Upper Extremity Surgery in Cervical Spinal Cord Injury: A Prospective Comparative Mixed Methods Study.

BACKGROUND: Cervical spinal cord injury (SCI) is a devastating injury. Restoring upper extremity function is a top priority, which can be accomplished by tendon transfer (TT) and nerve transfer (NT) surgeries. The purpose of this prospective comparative study was to assess long-term changes in UE function between surgical (TT or NT) and non-surgical groups through a comprehensive mixed methods approach. METHODS: This multicenter, cohort study compared data among three groups: those undergoing 1) no surgery 2) TT surgery, or 3) NT surgery. Quantitative data, the Spinal Cord Independence Measure (SCIM) and Short Form Health Survey (SF-36), was collected at baseline and long-term follow-up (6-24 months). Qualitative semi-structured interview data was also obtained from these participants and their identified caregivers at baseline, early follow-up (1 month), and long-term follow-up (6-24 months). RESULTS: Thirty-one participants had quantitative data across all timepoints: no surgery (n=14), TT (n=7), and NT (n=10). SCIM scores improved in TT and NT groups compared to the no surgery group (p<0.05). SF-36 scores did not differ among groups. Qualitative data analysis (n=168 interviews) corroborated SCIM findings: surgical participants and their caregivers reported improvement in transfers and ability to perform activities of daily living, including grooming and self-catheterization. Improved use of electronics and ability to operate a motor vehicle were also reported. Post-operative therapy was identified as a critical component of achieving gains. CONCLUSION: Both TT and NT surgery leads to quantitative and qualitative functional gains as compared to the no surgery group. This comparative information should be used to help surgeons discuss treatment options.

Comparing surgeries to restore upper extremity function in tetraplegia: Impact on function during the perioperative period.

CONTEXT/OBJECTIVE: To assess short-term changes in health outcomes in people with cervical-level spinal cord injury (SCI) who underwent upper extremity (UE) reconstruction via either novel nerve transfer (NT) or traditional tendon transfer (TT) surgery with individuals who did not undergo UE surgical reconstruction. DESIGN: Prospective, comparative cohort pilot study. PARTICIPANTS: 34 participants with cervical SCI met the following inclusion criteria: age 18 or older, greater than 6 months post-injury, and mid-cervical level SCI American Spinal Injury Association Impairment Scale (AIS) A, B or C. SETTING: Two tertiary academic hospitals and their affiliated veterans' hospitals. METHODS: Health outcomes were assessed using two previously validated measures, the Spinal Cord Independence Measure (SCIM) and Short-Form Health Survey (SF-36). Demographic, surgical, and survey data were collected at the initial evaluation and one month postoperatively/post-baseline. RESULTS: 34 participants with cervical SCI were recruited across three cohorts: no surgery (n = 16), NT (n = 10), and TT (n = 8). The TT group had a decline in SCIM and SF-36 scores whereas the NT and no surgery groups experienced little change in independence or health status in the immediate perioperative period. CONCLUSIONS: Surgeons and rehabilitation providers must recognize differences in the perioperative needs of people with cervical SCI who chose to have restorative UE surgery. Future work should focus on further investigation of health outcomes, change in function, and improving preoperative counseling and cross-disciplinary management.

Caregiving for People With Spinal Cord Injury Undergoing Upper Extremity Reconstructive Surgery: A Prospective Exploration of Lived Experiences, Perioperative Care, and Change Across Time.

Background: Nerve transfer (NT) and tendon transfer (TT) surgeries can enhance upper extremity (UE) function and independence in individuals with cervical spinal cord injury (SCI). Caregivers are needed to make this surgery possible, yet caregivers experience their own set of challenges. Objectives: This comparative study explored the perioperative and nonoperative experiences of caregivers of individuals with cervical SCI, focusing on daily life activities, burden, and mental health. Methods: Caregivers of individuals with cervical SCI were recruited and grouped by treatment plan for the person with SCI: (1) no surgery (NS), (2) TT surgery, and (3) NT surgery. Semistructured interviews were conducted at baseline/preoperative, early follow-up/postoperative, and late follow-up/postoperative. Caregivers were asked about their daily life, mental health, and challenges related to caregiving. Interviews were audio recorded, transcribed verbatim, and analyzed using thematic analysis. Quantitative, single-item standardized burden score (0-100) data were collected at each timepoint. Results: Participants included 23 caregivers (18 family members, 4 friends, 1 hired professional). The surgeries often brought hope and motivation for caregivers. Caregivers reported increased burden immediately following surgery (less for the NT compared to TT subgroup) yet no long-term changes in the amount and type of care they provided. NS caregivers discussed social isolation, relationship dysfunction, and everyday challenges. Conclusion: Health care providers should consider the changing needs of SCI caregivers during perioperative rehabilitation. As part of the shared surgical decision-making approach, providers should educate caregivers about the postoperative process and the extent and potential variability of short- and long-term care needs.

