BackgroundThe rate of elective Caesarean Section (CS) is rising in many countries. Many obstetric units in the UK have either introduced or are planning to introduce enhanced recovery (ER) as a means of reducing length of stay for planned CS. However, to date there has been very little evidence produced regarding the necessary components of ER for the obstetric population. We conducted a rapid review of the composition of published ER pathways for elective CS and undertook an umbrella review of systematic reviews evaluating ER components and pathways in any surgical setting.MethodsPathways were identified using MEDLINE, EMBASE and the National Guideline Clearing House, appraised using the Appraisal of Guidelines for Research and Evaluation (AGREE II) tool and their components tabulated. Systematic reviews were identified using the Cochrane Library and Database of Abstracts of Reviews of Effects (DARE) and appraised using The Grading of Recommendations Assessment, Development and Evaluation (GRADE). Two reviewers aggregated summaries of findings for Length of Stay (LoS).ResultsFive clinical protocols were identified, involving a total of 25 clinical components; 3/25 components were common to all five pathways (early oral intake, mobilization and removal of urinary catheter). AGREE II scores were generally low. Systematic reviews of single components found that minimally invasive Joel-Cohen surgical technique, early catheter removal and post-operative antibiotic prophylaxis reduced LoS after CS most significantly by around half to 1 and a half days. Ten meta-analyses of multi-component Enhanced Recovery after Surgery (ERAS) packages demonstrated reductions in LoS of between 1 and 4 days. The quality of evidence was mostly low or moderate.ConclusionsFurther research is needed to develop, using formal methods, and evaluate pathways for enhanced recovery in elective CS. Appropriate quality improvement packages are needed to optimise their implementation.Electronic supplementary materialThe online version of this article (doi:10.1186/s12884-017-1265-0) contains supplementary material, which is available to authorized users.
Background It is good practice for the public to be involved in developing health research. Resources should be available for researchers to fund the involvement of the public in the development of their grants.
Background Preventative medication reduces hospitalisations in people with cystic fibrosis (PWCF) but adherence is poor. We assessed the feasibility of a randomised controlled trial of a complex intervention, which combines display of real time adherence data and behaviour change techniques. Methods Design: Pilot, open-label, parallel-group RCT with concurrent semi-structured interviews. Participants: PWCF at two Cystic Fibrosis (CF) units. Eligible: aged 16 or older; on the CF registry. Ineligible: post-lung transplant or on the active list; unable to consent; using dry powder inhalers. Interventions: Central randomisation on a 1:1 allocation to: (1) intervention, linking nebuliser use with data recording and transfer capability to a software platform, and behavioural strategies to support self-management delivered by trained interventionists ( n = 32); or, (2) control, typically face-to-face meetings every 3 months with CF team ( n = 32). Outcomes: RCT feasibility defined as: recruitment of ≥ 48 participants (75% of target) in four months (pilot primary outcome); valid exacerbation data available for ≥ 85% of those randomised (future RCT primary outcome); change in % medication adherence; FEV 1 percent predicted (key secondaries in future RCT); and perceptions of trial procedures, in semi-structured interviews with intervention ( n = 14) and control ( n = 5) participants, interventionists ( n = 3) and CF team members ( n = 5). Results The pilot trial recruited to target, randomising 33 to intervention and 31 to control in the four-month period, June–September 2016. At study completion (30th April 2017), 60 (94%; Intervention = 32, Control =28) participants contributed good quality exacerbation data (intervention: 35 exacerbations; control: 25 exacerbation). The mean change in adherence and baseline-adjusted FEV 1 percent predicted were higher in the intervention arm by 10% (95% CI: -5.2 to 25.2) and 5% (95% CI -2 to 12%) respectively. Five serious adverse events occurred, none related to the intervention. The mean change in adherence was 10% (95% CI: -5.2 to 25.2), greater in the intervention arm. Interventionists delivered insufficient numbers of review sessions due to concentration on participant recruitment. This left interventionists insufficient time for key intervention procedures. A total of 10 key changes that were made to RCT procedures are summarised. Conclusions With improved research processes and lower monthly participant recruitment targets, a full-scale trial is feasible. Trial registration ISRCTN13076797...
Knight DPhil m , on behalf of the NIHR hibernated influenza studies collaborative group
Background Cystic fibrosis (CF) is a life-limiting genetic condition in which daily therapies to maintain lung health are critical, yet treatment adherence is low. Previous interventions to increase adherence have been largely unsuccessful and this is likely due to a lack of focus on behavioural evidence and theory alongside input from people with CF. This intervention is based on a digital platform that collects and displays objective nebuliser adherence data. The purpose of this paper is to identify the specific components of an intervention to increase and maintain adherence to nebuliser treatments in adults with CF with a focus on reducing effort and treatment burden. Methods Intervention development was informed by the Behaviour Change Wheel (BCW) and person-based approach (PBA). A multidisciplinary team conducted qualitative research to inform a needs analysis, selected, and refined intervention components and methods of delivery, mapped adherence-related barriers and facilitators, associated intervention functions and behaviour change techniques, and utilised iterative feedback to develop and refine content and processes. Results Results indicated that people with CF need to understand their treatment, be able to monitor adherence, have treatment goals and feedback and confidence in their ability to adhere, have a treatment plan to develop habits for treatment, and be able to solve problems around treatment adherence. Behaviour change techniques were selected to address each of these needs and were incorporated into the digital intervention developed iteratively, alongside a manual and training for health professionals. Feedback from people with CF and clinicians helped to refine the intervention which could be tailored to individual patient needs. Conclusions The intervention development process is underpinned by a strong theoretical framework and evidence base and was developed by a multidisciplinary team with a range of skills and expertise integrated with substantial input from patients and clinicians. This multifaceted development strategy has ensured that the intervention is usable and acceptable to people with CF and clinicians, providing the best chance of success in supporting people with CF with different needs to increase and maintain their adherence. The intervention is being tested in a randomised controlled trial across 19 UK sites.
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