Healthcare professionals' perspectives on dietary advice provided to people with an ileostomy.

BACKGROUND: Diet is a common concern among people with an ileostomy as it can be associated with serious and burdensome complications, for example, dehydration and obstruction, and dietary advice is often unsatisfactory. In this study, we explored healthcare professionals' (HCPs) perspectives on dietary advice for ileostomy management. METHODS: Semi-structured interviews were conducted with HCPs, from multiple professions, who provide dietary advice to patients with an ileostomy. A framework approach to thematic analysis was used to understand and compare HCPs' experiences, beliefs and attitudes that influence how dietary advice is provided and the effectiveness of dietary management. RESULTS: Findings from interviews with 21 HCPs, across 3 hospitals, related to 7 key themes: tailoring of dietary advice to the patient, patient autonomy and communication, HCP knowledge and understanding, patient pathway, mixed messages, access to formal and social support and patient understanding and relationship with dietary advice. Profession was a strong determinator of what and how dietary advice is provided; however, closer team working increased consistency in dietary advice. Lack of scientific research and consensus contributes to mixed messages and reduced confidence in dietary advice for people with an ileostomy. Due to individual differences between patients, experiential learning with diet is key to self-management and is encouraged in a controlled way by HCPs; however, a lack of 'one-size-fits-all' guidance can be difficult for some. CONCLUSION: The study findings should inform HCPs caring for patients with an ileostomy, and researchers designing and evaluating interventions, to improve how patients receive dietary advice for ileostomy management.

Impact of low iodine diets on ablation success in differentiated thyroid cancer: A mixed-methods systematic review and meta-analysis.

BACKGROUND: Debate remains regarding whether to recommend a low iodine diet (LID) before radioactive-iodine treatment and its duration and stringency. This mixed-methods review aimed to determine if iodine status affects treatment success, the most effective diet to reduce iodine status, and how LID impacts wellbeing. METHODS: Five electronic databases were searched until February 2021. An effectiveness synthesis (quantitative studies) and views synthesis (qualitative, survey, and experience-based evidence) were conducted individually and then integrated. Quality assessment was undertaken. RESULTS: Fifty-six quantitative and three qualitative studies were identified. There was greater ablation success for those with an iodine status of <50 mcg/L (or mcg/gCr) compared with ≥250 (odds ratio [OR] = 2.63, 95% confidence interval [CI], 1.18-5.86, n = 283, GRADE certainty of evidence very low). One study compared <50 mcg/L (or mcg/gCr) to 100-199 and showed similar rates of ablation success (OR = 1.59, 95% CI, 0.48-6.15, n = 113; moderate risk of bias). People following a stricter LID before ablation had similar rates of success to a less-strict diet (OR = 0.67, 95% CI, 0.26-1.73, n = 256, GRADE certainty of evidence very low). A stricter LID reduced iodine status more than a less strict (SMD = -0.40, 95% CI, -0.56 to -0.24, n = 816), and reduction was seen after 1 and 2 weeks. The main challenges were a negative impact on psychological health, over restriction, confusion, and difficulty for sub-groups. CONCLUSIONS: Although a LID of 1-2 weeks reduces iodine status, it remains unclear whether iodine status affects treatment success as only a few low-quality studies have examined this. LIDs are challenging for patients. Higher-quality studies are needed to confirm whether a LID is necessary.

A qualitative exploration of attitudes to walking in the retirement life change.

BACKGROUND: Walking is a simple activity that could help to reduce the prevalence of chronic diseases in all populations. Furthermore, an inverse dose-response relationship exists between steps taken and risk of premature death and cardiovascular events in middle-aged and older adults. There is a lack of information on how to effectively engage older adults around retirement age in walking. This qualitative study explored attitudes towards walking in older people with regard to habits, intensity, preferences and strategies for increasing walking behaviour. METHODS: In-depth qualitative interviews were conducted with 26 older adults who were either close to retirement or recently retired. An inductive thematic analysis was conducted. RESULTS: Three themes were identified from the data; 1) Engagement and perceived value of walking; was focused on the meaning of walking for the participant and the attributes they associate with their walking practice. 2) Integration and connectivity of walking; was focused on how participants integrate walking in their daily lives and whether walking can be practiced as a viable means of connectivity. 3) Strategies to increase walking; was focused on what factors motivate participants in their walking practice and what strategies they perceived to be beneficial to increase walking distance and intensity at an individual level. DISCUSSION: The views of walking in people of retirement age were represented within 3 key themes. The factors contained in these themes that may influence future walking practice are discussed with regard to future strategies to promote walking in the retirement life change. CONCLUSION: It may be beneficial to promote qualitative aspects of walking practice and strive for regularity rather than intensity of walking to accrue the social, psychological and intellectual benefits reported by individuals in the retirement life change.

Low iodine diet advice and differentiated thyroid cancer treatment: A historic exploration in three UK centres.

