Systematic review on reporting of components and outcomes in randomized clinical trials of paraoesophageal hernia mesh repair.

BACKGROUND: Surgical interventions, such as paraoesophageal hernia (POH) repair, are complex with multiple components that require consideration in the reporting of clinical trials. Many aspects of POH repair, including mesh hiatal reinforcement and fundoplication type, are contentious. This review summarizes the reporting of components and outcomes in RCTs of POH repair. METHODS: Systematic searches identified RCTs of POH repair published from 1995 to 2020. The patient selection criteria for RCT involvement were noted. The components of the surgical interventions in these RCTs were recorded using the CONSORT guidelines for non-pharmacological treatments, Template for Intervention Description and Replication (TIDieR) and Blencowe frameworks. The outcomes were summarized and definitions sought for critical variables, including recurrence. RESULTS: Of 1918 abstracts and 21 screened full-text articles, 12 full papers reporting on six RCTs were included in the review. The patient selection criteria and definitions of POH between trials varied considerably. Although some description of trial interventions was provided in all RCTs, this varied in depth and detail. Four RCTs described efforts to standardize the trial intervention. Outcomes were reported inconsistently, were rarely defined fully, and overall trial conclusions varied during follow-up. CONCLUSION: This lack of detail on the surgical intervention in POH repair RCTs prevents full understanding of what exact procedure was evaluated and how it should be delivered in clinical practice to gain the desired treatment effects. Improved focus on the definitions, descriptions and reporting of surgical interventions in POH repair is required for better future RCTs.

The role of bile acids in reducing the metabolic complications of obesity after bariatric surgery: a systematic review.

BACKGROUND: Bariatric surgery is currently the most efficacious treatment for obesity and its associated metabolic co-morbidities, such as diabetes. The metabolic improvements occur through both weight-dependent and weight-independent mechanisms. Bile acids (BAs) have emerged as key signalling molecules that have a central role in modulating many of the physiological effects seen after bariatric surgery. This systematic review assesses the evidence from both human and animal studies for the role of BAs in reducing the metabolic complications of obesity following bariatric surgery. METHODS: We conducted a systematic search of Medline and Embase databases to identify all articles investigating the role of BAs in mediating the metabolic changes observed following bariatric surgery in both animal and human studies. Boolean logic was used with relevant search terms, including the following MeSH terms: 'bile acids and salts', 'bariatric surgery', 'metabolic surgery', 'gastrointestinal tract/surgery' and 'obesity/surgery'. RESULTS: Following database searches (n=1197), inclusion from bibliography searches (n=2) and de-duplication (n=197), 1002 search results were returned. Of these, 132 articles were selected for full-text review, of which 38 articles were deemed relevant and included in the review. The findings support the effects of BAs on satiety, lipid and cholesterol metabolism, incretins and glucose homoeostasis, energy metabolism, gut microbiota and endoplasmic reticulum stress following bariatric surgery. Many of these metabolic effects are modulated through the BA receptors FXR and TGR5. We also explore a possible link between BAs and carcinogenesis following bariatric surgery. CONCLUSIONS: Overall there is good evidence to support the role of BAs in the metabolic effects of bariatric surgery through the above mechanisms. BAs could serve as a novel therapeutic pharmacological target for the treatment of obesity and its associated co-morbidities.

Land application of sewage sludge (biosolids) in Australia: risks to the environment and food crops.

