Hodis, Howard N; Mack, Wendy J; Shoupe, Donna; Azen, Stanley P; Stanczyk, Frank Z; Hwang-Levine, Juliana; Budoff, Matthew J; Henderson, Victor W
This study aims to present methods and baseline data from the Early versus Late Intervention Trial with Estradiol (ELITE), the only clinical trial designed to specifically test the timing hypothesis of postmenopausal hormone therapy (HT). The timing hypothesis posits that HT effects depend on the temporal initiation of HT relative to time since menopause. ELITE is a randomized, double-blind, placebo-controlled trial with a 2 × 2 factorial design. Six hundred forty-three healthy postmenopausal women without cardiovascular disease were randomized to oral estradiol or placebo for up to 6 to 7 years according to time since menopause (mean age (55.4 vs 65.4 y) and median time since menopause (3.5 vs 14.3 y). Expected risk factors (age, blood pressure, and body mass index) were associated with CIMT at baseline in both strata. In the early postmenopausal group, but not in the late postmenopausal group, we observed significant associations between CIMT and factors that may play a role in the responsiveness of atherosclerosis progression according to timing of HT initiation. These include low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, sex hormone-binding globulin, and serum total estradiol. The ELITE randomized controlled trial is timely and unique. Baseline data indicate that ELITE is well-positioned to test the HT timing hypothesis in relation to atherosclerosis progression and coronary artery disease.
Kitahara, Tadashi; Okamoto, Hidehiko; Fukushima, Munehisa; Sakagami, Masaharu; Ito, Taeko; Yamashita, Akinori; Ota, Ichiro; Yamanaka, Toshiaki
.... Because mental/physical stress and subsequent increase in the stress hormone vasopressin supposedly trigger Meniere's disease, we set a pilot study to seek new therapeutic interventions, namely...
Manson, JoAnn E.; Chlebowski, Rowan T.; Stefanick, Marcia L.; Aragaki, Aaron K.; Rossouw, Jacques E.; Prentice, Ross L.; Anderson, Garnet; Howard, Barbara V.; Thomson, Cynthia A.; LaCroix, Andrea Z.; Wactawski-Wende, Jean; Jackson, Rebecca D.; Limacher, Marian; Margolis, Karen L.; Wassertheil-Smoller, Sylvia; Beresford, Shirley A.; Cauley, Jane A.; Eaton, Charles B.; Gass, Margery; Hsia, Judith; Johnson, Karen C.; Kooperberg, Charles; Kuller, Lewis H.; Lewis, Cora E.; Liu, Simin; Martin, Lisa W.; Ockene, Judith K.; O’Sullivan, Mary Jo; Powell, Lynda; Simon, Michael S.; Van Horn, Linda; Vitolins, Mara Z.; Wallace, Robert B.
IMPORTANCE Menopausal hormone therapy continues in clinical use but questions remain regarding its risks and benefits for chronic disease prevention. OBJECTIVE To provide a comprehensive, integrated overview of findings from the two Women’s Health Initiative (WHI) hormone therapy (HT) trials with extended post-intervention follow up. DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS 27,347 postmenopausal women, age 50–79 years, were enrolled at 40 US centers. Interventions were conjugated equine estrogens (CEE, 0.625 mg/day) with medroxyprogesterone acetate (MPA, 2.5 mg/day) for women with an intact uterus (N = 16,608) and CEE alone for women with hysterectomy (N= 10,739), or their placebos. Intervention continued for 5.6 and 7.2 years (median), respectively, with cumulative follow-up of 13 years through September 30, 2010. MAIN OUTCOMES AND MEASURES The primary efficacy and safety outcomes were coronary heart disease (CHD) and invasive breast cancer, respectively. A global index also included stroke, pulmonary embolism, colorectal cancer, endometrial cancer, hip fracture, and deaths. Secondary and quality-of-life outcomes were also assessed. RESULTS During the intervention phase for CEE+MPA, the hazard ratio (HR) for CHD was 1.18 (95% confidence interval [CI] 0.95–1.45) and overall risks outweighed benefits, with increases in invasive breast cancer, stroke, pulmonary embolism, and the global index. Other risks included increased dementia (in women >65 years), gallbladder disease, and urinary incontinence, while benefits included decreased hip fractures, diabetes, and vasomotor symptoms. Post-intervention, most risks and benefits dissipated, although some elevation in breast cancer risk persisted (cumulative hazard ratio [HR] =1.28; 95% confidence interval, 1.11–1.48). During intervention for CEE alone, risks and benefits were more balanced, with a HR for CHD of 0.94 (0.78–1.14), increased stroke and venous thrombosis, decreased hip fractures and diabetes
