Background Clinical decisions made early after stroke can make the difference between survival with disability or death. We aimed to develop, implement and evaluate a new Shared decision making (SDM) process for severe stroke into a regional 36 bedded stroke unit.Methods We developed the process through four coproduction workshops, attempted its implementation then its impact on death at 6 months, discharge destination and tube feeding. We also explored patients, families and staff views about SDM.Results Eleven people (staff and people with lived experience of stroke) attended the first co-production workshop, eight the second, seven the third and six the fourth. The new SDM process incorporated Tailored Talks (a digital platform with information about stroke and its prognosis) and an implementation plan (including staff training). We implemented this process on 1st August 2022.Only 8/1020 patients received Tailored Talks (4 before and 4 after implementation). For the entire group there was no change tube feeding, discharge destination or death. The proportion of people with severe strokes dead at six months was higher before implementation. Twenty-one patients or family members provided views about SDM quality, but the sample size was too small to draw conclusions. Staff interviews suggested that insufficient time, lack of a ‘human touch’ and inadequate leadership explained the lack of implementation.Conclusion Our co-produced SDM was not effectively implemented into a stroke unit and there was no change in the use of tube feeding or death in 1020 patients.Key points Shared decision making after severe stroke is complex.A co-produced new process for shared decision making after severe stroke was not effectively implemented into clinical practice.There was no change in tube feeding, death or institutionalisation.### Competing Interest StatementThe authors have declared no competing interest.### Funding StatementThis work was supported by Edinburgh and Lothian Health Foundation Reference 1339### Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:Ethics approval was given by Scotland A research ethics committee (21/SS/0044)I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.YesAll data produced in the present work are contained in the manuscript

Background Predicting specific abilities (e.g. walk and talk) to provide a functional profile six months after disabling stroke could help patients/families prepare for the consequences of stroke and facilitate involvement in treatment decision-making. Aim To develop new statistical models to predict specific abilities six months after stroke and test their performance in an independent cohort of patients with disabling stroke. Methods We developed models to predict six specific abilities (to be independent, walk, talk, eat normally, live without major anxiety/depression, and to live at home) using data from seven large multicenter stroke trials with multivariable logistic regression. We included 13,117 participants recruited within three days of hospital admission. We assessed model discrimination and derived optimal cut-off values using four statistical methods. We validated the models in an independent single-center cohort of patients (n = 403) with disabling stroke. We assessed model discrimination and calibration and reported the performance of our models at the statistically derived cut-off values. Results All six models had good discrimination in external validation (AUC 0.78–0.84). Four models (predicting to walk, eat normally, live without major anxiety/depression, live at home) calibrated well. Models had sensitivities between 45.0 and 97.9% and specificities between 21.6 and 96.5%. Conclusions We have developed statistical models to predict specific abilities and demonstrated that these models perform reasonably well in an independent cohort of disabling stroke patients. To aid decision-making regarding treatments, further evaluation of our models is required.

Background and Purpose:Stroke is the second commonest cause of death worldwide and a leading cause of severe disability, yet there are no published trials of palliative care in stroke. To design and evaluate palliative care interventions for people with stroke, researchers need to know what measurable outcomes matter most to patients and families, stroke professionals, and other service providers. Methods:A multidisciplinary steering group of professionals and laypeople managed the study. We synthesized recommendations from respected United Kingdom and international consensus documents to generate a list of outcome domains and then performed a rapid scoping literature review to identify potential outcome measures for use in future trials of palliative care after stroke. We then completed a 3-round, online Delphi survey of professionals, and service users to build consensus about outcome domains and outcome measures. Finally, we held a stakeholder workshop to review and finalize this consensus. Results:We generated a list of 36 different outcome domains from 4 key policy documents. The rapid scoping review identified 43 potential outcome measures that were used to create a shortlist of 16 measures. The 36 outcome domains and 16 measures were presented to a Delphi panel of diverse healthcare professionals and lay service users. Of 48 panelists invited to take part, 28 completed all 3 rounds. Shared decision-making and quality of life were selected as the most important outcome domains for future trials of palliative care in stroke. Additional comments highlighted the need for outcomes to be feasible, measurable, and relevant beyond the initial, acute phase of stroke. The stakeholder workshop endorsed these results. Conclusions:Future trials of palliative care after stroke should include pragmatic outcome measures, applicable to the evolving patient and family experiences after stroke and be inclusive of shared decision-making and quality of life.

