Dose, Content, and Context of Usual Care in Stroke Upper Limb Motor Interventions: A Systematic Review.

OBJECTIVE: The objectives of this systematic review were to describe the current dose and content of usual care upper limb motor intervention for inpatients following stroke and examine if context factors alter dose and content. DATA SOURCES: A systematic search (EMBASE, MEDLINE) was completed from January 2015 to February 2023 (PROSPERO CRD42021281986). METHODS: Studies were eligible if they reported non-protocolised usual care upper limb motor intervention dose data for stroke inpatients. Studies were rated using the Johanna Briggs Institute critical appraisal tool. Data were descriptively reported for dose dimensions of time (on task or, in therapy) and intensity (repetitions, repetition/minute), content (intervention type/mode), and context (e.g., severity strata). RESULTS: Eight studies were included from four countries, largely reflecting inpatient rehabilitation. Time in therapy ranged from 23 to 121 min/day. Time on task ranged from 8 to 44 min/day. Repetitions ranged from 36 to 57/session, and 15 to 282/day. Time on task was lowest in the stratum of people with severe upper limb impairment (8 min/day), the upper limit for this stratum was 41.5 min/day. There was minimal reporting of usual care content across all studies. CONCLUSION: Upper limb motor intervention dose appears to be increasing in usual care compared to prior reports (e.g., average 21 min/day and 23 to 32 repetitions/session). Context variability suggests that doses are lowest in the stratum of patients with a severely impaired upper limb. Consistent reporting of the multiple dimensions of dose and content is necessary to better understand usual care offered during inpatient rehabilitation.

Advancing Stroke Recovery Through Improved Articulation of Nonpharmacological Intervention Dose.

Dose articulation is a universal issue of intervention development and testing. In stroke recovery, dose of a nonpharmaceutical intervention appears to influence outcome but is often poorly reported. The challenges of articulating dose in nonpharmacological stroke recovery research include: (1) the absence of specific internationally agreed dose reporting guidelines; (2) inadequate conceptualization of dose, which is multidimensional; and (3) unclear and inconsistent terminology that incorporates the multiple dose dimensions. To address these challenges, we need a well-conceptualized and consistent approach to dose articulation that can be applied across stroke recovery domains to stimulate critical thinking about dose during intervention development, as well as promote reporting of planned intervention dose versus actually delivered dose. We followed the Design Research Paradigm to develop a framework that guides how to articulate dose, conceptualizes the multidimensional nature and systemic linkages between dose dimensions, and provides reference terminology for the field. Our framework recognizes that dose is multidimensional and comprised of a duration of days that contain individual sessions and episodes that can be active (time on task) or inactive (time off task), and each individual episode can be made up of information about length, intensity, and difficulty. Clinical utility of this framework was demonstrated via hypothetical application to preclinical and clinical domains of stroke recovery. The suitability of the framework to address dose articulation challenges was confirmed with an international expert advisory group. This novel framework provides a pathway for better articulation of nonpharmacological dose that will enable transparent and accurate description, implementation, monitoring, and reporting, in stroke recovery research.

Timing and Dose of Upper Limb Motor Intervention After Stroke: A Systematic Review.