Quantifying Tenodesis Hand Function in Cervical Spinal Cord Injury: Implications for Function.

PURPOSE: Cervical spinal cord injury (SCI) has a profound effect on upper-extremity function. Individuals with stiffness and/or spasticity may have more, or less, useful tenodesis function. This study examined the variability present before any reconstructive surgery. METHODS: Tenodesis pinch and grasp were measured with the wrist in maximal active extension. Tenodesis pinch was the contact point of the thumb with the index finger proximal phalanx (T-IF:P1), middle phalanx (T-IF:P2), distal phalanx (T-IF:P3), or absent (T-IF:absent). Tenodesis grasp was the distance from the long finger to the distal palmar crease (LF-DPC). Activities of daily living function was assessed using the Spinal Cord Independence Measure (SCIM). RESULTS: The study included 27 individuals (4 females, 23 males; mean age 36 years, mean time since SCI 6.8 years). The mean International Classification for Surgery of the Hand in Tetraplegia (ICSHT) group classification was 3. In the dominant hand, individuals with a T-IF tenodesis pinch to P1 or P2 had significantly higher total SCIM scores (43.7 and 34.2, respectively) compared to those with absent T-IF tenodesis pinch (SCIM 17.8). Shorter LF-DPC distance with tenodesis grasp (improved finger closing) also correlated with improved SCIM mobility and total scores. No association was found between the ICSHT group and SCIM score or tenodesis measures. CONCLUSIONS: Quantifying tenodesis with pinch (T-IF) and grasp (LF-DPC) is a simple method to characterize hand movement in individuals with cervical SCI. Better tenodesis pinch and grasp were associated with improved activities of daily living performance. CLINICAL RELEVANCE: Differences in grasp function have implications for mobility, and differences in pinch function have implications for all functions, particularly self-care. These physical measurements could be used to assess movement changes after nonsurgical and surgical treatment in tetraplegia.

Surgery to restore upper extremity function in tetraplegia-Preferences for early and frequent access to information.

INTRODUCTION: People with cervical spinal cord injury (SCI) identify improving upper extremity (UE) function as a top priority. In addition to comprehensive rehabilitation, UE surgeries, including nerve and tendon transfers, enhance function. However, barriers exist to disseminating information about surgical options to enhance UE function. OBJECTIVE: To assess the experiences and preferences of people with cervical SCI and their caregivers in accessing information about surgery to enhance UE function. DESIGN: Prospective cohort study. Participants were followed up for 24 months and completed up to three interviews. SETTING: Tertiary care at academic and affiliated Veterans Administration Health Care Centers. PARTICIPANTS: Adults with cervical SCI (n = 35) ages 18 to 80 years with mid-cervical SCI American Spinal Injury Association Impairment Scale A, B, or C (at least 6 months post-injury) and their caregivers (n = 23) were eligible to participate. Participants were enrolled in three groups: nerve transfer, tendon transfer, or no UE reconstructive surgery. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Semi-structured interviews about surgical knowledge and experiences. RESULTS: Data were analyzed and three themes were identified. First, providing information about UE surgical options early post-injury was recommended. The acute or inpatient rehabilitation phases of recovery were the preferred times to receive surgical information. Second, challenges with information dissemination were identified. Participants learned about UE surgery through independent research, medical provider interactions, or peers. Third, peers were identified as valuable resources for SCI needs and surgical information. CONCLUSIONS: Following cervical SCI, information about UE reconstructive surgeries should be a standard component of education during rehabilitation. An increased understanding of the reconstructive options available to improve UE function is necessary to educate stakeholders. Future research is needed to support the development of strategies to effectively present surgical information to individuals with SCI and health care providers.

Beyond the Cubital Tunnel: Use of Adjunctive Procedures in the Management of Cubital Tunnel Syndrome.

