Earfold™: A combined approach with conchal bowl reduction.

BACKGROUND: Prominent ear deformity is common amongst the human population and is partly due to underdevelopment of the antihelical fold, a prominent conchal bowl, or both. Recently, the senior author described a minimally invasive technique for changing the shape of the antihelical fold using the Earfold™ implant (Allergan plc, Dublin, Ireland). However, there is still a paucity of data regarding outcomes from combing this approach with surgical techniques to correct conchal bowl hypertrophy. OBJECTIVES AND METHODS: Questionnaire-based study evaluating outcomes in consecutive patients undergoing treatment with Earfold™ and conchal bowl reduction. Patient reported outcome measures were assessed with a validated questionnaire. Data on complications were obtained from the patient's case notes and free-text sections of the questionnaire. RESULTS: Completed questionnaires were received from 8 patients out of a total of 18 who underwent the combination treatment (44% response rate). Statistically significant differences were noted in nearly all questions (18/19) relating to changes in ear appearance as a result of the surgery, with all patients being satisfied following the combined procedure. Improvements in subjective outcomes were compared to previous studies evaluating treatment with Earfold™. CONCLUSIONS: The Earfold™ implant can be combined safely with other otoplasty techniques to achieve a good outcome in a carefully selected patient population.

Reflections and future directions for psychological science in Prosthetics and Orthotics International.

In the inaugural edition of Prosthetics and Orthotics International in 1977, Dr Sidney Fishman identified the Psychological Sciences as one of six indispensable areas of skill and knowledge in professional prosthetic-orthotic practice. Since then, there have been substantial changes and developments in the complexity and capabilities of assistive technologies, greater emphasis on understanding the relationships between people and enabling technologies, growing recognition of the importance of the contexts and environments that support their use, and changes in both health care services and the professional development of prosthetists and orthotists. The aim of this narrative review is to reflect on the role of Prosthetics and Orthotics International in shaping the evolving understanding of psychology in prosthetics and orthotics. There remains considerable potential and opportunity for the development and application of psychology in addressing the challenges of disability globally. However, a broad interpretation and application of the principles of rehabilitation psychology are needed if we are to meaningfully incorporate psychological science into the knowledge that informs prosthetic and orthotic practice.

Physical and psychological effects of different temperature-controlled breast prostheses on patients with breast cancer during rehabilitation: a randomized controlled study (CONSORT).

BACKGROUND: Breast loss causes negative influence on women physically, psychologically, and socially. Breast prosthesis can improve patient's figure externally, increase self-confidence, thus improving quality of life (QOL). Prospective study of different breast prostheses has not yet been performed in China. Our objective was to evaluate the QOL of patients wearing different types of breast prostheses and to compare the physical and psychological effects of different temperature-controlled breast prostheses on patients. METHODS: Thirty patients with breast cancer were recruited through the Yankang E-follow-up Platform at the Department of Breast Surgery of Fudan University, Shanghai Cancer Center and were randomized into either intervention or control group. Random number tables were used in this study for randomization. In the first 6 weeks of the study, self-adhesive breast prostheses and conventional breast prostheses had been used in the intervention and control group, respectively. In the later 6 weeks, the breast prostheses used were switched into another kind. Several dimensional parameters including skin conditions, breast prosthesis knowledge, breast prosthesis knowledge, QOL, and body image were examined by different questionnaires in the end of both 6th and 12th week. RESULTS: There were no significant difference in QOL and body image between the 2 groups during 6th and 12th week. At the 6th week of the study, patients of the intervention group preferred to the self-adhesive breast prosthesis, indicating that the self-adhesive breast prosthesis seemed more likely to feel like part of their body, while prosthesis cleaning remaining their biggest concern. At the end of 12th week, in comparison with the number at 6th week, more patients in both groups were willing to choose self-adhesive breast prosthesis. CONCLUSIONS: We conclude that women are satisfied with the temperature-controlled breast prosthesis and are more willing to choose self-adhesive breast prostheses although cleaning remains a problem. In China, patients still lack information about breast prostheses. Therefore, specialist breast nurses should provide comprehensive information about breast prostheses, assist patients in selecting suitable breast prostheses, collect feedback about the prostheses, and reduce each patient's physical and mental discomfort.

