Psychometric properties of patient-reported outcome measures for hip arthroscopic surgery
- Kemp, Joanne, Collins, Natalie, Roos, Ewa, Crossley, Kay
- Authors: Kemp, Joanne , Collins, Natalie , Roos, Ewa , Crossley, Kay
- Date: 2013
- Type: Text , Journal article
- Relation: American Journal of Sports Medicine Vol. 41, no. 9 (2013), p. 2065-2073
- Full Text: false
- Reviewed:
- Description: Background: Patient-reported outcomes (PROs) are considered the gold standard when evaluating outcomes in a surgical population. While the psychometric properties of some PROs have been tested, the properties of newer PROs in patients undergoing hip arthroscopic surgery remain somewhat unknown. Purpose: To evaluate the reliability, validity, responsiveness, and interpretability of 5 PROs (Copenhagen Hip and Groin Outcome Score [HAGOS], Hip Disability and Osteoarthritis Outcome Score [HOOS], Hip Outcome Score [HOS], International Hip Outcome Tool [iHOT-33], and Modified Harris Hip Score [MHHS]) in a population undergoing hip arthroscopic surgery and also to provide a recommendation of the best PROs in patients undergoing hip arthroscopic surgery. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Study participants were adults (mean age, 37 ± 11 years) who had undergone hip arthroscopic surgery 12 to 24 months previously and pain-free, healthy age-matched controls (mean age, 35 ± 11 years). Baseline characteristics including age, height, weight, waist girth, physical activity, and occupation were collected for both groups. The hip arthroscopic surgery group completed the 5 PRO questionnaires on 3 occasions, while the healthy control group completed the PRO questionnaires on 1 occasion. The reliability (test-retest reliability [intraclass correlation coefficient, or ICC] and minimal detectable change [MDC]), validity (construct validity, ability to detect a difference between groups, acceptability including floor and ceiling effects), responsiveness, and interpretability (minimal important change [MIC]) of each measure were calculated. Results: The test-retest reliability of PROs was excellent (ICC, 0.91-0.97), with an MDC of<20%. The HOOS, HAGOS, and iHOT- 33 had acceptable content validity. All PROs demonstrated construct validity and were able to detect a difference between the hip arthroscopic surgery and control groups. No measures demonstrated a floor effect; however, the MHHS and subscales relating to activities of daily living of the HOOS, HOS, and HAGOS demonstrated a ceiling effect. The HOOS, iHOT-33, and MHHS demonstrated adequate responsiveness, and the MIC for all measures was<11 points of a possible 100 points. Conclusion: The PROs of the HOOS and iHOT-33 demonstrate psychometric properties that may enable researchers and clinicians to use them with confidence in a population undergoing hip arthroscopic surgery. The psychometric properties of the MHHS, HOS, and some subscales of the HAGOS are reduced, and these PROs may be less valuable in this group. © 2013 The Author(s). National Health and Medical Research Council (Australia) Health Professional Research Training (Postdoctoral) Fellowship (No. 628918).
Anxiety online-A virtual clinic: Preliminary outcomes following completion of five fully automated treatment programs for anxiety disorders and symptoms
- Klein, Britt, Meyer, Denny, Austin, David, Kyrios, Michael
- Authors: Klein, Britt , Meyer, Denny , Austin, David , Kyrios, Michael
- Date: 2011
- Type: Text , Journal article
- Relation: Journal of Medical Internet Research Vol. 13, no. 4 (2011), p.
