A Prospective, Observational Cost Comparison of Laparoscopic and Open Appendicectomy in Three Tertiary Hospitals in Nigeria.

BACKGROUND: The clinical benefits of laparoscopic appendicectomy are well recognized over open appendicectomy. However, laparoscopic procedures are not frequently conducted in many low-and middle-income countries (LMICs) for several reasons, including perceived higher costs. The aim of this study was to assess the feasibility and cost of laparoscopic appendicectomy compared to open appendicectomy in Nigeria. METHODS: A multicenter, prospective, cohort study among patients undergoing appendicectomy was conducted at three tertiary hospitals in Nigeria. Data were collected from October 2020 to February 2022 and analyses compared the average healthcare costs at 30 days after surgery. Quantile regression was conducted to identify variables that had an impact on the costs, reported in Nigerian Naira (Naira) and US dollars ($), with standard deviations (SD). FINDINGS: This study included 105 patients, of which 39 had laparoscopic appendicectomy and 66 had open appendicectomy. The average healthcare cost of laparoscopic appendicectomy (147,562 Naira (SD: 97,130) or $355 (SD: 234)) was higher than open appendicectomy (113,556 Naira (SD: 88,559) or $273 (SD: 213)). The average time for return to work was shorter with laparoscopic than open appendicectomy (mean: 8 days vs. 14 days). At the average daily income of $5.06, laparoscopic appendicectomy was associated with 9778 Naira or $24 cost savings in return to work. Further, 5.1% of laparoscopic appendicectomy patients had surgical site infections compared to 22.7% for open appendicectomy. Regression analysis results showed that laparoscopic appendicectomy was associated with $14 higher costs than open appendicectomy, albeit non-significant (p = 0.53). INTERPRETATION: Despite selection bias in this real-world study, laparoscopic appendicectomy was associated with a slightly higher overall cost, a lower societal cost, a lower infection rate, and a faster return to work, compared to open appendicectomy. It is technically and financially feasible, and its provision in Nigeria should be expanded.

Reducing arthritis fatigue impact: two-year randomised controlled trial of cognitive behavioural approaches by rheumatology teams (RAFT).

OBJECTIVES: To see if a group course delivered by rheumatology teams using cognitive-behavioural approaches, plus usual care, reduced RA fatigue impact more than usual care alone. METHODS: Multicentre, 2-year randomised controlled trial in RA adults (fatigue severity>6/10, no recent major medication changes). RAFT (Reducing Arthritis Fatigue: clinical Teams using CB approaches) comprises seven sessions, codelivered by pairs of trained rheumatology occupational therapists/nurses. Usual care was Arthritis Research UK fatigue booklet. Primary 26-week outcome fatigue impact (Bristol RA Fatigue Effect Numerical Rating Scale, BRAF-NRS 0-10). Intention-to-treat regression analysis adjusted for baseline scores and centre. RESULTS: 308/333 randomised patients completed 26 week data (156/175 RAFT, 152/158 Control). Mean baseline variables were similar. At 26 weeks, the adjusted difference between arms for fatigue impact change favoured RAFT (BRAF-NRS Effect -0.59, 95% CI -1.11 to -0.06), BRAF Multidimensional Questionnaire (MDQ) Total -3.42 (95% CI -6.44 to -0.39), Living with Fatigue -1.19 (95% CI -2.17 to -0.21), Emotional Fatigue -0.91 (95% CI -1.58 to -0.23); RA Self-Efficacy (RASE, +3.05, 95% CI 0.43 to 5.66) (14 secondary outcomes unchanged). Effects persisted at 2 years: BRAF-NRS Effect -0.49 (95% CI -0.83 to -0.14), BRAF MDQ Total -2.98 (95% CI -5.39 to -0.57), Living with Fatigue -0.93 (95% CI -1.75 to -0.10), Emotional Fatigue -0.90 (95% CI -1.44, to -0.37); BRAF-NRS Coping +0.42 (95% CI 0.08 to 0.77) (relevance of fatigue impact improvement uncertain). RAFT satisfaction: 89% scored > 8/10 vs 54% controls rating usual care booklet (p<0.0001). CONCLUSION: Multiple RA fatigue impacts can be improved for 2 years by rheumatology teams delivering a group programme using cognitive behavioural approaches. TRIAL REGISTRATION NUMBER: ISRCTN52709998.