Patient Attitudes Toward Testicular Prosthesis Placement After Orchiectomy.

Orchiectomy is the standard of care for many testicular conditions. Testicular prosthesis placement (TPP) can mitigate psychosocial burden, restore self-image, and improve quality of life for patients requiring orchiectomy. Limited data exist regarding patient attitudes and counseling on TPP in the United States. The objective of this study was to characterize patient experiences after TPP, rationale for pursuing/declining TPP, and satisfaction levels. Patients with a history of urologic conditions warranting orchiectomy were identified and sent an anonymous survey addressing demographics, pre/post counseling, attitudes toward TPP, satisfaction rates, and postoperative complications. Sixteen percent (76/480) of patients completed the survey. Of these, 50.8% (32/63) undergoing orchiectomy were counseled by their surgeon about TPP, and 22.2% (14/63) received a prosthesis. The most common reasons for declining TPP included lack of concern for cosmetic appearance and lack of counseling. Leading reasons for pursuing TPP included improving self-confidence and cosmetic appearance. Although 71% (10/14) of patients were satisfied with TPP, they did highlight areas for improvement. Twenty percent (2/10) felt their implant was too high, 60% (6/10) felt their implant was too firm, 10% (1/10) endorsed discomfort during sex, and 30% (3/10) felt that TPP did not match their size expectations. Despite these findings, 71% (10/14) reported that they would have TPP again and 79% (11/14) would recommend TPP to others. TPP improves body image and quality of life following orchiectomy. Provider counseling plays an important role in influencing a patient's decision to undergo TPP. Areas of improvement include implant positioning and more effective replication of testicular consistency.

Implicit development of gaze strategies support motor improvements during action encoding training of prosthesis use.

BACKGROUND: Action observation training has been suggested to facilitate motor improvements in the lives of persons with neural injury. Previous studies have shown that for persons with upper limb amputation, matched limb training, where prosthesis users emulate each other, has shown promise above mismatched training where a prosthesis user emulates actions of a person with sound limbs (most commonly that of a therapist). OBJECTIVE: The mechanism underlying the matched limb training benefit is unclear. Gaze strategies may reveal unique patterns between matched and mismatched training which could explain improvements in motor function in matched limb training. METHODS: Twenty persons with sound limbs were trained on how to use a prosthesis simulator using matched or mismatched limb training in a single session. Eye movements were recorded during the training phase. Kinematics were recorded as persons performed the task. RESULTS: Gaze patterns showed differences between the training groups. The mismatched group demonstrated a higher probability of gaze on the path between the start and end of the action, while the matched group demonstrated a significantly higher probability of focusing on the elements of the path of the action and a trend of focusing on the shoulders. Kinematics also revealed overall improvements in motor control for the matched group. CONCLUSIONS: This study proposes a putative mechanism that may explain improvements in matched limb training through shifting gaze strategies. Further work is needed to understand whether implicit visual strategies seen during matched limb training might encourage motor learning during functional training with prostheses.

Olfactory implant: Demand for a future treatment option in patients with olfactory dysfunction.

OBJECTIVES: Therapeutic options in olfactory dysfunction (OD) are limited. Numerous studies have shown impact of OD on quality of life. Lately, various studies support benefits of olfactory training, but therapy-refractory cases leave doctors and patients locked in a stalemate. An olfactory implant (OI), in analogy to the widely successful cochlear implant, still seems far away from realization. The present study sought to evaluate the demand of OI in patients with OD. METHODS: Sixty-one patients (28 females and 33 males, mean age/standard deviation 54.9/17.6 years) with OD were recruited. We performed olfactory testing for threshold (T), discrimination (D), and identification (I) using Sniffin' Sticks; summed scores (TDI) allowed us to determine normosmia, hyposmia, and anosmia. We applied questionnaires on the importance of smell (IOS), on olfactory disorders (QOD) and on the interest/willingness for OI, considering the need for skull base/head surgery. RESULTS: Twenty-one patients (34.4%) stated that OI could be a future treatment option for them. This decision significantly correlated with TDI, I, complaint-related questions of the QOD, and IOS (P < .05). CONCLUSION: With approximately one-third of patients considering OI as a therapy option, this study seems to indicate a demand for OI. In selected patients, with a high degree of complaints, low olfactory test scores, and maybe an additional occupational need for olfactory function, OI might be an option if future developments warrant safety of OI procedures. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:312-316, 2019.

