uConsent: Addressing the gap in measuring understanding of informed consent in clinical research.

The purpose of this study was to establish the technical merit, feasibility, and generalizability of a new measure of understanding of informed consent for use with clinical research participants. A total of 109 teens/young adults at a large, pediatric medical center completed the consenting process of a hypothetical biobanking study. Data were analyzed using a combination of classical and modern theory analytic methods to produce a final set of 19 items referred to as the uConsent scale. A requirement of the scale was that each item mapped directly onto one or more of the Basic Elements of Informed Consent from the 2018 Final Rule. Descriptive statistics were computed for each item as well as the scale as a whole. Partial credit (Rasch) logistic modeling was then used to generate difficulty/endorsability estimates for each item. The final, 19-item uConsent scale was derived using inferential methods to yield a set of items that ranged across difficulty levels (-3.02 to 3.10 logits) with a range of point-measure correlations (0.12 to 0.50), within-range item- and model-fit statistics, varying item types mapped to both Bloom's Taxonomy of Learning and required regulatory components of the 2018 Final Rule. Median coverage rate for the uConsent scale was 95% for the 25 randomly selected studies from ClinicalTrials.gov. The uConsent scale may be used as an effective measure of informed consent when measuring and documenting participant understanding in clinical research studies today.

Impact of brachial plexus birth injury on health-related quality of life in adulthood: a mixed methods survey study.

PURPOSE: To describe the scope and nature of health concerns, functional impairments, and quality of life issues among adults with brachial plexus birth injury (BPBI). METHODS: A mixed methods study was conducted by surveying two social media networks of adults with BPBI using a combination of closed-ended and open-ended questions regarding the role of BPBI on ones' health, function, and quality of life. Closed-ended responses were compared across ages and genders. Open-ended responses were qualitatively analyzed to expand upon the close-ended responses. RESULTS: Surveys were completed by 183 respondents (83% female, age range 20-87 years). BPBI was reported to impact hand and arm use in 80% of participants (including affected and unaffected limbs and bimanual tasks), overall health in 60% (predominantly pain), activity participation in 79% (predominantly activities of daily living and leisure), life roles in 76% (predominantly occupation and parenting), and overall quality of life in 73% (predominantly self-esteem, relationships, and appearance). Significantly more females than males reported other medical conditions and an impact on hand and arm use and life roles. No other responses varied by age or gender. CONCLUSIONS: BPBI affects many facets of health related quality of life in adulthood with variability among affected individuals.

Brachial plexus birth injury's scope of impact in adulthood is broad, covering every aspect of HRQoL.The focus of rehabilitation for brachial plexus birth injury (BPBI) through the lifespan should extend beyond improving physical musculoskeletal function and include comprehensive support for physical, emotional, social, and life role concerns.Brachial plexus birth injury's nature of impact in adulthood varies among individuals within each aspect of health-related quality of life.The variability of BPBI's impact in adulthood underscores the need for individualized, patient-centered assessment and rehabilitative care.

Use of supported standing in males with Duchenne muscular dystrophy: Individual and family perspectives.

PURPOSE: This study aimed to explore stander use in individuals with Duchenne Muscular Dystrophy (DMD). METHODS: This mixed method research study employed a survey with categorical and open-ended questions related to stander use. Categorical responses were analyzed quantitatively. Qualitative analysis of open-ended responses was linked to the International Classification of Function. Qualitative and quantitative results were merged to derive meta-inferences. RESULTS: Of 147 respondents, 28.6% (n = 42) reported stander use. Equipment used included sit-to-stand stander (n = 27), power standing feature in a wheelchair (n = 13), and unspecified equipment (n = 2). Economic services were the most common barrier to stander obtainment. Age of loss of ambulation (LOA) and age of start of stander use were positively correlated (r = 0.61, p < 0.0001, n = 36), with 59.5% initiating stander use after LOA. Twenty-nine respondents reported standing less than the recommended dose of 60-90 minutes at least five days a week, with frequency directionally less than five days per week (p = 0.06) and time significantly less than 60-90 minutes (p = 0.002). Respondents' total dose was significantly lower than the recommended 300 minutes (p = 0.02). Lack of time and presence of contractures contributed to decreased duration of use. CONCLUSION: This study provides a greater understanding of stander use among individuals with DMD and can assist with decision making about stander use prior to complications of disease progression to promote optimal health despite reported barriers.

ICF linking of patient-reported therapy goals for children with acquired upper extremity impairment.

BACKGROUND: Patient reported outcome measures are used to evaluate hand therapy outcomes. Yet, limited evidence is available regarding the outcomes children desire from hand therapy. PURPOSE: To determine the desired treatment outcomes of children with acquired upper extremity impairments. STUDY DESIGN: Descriptive case series METHODS: Two raters independently applied International Classification of Function, Disability and Health (ICF) linking rules to the Canadian Occupational Performance goals of 151 children, age 6-18, receiving occupational therapy for acquired upper extremity impairments. Prevalence of the linked ICF codes was examined using frequency distributions. Kappa and the proportion of positive agreement assessed inter-rater agreement of the linked codes. RESULTS: Following consensus, two independent raters linked 894 meaningful concepts to the study population's 501 goals derived from the Canadian Occupational Performance. Ninety-two unique ICF codes were linked to these 894 meaningful concepts. Twenty-three ICF codes account for 77.2% of the most frequently linked codes. For these top 23 codes, the greatest proportion (51.4%) of ICF codes are in the d4 mobility chapter representing specific constructs of hand and arm use. The second largest proportion (14.2%) of linked codes are in the d9 Community, society and civic life chapter aligning with participation in sports, music, performing arts and play. Within the d5 self-care chapter, the study population's top priorities included hair care, fitness and drinking. The primary concerns within the b body functions domain are reduced pain, improved joint mobility and strength. CONCLUSION: The study population's top priorities align with specific dimensions of hand and arm use and participation in sports and fitness, performing arts, and play. Further research may elucidate alignment of these patient-desired outcomes and the item banks of commonly used patient reported outcome measurement scales in this population.

