Effect of Load, Angle, and Contraction Type on Clinically Assessed Knee Joint Position Sense.

CONTEXT: Proprioception is an individual's awareness of body position in 3-dimensional space. How proprioceptive acuity changes under varying conditions such as joint position, load, and concentric or eccentric contraction type is not well understood. In addition, a limitation of the variety of techniques to assess proprioception is the lack of clinically feasible methods to capture proprioceptive acuity. The purpose of this study was to implement a readily available instrument, a smartphone, in the clinical evaluation of knee active joint position sense and to determine how joint angle, joint loading, and quadriceps contraction type affect an individual's active joint position sense. DESIGN: Cross-over study. METHODS: Twenty healthy, physically active university participants (10 women and 10 men: 21.4 [2.0] y; 1.73 [0.1] m; 70.9 [14.3] kg) were recruited. Individuals were included if they had no neurological disorder, no prior knee surgery, and no recent knee injury. The participants were given a verbal instruction to locate a target angle and then were tasked with reproducing the target angle without visual or verbal cues. An accelerometer application on a smartphone was used to assess the angle to the nearest tenth of a degree. Three variables, each with 2 levels, were analyzed in this study: load (weighted and unweighted), contraction type (eccentric and concentric), and joint position (20° and 70°). A repeated-measures analysis of variance was conducted to assess the within-subjects factors of load, contraction, and position. RESULTS: A significant difference of 0.50° (0.19°) of greater error with eccentric versus concentric contraction (P = .02) type was identified. In addition, a significant interaction was found for contraction × position, with a mean increase in error of 0.98° (0.33°) at the 20° position when contracting eccentrically (P = .03). CONCLUSIONS: Contraction type, specifically eccentric contraction at 20°, showed significantly greater error than concentric contraction. This suggests that, during eccentric contractions of the quadriceps, there may be decreased proprioceptive sensitivity compared with concentric contractions.

T1rho and T2 mapping of ankle cartilage of female and male ballet dancers.

BACKGROUND: Since ballet dancers begin their training before skeletal maturity, accurate and non-invasive identification of cartilage diseases is clinically important. Angle-dependent analysis of T1rho and T2 sequences can be useful for quantification of the composition of cartilage. PURPOSE: To investigate the angle-dependent T1rho and T2 profiles of ankle cartilage in non-dancers and dancers. MATERIAL AND METHODS: Ten female non-dancers, ten female dancers, and 9 male dancers were evaluated using T1rho and T2 mapping sequences. Manual segmentation of talar and tibial cartilage on these images was performed by two radiologists. Inter- and intra-rater reliabilities were calculated using intraclass correlation coefficients (ICCs) and Bland-Altman analysis. Mean thickness and volume of cartilage were estimated. Angle-dependent relaxation time profiles of talar and tibial cartilage were created. RESULTS: ICCs of the number of segmented pixels were poor to excellent. Bland-Altman plots indicated that differences were associated with segment sizes. Segmented cartilage on T1rho demonstrated larger thickness and volume than those on T2 in all populations. Male dancers showed larger cartilage thickness and volume than female dancers and non-dancers. Each cartilage demonstrated angular-dependent T1rho and T2 profiles. Minimal T1rho and T2 values were observed at approximately 180°-200°; higher values were seen at the angle closer to the magic angle. Minimal T2 value of talar cartilage of dancers was larger than that of non-dancers. CONCLUSION: In this small cohort study, regional and sex variations of ankle cartilage T1rho and T2 values in dancers and non-dancers were demonstrated using an angle-dependent approach.

A Tenuous Pas de Deux: Examining University Dancers' Access to and Satisfaction with Healthcare Delivery.