Australia is a large exporter of agricultural products, with producers responsible for a range of quality assurance programs to ensure that food crops are free from various contaminants of detriment to human health. Large volumes of treated sewage sludge (biosolids), although low by world standards, are increasingly being recycled to land, primarily to replace plant nutrients and to improve soil properties; they are used in agriculture, forestry, and composted. The Australian National Biosolids Research Program (NBRP) has linked researchers to a collective goal to investigate nutrients and benchmark safe concentrations of metals nationally using a common methodology, with various other research programs conducted in a number of states specific to regional problems and priorities. The use of biosolids in Australia is strictly regulated by state guidelines, some of which are under review following recent research outcomes. Communication and research between the water industry, regulators and researchers specific to the regulation of biosolids is further enhanced by the Australian and New Zealand Biosolids Partnership (ANZBP). This paper summarises the major issues and constraints related to biosolids use in Australia using specific case examples from Western Australia, a member of the Australian NBRP, and highlights several research projects conducted over the last decade to ensure that biosolids are used beneficially and safely in the environment. Attention is given to research relating to plant nutrient uptake, particularly nitrogen and phosphorus (including that of reduced phosphorus uptake in alum sludge-amended soil); the risk of heavy metal uptake by plants, specifically cadmium, copper and zinc; the risk of pathogen contamination in soil and grain products; change to soil pH (particularly following lime-amended biosolids); and the monitoring of faecal contamination by biosolids in waterbodies using DNA techniques. Examples of products that are currently produced in Western Australia from sewage sludge include mesophilic anaerobically digested and dewatered biosolids cake, lime-amended biosolids, alum sludge and compost.

Investigating the Role of Diet and Exercise in Gut Microbe-Host Cometabolism.

We investigated the individual and combined effects of diet and physical exercise on metabolism and the gut microbiome to establish how these lifestyle factors influence host-microbiome cometabolism. Urinary and fecal samples were collected from athletes and less active controls. Individuals were further classified according to an objective dietary assessment score of adherence to healthy dietary habits according to WHO guidelines, calculated from their proton nuclear magnetic resonance (1H-NMR) urinary profiles. Subsequent models were generated comparing extremes of dietary habits, exercise, and the combined effect of both. Differences in metabolic phenotypes and gut microbiome profiles between the two groups were assessed. Each of the models pertaining to diet healthiness, physical exercise, or a combination of both displayed a metabolic and functional microbial signature, with a significant proportion of the metabolites identified as discriminating between the various pairwise comparisons resulting from gut microbe-host cometabolism. Microbial diversity was associated with a combination of high adherence to healthy dietary habits and exercise and was correlated with a distinct array of microbially derived metabolites, including markers of proteolytic activity. Improved control of dietary confounders, through the use of an objective dietary assessment score, has uncovered further insights into the complex, multifactorial relationship between diet, exercise, the gut microbiome, and metabolism. Furthermore, the observation of higher proteolytic activity associated with higher microbial diversity indicates that increased microbial diversity may confer deleterious as well as beneficial effects on the host.IMPORTANCE Improved control of dietary confounders, through the use of an objective dietary assessment score, has uncovered further insights into the complex, multifactorial relationship between diet, exercise, the gut microbiome, and metabolism. Each of the models pertaining to diet healthiness, physical exercise, or a combination of both, displayed a distinct metabolic and functional microbial signature. A significant proportion of the metabolites identified as discriminating between the various pairwise comparisons result from gut microbe-host cometabolism, and the identified interactions have expanded current knowledge in this area. Furthermore, although increased microbial diversity has previously been linked with health, our observation of higher microbial diversity being associated with increased proteolytic activity indicates that it may confer deleterious as well as beneficial effects on the host.

Influence of peroxyacetic acid-based carcass rinse on the onset of "blown pack" spoilage in artificially inoculated vacuum-packed chilled beef.

"Blown pack" spoilage is an increasingly reported spoilage condition of vacuum-packed chilled meats. This spoilage condition is primarily caused by a psychrophilic obligately anaerobic microorganism, Clostridium estertheticum. The present study investigated whether peroxyacetic acid (POAA)-based carcass rinse can delay the onset of gas production in chilled vacuum-packed beef artificially inoculated with C. estertheticum spores. The variables studied were (i) two prepackaging meat rinses (water and POAA-based rinse); (ii) three levels of C. estertheticum spores (0, 4, and 40 spores per cm2); and (iii) three postpackaging storage temperatures (-1.5, 0, and 2 degrees C). Treatment with POAA-based rinse marginally delayed the onset of pack blowing in packs carrying high numbers of C. estertheticum spores but not in packs carrying low levels of inoculum or in uninoculated controls. The presence of as few as 4 spores per cm2 of meat surface effectively decreased by two-thirds the nominal shelf life of vacuum-packed chilled beef. Increasing the inoculum by 10-fold to 40 spores per cm2 resulted in the additional acceleration of the onset of pack blowing. The onset of gas production was significantly delayed by storing the packaged product at -1.5 degrees C rather than at 0 degrees C. The results of this study indicate that the POAA-based rinse tested will not eliminate the spoilage threat posed by clostridial blown pack spoilage spores present on meat surfaces. POAA-based rinse can be used alone to achieve some extension of shelf life of beef cuts heavily contaminated with C. estertheticum spores. Alternatively, the rinse may offer an opportunity for a more substantial extension of shelf life of contaminated cuts when used with additional hurdles.