Background Treatment decision-making by family members on behalf of patients with major stroke can be challenging because of the shock of the diagnosis and lack of knowledge of the patient’s treatment preferences. We aimed to understand how, and why, family members made certain treatment decisions, and explored their information and support needs. Method Semi-structured interviews with family members (n=24) of patients with major stroke, within two weeks of hospital admission. Data were analysed thematically. Results Families’ approach to treatment decision-making lay on a spectrum according to the patient’s state of health pre-stroke (i.e. patient’s prior experience of illness and functional status) and any views expressed about treatment preferences in the event of life-threatening illness. Support and information needs varied according to where they were on this spectrum. At one extreme, family members described deciding not to initiate life-extending treatments from the outset because of the patients’ deteriorating health and preferences expressed pre-stroke. Information from doctors about poor prognosis was merely used to confirm this decision. In the middle of the spectrum were family members of patients who had been moderately independent pre-stroke. They described the initial shock of the diagnosis and how they had initially wanted all treatments to continue. However, once they overcame their shock, and had gathered relevant information, including information about poor prognosis from doctors, they decided that life-extending treatments were no longer appropriate. Many reported this process to be upsetting and expressed a need for psychological support. At the other end of the spectrum were family members of previously independent patients whose preferences pre-stroke had not been known. Family members described feeling extremely distressed at such an unexpected situation and wanting all treatments to continue. They described needing psychological support and hope that the patient would survive. Conclusion The knowledge that family members’ treatment decision-making approaches lay on a spectrum depending on the patient’s state of health and stated preferences pre-stroke may allow doctors to better prepare for discussions regarding the patient’s prognosis. This may enable doctors to provide information and support that is tailored towards family members’ needs.

Introduction: If health professionals are to involve major stroke patients and their families in making decisions about treatments, they need to describe prognosis in terms that are easily understood. We suggest that referring to "specific abilities", such as ability to be independent, walk, talk, eat normally, be continent, live without severe pain, live without major anxiety or depression and to live at home may be more easily understood than terms such as disabled based on the modified Rankin scale (mRs). Objective: We aimed to describe the "specific abilities" and quality of life of patients in each mRs level at six months after major stroke. Patients and methods: A longitudinal cohort study of patients admitted to hospital with major stroke with follow up at six months. Results: We recruited 403 patients, mean age 77.5yrs. The number (%) in each mRs level at six months was 0 (no problems): 8 (2%), 1: 45(11.2%), 2: 7(1.7%), 3: 149(37.1%), 4: 46(11.4%), 5: 36(9.0%) and 6(dead) 111(27.6%). Patients within each mRs level varied with respect to their "specific abilities" and quality of life. For example, of the 36(9%) patients with mRs 5, 30 (83%) could talk, 14(39%) were continent, 33(92%) were not in severe pain, 22(61%) did not have major anxiety/depression and 5(14%) could live at home. Their median utility (derived from HRQoL) was -0.08 (range -0.35 to 0.43). Discussion and Conclusions: Describing prognosis with the mRs does not convey the variation in specific abilities and HRQoL amongst patients with major stroke. Therefore, describing prognosis in terms of "specific abilities" may be more appropriate.

BACKGROUND:Some treatments after a disabling stroke increase the likelihood patients will survive longer but with significant disability. Patients and doctors should make collaborative decisions regarding these treatments. However, this can be challenging. To better understand treatment decision-making in acute disabling stroke, we explored the experiences, views and needs of stroke survivors in hospital and six months later. METHODS:Fifteen patients who had a disabling stroke were interviewed within a week of their diagnosis; eleven were re-interviewed six months later. Data were analysed thematically and longitudinally. RESULTS:Patients' functional abilities prior to their stroke and need for hope of functional recovery appeared to impact on their involvement in decision-making. In the early period post stroke, patients who were functionally independent pre- stroke described being emotionally devastated and ill-prepared for the consequences of stroke. They appeared unaware that treatments offered might extend their life but with significant disability and took all treatments in the hope of functional recovery. Those who were dependent pre-stroke appeared to be more stoic, had considered treatment implications and decided against such treatments. At follow-up, all patients had varying unmet psychological needs which appeared to contribute to poor quality of life. In the early period post stroke, patients looked for various ways to cultivate and maintain hope of functional recovery. While patients continued to look for hope at six months, they also reported wishing they had been given realistic information in the early period after stroke in order to prepare for the consequences. CONCLUSION:Stroke survivors may benefit from psychological support. A collaborative approach towards treatment decision-making may not be realistic in all patients especially when they may be emotionally distressed and looking to maintain a positive outlook. Communication strategies to balance maintaining hope without providing false hope may be appropriate. Patients' information needs may need reassessed at different time points.

People who are well may regard survival with disability as being worse than death. However, this is often not the case when those surviving with disability (e.g. stroke survivors) are asked the same question. Many routine treatments provided after an acute stroke (e.g. feeding via a tube) increase survival, but with disability. Therefore, clinicians need to support patients and families in making informed decisions about the use of these treatments, in a process termed shared decision making. This is challenging after acute stroke: there is prognostic uncertainty, patients are often too unwell to participate in decision making, and proxies may not know the patients’ expressed wishes (i.e. values). Patients’ values also change over time and in different situations. There is limited evidence on successful methods to facilitate this process. Changes targeted at components of shared decision making (e.g. decision aids to provide information and discussing patient values) increase patient satisfaction. How this influences decision making is unclear. Presumably, a “shared decision-making tool” that introduces effective changes at various stages in this process might be helpful after acute stroke. For example, by complementing professional judgement with predictions from prognostic models, clinicians could provide information that is more accurate. Decision aids that are personalized may be helpful. Further qualitative research can provide clinicians with a better understanding of patient values and factors influencing this at different time points after a stroke. The evaluation of this tool in its success to achieve outcomes consistent with patients’ values may require more than one clinical trial.

