The COVID-19 pandemic and follow-up for shoulder surgery: The impact of a shift toward telemedicine on validated patient-reported outcomes

Introduction The emergence of COVID-19 and its ensuing restrictions on in-person healthcare has resulted in a sudden shift towards the utilization of telemedicine. The purpose of this study is to assess patient satisfaction and patient-reported outcome measures (PROMs) for individuals who underwent follow-up for shoulder surgery using telemedicine compared to those who received traditional in-person clinic follow-up. Methods Patients who underwent either rotator cuff repair or total shoulder arthroplasty during a designated pre-COVID-19 (traditional clinic follow-up) or peri-COVID-19 (telemedicine follow-up) span of time were identified. PROMs including the American Shoulder and Elbow Surgeons standardized assessment form, the three-level version of the EQ-5D form, the 12-Item Short Form survey, and a modified version of a published telemedicine survey were administered to participants six months post-operatively via phone call. Results Sixty patients agreed to participate. There was no significant difference between the pre-COVID-19 and peri-COVID-19 groups in patient satisfaction with their follow-up visit ( p = 0.289), nor was there a significant difference in PROMs between the two groups. In total, 83.33% of the telemedicine group and 70.37% of the in-person clinic group preferred traditional in-person follow-up over telemedicine. Discussion In a cohort of patients who underwent telemedicine follow-up for shoulder surgery during the COVID-19 pandemic, there was no difference in patient satisfaction and PROMs compared to traditional in-person clinic follow-up. This study indicates that while the majority of participants preferred face-to-face visits, patients were relatively satisfied with their care and had similar functional outcome scores in both groups, despite the large disruption in healthcare logistics caused by COVID-19.

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Gait Analysis 1 Year after Primary TKA: No Difference between Gap Balancing and Measured Resection Technique

The Journal of Knee Surgery ◽

10.1055/s-0039-3402079 ◽

2019 ◽

Cited By ~ 1

Author(s):

Hermes H. Miozzari ◽

Stéphane Armand ◽

Katia Turcot ◽

Anne Lübbeke ◽

Alice Bonnefoy-Mazure

Keyword(s):

Short Form ◽

Surgical Techniques ◽

Patient Reported Outcome Measures ◽

Control Group ◽

Global Satisfaction ◽

Press Fit ◽

Gait Parameters ◽

Significant Difference ◽

Patient Reported

AbstractMechanical alignment in total knee arthroplasty (TKA) can be achieved using dependent bone cuts. The hypothesis is that patients have a better balanced TKA, as a result. The aim of this study was to determine if this technique is superior to an independent bone cut technique in terms of gait parameters, patient-reported outcome measures (PROMs), and satisfaction assessed before surgery and at 1-year follow-up. A total of 58 patients were evaluated before and 1 year following TKA, using the Press Fit Condylar (PFC) Sigma posterior stabilizer (PS) design; 39 (70 ± 8 years; 27 women) with independent bone cuts and 19 (71 ± 7 years; 12 women) with dependent bone cuts using the Specialist TRAM. Gait was evaluated with a three-dimensional motion analysis system for spatiotemporal and kinematics parameters. Pain and functional levels were assessed using the Western Ontario and McMaster Universities arthritis index (WOMAC); general health was assessed by the short form (SF)-12. Global satisfaction, as well as patient satisfaction, related to pain and functional levels were assessed using a five-point Likert's scale. No significant difference was found between both groups in terms of age, body mass index, pain, and functional levels at baseline. At 1-year follow-up, despite an overall improvement in gait, WOMAC, SF-12 physical score and pain, none of the patients showed gait parameters comparable to a healthy control group. No surgical technique effect was observed on gait, clinical outcomes, and satisfaction level. While observing an overall improvement at 1-year follow-up, we did not find any significant difference between the two surgical techniques in terms of gait parameters, patients' outcomes, and satisfaction.

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Nonresponder bias in hand surgery: analysis of 1945 cases lost to follow-up over a 6-year period

Journal of Hand Surgery (European Volume) ◽

10.1177/17531934211045627 ◽

2021 ◽

pp. 175319342110456

Author(s):

Paul H. C. Stirling ◽

Paul J. Jenkins ◽

Nathan Ng ◽

Nicholas D. Clement ◽

Andrew D. Duckworth ◽

...