- Full Text:
- Reviewed:
- Description: Background: The development of e-mental health interventions to treat or prevent mental illness and to enhance wellbeing has risen rapidly over the past decade. This development assists the public in sidestepping some of the obstacles that are often encountered when trying to access traditional face-to-face mental health care services. Objective: The objective of our study was to investigate the posttreatment effectiveness of five fully automated self-help cognitive behavior e-therapy programs for generalized anxiety disorder (GAD), panic disorder with or without agoraphobia (PD/A), obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), and social anxiety disorder (SAD) offered to the international public via Anxiety Online, an open-access full-service virtual psychology clinic for anxiety disorders. Methods: We used a naturalistic participant choice, quasi-experimental design to evaluate each of the five Anxiety Online fully automated self-help e-therapy programs. Participants were required to have at least subclinical levels of one of the anxiety disorders to be offered the associated disorder-specific fully automated self-help e-therapy program. These programs are offered free of charge via Anxiety Online. Results: A total of 225 people self-selected one of the five e-therapy programs (GAD, n = 88; SAD, n = 50; PD/A, n = 40; PTSD, n = 30; OCD, n = 17) and completed their 12-week posttreatment assessment. Significant improvements were found on 21/25 measures across the five fully automated self-help programs. At postassessment we observed significant reductions on all five anxiety disorder clinical disorder severity ratings (Cohen d range 0.72-1.22), increased confidence in managing one's own mental health care (Cohen d range 0.70-1.17), and decreases in the total number of clinical diagnoses (except for the PD/A program, where a positive trend was found) (Cohen d range 0.45-1.08). In addition, we found significant improvements in quality of life for the GAD, OCD, PTSD, and SAD e-therapy programs (Cohen d range 0.11-0.96) and significant reductions relating to general psychological distress levels for the GAD, PD/A, and PTSD e-therapy programs (Cohen d range 0.23-1.16). Overall, treatment satisfaction was good across all five e-therapy programs, and posttreatment assessment completers reported using their e-therapy program an average of 395.60 (SD 272.2) minutes over the 12-week treatment period. Conclusions: Overall, all five fully automated self-help e-therapy programs appear to be delivering promising high-quality outcomes; however, the results require replication. © Britt Klein, Denny Meyer, David William Austin, Michael Kyrios.
- Authors: Klein, Britt , Meyer, Denny , Austin, David , Kyrios, Michael
- Date: 2011
- Type: Text , Journal article
- Relation: Journal of Medical Internet Research Vol. 13, no. 4 (2011), p.
- Full Text:
- Reviewed:
- Description: Background: The development of e-mental health interventions to treat or prevent mental illness and to enhance wellbeing has risen rapidly over the past decade. This development assists the public in sidestepping some of the obstacles that are often encountered when trying to access traditional face-to-face mental health care services. Objective: The objective of our study was to investigate the posttreatment effectiveness of five fully automated self-help cognitive behavior e-therapy programs for generalized anxiety disorder (GAD), panic disorder with or without agoraphobia (PD/A), obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), and social anxiety disorder (SAD) offered to the international public via Anxiety Online, an open-access full-service virtual psychology clinic for anxiety disorders. Methods: We used a naturalistic participant choice, quasi-experimental design to evaluate each of the five Anxiety Online fully automated self-help e-therapy programs. Participants were required to have at least subclinical levels of one of the anxiety disorders to be offered the associated disorder-specific fully automated self-help e-therapy program. These programs are offered free of charge via Anxiety Online. Results: A total of 225 people self-selected one of the five e-therapy programs (GAD, n = 88; SAD, n = 50; PD/A, n = 40; PTSD, n = 30; OCD, n = 17) and completed their 12-week posttreatment assessment. Significant improvements were found on 21/25 measures across the five fully automated self-help programs. At postassessment we observed significant reductions on all five anxiety disorder clinical disorder severity ratings (Cohen d range 0.72-1.22), increased confidence in managing one's own mental health care (Cohen d range 0.70-1.17), and decreases in the total number of clinical diagnoses (except for the PD/A program, where a positive trend was found) (Cohen d range 0.45-1.08). In addition, we found significant improvements in quality of life for the GAD, OCD, PTSD, and SAD e-therapy programs (Cohen d range 0.11-0.96) and significant reductions relating to general psychological distress levels for the GAD, PD/A, and PTSD e-therapy programs (Cohen d range 0.23-1.16). Overall, treatment satisfaction was good across all five e-therapy programs, and posttreatment assessment completers reported using their e-therapy program an average of 395.60 (SD 272.2) minutes over the 12-week treatment period. Conclusions: Overall, all five fully automated self-help e-therapy programs appear to be delivering promising high-quality outcomes; however, the results require replication. © Britt Klein, Denny Meyer, David William Austin, Michael Kyrios.
