Clinical Governance

Data from consecutive patients admitted to the cardiac intensive care unit (CICU) following cardiac surgery at Wythenshawe Hospital (part of Manchester University NHS Foundation trust) were collected prospectively between January 2013 and May 2015. Wythenshawe Hospital is a tertiary centre for adult cardiac surgery, cardiothoracic transplantation and mechanical circulatory support as a bridge to cardiac transplantation or recovery. Patients requiring RRT preoperatively and those with no preoperative creatinine values were excluded as shown in Fig. 1. Patients who received mechanical circulatory support were excluded from length of stay (LOS) analyses as their CICU stay was prolonged while awaiting definitive treatment. All data were collected as part of the Vascular Governance North West (VGNW) database and processed according this project’s protocols and ethical approvals.Fig. 1

Flow chart for inclusion of patients in analyses. RRT = renal replacement therapy, sCR = serum creatinine result, MCS = mechanical circulatory support, PLOS = prolonged length of stay

Serum creatinine concentration was usually measured daily and all available results were extracted from the hospital’s pathology laboratory database. Our institution’s laboratory measures creatinine using techniques based on Jaffe chemistry with a total imprecision of < 6%. Every creatinine value for each patient was analysed and both relative and absolute increases in creatinine were used to classify AKI stages according to the KDIGO criteria (Table 1). The relative increases were calculated using the most recently recorded preoperative level as the baseline value. Urine output was recorded hourly on the CICU electronic patient record. Where the hourly value was recorded as none or zero, this value was accepted whereas when no value was entered for a given hour the next volume of urine recorded was divided equally by the number of blank hours prior to this recording. Whenever urine output fell below the thresholds in the KDIGO criteria, the time and appropriate stage of AKI was recorded. The need for RRT and postoperative LOS on CICU were identified from the electronic patient record. Serum creatinine concentration and urine output measurements recorded after initiation of RRT were not included in analyses as both are influenced heavily by RRT itself.
The hospital clinical governance database recorded 2-year all-cause mortality and the preoperative comorbidity, urgency and complexity of surgery as measured by the logistic EuroSCORE [16 (link)]. Prolonged LOS was defined as a CICU stay longer than 120 h for cardiac transplant patients or > 72 h for all other patients.

The SMILE project will apply an observational prospective study design to follow a cohort of socioeconomically-diverse South Australian newborns and their primary care-givers (mothers will be used in this paper from here on), from birth until they reach toddler age. A multivariable, multilevel approach will be applied to data collection and analysis. The timeline and main groups of outcome and explanatory variables are outlined in Table 1.
The project has received ethical approval from the Southern Adelaide Clinical Human Research Ethics Committee (HREC # 50.13, approval date: 28 Feb 2013), the South Australian Women and Children Health Network (HREC # HREC/13/WCHN/69, approval date: 7 Aug 2013) and clinical governance clearance from the three participating maternity hospitals in Adelaide, Australia.
The study participant recruitment has commenced since July 2013 and is expected to last 12 months. The 3-month and 6-month data collection is ongoing.