Keyword(s):

Postoperative Outcome ◽

Hand Surgery ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Level Of Evidence ◽

Loss To Follow Up ◽

Significant Difference ◽

Patient Reported ◽

The Impact

The primary aim of this study was to identify factors associated with nonresponse to routinely collected patient-reported outcome measures (PROMs) after hand surgery. The secondary aim was to investigate the impact of nonresponder bias on postoperative PROMs. We identified 4357 patient episodes for which the patients received pre- and 1-year postoperative questionnaires. The response rate was 55%. Univariate and regression analyses were undertaken to determine factors predicting nonresponse. We developed a predictive model for the postoperative Quick version of the Disabilities of the Arm, Shoulder, and Hand (QuickDASH) scores for nonresponders using imputation. Younger age, increasing deprivation, higher comorbidity, worse preoperative QuickDASH scores and unemployment predicted nonresponse. No significant difference in mean postoperative QuickDASH score was observed between the responders, and the scores for the responders combined with the predicted scores for the nonresponders. Preoperative function was the primary predictor of postoperative outcome. These results challenge the dogma that ‘loss to follow-up’ automatically invalidates the results of a study. Level of evidence: III

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SP9.1.1 The Impact of Anaesthetic Use on Healing in Sub-cutaneous Abscess Management: A Retrospective Before and After Cohort Study

British Journal of Surgery ◽

10.1093/bjs/znab361.165 ◽

2021 ◽

Vol 108 (Supplement_7) ◽

Author(s):

Hannah Elkadi ◽

Eleanor Dodd ◽

Theodore Poulton ◽

William Bolton ◽

Joshua Burke ◽

...

Keyword(s):

Wound Healing ◽

Local Anaesthetic ◽

Surrogate Endpoints ◽

Incision And Drainage ◽

Number Of Patients ◽

Significant Difference ◽

Patient Reported ◽

Before And After ◽

The Impact

Abstract Aims Despite being the most common surgical procedure, there is wide variation that exists in the management of simple subcutaneous abscesses with no national guideline describing best practice. During the COVID-19 Pandemic national guidelines promoted the use of regional or local anaesthetic (LA) instead of general anaesthesia (GA) to avoid aerosol generating intubation associated with GA. This study aimed to assess the impact of anaesthetic choice in outcomes following incision and drainage of subcutaneous abscesses. Methods Two cohorts of patients undergoing abscess incision and drainage at St. James’ University Hospital Leeds were retrospectively identified over a 14-week period before and after the introduction of the new COVID-19 anaesthetic guidelines. Wound healing surrogate endpoints were used: i) total number of follow up appointments and ii) attendance to healthcare services after 30 days from I&D. Result 133 patients were included. Significantly more procedures were performed under LA after the intervention (84.1% vs 5.7%; p < 0.0001) with a significant reduction in wound packing (68.3% vs 87.1%. p=0.00473). Follow up data found no significant difference in the average number of follow-up appointments (7.46 vs 5.11; p = 0.0731) and the number of patients who required ongoing treatment after 30 days (n = 14 vs n = 14, p = 0.921). Conclusion Drainage of simple subcutaneous abscess under 5 cm is safe under local anaesthetic with no significant difference in surrogate endpoints of wound healing observed in this patient cohort. Recurrent packing may not be required. Future work should explore patient reported measures such as pain management and the health economics of this intervention.

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Feasibility of Collecting Multiple Patient-Reported Outcome Measures Alongside the Dutch Arthroplasty Register

Journal of Patient Experience ◽

10.1177/2374373519853166 ◽

2019 ◽

Vol 7 (4) ◽

pp. 484-492

Author(s):

Claire Tilbury ◽

Claudia S Leichtenberg ◽

Bart L Kaptein ◽

Lennard A Koster ◽

Suzan H M Verdegaal ◽

...