- Gliddon, Emma, Cosgrove, Victoria, Berk, Lesley, Lauder, Sue, Mohebbi, Mohammadreza, Grimm, David, Dodd, Seetal, Coulson, Carolyn, Raju, Karishma, Suppes, Trisha, Berk, Michael
- Authors: Gliddon, Emma , Cosgrove, Victoria , Berk, Lesley , Lauder, Sue , Mohebbi, Mohammadreza , Grimm, David , Dodd, Seetal , Coulson, Carolyn , Raju, Karishma , Suppes, Trisha , Berk, Michael
- Date: 2019
- Type: Text , Journal article
- Relation: Bipolar Disorders Vol. 21, no. 1 (2019), p. 28-39
- Full Text: false
- Reviewed:
- Description: Objectives MoodSwings 2.0 is an online self-guided intervention for bipolar disorder that includes educational modules, interactive tools, and discussion forums. The primary aim of the study was to determine if participation in MoodSwings 2.0 would result in decreased symptoms of depression and mania compared to the control condition. Secondary aims were to identify improvements in core depression symptoms, quality of life, medication adherence, functioning, and time to relapse. Methods This was a three-arm randomized controlled trial that compared two intervention arms against a peer support control group (forum). A total of 304 adults aged 21 to 65 years with a diagnosis of bipolar disorder were assigned to a forum-only control group (Group 1; n = 102), a forum plus modules treatment group (Group 2; n = 102), or a forum, modules, and tools treatment group (Group 3; n = 100), in addition to usual care. Results There was a significant intervention impact showing improvement on the primary outcome of depression for Group 2 compared to Group 1 (P = .05) with effect sizes (Cohen's d) ranging from 0.17 to 0.43. There was also a significant intervention impact showing improvement on the secondary outcome of core depression for Group 2 (P = .02) and Group 3 (P = .05), but worse physical functioning for Group 3 (P = .01), compared to Group 1. Conclusions This study provides evidence of the efficacy of internet-based psychoeducation interventions for bipolar disorder in reducing depressive symptoms. Further investigation is needed to assess effectiveness in a public program.
Testing the NKT cell hypothesis in lenalidomide-treated myelodysplastic syndrome patients
- Chan, Angela, Neeson, Paul, Leeansyah, Edwin, Tainton, K., Quach, Hang, Prince, Henry, Godfrey, Dale, Ritchie, David, Berzins, Stuart
- Authors: Chan, Angela , Neeson, Paul , Leeansyah, Edwin , Tainton, K. , Quach, Hang , Prince, Henry , Godfrey, Dale , Ritchie, David , Berzins, Stuart
- Date: 2010
- Type: Text , Journal article
- Relation: Leukemia Vol. 24, no. 3 (2010), p. 592-600
- Full Text: false
- Reviewed:
- Description: Myelodysplastic syndrome (MDS) comprises a group of clonal bone marrow disorders characterized by ineffective hematopoiesis and increased predisposition to acute myeloid leukemia. The causes of MDS remain poorly defined, but several studies have reported the NKT cell compartment of patients with MDS is deficient in number and functionally defective. In support of a central role for NKT cells, a pilot clinical study reported that lenalidomide (an approved treatment for MDS) increased NKT cell numbers in patients with MDS, and several in vitro studies showed lenalidomide specifically promoted NKT cell proliferation and cytokine production. We tested this in a much larger study and confirm a moderate in vitro augmentation of some NKT cell functions by lenalidomide, but find no impact on the NKT cell compartment of patients treated with lenalidomide, despite a consistently positive clinical response. We further show that the frequency and cytokine production of NKT cells is normal in patients with MDS before treatment and remains stable throughout 10 months of lenalidomide therapy. Collectively, our data challenge the concept that NKT cell defects contribute to the development of MDS, and show that a clinical response to lenalidomide is not dependent on modulation of NKT cell frequency or function. © 2010 Macmillan Publishers Limited All rights reserved.
