Adaptation and study protocol for harvest for health together Arizona: A mentored community garden intervention for survivors of cancer.

Background: Current health behavior recommendations for skin cancer prevention, treatment, and survivorship are the same for survivors of other cancers; they include eating a healthy diet, being physically active, maintaining a healthy weight, and minimizing ultraviolet (U.V.) exposure. Few interventions exist to support health behaviors beyond U.V. exposure. We adapted Harvest for Health, a home-based mentored gardening intervention for cancer survivors, for implementation in Arizona as a community-based intervention. Methods: Stakeholder-informed adaptations for Harvest for Health Together Arizona (H4H2-AZ) included updating intervention materials to be relevant to the arid desert environment, emphasizing the importance of sun safety in cancer survivorship, and shifting from a home-based to a community-based delivery model. Participants will be enrolled in cohorts aligned with growing seasons (e.g., spring, monsoon, fall) and matched to an individual 30 ft2 community garden plot for two growing seasons (6 months). Original intervention components retained are: 1) Master Gardeners deliver the intervention providing one-to-one mentorship and 2) gardening materials and supplies provided. This pilot six-month single-arm intervention will determine feasibility, acceptability, and appropriateness of an evidence-based adapted mentored community gardening intervention for survivors of skin cancer as primary outcomes. Secondary outcomes are to explore the effects on cancer preventive health behaviors and health-related quality of life. Discussion: This pilot single-arm intervention will determine feasibility, acceptability, and appropriateness of an evidence-based adapted mentored community gardening intervention for survivors of skin cancer. If successful, the intervention could be widely implemented throughout existing Master Gardener programs and community garden networks for survivors of other cancers. Trial registration: ClinicalTrials.gov identifier: NCT05648604. Trial registered on December 13, 2022.

Generalised eruptive histiocytosis preceded by systemic symptoms.

Generalised eruptive histiocytosis is a rare proliferative disease that typically presents with indolent cutaneous eruptions. We describe the case of a 73-year-old man presenting with diffuse, asymptomatic crops of pink to dusky red papules preceded by general malaise, myalgias, fluctuating fever, chills, and weight loss. Histological evaluation revealed a non-Langerhans cell histiocytic dermal infiltrate with spindle cell features and chronic inflammation, reactive for CD68 and negative for both S100 and CD1a. Malignancy screening was negative. This report aims to highlight a unique presentation of generalised eruptive histiocytosis, emphasise histological findings, and discuss considerations for malignancy screening.

Educational interventions for primary care providers to improve clinical skin examination for skin cancer.

BACKGROUND AND PURPOSE: Skin cancer, the most commonly diagnosed cancer in the United States, is a serious health care concern. Early skin cancer detection improves prognosis; most common early detection approach is a comprehensive clinical skin examination (CSE). A CSE consists of skin cancer risk assessment, head-to-toe skin examination, and skin lesion assessment. Nurse practitioners (NPs) currently lack adequate training and confidence to conduct CSE. The goal of this systematic review was to learn more about published interventions targeting CSE training for primary care NPs and/or other primary care providers. The findings were categorized based on the established procedures for intervention development. METHODS: The databases PubMed, Google Scholar, CINAHL, and Web of Science were searched. Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, 10 articles were selected for data extraction. CONCLUSIONS: There is a paucity of articles that report rigorously developed interventions aimed at educating primary care NPs to conduct CSE. Existing CSE interventions were not tested for efficacy or effectiveness, and the implementation methods were weak or not reported. A synthesis of the review findings revealed inadequately reported sample characteristics, vague intervention goals, unspecified frequency or duration of interventions, and lack of standardized intervention protocols. IMPLICATIONS FOR PRACTICE: This review builds a foundation for more rigorously developed interventions to improve CSE and provides guidance for NPs to select education on CSE and other clinical foci. Future research will guide the development and evaluate the effectiveness of CSE education, which ultimately could improve skin cancer prognosis interventions and lack of standardized intervention protocols.