Keyword(s):

Outcome Measures ◽

Short Form ◽

Response Rates ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Participation Rates ◽

Arthroplasty Register ◽

Patient Reported ◽

Lost To Follow Up

Background: Compliance rates with patient-reported outcome measures (PROMs) collected alongside arthroplasty registries vary in the literature. We described the feasibility of a routinely collected set PROMs alongside the Dutch Arthroplasty Register. Methods: The longitudinal Leiden Orthopaedics Outcomes of OsteoArthritis Study is a multicenter (7 hospitals), observational study including patients undergoing total hip or total knee arthroplasty (THA or TKA). A set of PROMs: Short Form-12, EuroQol 5 Dimensions, Hip/Knee injury and Osteoarthritis Outcome Score, Oxford Hip/Knee Score was collected preoperatively and at 6, 12, 24 months, and every 2 years thereafter. Participation rates and response rates were recorded. Results: Between June 2012 and December 2014, 1796 THA and 1636 TKA patients were invited, of whom 1043 THA (58%; mean age 68 years [standard deviation, SD: 10]) and 970 TKA patients (59%; mean age 71 years [SD 9.5]) participated in the study. At 6 months, 35 THA/38 TKA patients were lost to follow-up. Response rates were 90% for THA (898/1000) and 89% for TKA (827/932) participants. At 1 and 2 years, 8 and 18 THA and 17 and 11 TKA patients were lost to follow-up, respectively. The response rates among those eligible were 87% (866/992) and 84% (812/972) for THA and 84% (771/917) and 83% (756/906) for TKA patients, respectively. The 2-year questionnaire was completed by 78.5% of the included THA patients and by 77.9% of the included TKA patients. Conclusions: About 60% of patients undergoing THA or TKA complete PROMs preoperatively, with more than 80% returning follow-up PROMs. To increase the participation rates, more efforts concerning the initial recruitment of patients are needed.

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Bilateral total shoulder arthroplasty: A systematic review of clinical outcomes

Shoulder & Elbow ◽

10.1177/1758573220916822 ◽

2020 ◽

pp. 175857322091682

Author(s):

John-Rudolph H Smith ◽

Darby A Houck ◽

Jessica A Hart ◽

Jonathan T Bravman ◽

Rachel M Frank ◽

...

Keyword(s):

Patient Satisfaction ◽

Clinical Outcomes ◽

Shoulder Arthroplasty ◽

English Language ◽

External Rotation ◽

Total Shoulder Arthroplasty ◽

Cochrane Library ◽

Level Of Evidence ◽

Patient Reported

Background The purpose of this study was to describe the clinical outcomes following bilateral total shoulder arthroplasty (TSA). Methods A systematic search of the PubMed, Embase, and Cochrane Library databases following PRISMA guidelines was performed. English-language literature published from 2010 to 2018 analyzing bilateral TSA (anatomic and/or reverse) with a minimum one-year follow-up was reviewed by two independent reviewers. Study quality was evaluated with the Modified Coleman Methodology Score and the methodological index for non-randomized studies score. Results Eleven studies (1 Level II, 3 Level III, 7 Level IV) with 292 patients were included. Two studies reported on bilateral anatomic TSA ( n = 54), six reported on bilateral reverse TSA (RTSA; n = 168), two reported on anatomic TSA with contralateral RTSA (TSA/RTSA; n = 31), and one compared bilateral anatomic TSA ( n = 26) and bilateral RTSA ( n = 13). Among studies, mean revision rate ranged from 0% to 10.53% and mean complication rate ranged from 4.9% to 31.3%. At final follow-up, patients experienced significant overall improvements in range of motion and patient-reported outcome score measurements. However, bilateral anatomic TSA resulted in greater improvements in external rotation compared to bilateral RTSA. Overall patient satisfaction was 91.0%. Conclusion The available data indicate that bilateral TSA allows for functional and pain improvements and result in high patient satisfaction. Level of evidence IV.

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Mid-Term (4-10 year) Outcomes of INBONE I Total Ankle Arthroplasty with Deformity Analysis

Foot & Ankle Orthopaedics ◽

10.1177/2473011417s000190 ◽

2017 ◽

Vol 2 (3) ◽

pp. 2473011417S0001

Author(s):

Andrew Harston ◽

James Nunley ◽

Mark Easley ◽

James DeOrio ◽

Samuel Adams ◽

...