The storage life of chicken carcasses packaged under carbon dioxide.

Broiler chicken carcasses were packaged under vacuum in film of low oxygen transmission rate, or under CO2 in gas-impermeable aluminum foil laminate. The packaged carcasses were stored at +3 or -1.5 degrees C. The initial flora was dominated by enterobacteria. Vacuum-packaged carcasses developed microbial populations in which enterobacteria continued to predominate, and were spoiled by persistent putrid odours after 2 weeks storage at 3 degrees C or 3 weeks storage at -1.5 degrees C. Growth of enterobacteria was inhibited on carcasses packaged under CO2, the microflora that developed being dominated by lactobacilli. However, slow growth of the enterobacteria eventually resumed, and putrid spoilage was apparent after 7 weeks storage at 3 degrees C or 14 weeks storage at -1.5 degrees C.

Association of psychrotrophic Clostridium spp. with deep tissue spoilage of chilled vacuum-packed lamb.

Early spoilage of commercial vacuum-packed chilled lamb legs was manifested as an objectionable 'cheesy', deep tissue odour that became evident when a cut was made into the stifle joint. Investigation of the probable causative agents led to the isolation of two psychrotrophic strains of clostridia. The isolates could not be identified using traditional identification schemes. One isolate was able to produce strong, objectionable 'cheesy' odours in deep tissues of artificially inoculated beef.

The effect of the initial gas volume to meat weight ratio on the storage life of chilled beef packaged under carbon dioxide.

Normal pH (5·5-5·7) and high pH (>6·0) beef cuts of 400 g were vacuum packaged in polyvinylidine chloride (PVDC) laminate, in aluminium foil laminate or in foil laminate with a CO(2) scavenger (Ba(OH)(2)); or were packaged under CO(2) in foil laminate with CO(2) added at 200, 400, 700, 1000 or 2000 ml per kg of meat. The process used to prepare meat before packaging resulted in an initial flora containing a high fraction of eneterobacteria but with undetectable numbers of lactobacilli. During storage at +1°C, all vacuum packaged meat developed floras containing substantial fractions of enterobacteria. The enterobacteria fractions were larger on high pH than on normal pH meat, and on normal pH meat in PVDC or in foil laminate plus CO(2) scavenger packs than on normal pH meat in foil laminate without the CO(2) scavenger. All vacuum packaged meat was spoiled by putrid flavours, high pH meat at 7 weeks and normal pH meat at 12 weeks. Increasing amounts of added CO(2) progressively retarded the development of putrid spoilage, as growth of the spoilage floras was slowed while the relative numbers of lactobacilli in the floras were enhanced. With the two largest amounts of added CO(2), spoilage was delayed until 15 weeks and 21 weeks for high pH meat and normal pH meat, respectively, and enterobacteria were detected in the spoilage floras only at later sampling times. With lesser amounts of added CO(2), enterobacteria persisted or re-emerged at earlier times, in the floras.

Modification of in-pack conditions to extend the storage life of vacuum packaged lamb.