BACKGROUND AND AIMS: Patients with differentiated thyroid cancer are often advised to follow a low iodine diet (LID) one to two weeks before radioiodine remnant ablation (RRA). We describe treatment practices and ablation success rates in centres (C1, C2, C3) in the UK with different approaches to LID advice. METHODS: Historic cohort of patients with differentiated thyroid cancer treated with RRA in 2015/16 in C1 (n = 50, 1-week LID), C2 (n = 59, 2-week LID) and C3 (n = 108, no LID advice). Response to RRA was stratified as excellent, indeterminate, or incomplete by the adapted American Thyroid Association Dynamic Risk Stratification Score. RESULTS: There was little difference in age, sex and staging between centres, but the percentage receiving 1.1 GBq vs higher administered activities differed (C1:22%, C2:44%, C3:15%, p < 0.001). Excellent response was recorded for: C1:48%, C2:36%, C3:49% (p = 0.61). Differences in RRA preparation and outcome assessment at C3 precluded comparison across all centres. Adjusted odds ratio for excellent response at C2 vs C1 was 0.57 (95%CI: 0.25,1.32), p = 0.19. CONCLUSIONS: There was no evidence that advising a LID for 2-weeks before RRA improves outcomes compared to 1-week. For definitive recommendations on LIDs prior to RRA, a prospective multi-centre study with a more homogenous approach to patient management or, randomised controlled trial, is needed.

Pre-admission interventions (prehabilitation) to improve outcome after major elective surgery: a systematic review and meta-analysis.

OBJECTIVE: To determine the benefits and harms of pre-admission interventions (prehabilitation) on postoperative outcomes in patients undergoing major elective surgery. DESIGN: Systematic review and meta-analysis of randomised controlled trials (RCTs) (published or unpublished). We searched Medline, Embase, CENTRAL, DARE, HTA and NHS EED, The Cochrane Library, CINAHL, PsychINFO and ISI Web of Science (June 2020). SETTING: Secondary care. PARTICIPANTS: Patients (≥18 years) undergoing major elective surgery (curative or palliative). INTERVENTIONS: Any intervention administered in the preoperative period with the aim of improving postoperative outcomes. OUTCOMES AND MEASURES: Primary outcomes were 30-day mortality, hospital length of stay (LoS) and postoperative complications. Secondary outcomes included LoS in intensive care unit or high dependency unit, perioperative morbidity, hospital readmission, postoperative pain, heath-related quality of life, outcomes specific to the intervention, intervention-specific adverse events and resource use. REVIEW METHODS: Two authors independently extracted data from eligible RCTs and assessed risk of bias and the certainty of evidence using Grading of Recommendations, Assessment, Development and Evaluation. Random-effects meta-analyses were used to pool data across trials. RESULTS: 178 RCTs including eight types of intervention were included. Inspiratory muscle training (IMT), immunonutrition and multimodal interventions reduced hospital LoS (mean difference vs usual care: -1.81 days, 95% CI -2.31 to -1.31; -2.11 days, 95% CI -3.07 to -1.15; -1.67 days, 95% CI -2.31 to -1.03, respectively). Immunonutrition reduced infective complications (risk ratio (RR) 0.64 95% CI 0.40 to 1.01) and IMT, and exercise reduced postoperative pulmonary complications (RR 0.55, 95% CI 0.38 to 0.80, and RR 0.54, 95% CI 0.39 to 0.75, respectively). Smoking cessation interventions reduced wound infections (RR 0.28, 95% CI 0.12 to 0.64). CONCLUSIONS: Some prehabilitation interventions may reduce postoperative LoS and complications but the quality of the evidence was low. PROSPERO REGISTRATION NUMBER: CRD42015019191.

Self-regulation in Barth syndrome: a qualitative perspective of adolescents, adults and parents in the U.K.

BACKGROUND: Barth syndrome (BS) is a life-threatening genetic disease caused by abnormal lipids in the mitochondria of cells and mostly affects young males. Those living with BS have severe exercise intolerance, lethargy and fatigue due to muscle disease which affect their daily life. Previous research suggests a need for qualitative exploration of self-regulation in BS and the inter-personal processes at play in family life. Therefore this study aimed to explore self-regulation and coping strategies and inter-personal responses in individuals and families affected by Barth syndrome. A multi-perspective qualitative study based on face to face, semi-structured, in-depth interviews with 11 participants (9-27 years, mean 15 years) with BS and/or their parents participating in a randomised double-blind clinical drug trial (CARDIOMAN). Interviews were transcribed verbatim and managed in NVivo prior to conducting a thematic analysis (AS and GH). RESULTS: Four key themes were identified: diagnosis and treatment, social support, identity and social integration, symptoms and self-regulation. The present findings suggest that self-regulation and coping in boys with BS was interpersonal and contingent on parental awareness such that parents were aware that their child had a limited energy reserve and that had to be managed due to the implications of fatigue for daily living. CONCLUSION: The findings support previous quantitative work demonstrating that children and parents tend to share a coherent view of BS. However, there is a need for greater awareness from others within the wider context of social and employment networks to minimise adverse implications for future life choices.

Experiences of low iodine diets in the treatment of differentiated thyroid cancer with radioactive iodine ablation therapy.