This systematic review aimed to investigate timing, dose, and efficacy of upper limb intervention during the first 6 months poststroke. Three online databases were searched up to July 2020. Titles/abstracts/full-text were reviewed independently by 2 authors. Randomized and nonrandomized studies that enrolled people within the first 6 months poststroke, aimed to improve upper limb recovery, and completed preintervention and postintervention assessments were included. Risk of bias was assessed using Cochrane reporting tools. Studies were examined by timing (recovery epoch), dose, and intervention type. Two hundred and sixty-one studies were included, representing 228 (n=9704 participants) unique data sets. The number of studies completed increased from one (n=37 participants) between 1980 and 1984 to 91 (n=4417 participants) between 2015 and 2019. Timing of intervention start has not changed (median 38 days, interquartile range [IQR], 22-66) and study sample size remains small (median n=30, IQR 20-48). Most studies were rated high risk of bias (62%). Study participants were enrolled at different recovery epochs: 1 hyperacute (<24 hours), 13 acute (1-7 days), 176 early subacute (8-90 days), 34 late subacute (91-180 days), and 4 were unable to be classified to an epoch. For both the intervention and control groups, the median dose was 45 (IQR, 600-1430) min/session, 1 (IQR, 1-1) session/d, 5 (IQR, 5-5) d/wk for 4 (IQR, 3-5) weeks. The most common interventions tested were electromechanical (n=55 studies), electrical stimulation (n=38 studies), and constraint-induced movement (n=28 studies) therapies. Despite a large and growing body of research, intervention dose and sample size of included studies were often too small to detect clinically important effects. Furthermore, interventions remain focused on subacute stroke recovery with little change in recent decades. A united research agenda that establishes a clear biological understanding of timing, dose, and intervention type is needed to progress stroke recovery research. Prospective Register of Systematic Reviews ID: CRD42018019367/CRD42018111629.

Backpack health reduces data-sharing barriers between the medical community and individuals with rare diseases.

Technology has changed the way we approach medical care: health data is constantly being generated, medical discoveries are progressing more rapidly, and individuals are more connected across the world than ever before. Backpack Health is a global personal health record platform that harnesses the power of technology to connect users to their primary health data sources, the medical community, and researchers. By syncing with existing patient portals, health data can be stored on the Backpack Health platform and easily accessed and controlled by users in one connected interface. Individuals manage and collate their current and past conditions, genetic test results, symptoms, medications, procedures, labs, and other health data. Users are empowered to disseminate their information to clinicians, researchers, foundations, and pharmaceutical and biotechnology companies they connect with through the Backpack Health application. Here, we describe how two rare disease advocacy groups, The Marfan Foundation and Project Alive, utilize Backpack Health to connect with their target populations. Through secure transfer of pseudonymized data, groups can query their members to improve understanding of clinical features and to facilitate meaningful research. Responses to the groups' surveys show strong member engagement with high completion rates and increases in new Backpack Health users when surveys are deployed. Data from these surveys have been published and used to better inform clinical outcomes for treatment trials. By connecting users directly to the foundations, clinicians, researchers, and industry partners working on their condition, Backpack Health is instrumental in fast-tracking medical discoveries and treatment for rare diseases.

Facilitated referral pathway for genetic testing at the time of ovarian cancer diagnosis: uptake of genetic counseling and testing and impact on patient-reported stress, anxiety and depression.

BACKGROUND: Timely genetic testing at ovarian cancer diagnosis is essential as results impact front line treatment decisions. Our objective was to determine rates of genetic counseling and testing with an expedited genetics referral pathway wherein women with newly-diagnosed ovarian cancer are contacted by a genetics navigator to facilitate genetic counseling. METHODS: Patients were referred for genetic counseling by their gynecologic oncologist, contacted by a genetics navigator and offered appointments for genetic counseling. Patients completed quality of life (QoL) surveys immediately pre- and post-genetic assessment and 6 months later. The primary outcome was feasibility of this pathway defined by presentation for genetic counseling. RESULTS: From 2015 to 2018, 100 patients were enrolled. Seventy-eight had genetic counseling and 73 testing. Median time from diagnosis to genetic counseling was 34 days (range 10-189). Among patients who underwent testing, 12 (16%) had pathogenic germline mutations (BRCA1-7, BRCA2-4, MSH2-1). Sixty-five patients completed QoL assessments demonstrating stress and anxiety at time of testing, however, scores improved at 6 months. Despite the pathway leveling financial and logistical barriers, patients receiving care at a public hospital were less likely to present for genetic counseling compared to private hospital patients (56% versus 84%, P = 0.021). CONCLUSIONS: Facilitated referral to genetic counselors at time of ovarian cancer diagnosis is effective, resulting in high uptake of genetic counseling and testing, and does not demonstrate a long term psychologic toll. Concern about causing additional emotional distress should not deter clinicians from early genetics referral as genetic testing can yield important prognostic and therapeutic information.

Recontact practices of cancer genetic counselors and an exploration of professional, legal, and ethical duty.