BACKGROUND: Dance is a rigorous art form and athletic activity accompanied by a high injury rate. The purpose of this study was to gather injury and healthcare availability information from university dancers to better understand dancers' access to professional medical attention and their satisfaction with the medical advice they receive. METHODS: An author-designed online questionnaire about dance-related injury (DRI), access to healthcare, and satisfaction with healthcare was distributed to dancers at 102 American post-secondary institutions in 2 states that offer programs in dance; 211 dancers completed the survey. RESULTS: 75% of dancers reported seeking healthcare advice from dance teachers. A majority (55%) who visited healthcare professionals for a DRI disclosed negative experiences; the top reasons stemmed from the professionals' not understanding dancers (70%), providing unhelpful advice (43%), or not spending enough time in the healthcare consultation (33%). Of dancers who reported positive experiences, they most commonly discovered the provider by word-of-mouth (89%) or through the provider's affiliation with their institution (41%). CONCLUSION: Dancers tend to access healthcare when it is available to them but find the lack of relevant and applicable advice from healthcare practitioners the biggest contributors to their negative experience with the healthcare system. When confronted with DRIs, dancers tend to seek advice from their dance instructors. To ensure proper evaluation, instructors should refer dancers to licensed healthcare providers, and dance medicine practitioners should make themselves known to dancers through both formal and informal networks.

Is mortality due to primary malignant brain and other central nervous system tumors decreasing?

Primary malignant brain and other central nervous system tumors (BT) are a rare cancer that causes morbidity and mortality disproportionate to their incidence. This study presents the most up-to-date mortality data for malignant BT in the United States (US) by histology groupings, age, race, and sex. Mortality rates for malignant BT were generated using the Center for Disease Control's National Vital Statistics Systems (NVSS, ~100% of US) data from 1975 to 2012. Histology-specific incidence-based mortality rates were calculated using the National Cancer Institute's Surveillance, Epidemiology, and End-Results 9 (SEER9, ~9.4% of US) data from 1975 to 2012. Joinpoint modeling was used to estimate trends. Mortality was similar in both the NVSS and SEER9 datasets. Overall, mortality from 1975 to 2012 was higher among men, higher in older individuals, and higher in Whites compared to other races. Persons age 65+ years had significant increases in mortality for all malignant tumors overall and for glioma histologies, while persons age <20 years had no significant changes in mortality. This study reports up-to-date mortality rates by histology groupings, age, race, and sex for malignant BT. There have been no significant changes in overall mortality due to these tumors from 1975 to 2012. There have been significant increases in mortality in the elderly (age 65+ years), especially those age 75-84 years, mirroring the effect of overall population aging. Examining age-, race-, sex-, and histology-specific morality at the population level can provide important information for clinicians, researchers, and public health planning.

Kinematic analysis of hip and knee rotation and other contributors to ballet turnout.

Turnout, or external rotation (ER) of the lower extremities, is essential in ballet. The purpose of this study was to utilise physical examination and a biomechanical method for obtaining functional kinematic data using hip and knee joint centres to identify the relative turnout contributions from hip rotation, femoral anteversion, knee rotation, tibial torsion, and other sources. Ten female dancers received a lower extremity alignment assessment, including passive hip rotation, femoral anteversion, tibial torsion, weightbearing foot alignment, and Beighton hypermobility score. Next, turnout was assessed using plantar pressure plots and three-dimensional motion analysis; participants performed turnout to ballet first position on both a plantar pressure mat and friction-reducing discs. A retro-reflective functional marker motion capture system mapped the lower extremities and hip and knee joint centres. Mean total turnout was 129±15.7° via plantar pressure plots and 135±17.8° via kinematics. Bilateral hip ER during turnout was 49±10.2° (36% of total turnout). Bilateral knee ER during turnout was 41±5.9° (32% of total turnout). Hip ER contribution to total turnout measured kinematically was less than expected compared to other studies, where hip ER was determined without functional kinematic data. Knee ER contributed substantially more turnout than expected or previously reported. This analysis method allows precise assessment of turnout contributors.

Assessment of female ballet dancers' ankles in the en pointe position using high field strength magnetic resonance imaging.