Full Text Available Meniere's disease, a common inner ear condition, has an incidence of 15-50 per 100,000. Because mental/physical stress and subsequent increase in the stress hormone vasopressin supposedly trigger Meniere's disease, we set a pilot study to seek new therapeutic interventions, namely management of vasopressin secretion, to treat this disease. We enrolled 297 definite Meniere's patients from 2010 to 2012 in a randomized-controlled and open-label trial, assigning Group-I (control traditional oral medication, Group-II abundant water intake, Group-III tympanic ventilation tubes and Group-IV sleeping in darkness. Two hundred sixty-three patients completed the planned 2-year-follow-up, which included assessment of vertigo, hearing, plasma vasopressin concentrations and changes in stress/psychological factors. At 2 years, vertigo was completely controlled in 54.3% of patients in Group-I, 81.4% in Group-II, 84.1% in Group-III, and 80.0% in Group-IV (statistically I < II = III = IV. Hearing was improved in 7.1% of patients in Group-I, 35.7% in Group-II, 34.9% in Group-III, and 31.7% in Group-IV (statistically I < II = III = IV. Plasma vasopressin concentrations decreased more in Groups-II, -III, and -IV than in Groups-I (statistically I < II = III = IV, although patients' stress/psychological factors had not changed. Physicians have focused on stress management for Meniere's disease. However, avoidance of stress is unrealistic for patients who live in demanding social environments. Our findings in this pilot study suggest that interventions to decrease vasopressin secretion by abundant water intake, tympanic ventilation tubes and sleeping in darkness is feasible in treating Meniere's disease, even though these therapies did not alter reported mental/physical stress levels.ClinicalTrials.gov NCT01099046.
Fairhall, Nicola; Aggar, Christina; Kurrle, Susan E; Sherrington, Catherine; Lord, Stephen; Lockwood, Keri; Monaghan, Noeline; Cameron, Ian D
Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity). Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty.We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a new approach to the treatment of older people at risk of further
Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a
Research has established the principle of hormonal male contraception based on suppression of gonadotropins and spermatogenesis. All hormonal male contraceptives use testosterone, but only in East Asian men can testosterone alone suppress spermatogenesis to a level compatible with contraceptive protection. In Caucasians, additional agents are required of which progestins are favored. Clinical trials concentrate on testosterone combined with norethisterone, desogestrel, etonogestrel or depot-medroxyprogesterone acetate. The first randomized, placebo-controlled clinical trial performed by the pharmaceutical industry demonstrated the effectiveness of a combination of testosterone undecanoate and etonogestrel in suppressing spermatogenesis in volunteers. Copyright © 2010 Elsevier Inc. All rights reserved.
Nov 5, 2013 ... Maternal hormonal interventions as a risk factor for Autism. Spectrum Disorder: An epidemiological assessment from India. MADHU POORNIMA MAMIDALA. 1. , ANUPAMA POLINEDI. 1. , PTV PRAVEEN KUMAR. 2. , N RAJESH. 3. ,. OMSAI RAMESH VALLAMKONDA. 4. , VRAJESH UDANI. 5.