The duty to recontact continues to be revisited in the field of clinical genetics and is currently relevant for cancer genetic counseling given the transition from single-gene to multi-gene panel testing. We recruited cancer genetic counselors through the National Society of Genetic Counselors list-serv to complete an online survey assessing current practices and perspectives regarding recontacting patients about diagnostic genetic tests. Forty-one percent of respondents reported that they have recontacted patients to offer updated (new) diagnostic genetic testing (40/97). A majority (61%, 17/28), of genetic counselors who reported recontact specifically for panel testing indicated that the availability of management recommendations for genes not previously tested routinely was an important factor in the decision to recontact. All respondents who recontacted patients reported "improved patient care" as a perceived benefit. Respondents indicated that recontact is mostly a patient responsibility (49%), followed by a shared responsibility between the provider and patient (43%). Few respondents (2%) reported a uniform ethical duty to recontact patients regarding new and updated testing, while the majority (89%) felt that there was some degree of ethical duty. A greater percentage of those who reported past recontact practices reported intention to recontact in the future (p = 0.001). There is little consensus among the genetic counselor respondents about how to approach the recontacting of patients to offer updated genetic testing.

Prospective study of germline genetic testing in incident cases of pancreatic adenocarcinoma.

BACKGROUND: The objective of this study was to investigate the prevalence of pathogenic germline variants (PGVs) in 32 cancer susceptibility genes in individuals with newly diagnosed pancreatic ductal adenocarcinoma (PDAC). A key secondary objective was to evaluate how often PGVs would have been undetected with existing genetic testing criteria. METHODS: From May 2016 through May 2017, this multicenter cohort study enrolled consecutive patients aged 18 to 89 years with histologically confirmed PDAC diagnosed within the previous 12 weeks. Demographics, medical histories, and 3-generation pedigrees were collected from participants who provided samples for germline DNA analysis. RESULTS: Four hundred nineteen patients were deemed eligible, 302 were enrolled, and 298 were included in the final cohort. Clinically actionable variants were reported in 29 PDAC patients (9.7%), with 23 (7.7%) having a PGV associated with an increased risk for PDAC. Six of 23 individuals (26%) with PDAC-associated gene mutations did not meet currently established genetic testing criteria. According to guideline-based genetic testing, only 11 of the 23 PGVs (48%) in known PDAC genes would have been detected. Six additional patients (2%) had PGVs associated with an increased risk for other cancers. CONCLUSIONS: These findings support the significant prevalence of PGVs associated with PDAC and the limitations of current paradigms for selecting patients for genetic testing, and they thereby lend support for universal germline multigene genetic testing in this population.

Improved Assessment of Chest pain Trial (IMPACT): assessing patients with possible acute coronary syndromes.

OBJECTIVE: To examine the safety and efficacy of the Improved Assessment of Chest pain Trial (IMPACT) protocol, a strategy for accelerated assessment of patients presenting to emergency departments (EDs) with chest pain. DESIGN, SETTING AND PARTICIPANTS: IMPACT was an intervention trial at a single tertiary referral hospital (Royal Brisbane and Women's Hospital) during February 2011 - March 2014. 1366 prospectively recruited patients presenting to the ED with symptoms of suspected acute coronary syndrome (ACS) were stratified into groups at low, intermediate or high risk of an ACS. INTERVENTION: High risk patients were treated according to NHFA/CSANZ guidelines. Low and intermediate risk patients underwent troponin testing (sensitive assay) 0 and 2 hours after presentation. Intermediate risk patients underwent objective testing after the second troponin test; low risk patients were discharged without further objective testing. MAIN OUTCOME MEASURES: The primary outcome was an ACS within 30 days of presentation. Secondary outcomes were ED and hospital lengths of stay (LOS). RESULTS: The IMPACT protocol stratified 244 (17.9%) patients to low risk, 789 (57.7%) to intermediate risk, and 333 (24.4%) to high risk categories. The overall 30-day ACS rate was 6.6%, but there were no ACS events in the low risk group, and 14 (1.8%) in the intermediate risk group. The median hospital LOS was 5.1 hours (IQR, 4.2-5.6 h) for low risk and 7.7 hours (IQR, 6.1-21 h) for intermediate risk patients. CONCLUSIONS: The IMPACT protocol safely and efficiently allowed a large proportion of patients presenting to EDs with chest pain to undergo accelerated assessment for risk of an ACS. CLINICAL TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12611000206921.