- Klein, Britt, Mitchell, Joanna, Abbott, Jo-Anne, Shandley, Kerrie, Austin, David, Gilson, Kathryn, Kiropoulos, Litza, Cannard, Gwenda, Redman, Tomi
- Authors: Klein, Britt , Mitchell, Joanna , Abbott, Jo-Anne , Shandley, Kerrie , Austin, David , Gilson, Kathryn , Kiropoulos, Litza , Cannard, Gwenda , Redman, Tomi
- Date: 2010
- Type: Text , Journal article
- Relation: Journal of Anxiety Disorders Vol. 24, no. 6 (2010), p. 635-644
- Full Text: false
- Reviewed:
- Description: This study was an open trial evaluation of a 10-week therapist-assisted cognitive behavior therapy (CBT) internet intervention (PTSD Online) undertaken with people with a primary clinical diagnosis of posttraumatic stress disorder (PTSD) (n= 22) at pre-assessment. Participants were re-assessed at post-assessment and 3-month follow-up. Significant improvements on PTSD severity ratings and related PTSD symptomatology were observed at post-assessment and maintained at 3-month follow-up. At post-assessment, 69.2% of the sample showed clinically significant improvement and 77% of the sample at follow-up assessment. Non-significant, yet improved, change was observed on all other general psychological measures. Overall, treatment satisfaction was good (69%), participant therapeutic alliance ratings were high (87.5%), and the average total therapist time required was 194.5. min. PTSD Online appears to be an efficacious treatment option for people with PTSD that can be provided entirely remotely, with far less therapist time than traditional face-to-face treatment, and without compromising therapeutic alliance. © 2010 Elsevier Ltd.
- Abbott, Jo-Anne, Kaldo, Viktor, Klein, Britt, Austin, David, Hamilton, Catherine, Piterman, Leon, Williams, Ben, Andersson, Gerhard
- Authors: Abbott, Jo-Anne , Kaldo, Viktor , Klein, Britt , Austin, David , Hamilton, Catherine , Piterman, Leon , Williams, Ben , Andersson, Gerhard
- Date: 2009
- Type: Text , Journal article
- Relation: Cognitive Behaviour Therapy Vol. 38, no. 3 (2009), p. 162-173
- Full Text: false
- Reviewed:
- Description: The effectiveness of a therapist-supported Internet intervention program for tinnitus distress in an industrial setting was evaluated using a cluster randomised design. Fifty-six Australian employees of two industrial organisations were randomly assigned, based on their work site (18 work sites from BP Australia and five from BHP Billiton), to either a cognitive behavioural therapy (CBT) program or an information-only control program. Participants were assessed at pre- and postprogram, measuring tinnitus distress, depression, anxiety, stress, quality of life, and occupational health. The CBT program was not found to be superior to the information program for treating tinnitus distress. A high attrition rate and small sample size limit the generalisability of the findings, and further developments of the program and assessment process are needed to enhance engagement and compliance. © 2009 Taylor & Francis.
Acupuncture for comorbid depression and insomnia in perimenopause : a feasibility patient-assessor-blinded, randomized, and sham-controlled clinical trial
- Zhao, Fei, Zheng, Zhen, Fu, Qiang-Qiang, Conduit, Russell, Xu, Hong, Wang, Hui-ru, Huang, Yu-Ling, Jiang, Ting, Zhang, Wen-Jing, Kennedy, Gerard
- Authors: Zhao, Fei , Zheng, Zhen , Fu, Qiang-Qiang , Conduit, Russell , Xu, Hong , Wang, Hui-ru , Huang, Yu-Ling , Jiang, Ting , Zhang, Wen-Jing , Kennedy, Gerard
- Date: 2023
- Type: Text , Journal article
- Relation: Frontiers in Public Health Vol. 11, no. (2023), p.
- Full Text:
- Reviewed:
- Description: Background and objective: Whilst acupuncture is widely used for treating psychosomatic diseases, there is little high-quality evidence supporting its application in comorbid perimenopausal depression (PMD) and insomnia (PMI) which are common complaints during climacteric. This feasibility, patient-assessor-blinded, randomized, sham-controlled clinical trial addresses this gap by investigating the efficacy and safety of acupuncture on depressed mood and poor sleep in women with comorbid PMD and PMI. Methods: Seventy eligible participants were randomly assigned to either real-acupuncture (RA) or sham-acupuncture (SA) groups. Either RA or SA treatment were delivered in 17 sessions over 8 weeks. The primary outcomes for mood and sleep were changes on 17-items Hamilton Depression Rating Scale (HAM-D17) and Pittsburgh Sleep Quality Index (PSQI) scores, from baseline to 16-week follow-up. Secondary outcome measures involved anxiety symptoms, perimenopausal symptoms, quality of life, participants' experience of and satisfaction with the acupuncture treatment. Blood samples were taken to measure reproductive hormone levels. Intention-To-Treat and Per-Protocol analyses were conducted with linear mixed-effects models. The James' and Bang's blinding indices were used to assess the adequacy of blinding. Results: Sixty-five participants completed all treatment sessions, and 54 and 41 participants completed the eight- and 16-week follow-ups, respectively. At post-treatment and 8-week follow-up, the RA group showed a significantly greater reduction in PSQI scores than the SA group did; although the reduction of HAM-D17 scores in RA group was significant, the change was not statistically different from that of SA. There were no significant mean differences between baseline and 16-week follow-up in either HAM-D17 or PSQI in either group. There were no significant between-group differences in serum reproductive hormone levels. All treatments were tolerable and no serious adverse events were reported, and the blinding was successful. Conclusion: Acupuncture is safe and can contribute to clinically relevant improvements in comorbid PMD and PMI, with satisfactory short-and medium-term effects. Whether the anti-depressive benefit of acupuncture is specific or non-specific remains to be determined. No evidence was found for any longer-term benefit of acupuncture compared to sham at 16 weeks. Further research is required to elucidate mechanisms underlying the short to medium term effects of acupuncture. Copyright © 2023 Zhao, Zheng, Fu, Conduit, Xu, Wang, Huang, Jiang, Zhang and Kennedy.