Randomized controlled trials were launched in 1985 to test the effects of multiple vitamin and mineral interventions on total mortality and total and cause-specific cancer mortality in a rural Chinese population
Dalky, Heyam F
This article reviews the literature evaluating the effectiveness of various stigma reduction interventions related to mental health illnesses. An integrated search of the English language literature from 1998 to May 2008 was done using CINAHL, Medline, PubMed, Scopus, and PsychINFO databases. The results of this review emphasize that experimental clinical trials hold promise for providing evidence-based data that can be used in mental health practice. Educational and contact-based strategies used in various stigma reduction programs resulted in the most durable gains in knowledge as well as positive attitudinal and behavioral changes needed to decrease the stigma associated with mental illness. Special stigma reduction programs are to be planned for adolescent and elderly targets. Future studies have yet to be designed to identify cost-effective stigma reduction programs. Moreover, interventional studies from different cultures are encouraged. Cross-cultural interventions need to be evaluated and modified to ensure providing culturally relevant interventions.
Wedick Nicole M
Full Text Available Abstract Background Findings from observational studies suggest that sex hormone-binding globulin (SHBG and endogenous sex hormones may be mediators of the putative relation between coffee consumption and lower risk of type 2 diabetes. The objective of this study was to evaluate the effects of caffeinated and decaffeinated coffee on SHBG and sex hormone levels. Findings After a two-week run-in phase with caffeine abstention, we conducted an 8-week parallel-arm randomized controlled trial. Healthy adults (n = 42 were recruited from the Boston community who were regular coffee consumers, nonsmokers, and overweight. Participants were randomized to five 6-ounce cups of caffeinated or decaffeinated instant coffee or water (control group per day consumed with each meal, mid-morning, and mid-afternoon. The main outcome measures were SHBG and sex hormones [i.e., testosterone, estradiol, dehydroepiandrosterone sulfate]. No significant differences were found between treatment groups for any of the studied outcomes at week 8. At 4 weeks, decaffeinated coffee was associated with a borderline significant increase in SHBG in women, but not in men. At week 4, we also observed several differences in hormone concentrations between the treatment groups. Among men, consumption of caffeinated coffee increased total testosterone and decreased total and free estradiol. Among women, decaffeinated coffee decreased total and free testosterone and caffeinated coffee decreased total testosterone. Conclusions Our data do not indicate a consistent effect of caffeinated coffee consumption on SHBG in men or women, however results should be interpreted with caution given the small sample size. This is the first randomized trial investigating the effects of caffeinated and decaffeinated coffee on SHBG and sex hormones and our findings necessitate further examination in a larger intervention trial.
Rada, Gabriel; Capurro, Daniel; Pantoja, Tomas; Corbalán, Javiera; Moreno, Gladys; Letelier, Luz M; Vera, Claudio
Hot flushes are common in women with a history of breast cancer. Hormonal therapies are known to reduce these symptoms but are not recommended in women with a history of breast cancer due to their potential adverse effects. The efficacy of non-hormonal therapies is still uncertain. To assess the efficacy of non-hormonal therapies in reducing hot flushes in women with a history of breast cancer. We searched the Cochrane Breast Cancer Group Specialised Register, CENTRAL (The Cochrane Library), MEDLINE, EMBASE, LILACS, CINAHL, PsycINFO (August 2008) and WHO ICTRP Search Portal. We handsearched reference lists of reviews and included articles, reviewed conference proceedings and contacted experts. Randomized controlled trials (RCTs) comparing non-hormonal therapies with placebo or no therapy for reducing hot flushes in women with a history of breast cancer. Two authors independently selected potentially relevant studies, decided upon their inclusion and extracted data on participant characteristics, interventions, outcomes and the risk of bias of included studies. Sixteen RCTs met our inclusion criteria. We included six studies on selective serotonin (SSRI) and serotonin-norepinephrine (SNRI) reuptake inhibitors, two on clonidine, one on gabapentin, two each on relaxation therapy and homeopathy, and one each on vitamin E, magnetic devices and acupuncture. The risk of bias of most studies was rated as low or moderate. Data on continuous outcomes were presented inconsistently among studies, which precluded the possibility of pooling the results. Three pharmacological treatments (SSRIs and SNRIs, clonidine and gabapentin) reduced the number and severity of hot flushes. One study assessing vitamin E did not show any beneficial effect. One of two studies on relaxation therapy showed a significant benefit. None of the other non-pharmacological therapies had a significant benefit. Side-effects were inconsistently reported. Clonidine, SSRIs and SNRIs, gabapentin and relaxation
Nijland, Esmé Aurelia
Effects of hormone treatment on sexual functioning in postmenopausal women. Pharmacological intervention and female sexuality: a complex, controversial clinical and social issue. The studies presented in this thesis have been conducted to investigate the effects of hormone therapy (HT) and tibolone
Sas, T.C.J.; Ridder, M.A. de; Wit, J.M.; Rotteveel, J.J.; Oostdijk, W.; Reeser, H.M.; Otten, B.J.; Muinck Keizer-Schrama, S.M.P.F. de
AIM: To investigate the effect of 2 growth hormone (GH) doses on adult height (AH) in GH deficiency (GHD). METHODS: A multicenter, randomized, controlled dose-response trial compared attained AH minus target height (TH) between children receiving 0.7 mg/m(2)/day biosynthetic GH (approx. 0.025
Sas, T.C.J.; de Ridder, M.A.J.; Wit, J.M.; Rotteveel, J.; Oostdijk, W.; Reeser, H.M.; Otten, B.J.; Keizer-Schrama, S.M.P.F.