BACKGROUND AND AIMS: International guidelines on the treatment of differentiated thyroid cancers (DTC) promote the use of low iodine diets (LID) prior to radioactive iodine remnant ablation (RIA), as high iodine status may interfere with radioiodine uptake. Most UK treatment centres adhere to these guidelines and advise people to consume a LID. There is limited research as to how people cope with the LID or its impact on daily life and wellbeing, and no studies have been conducted in the UK. This study explored peoples' views and experiences in relation to consuming a LID during treatment for DTC with RIA. METHODS: Twenty-eight semi-structured interviews were conducted with people from across three treatment centres where differing advice had been delivered regarding a LID. Interviews were recorded, transcribed verbatim and key themes were developed through inductive thematic analyses. RESULTS: Individuals advised to consume a LID believed that adhering to the diet would help their treatment. Most restricted their diets beyond what was recommended and there was confusion surrounding what they could eat as part of the diet. Food selection and preparation were important which included substitution of foods and ingredient checking. Being on the diet was considered to have both a physical and psychological impact. CONCLUSIONS: The findings of this study provide a qualitative insight into the lived experiences of people with DTC in relation to consuming a LID. The results have relevance for professionals providing dietary guidance at oncology centres treating patients with RIA therapy in the UK.

A Survey of UK Centres on Low Iodine Diet Recommendations prior to Radioiodine Ablation Therapy for Differentiated Thyroid Cancer.

BACKGROUND: Guidelines suggest that a low iodine diet (LID) is advised prior to radioiodine ablation (RIA) for thyroid cancer. We aim to describe current practice regarding LID advice in the UK, determine uptake of the 2016 UK LID Working Group diet sheet and discover whether there are differences in practice. METHODS: We used an online survey distributed between November 2018 and April 2019 to centres in the UK that administer 131I. We asked questions on whether a LID is advised, for how long, how advice is presented, whether and how compliance is measured and whether treatment is delayed if LID advice is not followed. RESULTS: Fifty-six clinicians from 47 centres that carry out RIA for thyroid cancer responded. Forty-four centres (94%) advise a LID prior to RIA, the majority for 14 days (82%). Two-thirds of the centres use the UK LID Working Group diet sheet. Patients are told to resume normal eating when 131I is administered at 17 centres (39%), with 18 (41%) advising waiting for 24-48 h after administration. Most centres (95%) use only a simple question or do not assess compliance. Only 2 (5%) indicate that RIA would be delayed if someone said they had not followed LID advice. CONCLUSIONS: UK practice regarding LID prior to RIA for thyroid cancer is consistent with current guidelines, but non-adherence does not usually delay RIA. The UK Low Iodine Diet Working Group diet sheet is widely recognised and used. Practice could be improved by centres working to harmonise advice on when to restart a normal diet.

A feasibility randomised controlled trial of short-term fasting prior to CAPOX chemotherapy for stage 2/3 colorectal cancer: SWiFT protocol.

BACKGROUND: Capecitabine and oxaliplatin (CAPOX) chemotherapy is a standard treatment for stage 2/3 colorectal cancer. Treatment is associated with dose-limiting toxicities such as neutropenia, vomiting, diarrhoea, and stomatitis. Short-term fasting prior to chemotherapy may help protect normal cells from the toxic effects of chemotherapy by allowing them to conserve energy for maintenance and repair. However, there is a lack of evidence to support the efficacy of short-term fasting in protecting against chemotherapy-related toxicities in humans, and it is not known whether people due to undergo chemotherapy will be willing and able to follow a short-term fast. Preliminary data confirming this is feasible are required before adequately powered trials can be designed and conducted. METHODS: The short-term, water only, fasting trial (SWiFT) is a two-armed feasibility randomised controlled trial, aiming to recruit 30 people scheduled to begin routine treatment with CAPOX chemotherapy for stage 2/3 colorectal cancer. Participants will be randomly allocated, in a 1:1 ratio, to either a 36-h fast or standard dietary advice prior to chemotherapy administration for the first 3 cycles of chemotherapy. The primary outcome measures will assess the feasibility of the trial and include: adherence to intervention, recruitment, retention, and data completion rates as well as the acceptability of the intervention which will be qualitatively assessed. The secondary outcome measures aim to provide further information on possible outcomes of interest for a definitive trial and include side effects of chemotherapy, quality of life, markers of cellular metabolism and inflammation, appetite, and sarcopenia. DISCUSSION: It is not known whether it is possible to recruit to a trial of short-term fasting in this population, or whether participants would be able to adhere to the intervention. Therefore, we aim to test the feasibility of a pre-chemotherapy, 36-h, water-only fast in people receiving CAPOX chemotherapy for stage 2/3 colorectal cancer. TRIAL REGISTRATION: This trial has been registered with the ISRCTN Registry. Trial registration no: ISRCTN17994717. Date of registration: 23 October 2018. URL: http://www.isrctn.com/ISRCTN17994717.

Dietary restriction during the treatment of cancer: results of a systematic scoping review.

BACKGROUND: Diets that restrict energy or macronutrient intake (e.g. fasting/ketogenic diets (KDs)) may selectively protect non-tumour cells during cancer treatment. Previous reviews have focused on a subset of dietary restrictions (DR) or have not performed systematic searches. We conducted a systematic scoping review of DR at the time of cancer treatment. METHODS: MEDLINE, Embase, CINAHL, AMED and Web of Science databases were searched for studies of adults undergoing DR alongside treatment for cancer. Search results were screened against inclusion/exclusion criteria. Data from included studies were extracted by two independent reviewers. Results were summarised narratively. RESULTS: Twenty-three independent studies (34 articles), with small sample sizes, met the inclusion criteria. Four categories were identified: KDs (10 studies), fasting (4 studies), protein restriction (5 studies) and combined interventions (4 studies). Diets were tolerated well, however adherence was variable, particularly for KDs. Biomarker analysis in KDs and fasting resulted in the expected increase in ketones or reduction in insulin-like growth factors, respectively, however they did not reduce glucose. CONCLUSIONS: Future research with adequately powered studies is required to test the effects of each DR intervention on treatment toxicities and outcomes. Further research into improving adherence to DR may improve the feasibility of larger trials.