BACKGROUND: The en pointe position of the ankle in ballet is extreme. Previously, magnetic resonance imaging (MRI) of ballet dancers' ankles en pointe was confined to a low field, open MR device. PURPOSE: To develop a reproducible ankle MRI protocol for ballet dancers en pointe and to assess the positions of the key structures in the dancers ankles. MATERIAL AND METHODS: Six female ballet dancers participated; each was randomly assigned to stand en pointe while one of her feet and ankles was splinted with wooden rods affixed with straps or to begin with the ankle in neutral position. She lay in an MR scanner with the ankle inside a knee coil for en pointe imaging and inside an ankle/foot coil for neutral position imaging. Proton density weighted images with and without fat suppression and 3D water excitation gradient recalled echo images were obtained en pointe and in neutral position in sagittal, axial, and coronal planes. We compared the bones, cartilage, and soft tissues within and between positions. RESULTS: No difficulties using the protocol were encountered. En pointe the posterior articular surface of the tibial plafond was incongruent with the talar dome and rested on the posterior talus. The posterior edge of the plafond impinged Kager's fat pad. All participants exhibited one or more small ganglion cysts about the ankle and proximal foot, as well as fluid accumulation in the flexor and fibularis tendon sheaths. CONCLUSION: Our MRI protocol allows assessment of female ballet dancers' ankles in the extreme plantar flexion position in which the dancers perform. We consistently noted incongruence of the talocrural joint and convergence of the tibia, talus, and calcaneus posteriorly. This protocol may be useful for clinicians who evaluate dancers.

Validation of the Ottawa Ankle Rules for Acute Foot and Ankle Injuries.

UNLABELLED: The original and modified Ottawa Ankle Rules (OARs) were developed as clinical decision rules for use in emergency departments. However, the OARs have not been evaluated as an acute clinical evaluation tool. OBJECTIVE: To evaluate the measures of diagnostic accuracy of the OARs in the acute setting. METHODS: The OARs were applied to all appropriate ankle injuries at 2 colleges (athletics and club sports) and 21 high schools. The outcomes of OARs, diagnosis, and decision for referral were collected by the athletic trainers (ATs) at each of the locations. Contingency tables were created for evaluations completed within 1 h for which radiographs were obtained. From these data the sensitivity, specificity, positive and negative likelihood ratios, and positive and negative predictive values were calculated. RESULTS: The OARs met the criteria for radiographs in 100 of the 124 cases, of which 38 were actually referred for imaging. Based on radiographic findings in an acute setting, the OARs (n = 38) had a high sensitivity (.88) and are good predictors to rule out the presence of a fracture. Low specificity (0.00) results led to a high number of false positives and low positive predictive values (.18). CONCLUSION: When applied during the first hour after injury the OARs significantly overestimate the need for radiographs. However, a negative finding rules out the need to obtain radiographs. It appears the AT's decision making based on the totality of the examination findings is the best filter in determining referral for radiographs.

Postural Stability Assessment of University Marching Musicians Using Force Platform Measures.

Lower extremity injury is prevalent in marching musicians, and poor postural stability is a possible risk factor for this. The external load of an instrument may predispose these performers to injury by decreasing postural stability. The purpose of this study was to determine the relationship between instrument load and static and dynamic postural stability in this population. Fourteen university marching musicians were recruited and completed a balance assessment protocol on a force platform with and without their instrument. Mean center of pressure (CoP) displacement was then calculated for each exercise in the anterior/posterior and medial/lateral planes. Mean anterior/posterior CoP displacement significantly increased in the instrument condition for the static surface, eyes closed, 2 feet condition (p≤0.005; d=0.89). No significant differences were found in the medial/lateral plane between non-instrument and instrument conditions. Significant differences were not found between test stance conditions independent of group. Comparisons between the non-instrument-loaded and instrument-loaded conditions revealed possible significance of instrument load on postural stability in the anterior/posterior plane. Mean differences indicated that an unstable surface created a greater destabilizing effect on postural stability than instrument load.