BACKGROUND: Our management of cubital tunnel syndrome has expanded to involve multiple adjunctive procedures, including supercharged end-to-side anterior interosseous to ulnar nerve transfer, cross-palm nerve grafts from the median to ulnar nerve, and profundus tenodesis. We also perform intraoperative brief electrical stimulation in patients with severe disease. The aims of this study were to evaluate the impact of adjunctive procedures and electrical stimulation on patient outcomes. METHODS: We performed a retrospective review of 136 patients with cubital tunnel syndrome who underwent operative management from 2013 to 2018. A total of 38 patients underwent adjunctive procedure(s), and 33 received electrical stimulation. A historical cohort of patients who underwent cubital tunnel surgery from 2009 to 2011 (n = 87) was used to evaluate the impact of adjunctive procedures. Study outcomes were postoperative improvements in Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire scores, pinch strength, and patient-reported pain and quality of life. RESULTS: In propensity score-matched samples, patients who underwent adjunctive procedures had an 11.3-point greater improvement in DASH scores than their matched controls (P = .0342). In addition, patients who received electrical stimulation had significantly improved DASH scores relative to baseline (11.7-point improvement, P < .0001), whereas their control group did not. However, when compared between treatment arms, there were no significant differences for any study outcome. CONCLUSIONS: Patients who underwent adjunctive procedures experienced greater improvement in postoperative DASH scores than their matched pairs. Additional studies are needed to evaluate the effects of brief electrical stimulation in compression neuropathy.

Recruiting hand therapists improves disposal of unused opioid medication.

BACKGROUND: Opioids often remain unused after upper extremity surgery, and leftover prescriptions are frequently diverted. When administered in a hand surgery clinic, an educational brochure outlining a simple method of opioid disposal has been shown to improve disposal rates after surgery. PURPOSE: To understand whether administration of an opioid disposal educational brochure in a hand therapy clinic would increase opioid disposal rates, compared to a hand surgery clinic. STUDY DESIGN: Prospective cohort study. METHODS: Patients who presented to a hand therapy clinic postoperatively were recruited to participate in this prospective cohort study. An educational brochure outlining a simple method of opioid disposal was made available at the hand therapy and surgery clinics. A questionnaire was later issued to obtain: location of brochure receipt, demographic information, pre- and post-operative opioid use history, and opioid disposal patterns. Chi-square tests and multivariable binary logistic regression assessed associations between medication disposal and explanatory variables. RESULTS: Patients who received the brochure were significantly more likely to dispose of excess opioid medication, compared to those who did not receive the brochure (57.1% vs 10.8%, p < .001). Patients who received the brochure at the hand therapy clinic were significantly more likely to dispose of excess opioids (86.4%) compared to those who received the brochure at the surgery clinic (25.0%). Older age was predictive of increased disposal (p =.028*). There were no significant associations between gender, length of follow-up, or surgery type with the incidence of opioid disposal. CONCLUSION: Recruiting both hand therapists and surgeons in the distribution of a simple, educational brochure on opioid disposal can increase disposal rates. Patients who received the brochure from the hand therapist were more likely to dispose of excess opioids. The longstanding patient-therapist relationship creates an opportunity for educational initiatives and discussion of stigmatized topics, such as opioid use.

Quantifying Donor Deficits Following Nerve Transfer Surgery in Tetraplegia.

PURPOSE: Nerve transfer (NT) surgery can improve function in people with cervical spinal cord injury (SCI). However, the impact of donor nerve deficits remains unclear. The purpose of this study was to quantify donor deficits experienced by individuals with cervical SCI following NT. METHODS: This prospective single-arm, comparative study included people with SCI undergoing upper extremity NTs. Myometry was used to assess muscle strength at baseline and follow-up. The Spinal Cord Independence Measure was used to measure the ability to perform activities of daily living. RESULTS: Ten individuals underwent 20 NTs to restore elbow extension (donor, posterior deltoid; n = 2), hand opening (donor, supinator; n = 7), and hand closing (donor, brachialis; n = 11). Shoulder abduction strength decreased (-5.6% at early and -4.5% late follow-up) in the elbow extension NT. Wrist extension strength decreased at early (-46.9% ± 30.3) and increased by late (76.4% ± 154.0) follow-up in the hand opening NT. No statistically significant change in elbow flexion strength was noted in the hand closing NT. Spinal Cord Independence Measure scores did not change significantly between baseline and early postoperative follow-up; they improved at late follow-up. CONCLUSIONS: Use of expendable donor nerves with redundant function to perform NT surgery has relatively little impact on strength or capacity to perform activities of daily living, even in the unique and highly vulnerable SCI population. Early, temporary loss in wrist extension strength can be seen after the supinator to posterior interosseous nerve transfer. This study offers quantitative data about possible diminution of donor function after NT, enabling hand surgeons to better counsel individuals contemplating upper extremity reconstruction. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic I.