- Authors: Zhao, Fei , Zheng, Zhen , Fu, Qiang-Qiang , Conduit, Russell , Xu, Hong , Wang, Hui-ru , Huang, Yu-Ling , Jiang, Ting , Zhang, Wen-Jing , Kennedy, Gerard
- Date: 2023
- Type: Text , Journal article
- Relation: Frontiers in Public Health Vol. 11, no. (2023), p.
- Full Text:
- Reviewed:
- Description: Background and objective: Whilst acupuncture is widely used for treating psychosomatic diseases, there is little high-quality evidence supporting its application in comorbid perimenopausal depression (PMD) and insomnia (PMI) which are common complaints during climacteric. This feasibility, patient-assessor-blinded, randomized, sham-controlled clinical trial addresses this gap by investigating the efficacy and safety of acupuncture on depressed mood and poor sleep in women with comorbid PMD and PMI. Methods: Seventy eligible participants were randomly assigned to either real-acupuncture (RA) or sham-acupuncture (SA) groups. Either RA or SA treatment were delivered in 17 sessions over 8 weeks. The primary outcomes for mood and sleep were changes on 17-items Hamilton Depression Rating Scale (HAM-D17) and Pittsburgh Sleep Quality Index (PSQI) scores, from baseline to 16-week follow-up. Secondary outcome measures involved anxiety symptoms, perimenopausal symptoms, quality of life, participants' experience of and satisfaction with the acupuncture treatment. Blood samples were taken to measure reproductive hormone levels. Intention-To-Treat and Per-Protocol analyses were conducted with linear mixed-effects models. The James' and Bang's blinding indices were used to assess the adequacy of blinding. Results: Sixty-five participants completed all treatment sessions, and 54 and 41 participants completed the eight- and 16-week follow-ups, respectively. At post-treatment and 8-week follow-up, the RA group showed a significantly greater reduction in PSQI scores than the SA group did; although the reduction of HAM-D17 scores in RA group was significant, the change was not statistically different from that of SA. There were no significant mean differences between baseline and 16-week follow-up in either HAM-D17 or PSQI in either group. There were no significant between-group differences in serum reproductive hormone levels. All treatments were tolerable and no serious adverse events were reported, and the blinding was successful. Conclusion: Acupuncture is safe and can contribute to clinically relevant improvements in comorbid PMD and PMI, with satisfactory short-and medium-term effects. Whether the anti-depressive benefit of acupuncture is specific or non-specific remains to be determined. No evidence was found for any longer-term benefit of acupuncture compared to sham at 16 weeks. Further research is required to elucidate mechanisms underlying the short to medium term effects of acupuncture. Copyright © 2023 Zhao, Zheng, Fu, Conduit, Xu, Wang, Huang, Jiang, Zhang and Kennedy.