A process evaluation of the PLAN-A intervention (Peer-Led physical Activity iNtervention for Adolescent girls).

BACKGROUND: Few adolescent girls engage in enough physical activity (PA) to meet recommendations and there is a need for new interventions to increase girls PA. We have previously published the results of the PLAN-A cluster randomised feasibility trial which was a peer-led school-based PA intervention, showing that the intervention was feasible and held promise to increase the PA of girls aged 12-13 years. In PLAN-A, pupils nominated by their peers as influential attend training to teach them how to influence, promote and normalise physical activity amongst their peer-group. This paper reports the results of the process evaluation of the PLAN-A feasibility study, specifically focussing on acceptability to key stakeholders, intervention fidelity, receipt/experiences and perceived effect and suggested intervention refinements before proceeding to a definitive RCT. METHODS: A mixed-methods process evaluation triangulated data from qualitative focus groups and interviews with peer-supporter and non peer-supporter pupils (N = 52), parents (N = 12), teachers (N = 6) and intervention training deliverers (N = 5), quantitative questionnaires, and observations of intervention delivery. Quantitative data were analysed descriptively, and qualitative data were analysed with the Framework Method. RESULTS: The duration, timings, content and delivery of the peer-supporter training were acceptable. There was good fidelity to the intervention manual and its underpinning theory including high fulfilment of session objectives and use of an autonomy-supportive motivational style. Peer-supporters engaged with and enjoyed the training and retained key peer-supporter messages (what counts as PA, encouragement, empathy and subtlety). Parents and teachers were supportive of the intervention and reported perceived effects including increased PA and awareness of it, improved peer relationships, and confidence. Suggested intervention refinements included increasing participatory learning, reducing technical jargon, and providing more support to overcome challenges to giving peer support. CONCLUSIONS: PLAN-A can be delivered as planned, is well-received, and appears to be effective in empowering adolescent girls to support their peer group to become more active. The refinements identified can be made within the original intervention structure, before proceeding to a definitive trial. TRIAL REGISTRATION: ISCTRN, ISRCTN12543546 , Registered on 28/7/2015.

Results of a feasibility cluster randomised controlled trial of a peer-led school-based intervention to increase the physical activity of adolescent girls (PLAN-A).

BACKGROUND: Most adolescent girls in the UK do not meet government physical activity recommendations and effective interventions are needed. This study reports the results of a feasibility trial of PLAN-A, a novel school-based peer-led physical activity intervention for adolescent girls. METHODS: A two-arm cluster randomised controlled feasibility study was conducted in six English secondary schools (4 intervention & 2 control). Year 8 (age 12-13) girls were eligible and randomisation was at school-level. The intervention involved training Year 8 girls (out of school for two consecutive days, plus one top-up day 5 weeks later), who were identified by their peers as influential, to provide informal support to their friends to increase their physical activity. Feasibility of the intervention and the research was examined, including: recruitment, training attendance and data provision rates, evidence of promise of the intervention to affect weekday moderate-to-vigorous physical activity (MVPA), intervention cost and estimation of the sample size for a definitive trial. Accelerometer and questionnaire data were collected at the beginning of Year 8 (Time 0), the end of Year 8 (10-weeks after peer-supporter training) and the beginning of Year 9 (Time 2). RESULTS: Four hundred twenty-seven girls were recruited (95% recruitment rate). 55 girls consented to be a peer-supporter and 53 peer-supporters were trained (97% of those invited). Accelerometer return rates exceeded 85% at each time point and wear time criteria was met by 83%, 71% and 62% participants at Time 0, 1 and 2 respectively. Questionnaire data were provided by >91% of participants at each time point. Complete-case adjusted linear regression analysis showed evidence of a 6.09 minute (95% CI = 1.43, 10.76) between-arms difference in weekday MVPA at Time 2 in favour of the intervention arm. On average PLAN-A cost £2685 per school to deliver (£37 per Year 8 girl). There were no adverse events. A trial involving 20 schools would be adequately powered to detect a between-arms difference in weekday MVPA of at least six minutes. CONCLUSIONS: The PLAN-A intervention adopts a novel peer-led approach, is feasible, and shows evidence of promise to positively affect girls' physical activity levels. A definitive trial is warranted. TRIAL REGISTRATION: ISCTRN, ISRCTN12543546, Registered on 28/7/2015, URL of registry record: http://www.isrctn.com/ISRCTN12543546.

