.8%)). Diagnoses included connective tissue disease-associated ILD (33.3%), idiopathic pulmonary fibrosis (IPF) (24.7%), unclassifiable ILD (22.3%), chronic hypersensitivity pneumonitis (HP) (7.5%), sarcoidosis (3.2%), non-IPF idiopathic interstitial pneumonias (3.0%, including idiopathic nonspecific interstitial pneumonia (NSIP) in 0.9%), and other ILDs (6.0%). Patient-reported exposures were most frequent amongst chronic HP, but common across all ILD subtypes. The CCI was ≤2 in 81% of patients, with a narrow distribution and range of values. Conclusions CTD-ILD, IPF, and unclassifiable ILD made up 80% of ILD diagnoses at ILD referral centers in Canada, while idiopathic NSIP was rare when adhering to recommended diagnostic criteria. CCI had a very narrow distribution across our cohort suggesting it may be a poor discriminator in assessing the impact of comorbidities on patients with ILD.


2021 ◽  
pp. 1-11
Author(s):  
Jonathan James ◽  
James Selfe ◽  
Peter Goodwin

OBJECTIVES: To assess the feasibility of a 30-minute education session for patients with patellofemoral pain on levels of catastrophizing and kinesiophobia. DESIGN: Randomised feasibility study SETTING: Three sites within a single NHS Organisation in England. PARTICIPANTS: Thirty-one adult patients were screened for inclusion, resulting in twenty-four who had a clinical diagnosis of patellofemoral pain being randomised equally to either the intervention or control group. INTERVENTION: Participants were randomised to either control or intervention conditions; both received standardized physiotherapy while the intervention/experimental group received a 30-minute educational session addressing causes of pain, beliefs about noise that comes from the joint, the impact of the pain on activity, the influence of other family members’ experience and beliefs about knee pain. Intervention participants were also given an education leaflet: ‘Managing My Patellofemoral Pain’. MAIN OUTCOMES: recruitment, retention, intervention fidelity. Patient reported outcome measures (PROMs): Knee injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF), Pain Catastrophizing Scale (PCS) and Tampa Scale for Kinesiophobia (TSK). RESULTS: The study was successful in recruiting and retaining participants and was delivered as intended. In addition, sufficient clinical data were generated to calculate the required sample size for a future study of efficacy CONCLUSIONS: This study which featured a 30-minute education session targeting levels of catastrophizing and kinesiophobia is feasible and identified that the TSK may be the most appropriate PROMs for a future study of efficacy of this intervention. Allowing for a drop out of 20%as identified in similar studies, 86 participants (per arm) in a two-arm study would be required for a traditional randomised controlled trial design.


2018 ◽  
Vol 57 (04) ◽  
pp. 160-167 ◽  
Author(s):  
Sabine Haufe ◽  
Ralph Hohenberger ◽  
Matti Hein ◽  
Clemens Kratochwil ◽  
Hendrik Rathke ◽  
...  

Summary Introduction: Xerostomia following radioiodine therapy (RIT) in patients suffering from differentiated thyroid cancer is a common side effect in 2 % to 67 % of patients treated with radioiodine (I-131). In order to evaluate the impact of sialendoscopy on health related quality of life (HRQOL) in patients suffering from therapy induced sialadenitis and xerostomia, we analyzed findings from two dedicated questionnaires (Xerostomy Questionnaire XQ and Xerostomy Inventory XI) in patients before and three months after sialendoscopy. Procedures: In total, 12 patients suffering from differentiated thyroid carcinoma (10 women and 2 men) were evaluated. All patients had experienced conservative management. Patients were offered a sialendoscopy procedure if no major contradictions were present. Patients who denied the procedure formed the control group. Pre- and (three months) postoperative HRQOL was measured with the Patient Reported Outcome Measures (PROM) Xerostomia Questionnaire (XQ) and the Xerostomia Inventory (XI), as well as by a pre- and post-interventional salivary gland scintigram. Patients were graded according to their sialendoscopical findings. Results: Interventional group presented with significant improvements in HRQOL measurements regarding XQ and XI-scores three months postoperatively. Control group showed no significant changes in the XQ or the XI scores. Number of RIT and cumulative activity of I-131 did not correlate with higher disease grade in regards to sialendoscopical findings nor did it correlate with higher XQand XI scores. Pre- and post-interventional salivary gland scintigram stated that parotid glands are more severely damaged than submandibular glands (SMG), but no significant scintigraphically changes could be detected after sialendoscopy. Conclusion: Sialendoscopy in patients suffering from therapy induced sialadenitis and xerostomia seems to be beneficial when evaluating the impact on HRQOL. Functional parameters measured by salivary gland scintigram did not show significant changes in post-interventional scintigrams.