Too much information? A document analysis of sport safety resources from key organisations
- Bekker, Sheree, Finch, Caroline
- Authors: Bekker, Sheree , Finch, Caroline
- Date: 2016
- Type: Text , Journal article
- Relation: BMJ Open Vol. 6, no. 5 (2016), p. 1-8
- Relation: http://purl.org/au-research/grants/nhmrc/1058737
- Relation: http://purl.org/au-research/grants/nhmrc/565907
- Full Text:
- Reviewed:
- Description: Objectives: The field of sport injury prevention has seen a marked increase in published research in recent years, with concomitant proliferation of lay sport safety resources, such as policies, fact sheets and posters. The aim of this study was to catalogue and categorise the number, type and topic focus of sport safety resources from a representative set of key organisations. Design: Cataloguing and qualitative document analysis of resources available from the websites of six stakeholder organisations in Australia. Setting: This study was part of a larger investigation, the National Guidance for Australian Football Partnerships and Safety (NoGAPS) project. Participants: The NoGAPS study provided the context for a purposive sampling of six organisations involved in the promotion of safety in Australian football. These partners are recognised as being highly representative of organisations at national and state level that reflect similarly in their goals around sport safety promotion in Australia. Results: The catalogue comprised 284 resources. More of the practical and less prescriptive types of resources, such as fact sheets, than formal policies were found. Resources for the prevention of physical injuries were the predominant sport safety issue addressed, with risk management, environmental issues and social behaviours comprising other categories. Duplication of resources for specific safety issues, within and across organisations, was found. Conclusions: People working within sport settings have access to a proliferation of resources, which creates a potential rivalry for sourcing of injury prevention information. Important issues that are likely to influence the uptake of safety advice by the general sporting public include the sheer number of resources available, and the overlap and duplication of resources addressing the same issues. The existence of a large number of resources from reputable organisations does not mean that they are necessarily evidence based, fully up to date or even effective in supporting sport safety behaviour change. © 2016, BMJ Publishing Group. All rights reserved.
- Authors: Bekker, Sheree , Finch, Caroline
- Date: 2016
- Type: Text , Journal article
- Relation: BMJ Open Vol. 6, no. 5 (2016), p. 1-8
- Relation: http://purl.org/au-research/grants/nhmrc/1058737
- Relation: http://purl.org/au-research/grants/nhmrc/565907
- Full Text:
- Reviewed:
- Description: Objectives: The field of sport injury prevention has seen a marked increase in published research in recent years, with concomitant proliferation of lay sport safety resources, such as policies, fact sheets and posters. The aim of this study was to catalogue and categorise the number, type and topic focus of sport safety resources from a representative set of key organisations. Design: Cataloguing and qualitative document analysis of resources available from the websites of six stakeholder organisations in Australia. Setting: This study was part of a larger investigation, the National Guidance for Australian Football Partnerships and Safety (NoGAPS) project. Participants: The NoGAPS study provided the context for a purposive sampling of six organisations involved in the promotion of safety in Australian football. These partners are recognised as being highly representative of organisations at national and state level that reflect similarly in their goals around sport safety promotion in Australia. Results: The catalogue comprised 284 resources. More of the practical and less prescriptive types of resources, such as fact sheets, than formal policies were found. Resources for the prevention of physical injuries were the predominant sport safety issue addressed, with risk management, environmental issues and social behaviours comprising other categories. Duplication of resources for specific safety issues, within and across organisations, was found. Conclusions: People working within sport settings have access to a proliferation of resources, which creates a potential rivalry for sourcing of injury prevention information. Important issues that are likely to influence the uptake of safety advice by the general sporting public include the sheer number of resources available, and the overlap and duplication of resources addressing the same issues. The existence of a large number of resources from reputable organisations does not mean that they are necessarily evidence based, fully up to date or even effective in supporting sport safety behaviour change. © 2016, BMJ Publishing Group. All rights reserved.