Living With Cervical Spinal Cord Injury During the COVID-19 Pandemic: A Qualitative Study.

Objective: To understand how COVID-19 has affected the daily lives of people living with cervical spinal cord injury (SCI). Design: Cross sectional qualitative study. Setting: Academic medical center in the Midwestern United States. Participants: Ten community-dwelling individuals (8 men, 2 women), average 11.6 years post-mid-cervical level SCI (N=10). Interventions: Not applicable. Main Outcome Measures: Semistructured interviews were completed by phone. The research team used thematic analysis and inductive strategies to analyze the data in this exploratory investigation. Results: People with cervical SCI living in the United States during the spring of 2020 experienced changes to their daily lives. Participants described how interactions with caregivers for activities of daily living were complicated by fear about contracting and/or transmitting COVID-19. The pandemic limited this population's access to medical care and adversely affected their mental and physical health. Telemedicine was seen as a helpful alternative to in-person visits. Some participants felt that their previous life-altering experience (SCI) better prepared them to cope with the pandemic and "roll with things." Conclusions: Learning about how people with SCI cope, persevere, and survive to overcome adversity during the pandemic should inform future research to support those with SCI. Improving telemedicine and rewarding and recognizing caregivers for their role in maintaining health are important first steps. We must continue to be creative about improving our health care systems and access for people with disabilities, particularly during this and future public health crises.

Evaluation for Late Nerve Transfer Surgery in Spinal Cord Injury: Predicting the Degree of Lower Motor Neuron Injury.

PURPOSE: Nerve transfer surgery is used to restore upper extremity function following cervical spinal cord injury (SCI) with substantial variation in outcomes. The injury pattern in SCI is complex and can include isolated upper motor neuron (UMN) and combined UMN/lower motor neuron (LMN) dysfunction. The purpose of the study was to determine the most effective diagnostic technique for determining suitable candidates for nerve transfer surgery in SCI. METHODS: Medical records were reviewed of patients who had nerve transfers to restore upper extremity function in SCI. Data collected included (1) preoperative clinical examination and electrodiagnostic testing; (2) intraoperative neuromuscular stimulation (NMS); and (3) nerve histopathology. Preoperative, intraoperative, and postoperative data were compared to identify predictors of isolated UMN versus combined UMN/LMN injury patterns. RESULTS: The study sample included 22 patients with 50 nerve transfer surgeries and included patients ranging from less than 1 year to over a decade post-SCI. Normal recipient nerve conduction studies (NCS) before surgery corresponded to the intraoperative presence of recipient NMS and postoperative histopathology that showed normal nerve architecture. Conversely, abnormal recipient NCS before surgery corresponded with the absence of recipient NMS during surgery and patterns of denervation on postoperative histopathology. Normal donor preoperative manual muscle testing corresponded with the presence of donor NMS during surgery and normal nerve architecture on postoperative histopathology. An EMG of corresponding musculature did not correspond with intraoperative donor or recipient NMS or histopathological findings. CONCLUSIONS: NCS better predict patterns of injury in SCI than EMG. This is important information for clinicians evaluating people for late nerve transfer surgery even years post-SCI. TYPE OF STUDY/LEVEL OF EVIDENCE: Diagnostic II.

Perspectives of Decisional Surrogates and Patients Regarding Critical Illness Genetic Research.

