ObjectivesTo assess the feasibility of using video recordings of neonatal resuscitation (NR) to evaluate the quality of care in a low-resource district hospital.DesignProspective observational feasibility study.SettingChake-Chake Hospital, a district hospital in Pemba, Tanzania, in April and May 2019.ParticipantsAll delivering women and their newborns were eligible for participation.Main outcome measuresMotion-triggered cameras were mounted on resuscitation tables and provided recordings that were analysed for quality of care indicators based on the national NR algorithm. Assessment of feasibility was conducted using Bowen’s 8-point framework for feasibility studies.Results91% (126 of 139) of women and 96% (24 of 26) of health workers were comfortable or very comfortable with the video recordings. Of 139 newborns, 8 underwent resuscitation with bag and mask ventilation. In resuscitations, heat loss prevention measures were not performed in half of the cases (four of eight), clearing the airway was not performed correctly in five of eight cases, and all newborns were suctioned vigorously and repeatedly, even when not indicated. In a quarter (two of eight) of cases, the newborn’s head was not positioned correctly. Additionally, two of the eight newborns needing ventilation were not ventilated within the first minute of life. In none of the eight cases did ventilation appear to be performed effectively.ConclusionsIt proved feasible to use video recordings to assess quality of care during NR in a low-resource setting, and the method was considered acceptable for the delivering women and health workers. Recordings of eight resuscitations all demonstrated deviations from NR guidelines.

IntroductionIn the management of type 2 diabetes, autonomy-supporting interventions may be a prerequisite to achieving more long-term improvement. Preliminary evidence has shown that the guided self-determination (GSD) method might have an effect on haemoglobin A1c and diabetes distress in people with type 1 diabetes. Previous trials were at risk of uncertainty. Thus, the objective is to investigate the benefits and harms of a GSD intervention versus an attention control group intervention in adults with type 2 diabetes.Methods and analysisThis trial protocol is guided by the The Standard Protocol Items: Recommendations for International Trials Statement. We describe the protocol for a pragmatic randomised, dual-centre, parallel-group, superiority clinical trial testing a GSD intervention versus an attention control for people with type 2 diabetes in outpatient clinics. The participants (n=224) will be recruited from two diverse regions of Denmark. The experimental stepped-care intervention will consist of three to five GSD sessions lasting up to 1 hour with a trained GSD facilitator. The sessions will be conducted face to face, by video conference or over the telephone. The attention controls will receive three to five sessions lasting up to an hour with a communication-trained healthcare professional provided face to-face, by video conference, or over the telephone. Participants will be included if they have type 2 diabetes,>18 years old, are not pregnant. Participants will be assessed before randomisation, at 5-month, and 12-month follow-up, the latter being the primary. The primary outcome is diabetes distress. Secondary outcomes are quality of life, depressive symptoms and non-serious adverse events. Exploratory outcomes are haemoglobin A1c, motivation and serious adverse events. Data will be collected using REDCap and analysed using Stata V.16.Ethics and disseminationThe trial will be conducted in compliance with the protocol, the Helsinki Declaration in its latest form, International Harmonisation of Good Clinical Practice guidelines and the applicable regulatory requirement(s). The trial has been approved by the Danish Data Protection Agency (P-2020-864). The Ethics Committee of the Capital Region of Denmark reviewed the trial protocol, but exempted the trial protocol from full review (H-20003638). The results of the trial will be presented at the outpatient clinics treating people with type 2 diabetes, at national and international conferences as well as to associations for people with diabetes and their relatives.Trial registration numberClinicalTrials.gov identifier: NCT04601311.

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Background Autonomy supporting interventions, such as self-determination theory and guided self-determination interventions, may be a prerequisite to achieve long-term improvements in people with diabetes. Such interventions have never been systematically reviewed assessing benefits and harms and controlling the risks of random errors using trial sequential analysis methodology. This systematic review investigates the benefits and harms of self-determination theory-based interventions versus usual care in people with diabetes. Methods We followed Cochrane guidelines and the PRISMA checklist. Randomized clinical trials assessing interventions theoretically based on guided self-determination or self-determination theory in any setting were included. A comprehensive search (latest search April 2022) was undertaken in CENTRAL, MEDLINE, EMBASE, LILACS, PsycINFO, SCI-EXPANDED, CINAHL, SSCI, CPCI-S, and CPCI-SSH to identify relevant trials. Our primary outcomes were quality of life, all-cause mortality, and serious adverse events. Our secondary outcomes were diabetes distress, depressive symptoms, and non-serious adverse events not considered serious. Exploratory outcomes were glycated hemoglobin and motivation (autonomy, controlled, amotivation). Outcomes were assessed at the end of the intervention (primary timepoint) and at maximum follow-up. The analyses were conducted using Review Manager 5.4 and Trial Sequential Analysis 0.9.5.10. Two authors independently screened, extracted data, and performed risk of bias assessment of included trials using the Cochrane risk of bias tool 1.0. Certainty of the evidence was assessed by GRADE. Results Our search identified 5578 potentially eligible studies of which 11 randomized trials (6059 participants) were included. All trials were assessed at overall high risk of bias. We found no effect of self-determination theory-based interventions compared with usual care on quality of life (mean difference 0.00 points, 95% CI -4.85, 4.86, I2=0%; 225 participants, 3 trials, TSA-adjusted CI -11.83, 11.83), all-cause mortality, serious adverse events, diabetes distress, depressive symptoms, adverse events, glycated hemoglobulin A1c, or motivation (controlled). The certainty of the evidence was low to very low for all outcomes. We found beneficial effect on motivation (autonomous and amotivation; low certainty evidence). Conclusions We found no effect of self-determination-based interventions on our primary or secondary outcomes. The evidence was of very low certainty. Systematic review registration The protocol has been registered in PROSPERO reg.no CRD42020181144.