Single versus repeated exposure to human polarized intestinal epithelial monolayers for in vitro protein hazard characterization.

Recent studies suggest human-derived intestinal epithelial cell (IEC) lines cultured as polarized monolayers on permeable Transwell® filters are effective at differentiating between hazardous and non-hazardous proteins following a single exposure. In this study, IEC polarized monolayers were subjected to hazardous or non-hazardous proteins in nine exposures over 30 days and compared to a single exposure of the same protein. The objective was to evaluate whether repeated exposures to a protein differently alter barrier integrity or compromise cell viability compared to single exposures. Proteins tested included Clostridium difficile toxin A, Streptolysin O, Wheat Germ Agglutinin, Phaseolus vulgaris Hemagglutinin-E, bovine serum albumin, porcine serum albumin, and fibronectin. Evidence of diminished barrier integrity and/or cell viability following exposure to hazardous proteins was more pronounced in magnitude when IECs were subjected to multiple rather than single exposures. In some cases, an effect on IEC monolayers was observed only with repeated exposures. In general, IEC responses to non-hazardous proteins following either single or repeated exposures were minimal. Results from these studies support the utility of using cultured human IEC polarized monolayers to differentiate between hazardous and non-hazardous proteins and suggest that repeated exposures may reveal a greater magnitude of response when compared to single exposures.

Extended exposure duration of cultured intestinal epithelial cell monolayers in characterizing hazardous and non-hazardous proteins.

Recent studies suggest that human derived intestinal epithelial cells (IECs) cultured as polarized monolayers on Transwell® filters may respond differently when exposed to hazardous and non-hazardous proteins. This experimental platform was based on apical exposure of IEC monolayers to test proteins for 24 h followed by assessment of barrier integrity and cell viability. In this study, Caco-2 and T84 IEC polarized monolayers were evaluated for barrier integrity and cytotoxicity following exposure to hazardous and non-hazardous proteins for 24, 48 and 72 h. Hazardous proteins included Clostridium difficile toxin A (ToxA), Streptolysin O (SLO), Wheat Germ Agglutinin (WGA), and Phaseolus vulgaris haemagglutinin-E (PHA-E). Non-hazardous proteins included bovine serum albumin (BSA), porcine serum albumin (PSA), and fibronectin (Fbn). In general, evidence of diminished barrier integrity or cell viability observed following exposure to hazardous proteins for 24 h was more pronounced after 48 and 72 h for both IEC monolayers. Non-hazardous proteins exhibiting no impact following 24 h of exposure elicited minimal effects over longer exposure durations. These results support the utility of using cultured human IEC polarized monolayers to differentiate between hazardous and non-hazardous proteins and suggest that longer durations of exposure may further improve the ability to distinguish between them.

Primary human polarized small intestinal epithelial barriers respond differently to a hazardous and an innocuous protein.

An experimental platform employing human derived intestinal epithelial cell (IEC) line monolayers grown on permeable Transwell® filters was previously investigated to differentiate between hazardous and innocuous proteins. This approach was effective at distinguishing these types of proteins and perturbation of monolayer integrity, particularly transepithelial electrical resistance (TEER), was the most sensitive indicator. In the current report, in vitro indicators of monolayer integrity, cytotoxicity, and inflammation were evaluated using primary (non-transformed) human polarized small intestinal epithelial barriers cultured on Transwell® filters to compare effects of a hazardous protein (Clostridium difficile Toxin A [ToxA]) and an innocuous protein (bovine serum albumin [BSA]). ToxA exerted a reproducible decrease on barrier integrity at doses comparable to those producing effects observed from cell line-derived IEC monolayers, with TEER being the most sensitive indicator. In contrast, BSA, tested at concentrations substantially higher than ToxA, did not cause changes in any of the tested variables. These results demonstrate a similarity in response to certain proteins between cell line-derived polarized IEC models and a primary human polarized small intestinal epithelial barrier model, thereby reinforcing the potential usefulness of cell line-derived polarized IECs as a valid experimental platform to differentiate between hazardous and non-hazardous proteins.