High pH (>5·9) lamb loins from a research abattoir were subjected to differing packaging treatments to determine whether package modification could reliably extend the storage life of chilled lamb cuts beyond that attained by cuts vacuum-packaged in film of low gas permeability, as in current commercial practice. Treatments applied were carbon dioxide flushing or addition of a citrate buffer (pH 4·8), a 5% lactic acid solution or a Lactobacillus inoculum (plastic packs only) and packaging in a plastic film of moderately low oxygen permeability (140 cc/m(2)/24 h at 25°C and 90% relative humidity) or in a foil laminate of immeasurably low oxygen permeability. After 12 weeks' storage at -0.5°C, the cuts packaged in the plastic film were spoiled by off-odours produced by enterobacteria, except for inoculated cuts, which, instead, had developed unacceptable dairy flavours. In contrast, cuts packaged in foil laminate developed floras of lactobacilli that had not caused spoilage after 12 weeks, and meat colour was much improved by the exclusion of oxygen. Loin cuts from a commercial packaging operation were packaged in a shrinkable plastic film of low oxygen permeability (30 to 40 cc/m(2)/24 h at 25°C and 90% relative humidity), in foil laminate, or in foil laminate after the addition of 5% lactic acid solution. For the first 6 weeks, cuts were stored in a commercial chiller nominally operating at 0°C; subsequently, they were held in a laboratory chiller at -0.5°C. Some cuts packaged in the shrinkable plastic were spoiled after 9 weeks' storage and all were spoiled at 12 weeks, because of off-flavours produced by enterobacteria. All cuts packaged in the foil laminate were very acceptable at 9 weeks but most were spoiled by off-flavours at 12 weeks. Most cuts treated with lactic acid and packaged in foil laminate were unspoiled after 12 weeks. The packaging requirements indicated to be necessary for reliable extension of the storage life of vacuum packaged lamb are discussed.

Packaging conditions for extended storage of chilled dark, firm, dry beef.

Normal-pH (5·5-5·7) and high-pH (> 6·0) beef cuts of 500g were vacuum packaged in polyvinylidene chloride (PVDC), metalized polyester or aluminium foil laminates, or in foil laminate packs inflated with 1 litre of CO(2). During storage at + 1°C. vacuum packaged cuts developed spoilage floras of lactobacilli and enterobacteria; cuts stored under CO(2) developed floras of lactobacilli alone. Floras on all high-pH vacuum packaged cuts approached maximum numbers after 6 weeks' storage. At this time, cuts in PVDC laminate showed early symptoms of spoilage, but such symptoms did not develop in other vacuum packaged high-pH cuts until 9 or more weeks. Similarly, normal-pH cuts in PVDC film showed spoilage symptoms at 12 weeks, but such symptoms did not develop in other vacuum packaged normal-pH cuts until 15 weeks. Both normal- and high-pH cuts packaged under CO(2) were unspoiled at 15 weeks.

Effect of residual oxygen on the colour, odour and taste of carbon dioxide-packaged beef, lamb and pork during short term storage at chill temperatures.

Samples of boneless pork, lamb, beef (high and normal pH) were packaged in '100%' carbon dioxide atmospheres in foil laminate pouches. These pouches were fitted with a septum and a gas sampling port that allowed the introduction of air and removal of gas samples for analysis from the sealed packs. After sealing, measured volumes of air were introduced into test packs that had been gassed at a carbon dioxide volume to meat weight ratio of either 1 litre/kg or 2 litres/kg, to give initial atmospheres containing approximately 0·1, 0·2 and 1·0% oxygen. After 24 and 168 h storage at -1·5 ± 0·5°C, test packs were removed and compared with similarly treated control packs without added oxygen with respect to meat odour, taste and colour. No significant differences between the test and control packs in respect to odour or taste were evident with any meat type. The tendency to develop browning in response to the presence of residual oxygen within packs, increased in the order: pork, normal pH beef, normal pH lamb, high pH beef. Beef and lamb developed noticeable browning in packs containing more than 0·15% total oxygen while pork was able to tolerate 1% oxygen without obvious detrimental effects. For all meat types, the colour stability was greater in packs gassed to the higher gas volume to meat weight ratio.

Structural changes developing with rigor that facilitate bacterial invasion of muscle tissue.

