Browsing by Author "Frampton C"
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- ItemBenchmarking total hip replacement constructs using noninferiority analysis: the New Zealand joint registry study.(BioMed Central Ltd, 2021) Wyatt M; Frampton C; Whitehouse M; Deere K; Sayers A; Kieser DBACKGROUND: The aim of this study was to compare the relative performance of total hip replacement constructs and discern if there is substantial variability in performance in currently commonly used prostheses in the New Zealand Joint Registry (NZJR) using a noninferiority analysis. METHODS: All patients who underwent a primary total hip replacement (THR) registered in the NZJR between 1st January 1999 to June 2020 were identified. Using a noninferiority analysis, the performance of hip prostheses were compared with the best performing contemporary construct. Construct failure was estimated using the 1-Kaplan Meier survival function method to estimate net failure. The difference in failure between the contemporary benchmark and other constructs was examined. RESULTS: In total 135,432 THR were recorded comprising 1035 different THR constructs. Notably 328 constructs were used just once. Forty-eight constructs (62,251 THR) had > 500 procedures at risk at 3 years post-primary of which 28 were inferior by at least 20% relative risk of which, 10 were inferior by at least 100% relative risk. Sixteen constructs were identified with > 500 procedures at risk at 10 years with 9 inferior by at least 20%, of which one was inferior by > 100% relative risk. There were fewer constructs noninferior to the best practice benchmark when we performed analysis by gender. In females at 10 years, from 5 constructs with > 500 constructs at risk, 2 were inferior at the 20% margin. In males at 10 years, there were only 2 eligible constructs of which one was inferior at the 20% margin. CONCLUSIONS: We discerned that there is substantial variability in construct performance and at most time points, just over half of constructs are inferior to the best performing construct by at least 20%. These results can facilitate informed decision-making when considering THR surgery.
- ItemEffects of defatted rice bran-fortified bread on gut microbiome, cardiovascular risk, gut discomfort, wellbeing and gut physiology in healthy adults with low dietary fibre intake(Elsevier Ltd on behalf of the European Society for Clinical Nutrition and Metabolism, 2025-06) Ng HM; Maggo J; Wall CL; Bayer SB; Mullaney JA; Cabrera D; Fraser K; Cooney JM; Günther CS; McNabb WC; Foster M; Frampton C; Gearry RB; Roy NCBackground & aims: Inadequate dietary fibre (DF) intake is associated with suboptimal gut function and increased risk of several human diseases. Bread is commonly consumed and is ideal to incorporate cereal bran to increase DF content. No human studies have investigated the effects of defatted rice bran (DRB) in bread, which has triple the DF of white bread, purported hypo-allergenicity and a unique nutrient profile, as a dietary intervention in healthy adults. This study aims to assess the relative abundances of a composite of key faecal microbial genera and species involved in DF fermentation and metabolism following the habitual intake of DRB-fortified bread and its influence on other biological markers of host and microbial interactions, cardiovascular risk profile, patient-reported outcomes, total DF intake, and gut physiology in healthy adults with low baseline DF intake. Methods: Fifty-six healthy adults with low baseline DF intake (<18 g/day (females), <22 g/day (males)) completed a two-arm, placebo-controlled, double-blind, randomised, crossover study. Participants consumed three (females) or four (males) slices of DRB-fortified bread or control bread daily as part of their usual diet for four weeks, with the intervention periods separated by a two-week washout. Outcomes included faecal microbiota composite (primary outcome); relative abundances (taxa and gene); faecal moisture content and bile acid concentrations; plasma and faecal organic acid concentrations; cardiovascular risk profile; gut comfort, psychological wellbeing parameters; total DF intake; whole gut transit time, and were measured at baseline and following each intervention phase. Additionally, in a sub-study, 15 participants ingested gas-sensing capsules to assess whole and regional gut transit times, and total and regional colonic hydrogen and carbon dioxide concentrations at the same timepoints. Results: DRB-fortified bread consumption significantly increased total DF intake from 20.7 g/day to 43.4 g/day (p < 0.001). No significant differences were observed in the primary outcome, microbial taxa composite within and between groups (False Discovery Rate (FDR) correction, p > 