BACKGROUND: Critical illness research is challenging due to disease severity and because patients are frequently incapacitated. Surrogates called upon to provide consent might not accurately represent patient preferences. Though commonplace, genetic data collection adds complexity in this context. We undertook this investigation to understand whether surrogate decision makers would be receptive to permitting participation in a critical illness genetics study and whether their decision making was consistent with that of the patient represented. METHODS: We invited individuals identified as surrogates for critically ill adults, if required, as well as patients once recovered to participate in a survey designed to understand attitudes about genetic research. Associations between dependent (receptivity to participation, concordance of responses) and independent variables were tested using bivariate and multivariate logistic regression analyses. RESULTS: Most of the entire surrogate sample (n=439) reported familiarity with research, including genetic research; tended to view research as useful; and were receptive to allowing their family member participate (with 39.6% and 38.1% stating that this would be "very" and "somewhat likely," respectively) even absent direct benefit. Willingness to participate was similar comparing genetic and non-genetic studies (χ2 [1,n=439]=0.00127, p=0.972), though respondents expressed worry regarding lack of confidentiality of genetic data. Responses were concordant in 70.8% of the 192 surrogate-patient pairs analyzed. In multivariate analysis, African American race was associated with less receptivity to genetic data collection (p<0.05). No factors associated with concordance of surrogate-patient response were identified. CONCLUSIONS: Surrogates' receptivity to critical illness research was not influenced by whether the study entailed collection of genetic data. While more than two-thirds of surrogate-patient responses for participation in genetics research were concordant, concerns expressed regarding genetic data often related to breach of confidentiality. Emphasizing safeguards in place to minimize such breeches might prove an effective strategy for enhancing recruitment.

Does difficulty functioning in the surrogate role equate to vulnerability in critical illness research? Use of path analysis to examine the relationship between difficulty providing substituted judgment and receptivity to critical illness research participation.

PURPOSE: Individuals who struggle to provide substitute judgment for the critically ill often find it challenging to engage in decision making for therapeutic interventions. Although essential to the conduct of research, how these individuals respond to requests for clinical trial participation is poorly understood. METHODS: Survey data collected to examine surrogate attitudes toward research provided the conceptual framework to explore influences on decision making. Path analysis was used to derive the final model (nonlatent, fully recursive, 1 indicator/variable). RESULTS: Surrogates with list-wise complete records (406) were analyzed. The following variables were not retained in the final model: education, income, religiosity, decision-making experience, discussion of patient's wishes, number of individuals assisting with decision making, trust in care providers, difficulty making decisions, and responsibility for decision making. Being white and having experience making treatment decisions for the patient during the current intensive care unit encounter affected the likelihood the surrogate would permit participation in research positively (parameter estimates, 0.281 and 0.06, respectively). No variable reflecting difficulty functioning in the surrogate role was associated with permitting research participation. CONCLUSIONS: We were unable to demonstrate a relationship between perceived difficulty in decision making in the surrogate role and receptivity to clinical trial participation.

Surrogate receptivity to participation in critical illness genetic research: aligning research oversight and stakeholder concerns.

BACKGROUND: Collection of genetic biospecimens as part of critical illness investigations is increasingly commonplace. Oversight bodies vary in restrictions imposed on genetic research, introducing inconsistencies in study design, potential for sampling bias, and the possibility of being overly prohibitive of this type of research altogether. We undertook this study to better understand whether restrictions on genetic data collection beyond those governing research on cognitively intact subjects reflect the concerns of surrogates for critically ill patients. METHODS: We analyzed survey data collected from 1,176 patients in nonurgent settings and 437 surrogates representing critically ill adults. Attitudes pertaining to genetic data (familiarity, perceptions, interest in participation, concerns) and demographic information were examined using univariate and multivariate techniques. RESULTS: We explored differences among respondents who were receptive (1,333) and nonreceptive (280) to genetic sample collection. Whereas factors positively associated with receptivity to research participation were "complete trust" in health-care providers (OR, 2.091; 95% CI, 1.544-2.833), upper income strata (OR, 2.319; 95% CI, 1.308-4.114), viewing genetic research "very positively" (OR, 3.524; 95% CI, 2.122-5.852), and expressing "no worry at all" regarding disclosure of results (OR, 2.505; 95% CI, 1.436-4.369), black race was negatively associated with research participation (OR, 0.410; 95% CI, 0.288-0.585). We could detect no difference in receptivity to genetic sample collection comparing ambulatory patients and surrogates (OR, 0.738; 95% CI, 0.511-1.066). CONCLUSIONS: Expressing trust in health-care providers and viewing genetic research favorably were associated with increased willingness for study enrollment, while concern regarding breach of confidentiality and black race had the opposite effect. Study setting had no bearing on willingness to participate.

Factors affecting stress experienced by surrogate decision makers for critically ill patients: implications for nursing practice.