Pre-rigor skeletal muscle fibres shrank in hypertonic and swelled in hypotonic fixative solutions, but the radial dimensions of post-rigor muscle fibres did not change with variations in the effective osmolalities of fixative solutions. Muscle fibres apparently undergo radial shrinkage during the development of rigor and, in so doing, can pull away from their surrounding endomysia. The resulting gaps between post-rigor muscle fibres and endomysia probably contain muscle cell cytoplasm. Bacteria penetrate muscle tissue via these gap regions.

The retail display life of steaks prepared from chill stored vacuum and carbon dioxide-packed sub-primal beef cuts.

Chilled striploins and cube rolls from ten Australian steers (grain-fed for 150 days) were trimmed of external fat and cut transversely into portions approximately 10 cm thick, each weighing between 750 and 1000 g. These 'retailer-ready' cuts were each wrapped in drip saver pads and slid inside a plastic sleeve before being individually placed into a clear plastic high oxygen barrier film, metallized film or conventional vacuum bag. Cuts in clear plastic and metallized film packs were packaged in an oxygen-free saturated carbon dioxide atmosphere (CO(2)-CAP), those in vacuum bags were conventionally vacuum-packed. All packs were returned to the chiller for further cooling. After 24 hr, half the clear plastic and metallized CO(2)-CAP packs were carbon dioxide master-packed in groups of eight. Retailer-ready cuts in both clear plastic and metallized film single unit and master-packed CO(2)-CAP packs were air freighted to New Zealand and sea freighted to Japan for assessment. The control vacuum packs were all consigned to New Zealand. Assessments in both countries after 39-89 days storage at between 0 °C and -1.0 °C indicated that fat colour stability limited the retail display life of steaks cut from meat in these retailer-ready packs to approximately 48 hr. In this regard, meat from single unit CO(2)-CAP, master pack CO(2)-CAP and vacuum packs performed similarly. Lean meat colour and sensory attributes remained acceptable for up to 48 hr after displayed product was rejected because of grey-green fat discoloration. The microbiological status of retailer-ready cuts removed from CO(2)-CAP packs after 89 days chilled storage was superior to that of cuts from vacuum packs. Clear plastic and metallized film CO(2)-CAP packs performed comparably.

The chilled storage life and retail display performance of vacuum and carbon dioxide packed hot deboned beef striploins.

Two cooling regimes that complied with the New Zealand meat hygiene requirement that hot deboned meat be chilled to +7 °C or less within 24 hr of leaving the slaughter floor were evaluated for the production of chilled table meats. Electrically stimulated hot deboned bull beef half striploins were either vacuum or carbon dioxide packed before being cooled in accordance with either Regime 1 (cool at +5 °C for 24 hr, transfer to chiller operating at -1.0 ± 0.5 °C) or Regime 2 (cool at +5 °C for 24 hr, hold at 5 °C for 6 days, transfer to chiller operating at -1.0 ± 0.5 °C). Striploins were removed from -1.0 °C storage 8, 28, 42, 56, 70, 84 and 98 days after slaughter and subjected to microbiological, tenderness, sensory and retail display performance evaluations. Both Regimes 1 and 2 produced meat of acceptable mean tenderness, 8 kgF (MIRINZ Tenderometer) in either vacuum or carbon dioxide packs within 28 and 8 days of slaughter, respectively. However, 70 days after slaughter the first signs of over-ageing became apparent. Steaks from Regimes 1 and 2 maintained acceptable visual appearance during retail display at 5 °C for 48 hr and 24 hr, respectively. After these times, the product was judged by the panel to be unacceptable because of its dull dark lean tissue and grey to green discoloration of the fat. Poor colour stability during retail display was mirrored by deterioration of sensory attributes, particularly aroma which is indicative of incipient spoilage. While carbon dioxide packaging in combination with Regime 1 offered an initial microbiological advantage over vacuum packaging, this advantage was not, however, carried over into retail display. Poor colour and sensory stability during retail display suggest that chilled table cuts derived from hot deboned bull beef are more suited to the Hotel-Restaurant-Institutional (HRI) trade than supermarket retailing. To serve the HRI, vacuum packed hot deboned bull beef primal cuts processed by Regime 1 appear to be the combination of choice. This combination would enable commercial processors to produce quality table beef with a chilled storage life of up to 70 days.