Relationship Between Physiological Parameters and Acute Coronary Syndrome in Patients Presenting to the Emergency Department With Undifferentiated Chest Pain.

UNLABELLED: The investigators of this study sought to examine whether abnormal physiological parameters are associated with increased risk for acute coronary syndrome (ACS) in patients presenting to the emergency department (ED) with chest pain. METHODS: We used prospectively collected data on adult patients presenting with suspected ACS in 2 EDs in Australia and New Zealand. Trained research nurses collected physiological data including temperature, respiratory rate, heart rate, and systolic blood pressure (SBP) on presentation to the ED. The primary endpoint was ACS within 30 days of presentation, as adjudicated by cardiologists using standardized guidelines. The prognostic utility of physiological parameters for ACS was examined using risk ratios. RESULTS: Acute coronary syndrome was diagnosed in 384 of the 1951 patients (20%) recruited. Compared with patients whose SBP was between 100 and 140 mm Hg, patients with an SBP of lower than 100 mm Hg or higher than 140 mm Hg were 1.4 times (95% confidence interval, 1.2-1.7) more likely to have ACS. Similarly, compared with patients whose temperature was between 36.5°C and 37.5°C, patients with temperature of lower than 36.5°C or higher than 37.5°C were 1.4 times (95% confidence interval, 1.1-1.6) more likely to have ACS. Heart rate and respiratory rate were not predictors of ACS. CONCLUSIONS: Patients with abnormal temperature or SBP were slightly more likely to have ACS, but such risk was of too small a magnitude to be useful in clinical decision making. Other physiological parameters (heart rate and respiratory rate) had no prognostic value. The use of physiological parameters cannot reliably confirm or rule out ACS.

Time to presentation and 12-month health outcomes in patients presenting to the emergency department with symptoms of possible acute coronary syndrome.

OBJECTIVE: To define the association between time taken to present to the emergency department (ED) with symptoms of possible acute coronary syndrome (ACS) and 1-year outcomes. We also determined whether particular patient characteristics are associated with delays in seeking care after symptom onset. METHODS: We collected data, which included a customised case report form to record symptom onset, on adult patients presenting with suspected ACS to two EDs in Australia and New Zealand. Such patients were followed up prospectively for 1 year. The composite primary endpoint included death, acute myocardial infarction, unstable angina pectoris treated with revascularisation or readmission with heart failure occurring after discharge but within 12 months after the index presentation. RESULTS: ACS was diagnosed at presentation in 420 (16.8%) of 2515 patients recruited. Cox regression was conducted to assess the relationship between presentation time and the rate of primary endpoints after controlling for age, ethnicity, prior angina, prior coronary artery bypass graft and index diagnosis. Middle (2-6 h) and late presenters (>6 h postsymptom onset) developed the primary endpoint at a rate 1.22 (95% CI 0.80 to 1.85) and 1.57 (1.07 to 2.31) times higher than early presenters. Patients with known risk factors and cardiovascular disease were more likely to present late to the ED. CONCLUSIONS: There is an independent association between time to presentation and 1-year cardiac outcomes following initial chest pain assessment for ED patients with possible cardiac chest pain in the Australian and New Zealand setting. This association occurred irrespective of the eventual diagnosis. Effective public health campaigns and other measures that facilitate early presentation with symptoms for patients with symptoms suggestive of ACS are justified and may improve prognosis. TRIAL REGISTRATION NUMBER: ACTRN12611001069943.

Factors associated with triage assignment of emergency department patients ultimately diagnosed with acute myocardial infarction.