Protocol for a cluster randomised controlled trial of an intervention to improve the mental health support and training available to secondary school teachers - the WISE (Wellbeing in Secondary Education) study.

BACKGROUND: Teachers are reported to be at increased risk of common mental health disorders compared to other occupations. Failure to support teachers adequately may lead to serious long-term mental disorders, poor performance at work (presenteeism), sickness absence and health-related exit from the profession. It also jeopardises student mental health, as distressed staff struggle to develop supportive relationships with students, and such relationships are protective against student depression. A number of school-based trials have attempted to improve student mental health, but these have mostly focused on classroom based approaches and have failed to establish effectiveness. Only a few studies have introduced training for teachers in supporting students, and none to date have included a focus on improving teacher mental health. This paper sets out the protocol (version 4.4 20/07/16) for a study aiming to address this gap. METHODS: Cluster randomised controlled trial with secondary schools as the unit of randomisation. Intervention schools will receive: i) Mental Health First Aid (MHFA) training for a group of staff nominated by their colleagues, after which they will set up a confidential peer support service for colleagues ii) training in MHFA for schools and colleges for a further group of teachers, which will equip them to more effectively support student mental health iii) a short mental health awareness raising session and promotion of the peer support service for all teachers. Comparison schools will continue with usual practice. The primary outcome is teacher wellbeing measured using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcomes are teacher depression, absence and presenteeism, and student wellbeing, mental health difficulties, attendance and attainment. Measures will be taken at baseline, one year follow up (teachers only) and two year follow up. Economic and process evaluations will be embedded within the study. DISCUSSION: This study will establish the effectiveness and cost-effectiveness of an intervention that supports secondary school teachers' wellbeing and mental health, and improves their skills in supporting students. It will also provide information regarding intervention implementation and sustainability. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN95909211 registered 24/03/16.

Safety and effectiveness of surgical fixation versus non-surgical methods for the treatment of flail chest in adult populations: a systematic review and meta-analysis.

PURPOSE: The objective of this systematic review is to compare the safety and efficacy of surgical fixation of rib fractures against non-surgical interventions for the treatment of flail chest in the adult population. METHODS: A search was performed on the 22nd of July 2020 to identify articles comparing surgical fixation versus clinical management for flail chest in adults, with a description of the outcome parameters (resource utility, mortality, adverse effects of the intervention and adverse progression in pulmonary status). Relevant randomised controlled trials were selected, their risk of bias assessed, and the data then extracted and analysed. RESULTS: 157 patients were included from four studies in the analyses, with 79 and 78 patients in the surgical and non-surgical groups, respectively. The pooled effects of all outcomes tended towards favouring surgical intervention. Surgical intervention was associated with lower rates of pneumonia (I2 = 46%, Tau2 = 0.16, p = 0.16), significantly lower rates of tracheostomy (I2 = 76%, Tau2 = 0.67, p = 0.02), and a significantly lower duration of mechanical ventilation (I2 = 88%, Tau2 = 33.7, p < 0.01) in comparison to the non-surgical management methods. CONCLUSION: Our results suggest that surgical intervention reduces the need for tracheostomy, reduces the time spent in the intensive care unit following a traumatic flail chest injury and could reduce the risk of acquiring pneumonia after such an event. There is a need for further well-designed studies with sufficient sample sizes to confirm the results of this study and also detect other possible effects of surgical intervention in the treatment of traumatic flail chest in adults.