On Replacement Body Parts.

Technological advances are making devices that functionally replace body parts-artificial organs and limbs-more widely used, and more capable of providing patients with lives that are close to "normal." Some of the ethical issues this is likely to raise relate to how such prostheses are conceptualized. Prostheses are ambiguous between being inanimate objects and sharing in the status of human bodies-which already have an ambiguous status, as both objects and subjects. At the same time, the possibility of replacing body parts with artificial objects puts pressure on the normative status typically accorded to human bodies, seemingly confirming that body parts are replaceable objects. The paper argues that bodies' normative status relies on the relation of a body to a person and shows that persons could have similar relations to prostheses. This suggests that in approaching ethical issues surrounding prostheses, it is appropriate to regard them as more like body parts than like objects.

Résultats des cures herniaires inguinales par prothèse à l'hôpital de zone de Ouidah

Les cures herniaires inguinales occupent la 2e place des activités chirurgicales à l'hôpital de zone de Ouidah. La plupart des cures à froid se font par prothèse depuis 2016. L'objectif de ce travail est d'analyser les résultats préliminaires dans cet hôpital. Il s'agit d'une étude transversale rétrospective à visée analytique avec revue des patients qui a pris en compte les malades opérés d'une hernie inguinale par prothèse à l'hôpital de zone de Ouidah de juillet 2016 à août 2017. Trente-six patients ont été recrutés au cours de notre étude. La moyenne d'âge de nos patients était de 55,33 ans, avec des extrêmes de 35 à 75 ans. Notre échantillon d'étude était exclusivement de sexe masculin. Chez 69,44% des patients la hernie est survenue par efforts physiques. Elle est survenue spontanément chez 22,22 %. Le reste des hernies étaient survenu dans un contexte de dysurie chez 2,78 % des patients et de constipation chronique chez 5,56%. Le siège prédominant de la hernie de l'aine dans notre série est inguinal droit chez 58,33 % alors qu'à gauche il n'est que de 33,33 %. Nous avons réalisé nos interventions chirurgicales sous anesthésie locorégionale type rachianesthésie chez tous nos patients. La moyenne de la durée des interven- tions était de 68,88 minutes. Selon la classification de Nyhus, 58,33 % de nos patients étaient classés Nyhus IIIa. La durée moyenne d'hospitalisation était de 56 heures. Les suites opératoires étaient simples chez 88,89 % des patients. Nous avons noté une mauvaise représentation psychologique de la prothèse chez 2,78%

Self-retaining support implant: an anchorless system for the treatment of pelvic organ prolapse-2-year follow-up.

INTRODUCTION AND HYPOTHESIS: The search for an improved vaginal mesh prompted the development of a new anchorless implant. The objective was to report on outcome after 2 years of a technique using a self-retaining support (SRS) implant. METHODS: Patients with anterior vaginal wall prolapse, with/without apical prolapse, were recruited. Participants underwent surgical repair using the SRS device. Demographic data, pre-surgical Pelvic Organ Prolapse Quantification (POP-Q) scoring, quality of life (QoL) questionnaires (Pelvic Floor Distress Inventory Short Form 20 [PFDI-20], Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 [PISQ-12]), and surgical data were collected. Patients were followed at 2 weeks, 2, 6, 12, and 24 months after surgery. Objective anatomical success was defined using the NIH criteria. RESULTS: Twenty women were recruited for the study with an average age of 62.1 years and an average parity of 4.0 deliveries. Average BMI was 28. Pre-operative mean POP-Q measurements were Aa =1.40 (-1 to 3) cm, Ba = 2.3 (-1 to 6) cm and C = 0.4 (-7 to 6) cm. Surgical time averaged 31.2 min. Estimated blood loss averaged 165 ml. No intra-operative complications were observed. One case (5%) of frame erosion was documented 8 months after surgery. At 2 years' follow-up, mean POP-Q measurements were: Aa = -2.95 (-3 to -2) cm, Ba = -2.85 (-3 to -2) cm, and C point -6.90 (-10 to -3) cm. Seventeen (85%) patients had stage 0 and 3 patients (15%) had stage 1. No mesh erosions or chronic pelvic pain were documented at follow-up. The total PFDI score at follow-up was decreased by 92.8 points (p < 0.0001). CONCLUSIONS: At 2 years' follow-up, the SRS implant was found to be safe, showing no intra-operative or immediate post-operative complications. All women presented with POP-Q measurements of the anterior and apical compartment at normal value (Ba ≤ -2 cm) and statistically significant subjective improvement.