Business Process Modelling is an Essential Part of a Requirements Analysis. Contribution of EFMI Primary Care Working Group.

OBJECTIVES: To perform a requirements analysis of the barriers to conducting research linking of primary care, genetic and cancer data. METHODS: We extended our initial data-centric approach to include socio-cultural and business requirements. We created reference models of core data requirements common to most studies using unified modelling language (UML), dataflow diagrams (DFD) and business process modelling notation (BPMN). We conducted a stakeholder analysis and constructed DFD and UML diagrams for use cases based on simulated research studies. We used research output as a sensitivity analysis. RESULTS: Differences between the reference model and use cases identified study specific data requirements. The stakeholder analysis identified: tensions, changes in specification, some indifference from data providers and enthusiastic informaticians urging inclusion of socio-cultural context. We identified requirements to collect information at three levels: micro- data items, which need to be semantically interoperable, meso- the medical record and data extraction, and macro- the health system and socio-cultural issues. BPMN clarified complex business requirements among data providers and vendors; and additional geographical requirements for patients to be represented in both linked datasets. High quality research output was the norm for most repositories. CONCLUSIONS: Reference models provide high-level schemata of the core data requirements. However, business requirements' modelling identifies stakeholder issues and identifies what needs to be addressed to enable participation.

Toxicology studies with N-acetyl-L-serine.

N-Acetyl-L-serine (NAS) is a component of dietary proteins and a minor constituent of foods as a free amino acid. The current paper reports the outcome of toxicology studies conducted to assess the safety of NAS. No evidence of mutagenicity was observed in the reverse bacterial mutation assay. Genotoxicity was not observed in the bone marrow micronucleus assay conducted in mice. No mortalities or evidence of adverse effects were observed in Sprague-Dawley (SD) rats following acute oral administration at a dose of 2000 mg of NAS/kg of body weight. Similarly, no evidence of adverse effects was observed in SD rats following repeated dose dietary exposure (28-days) to targeted doses of 100, 500, or 1000 mg of NAS/kg of body weight/day. All rats survived until scheduled sacrifice and no biologically significant differences were observed in any of the response variables from the NAS exposure groups compared with untreated control groups. Based on these results, NAS does not represent a risk for mutagenicity or genotoxicity, is not acutely toxic, and the no-observed-adverse-effect-level (NOAEL) for systemic toxicity from repeated dose dietary exposure to NAS is 839.7 and 893.6 mg of NAS/kg of body weight/day for male and female rats, respectively.

Safety assessment of N-acetyl-L-threonine.

N-acetyl-L-threonine (NAT) is a dietary constituent that has been identified at low concentrations (< 1 microg/g fresh weight) in numerous foods. The current paper reports the outcome of toxicology studies conducted to assess the effects of NAT. No evidence of mutagenicity or genotoxicity was observed in in vitro bacterial or in vivo mammalian studies. No mortalities or evidence of adverse effects were observed in Sprague-Dawley (SD) rats following acute oral administration of 2000 mg of NAT/kg of body weight (kg of bw). A 28-day repeated dose toxicity study was conducted in SD rats by incorporating NAT into diets at concentrations targeting up to 1000 mg of NAT/kg of bw/day. All rats survived until scheduled sacrifice and no biologically significant differences were observed in any of the NAT treatment groups for body weights, feed consumption, clinical signs, behavioral, ophthalmology, hematology, coagulation, clinical chemistry, organ weights, or gross or microscopic changes. Based on these results, NAT does not represent a risk for mutagenicity or genotoxicity, is not acutely toxic, and the no-observed-adverse-effect-level (NOAEL) for systemic toxicity from repeated dose dietary exposure to NAT is 848.5 and 913.6 mg/kg of bw/day for male and female SD rats, respectively.