2020 ◽  
Vol 41 (1) ◽  
pp. 34-44 ◽  
Author(s):  
So-Eun Han ◽  
Kyeong-Tae Lee ◽  
Saik Bang

Abstract Background Prosthetic breast reconstruction has been gaining popularity and a variety of implant options are currently available. Therefore, it is important to evaluate the safety and efficacy of newly developed shaped implants compared with those of conventional round implants. To date, few studies have investigated the outcomes of breast reconstruction with shaped versus round implants. Objectives The present study aimed to comprehensively compare, via meta-analytic methodology, shaped and round breast implant reconstruction in terms of complication profiles and aesthetic satisfaction. Methods PubMed/MEDLINE, Ovid, and Cochrane databases were searched to identify relevant studies presenting the complication rates for shaped and round implant groups. The relative risks of the following complications between the groups were calculated: infection, seroma, capsular contracture, rupture, rippling, reconstruction failure, and implant exchange or removal. Outcomes of aesthetic satisfaction included aesthetic results and patient-reported outcomes. Results Meta-analysis of 8 retrospective cohort studies, representing 2490 cases of implant-based breast reconstruction, was performed. There were no significant differences in the risks of infection, seroma, capsular contracture, and reconstruction failure between the 2 groups. The risks of implant rupture and rippling were significantly reduced with shaped implants. In a subgroup analysis of shaped/textured and round/smooth implants, the risk of infection was significantly enhanced in the former, whereas incidences of other complications, including capsular contracture and reconstruction failure, were similar. Aesthetic satisfaction analysis of the 2 groups demonstrated similar outcome scores with favorable overall results. Conclusions Our results suggest that both shaped and round implants might provide favorable breast reconstruction outcomes with similarly low complication rates and aesthetic results. Level of Evidence: 4


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Lisa M. Wintner ◽  
◽  
Johannes M. Giesinger ◽  
Monika Sztankay ◽  
Andrew Bottomley ◽  
...  

Abstract Background In oncology, detection and tracking of adverse events are of top priority and rely mostly on the Common Terminology Criteria for Adverse Events (CTCAE). Besides, clinical trials use as well patient-reported outcomes (PROs) to assess those adverse events, which are only accessible through patient self-reporting, such as fatigue, pain, and sleep disorders. Especially those issues that are not visible from the outside are often misinterpreted and underestimated by mere provider ratings. This trial aims at evaluating the impact of providing PRO data to providers on the accuracy of adverse event assessment in terms of inter-rater reliability of CTCAE ratings. Methods The trial uses a cross-sectional, unblinded, randomized controlled trial design with two trial arms and a single assessment time point. Eligible patients (aged 18 and above, any cancer diagnosis, currently under treatment, inpatient or day clinic setting, present symptom burden, no psychiatric or mental problems, written informed consent) complete an electronic version of the EORTC QLQ-C30 and 16 additional questions taken from the EORTC Item Library. PRO data is immediately processed and made available to CTCAE rating providers for conducting their ratings during the medical encounter. Patients are randomly assigned 1:1 to the intervention group (providers see PRO results on the same screen as the CTCAE rating) and the control group (no access to PRO data during the CTCAE rating). A superiority analysis will compare the inter-rater reliability (using intra-class correlation (ICC) coefficients) between the control and the intervention groups for each adverse event evaluated. Discussion The presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events. The new insights gained may lead to a new strategy for evaluating adverse events in clinical trials by combining patient and provider ratings. This might also have implications for daily clinical practice and cancer registries. Trial registration ClinicalTrials.gov NCT04066868. Registered on August 26, 2019. Competence Center for Clinical Trials of the Medical University of Innsbruck 20190513-2007. Registered on May 14, 2019. (version 6.0, March 18, 2019)


2020 ◽  
pp. 001857872097046
Author(s):  
Nirmal Raj Marasine ◽  
Sabina Sankhi ◽  
Rajendra Lamichhane

Aim: We aimed to evaluate the impact of pharmaceutical service intervention on medication adherence and patient-reported outcomes among patients diagnosed with depression in a private psychiatric hospital in Nepal. Methods: A single-center, open trial with a parallel design was conducted among 18 to 65 years aged patients, diagnosed with depression and under antidepressant medication(s) for ≥2 months. Patients were randomised into either the intervention or control group. The control group (n = 98) received the usual care, while the intervention group (n = 98) received a pharmaceutical service intervention. The two groups were compared using the Mann-Whitney U test, independent t-test, or chi-square test at 2 and 4 months for changes in medication adherence and patient-reported [severity of depression and health-related quality of life (HRQoL)] outcomes. Results: One hundred ninety adult patients were enrolled in the study. At baseline, there were no significant differences in any of the outcome measures between the intervention and control groups. At 2 and 4 months, the intervention group had a significant improvement only in medication adherence ( P < .001) compared with the control group [MGL score: 1 (2) vs 2 (2) and 1 (1) vs 2 (1), P < .001, respectively]. Conclusion: Our study suggests that a brief pharmaceutical service intervention in the hospital setting can have a significant impact on patients’ adherence to antidepressants but does not improve their severity of depression and HRQoL.


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