Early enteral nutrition within 24 hours of lower gastrointestinal surgery versus later commencement for length of hospital stay and postoperative complications.

BACKGROUND: This is an update of the review last published in 2011. It focuses on early postoperative enteral nutrition after lower gastrointestinal surgery. Traditional management consisted of 'nil by mouth', where patients receive fluids followed by solids after bowel function has returned. Although several trials have reported lower incidence of infectious complications and faster wound healing upon early feeding, other trials have shown no effect. The immediate advantage of energy intake (carbohydrates, protein or fat) could enhance recovery with fewer complications, and this warrants a systematic evaluation. OBJECTIVES: To evaluate whether early commencement of postoperative enteral nutrition (within 24 hours), oral intake and any kind of tube feeding (gastric, duodenal or jejunal), compared with traditional management (delayed nutritional supply) is associated with a shorter length of hospital stay (LoS), fewer complications, mortality and adverse events in patients undergoing lower gastrointestinal surgery (distal to the ligament of Treitz). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library 2017, issue 10), Ovid MEDLINE (1950 to 15 November 2017), Ovid Embase (1974 to 15 November 2017). We also searched for ongoing trials in ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform (15 November 2017). We handsearched reference lists of identified studies and previous systematic reviews. SELECTION CRITERIA: We included randomised controlled trials (RCT) comparing early commencement of enteral nutrition (within 24 hours) with no feeding in adult participants undergoing lower gastrointestinal surgery. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study quality using the Cochrane 'Risk of bias' tool tailored to this review and extracted data. Data analyses were conducted according to the Cochrane recommendations.We rated the quality of evidence according to GRADE.Primary outcomes were LoS and postoperative complications (wound infections, intraabdominal abscesses, anastomotic dehiscence, pneumonia).Secondary outcomes were: mortality, adverse events (nausea, vomiting), and quality of life (QoL).LoS was estimated using mean difference (MD (presented as mean +/- SD). For other outcomes we estimated the common risk ratio (RR) and calculated the associated 95% confidence intervals. For analysis, we used an inverse-variance random-effects model for the primary outcome (LoS) and Mantel-Haenszel random-effects models for the secondary outcomes. We also performed Trial Sequential Analyses (TSA). MAIN RESULTS: We identified 17 RCTs with 1437 participants undergoing lower gastrointestinal surgery. Most studies were at high or unclear risk of bias in two or more domains. Six studies were judged as having low risk of selection bias for random sequence generation and insufficient details were provided for judgement on allocation concealment in all 17 studies. With regards to performance and deception bias; 14 studies reported no attempt to blind participants and blinding of personnel was not discussed either. Only one study was judged as low risk of bias for blinding of outcome assessor. With regards to incomplete outcome data, three studies were judged to be at high risk because they had more than 10% difference in missing data between groups. For selective reporting, nine studies were judged as unclear as protocols were not provided and eight studies had issues with either missing data or incomplete reporting of results.LOS was reported in 16 studies (1346 participants). The mean LoS ranged from four days to 16 days in the early feeding groups and from 6.6 days to 23.5 days in the control groups. Mean difference (MD) in LoS was 1.95 (95% CI, -2.99 to -0.91, P < 0.001) days shorter in the early feeding group. However, there was substantial heterogeneity between included studies (I2 = 81, %, Chi2 = 78.98, P < 0.00001), thus the overall quality of evidence for LoS is low. These results were confirmed by the TSA showing that the cumulative Z-curve crossed the trial sequential monitoring boundary for benefit.We found no differences in the incidence of postoperative complications: wound infection (12 studies, 1181 participants, RR 0.99, 95%CI 0.64 to 1.52, very low-quality evidence), intraabdominal abscesses (6 studies, 554 participants, RR 1.00, 95%CI 0.26 to 3.80, low-quality evidence), anastomotic leakage/dehiscence (13 studies, 1232 participants, RR 0.78, 95%CI 0.38 to 1.61, low-quality evidence; number needed to treat for an additional beneficial outcome (NNTB) = 100), and pneumonia (10 studies, 954 participants, RR 0.88, 95%CI 0.32 to 2.42, low-quality evidence; NNTB = 333).Mortality was reported in 12 studies (1179 participants), and showed no between-group differences (RR = 0.56, 95%CI, 0.21 to 1.52, P = 0.26, I2 = 0%, Chi2 = 3.08, P = 0.96, low-quality evidence). The most commonly reported cause of death was anastomotic leakage, sepsis and acute myocardial infarction.Seven studies (613 participants) reported vomiting (RR 1.23, 95%CI, 0.96 to 1.58, P = 0.10, I2 = 0%, Chi2 = 4.98, P = 0.55, low-quality evidence; number needed to treat for an additional harmful outcome (NNTH) = 19), and two studies (118 participants) reported nausea (RR 0.95, 0.71 to 1.26, low-quality evidence). Four studies reported combined nausea and vomiting (RR 0.94, 95%CI 0.51 to 1.74, very low-quality evidence). One study reported QoL assessment; the scores did not differ between groups at 30 days after discharge on either QoL scale EORTC QLQ-C30 or EORTC QlQ-OV28 (very low-quality evidence). AUTHORS' CONCLUSIONS: This review suggests that early enteral feeding may lead to a reduced postoperative LoS, however cautious interpretation must be taken due to substantial heterogeneity and low-quality evidence. For all other outcomes (postoperative complications, mortality, adverse events, and QoL) the findings are inconclusive, and further trials are justified to enhance the understanding of early feeding for these. In this updated review, only a few additional studies have been included, and these were small and of poor quality.To improve the evidence, future trials should address quality issues and focus on clearly defining and measuring postoperative complications to allow for better comparison between studies. However due to the introduction of fast track protocols which already include an early feeding component, future trials may be challenging. A more feasible trial may be to investigate the effect of differing postoperative energy intake regimens on relevant outcomes.