Comparison of broiler performance when fed diets containing event DP-3O5423-1, nontransgenic near-isoline control, or commercial reference soybean meal, hulls, and oil.

DP-3Ø5423-1 (305423) is a genetically modified soybean that was produced by biolistic insertion of the gm-fad2-1 gene fragment and gm-hra genes into the germline of soybean seeds. Expression of gm-fad2-1 results in greater concentrations of oleic acid (18:1) by suppressing expression of the endogenous FAD2-1 gene, which encodes an n-6 fatty acid desaturase enzyme that catalyzes desaturation of 18:1 to linoleic acid (18:2). The GM-HRA protein expressed by the gm-hra gene is a modified version of the soybean acetolactate synthase enzyme that is used as a selectable marker during transformation. A 42-d feeding trial was conducted with broiler chickens to compare the nutritional performance of 305423 soybeans with nontransgenic soybeans. Diets were prepared using processed fractions (meal, hulls, and oil) from 305423 soybean plants. For comparison, additional diets were produced with soybean fractions obtained from a nontransgenic near-isoline (control) and nontransgenic commercial Pioneer brand varieties (93B86, 93B15, and 93M40). Diets were fed to Ross x Cobb broilers (n = 120/group, 50% male and 50% female) in 3 phases. Starter, grower, and finisher diets contained 26.5, 23, and 21.5% soybean meal, respectively. Soybean hulls and oil were added at 1.0 and 0.5%, respectively, across all diets in each phase. No statistically significant differences were observed in growth performance (BW, mortality, feed efficiency), organ yield (liver and kidney), or carcass yield (breast, thigh, leg, wing, and abdominal fat) variables between broilers consuming diets prepared with isolated fractions from 305423 or near-isoline control soybean. Additionally, all performance and carcass variables from control and 305423 soybean treatment groups fell within tolerance intervals constructed for each response variable using data from broilers fed diets prepared with reference soybean fractions. Based on the results from this study, it was concluded that 305423 soybeans were nutritionally equivalent to non-transgenic control soybeans with a comparable genetic background.

Meta-analysis: Helicobacter pylori'test and treat' compared with empirical acid suppression for managing dyspepsia.

BACKGROUND: Which of Helicobacter pylori'test and treat' or empirical acid suppression should be preferred for the initial management of uncomplicated dyspepsia is controversial. Aim To conduct an individual patient data meta-analysis of randomized controlled trials (RCTs) of 'test and treat' vs. empirical acid suppression in adults with uncomplicated dyspepsia in primary care. METHODS: Investigators provided original data sets for analysis. Effect of management strategy on symptom status and dyspepsia-related resource use at 12-month follow-up was examined by pooling symptom and cost data to obtain relative risk (RR) of remaining symptomatic at 12 months and weighted mean difference (WMD) in costs between the two strategies with 95% confidence intervals (CI). RESULTS: We identified three eligible RCTs containing 1547 patients, 791 (51%) of whom were assigned to 'test and treat'. There was no difference detected in symptom-cure at 12 months (RR = 0.99; 95% CI: 0.95-1.03). There was a nonsignificant trend towards cost-savings with 'test and treat' (WMD in costs = - 28.91 pound; 95% CI: - 68.48 pound to 10.65 pound). CONCLUSIONS: There was little difference in symptom-resolution or costs between the two strategies. A combination of patient and physician preference should determine the initial approach to the management of uncomplicated dyspepsia.

Systematic reviews of the clinical effectiveness and cost-effectiveness of proton pump inhibitors in acute upper gastrointestinal bleeding.

OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of proton pump inhibitors (PPIs) in the prevention and treatment of acute upper gastrointestinal (UGI) haemorrhage, as well as to compare this with H2-receptor antagonist (H2RA), Helicobacter pylori eradication (in infected patients) or no therapy, for the prevention of first and/or subsequent bleeds among patients who continue to use non-steroidal anti-inflammatory drugs (NSAIDs). Also to evaluate the clinical effectiveness of PPI therapy, compared with other treatments, for the prevention of subsequent bleeds in patients who had previously experienced peptic ulcer (PU) bleeding. DATA SOURCES: Electronic databases and major conference proceedings were searched up to February 2006. REVIEW METHODS: Data were collected from the systematic reviews addressing each research objective. These were then entered into an economic model to compare the costs and quality-adjusted life-days of alternative management strategies over a 28-day period for patients who have had UGI bleeding. A Markov model with a Monte Carlo simulation used data from the systematic reviews to identify the most cost-effective treatment strategy for the prevention of UGI bleeding (first and subsequent) among NSAID users using an outcome of costs per quality-adjusted life-years (QALYs) over a lifetime from age 50 years. RESULTS: PPI treatment initiated after endoscopic diagnosis of PU bleeding significantly reduced re-bleeding and surgery compared with placebo or H2RA. Although there was no evidence of an overall effect of PPI treatment on all-cause mortality, PPIs significantly reduced mortality in subgroups when studies conducted in Asia were examined in isolation or when the analysis was confined to patients with high-risk endoscopic findings. PPI treatment initiated prior to endoscopy in UGI bleeding significantly reduced the proportion of patients with stigmata of recent haemorrhage (SRH) at index endoscopy compared with placebo or H2RA, but there was no evidence that PPI treatment affected clinically important outcomes. Giving oral PPI both before and after endoscopy, with endoscopic haemostatic therapy (EHT) for those with major SRH, is preferred to all others on cost-effectiveness grounds at any threshold over 25,000 pounds per QALY, even if only short-term effects are taken into account, and at any threshold over 200 pounds per life-year gained if long-term effects are included. The risk of NSAID-induced endoscopic gastric and duodenal ulcers was reduced by standard doses of PPI and misoprostol, and double doses of H2RAs. Standard doses of H2RAs reduced the risk of endoscopic duodenal ulcers. PPIs reduced NSAID-induced dyspepsia. PPIs were superior to misoprostol in preventing recurrence of NSAID-induced endoscopic duodenal ulcers, but PPIs were comparable to misoprostol in preventing the recurrence of NSAID-induced endoscopic gastric ulcers. Full-dose misoprostol reduced bleeding, perforation or gastric outlet obstruction due to NSAID-induced ulcers, but misoprostol was poorly tolerated and associated with frequent adverse effects. H. pylori eradication treatment was equally effective with PPI treatment for the primary or secondary prevention of endoscopic ulcers in NSAID users. H. pylori eradication treatment was more effective than placebo for the primary prevention of endoscopic PU and for the prevention of re-bleeding from PU in NSAID users. With regard to primary and secondary prevention of bleeding PU in NSAID users, the two most cost-effective strategies are H. pylori eradication alone, and H. pylori eradication followed by misoprostol (substituted by a PPI, if misoprostol is not tolerated) at an additional 4810 pounds per QALY. In patients who had previously experienced a bleed from a PU, re-bleeding was less frequent after H. pylori eradication therapy than after non-eradication antisecretory therapy, whether or not the latter was combined with long-term maintenance antisecretory therapy. CONCLUSIONS: PPI treatment compared with placebo or H2RA reduces mortality following PU bleeding among patients with high-risk endoscopic findings, and reduces re-bleeding rates and surgical intervention. PPI treatment initiated prior to endoscopy in UGI bleeding significantly reduces the proportion of patients with SRH at index endoscopy but does not reduce mortality, re-bleeding or the need for surgery. The strategy of giving oral PPI before and after endoscopy, with EHT for those with major SRH, is likely to be the most cost-effective. Treatment of H. pylori infection was found to be more effective than antisecretory therapy in preventing recurrent bleeding from PU. H. pylori eradication alone or eradication followed by misoprostol (with switch to PPI, if misoprostol is not tolerated) are the two most cost-effective strategies for preventing bleeding ulcers among H. pylori-infected NSAID users, although the data cannot exclude PPIs also being cost-effective. Further large randomised controlled trials are needed to address areas such as PPI administration prior to endoscopic diagnosis, different doses and administration of PPIs, as well as the primary and secondary prevention of UGI bleeding.