Pediatric hand therapists' experiences with outcomes measurement: An interpretive descriptive study.

BACKGROUND: Demonstrating that pediatric hand therapy patients are achieving improved functional and health status outcomes is critical as reimbursement for therapy services shifts to value-based reimbursement. Yet, practice patterns of outcomes assessment in pediatric hand therapy are unknown. PURPOSE: Explore how pediatric hand therapists describe their experience measuring treatment outcomes and using patient reported outcome measures (PROMs). Secondarily, to elucidate what therapists perceive children and adolescents receiving hand therapy desire as treatment outcomes. STUDY DESIGN: Interpretive descriptive qualitative study METHODS: Pediatric hand therapists were recruited through an email invitation sent to members of the Pediatric Hand Study Group to participate in one-on-one interviews over a teleconference link. Interviews were transcribed verbatim and coded to derive themes. Data collection and analysis were iterative. RESULTS: Ten therapists with a median 13 years (range, 2-25 years) of experience practicing in pediatric hand therapy completed interviews. Overall, participants reported using 52 unique outcomes measures, including 20 PROMs. The following themes were elucidated: (1) Complexity and variability in pediatric hand therapy practice and outcomes assessment; (2) Barriers to PROM use; (3) Value of PROM utilization; (4) Desired characteristics of an optimal PROM for pediatric hand therapy. CONCLUSION: Practice with outcomes assessment is variable. PROM utilization in pediatric hand therapy practice may be improved with the development of a PROM that is aligned with the pediatric population's outcomes priorities.

Evaluation of a Grip-Strengthening Algorithm for the Initial Treatment of Chronic, Nonspecific Wrist Pain in Adolescents.

Purpose: Chronic, nonspecific wrist pain in adolescents can be challenging to assess and treat. We hypothesized that an algorithmic approach beginning with grip strengthening can alleviate pain, improve function, and identify patients in need of further intervention. Methods: We retrospectively reviewed the results of a grip-strengthening protocol for adolescents with chronic, nonspecific wrist pain. Before and after treatment, grip strength was measured using handheld dynamometry, and patient-reported pain and function were measured using the adolescent self-reported Pediatric Outcomes Data Collection Instrument's (PODCI's) Pain/Comfort and Upper Extremity Function domains (PODCI/pain and PODCI/UE, respectively). Results: Thirty-two patients (28 female, 4 male) were included, with a mean age of 14 years (range, 10-18 years) and the dominant hand affected in 19, nondominant hand in 9, and bilateral impacts in 4. The mean symptom duration prior to presentation was 9 months (range, 1-63 months); 17 patients had undergone prior immobilization and 5 prior occupational/physical therapy. Grip-strengthening treatment, lasting a mean of 40 days (range, 21-82 days) with a median of 4 therapy visits (range, 2-6), was associated with significantly improved grip strength (mean, 32-48 lbs), PODCI/pain scores (mean, 49.0-78.2 points), and PODCI/UE scores (mean, 78.2-91.2 points). Improvements in grip strength correlated with improvements in PODCI/pain and PODCI/UE scores (r = 0.64 and 0.70, respectively). Eight patients (25%) had either no or incomplete pain relief: 5 underwent successful further intervention (2 ganglion cyst excisions, 1 triangular fibrocartilage complex repair, 1 arthroscopic debridement, 1 steroid injection), 2 received ongoing pain management for generalized pain syndromes, and 1 was lost to further follow-up. No pretreatment variables were identified that predicted failure. Conclusions: Grip strengthening relieves pain and improves function in the majority of adolescents with chronic, nonspecific wrist pain. Systematic use of this protocol helps to identify patients who require further intervention. Type of study/level of evidence: Therapeutic IV.

A psychometric comparison of patient-reported outcome measures used in pediatric hand therapy.

STUDY DESIGN: Retrospective case series. INTRODUCTION: Patient-reported outcome measures are important for research and also for informing clinical practice. The Pediatric Outcomes Data Collection Instrument (PODCI) and the Canadian Occupational Performance Measure (COPM) are commonly used in pediatric hand therapy. Both are validated in research, but no data exist regarding their relative merits for clinical practice. PURPOSE OF THE STUDY: This study compares the psychometric properties of the PODCI and COPM in children receiving hand therapy to examine their relative utility in clinical practice. METHODS: We assessed the psychometric properties of the PODCI and COPM in 75 children receiving hand therapy. Treatment outcomes were assessed simultaneously with the PODCI (Upper Extremity Function and Pain and Comfort scales), COPM (Performance and Satisfaction scales) at baseline and posttreatment time points. Interim scores were included for a subset of patients. Each scale was assessed for responsiveness, ceiling effect, and concurrent and discriminate validity. RESULTS: All scales, except PODCI/Pain from interim to completion, were able to detect changes over the course of therapy. However, both COPM scales demonstrated greater responsiveness and less severe ceiling effects than both PODCI scales at all time points. All scales had weak concurrent validity and limited discriminate validity. CONCLUSIONS: The COPM is more responsive to changes during treatment and less hindered by a ceiling effect than the PODCI. Weak concurrent validity between the PODCI and COPM suggests that they measure different things in this population.