Keyword(s):

Short Form ◽

Total Ankle Arthroplasty ◽

Coronal Plane ◽

Consecutive Series ◽

Ankle Arthroplasty ◽

Sf 36 ◽

Significant Difference ◽

Patient Reported ◽

Plane Deformity

Category: Ankle, Ankle Arthritis Introduction/Purpose: Concerns for limited coronal plane stability prompted the manufacturer and designers of the INBONE total ankle arthroplasty system to replace the original saddle-shaped talar component (INBONE I) with a sulcus-shaped talar component (INBONE II). Prior to the availability of the INBONE II talar component, numerous INBONE I total ankle replacements were performed. To our knowledge mid-term outcomes of INBONE I total ankle arthroplasty have not been reported. This study compares the mid-term outcomes of patients with and without preoperative coronal plane deformity who underwent total ankle replacement with the INBONE I prosthesis. In our opinion, the longer-term outcomes of the INBONE I prosthesis are important for patient and surgeon education. Methods: A consecutive series of patients, from May, 2007 to September, 2011, at a single institution who underwent total ankle arthroplasty with the INBONE I Total Ankle Arthroplasty (Wright Medical) were prospectively enrolled. Pain and patient- reported function were assessed preoperatively and at yearly follow-ups with use of a visual analog scale (VAS) for pain, the American Orthopaedic Foot & Ankle Society (AOFAS) ankle- hindfoot score, the Short Musculoskeletal Function Assessment (SMFA), and the Short Form-36 (SF-36) Health Survey. We analyzed the data for complications, reoperations, and failures (defined as undergoing revision for exchange or removal of the metallic components for any reason). Patients were grouped according to coronal plane tibiotalar alignment (preoperative coronal plane malalignment of >10 degrees and <10 degrees deformity) and outcomes compared. Results: One-hundred fifty-five INBONE I prostheses were implanted in 151 patients, with minimum 4 year clinical and radiographic follow-up. Follow-up ranged from 48-113 months with an average of 67 months. There was significant (p<0.05) improvement in the VAS, AOFAS, SMFA, and SF-36 scores at most recent follow-up. Forty-five patients (29%) had 49 additional surgeries for impingement, loosening/subsidence, malalignment, ligament instability, polyethylene exchange, and/or infection. There were 14 implant failures with overall survivorship of 90.3%. There was no statistically significant difference in outcomes between patients with coronal plane deformity >10 degrees (47.7%) and <10 degrees (52.3%). Patients with >10 degrees had fewer reoperations (19 vs. 30) and fewer revisions (5 vs. 9) when compared to patients with <10 degrees deformity. Conclusion: Patients who underwent INBONE I total ankle arthroplasty demonstrated significant improvement in pain and patient-reported outcomes at a mean of 5.7 years post-operatively. The patients with preoperative coronal plane tibiotalar deformity had similar pain relief, function, and need for additional surgeries and revisions. Despite the presumed shortcomings of the INBONE I’s saddle-shaped talar design, this operation shows promising results, with or without deformity, at mid-term follow- up with survivorship of 90.3%.

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Total Joint Replacement of Ankle, Knee, and Hip: How Do Patients Perceive Their Operative Outcomes at 10 Years?

Foot & Ankle Orthopaedics ◽

10.1177/24730114211022735 ◽

2021 ◽

Vol 6 (3) ◽

pp. 247301142110227

Author(s):

Jayasree Ramaskandhan ◽

Karen Smith ◽

Simon Kometa ◽

Nachiappan Chockalingam ◽

Malik Siddique

Keyword(s):