OBJECTIVES: This study explores surrogate decision-makers' (SDMs) challenges making decisions related to the care of patients in critical care, to (1) characterise the SDM stress, (2) identify personal, social, care-related factors influencing stress and (3) consider implications of findings to improving critical care practice. METHODOLOGY: Semi-structured interviews were conducted with SDMs of critically ill patients receiving care in two tertiary care institutions. Transcripts were analysed using a grounded theory approach. Domains explored were: stress characteristics, stress mitigators, coping strategies, social networks, SDM decision-making role, decision-making concordance, knowledge of patient's preferences, experience with provider team, SDM-provider communication, patient outcome certainty. MAIN OUTCOMES: We interviewed 34 SDMs. Most were female and described long-term relationships with patients. SDMs described the strain of uncertain outcomes and decision-making without clear, consistent information from providers. Decision-making anxiety was buffered by SDMs' active engagement of social networks, faith and access to clear communication from providers. CONCLUSION: Stress is a very real factor influencing SDMs confidence and comfort making decisions. These findings suggest that stress can be minimised by improving communication between SDMs and medical providers. Nurses' central role in the ICU makes them uniquely poised to spearhead interventions to improve provider-SDM communication and reduce SDM decision-making anxiety.

Sagittal range of motion after extensive cervical fusion.

BACKGROUND CONTEXT: Complicated cervical spine revision and deformity correction surgeries are becoming increasingly common. These challenging operations often necessitate fusion of the entire cervical spine. Patients frequently express concern over the likely loss of range of motion (ROM) of the neck postoperatively. However, we are aware of no study that specifically examines the sagittal cervical ROM after extensive cervical fusion. PURPOSE: To characterize sagittal ROM after extensive cervical fusion. STUDY DESIGN: Retrospective case series. PATIENT SAMPLE: Thirty patients were included. OUTCOME MEASURES: Radiographs at final follow-up were measured for cervical ROM by the occipitocervical and cervicosternal angles with the neck in full flexion and extension. METHODS: The surgical and medical records at one tertiary referral academic institution were used to identify adults who had undergone extensive cervical fusion between 1996 and 2008. An "extensive cervical fusion" entailed an upper instrumented vertebra proximal to C3 and lower instrumented vertebra distal to C7. Radiographs at final follow-up were measured for cervical ROM by the occipitocervical and cervicosternal angles with the neck in full flexion and extension. RESULTS: The average age at surgery was 58.3±10.0 years. The surgical levels were occiput-T1 (one patient), occiput-T4 (one patient), occiput-T6 (one patient), C1-T1 (one patient), C1-T2 (one patient), C2-T1 (nine patients), C2-T2 (eight patients), C2-T3 (six patients), and C2-T4 (two patients). Twenty-seven of the procedures were revisions. The other surgical indications were chin-on-chest deformity (one patient), cervical scoliosis (one patient), and multilevel cervical myelopathy (one patient). The mean follow-up period was 34.5±30.9 months (range, 6-154 months). The mean cervical ROM values by the occipitocervical and cervicosternal angles were 29.5±11.0° and 7.5±5.0°, respectively. The mean total cervical ROM value was 34.1±14.7°. CONCLUSIONS: A substantial degree of sagittal ROM can be maintained after extensive surgical fusion of the cervical spine.

Critical illness research involving collection of genomic data: the conundrum posed by low levels of genomic literacy among surrogate decision makers for critically ill patients.

Critical illness clinical trials that entail genomic data collection pose unique challenges. In this qualitative study, we found that surrogate decision makers (SDMs) for critically ill individuals, such as those who would be approached for study participation, appeared to have a limited grasp of genomic principles. We argue that low levels of genomic literacy should neither preclude nor be in conflict with the conduct of ethically rigorous clinical trials.

Perspectives of surrogate decision makers for critically ill patients regarding gene variation research.