Group cognitive-behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations.

BACKGROUND: Fatigue is a major problem in rheumatoid arthritis (RA). There is evidence for the clinical effectiveness of cognitive-behavioural therapy (CBT) delivered by clinical psychologists, but few rheumatology units have psychologists. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of a group CBT programme for RA fatigue [named RAFT, i.e. Reducing Arthritis Fatigue by clinical Teams using cognitive-behavioural (CB) approaches], delivered by the rheumatology team in addition to usual care (intervention), with usual care alone (control); and to evaluate tutors' experiences of the RAFT programme. DESIGN: A randomised controlled trial. Central trials unit computerised randomisation in four consecutive cohorts within each of the seven centres. A nested qualitative evaluation was undertaken. SETTING: Seven hospital rheumatology units in England and Wales. PARTICIPANTS: Adults with RA and fatigue severity of ≥ 6 [out of 10, as measured by the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale (BRAF-NRS)] who had no recent changes in major RA medication/glucocorticoids. INTERVENTIONS: RAFT - group CBT programme delivered by rheumatology tutor pairs (nurses/occupational therapists). Usual care - brief discussion of a RA fatigue self-management booklet with the research nurse. MAIN OUTCOME MEASURES: Primary - fatigue impact (as measured by the BRAF-NRS) at 26 weeks. Secondary - fatigue severity/coping (as measured by the BRAF-NRS); broader fatigue impact [as measured by the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)]; self-reported clinical status; quality of life; mood; self-efficacy; and satisfaction. All data were collected at weeks 0, 6, 26, 52, 78 and 104. In addition, fatigue data were collected at weeks 10 and 18. The intention-to-treat analysis conducted was blind to treatment allocation, and adjusted for baseline scores and centre. Cost-effectiveness was explored through the intervention and RA-related health and social care costs, allowing the calculation of quality-adjusted life-years (QALYs) with the EuroQol-5 Dimensions, five-level version (EQ-5D-5L). Tutor and focus group interviews were analysed using inductive thematic analysis. RESULTS: A total of 308 out of 333 patients completed 26 weeks (RAFT, n/N = 156/175; control, n/N = 152/158). At 26 weeks, the mean BRAF-NRS impact was reduced for the RAFT programme (-1.36 units; p < 0.001) and the control interventions (-0.88 units; p < 0.004). Regression analysis showed a difference between treatment arms in favour of the RAFT programme [adjusted mean difference -0.59 units, 95% confidence interval (CI) -1.11 to -0.06 units; p = 0.03, effect size 0.36], and this was sustained over 2 years (-0.49 units, 95% CI -0.83 to -0.14 units; p = 0.01). At 26 weeks, further fatigue differences favoured the RAFT programme (BRAF-MDQ fatigue impact: adjusted mean difference -3.42 units, 95% CI -6.44 to - 0.39 units, p = 0.03; living with fatigue: adjusted mean difference -1.19 units, 95% CI -2.17 to -0.21 units, p = 0.02; and emotional fatigue: adjusted mean difference -0.91 units, 95% CI -1.58 to -0.23 units, p = 0.01), and these fatigue differences were sustained over 2 years. Self-efficacy favoured the RAFT programme at 26 weeks (Rheumatoid Arthritis Self-Efficacy Scale: adjusted mean difference 3.05 units, 95% CI 0.43 to 5.6 units; p = 0.02), as did BRAF-NRS coping over 2 years (adjusted mean difference 0.42 units, 95% CI 0.08 to 0.77 units; p = 0.02). Fatigue severity and other clinical outcomes were not different between trial arms and no harms were reported. Satisfaction with the RAFT programme was high, with 89% of patients scoring ≥ 8 out of 10, compared with 54% of patients in the control arm rating the booklet (p < 0.0001); and 96% of patients and 68% of patients recommending the RAFT programme and the booklet, respectively, to others (p < 0.001). There was no significant difference between arms for total societal costs including the RAFT programme training and delivery (mean difference £434, 95% CI -£389 to £1258), nor QALYs gained (mean difference 0.008, 95% CI -0.008 to 0.023). The probability of the RAFT programme being cost-effective was 28-35% at the National Institute for Health and Care Excellence's thresholds of £20,000-30,000 per QALY. Tutors felt that the RAFT programme's CB approaches challenged their usual problem-solving style, helped patients make life changes and improved tutors' wider clinical practice. LIMITATIONS: Primary outcome data were missing for 25 patients; the EQ-5D-5L might not capture fatigue change; and 30% of the 2-year economic data were missing. CONCLUSIONS: The RAFT programme improves RA fatigue impact beyond usual care alone; this was sustained for 2 years with high patient satisfaction, enhanced team skills and no harms. The RAFT programme is < 50% likely to be cost-effective; however, NHS costs were similar between treatment arms. FUTURE WORK: Given the paucity of RA fatigue interventions, rheumatology teams might investigate the pragmatic implementation of the RAFT programme, which is low cost. TRIAL REGISTRATION: Current Controlled Trials ISRCTN52709998. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 57. See the NIHR Journals Library website for further project information.