Stunt performers' reluctance to self-report head trauma: a qualitative study.

BACKGROUND: Mild traumatic brain injuries receive voluminous attention in the research literature, but this is confined almost entirely to sports and military contexts. As an occupation, performing stunts in film, television, and entertainment places the head at high risk of repetitive impact and whiplash, but stunt performers do not enjoy the same level of healthcare supervision and access as that provided to sports participants. Therefore, the aim of this study was to evaluate stunt performers' qualitative perceptions of reporting and management of head trauma in their industry. METHODS: After giving their informed consent, 87 motion picture and television stunt performers responded to a query about their views of ways to improve how stunt performers' occupational head trauma-specifically head impacts and head whips that could cause a concussion-are reported and managed. We analyzed their responses via content and thematic analyses. Two researchers independently marked and categorized key words, phrases, and texts to identify codes that described participants' comments. They then revised, discussed, and resolved coding discrepancies through consensus to establish inter-coder reliability. Next, we identified thematic patterns that described participants' understanding of the stunt performer industry and what must change to facilitate reporting of head trauma. We derived themes from data that occurred multiple times, both within and across short answer responses. RESULTS: We identified three primary themes cited by the stunt performers as needs in their industry: (1) Need to Reduce the Stigma of Reporting a Stunt-Related Injury, (2) Need to Eliminate the "Cowboy Culture," and (3) Need to Improve the Quality of the Work Environment. CONCLUSIONS: Stunt performers are crucial members of a global entertainment industry valued at approximately US$100 billion annually. A large segment of the world's population consumes their work in motion pictures, television, and live entertainment. When they are given an anonymous opportunity to speak, stunt performers offer insight into and recommendations for industry changes-primarily cultural and educational in nature-that could improve their physical and mental health, career longevity, and employability when they are confronted with head trauma.

Head Trauma and Concussions in Film and Television Stunt Performers: An Exploratory Study.

OBJECTIVES: The aims of the study were to assess prevalence and management of head impacts in stunt performers and to evaluate performers' quality of life and ability to work after head injury. METHODS: Stunt performers completed an online survey about head impacts/head whips history, diagnosed concussions, reasons for not reporting injuries, health care sought after head impacts, attitudes toward on-set concussion management, perceived ability to work as a stunt performer, and health-related quality of life. RESULTS: One hundred seventy-three performers (80%) indicated at least one head impact/head whip during their stunt career. Of these, 86% exhibited concussion-like symptoms and 38% received one or more concussion diagnoses. Sixty-five percent continued working with concussion-like symptoms. Short Form-12 mental component scores were suggestive of depression in 42%. CONCLUSIONS: Concussion seems to be a serious occupational health issue in stunt performers. We suggest that concussion management, risk reduction, and education should be addressed in this community.

Force Attenuation Properties of Padded Dance Support Socks.

BACKGROUND: Foot injuries occur frequently in dancers, and researchers have investigated different protective measures to reduce their incidence. Research has primarily focused on ballet, but foot injuries also are common in modern and contemporary dance where footwear is not worn. While padded dance socks are a potential solution, the extent to which they provide force reduction for the feet is unknown.
Purpose: This study investigates the extent to which padded dance support socks can reduce force on the foot during a dance sequence and when landing from a sauté jump.
Methods: Twenty-one injury-free dancers (2 M, 19 F; age: 21.5 ± 6.7 years; height: 165.5 ± 6.1 cm; mass: 68.6 ± 15.0 kg) volunteered for this randomized, cross-over design study. Participants per- formed a 40-second modern dance sequence and a sauté jump landing under two conditions: wearing Apolla Performance Shock™ dance socks (DS) and with bare feet (BF). During these activities, 1.0 cm diameter circular force transducers were affixed under the first metatarsophalangeal joint and under the center of the heel. The sensors wirelessly recorded peak toe force, peak heel force, mean toe force, and mean heel force during dancing. A force platform measured vertical ground reaction force (VGRF) and time to peak VGRF, while the foot sensors measured peak toe force and peak heel force, during the jump landings. A Noraxon MR3.12 biomechanics system synchronized and recorded the data. All force data were normalized to body weight (BW). Dependent samples t-tests were used to assess pairwise differences in these measures between the DS and BF conditions. Alpha was set at p < 0.05.
Results: Mean and peak heel forces/BW when dancing with DS were significantly lower than during BF dancing (mean: p = 0.015; peak: p = 0.0004). Peak VGRF/BW when landing from the sauté jump with DS was significantly lower compared with landing in BF (p = 0.035). All other variables were not significantly different between conditions, but all DS force values were lower than BF.
Conclusions: We offer evidence that padded dance socks may reduce foot forces dancers commonly encounter during modern dance. The trends we recorded require further study to assess the extent to which the socks exhibit beneficial effects when considering both the many hours dancers train and the cumulative effects of impacts sustained by their feet.