Comparison of broiler performance when fed diets containing event DP-356Ø43-5 (Optimum GAT), nontransgenic near-isoline control, or commercial reference soybean meal, hulls, and oil.

Event DP-356Ø43-5 (356043; Optimum GAT) is a genetically modified soybean (Glycine max) that was produced by insertion of the gat4601 and gm-hra genes. The expression products of these genes are the glyphosate acetyltransferase 4601 and acetolactate synthase proteins, respectively. Expression of the glyphosate acetyltransferase 4601 protein confers tolerance in planta to the herbicidal active ingredient glyphosate, whereas expression of the acetolactate synthase protein confers tolerance to sulfonylurea and imidazolinone herbicides. The objective of this study was to compare the nutritional equivalence of 356043 soybeans to nontransgenic soybeans in a 42-d feeding trial in broiler chickens. Diets were prepared using processed fractions (meal, hulls, and oil) from untreated 356043 soybean plants or from soybean plants treated with a mixture of glyphosate, chlorimuron, and thifensulfuron (356043 + Gly/SU). For comparison, additional diets were produced with soybean fractions obtained from a nontransgenic near-isoline (control; 091) and nontransgenic commercial Pioneer varieties (93B86, 93B15, and 93M40). Diets were fed to Ross x Cobb broilers (n = 120/group, 50% male and 50% female) in 3 phases. Starter diets contained 30% soybean meal, grower diets 26% soybean meal, and finisher diets 21.5% soybean meal. Soybean hulls and oil were added at 1.0 and 0.5%, respectively, across all diets in each phase. No statistically significant differences were observed in mortality, growth performance variables, or carcass and organ yields between broilers consuming diets produced with 356043 or 356043 + Gly/SU soybean fractions and those consuming diets produced with near-isoline control soybean fractions. Additionally, all performance and carcass variables from control, 356043, and 356043 + Gly/SU soybean treatment groups fell within the tolerance intervals constructed using data from reference soybean groups. Based on the results from this study, it was concluded that 356043 soybean was nutritionally equivalent to nontransgenic control soybean with a comparable genetic background.

Initial management strategies for dyspepsia.

BACKGROUND: This review considers management strategies (combinations of initial investigation and empirical treatments) for dyspeptic patients. Dyspepsia was defined to include both epigastric pain and heartburn. OBJECTIVES: To determine the effectiveness, acceptability, and cost effectiveness of the following initial management strategies for patients presenting with dyspepsia: (a) Initial pharmacological therapy (including endoscopy for treatment failures). (b) Early endoscopy. (c) Testing for Helicobacter pylori (H. pylori )and endoscope only those positive. (d) H. pylori eradication therapy with or without prior testing. SEARCH STRATEGY: Trials were located through electronic searches and extensive contact with trialists. SELECTION CRITERIA: All randomised controlled trials of dyspeptic patients presenting in primary care. DATA COLLECTION AND ANALYSIS: Data were collected on dyspeptic symptoms, quality of life and use of resources. An individual patient data meta-analysis of health economic data was conducted MAIN RESULTS: Twenty-five papers reporting 27 comparisons were found. Trials comparing proton pump inhibitors (PPI) with antacids (three trials) and histamine H2-receptor antagonists (H2RAs) (three trials), early endoscopy with initial acid suppression (five trials), H. pylori test and endoscope versus usual management (three trials), H. pylori test and treat versus endoscopy (six trials), and test and treat versus acid suppression alone in H. pylori positive patients (four trials), were pooled. PPIs were significantly more effective than both H2RAs and antacids. Relative risks (RR) and 95% confidence intervals (CI) were; for PPI compared with antacid 0.72 (95% CI 0.64 to 0.80), PPI compared with H2RA 0.63 (95% CI 0.47 to 0.85). Results for other drug comparisons were either absent or inconclusive. Initial endoscopy was associated with a small reduction in the risk of recurrent dyspeptic symptoms compared with H. pylori test and treat (OR 0.75, 95% CI 0.58 to 0.96), but was not cost effective (mean additional cost of endoscopy US$401 (95% CI $328 to 474). Test and treat may be more effective than acid suppression alone (RR 0.59 95% CI 0.42 to 0.83). AUTHORS' CONCLUSIONS: Proton pump inhibitor drugs (PPIs) are effective in the treatment of dyspepsia in these trials which may not adequately exclude patients with gastro-oesophageal reflux disease (GORD). The relative efficacy of histamine H2-receptor antagonists (H2RAs) and PPIs is uncertain. Early investigation by endoscopy or H. pylori testing may benefit some patients with dyspepsia but is not cost effective as part of an overall management strategy.

