FUNDING: Pfizer.
PATIENTS AND METHODS: Free buccal fat pad grafting was carried out in 15 patients in our institution. All were harvested using an intraoral approach. The buccal fat pad graft was used to correct periorbital contour depressions, nasal tip deformities, as a camouflage graft over exposed silicon nasal implants and as a filler in the depression deformity after mass excision.
RESULTS: All 15 patients demonstrated good contour deformity correction without a significant graft resorption up to 3 years of follow-up. There were no donor site complications. The amount used ranged from 1 to 5 cc in volume as a spacer or barrier for the moderate-sized volume defect or depression, even though more than 5 cc of fat graft could be harvested if required.
CONCLUSION: In conclusion, the buccal fat pad graft represents an easy, expedient and exceptional tool for the correction of contour deformities, volume replacement or for aesthetic augmentation.
LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
METHODS: a steering committee was assembled and 10 working Groups were created to provide preliminary evidence-based recommendations. A cross-cutting theme on patient's perspective was also created. In addition, a worldwide multidisciplinary group of experts and stakeholders, to review the proposed recommendations and to participate in a Delphi process to achieve consensus for the final recommendations, was brought together.
CONCLUSION: in this New Horizons article, the global challenges in falls prevention are depicted, the goals of the worldwide task force are summarised and the conceptual framework for development of a global falls prevention and management guideline is presented.
OBJECTIVES: to create a set of evidence- and expert consensus-based falls prevention and management recommendations applicable to older adults for use by healthcare and other professionals that consider: (i) a person-centred approach that includes the perspectives of older adults with lived experience, caregivers and other stakeholders; (ii) gaps in previous guidelines; (iii) recent developments in e-health and (iv) implementation across locations with limited access to resources such as low- and middle-income countries.
METHODS: a steering committee and a worldwide multidisciplinary group of experts and stakeholders, including older adults, were assembled. Geriatrics and gerontological societies were represented. Using a modified Delphi process, recommendations from 11 topic-specific working groups (WGs), 10 ad-hoc WGs and a WG dealing with the perspectives of older adults were reviewed and refined. The final recommendations were determined by voting.
RECOMMENDATIONS: all older adults should be advised on falls prevention and physical activity. Opportunistic case finding for falls risk is recommended for community-dwelling older adults. Those considered at high risk should be offered a comprehensive multifactorial falls risk assessment with a view to co-design and implement personalised multidomain interventions. Other recommendations cover details of assessment and intervention components and combinations, and recommendations for specific settings and populations.
CONCLUSIONS: the core set of recommendations provided will require flexible implementation strategies that consider both local context and resources.
AIM: To investigate the efficacy and tolerability of mixed soluble/insoluble fibre vs. psyllium in a randomized double-blind controlled trial.
METHODS: Constipated patients (Rome III) received mixed fibre or psyllium, 5 g b.d., for 4 weeks. Daily symptoms and stool habit were assessed using stool diary. Subjects with ≥1 complete spontaneous bowel movement/week above baseline for ≥2/4 weeks were considered responders. Secondary outcome measures included stool consistency, bowel satisfaction, straining, gas, bloating, taste, dissolvability and quality of life (QoL).
RESULTS: Seventy-two subjects (mixed fibre = 40; psyllium = 32) were enrolled and two from psyllium group withdrew. The mean complete spontaneous bowel movement/week increased with both mixed fibre (P < 0.0001) and psyllium (P = 0.0002) without group difference. There were 30 (75%) responders with mixed fibre and 24 (75%) with psyllium (P = 0.9). Stool consistency increased (P = 0.04), straining (P = 0.006) and bloating scores decreased (P = 0.02) without group differences. Significantly more patients reported improvement in flatulence (53% vs. 25%, P = 0.01) and felt that mixed fibre dissolved better (P = 0.02) compared to psyllium. QoL improved (P = 0.0125) with both treatments without group differences.
CONCLUSIONS: Mixed fibre and psyllium were equally efficacious in improving constipation and QoL. Mixed fibre was more effective in relieving flatulence, bloating and dissolved better. Mixed fibre is effective and well tolerated.
METHODS AND RESULTS: We compared 5697 chronic HF patients of Indian (26%), white (23%), Chinese (17%), Japanese/Koreans (12%), black (12%), and Malay (10%) ethnicities from the HF-ACTION and ASIAN-HF multinational studies using the Kansas City Cardiomyopathy Questionnaire (KCCQ; range 0-100; higher scores reflect better health status). KCCQ scores were lowest in Malay (58±22) and Chinese (60±23), intermediate in black (64±21) and Indian (65±23), and highest in white (67±20) and Japanese or Korean patients (67±22) after adjusting for age, sex, educational status, HF severity, and risk factors. Self-efficacy, which measures confidence in the ability to manage symptoms, was lower in all Asian ethnicities (especially Japanese/Koreans [60±26], Malay [66±23], and Chinese [64±28]) compared to black (80±21) and white (82±19) patients, even after multivariable adjustment (P
Method: Fifteen hearing mothers of children with severe-to-profound sensorineural hearing loss were interviewed. Interviews were transcribed verbatim, and a grounded theory approach was used to inductively analyze parental stress in mothers of D/HH children. Theory generation was achieved through triangulation of data sources and systematic organization of data into codes. The coding process identified salient themes that were constantly cross-checked and compared across data to further develop categories, properties, and tentative hypotheses.