Ankle and foot contributions to extreme plantar- and dorsiflexion in female ballet dancers.

BACKGROUND: Female ballet dancers require extreme ankle motion. The objective of this study was to quantify the relative contributions of the ankle and various foot joints to extreme plantarflexion (PF) and dorsiflexion (DF) in female ballet dancers using an X-ray superimposition technique and digital graphics software. MATERIALS AND METHODS: One asymptomatic ankle was studied in each of seven experienced female ballet dancers. Three lateral weightbearing X-rays were taken of each ballet dancer's ankle: en pointe (maximum PF), in neutral position, and in demi-plié (maximum DF). Using graphics software, a subject's three X-ray images were superimposed and the tali were aligned. On each image the tibia, navicular, intermediate cuneiform, and first metatarsal were marked. Positional differences of a bone's line among the three images demonstrated angular movement of the bone in degrees. The neutral position was the reference from which PF and DF of the bones were calculated. RESULTS: The talocrural joint contributed the most motion of any pair of bones evaluated for both PF and DF, with mean movements of 57.6 ± 5.2 degrees en pointe and 24.6 ± 9.6 degrees in demi-plié. Approximately 70% of total PF and DF were attributable to the talocrural joint, with the remaining 30% coming from motion between adjacent pairs of the studied foot bones. CONCLUSION: Superimposed X-rays for assessing ankle and foot contributions to the extreme positions required of female ballet dancers offer insight into how these positions are attained that is not available via goniometry. CLINICAL RELEVANCE: Functional information gained from this study may assist clinicians in assessing ankle and foot pain in these individuals.

Snake Bite Management: A Scoping Review of the Literature.

BACKGROUND: Around the world, snake bite envenomation remains an underreported human health hazard. Envenomation can cause local and systemic complications, especially when there is a lack of antivenom availability. Although there are established guidelines regarding snake bite management acute care, there is a paucity of data regarding surgical intervention and the plastic surgeon's role treating this unique patient population. METHODS: A review was conducted identifying relevant published articles involving snake bite management and treatment in PubMed and EMBASE. RESULTS: One hundred ten articles were identified and 77 met inclusion criteria. Snake bite envenomation can result in complications that are dependent upon a variety of variables. The literature has shown the best field treatment to be timely transportation to the nearest medical facility, along with antivenom administration. The cytotoxic, hemotoxic, and neurotoxic effects of venom can cause a variety of local soft tissue and systemic complications. Surgical interventions such as fasciotomies, wound debridements, skin grafts, and tissue flaps may be necessary in these patients to optimize functional and aesthetic outcomes. Disparities in access to care in resource limited settings are discussed. CONCLUSIONS: Global health disparities and insufficient antivenom distribution create an inequality of care in snake bite patients. Plastic surgeons have an important role in managing acute and chronic complications of snake bite envenomations that can lead to improved patient outcomes.

Concussions in Dancers and Other Performing Artists.