- Gammon, Cheryl, Kruger, Rozanne, Brown, Stephen, Conlon, Cathryn, von Hurst, Pamela, Stonehouse, Welma
- Authors: Gammon, Cheryl , Kruger, Rozanne , Brown, Stephen , Conlon, Cathryn , von Hurst, Pamela , Stonehouse, Welma
- Type: Text , Journal article
- Relation: Nutrition Research Vol. 34, no. (2014), p.235-240
- Full Text: false
- Reviewed:
- Description: Increasing fruit and vegetable consumption is a key lifestyle modification in the prevention and treatment of hypertension. Kiwifruit has previously been shown to have favorable effects on blood pressure (BP), likely through inhibiting angiotensin I-converting enzyme activity. We hypothesized that the replacement of 2 fruit servings in a healthy diet with 2 green kiwifruit a day would significantly improve BP and other markers of cardiovascular function, including heart rate, stroke volume, cardiac output, and total peripheral resistance, in a group of hypercholesterolemic men. Using a controlled cross-over study design, 85 subjects completed a 4-week healthy diet run-in period before randomization to one of two 4-week intervention sequences in which they either consumed 2 green kiwifruit a day plus a healthy diet (intervention) or consumed a healthy diet alone (control). Blood pressure and other measures of cardiovascular function (using a Finometer MIDI [Finapres Medical Systems B.V, Amsterdam, The Netherlands] and standard oscillometric device) and anthropometric measurements were taken before and at the end of the treatment periods. A physical activity questionnaire was completed during the last visit. Subjects were found to be predominantly normotensive (43.5%) or prehypertensive (50.6%) and quite physically active (>30 minutes of moderate to vigorous physical activity/day in >80% subjects). No significant differences were seen for BP or any of the other markers, including heart rate, stroke volume, cardiac output, and total peripheral resistance. In conclusion, in this hypercholesterolemic, nonhypertensive group, no beneficial effects on BP or other markers of cardiovascular function were seen when consuming 2 kiwifruit a day against the background of a healthy diet.
- Davis, Ian, Long, Anne, Yip, Sonia, Espinoza, David, Thompson, John, Kichenadasse, Ganessan, Harrison, Michelle, Lowenthal, Ray, Pavlakis, Nick, Azad, Arman, Kannourakis, George, Steer, Christopher, Goldstein, David, Shapiro, Jeremy, Harvie, Rozelle, Jovanovic, Lidija, Hudson, Amanda, Nelson, Chris, Stockler, Martin, Martin, Andrew
- Authors: Davis, Ian , Long, Anne , Yip, Sonia , Espinoza, David , Thompson, John , Kichenadasse, Ganessan , Harrison, Michelle , Lowenthal, Ray , Pavlakis, Nick , Azad, Arman , Kannourakis, George , Steer, Christopher , Goldstein, David , Shapiro, Jeremy , Harvie, Rozelle , Jovanovic, Lidija , Hudson, Amanda , Nelson, Chris , Stockler, Martin , Martin, Andrew
- Date: 2015
- Type: Text , Journal article
- Relation: Annals of Oncology Vol. 26, no. 6 (2015), p. 1118-1123
- Full Text: false
- Reviewed:
- Description: Background: We hypothesised that alternating inhibitors of the vascular endothelial growth factor receptor (VEGFR) and mammalian target of rapamycin pathways would delay the development of resistance in advanced renal cell carcinoma (aRCC). Patients and methods: A single-arm, two-stage, multicentre, phase 2 trial to determine the activity, feasibility, and safety of 12-week cycles of sunitinib 50 mg daily 4 weeks on / 2 weeks off, alternating with everolimus 10 mg daily for 5 weeks on / 1 week off, until disease progression or prohibitive toxicity in favourable or intermediate-risk aRCC. The primary end point was proportion alive and progression-free at 6 months (PFS6m). The secondary end points were feasibility, tumour response, overall survival (OS), and adverse events (AEs). The correlative objective was to assess biomarkers and correlate with clinical outcome. Results: We recruited 55 eligible participants from September 2010 to August 2012. Demographics: mean age 61, 71% male, favourable risk 16%, intermediate risk 84%. Cycle 2 commenced within 14 weeks for 80% of participants; 64% received >= 22 weeks of alternating therapy; 78% received >= 22 weeks of any treatment. PFS6m was 29/55 (53%; 95% confidence interval [CI] 40% to 66%). Tumour response rate was 7/55 (13%; 95% CI 4% to 22%, all partial responses). After median follow-up of 20 months, 47 of 55 (86%) had progressed with a median progression-free survival of 8 months (95% CI 5-10), and 30 of 55 (55%) had died with a median OS of 17 months (95% CI 12-undefined). AEs were consistent with those expected for each single agent. No convincing prognostic biomarkers were identified. Conclusions: The EVERSUN regimen was feasible and safe, but its activity did not meet pre-specified values to warrant further research. This supports the current approach of continuing anti-VEGF therapy until progression or prohibitive toxicity before changing treatment.
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