Aim: To investigate the effect of 2 growth hormone (GH) doses on adult height (AH) in GH deficiency (GHD). Methods: A multicenter, randomized, controlled dose-response trial compared attained AH minus target height (TH) between children receiving 0.7 mg/m
Rock, Cheryl L; Flatt, Shirley W; Thomson, Cynthia A; Stefanick, Marcia L; Newman, Vicky A; Jones, Lovell A; Natarajan, Loki; Ritenbaugh, Cheryl; Hollenbach, Kathryn A; Pierce, John P; Chang, R Jeffrey
Diet intervention trials are testing whether postdiagnosis dietary modification can influence breast cancer recurrence and survival. One possible mechanism is an effect on reproductive steroid hormones. Serum reproductive steroid hormones were measured at enrollment and 1 year in 291 women with a history of breast cancer who were enrolled onto a randomized, controlled diet intervention trial. Dietary goals for the intervention group were increased fiber, vegetable, and fruit intakes and reduced fat intake. Estradiol, bioavailable estradiol, estrone, estrone sulfate, androstenedione, testosterone, dehydroepiandrosterone sulfate, follicle-stimulating hormone, and sex hormone-binding globulin were measured. The intervention (but not the comparison) group reported a significantly lower intake of energy from fat (21% v 28%), and higher intake of fiber (29 g/d v 22 g/d), at 1-year follow-up (P <.001). Significant weight loss did not occur in either group. A significant difference in the change in bioavailable estradiol concentration from baseline to 1 year in the intervention (-13 pmol/L) versus the comparison (+3 pmol/L) group was observed (P <.05). Change in fiber (but not fat) intake was significantly and independently related to change in serum bioavailable estradiol (P <.01) and total estradiol (P <.05) concentrations. Results from this study indicate that a high-fiber, low-fat diet intervention is associated with reduced serum bioavailable estradiol concentration in women diagnosed with breast cancer, the majority of whom did not exhibit weight loss. Increased fiber intake was independently related to the reduction in serum estradiol concentration.