A mixed methods survey of social anxiety, anxiety, depression and wig use in alopecia.

OBJECTIVES: This study aimed to examine levels of social anxiety, anxiety and depression reported by people with alopecia as a result of a dermatological condition and associations with wig use. The study also sought to report on experiences of wearing wigs in social situations and the relationship with social confidence. DESIGN: A cross-sectional survey was sent by email to the Alopecia UK charity mailing list and advertised on social media. PARTICIPANTS: Inclusion criteria were a diagnosis of alopecia, aged 13 or above and sufficient English to complete the survey. Exclusion criteria included experiencing hair loss as a result of chemotherapy treatment or psychological disorder. Participants (n=338) were predominantly female (97.3%), Caucasian (93.5%) and aged between 35 and 54 years (49.4%) with a diagnosis of alopecia areata (82.6%). MAIN OUTCOME MEASURES: The Social Phobia Inventory measured symptoms of social anxiety, and the Hospital Anxiety and Depression Scale was used to measure symptoms of anxiety and depression. Survey questions were designed to measure the use of wigs. Open-ended questions enabled participants to comment on their experiences of wearing wigs. RESULTS: Clinically significant levels of social anxiety (47.5%), anxiety (35.5%) and depression (29%) were reported. Participants who reported worries about not wearing a wig reported significantly higher levels of depression: t(103)=3.40, p≤0.001; anxiety: t(109)=4.80, p≤0.001; and social anxiety: t(294)=3.89, p≤0.001. Wearing wigs was reported as increasing social confidence; however, the concealment it afforded was also reported as both reducing fear of negative evaluation and maintaining anxiety. DISCUSSION: Overall, 46% of participants reported that wearing a wig had a positive impact on their everyday life with negative experiences related to fears of the wig being noticed. Psychological interventions alongside wig provision would be beneficial for people living with alopecia.

A Nonsurgical Approach to Adolescent Breast Asymmetry Using External Prostheses.

PURPOSE: Currently, there are few nonsurgical treatment options for pediatric patients with developmental breast asymmetry. Our group established a partnership with a prosthetic unit within a local oncology center to provide custom-fit breast prostheses for young women with breast asymmetry. The purpose of this study was to describe the effect of this experience on patients' self-esteem and body image. METHODS: Patients were administered an anonymous satisfaction survey at least 1 month after their first fitting at the prosthetic unit. The survey was designed to evaluate body image, self-esteem, as well as social and emotional well-being before and after treatment. Thematic analysis was used to assess their experiences. RESULTS: Seventeen patients, aged 12-19 years, visited the prosthetic unit and subsequently completed the retrospective survey. After using the breast prostheses, 14 (82.4%) patients reported an improvement in body image and 12 (70.6%) patients reported an improvement in self-esteem. Benefits pertaining to three emergent themes were revealed: "body wholeness/symmetry," "body image and psychological well-being," and "esthetic outcome." CONCLUSIONS: Results from the survey demonstrate the ease and efficacy of a form of nonsurgical treatment for adolescent breast asymmetry. Our partnership with an adult oncology center can serve as a national model to support the development of similar treatment programs. Existing resources that have been previously used only for adult breast cancer survivors can be effectively applied to the adolescent population to ameliorate the negative psychological effects of breast asymmetry.

Understanding the low uptake of bone-anchored hearing aids: a review.