BACKGROUND: The objective of this study was to explore factors associated with the triage category assigned by the triage nurse for patients ultimately diagnosed with acute myocardial infarction. METHODS: This was a retrospective analysis of 12 months of data, on adult emergency department patients ultimately diagnosed with acute myocardial infarction. Data were obtained from hospital databases and included patient demographics, patient clinical characteristics and nurses' experience. RESULTS: Of the 153 patients, 20% (95% CI: 14-27%) were given a lower urgency triage category than recommended by international guidelines. Compared to patients who were triaged Australasian Triage Category 1 or 2, patients with an Australasian Triage Category 3-5 were older (mean age 76 versus 68 years), more likely to be female (63% versus 32%), more likely to present without chest pain (93% versus 35%) and less likely to have a cardiac history (3.3% versus 17.9%). A slightly higher proportion of patients Australasian Triage Category 3-5 were triaged by an experienced nurse (50%) compared to patients categorised Australasian Triage Category 1-2 (35.2%) but this finding did not reach statistical significance. CONCLUSIONS: One in five presentations was given a lower urgency triage category than recommended by international guidelines, potentially leading to delays in medical treatment. The absence of chest pain was the defining characteristic in this group of patients, along with other factors identified by previous research such as being of female sex and elderly.

Rescreening for genetic mutations using multi-gene panel testing in patients who previously underwent non-informative genetic screening.

OBJECTIVE: The availability of next-generation sequencing and identification of multiple cancer-related genes has caused a shift away from single gene testing towards multi-gene panel testing for hereditary cancer syndromes. However, the utility of panels in individuals who previously underwent non-informative genetic screening has yet to be evaluated. We aim to evaluate the use of rescreening and results of multi-gene panels in this rescreened population. METHODS: We reviewed the medical records for patients who had previously undergone genetic testing and then underwent multi-gene panel testing at a single institution between 9/2013 and 11/2014. RESULTS: One hundred and twenty-seven patients with prior genetic testing underwent multi-gene panels. One hundred and four patients (82%) had a history of cancer and 118 (93%) had at least one family member with cancer. On primary testing, no pathogenic mutations were detected and 10 patients (8%) were found to have variants of uncertain significance (VUS). On repeat multi-gene panel testing, nine patients (7%) were found to have a pathogenic mutation and 53 patients (42%) were VUS not identified on prior testing. CONCLUSIONS: Seven percent of patients with non-informative primary testing were found to have a pathogenic mutation with multi-gene panels, suggesting that there is a potential benefit to be gained from rescreening. However, 42% of patients were found to have new VUS with panels, a result that can cause patients anxiety without clear clinical implications.

Cost and outcomes of assessing patients with chest pain in an Australian emergency department.

OBJECTIVES: We sought to characterise the demographics, length of admission, final diagnoses, long-term outcome and costs associated with the population who presented to an Australian emergency department (ED) with symptoms of possible acute coronary syndrome (ACS). DESIGN, SETTING AND PARTICIPANTS: Prospectively collected data on ED patients presenting with suspected ACS between November 2008 and February 2011 was used, including data on presentation and at 30 days after presentation. Information on patient disposition, length of stay and costs incurred was extracted from hospital administration records. MAIN OUTCOME MEASURES: Primary outcomes were mean and median cost and length of hospital stay. Secondary outcomes were diagnosis of ACS, other cardiovascular conditions or non-cardiovascular conditions within 30 days of presentation. RESULTS: An ACS was diagnosed in 103 (11.1%) of the 926 patients recruited. 193 patients (20.8%) were diagnosed with other cardiovascular-related conditions and 622 patients (67.2%) had non-cardiac-related chest pain. ACS events occurred in 0 and 11 (1.9%) of the low-risk and intermediate-risk groups, respectively. Ninety-two (28.0%) of the 329 high-risk patients had an ACS event. Patients with a proven ACS, high-grade atrioventricular block, pulmonary embolism and other respiratory conditions had the longest length of stay. The mean cost was highest in the ACS group ($13 509; 95% CI, $11 794-$15 223) followed by other cardiovascular conditions ($7283; 95% CI, $6152-$8415) and non-cardiovascular conditions ($3331; 95% CI, $2976-$3685). CONCLUSIONS: Most ED patients with symptoms of possible ACS do not have a cardiac cause for their presentation. The current guideline-based process of assessment is lengthy, costly and consumes significant resources. Investigation of strategies to shorten this process or reduce the need for objective cardiac testing in patients at intermediate risk according to the National Heart Foundation and Cardiac Society of Australia and New Zealand guideline is required.