Early enteral nutrition within 24 hours of lower gastrointestinal surgery versus later commencement for length of hospital stay and postoperative complications.

BACKGROUND: This is an update of the review last published in 2011. It focuses on early postoperative enteral nutrition after lower gastrointestinal surgery. Traditional management consisted of 'nil by mouth', where patients receive fluids followed by solids after bowel function has returned. Although several trials have reported lower incidence of infectious complications and faster wound healing upon early feeding, other trials have shown no effect. The immediate advantage of energy intake (carbohydrates, protein or fat) could enhance recovery with fewer complications, and this warrants a systematic evaluation. OBJECTIVES: To evaluate whether early commencement of postoperative enteral nutrition (within 24 hours), oral intake and any kind of tube feeding (gastric, duodenal or jejunal), compared with traditional management (delayed nutritional supply) is associated with a shorter length of hospital stay (LoS), fewer complications, mortality and adverse events in patients undergoing lower gastrointestinal surgery (distal to the ligament of Treitz). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library 2017, issue 10), Ovid MEDLINE (1950 to 15 November 2017), Ovid Embase (1974 to 15 November 2017). We also searched for ongoing trials in ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform (15 November 2017). We handsearched reference lists of identified studies and previous systematic reviews. SELECTION CRITERIA: We included randomised controlled trials (RCT) comparing early commencement of enteral nutrition (within 24 hours) with no feeding in adult participants undergoing lower gastrointestinal surgery. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study quality using the Cochrane 'Risk of bias' tool tailored to this review and extracted data. Data analyses were conducted according to the Cochrane recommendations.We rated the quality of evidence according to GRADE.Primary outcomes were LoS and postoperative complications (wound infections, intraabdominal abscesses, anastomotic dehiscence, pneumonia).Secondary outcomes were: mortality, adverse events (nausea, vomiting), and quality of life (QoL).LoS was estimated using mean difference (MD (presented as mean +/- SD). For other outcomes we estimated the common risk ratio (RR) and calculated the associated 95% confidence intervals. For analysis, we used an inverse-variance random-effects model for the primary outcome (LoS) and Mantel-Haenszel random-effects models for the secondary outcomes. We also performed Trial Sequential Analyses (TSA). MAIN RESULTS: We identified 17 RCTs with 1437 participants undergoing lower gastrointestinal surgery. Most studies were at high or unclear risk of bias in two or more domains. Six studies were judged as having low risk of selection bias for random sequence generation and insufficient details were provided for judgement on allocation concealment in all 17 studies. With regards to performance and deception bias; 14 studies reported no attempt to blind participants and blinding of personnel was not discussed either. Only one study was judged as low risk of bias for blinding of outcome assessor. With regards to incomplete outcome data, three studies were judged to be at high risk because they had more than 10% difference in missing data between groups. For selective reporting, nine studies were judged as unclear as protocols were not provided and eight studies had issues with either missing data or incomplete reporting of results.LOS was reported in 16 studies (1346 participants). The mean LoS ranged from four days to 16 days in the early feeding groups and from 6.6 days to 23.5 days in the control groups. Mean difference (MD) in LoS was 1.95 (95% CI, -2.99 to -0.91, P < 0.001) days shorter in the early feeding group. However, there was substantial heterogeneity between included studies (I2 = 81, %, Chi2 = 78.98, P < 0.00001), thus the overall quality of evidence for LoS is low. These results were confirmed by the TSA showing that the cumulative Z-curve crossed the trial sequential monitoring boundary for benefit.We found no differences in the incidence of postoperative complications: wound infection (12 studies, 1181 participants, RR 0.99, 95%CI 0.64 to 1.52, very low-quality evidence), intraabdominal abscesses (6 studies, 554 participants, RR 1.00, 95%CI 0.26 to 3.80, low-quality evidence), anastomotic leakage/dehiscence (13 studies, 1232 participants, RR 0.78, 95%CI 0.38 to 1.61, low-quality evidence; number needed to treat for an additional beneficial outcome (NNTB) = 100), and pneumonia (10 studies, 954 participants, RR 0.88, 95%CI 0.32 to 2.42, low-quality evidence; NNTB = 333).Mortality was reported in 12 studies (1179 participants), and showed no between-group differences (RR = 0.56, 95%CI, 0.21 to 1.52, P = 0.26, I2 = 0%, Chi2 = 3.08, P = 0.96, low-quality evidence). The most commonly reported cause of death was anastomotic leakage, sepsis and acute myocardial infarction.Seven studies (613 participants) reported vomiting (RR 1.23, 95%CI, 0.96 to 1.58, P = 0.10, I2 = 0%, Chi2 = 4.98, P = 0.55, low-quality evidence; number needed to treat for an additional harmful outcome (NNTH) = 19), and two studies (118 participants) reported nausea (RR 0.95, 0.71 to 1.26, low-quality evidence). Four studies reported combined nausea and vomiting (RR 0.94, 95%CI 0.51 to 1.74, very low-quality evidence). One study reported QoL assessment; the scores did not differ between groups at 30 days after discharge on either QoL scale EORTC QLQ-C30 or EORTC QlQ-OV28 (very low-quality evidence). AUTHORS' CONCLUSIONS: This review suggests that early enteral feeding may lead to a reduced postoperative LoS, however cautious interpretation must be taken due to substantial heterogeneity and low-quality evidence. For all other outcomes (postoperative complications, mortality, adverse events, and QoL) the findings are inconclusive, and further trials are justified to enhance the understanding of early feeding for these. In this updated review, only a few additional studies have been included, and these were small and of poor quality.To improve the evidence, future trials should address quality issues and focus on clearly defining and measuring postoperative complications to allow for better comparison between studies. However due to the introduction of fast track protocols which already include an early feeding component, future trials may be challenging. A more feasible trial may be to investigate the effect of differing postoperative energy intake regimens on relevant outcomes.