Priya, Khushboo; Rajaram, Shalini; Goel, Neerja
To compare the efficacy and acceptability of combined hormonal vaginal ring with combined oral hormonal pill in women with idiopathic chronic pelvic pain. Randomised prospective interventional trial conducted in 60 women with idiopathic chronic pelvic pain. Women were randomised into two groups of 30 each. In each group, treatment was given for 84 days using either combined vaginal ring or combined oral hormonal pill. Hormonal vaginal ring releases 15mcg of ethinyl estradiol and 120mcg of the etonogestrel per day while the hormonal pill contained 30mcg of ethinyl estradiol and 150mcg of levonorgestrel. There was no ring or pill free week. After every 28 days, pain relief was measured using visual analogue scale (VAS), and verbal rating score (VRS) calculated by summing dysmenorrhea, non-cyclic pelvic pain (NCCP) and deep dyspareunia scores. Side effects, compliance, satisfaction, and user acceptability were also measured. Data was analyzed using various parametric and non-parametric tests. Reduction in mean VAS score at end of treatment in ring group was 6.23 (95% confidence interval [CI], 5.45-7.01; ppill group (95% CI, 4.83-6.23; ppill users (95% CI, 3.63-5.10; ppill group at end of one month after stopping treatment. Compliance, satisfaction, and user acceptability were higher in ring users (80%) than pill users (70%) and a higher incidence of nausea was seen in pill group. Present study demonstrates for first time that both vaginal and oral hormonal therapy are effective in treatment of idiopathic chronic pelvic pain and vaginal ring may be a better choice with higher satisfaction rate and fewer side effects. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
Full Text Available BACKGROUND Hot flushes are common in women with a history of breast cancer. Hormonal therapies are known to reduce these symptoms but are not recommended in women with a history of breast cancer due to their potential adverse effects. The efficacy of non-hormonal therapies is still uncertain. OBJECTIVE To assess the efficacy of non-hormonal therapies in reducing hot flushes in women with a history of breast cancer. METHODS Search methods: We searched the Cochrane Breast Cancer Group Specialised Register, CENTRAL (The Cochrane Library, Medline, Embase, Lilacs, CINAHL, PsycINFO (August 2008 and WHO ICTRP Search Portal. We handsearched reference lists of reviews and included articles, reviewed conference proceedings and contacted experts. Selection criteria: Randomized controlled trials (RCTs comparing non-hormonal therapies with placebo or no therapy for reducing hot flushes in women with a history of breast cancer. Data collection and analysis: Two authors independently selected potentially relevant studies, decided upon their inclusion and extracted data on participant characteristics, interventions, outcomes and the risk of bias of included studies. MAIN RESULTS Sixteen RCTs met our inclusion criteria. We included six studies on selective serotonin (SSRI and serotonin-norepinephrine (SNRI reuptake inhibitors, two on clonidine, one on gabapentin, two each on relaxation therapy and homeopathy, and one each on vitamin E, magnetic devices and acupuncture. The risk of bias of most studies was rated as low or moderate. Data on continuous outcomes were presented inconsistently among studies, which precluded the possibility of pooling the results. Three pharmacological treatments (SSRIs and SNRIs, clonidine and gabapentin reduced the number and severity of hot flushes. One study assessing vitamin E did not show any beneficial effect. One of two studies on relaxation therapy showed a significant benefit. None of the other non-pharmacological therapies
Full Text Available BACKGROUND Hot flushes are common in women with a history of breast cancer. Hormonal therapies are known to reduce these symptoms but are not recommended in women with a history of breast cancer due to their potential adverse effects. The efficacy of non-hormonal therapies is still uncertain. OBJECTIVE To assess the efficacy of non-hormonal therapies in reducing hot flushes in women with a history of breast cancer. METHODS Search methods: We searched the Cochrane Breast Cancer Group Specialised Register, CENTRAL (The Cochrane Library, Medline, Embase, Lilacs, CINAHL, PsycINFO (August 2008 and WHO ICTRP Search Portal. We handsearched reference lists of reviews and included articles, reviewed conference proceedings and contacted experts. Selection criteria: Randomized controlled trials (RCTs comparing non-hormonal therapies with placebo or no therapy for reducing hot flushes in women with a history of breast cancer. Data collection and analysis: Two authors independently selected potentially relevant studies, decided upon their inclusion and extracted data on participant characteristics, interventions, outcomes and the risk of bias of included studies. MAIN RESULTS Sixteen RCTs met our inclusion criteria. We included six studies on selective serotonin (SSRI and serotonin-norepinephrine (SNRI reuptake inhibitors, two on clonidine, one on gabapentin, two each on relaxation therapy and homeopathy, and one each on vitamin E, magnetic devices and acupuncture. The risk of bias of most studies was rated as low or moderate. Data on continuous outcomes were presented inconsistently among studies, which precluded the possibility of pooling the results. Three pharmacological treatments (SSRIs and SNRIs, clonidine and gabapentin reduced the number and severity of hot flushes. One study assessing vitamin E did not show any beneficial effect. One of two studies on relaxation therapy showed a significant benefit. None of the other non-pharmacological therapies
Hormones are your body's chemical messengers. They travel in your bloodstream to tissues or organs. They work ... glands, which are special groups of cells, make hormones. The major endocrine glands are the pituitary, pineal, ...