Review article: Helicobacter pylori and gastro-oesophageal reflux disease.

Epidemiological studies demonstrate a negative association between Helicobacter pylori infection and gastro-oesophageal reflux disease and its complications. This might represent a protective effect because of the tendency for H. pylori infection to lower gastric acid secretion with advancing age. However, studies of the effect of H. pylori eradication on gastro-oesophageal reflux disease have failed to show any worsening of gastro-oesophageal reflux disease symptoms. Several interactions between H. pylori and proton-pump inhibitor therapy used to treat gastro-oesophageal reflux disease need to be considered. Helicobacter pylori infection improves the control of gastric acidity by proton-pump inhibitors and this produces a small advantage in clinical control of reflux disease. The infection prevents rebound acid hypersecretion occurring when proton-pump inhibitor therapy is discontinued. However, concerns have been expressed that the body gastritis induced by proton-pump inhibitor therapy in H. pylori-infected subjects might increase the risk of gastric cancer. At present, it is unclear whether H. pylori should be eradicated in gastro-oesophageal reflux disease patients.

Variation in the use of H. pylori tests in UK general practice--a qualitative study.

BACKGROUND: Although serology is the main Helicobacter pylori test used by general practitioners in the UK, there is no information available on variation in requesting rates. AIM: To explore the reasons for any variation in H. pylori serology testing by general practices in the UK using qualitative methods. METHODS: Serology requesting rates were determined using laboratory and population data. Staff from randomly selected practices in the lowest and highest quintiles of testing attended focus groups to discuss the management of H. pylori and dyspepsia. Transcribed data were analysed using an interpretative phenomenological approach. RESULTS: Serology submission varied 600-fold (0.1-59/1000 population/year) and H. pylori positivity rate 17-100%. Low-testing practices were less aware of the benefits of H. pylori testing and had shorter endoscopy waiting times. They preferred endoscopy diagnosis over serology test. Three high-testing practices had a high non-white population with high H. pylori positivity. Most staff knew little about the predictive value of serology, the availability of urea breath test on prescription or the existence of a stool test. CONCLUSIONS: Seroprevalence of H. pylori is still high in dyspeptics, especially in non-white populations. Laboratories and primary care trusts should audit H. pylori requests and endoscopy referrals, target education at high endoscopy referrers and low H. pylori testers and inform clinicians of the more accurate H. pylori tests and NICE dyspepsia guidance.

Managing dyspepsia without alarm signs in primary care: new national guidance for England and Wales.