Rheumatoid arthritis (RA) is a lifelong inflammatory condition affecting multiple joints, with fatigue as a major consequence. Cognitive­behavioural therapy (CBT) helps patients work out links between symptoms, behaviours and thoughts driving those behaviours (e.g. why someone pushes on when exhausted), and understanding these links helps patients make changes. A CBT programme for groups of RA patients, facilitated by a psychologist, reduces fatigue impact. However, few rheumatology teams have psychologists. The study tested whether or not rheumatology nurses and occupational therapists (OTs) could facilitate the programme [named RAFT, i.e. Reducing Arthritis Fatigue by clinical Teams using cognitive­behavioural (CB) approaches] after brief training. The study compared the RAFT programme with usual care for RA fatigue (i.e. a short discussion of an arthritis fatigue booklet). All 333 patients received usual care, and then half of the patients were allocated (by chance) to also attend the seven-session RAFT programme. The study compared the RAFT programme with usual care for effects on fatigue, quality of life, cost and value for money. In addition, the rheumatology nurse and OT RAFT tutors were interviewed for their views on the RAFT programme. The study found that patients' fatigue impact was reduced by both the RAFT programme and usual care at 6 months and 2 years, but patients undertaking the RAFT programme improved significantly more than those receiving usual care alone. Differences were seen for improvements in fatigue impact, fatigue coping, emotional fatigue and living with fatigue. Patients were very satisfied with the RAFT programme and attended most of the sessions. The study found no significant difference between the NHS costs of the RAFT programme and usual care. Neither the RAFT programme nor usual care changed quality of life; therefore, standard value-for-money tests showed no difference between them. Tutors found that the CB questioning approach of the RAFT programme was different from their usual problem-solving style, but helped patients make life changes, and the new CB skills improved tutors' wider clinical practice. In conclusion, the trial has shown that the RAFT programme has a small to medium effect on reducing fatigue impact in patients with RA and is a potentially low-cost intervention that can be delivered by rheumatology nurses and OTs rather than a psychologist.

A cluster randomised controlled trial of the Wellbeing in Secondary Education (WISE) Project - an intervention to improve the mental health support and training available to secondary school teachers: protocol for an integrated process evaluation.