Patient experiences living with pancreatic cancer risk.

BACKGROUND: Pancreatic cancer (PancCa) is recognized as a component of many well-described hereditary cancer syndromes. Minimal research has focused on patient needs and experiences living with this risk. PURPOSE: To understand the meaning and experience of living with familial PancCa risk and to explore experiences related to screening and prevention of PancCa. METHODS: Participants underwent semi-structured, in-depth interviews. Adults without PancCa and who met familial or hereditary risk criteria were eligible. Thematic analysis was completed on the transcripts in order to identify patterns, consistencies, and differences. Narrative review of existing literature related to women living with hereditary breast and ovarian cancer (HBOC) risk was completed to explore similarities and differences between published findings and our current findings. RESULTS: Nineteen individuals (9 male, 10 female) participated. Major themes addressed participants' family experiences with PancCa and PancCa death and the associated grief from the experiences. Family experiences impacted how participants interpreted and approached their own cancer risk and participated in the cancer screening program. Participants wanted to control their cancer risk and sought information and resources to prevent PancCa or PancCa related death. Distress related to risk was not described as constant but occurred around salient time points. CONCLUSION & FUTURE IMPLICATIONS: Study results begin to describe the lived experience of individuals with PancCa risk. Through this research we have uncovered important variables to further understand, measure, and intervene upon in future research. Distress related to risk was not described as ongoing, but occurred around specific and salient time points that brought risk to the forefront. Individuals with familial PancCa risk may have a unique experience compared to other hereditary cancer syndromes due to the high mortality of the disease and uncertainty related to prevention and early detection outcomes.

Utility of Routine Exercise Stress Testing among Intermediate Risk Chest Pain Patients Attending an Emergency Department.

BACKGROUND: To assess the utility of routine exercise stress testing (EST) in patients at intermediate risk of acute coronary syndrome (ACS) according to the Heart Foundation of Australia/Cardiac Society of Australia and New Zealand (HFA/CSANZ) guidelines. METHOD: Prospective observational study of patients presenting to the Emergency Department (ED) with chest pain suggestive of ACS between November 2008 and July 2014. Participants included 1205 patients who presented to the ED with chest pain suggestive of ACS and who met the HFA/CSANZ intermediate risk criteria. The outcome was diagnosis of ACS occurring on presentation or within 30 days of presentation to the ED. ACS included acute myocardial infarction and unstable angina pectoris. RESULTS: Twenty (1.66%) of the intermediate risk patients were diagnosed with ACS. Of the 777 patients who underwent EST, eight had ACS. EST identified all ACS cases except for one patient with a negative test, who was ultimately diagnosed with ACS following angiography. 164 patients deemed inappropriate to undergo EST underwent an alternative form of objective testing, of which 12 were positive for ACS. 264 patients underwent no objective testing. CONCLUSION: EST stratifies intermediate risk patients to a near zero short-term risk of ACS. However, the overall yield of EST within this group of patients is extremely low. Intermediate risk patients with normal zero and six hour biomarkers have a very low probability of ACS, and over half of these patients ultimately diagnosed with ACS in this group were deemed unsuitable for EST anyway. Future research should focus on the identification of patients who do not require EST and the inclusion of routine EST within the HFA/CSANZ guidelines should be reconsidered.

Prevalence of Arm Weakness, Pre-Stroke Outcomes and Other Post-Stroke Impairments Using Routinely Collected Clinical Data on an Acute Stroke Unit.