Gale, E A M; Bingley, P J; Emmett, C L
Juvenile Diabetes Federation (JDF) units or more, and a non-diabetic oral glucose tolerance test. Participants were recruited from 18 European countries, Canada, and the USA, and were randomly allocated oral modified release nicotinamide (1.2 g/m2) or placebo for 5 years. Random allocation was done...... with a pseudorandom number generator and we used size balanced blocks of four and stratified by age and national group. Primary outcome was development of diabetes, as defined by WHO criteria. Analysis was done on an intention-to-treat basis. FINDINGS: There was no difference in the development of diabetes between...... secretion. INTERPRETATION: Large-scale controlled trials of interventions designed to prevent the onset of type 1 diabetes are feasible, but nicotinamide was ineffective at the dose we used....
DiVasta, Amy D; Feldman, Henry A; Sadler Gallagher, Jenny; Stokes, Natalie A; Laufer, Marc R; Hornstein, Mark D; Gordon, Catherine M
To assess whether add-back therapy with norethindrone acetate or norethindrone acetate plus conjugated equine estrogens is superior to maintain bone health in adolescents and young women using gonadotropin-releasing hormone agonists for endometriosis. Gonadotropin-releasing hormone agonists are associated with deleterious effects on bone. Hormonal add-back may mitigate these effects. Adolescents and young women (n=51) received a random, double-blind assignment to add-back with norethindrone acetate (5 mg/day) plus conjugated equine estrogens (0.625 mg/day) or norethindrone acetate plus placebo for 12 months. Body composition, bone mineral content, and bone mineral density (BMD) were obtained by dual-energy X-ray absorptiometry every 6 months. Quality-of-life measures were collected every 3 months. Intention-to-treat comparison of outcomes was conducted by repeated-measures analysis of variance. Thirty-four adolescents and young women completed the trial; dropouts did not differ from those who completed the trial. Bone mineral density was normal at baseline. At 12 months, total body bone mineral content and BMD had increased in the norethindrone acetate plus conjugated equine estrogens group (bone mineral content +37 g, Padd-back successfully preserved bone health and improved quality of life for adolescents and young women with endometriosis during 12 months of gonadotropin-releasing hormone agonist therapy. Combination norethindrone acetate plus conjugated equine estrogens add-back appears to be more effective for increasing total body bone mineral content, areal BMD, and lean mass than norethindrone acetate monotherapy. ClinicalTrials.gov; www.clinicaltrials.gov, NCT00474851. I.
Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia
Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…
Grimes, David A; Gallo, Maria F; Grigorieva, Vera; Nanda, Kavita; Schulz, Kenneth F
Male hormonal contraception has been an elusive goal. Administration of sex steroids to men can shut off sperm production through effects on the pituitary and hypothalamus. However, this approach also decreases production of testosterone, so an "add-back" therapy is needed. We conducted a systematic review of all randomized controlled trials of male hormonal contraception and azoospermia. Few significant differences emerged from these trials. Levonorgestrel implants combined with injectable testosterone enanthate (100 mg im) were significantly more effective than was levonorgestrel 125 microg po daily combined with testosterone patches [10 mg/d; odds ratio (OR) for azoospermia with the oral levonorgestrel regimen, 0.03; 95% CI, 0.00-0.29]. The addition of levonorgestrel 500 microg po daily improved the effectiveness of testosterone enanthate 100 mg im weekly by itself (OR for azoospermia with the combined regimen, 4.0; 95% CI, 1.00-15.99). Several regimens, including testosterone alone and gonadotropin-releasing hormone agonists and antagonists, had disappointing results. In conclusion, no male hormonal contraceptive is ready for clinical use. All trials published to date have been small exploratory studies. As a result, their power to detect important differences has been limited and their results have been imprecise. In addition, the definition of oligospermia has been imprecise or inconsistent in many reports. To avoid bias, future trials need to pay more attention on the methodological requirements for randomized controlled trials. Trials with adequate power would also be helpful.