BACKGROUND: Secondary school teachers have low levels of wellbeing and high levels of depression compared with the general population. Teachers are in a key position to support students, but poor mental health may be a barrier to doing so effectively. The Wellbeing in Secondary Education (WISE) project is a cluster randomised controlled trial (RCT) of an intervention to improve the mental health support and training available to secondary school teachers through delivery of the training package Mental Health First Aid and a staff peer support service. We will conduct a process evaluation as part of the WISE trial to support the interpretation of trial outcomes and refine intervention theory. The domains assessed will be: the extent to which the hypothesised mechanisms of change are activated; system level influences on these mechanisms; programme differentiation and usual practice; intervention implementation, including any adaptations; intervention acceptability; and intervention sustainability. METHODS: Research questions will be addressed via quantitative and qualitative methods. All study schools (n = 25) will provide process evaluation data, with more detailed focus group, interview and observation data being collected from a subsample of case study schools (4 intervention and 4 control). Mechanisms of change, as outlined in a logic model, will be measured via teacher and student surveys and focus groups. School context will be explored via audits of school practice that relate to mental health and wellbeing, combined with stakeholder interviews and focus groups. Implementation of the training and peer support service will be assessed via training observations, training participant evaluation forms, focus groups with participants, interviews with trainers and peer support service users, and peer supporter logs recording help provided. Acceptability and sustainability will be examined via interviews with funders, head teachers, trainers and peer support services users, and focus groups with training participants. DISCUSSION: The process evaluation embedded within the WISE cluster RCT will illuminate how and why the intervention was effective, ineffective or conferred iatrogenic effects. It will contribute to the refinement of the theory underpinning the intervention, and will help to inform any future implementation. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN95909211 registered on 24 March 2016.

Update to a protocol for a feasibility cluster randomised controlled trial of a peer-led school-based intervention to increase the physical activity of adolescent girls (PLAN-A).

BACKGROUND: Physical activity levels are low amongst adolescent girls, and this population faces specific barriers to being active. Peer influences on health behaviours are important in adolescence, and peer-led interventions might hold promise to change behaviour. This paper describes the protocol for a feasibility cluster randomised controlled trial of Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A), a peer-led intervention aimed at increasing adolescent girls' physical activity levels. In addition, this paper describes an update that has been made to the protocol for the PLAN-A feasibility cluster randomised controlled trial. METHODS/DESIGN: A two-arm cluster randomised feasibility trial will be conducted in six secondary schools (intervention n = 4; control n = 2) with year 8 (12-13 years old) girls. The intervention will operate at a year group level and consist of year 8 girls nominating influential peers within their year group to become peer supporters. Approximately 15% of the cohort will receive 3 days of training about physical activity and interpersonal communication skills. Peer supporters will then informally diffuse messages about physical activity amongst their friends for 10 weeks. Data will be collected at baseline (time 0 (T0)), immediately after the intervention (time 1 (T1)) and 12 months after baseline measures (time 2 (T2)). In this feasibility trial, the primary interest is in the recruitment of schools and participants (both year 8 girls and peer supporters), delivery and receipt of the intervention, data provision rates and identifying the cost categories for future economic analysis. Physical activity will be assessed using 7-day accelerometry, with the likely primary outcome in a fully powered trial being daily minutes of moderate-to-vigorous physical activity. Participants will also complete psychosocial questionnaires at each time point: assessing motivation, self-esteem and peer physical activity norms. Data analysis will be largely descriptive and focus on recruitment, attendance and data provision rates. The findings will inform the sample size required for a definitive trial. A detailed process evaluation using qualitative and quantitative methods will be conducted with a variety of stakeholders (i.e. pupils, parents, teachers and peer-supporter trainers) to identify areas of success and necessary improvements prior to proceeding to a definitive trial. DISCUSSION: The study will provide the information necessary to design a fully powered trial should PLAN-A demonstrate evidence of promise. This paper describes an update to the protocol for the PLAN-A feasibility cluster randomised controlled trial related to the data-linkage component. TRIAL REGISTRATION: ISRCTN12543546.