Developing and evaluating the implementation of a complex intervention: using mixed methods to inform the design of a randomised controlled trial of an oral healthcare intervention after stroke

<p>Abstract</p> <p>Background</p> <p>Many interventions delivered within the stroke rehabilitation setting could be considered complex, though some are more complex than others. The degree of complexity might be based on the number of and interactions between levels, components and actions targeted within the intervention. The number of (and variation within) participant groups and the contexts in which it is delivered might also reflect the extent of complexity. Similarly, designing the evaluation of a complex intervention can be challenging. Considerations include the necessity for intervention standardisation, the multiplicity of outcome measures employed to capture the impact of a multifaceted intervention and the delivery of the intervention across different clinical settings operating within varying healthcare contexts. Our aim was to develop and evaluate the implementation of a complex, multidimensional oral health care (OHC) intervention for people in stroke rehabilitation settings which would inform the development of a randomised controlled trial.</p> <p>Methods</p> <p>After reviewing the evidence for the provision of OHC following stroke, multi-disciplinary experts informed the development of our intervention. Using both quantitative and qualitative methods we evaluated the implementation of the complex OHC intervention across patients, staff and service levels of care. We also adopted a pragmatic approach to patient recruitment, the completion of assessment tools and delivery of OHC, alongside an attention to the context in which it was delivered.</p> <p>Results</p> <p>We demonstrated the feasibility of implementing a complex OHC intervention across three levels of care. The complementary nature of the mixed methods approach to data gathering provided a complete picture of the implementation of the intervention and a detailed understanding of the variations within and interactions between the components of the intervention. Information on the feasibility of the outcome measures used to capture impact across a range of components was also collected, though some process orientated uncertainties including eligibility and recruitment rates remain to be further explored within a Phase II exploratory trial.</p> <p>Conclusions</p> <p>Complex interventions can be captured and described in a manner which facilitates evaluation in the form of exploratory and subsequently definitive clinical trials. If effective, the evidence captured relating to the intervention context will facilitate translation into clinical practice.</p

New loci associated with birth weight identify genetic links between intrauterine growth and adult height and metabolism.

Birth weight within the normal range is associated with a variety of adult-onset diseases, but the mechanisms behind these associations are poorly understood. Previous genome-wide association studies of birth weight identified a variant in the ADCY5 gene associated both with birth weight and type 2 diabetes and a second variant, near CCNL1, with no obvious link to adult traits. In an expanded genome-wide association meta-analysis and follow-up study of birth weight (of up to 69,308 individuals of European descent from 43 studies), we have now extended the number of loci associated at genome-wide significance to 7, accounting for a similar proportion of variance as maternal smoking. Five of the loci are known to be associated with other phenotypes: ADCY5 and CDKAL1 with type 2 diabetes, ADRB1 with adult blood pressure and HMGA2 and LCORL with adult height. Our findings highlight genetic links between fetal growth and postnatal growth and metabolism

Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study

Background: The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on postoperative recovery needs to be understood to inform clinical decision making during and after the COVID-19 pandemic. This study reports 30-day mortality and pulmonary complication rates in patients with perioperative SARS-CoV-2 infection. Methods: This international, multicentre, cohort study at 235 hospitals in 24 countries included all patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery. The primary outcome measure was 30-day postoperative mortality and was assessed in all enrolled patients. The main secondary outcome measure was pulmonary complications, defined as pneumonia, acute respiratory distress syndrome, or unexpected postoperative ventilation. Findings: This analysis includes 1128 patients who had surgery between Jan 1 and March 31, 2020, of whom 835 (74·0%) had emergency surgery and 280 (24·8%) had elective surgery. SARS-CoV-2 infection was confirmed preoperatively in 294 (26·1%) patients. 30-day mortality was 23·8% (268 of 1128). Pulmonary complications occurred in 577 (51·2%) of 1128 patients; 30-day mortality in these patients was 38·0% (219 of 577), accounting for 81·7% (219 of 268) of all deaths. In adjusted analyses, 30-day mortality was associated with male sex (odds ratio 1·75 [95% CI 1·28–2·40], p\textless0·0001), age 70 years or older versus younger than 70 years (2·30 [1·65–3·22], p\textless0·0001), American Society of Anesthesiologists grades 3–5 versus grades 1–2 (2·35 [1·57–3·53], p\textless0·0001), malignant versus benign or obstetric diagnosis (1·55 [1·01–2·39], p=0·046), emergency versus elective surgery (1·67 [1·06–2·63], p=0·026), and major versus minor surgery (1·52 [1·01–2·31], p=0·047). Interpretation: Postoperative pulmonary complications occur in half of patients with perioperative SARS-CoV-2 infection and are associated with high mortality. Thresholds for surgery during the COVID-19 pandemic should be higher than during normal practice, particularly in men aged 70 years and older. Consideration should be given for postponing non-urgent procedures and promoting non-operative treatment to delay or avoid the need for surgery. Funding: National Institute for Health Research (NIHR), Association of Coloproctology of Great Britain and Ireland, Bowel and Cancer Research, Bowel Disease Research Foundation, Association of Upper Gastrointestinal Surgeons, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, and Yorkshire Cancer Research

Top ten research priorities relating to stroke nursing.

No abstract available

Development of a new model to engage patients and clinicians in setting research priorities

Objectives Equitable involvement of patients and clinicians in setting research and funding priorities is ethically desirable and can improve the quality, relevance and implementation of research. Survey methods used in previous priority setting projects to gather treatment uncertainties may not be sufficient to facilitate responses from patients and their lay carers for some health care topics. We aimed to develop a new model to engage patients and clinicians in setting research priorities relating to life after stroke, and to explore the use of this model within a James Lind Alliance (JLA) priority setting project. Methods We developed a model to facilitate involvement through targeted engagement and assisted involvement (FREE TEA model). We implemented both standard surveys and the FREE TEA model to gather research priorities (treatment uncertainties) from people affected by stroke living in Scotland. We explored and configured the number of treatment uncertainties elicited from different groups by the two approaches. Results We gathered 516 treatment uncertainties from stroke survivors, carers and health professionals. We achieved approximately equal numbers of contributions; 281 (54%) from stroke survivors/carers; 235 (46%) from health professionals. For stroke survivors and carers, 98 (35%) treatment uncertainties were elicited from the standard survey and 183 (65%) at FREE TEA face-to-face visits. This contrasted with the health professionals for whom 198 (84%) were elicited from the standard survey and only 37 (16%) from FREE TEA visits. Conclusions The FREE TEA model has implications for future priority setting projects and user-involvement relating to populations of people with complex health needs. Our results imply that reliance on standard surveys may result in poor and unrepresentative involvement of patients, thereby favouring the views of health professionals. </jats:sec

Top 10 research priorities relating to stroke nursing: a rigorous approach to establish a national nurse-led research agenda

AimTo determine the top 10 research priorities specific to stroke nursing.BackgroundIt is important that stroke nurses build their research capability and capacity. This project built on a previous James Lind Alliance prioritization project, which established the shared stroke research priorities of stroke survivors, carers and health professionals.DesignResearch priority setting project using James Lind Alliance methods; a survey for interim prioritization and a consensus meeting for final priority setting.MethodsBetween September - November 2014, stroke nurses were invited to select their top 10 priorities from a previously established list of 226 unique unanswered questions. These data were used to generate a list of shared research priorities (interim priority setting stage). A purposefully selected group of stroke nurses attended a final consensus meeting (April 2015) to determine the top 10 research priorities.ResultsDuring the interim prioritization stage, 97 stroke nurses identified 28 shared priority treatment uncertainties. At the final consensus meeting, 27 stroke nurses reached agreement on the top 10 stroke nursing research priorities. Five of the top 10 questions relate to stroke-specific impairments and five relate to rehabilitation and long-term consequences of stroke.ConclusionsThe research agenda for stroke nursing has now been clearly defined, facilitating nurses to undertake research, which is of importance to stroke survivors and carers and central to supporting optimal recovery and quality of life after stroke