0.10). As compared to control, the DRB group had increased relative abundances of Faecalibacterium prausnitzii (unadjusted p = 0.04), Bifidobacterium longum (unadjusted p = 0.12), and Bacteroides ovatus (unadjusted p = 0.10); lower relative abundances in Coprococcus genus (unadjusted p = 0.09), Roseburia faecis (unadjusted p = 0.02) and Prevotella copri species (unadjusted p = 0.05). However, no significant differences were observed in the relative abundances of these taxa within and between groups (FDR correction p > 0.10) and for most of the other outcomes between groups (p > 0.05). Only mean serum high-density lipoprotein (HDL) concentrations significantly increased (p = 0.006), and mean total cholesterol (TC) to HDL concentration ratio significantly lowered (p = 0.02) in the DRB group compared to the control group. Conclusion: This is the first human study to show that a high-DF DRB-fortified bread improved DF intake, HDL cholesterol profiles, and may affect the gut microbiota composition in healthy adults with low DF intake. These findings support the substitution of white bread with DRB-fortified bread as an effective method to improve DF intake, which may have subsequent benefits on gut physiology and metabolic health.
- ItemEffects of Defatted Rice Bran-Fortified Bread on the Gut Microbiota Composition of Healthy Adults With Low Dietary Fiber Intake: Protocol for a Crossover Randomized Controlled Trial(JMIR Publications, 2024-08-29) Ng HM; Maggo J; Wall CL; Bayer SB; McNabb WC; Mullaney JA; Foster M; Cabrera DL; Fraser K; Cooney J; Trower T; Günther CS; Frampton C; Gearry RB; Roy NCBACKGROUND: Inadequate dietary fiber (DF) intake is associated with several human diseases. Bread is commonly consumed, and its DF content can be increased by incorporating defatted rice bran (DRB). OBJECTIVE: This first human study on DRB-fortified bread primarily aims to assess the effect of DRB-fortified bread on the relative abundance of a composite of key microbial genera and species in fecal samples. Secondary outcomes include clinical (cardiovascular risk profile), patient-reported (daily bread consumption and bowel movement, gut comfort, general well-being, and total DF intake), biological (fecal microbiota gene abundances, and fecal and plasma metabolites), and physiome (whole-gut and regional transit time and gas fermentation profiles) outcomes in healthy adults with low DF intake. METHODS: This is a 2-armed, placebo-controlled, double-blinded, crossover randomized controlled trial. The study duration is 14 weeks: 2 weeks of lead-in, 4 weeks of intervention per phase, 2 weeks of washout, and 2 weeks of follow-up. Overall, 60 healthy adults with low DF intake (<18 g [female individuals] or <22 g [male individuals] per day) were recruited in Christchurch, New Zealand, between June and December 2022. Randomly assigned participants consumed 3 (female individuals) or 4 (male individuals) slices of DRB-fortified bread per day and then placebo bread, and vice versa. The DRB-fortified bread provided 8 g (female individuals) or 10.6 g (male individuals) of total DF, whereas the placebo (a matched commercial white toast bread) provided 2.7 g (female individuals) or 3.6 g (male individuals) of total DF. Before and after each intervention phase, participants provided fecal and blood samples to assess biological responses; completed a 3-day food diary to assess usual intakes and web-based questionnaires to assess gut comfort, general and mental well-being, daily bread intake, and bowel movement via an app; underwent anthropometry and blood pressure measurements; and drank blue food dye to assess whole-gut transit time. Additionally, 25% (15/60) of the participants ingested Atmo gas-sensing capsules to assess colonic gas fermentation profile and whole-gut and regional transit time. Mean differences from baseline will be compared between the DRB and placebo groups, as well as within groups (after the intervention vs baseline). For metabolome analyses, comparisons will be made within and between groups using postintervention values. RESULTS: Preliminary analysis included 56 participants (n=33, 59% female; n=23, 41% male). Due to the large dataset, data analysis was planned to be fully completed by the last quarter of 2024, with full results expected to be published in peer-reviewed journals by the end of 2024. CONCLUSIONS: This first human study offers insights into the prospect of consuming DRB-fortified bread to effectively modulate health-promoting gut microbes, their metabolism, and DF intake in healthy adults with low DF intake. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12622000884707; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383814. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59227.