Patient Satisfaction ◽

Joint Replacement ◽

Total Joint Replacement ◽

Short Form ◽

Case Series ◽

Total Ankle Replacement ◽

Ankle Replacement ◽

Sf 36 ◽

Patient Reported

Background: Patient-reported outcomes (PROMs) are an integral part of national joint registers in measuring outcomes of operative procedures and improving quality of care. There is lack of literature comparing outcomes of total ankle replacement (TAR) to total knee replacement (TKR) and total hip replacement (THR). The aim of this study was to compare PROMs between TAR, TKR, and THR patient groups at 1, 5, and 10 years. Methods: Prospective PROMs from patients who underwent a TAR, TKR, or THR procedure between 2003 and 2010 were studied. Patients were divided into 3 groups based on their index joint replacement (hip, knee, or ankle). Patient demographics (age, gender, body mass index), patient-reported outcome scores (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC], 36-Item Short Form Health Survey [SF-36]) and patient satisfaction scores (4-point Likert scale) at follow-up were compared between the 3 groups. Results: Data was available on 1797 THR, 2475 TKR, and 146 TAR patients. TAR patients were younger and reported fewer number of comorbidities. All 3 groups improved significantly from preoperative to 10 years for WOMAC scores ( P < .001). For SF-36 scores at 10 years, the THR group (32.2% follow-up) scored the highest for 3 domains ( P = .031) when compared to the TKR group (29.1% follow-up). All 3 groups had similar outcomes for 5 of 8 domains; P < .05). For patient satisfaction, the THR group reported overall 95.1% satisfaction followed by 89.8% for the TKR group and 83.9% in the TAR group (42.4% follow-up). Conclusion: In this cohort with diminishing numbers over the decade of time the patients were followed up we found that patients are equally happy with functional and general health outcomes from total ankle replacement vs other major lower extremity joint replacement. TAR surgery should be considered as a viable treatment option in this patient group. Level of Evidence: Level III, retrospective case series.

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Are responders to patient health surveys representative of those invited to participate? An analysis of the Patient-Reported Outcome Measures Pilot from the Australian Orthopaedic Association National Joint Replacement Registry

PLoS ONE ◽

10.1371/journal.pone.0254196 ◽

2021 ◽

Vol 16 (7) ◽

pp. e0254196

Author(s):

Ian A. Harris ◽

Kara Cashman ◽

Michelle Lorimer ◽

Yi Peng ◽

Ilana Ackerman ◽

...

Keyword(s):

Outcome Measures ◽

Joint Replacement ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Telephone Call ◽

Joint Replacement Registry ◽

Asa Score ◽

Significant Difference ◽

Patient Reported

Background Patient-reported outcome measures (PROMs) are commonly used to evaluate surgical outcome in patients undergoing joint replacement surgery, however routine collection from the target population is often incomplete. Representative samples are required to allow inference from the sample to the population. Although higher capture rates are desired, the extent to which this improves the representativeness of the sample is not known. We aimed to measure the representativeness of data collected using an electronic PROMs capture system with or without telephone call follow up, and any differences in PROMS reporting between electronic and telephone call follow up. Methods Data from a pilot PROMs program within a large national joint replacement registry were examined. Telephone call follow up was used for people that failed to respond electronically. Data were collected pre-operatively and at 6 months post-operatively. Responding groups (either electronic only or electronic plus telephone call follow up) were compared to non-responders based on patient characteristics (joint replaced, bilaterality, age, sex, American Society of Anesthesiologist (ASA) score and Body Mass Index (BMI)) using chi squared test or ANOVA, and PROMs for the two responder groups were compared using generalised linear models adjusted for age and sex. The analysis was restricted to those undergoing primary elective hip, knee or shoulder replacement for osteoarthritis. Results Pre-operatively, 73.2% of patients responded electronically and telephone follow-up of non-responders increased this to 91.4%. Pre-operatively, patients responding electronically, compared to all others, were on average younger, more likely to be female, and healthier (lower ASA score). Similar differences were found when telephone follow up was included in the responding group. There were little (if any) differences in the post-operative comparisons, where electronic responders were on average one year younger and were more likely to have a lower ASA score compared to those not responding electronically, but there was no significant difference in sex or BMI. PROMs were similar between those reporting electronically and those reporting by telephone. Conclusion Patients undergoing total joint replacement who provide direct electronic PROMs data are younger, healthier and more likely to be female than non-responders, but these differences are small, particularly for post-operative data collection. The addition of telephone call follow up to electronic contact does not provide a more representative sample. Electronic-only follow up of patients undergoing joint replacement provides a satisfactory representation of the population invited to participate.

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Minimum ten-year follow-up of a randomized trial comparing acetabular component fixation of two porous in-growth surfaces using radiosteriometric analysis

Bone & Joint Open ◽

10.1302/2633-1462.110.bjo-2020-0118.r1 ◽

2020 ◽

Vol 1 (10) ◽

pp. 653-662

Author(s):

Luthfur Rahman ◽

Mazin S. Ibrahim ◽

Lyndsay Somerville ◽

Matthew G. Teeter ◽

Douglas D. Naudie ◽

...