AimsTranscatheter aortic valve implantation (TAVI) is an increasingly common intervention for patients with aortic stenosis deemed high risk for major cardiac surgery, but identifying those who will benefit can be challenging. Frailty reflects physiological reserve and may be a useful prognostic marker in this population. We performed a systematic review and meta-analysis of the association between frailty and outcomes after TAVI.Methods and resultsFive databases were searched between January 2000 and May 2015. From 2623 articles screened, 54 were assessed for eligibility. Ten cohort studies (n = 4592) met the inclusion criteria of reporting a measure of frailty with early (<= 30 days) or late (>30 days) mortality and procedural complications following TAVI as defined by the Valve Academic Research Consortium (VARC). Frailty was associated with increased early mortality in four studies (n = 1900) (HR 2.35, 95% CI 1.78-3.09, P < 0.001) and increased late mortality in seven studies (n = 3159) (HR 1.63, 95% CI 1.34-1.97, P < 0.001). Objective frailty tools identified an even higher risk group for late mortality (HR 2.63, 95% CI 1.87-3.70, P < 0.001). Frail individuals undergoing TAVI have a mortality rate of 34 deaths per 100 patient years, compared with 19 deaths per 100 patient years in non-frail patients. There was limited reporting of VARC procedural outcomes in relation to frailty, preventing meta-analysis.ConclusionFrailty assessment in an already vulnerable TAVI population identifies individuals at even greater risk of poor outcomes. Use of objective frailty tools may inform patient selection, but this requires further assessment in large prospective registries.

BACKGROUNDParenteral fluids are commonly used in people with acute stroke with poor oral fluid intake. However, the balance between benefit and harm for different fluid regimens is unclear.OBJECTIVESTo assess whether different parenteral fluid regimens lead to differences in death, or death or dependence, after stroke based on fluid type, fluid volume, duration of fluid administration, and mode of delivery.SEARCH METHODSWe searched the Cochrane Stroke Group Trials Register (May 2015), the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews (CDSR) and the Database of Abstracts of Reviews of Effects (DARE) (Cochrane Library 2015, Issue 5), MEDLINE (2008 to May 2015), EMBASE (2008 to May 2015), and CINAHL (1982 to May 2015). We also searched ongoing trials registers (May 2015) and reference lists, performed cited reference searches, and contacted authors.SELECTION CRITERIARandomised trials of parenteral fluid regimens in adults with ischaemic or haemorrhagic stroke within seven days of stroke onset that reported death or dependence.DATA COLLECTION AND ANALYSISOne review author screened titles and abstracts. We obtained the full-text articles of relevant studies, and two review authors independently selected trials for inclusion and extracted data. We used Cochrane's tool for bias assessment.MAIN RESULTSWe included 12 studies (2351 participants: range 27 to 841).Characteristics: The 12 included studies compared hypertonic (colloids) with isotonic fluids (crystalloids); of these, five studies (1420 participants) also compared 0.9% saline with another fluid. No data were available to make other comparisons. Delay from stroke to recruitment varied from less than 24 hours to 72 hours. Duration of fluid delivery was between two hours and 10 days.Bias assessment: Investigators and participants in eight of the 12 included studies were blind to treatment allocation, seven of the 12 included studies gave details of randomisation, and eight of the 12 included studies reported all outcomes measured.RESULTSThere were no relevant completed trials that addressed the effect of volume, duration, or mode of fluid delivery on death or dependence in people with stroke.The odds of death or dependence were similar in participants allocated to colloids or crystalloid fluid regimens (odds ratio (OR) 0.97, 95% confidence interval (CI) 0.79 to 1.21, five studies, I² = 58%, low-quality evidence), and between 0.9% saline or other fluid regimens (OR 1.04, 95% CI 0.82 to 1.32, three studies, I² = 71%, low-quality evidence). There was substantial heterogeneity in these estimates.The odds of death were similar between colloids and crystalloids (OR 1.02, 95% CI 0.82 to 1.27, 12 studies, I² = 24%, moderate-quality evidence), and 0.9% saline and other fluids (OR 0.87, 95% CI 0.67 to 1.12, five studies, I² = 53%, low-quality evidence). The odds of pulmonary oedema were higher in participants allocated to colloids (OR 2.34, 95% CI 1.28 to 4.29, I² = 0%). Although the studies observed a higher risk of cerebral oedema (OR 0.20, 95% CI 0.02 to 1.74) and pneumonia (OR 0.58, 95% CI 0.17 to 2.01) with crystalloids, we could not exclude clinically important benefits or harms.AUTHORS' CONCLUSIONSWe found no evidence that colloids were associated with lower odds of death or dependence in the medium term after stroke compared with crystalloids, though colloids were associated with greater odds of pulmonary oedema. We found no evidence to guide the best volume, duration, or mode of parenteral fluid delivery for people with acute stroke.