Results: In general, two main themes emerged from the interviews: the contextual stressors and stress-reducing resources. The contextual stressors were labeled as distress over audiology-related needs, pressure to acquire new knowledge and skills, apprehension about the child's future, and demoralizing negative social attitudes. The stress-reducing resources that moderated parenting stress were identified to be the child's progress, mother's characteristics, professional support, and social support. The interaction between the identified stressors and adjustment process uncovered a central theme termed maternal coherence.
Conclusion: The substantive theory suggests that mothers of D/HH children can effectively manage parenting stress and increase well-being by capitalizing on relevant stress-reducing resources to achieve maternal coherence.
DESIGN: Recommendations from a working group of international experts in macular degeneration outcomes registry development and patient advocates, facilitated by the International Consortium for Health Outcomes Measurement (ICHOM).
METHODS: Modified Delphi technique, supported by structured teleconferences, followed by online surveys to drive consensus decisions. Potential outcomes were identified through literature review of outcomes collected in existing registries and reported in major clinical trials. Outcomes were refined by the working group and selected based on impact on patients, relationship to good clinical care, and feasibility of measurement in routine clinical practice.
RESULTS: Standardized measurement of the following outcomes is recommended: visual functioning and quality of life (distance visual acuity, mobility and independence, emotional well-being, reading and accessing information); number of treatments; complications of treatment; and disease control. Proposed data collection sources include administrative data, clinical data during routine clinical visits, and patient-reported sources annually. Recording the following clinical characteristics is recommended to enable risk adjustment: age; sex; ethnicity; smoking status; baseline visual acuity in both eyes; type of macular degeneration; presence of geographic atrophy, subretinal fibrosis, or pigment epithelial detachment; previous macular degeneration treatment; ocular comorbidities.
CONCLUSIONS: The recommended minimum outcomes and pragmatic reporting standards should enable standardized, meaningful assessments and comparisons of macular degeneration treatment outcomes. Adoption could accelerate global improvements in standardized data gathering and reporting of patient-centered outcomes. This can facilitate informed decisions by patients and health care providers, plus allow long-term monitoring of aggregate data, ultimately improving understanding of disease progression and treatment responses.
METHODS: This multinational cross-sectional survey was conducted in rehabilitation facilities in Malaysia, Indonesia, and Thailand. Community-dwelling adults with traumatic or nontraumatic spinal cord injury participating in the International Spinal Cord Injury Community Survey from 2017 to 2018 were enrolled. Data regarding bladder management/care, presence of bladder dysfunction, urinary tract infection, and quality of life score were extracted from the International Spinal Cord Injury Community Survey questionnaire. The impact of bladder care and urinary complications on quality of life was determined using univariable and multivariable regression analysis.
RESULTS: Questionnaires from 770 adults were recruited for analysis. After adjusting for all demographic and spinal cord injury-related data, secondary conditions, as well as activity and participation factors, urinary tract infection was an independent negative predictive factor of quality of life score ( P = 0.007, unstandardized coefficients = -4.563, multivariable linear regression analysis, enter method).
CONCLUSIONS: Among bladder care and urinary complication factors, urinary tract infection is the only factor negatively impacting quality of life. These results address the importance of proper bladder management and urinary tract infection prevention in persons with spinal cord injury to improve their quality of life.
METHODS: HELIOS-A was a phase 3, global, open-label study comparing the efficacy and safety of vutrisiran with an external placebo group (APOLLO study). Patients were randomized 3:1 to subcutaneous vutrisiran 25 mg every 3 months (Q3M) or intravenous patisiran 0.3 mg/kg every 3 weeks (Q3W) for 18 months.
RESULTS: HELIOS-A enrolled 164 patients (vutrisiran, n = 122; patisiran reference group, n = 42); external placebo, n = 77. Vutrisiran met the primary endpoint of change from baseline in modified Neuropathy Impairment Score +7 (mNIS+7) at 9 months (p = 3.54 × 10-12), and all secondary efficacy endpoints; significant improvements versus external placebo were observed in Norfolk Quality of Life-Diabetic Neuropathy, 10-meter walk test (both at 9 and 18 months), mNIS+7, modified body-mass index, and Rasch-built Overall Disability Scale (all at 18 months). TTR reduction with vutrisiran Q3M was non-inferior to within-study patisiran Q3W. Most adverse events were mild or moderate in severity, and consistent with ATTRv amyloidosis natural history. There were no drug-related discontinuations or deaths.
CONCLUSIONS: Vutrisiran significantly improved multiple disease-relevant outcomes for ATTRv amyloidosis versus external placebo, with an acceptable safety profile.
CLINICALTRIALS.GOV: NCT03759379.