Keyword(s):

Randomized Trial ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

P Value ◽

Significant Difference ◽

Patient Reported ◽

Acetabular Components

Aims To compare the in vivo long-term fixation achieved by two acetabular components with different porous ingrowth surfaces using radiostereometric analysis (RSA). Methods This was a minimum ten-year follow-up of a prospective randomized trial of 62 hips with two different porous ingrowth acetabular components. RSA exams had previously been acquired through two years of follow-up. Patients returned for RSA examination at a minimum of ten years. In addition, radiological appearance of these acetabular components was analyzed, and patient-reported outcome measures (PROMs) obtained. Results In all, 15 hips were available at ten years. There was no statistically significant difference in PROMS between the two groups; PROMs were improved at ten years compared to preoperative scores. Conventional radiological assessment revealed well-fixed components. There was minimal movement for both porous surfaces in translation (X, Y, Z, 3D translation in mm (median and interquartile range (IQR)), StikTite (Smith and Nephew, Memphis, Tennessee, USA): 0.03 (1.08), 0.12 (0.7), 0.003 (2.3), 0.37 (0.30), and Roughcoat (Smith and Nephew): -0.6 (0.59),–0.1 (0.49), 0.1 (1.12), 0.48 (0.38)), and rotation (X, Y, Z rotation in degrees (median and IQR), (Stiktite: -0.4 (3), 0.28 (2), -0.2 (1), and Roughcoat: - 0.4 (1),–0.1 (1), 0.2 (2)). There was no statistically significant difference between the two cohorts (p-value for X, Y, Z, 3D translation - 0.54, 0.46, 0.87, 0.55 and for X, Y, Z rotation - 0.41, 0.23, 0.23 respectively) at ten years. There was significant correlation between two years and ten years 3D translation for all components ( r = 0.81(p =< 0.001)). Conclusion Both porous ingrowth surfaces demonstrated excellent fixation on plain radiographs and with RSA at ten years. Short-term RSA data are good predictors for long-term migration data.

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Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial (Preprint)

10.2196/preprints.8915 ◽

2017 ◽

Author(s):

Rami A El Shafie ◽

Nina Bougatf ◽

Tanja Sprave ◽

Dorothea Weber ◽

Dieter Oetzel ◽

...

Keyword(s):

Patient Satisfaction ◽

Patient Care ◽

Short Form ◽

Mobile App ◽

University Hospital ◽

European Organization ◽

Curative Radiotherapy ◽

Patient Reported ◽

Oncologic Therapy

BACKGROUND The increasing role of consumer electronics and Web-enabled mobile devices in the medical sector opens up promising possibilities for integrating novel technical solutions into therapy and patient support for oncologic illnesses. A recent survey carried out at Heidelberg University Hospital suggested a high acceptance among patients for an additional approach to patient care during radiotherapy based on patient-reported outcomes by a dedicated mobile app. OBJECTIVE The aim of this trial (OPTIMISE-1: Oncologic Therapy Support Via Means of a Dedicated Mobile App – A Prospective Feasibility Evaluation) is to prospectively evaluate the feasibility of employing a mobile app for the systematic support of radiooncological patients throughout the course of their radiotherapy by monitoring symptoms and patient performance, and facilitating the background-exchange of relevant information between patient and physician. METHODS The present single-center, prospective, exploratory trial, conducted at Heidelberg University Hospital, assesses the feasibility of integrating an app-based approach into patient-care during radiotherapy. Patients undergoing curative radiotherapy for thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related quality of life (QoL) and symptoms, and their need to personally consult a physician by means of a mobile app during treatment. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and health-related QoL is assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires at the beginning (baseline) and end of radiotherapy, and at the first follow-up. RESULTS This trial will recruit 50 patients over a period of 12 months. Follow-up will be completed after 18 months, and publication of results is planned at 24 months after trial initiation. CONCLUSIONS This study will serve as a basis for future studies aiming to exploit the constant innovation in mobile medical appliances and integrate novel patient-centered concepts into patient care in the context of radiotherapy. CLINICALTRIAL ClinicalTrials.gov NCT03168048; https://clinicaltrials.gov/ct2/show/NCT03168048 (Archived at WebCite http://www.webcitation.org/6wtWGgi0X)

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