Correction: Using the Normalization Process Theory to qualitatively explore sense-making in implementation of the Enhanced Recovery After Surgery programme: "It's not rocket science".

[This corrects the article DOI: 10.1371/journal.pone.0195890.].

Using the Normalization Process Theory to qualitatively explore sense-making in implementation of the Enhanced Recovery After Surgery programme: "It's not rocket science".

INTRODUCTION: The Enhanced Recovery After Surgery programme (ERAS) is an approach to the perioperative care of patients encompassing multiple interventions and involving a wide range of different actors. It can thus be defined as a complex intervention. Despite the strength of the evidence-base in its support, the implementation of ERAS has been slow. This paper specifically explores the utility of Normalization Process Theory (NPT) as a methodological framework to aid exploration of ERAS implementation, with a focus on the core NPT construct coherence. METHODS AND MATERIALS: The study employed qualitative methods guided by NPT. Semi-structured interviews were conducted with twenty-six healthcare professionals working in three specialities (thoracic, colorectal, head and neck) in a UK hospital. Data were analysed using an adapted Framework Approach. RESULTS: Coherence, or sense-making work, was key to successful implementation and demonstrated in the importance of participants believing in ERAS both as an individual and as a team. In order to invest in ERAS individuals needed to be able to differentiate its practices favourably with those enacted pre-implementation (differentiation). Participants also needed to understand their specific tasks and responsibilities (individual specification) and build a shared understanding (communal specification), resolving differences in planning meetings. Belief in the worth of ERAS was often aligned to evidence for its effectiveness or benefit to patients (internalization), so implementing ERAS therefore 'made sense'. Sense-making work had strong links with aspects of implementation related to other NPT constructs including resource issues such as funding for data collection and feedback (reflexive monitoring: systemization) and failure to replace key staff members (collective action: skill set workability). CONCLUSIONS: NPT was found to be a valuable heuristic device to employ in the exploration of ERAS implementation processes. NPT was useful in facilitating recognition of the importance of coherence work to successful implementation. However despite participants' strong beliefs in the worth of ERAS, it was in translating these beliefs into action that barriers were encountered, highlighting the interconnectedness of NPT constructs and the complicated nature of implementing complex interventions.

The long-term impact of folic acid in pregnancy on offspring DNA methylation: follow-up of the Aberdeen Folic Acid Supplementation Trial (AFAST).

BACKGROUND: It has been proposed that maternal folic-acid supplement use may alter the DNA-methylation patterns of the offspring during the in-utero period, which could influence development and later-life health outcomes. Evidence from human studies suggests a role for prenatal folate levels in influencing DNA methylation in early life, but this has not been extended to consider persistent effects into adulthood. METHODS: To better elucidate the long-term impact of maternal folic acid in pregnancy on DNA methylation in offspring, we carried out an epigenome-wide association study (EWAS) nested within the Aberdeen Folic Acid Supplementation Trial (AFAST-a trial of two different doses: 0.2 and 5 mg, folic acid vs placebo). Offspring of the AFAST participants were recruited at a mean age of 47 years and saliva samples were profiled on the Illumina Infinium Human Methylation450 array. Both single-site and differentially methylated region analyses were performed. RESULTS: We found an association at cg09112514 (p = 4.03×10-9), a CpG located in the 5' untranslated region of PDGFRA, in the main analysis comparing the intervention arms [low- (0.2 mg) and high-dose (5 mg) folic acid combined (N = 43)] vs placebo (N = 43). Furthermore, a dose-response reduction in methylation at this site was identified in relation to the intervention. In the regional approach, we identified 46 regions of the genome that were differentially methylated in response to the intervention (Sidak p-value <0.05), including HLA-DPB2, HLA-DPB1, PAX8 and VTRNA2-1. Whereas cg09112514 did not replicate in an independent EWAS of maternal plasma folate, there was suggested replication of differential methylation in PAX8. CONCLUSIONS: The results of this study suggest that maternal folic-acid supplement use is associated with changes in the DNA methylation of the offspring that persist for many years after exposure in utero. These methylation changes are located in genes implicated in embryonic development, immune response and cellular proliferation. Further work to investigate whether these epigenetic changes translate into detectable phenotypic differences is required.