Influencing health care policy: nursing research and the ANA social policy statement.

This paper describes policy formation and its relationship to nursing research, examining ways in which nursing's disciplinary research can have greater influence on American health care policy. The American Nurses Association's Social Policy Statement (1995) is discussed in its role as a guide for nursing research efforts in a health care reform environment where favorable patient outcomes are key.

Bridging the nursing research-practice gap through research utilization.

This article explores the gap that currently exists between nursing research and nursing practice. The aim is to promote the conversion of new knowledge into practical innovations. Barriers to research utilization in practice settings come from both the academic and clinical arenas. Innovative models and strategies are needed to overcome these barriers. The purposes and value of research utilization and the clinical and academic strategies that facilitate research are discussed. Supporting clinical studies are provided as exemplars.

Nursing research and patient outcomes: tools for managing the transformation of the health care delivery system.

This paper outlines strategies for all nurses to participate in nursing's research agenda, which aims to enhance the scientific basis of nursing practice. The emphasis here is on generating data for the outcomes movement as a tool for transforming the American health care delivery system.

Comparison of weight loss achieved after laparoscopic adjustable gastric banding between Afro-Caribbean, Caucasian and South Asian adult female patients in a London bariatric centre.

INTRODUCTION: It has been shown that following laparoscopic adjustable gastric banding (LAGB) procedures, Afro-Caribbeans achieve poorer weight loss compared with Caucasians. The reasons for this are multifactorial. However, studies have been based on mainly female patients from the US and none to date have been from the UK. Furthermore, South Asians have not previously been compared. The aim of this study was to compare excess weight loss percentage (%EWL) outcomes up to five years following LAGB in Afro-Caribbean, Caucasian and South Asian females in a London-based teaching hospital. METHODS: An analysis was carried out of prospectively collected data of female patients aged ≥16 years of Afro-Caribbean, Caucasian or South Asian origin who underwent LAGB between October 2000 and December 2011. Data included demographics, co-morbidities and anthropometrics. RESULTS: Overall, 596 females underwent LAGB; 316 Caucasians (53.0%), 64 Afro-Caribbeans (10.8%) and 27 South Asians (4.5%) formed the majority of those who disclosed ethnicities. Age and initial body mass index (BMI) were comparable between Afro-Caribbeans and Caucasians (mean BMI: 47.3kg/m²[standard deviation [SD]: 7.5kg/m², range: 37.0-78.3kg/m²] vs 45.8kg/m²[SD: 7.1kg/m², range: 24.7-79.8kg/m²], p=0.225). A non-significant trend suggested less %EWL in Afro-Caribbeans than in Caucasians at 6 months, and at 1, 2, 3, 4 and 5 years (21.4% vs 24.4%, p=0.26; 27.4% vs 31.3%, p=0.27; 33.0% vs 36.8%, p=0.15; 39.0% vs 45.8%, p=0.14; 34.2% vs 45.3%, p=0.16; 37.1% vs 47.6%, p=0.67). South Asians and Caucasians had a similar age and preoperative BMI (mean BMI: 43.6kg/m² [range: 32.5-59.1kg/m²] vs 45.8kg/m² [range: 24.7-79.8kg/m²], p=0.08). The %EWL was greatest at three and four years among South Asians although numbers were small (n=4 and n=3 respectively). CONCLUSIONS: A non-significant trend suggests poorer weight loss outcomes in Afro-Caribbeans compared with Caucasians in our cohort. Discussion of realistic weight loss outcomes as well as enhanced follow-up and dietary modifications are required for Afro-Caribbean patients. Low numbers prevent definitive conclusions regarding South Asians. Multicentre studies across England are required to better define any differences between ethnicities.