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Abstract Background The Fostering Changes programme was developed by the Adoption and Fostering National Team at the Maudsley Hospital, South London, in conjunction with King’s College London. It is a 12-week group-based training programme for foster and kin carers, which aims to build positive relationships between carers and children, encourage positive child behaviour and set appropriate limits, through a practical skills-based approach. The programme also aims to improve foster carers’ understanding of the causes of children’s social and emotional difficulties and their confidence in applying this knowledge in various situations. Methods This is a pragmatic open-label individually randomised controlled trial, with embedded process evaluation. A total of 237 participants will be recruited from Welsh Local Authorities and Independent Fostering Providers; those allocated to the intervention group will be offered enrolment in the next Fostering Changes programme group at their site. Participants in the control group will be offered the Fostering Changes programme at the end of the follow-up period. Data will be collected at baseline, immediately following the 12 week Fostering Changes intervention, and 12 months from the start of the Fostering Changes programme. The primary outcome measure assesses the extent to which carers feel able to cope with and make positive changes to the lives of their foster children and is measured by the Carer Efficacy Questionnaire at 12 months. Discussion The trial will determine whether the Fostering Changes programme, in the long term, can deliver important, significant differences to the way foster carers build positive relationships with their foster children, encourage positive child behaviour and set appropriate limits, compared with usual care. Trial registration International Standard Randomised Controlled Trial Number, ISRCTN19090228 . Registered on 11 January 2017.

Abstract Background Pain after major lower limb amputation for peripheral arterial disease (PAD) is a significant problem. A perineural catheter (PNC) can be placed adjacent to the major nerve at the time of amputation with a continuous local anaesthetic infusion given postoperatively to try and reduce pain. Although low-quality observational data suggest that PNC usage reduces postoperative opioid requirements, there are limited data regarding its effect on pain. The aim of PLACEMENT is to explore the feasibility of running an effectiveness trial to assess the impact of a PNC with continuous local anaesthetic infusion, inserted at the time of amputation, on short and medium-term postoperative outcomes. Methods/design Fifty patients undergoing a major lower limb amputation (below or above the knee) for PAD will be recruited from two centres. Patients will be randomised in a 1:1 ratio to receive standard postoperative analgesia, with or without insertion of a PNC and local anaesthetic infusion for the first 5 postoperative days. Outcome data will be captured for the first 5 days, including pain scores (primary outcome, captured three times a day), opioid use, nausea or vomiting, itching, dizziness and complications. Patients will be contacted 2 and 6 months after surgery to assess quality of life, phantom limb pain, chronic stump pain and total healthcare costs. Semi-structured interviews will be conducted with at least 10 patients (dependent on saturation of analytic themes on preliminary coding) purposefully sampled to achieve variation in site and study arm. Interviews will explore patients’ perception of post-amputation pain and its treatment, and experience of study processes. Semi-structured interviews with 5–10 health professionals will explore feasibility, fidelity, and acceptability of the study. Data from this pilot will be used to assess feasibility of, and estimate parameters to calculate the sample size for an effectiveness trial. Full ethical approval has been granted (Wales Research Ethics Committee 3 reference number 16/WA/0353). Discussion PLACEMENT will be the first study to explore the feasibility of running an effectiveness trial on PNC usage for postoperative pain in amputees, and provide parameters to calculate the appropriate sample size for this study. Trial registration ISRCTN.com, ISRCTN85710690 . Registered on 21 October 2016. European Clinical Trials Database (EudraCT), 2016-003544-37. Registered on 24 August 2016.

Background: This update summarises key changes made to the protocol since the publication of the original protocol for the NAVKIDS2 trial of patient navigators for children with chronic kidney disease (CKD) experiencing social disadvantage and provides the statistical analysis plan (SAP) which has not previously been published.Methods/design: The original protocol was published in BMC Nephrology ( https://doi.org/10.1186/s12882-019-1325-y ) prior to the commencement of trial recruitment. During the course of the trial, some key methodological changes needed to be made including changes to eligibility criteria (addition of patients with CKD stages 1-2, broadening of financial status eligibility criterion, addition of patients living in rural/remote areas, modification of age eligibility to 0-16 years, addition of limits related to the language spoken by family, guidance regarding families with multiple eligible children), changes to sites, reduction of sample size, addition of virtual options for consent and study procedures in response to the COVID-19 pandemic, removal of staggered recruitment across sites, addition of outcomes, and changes to the timing and number of assessments. This update summarises the changes made and their rationale and provides the detailed plan for statistical analysis of the trial. These changes have been finalised prior to the completion of study follow-up and the commencement of data analysis.Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001152213 . Prospectively registered on 12 July 2018. [ABSTRACT FROM AUTHOR]