BACKGROUND: Bone-anchored hearing aids improve hearing for patients for whom conventional behind-the-ear aids are problematic. However, uptake of bone-anchored hearing aids is low and it is important to understand why this is the case. METHOD: A narrative review was conducted. Studies examining why people accept or decline bone-anchored hearing aids and satisfaction levels of people with bone-anchored hearing aids were reviewed. RESULTS: Reasons for declining bone-anchored hearing aids included limited perceived benefits, concerns about surgery, aesthetic concerns and treatment cost. No studies providing in-depth analysis of the reasons for declining or accepting bone-anchored hearing aids were identified. Studies of patient satisfaction showed that most participants reported benefits with bone-anchored hearing aids. However, most studies used cross-sectional and/or retrospective designs and only included people with bone-anchored hearing aids. CONCLUSION: Important avenues for further research are in-depth qualitative research designed to fully understand the decision-making process for bone-anchored hearing aids and rigorous quantitative research comparing satisfaction of people who receive bone-anchored hearing aids with those who receive alternative (or no) treatments.

Neuroprosthetics and the science of patient input.

Safe and effective neuroprosthetic systems are of great interest to both DARPA and CDRH, due to their innovative nature and their potential to aid severely disabled populations. By expanding what is possible in human-device interaction, these devices introduce new potential benefits and risks. Therefore patient input, which is increasingly important in weighing benefits and risks, is particularly relevant for this class of devices. FDA has been a significant contributor to an ongoing stakeholder conversation about the inclusion of the patient voice, working collaboratively to create a new framework for a patient-centered approach to medical device development. This framework is evolving through open dialogue with researcher and patient communities, investment in the science of patient input, and policymaking that is responsive to patient-centered data throughout the total product life cycle. In this commentary, we will discuss recent developments in patient-centered benefit-risk assessment and their relevance to the development of neural prosthetic systems.

Neuroprosthetics in amputee and brain injury rehabilitation.

The goals of rehabilitation medicine programs are to promote health, restore functional impairments and improve quality of life. The field of neuroprosthetics has evolved over the last decade given an improved understanding of neuroscience and the incorporation of advanced biotechnology and neuroengineering in the rehabilitation setting to develop adaptable applications to help facilitate recovery for individuals with amputations and brain injury. These applications may include a simple cognitive prosthetics aid for impaired memory in brain-injured individuals to myoelectric prosthetics arms with artificial proprioceptive feedback for those with upper extremity amputations. The integration of neuroprosthetics into the existing framework of current rehabilitation approaches not only improves quality-of-care and outcomes but help broadens current rehabilitation treatment paradigms. Although, we are in the infancy of the understanding the true benefit of neuroprosthetics and its clinical applications in the rehabilitation setting there is tremendous amount of promise for future research and development of tools to help facilitate recovery and improve quality of life in individuals with disabilities.

Halo and spillover effect illustrations for selected beneficial medical devices and drugs.

BACKGROUND: Negative news media reports regarding potential health hazards of implanted medical devices and pharmaceuticals can lead to a 'negative halo effect,' a phenomenon whereby judgments about a product or product type can be unconsciously altered even though the scientific support is tenuous. To determine how a 'negative halo effect' may impact the rates of use and/or explantation of medical products, we analyzed the occurrence of such an effect on three implanted medical devices and one drug: 1) intrauterine contraceptive devices (IUDs); 2) silicone gel-filled breast implants (SGBI); 3) metal-on-metal hip implants (MoM); and 4) the drug Tysabri. METHODS: Data on IUD use from 1965 to 2008 were gathered from the Department of Health and Human Services Vital and Health Statistics and peer-reviewed publications. Data regarding SGBI implant and explantation rates from 1989 to 2012 were obtained from the Institute of Medicine and the American Society of Plastic Surgeons. MoM implant and explantation data were extracted from the England and Wales National Joint Registry and peer-reviewed publications. Tysabri patient data were reported by Elan Corporation or Biogen Idec Inc. Data trends for all products were compared with historical recall or withdrawal events and discussed in the context of public perceptions following such events. RESULTS: We found that common factors altered public risk perceptions and patterns of continued use. First, a negative halo effect may be driven by continuing patient anxiety despite positive clinical outcomes. Second, negative reports about one product can spill over to affect the use of dissimilar products in the same category. Third, a negative halo effect on an entire category of medical devices can be sustained regardless of the scientific findings pertaining to safety. Fourth, recovery of a product's safety reputation and prevalent use may take decades in the U.S., even while these products may exhibit widespread use and good safety records in other countries. CONCLUSIONS: We conclude that the 'negative halo effect' associated with a stigma, rather than an objective risk-benefit assessment of medical products can increase negative health outcomes for patients due to reduced or inappropriate product usage.