Healthcare professionals' views of the enhanced recovery after surgery programme: a qualitative investigation.

BACKGROUND: The Enhanced Recovery After Surgery (ERAS) programme is an approach to the perioperative care of patients which aims to improve outcomes and speed up recovery after surgery. Although the evidence base appears strong for this programme, the implementation of ERAS has been slow. This study aimed to gain an understanding of the facilitating factors and challenges of implementing the programme with a view to providing additional contextual information to aid implementation. The study had a particular focus on the nutritional elements as these have been highlighted as important. METHODS: The study employed qualitative research methods, guided by the Normalisation Process Theory (NPT) to explore the experiences and opinions of 26 healthcare professionals from a range of disciplines implementing the programme. RESULTS: This study identified facilitating factors to the implementation of ERAS: alignment with evidence based practice, standardising practice, drawing on the evidence base of other specialties, leadership, teamwork, ERAS meetings, patient involvement and education, a pre-operative assessment unit, staff education, resources attached to obtaining The Commissioning for Quality and Innovation (CQUIN) money, the ward layout, data collection and feedback, and adapting the care pathway. A number of implementation challenges were also identified: resistance to change, standardisation affecting personalised patient care, the buy-in of relevant stakeholders, keeping ERAS visible, information provision to patients, resources, palatability of nutritional drinks, aligning different ward cultures, patients going to non-ERAS departments, spreading the programme within the hospital, differences in health issue, and utilising a segmental approach.  CONCLUSIONS: The findings presented here provide useful contextual information from diverse surgical specialties to inform healthcare providers when implementing ERAS in practice. Addressing the challenges and utilising the facilitating factors identified in this study, could speed up the rate at which ERAS is adopted, implemented and embedded.

Optimising the community-based approach to healthcare improvement: Comparative case studies of the clinical community model in practice.

Community-based approaches to healthcare improvement are receiving increasing attention. Such approaches could offer an infrastructure for efficient knowledge-sharing and a potent means of influencing behaviours, but their potential is yet to be optimised. After briefly reviewing challenges to community-based approaches, we describe in detail the clinical community model. Through exploring clinical communities in practice, we seek to identify practical lessons for optimising this community-based approach to healthcare improvement. Through comparative case studies based on secondary analysis, we examine two contrasting examples of clinical communities in practice - the USA-based Michigan Keystone ICU programme, and the UK-based Improving Lung Cancer Outcomes Project. We focus on three main issues. First, both cases were successful in mobilising diverse communities: favourable starting conditions, core teams with personal credibility, reputable institutional backing and embeddedness in wider networks were important. Second, top-down input to organise regular meetings, minimise conflict and empower those at risk of marginalisation helped establish a strong sense of community and reciprocal ties, while intervention components and measures common to the whole community strengthened peer-norming effects. Third, to drive implementation, technical expertise and responsiveness from the core team were important, but so too were 'hard tactics' (e.g. strict limits on local customisation); these were more easily deployed where the intervention was standardised across the community and a strong evidence-base existed. Contrary to the idea of self-organising communities, our cases make clear that vertical and horizontal forces depend on each other synergistically for their effectiveness. We offer practical lessons for establishing an effective balance of horizontal and vertical influences, and for identifying the types of quality problems most amenable to community-based improvement.

Contextual barriers to implementation in primary care: an ethnographic study of a programme to improve chronic kidney disease care.

BACKGROUND: Context is important in implementation-we know that what works in one setting may not work in the same way elsewhere. Primary care has been described as a unique context both in relation to the care delivered and efforts to carry out research and implementation of new evidence. OBJECTIVE: To explore some of the distinctive features of the primary care environment that may influence implementation. METHODS: We conducted an ethnographic study involving observations, interviews and documentary analysis of the ENABLE-CKD project, which involved general practices implementing a chronic kidney disease care bundle and offering self-management support tools to patients. Analysis was based on the constant comparative method. RESULTS: Four elements of the primary care environment emerged as important influences on the extent to which implementation was successful. First, the nature of delivering care in this setting meant that prioritizing one condition over others was problematic. Second, the lack of alignment with financial and other incentives affected engagement. Third, the project team lacked mechanisms through which engagement could be mandated. Fourth, working relationships within practices impacted on engagement. CONCLUSIONS: Those seeking to implement interventions in primary care need to consider the particular context if they are to secure successful implementation. We suggest that there are particular kinds of interventions, which may be best suited to the primary care context.

Professionalism Redundant, Reshaped, or Reinvigorated? Realizing the "Third Logic" in Contemporary Health Care.