Dancers and other performing artists are subject to head impacts that result in concussion-like symptoms. In spite of this, performing arts do not have access to the continual, focused emphasis on the diagnosis, management, and prevention of concussions that is commonplace in sports. Performing arts present a unique environment in which concussions occur and must be managed. This article outlines what is known about performing arts concussions, describes mechanisms of head impacts sustained by participants in dance and the related artforms of theater, circus, and film and television stunts, and offers concussion management guidelines for these artistic fields.

University Marching Band Members' Noise Dosages and Hearing Health-Related Knowledge.

OBJECTIVES: (1) To measure sound exposures of marching band and non-marching band students during a football game, (2) to compare these to sound level dose limits set by NIOSH, and (3) to assess the perceptions of marching band students about their hearing health risk from loud sound exposure and their use of hearing protection devices (HPDs). METHODS: Personal noise dosimetry was completed on six marching band members and the band director during rehearsals and performances. Dosimetry measurements for two audience members were collected during the performances. Noise dose values were calculated using NIOSH criteria. One hundred twenty-three marching band members responded to a questionnaire analyzing perceptions of loud music exposure, the associated hearing health risks, and preventive behavior. RESULTS: Noise dose values exceeded the NIOSH recommended limits among all six marching band members during rehearsals and performances. Higher sound levels were recorded during performances compared to rehearsals. The audience members were not exposed to hazardous levels. Most marching band members reported low concern for health effects from high sound exposure and minimal use of HPDs. CONCLUSION: High sound exposure and low concern regarding hearing health among marching band members reflect the need for comprehensive hearing conservation programs for this population.

Quantitative MRI Analysis of the Talocrural and Talonavicular Joints in Ballet Dancers.

The ankles of ballet dancers are routinely under heavy loading that may lead to osteoarthritic changes. It would be clinically useful to identify such pathology as early as possible in a dancer's career. Therefore, the purpose of this study was to compare quantitative measurements in magnetic resonance (MR) images of the talocrural and talonavicular joints in ballet dancers and healthy non-dancers for use in formulating prediction of chronic injury and degenerative joint disease in these locations. Quantitative measurements in MR images of the talocrural and talonavicular joints were compared in 10 female ballet dancers, 10 healthy female non-dancers, and nine male ballet dancers. Fat-suppressed density-weighted proton, T1rho, and T2 mapping images were acquired with a 3.0 T MR scanner. Medial and lateral subchondral bone distance between the tibia and talus (MSBD and LSBD), axial navicular-talus axis angle (ANT angle), sagittal talar neck angle against the posterior talocalcaneal joint (TN angle), and curvature of navicular surface at the talonavicular joint were measured on sagittal images. The medial subchondral bone distance was found to be significantly larger in female dancers than female non-dancers (4.05 mm vs. 2.75 mm, p < 0.05), whereas there were no significant differences in LSBD (2.63 mm vs. 2.63 mm, p = 0.87). Axial navicular talus angles in female dancers were significantly larger than those in female non-dancers (38.9° vs. 24.3°, p < 0.05). There was a tendency for the TN angle to be smaller and navicular curvature (NC) to be larger in female dancers compared to female non-dancers, though the differences were not significant (TN angle: 16.6° vs. 22.3°, p = 0.09, and NC: 0.186 vs. 0.165, p = 0.28). There were no significant differences in T1rho or T2 values of talonavicular joint cartilage. These results show that the bony anatomy of dancers' ankles may adapt to the stresses placed on them by ballet.

Magnetic resonance imaging of the ankle in female ballet dancers en pointe.