AIM: To report new recommendations for the primary care management of dyspepsia without alarm signs in England and Wales. METHOD: An independent, representative group of health care professionals, patient representatives and researchers developed the guideline using evidence-based and small group-working principles, and incorporated extensive peer-reviewing and feedback from stakeholder organizations. RESULTS: Referral to investigate dyspepsia should be made for alarm signs and not on the basis of age alone, reflecting the balance of benefit and harm from endoscopy. Empirical management without formal diagnosis is appropriate for most patients: reviewing patient history, lifestyle, over-the-counter medicines, and providing a course of proton-pump inhibitors and/or Helicobacter pylori test and treatment. Patients with ongoing symptoms require at least annual review to discuss symptoms and lifestyle, and as appropriate, encourage stepping down prescribed medication and returning to self-care. A new strategy included in the step down process is the use of therapies 'on-demand'. CONCLUSION: The guideline provides structured and supported recommendations for both undiagnosed and endoscopically investigated dyspepsia. Some favour increased investigation to detect Barrett's oesophagus and carcinoma. However, there is inconclusive evidence that patients without alarm signs will benefit subsequently from endoscopy, while investigation involves a small but real risk of harm.

Symptom evaluation in reflux disease: workshop background, processes, terminology, recommendations, and discussion outputs.

There has been no published indepth systematic evaluation of the best approaches to symptom evaluation in gastro-oesophageal reflux disease (GORD). A two day international multidisciplinary workshop was therefore held in Marrakech, Morocco, in September 2002 to address these issues. The aim of the workshop was to critically review the data regarding the reliability, processes, and priorities for symptom evaluation in GORD patients. The workshop was designed to give outputs that could be readily reported and to arrive at specific recommendations on best practice in symptom evaluation in reflux disease.

Initial management strategies for dyspepsia.

BACKGROUND: This review considers management strategies (combinations of initial investigation and empirical treatments) for dyspeptic patients. Dyspepsia was defined to include both epigastric pain and heartburn. OBJECTIVES: To determine the effectiveness, acceptability, and cost effectiveness of the following initial management strategies for patients presenting with dyspepsia (a) initial pharmacological therapy (including endoscopy for treatment failures) (b) early endoscopy (c) testing for Helicobacter pylori and endoscope only those positive (d) H.pylori eradication therapy with or without prior testing. SEARCH STRATEGY: Trials were located through electronic searches and extensive contact with trialists. SELECTION CRITERIA: All randomised controlled trials of dyspeptic patients presenting in primary care. DATA COLLECTION AND ANALYSIS: Data was collected on dyspeptic symptoms, quality of life and use of resources. MAIN RESULTS: Twenty papers reporting 23 comparisons were found. Trials comparing proton pump inhibitors (PPI) with antacids (two trials) and H2 receptor antagonists (three trials), early endoscopy with initial acid suppression (five trials), H.pylori 'test and scope' v usual management (three trials), H.pylori test and treat v. endoscopy (four trials), and test and treat v. acid suppression alone in H.pylori positive patients (two trials), were pooled. PPIs were significantly more effective than both H2RAs and antacids. Relative risks (RR) and 95% CI were, for PPI: antacid 0.72 (0.64-0.80), PPI: H2RA 0.63 (0.47-0.85). Results for other drug comparisons were either absent or inconclusive. Initial endoscopy was associated with a small reduction in the risk of recurrent dyspeptic symptoms compared with initial prescribing (RR 0.89 (0.77-1.02). H.pylori test and endoscopy increases costs in primary care, but does not improve symptoms. H.pylori test and eradicate may be as effective as endoscopy- based management and reduces costs, by decreasing the proportion of patients that are endoscoped. 'Test and treat' may be more effective than acid suppression alone, RR 0.59 (0.42-0.83). REVIEWER'S CONCLUSIONS: PPIs are effective in the treatment of dyspepsia in these trials which may not adequately exclude patients with gastro-oesophageal reflux disease. The relative efficacy of H2RA and PPI is uncertain. Early investigation by endoscopy or H.pylori testing may benefit some patients with dyspepsia. The review will be updated in 2004 with an individual patient data meta-analysis of the economic data, and a subgroup analysis by age and predominant dyspeptic symptom.