Background: The Fostering Changes programme was developed by the Adoption and Fostering National Team at the Maudsley Hospital, South London, in conjunction with King's College London. It is a 12-week group-based training programme for foster and kin carers, which aims to build positive relationships between carers and children, encourage positive child behaviour and set appropriate limits, through a practical skills-based approach. The programme also aims to improve foster carers' understanding of the causes of children's social and emotional difficulties and their confidence in applying this knowledge in various situations.Methods: This is a pragmatic open-label individually randomised controlled trial, with embedded process evaluation. A total of 237 participants will be recruited from Welsh Local Authorities and Independent Fostering Providers; those allocated to the intervention group will be offered enrolment in the next Fostering Changes programme group at their site. Participants in the control group will be offered the Fostering Changes programme at the end of the follow-up period. Data will be collected at baseline, immediately following the 12 week Fostering Changes intervention, and 12 months from the start of the Fostering Changes programme. The primary outcome measure assesses the extent to which carers feel able to cope with and make positive changes to the lives of their foster children and is measured by the Carer Efficacy Questionnaire at 12 months.Discussion: The trial will determine whether the Fostering Changes programme, in the long term, can deliver important, significant differences to the way foster carers build positive relationships with their foster children, encourage positive child behaviour and set appropriate limits, compared with usual care.Trial Registration: International Standard Randomised Controlled Trial Number, ISRCTN19090228 . Registered on 11 January 2017. [ABSTRACT FROM AUTHOR]

Background: Pain after major lower limb amputation for peripheral arterial disease (PAD) is a significant problem. A perineural catheter (PNC) can be placed adjacent to the major nerve at the time of amputation with a continuous local anaesthetic infusion given postoperatively to try and reduce pain. Although low-quality observational data suggest that PNC usage reduces postoperative opioid requirements, there are limited data regarding its effect on pain. The aim of PLACEMENT is to explore the feasibility of running an effectiveness trial to assess the impact of a PNC with continuous local anaesthetic infusion, inserted at the time of amputation, on short and medium-term postoperative outcomes.Methods/design: Fifty patients undergoing a major lower limb amputation (below or above the knee) for PAD will be recruited from two centres. Patients will be randomised in a 1:1 ratio to receive standard postoperative analgesia, with or without insertion of a PNC and local anaesthetic infusion for the first 5 postoperative days. Outcome data will be captured for the first 5 days, including pain scores (primary outcome, captured three times a day), opioid use, nausea or vomiting, itching, dizziness and complications. Patients will be contacted 2 and 6 months after surgery to assess quality of life, phantom limb pain, chronic stump pain and total healthcare costs. Semi-structured interviews will be conducted with at least 10 patients (dependent on saturation of analytic themes on preliminary coding) purposefully sampled to achieve variation in site and study arm. Interviews will explore patients' perception of post-amputation pain and its treatment, and experience of study processes. Semi-structured interviews with 5-10 health professionals will explore feasibility, fidelity, and acceptability of the study. Data from this pilot will be used to assess feasibility of, and estimate parameters to calculate the sample size for an effectiveness trial. Full ethical approval has been granted (Wales Research Ethics Committee 3 reference number 16/WA/0353).Discussion: PLACEMENT will be the first study to explore the feasibility of running an effectiveness trial on PNC usage for postoperative pain in amputees, and provide parameters to calculate the appropriate sample size for this study.Trial Registration: ISRCTN.com, ISRCTN85710690 . Registered on 21 October 2016. European Clinical Trials Database (EudraCT), 2016-003544-37. Registered on 24 August 2016. [ABSTRACT FROM AUTHOR]