PURPOSE: We undertook this investigation to explore the manner in which surrogate decision makers for critically ill patients perceived genetic data collected in the context of clinical investigation. METHODS: Surrogate decision makers for critically ill patients cared for in intensive care units of two urban hospitals participated in focus groups designed to explore perceptions regarding gene variation research. RESULTS: Surrogate decision makers were generally familiar with genetic concepts and reported that they could provide an informed opinion regarding permitting (or declining) the participation of their loved ones in gene variation research. Respondents perceived the risk associated with this type of research largely as the risk associated with acquiring the sample (i.e., whether it involved an invasive procedure or not) but appreciated that genetic samples could provide information not readily obtained from nongenetic sources. Concerns about potential misuse of genetic data largely centered on misconduct, paternity, forensic applications, and insurance and employment discrimination. Although surrogate decision makers expressed that their loved ones would have interest in return of results and being recontacted for future use, these interests were secondary to confidentiality concerns. CONCLUSION: Respondents perceived genetic and nongenetic data as comparable. Informed consent processes that provide clear information regarding confidentiality protections, specimen handling, and parameters for future use may enhance enrollment.Genet Med 2013:15(5):368-373.

Real-time perspectives of surrogate decision-makers regarding critical illness research: findings of focus group participants.

OBJECTIVE: We undertook the current investigation to explore how the pressures of serving as a surrogate decision-maker (SDM) for an acutely ill family member influence attitudes regarding clinical investigation. METHODS: We conducted a prospective study involving SDMs for critically ill patients cared for in the ICUs of two urban hospitals. Measurements included participation in focus groups designed to explore perceptions of ICU care and clinical research. Audiotapes were transcribed and analyzed to identify common patterns and themes using grounded theory. Demographic and clinical data were summarized using standard statistical methods. RESULTS: Seventy-four SDMs (corresponding to 24% of eligible patients) participated. Most SDMs were women and described long-term relationships with the patients represented. SDMs described their role as "overwhelming," their emotions were accentuated by the fatigue of the ICU experience, and they relied on family members, social contacts, and religion as sources of support. Altruism was reported as a common motivation for potential study participation, a sentiment often strengthened by the critical illness episode. Although research was viewed as optional, some SDMs perceived invitation for research participation as tacit acknowledgment of therapeutic failure. SDMs expressed a preference for observational studies (perceived as low risk) over interventional designs (perceived as higher risk). Trust in the ICU team and the research enterprise seemed tightly linked. CONCLUSIONS: Despite significant emotional duress, SDMs expressed interest in investigation and described multiple factors motivating participation. Consent processes that minimize the effects of anxiety may be one strategy to enhance recruitment.

Considerations in the construction of an instrument to assess attitudes regarding critical illness gene variation research.

Clinical studies conducted in intensive care units are associated with logistical and ethical challenges. Diseases investigated are precipitous and life-threatening, care is highly technological, and patients are often incapacitated and decision-making is provided by surrogates. These investigations increasingly involve collection of genetic data. The manner in which the exigencies of critical illness impact attitudes regarding genetic data collection is unstudied. Given interest in understanding stakeholder preferences as a foundation for the ethical conduct of research, filling this knowledge gap is timely. The conduct of opinion research in the critical care arena is novel. This brief report describes the development of parallel patient/surrogate decision-maker quantitative survey instruments for use in this environment. Future research employing this instrument or a variant of it with diverse populations promises to inform research practices in critical illness gene variation research.

Examination of non-clinical factors affecting tracheostomy practice in an academic surgical intensive care unit.

OBJECTIVES: To gain insight into nonclinical factors potentially influencing tracheostomy practice and determine whether a specialized consultation form impacts tracheostomy utilization. DESIGN: Prospective, observational. SETTING: Surgical intensive care unit (SICU). PATIENTS: Patients requiring mechanical ventilatory support. Data abstracted from the Project Impact administrative database served as a practice benchmark. INTERVENTIONS: Prospective data collection, completion of online survey, and implementation of specialized tracheostomy consultation form. MEASUREMENTS AND MAIN RESULTS: Data were prospectively collected on 539 patients and 13 attending intensivists. Our SICU tracheostomy rate (54.2%) exceeded that of 18 comparable ICUs participating in Project Impact (13.9%, p < .001). We attempted to identify factors that might account for liberal tracheostomy use. In 41.5% (+/-0.6%) of patients undergoing tracheostomy, extubation had not occurred despite successful completion of spontaneous breathing trial on >or=1 occasion, a rate that varied significantly among attending intensivists responsible for decision making for this procedure (p < .001). Attending intensivists and postgraduate surgical trainees with SICU experience were surveyed to better understand perceptions of tracheostomy practice. Most respondents (96.1%) reported relying on spontaneous breathing trial to guide decision for extubation, 72.6% estimated that