Understanding the Lived Experience of Five Individuals with Mobility Aids.

The aim of our research is to understand the lived experience of people with mobility aids: How do people use their mobility aids and what is their lived experience with them? What problems do mobility aid users have outside the clinic? Our goal is to further study the needs of mobility aid users, mainly wheelchair, walker and prosthesis users, and furthermore, develop a technology platform and an application that supports more independent life for mobility aid users. In our study we interviewed five individuals about their experiences of using mobility aids. The aim was to recognize the main stages of the lived experience with mobility aids in order to understand how technology could help mobility aid users outside the clinic. The stages found in the lived experience with mobility aids are 1) Expectations 2) Getting the mobility aid 3) Using and living with the aid and 4) Change/Abandonment of the aid. In each of these stages we found important issues concerning the lived experience with mobility aids such as the importance of training to use mobility aids, the meaning of peer support, finding information online, what makes a mobility aid good, what kind of issues other people's perceptions may cause and how the built environment poses challenges for people with mobility aids.

Bone-anchored hearing aids in conductive and mixed hearing losses: why do patients reject them?

This study aimed to report the bone-anchored hearing aid uptake rate and the reasons for their rejection by patients with conductive and mixed hearing losses. A retrospective review was performed of 113 consecutive patients with unilateral or bilateral conductive or mixed hearing loss referred to the Greater Manchester bone-anchored hearing aid (BAHA) programme between September 2008 and August 2011. 98 (86.7 %) patients were deemed audiologically suitable for BAHA implantation. Of these, 38 (38.8 %) had BAHA implanted; 60 (61.2 %) patients declined. Of those who declined, 27 (45 %) cited anxiety over surgery, 18 (30 %) cited cosmetic reasons, 16 (26.7 %) perceived limited benefit from the device and six (10 %) preferred conventional hearing aids. Our study highlights a 38.8 % BAHA uptake rate in audiologically suitable patients. The main reasons cited for rejection of BAHA were anxiety over surgery and cosmetic concerns. It is important that clinicians address these early during consultation with prospective BAHA recipients and avoid rushing to implant these patients with a bone-anchored hearing aid.

Differential negative reinforcement of other behavior to increase wearing of a medical bracelet.

We used a changing criterion design to evaluate the extent to which differential negative reinforcement of other behavior increased compliance with wearing a medical alert bracelet for a young boy with autism. Results showed the duration for which the participant wore the bracelet systematically increased across trials from 5 s to 7 hr over several weeks.

Bone-anchored hearing aids are effective and associated with a high degree of satisfaction.

INTRODUCTION: The objective of this study was to evaluate patients' satisfaction with bone-anchored hearing aids (BAHA). METHODS: This study was retrospective and based on a postal questionnaire. The study sample consisted of patients undergoing surgery at Odense University Hospital in the 1992-2013-period. The questionnaire was a combination of Satisfaction with Amplification in Daily Life questions from the Hearing Aid Research Lab at the University of Memphis and questions used in a previous Danish study. We also used data from each patient's medical records. All information was collected in a database. RESULTS: The response rate was 80% and the user percentage 88. The majority of the patients used their BAHA seven days a week and most of the day. 88% reported that it was in their best interest that they had received a BAHA. 80% of the respondents were able to communicate better using their BAHA in one-on-one conversations. CONCLUSION: BAHA is helpful in one-on-one conversations in quiet surroundings. Sound quality in group situations seems to be the main problem associated with BAHA. However, this study showed that BAHA is an effective hearing aid that is associated with a high degree of satisfaction. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.