INTRODUCTION: The prevalence of upper limb motor weakness early post-stroke may be changing, which can have clinical and research implications. Our primary aim was to describe the prevalence of upper limb motor weakness early post-stroke, with a secondary aim to contextualize this prevalence by describing pre-stroke outcomes, other post-stroke impairments, functional activities, and discharge destination. METHODS: This cross-sectional observational study extracted clinical data from confirmed stroke patients admitted to a metropolitan stroke unit over 15-months. The primary upper limb weakness measure was Shoulder Abduction and Finger Extension (SAFE) score. Demographics (eg, age), clinical characteristics (eg, stroke severity), pre-stroke outcomes (eg, clinical frailty), other post-stroke impairments (eg, command following), functional activities (eg, ambulation), and discharge destination were also extracted. RESULTS: A total of 463 participants had a confirmed stroke and SAFE score. One-third of patients received ≥1 acute medical intervention(s). Nearly one-quarter of patients were classified as frail pre-stroke. Upper limb weakness (SAFE≤8) was present in 35% [95% CI: 30%-39%] at a median of 1-day post-stroke, with 22% presenting with mild-moderate weakness (SAFE5-8). The most common other impairments were upper limb coordination (46%), delayed recall (41%), and upper limb sensation (26%). After a median 3-day acute stroke stay, 52% of the sample were discharged home. CONCLUSION: Upper limb weakness was present in just over a third (35%) of the sample early post-stroke. Data on pre-stroke outcomes and the prevalence of other post-stroke impairments highlights the complexity and heterogeneity of stroke recovery. Further research is required to tease out meaningful recovery phenotypes and their implications.

Navigating Precision Oncology: Insights from an Integrated Clinical Data and Biobank Repository Initiative across a Network Cancer Program.

Advancing cancer treatment relies on the rapid translation of new scientific discoveries to patient care. To facilitate this, an oncology biobank and data repository program, also referred to as the "Moonshot" program, was launched in 2021 within the Integrated Network Cancer Program of the Allegheny Health Network. A clinical data program (CDP) and biospecimen repository were established, and patient data and blood and tissue samples have been collected prospectively. To date, the study has accrued 2920 patients, predominantly female (61%) and Caucasian (90%), with a mean age of 64 ± 13 years. The most common cancer sites were the endometrium/uterus (12%), lung/bronchus (12%), breast (11%), and colon/rectum (11%). Of patients diagnosed with cancer, 34% were diagnosed at stage I, 25% at stage II, 26% at stage III, and 15% at stage IV. The CDP is designed to support our initiative in advancing personalized cancer research by providing a comprehensive array of patient data, encompassing demographic characteristics, diagnostic details, and treatment responses. The "Moonshot" initiative aims to predict therapy responses and clinical outcomes through cancer-related biomarkers. The CDP facilitates this initiative by fostering data sharing, enabling comparative analyses, and informing the development of novel diagnostic and therapeutic methods.

Control intervention design for preclinical and clinical trials: Consensus-based core recommendations from the third Stroke Recovery and Rehabilitation Roundtable.

Control comparator selection is a critical trial design issue. Preclinical and clinical investigators who are doing trials of stroke recovery and rehabilitation interventions must carefully consider the appropriateness and relevance of their chosen control comparator as the benefit of an experimental intervention is established relative to a comparator. Establishing a strong rationale for a selected comparator improves the integrity of the trial and validity of its findings. This Stroke Recovery and Rehabilitation Roundtable (SRRR) taskforce used a graph theory voting system to rank the importance and ease of addressing challenges during control comparator design. "Identifying appropriate type of control" was ranked easy to address and very important, "variability in usual care" was ranked hard to address and of low importance, and "understanding the content of the control and how it differs from the experimental intervention" was ranked very important but not easy to address. The CONtrol DeSIGN (CONSIGN) decision support tool was developed to address the identified challenges and enhance comparator selection, description, and reporting. CONSIGN is a web-based tool inclusive of seven steps that guide the user through control comparator design. The tool was refined through multiple rounds of pilot testing that included more than 130 people working in neurorehabilitation research. Four hypothetical exemplar trials, which span preclinical, mood, aphasia, and motor recovery, demonstrate how the tool can be applied in practice. Six consensus recommendations are defined that span research domains, professional disciplines, and international borders.