- ItemImpact of Mānuka Honey on Symptoms and Quality of Life in Individuals With Functional Dyspepsia: Protocol for a Feasibility Randomized Controlled Trial(JMIR Publications, 2025-05-21) Ombasa L; Miller J; Ware L; Abbotts-Holmes H; Tang J; Gasser O; Fraser K; Bayer S; Kemp R; Costello R; Highton A; Evans J; Merry T; Schultz M; Frampton C; Gearry R; McNabb W; Roy N; Sarvestan JBackground: Functional dyspepsia is a common gastrointestinal condition that reduces the quality of life and increases health care costs. The lack of well-defined causes limits effective treatments. Consumers report using mānuka honey to treat gastrointestinal symptoms, although clinical evidence supporting such use is limited. Preclinical studies suggest its unique bioactive compounds may reduce gastrointestinal inflammation. Recently, 3,6,7-trimethyllumazine (Lepteridine), a natural pteridine in mānuka honey, was shown to inhibit enzymes involved in gastrointestinal inflammation in in vitro studies. Therefore, Lepteridine-standardized mānuka honey may deliver digestive health benefits. Objective: The aim of this feasibility study is to gather the data required to estimate sample size and support study logistics to design future trials. The primary objective will be preliminary assessments of the impact of Lepteridine-standardized mānuka honey on symptom severity and the quality of life in participants with mild-to-moderate functional dyspepsia. Other feasibility objectives include assessing the biological responses to mānuka honey standardized to medium and high levels of Lepteridine and measuring mānuka honey–derived metabolites in blood and urine. Methods: This is a 3-arm, parallel, controlled, double-blind, randomized feasibility study. A total of 75 healthy adults with symptoms of functional dyspepsia (Rome IV criteria) and mild-to-moderate dyspepsia severity (Short Form Leeds Dyspepsia Questionnaire) were recruited between October 2022 and September 2023. Participants were randomized into one of three groups: (1) mānuka honey standardized to contain 10 mg/kg Lepteridine, (2) mānuka honey standardized to contain 40 mg/kg Lepteridine, or (3) honey maple flavored syrup control. After a 2-week lead-in period, participants consumed 10 g of allocated intervention twice daily for 6 weeks. Throughout the study, participants completed daily bowel movement diaries and validated weekly questionnaires about their gastrointestinal symptoms and quality of life. Stool samples and 3-day diet records were collected at baseline and the end of the intervention. Blood samples were collected at baseline, weeks 2 and 4, and at the end of the intervention. In addition, 6 healthy participants without symptoms of functional dyspepsia were recruited to undergo an acute 5-hour assessment for the appearance of Lepteridine and related metabolites in plasma and urine following consumption of Lepteridine-standardized mānuka honey. The study was approved by the Northern B Health and Disability Ethics Committee. Results: Initial analysis includes 68 participants, with laboratory and data analyses being undertaken as of March 2024. The results of the primary and secondary outcomes will be published in peer-reviewed journals. Conclusions: This study will provide essential information on the potential efficacy and suitability of Lepteridine-standardized mānuka honey for designing future clinical trials investigating its effect in treating symptoms of functional dyspepsia. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12622001140741p; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384094 International Registered Report Identifier (IRRID): DERR1-10.2196/66417
- ItemIntersex adolescents seeking help for their depression: the case study of SPARX in New Zealandd.(SAGE Publications on behalf of The Royal Australian and New Zealand College of Psychiatrists, 2021-08) Lucassen MFG; Perry Y; Frampton C; Fleming T; Merry SN; Shepherd M; Stasiak KObjective: SPARX is a computerized cognitive behavioral therapy self-help program for adolescent depression that is freely available in New Zealand. At registration, users identify themselves as either male, female, intersex, or transgender. We aimed to describe the mental health of adolescent intersex users. Method: A secondary analysis of SPARX usage data over 5 years. Results: Of the 8922 adolescents users, 0.6% (n = 50) identified as intersex. Based on Patient Health Questionnaire 9 – modified for Adolescents (PHQ-A) results, 78.3% of intersex users had high levels of depression and/or self-harm and suicidal ideation. The mean PHQ-A scores for intersex users were significantly higher than for males and females (p < .001). As only three intersex users completed SPARX Level 4 or more (of the seven-level program), we were unable to meaningfully investigate any reductions in their depressive symptoms over time. Conclusions: There is a dearth of empirical data on the mental health of intersex adolescents. These results suggest that intersex adolescents seeking help from an online resource have high mental health needs compared with other young people, possibly because they defer seeking help.