The results of the systematic review of the literature on components of institutional care have been published elsewhere [10 (link)]. Eight domains of care were identified: living conditions; interventions for schizophrenia; physical health; restraint and seclusion; staff training and support; therapeutic relationship; autonomy and service user involvement; and clinical governance. The results of the Delphi exercise have also been previously reported [11 (link)] and eleven domains of care were identified: social policy and human rights; social inclusion; self management and autonomy; therapeutic interventions; governance; staffing; staff attitudes; therapeutic environment; post-discharge care; carers; physical health care [11 (link)]. Collation of each country's care standards by HK and TT identified seven domains: living environment; mental and physical health; therapeutic relationship; service users' rights and autonomy; service user involvement; staff training and support; clinical governance. The project steering committee (PSC) reviewed these findings and agreed on nine domains for inclusion in the toolkit (Living Environment; Treatments and Interventions including restraint and seclusion; Therapeutic Environment; Self-management and Autonomy; Social Policy, Citizenship and Advocacy; Clinical Governance; Social Interface; Human Rights; and Recovery Based Practice). These were further reviewed and agreed by an international panel of experts in social care, mental health rehabilitation, recovery based practice, service user experience, disability rights, international mental health law, international mental health policy and care standard setting.
Toolkit items for assessment of these domains were generated by the UK centres. The toolkit was designed to be completed by the manager of the facility since we were aware, due to the complexity of their mental health problems, that only some service users would have the capacity to complete such a measure. However, service users' experiences of care were assessed in a later Phase of the project to investigate the association between unit manager toolkit ratings and service user reports. Where possible, toolkit items were worded to avoid revealing which answer would lead to a higher quality rating. A mix of question formats was used (Likert scales, ordered categories, quantitative responses, binary responses, lists of yes/no's summed to create quantitative responses, and vignettes that asked the respondent to generate answers which were "checklisted" by the researcher and summed to give a quantitative response). The varied format of questions aimed to increase the accuracy of responses by avoiding a response set and make the toolkit more interesting to complete. The draft toolkit was reviewed by the PSC and the international expert panel and further questions were added if there was evidence for their inclusion from Phase 1 or if they appeared highly relevant across countries.
The toolkit was translated in each country and back translated by someone independent of the project. Back translations were reviewed at the lead centre in the UK and amendments agreed with each country. The toolkit was piloted in each country in one or two facilities. A training session was attended by all researchers involved in data collection to ensure clarity of understanding of all items and their scoring.

As primarily a retrospective service evaluation, the exploration has been registered and approved with Surrey and Borders Partnership NHS Foundation Trust clinical governance procedures (AU/002/10/2021). Service user/parental consent was obtained for each individual attending the National FASD Specialist Clinic for their anonymised data to be used in such evaluations to aid learning and to develop the clinic further. From all the cases seen in the National FASD Specialist Clinic since its origin in 2009, only a few cases declined to allow their data to be used for such purposes and were not included. Specific numbers for those declining are not held in the database. The database is ongoing and continues to develop.

Young people who participated in this study were users of a digital mental health service (Kooth.com). To be eligible to take part, young people had to have no previous engagement with counseling sessions within the service. Young people in the UK, commonly aged between 10 and 25 years, can access the digital mental health service online and anonymously register to receive web-based therapy services without cost. All participants for the study were required to have requested access to a synchronous text-based chat session with a practitioner in the digital service online and wait briefly until being seen by a practitioner. Data from young people were collected on the service between January 2021 and June 2021. Only data from young people using Kooth during that period who had explicitly provided research consent when using the service were available for this evaluation; no parental consent was sought for parents to preserve the safety of those aged under 16 years and anonymity during the evaluation; all users provided consent for research and evaluations at the point of registration at Kooth. Gender, age, and ethnicity were self-reported variables collected directly from the young people as part of the service sign-up process for the digital service. A service evaluation with the new measure alongside other comparator measures was deemed the best implementation approach to reduce disruption in the service (e.g., detracting people from accessing support due to research) and maintain clinical governance, as voluntary participation and information were provided prior to administering the instruments during the implementation of this instrument and the evaluation period.
Over this evaluation period, 1,401 young people accessed 1,901 chats within the service. On average, a young person accessed the chat 3.2 times during the study period (with a minimum of one and a maximum of 26 chats), and each chat lasted on average 52 min (SD = 21.6; extreme outliers removed). Young people who took part in the study were aged between 10 and 32 years, with an average age of 15.9 years (SD = 2.9). Most young people accessing the service were female (N = 1,087; 77.59%) from a white ethnic background (N = 1,111; 79.3%). In total, 1,435 (75.13%) chats included information about the participants' presenting concerns, as reported by practitioners. The majority indicated experiencing difficulties with anxiety/stress, suicidal thoughts, self-harm, and family relationships (Table 1).