BACKGROUND: Ballet dancers require extreme range of motion of the ankle, especially weight-bearing maximum plantar flexion (en pointe). In spite of a high prevalence of foot and ankle injuries in ballet dancers, the anatomy and pathoanatomy of this position have not been sufficiently studied in weight-bearing. Magnetic resonance imaging (MRI) is a beneficial method for such study. PURPOSE: To develop an MRI method of evaluating the ankles of female ballet dancers standing en pointe and to assess whether pathological findings from the MR images were associated with ankle pain reported by the subjects. MATERIAL AND METHODS: Nine female ballet dancers (age, 21+/-2.9 years; dance experience, 16+/-4.1 years; en pointe dance experience, 7+/-4.9 years) completed an ankle pain visual analog scale questionnaire and underwent T1- and T2-weighted scans using a 0.25 T open MRI device. The ankle was scanned in three positions: supine with full plantar flexion, standing with the ankle in anatomical position, and standing en pointe. RESULTS: Obtaining MR images of the ballet dancers en pointe was successful in spite of limitations imposed by the difficulty of remaining motionless in the en pointe position during scanning. MRI signs of ankle pathology and anatomical variants were observed. Convergence of the posterior edge of the tibial plafond, posterior talus, and superior calcaneus was noted in 100% of cases. Widened anterior joint congruity and synovitis/joint effusion were present in 71% and 67%, respectively. Anterior tibial and/or talar spurs and Stieda's process were each seen in 44%. However, clinical signs did not always correlate with pain reported by the subjects. CONCLUSION: This study successfully established an ankle imaging technique for ballet dancers en pointe that can be used in the future to assess the relationship between en pointe positioning and ankle pathoanatomy in ballet dancers.

Pathoanatomy of posterior ankle impingement in ballet dancers.

Dance is a high performance athletic activity that leads to great numbers of injuries, particularly in the ankle region. One reason for this is the extreme range of ankle motion required of dancers, especially females in classical ballet where the en pointe and demi-pointe positions are common. These positions of maximal plantar flexion produce excessive force on the posterior ankle and may result in impingement, pain, and disability. Os trigonum and protruding lateral talar process are two common and well-documented morphological variations associated with posterior ankle impingement in ballet dancers. Other less well-known conditions, of both bony and soft tissue origins, can also elicit symptoms. This article reviews the anatomical causes of posterior ankle impingement that commonly affect ballet dancers with a view to equipping healthcare professionals for improved effectiveness in diagnosing and treating this pathology in a unique type of athlete.

Patient Experiences with Avelumab in Treatment-Naïve Metastatic Merkel Cell Carcinoma: Longitudinal Qualitative Interview Findings from JAVELIN Merkel 200, a Registrational Clinical Trial.

BACKGROUND AND OBJECTIVE: Avelumab is approved for the treatment of metastatic Merkel cell carcinoma, a rare aggressive skin cancer with a poor prognosis. The aim of this qualitative study embedded in a clinical trial was to explore patient experiences while receiving avelumab. METHODS: All treatment-naïve patients with metastatic Merkel cell carcinoma entering part B of the phase II, open-label, international, JAVELIN Merkel 200 trial (NCT02155647) were invited to participate in optional semi-structured phone interviews before avelumab administration (baseline) and at weeks 13 and 25. Interviews were conducted by trained professionals, audio-recorded, transcribed and analysed. Key concepts identified at baseline were assessed during follow-up interviews. RESULTS: Twenty-nine patients completed the baseline interview; 19 had at least one follow-up interview. Baseline interviews described the patients' challenging journeys before being correctly diagnosed with Merkel cell carcinoma, the negative psychological burden of living with a symptomless disease and the hope for avelumab to be a successful therapy. During the trial, most patients reported an increased or continued sense of hope and willingness to fight metastatic Merkel cell carcinoma. Patients who self-reported disease improvement (n = 12) also reported stability or improvement in physical well-being and ability to do daily activities, having more energy, worrying less and being optimistic. Six patients who reported their condition as stable (n = 4) or worsened (n = 3) reported a worsening of physical well-being. Nine patients reported fatigue/tiredness on the day of and after receiving avelumab. Baseline and longitudinal experiences were similar across countries. CONCLUSIONS: This study suggests that patients experience perceptible benefits in physical and psychological well-being following treatment success with first-line avelumab in metastatic Merkel cell carcinoma.