- ItemNationwide Implementation of Unguided Cognitive Behavioral Therapy for Adolescent Depression: Observational Study of SPARX(JMIR Publications, 2024-09-03) Fleming T; Lucassen M; Frampton C; Parag V; Bullen C; Merry S; Shepherd M; Stasiak KBackground: Internet-based cognitive behavioral therapy (iCBT) interventions are effective in clinical trials; however, iCBT implementation data are seldom reported. Objective: The objective of this study is to evaluate uptake, adherence, and changes in symptoms of depression for 12-to 19-year-olds using an unguided pure self-help iCBT intervention (SPARX; Smart, Positive, Active, Realistic, X-factor thoughts) during the first 7 years of it being publicly available without referral in Aotearoa New Zealand. Methods: SPARX is a 7-module, self-help intervention designed for adolescents with mild to moderate depression. It is freely accessible to anyone with a New Zealand Internet Protocol address, without the need for a referral, and is delivered in an unguided “serious game” format. The New Zealand implementation of SPARX includes 1 symptom measure—the Patient Health Questionnaire adapted for Adolescents (PHQ-A)—which is embedded at the start of modules 1, 4, and 7. We report on uptake, the number of modules completed, and changes in depressive symptoms as measured by the PHQ-A. Results: In total, 21,320 adolescents aged 12 to 19 years (approximately 2% of New Zealand 12‐ to 19-year-olds) registered to use SPARX. Of these, 63.6% (n=13,564; comprising n=8499, 62.7% female, n=4265, 31.4% male, and n=800, 5.9% another gender identity or gender not specified; n=8741, 64.4% New Zealand European, n=1941, 14.3% Māori, n=1202, 8.9% Asian, n=538, 4.0% Pacific, and n=1142, 8.4% another ethnic identity; mean age 14.9, SD 1.9 years) started SPARX. The mean PHQ-A at baseline was 13.6 (SD 7.7) with 16.1% (n=1980) reporting no or minimal symptoms, 37.4% (n=4609) reporting mild to moderate symptoms (ie, the target group) and 46.7% (n=5742) reporting moderately severe or severe symptoms. Among those who started, 51.1% (n=6927) completed module 1, 7.4% (n=997) completed at least 4 modules, and 3.1% (n=416) completed all 7 modules. The severity of symptoms reduced from baseline to modules 4 and 7. Mean PHQ-A scores for baseline, module 4, and module 7 for those who completed 2 or more assessments were 14.0 (SD 7.0), 11.8 (SD 7.9), and 10.5 (SD 8.5), respectively; mean difference for modules 1-4 was 2.2 (SD 5.7; P<.001) and for modules 1-7 was 3.6 (SD 7.0; P<.001). Corresponding effect sizes were 0.38 (modules 1-4) and 0.51 (modules 1-7). Conclusions: SPARX reached a meaningful proportion of the adolescent population. The effect size for those who engaged with it was comparable to trial results. However, completion was low. Key challenges included logistical barriers such as slow download speeds and compatibility with some devices. Ongoing attention to rapidly evolving technologies and engagement with them are required. Real-world implementation analyses offer important insights for understanding and improving the impact of evidence-based digital tools and should be routinely reported.