Recent decades have seen the influence of the professions decline. Lately, commentators have suggested a revived role for a "new" professionalism in ensuring and enhancing high-quality health care in systems dominated by market and managerial logics. The form this new professionalism might take, however, remains obscure. This article uses data from an ethnographic study of three English health care improvement projects to analyze the place, potential, and limitations of professionalism as a means of engaging clinicians in efforts to improve service quality. We found that appeals to notions of professionalism had strong support among practitioners, but converting enthusiasm for the principle of professionalism into motivation to change practice was not straightforward. Some tactics used in pursuit of this deviated sharply from traditional models of collegial social control. In systems characterized by fissures between professional groups and powerful market and managerial influences, we suggest that professionalism must interact creatively but carefully with other logics.

Chewing gum for postoperative recovery of gastrointestinal function.

BACKGROUND: Ileus commonly occurs after abdominal surgery, and is associated with complications and increased length of hospital stay (LOHS). Onset of ileus is considered to be multifactorial, and a variety of preventative methods have been investigated. Chewing gum (CG) is hypothesised to reduce postoperative ileus by stimulating early recovery of gastrointestinal (GI) function, through cephalo-vagal stimulation. There is no comprehensive review of this intervention in abdominal surgery. OBJECTIVES: To examine whether chewing gum after surgery hastens the return of gastrointestinal function. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via Ovid), MEDLINE (via PubMed), EMBASE (via Ovid), CINAHL (via EBSCO) and ISI Web of Science (June 2014). We hand-searched reference lists of identified studies and previous reviews and systematic reviews, and contacted CG companies to ask for information on any studies using their products. We identified proposed and ongoing studies from clinicaltrials.gov, World Health Organization (WHO) International Clinical Trials Registry Platform and metaRegister of Controlled Trials. SELECTION CRITERIA: We included completed randomised controlled trials (RCTs) that used postoperative CG as an intervention compared to a control group. DATA COLLECTION AND ANALYSIS: Two authors independently collected data and assessed study quality using an adapted Cochrane risk of bias (ROB) tool, and resolved disagreements by discussion. We assessed overall quality of evidence for each outcome using Grades of Recommendation, Assessment, Development and Evaluation (GRADE). Studies were split into subgroups: colorectal surgery (CRS), caesarean section (CS) and other surgery (OS). We assessed the effect of CG on time to first flatus (TFF), time to bowel movement (TBM), LOHS and time to bowel sounds (TBS) through meta-analyses using a random-effects model. We investigated the influence of study quality, reviewers' methodological estimations and use of Enhanced Recovery After Surgery (ERAS) programmes using sensitivity analyses. We used meta-regression to explore if surgical site or ROB scores predicted the extent of the effect estimate of the intervention on continuous outcomes. We reported frequency of complications, and descriptions of tolerability of gum and cost. MAIN RESULTS: We identified 81 studies that recruited 9072 participants for inclusion in our review. We categorised many studies at high or unclear risk of the bias' assessed. There was statistical evidence that use of CG reduced TFF [overall reduction of 10.4 hours (95% CI: -11.9, -8.9): 12.5 hours (95% CI: -17.2, -7.8) in CRS, 7.9 hours (95% CI: -10.0, -5.8) in CS, 10.6 hours (95% CI: -12.7, -8.5) in OS]. There was also statistical evidence that use of CG reduced TBM [overall reduction of 12.7 hours (95% CI: -14.5, -10.9): 18.1 hours (95% CI: -25.3, -10.9) in CRS, 9.1 hours (95% CI: -11.4, -6.7) in CS, 12.3 hours (95% CI: -14.9, -9.7) in OS]. There was statistical evidence that use of CG slightly reduced LOHS [overall reduction of 0.7 days (95% CI: -0.8, -0.5): 1.0 days in CRS (95% CI: -1.6, -0.4), 0.2 days (95% CI: -0.3, -0.1) in CS, 0.8 days (95% CI: -1.1, -0.5) in OS]. There was statistical evidence that use of CG slightly reduced TBS [overall reduction of 5.0 hours (95% CI: -6.4, -3.7): 3.21 hours (95% CI: -7.0, 0.6) in CRS, 4.4 hours (95% CI: -5.9, -2.8) in CS, 6.3 hours (95% CI: -8.7, -3.8) in OS]. Effect sizes were largest in CRS and smallest in CS. There was statistical evidence of heterogeneity in all analyses other than TBS in CRS.There was little difference in mortality, infection risk and readmission rate between the groups. Some studies reported reduced nausea and vomiting and other complications in the intervention group. CG was generally well-tolerated by participants. There was little difference in cost between the groups in the two studies reporting this outcome.Sensitivity analyses by quality of studies and robustness of review estimates revealed no clinically important differences in effect estimates. Sensitivity analysis of ERAS studies showed a smaller effect size on TFF, larger effect size on TBM, and no difference between groups for LOHS.Meta-regression analyses indicated that surgical site is associated with the extent of the effect size on LOHS (all surgical subgroups), and TFF and TBM (CS and CRS subgroups only). There was no evidence that ROB score predicted the extent of the effect size on any outcome. Neither variable explained the identified heterogeneity between studies. AUTHORS' CONCLUSIONS: This review identified some evidence for the benefit of postoperative CG in improving recovery of GI function. However, the research to date has primarily focussed on CS and CRS, and largely consisted of small, poor quality trials. Many components of the ERAS programme also target ileus, therefore the benefit of CG alongside ERAS may be reduced, as we observed in this review. Therefore larger, better quality RCTS in an ERAS setting in wider surgical disciplines would be needed to improve the evidence base for use of CG after surgery.