Mohr, David C; Schueller, Stephen M; Riley, William T; Brown, C Hendricks; Cuijpers, Pim; Duan, Naihua; Kwasny, Mary J; Stiles-Shields, Colleen; Cheung, Ken
In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment, often leading to validation of tools that are outdated by the time that trial results are published. Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited. We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency. This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles (TIPs) aimed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition. The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology.
Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C
Background The Systolic Blood Pressure Intervention Trial (SPRINT) is a multicenter, randomized clinical trial of 9,361 participants with hypertension who are ≥ 50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal recruitment strategies and lessons learned during recruitment of the SPRINT cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥ 75 years, women, and minorities. Methods In collaboration with the National Institutes of Health Project Office and SPRINT Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began November 8, 2010 and ended March 15, 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Results Recruitment was scheduled to last 24 months to enroll a target of 9,250 participants; in just over 28 months, the trial enrolled 9,361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by SPRINT staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized /number screened) was 64% (9,361 randomized /14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those age ≥ 75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional clinics were included and inclusion criteria were broadened, keeping event rates
Höybye, Charlotte; Pfeiffer, Andreas F H; Ferone, Diego
was reported. No treatment-emergent anti-growth hormone binding antibodies were detected. TransCon GH demonstrated a linear, dose-dependent increase in growth hormone exposure without substantial accumulation. Growth hormone maximum serum concentration and insulin-like growth factor 1 exposure were similar......TransCon growth hormone is a sustained release human growth hormone prodrug in development in which unmodified growth hormone is transiently linked to a carrier molecule. It is intended as an alternative to daily growth hormone in the treatment of growth hormone deficiency. This was a multi......-center, randomized, open-label, active-controlled trial designed to compare the safety (including tolerability and immunogenicity), pharmacokinetics, and pharmacodynamics of three doses of weekly TransCon GH to daily growth hormone (Omnitrope). Thirty-seven adult males or females diagnosed with adult growth hormone...
Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63
Schnatz, Peter F; Jiang, Xuezhi; Aragaki, Aaron K; Nudy, Matthew; OʼSullivan, David M; Williams, Mark; LeBlanc, Erin S; Martin, Lisa W; Manson, JoAnn E; Shikany, James M; Johnson, Karen C; Stefanick, Marcia L; Payne, Martha E; Cauley, Jane A; Howard, Barbara V; Robbins, John
To analyze the treatment effect of calcium+vitamin D supplementation, hormone therapy, both, and neither on cardiovascular disease risk factors. We conducted a prospective, randomized, double-blind, placebo-controlled trial among Women's Health Initiative (WHI) participants. The predefined primary outcome was low-density lipoprotein cholesterol (LDL-C). Between September 1993 and October 1998, a total of 68,132 women aged 50-79 years were recruited and randomized to the WHI-Dietary Modification (n=48,835) and WHI-Hormone Therapy trials (n=27,347). Subsequently, 36,282 women from WHI-Hormone Therapy (16,089) and WHI-Dietary Modification (n=25,210) trials were randomized in the WHI-Calcium+Vitamin D trial to 1,000 mg elemental calcium carbonate plus 400 international units vitamin D3 daily or placebo. Our study group included 1,521 women who participated in both the hormone therapy and calcium+vitamin D trials and were in the 6% subsample of trial participants with blood sample collections at baseline and years 1, 3, and 6. The average treatment effect with 95% confidence interval, for LDL-C, compared with placebo, was -1.6, (95% confidence interval [CI] -5.5 to 2.2) mg/dL for calcium+vitamin D alone, -9.0 (95% CI -13.0 to -5.1) mg/dL for hormone therapy alone, and -13.8 (95% CI -17.8 to -9.8) mg/dL for the combination. There was no evidence of a synergistic effect of calcium+vitamin D+hormone therapy on LDL-C (P value for interaction=.26) except in those with low total intakes of vitamin D, for whom there was a significant synergistic effect on LDL (P value for interaction=.03). Reductions in LDL-C were greater among women randomized to both calcium+vitamin D and hormone therapy than for those randomized to either intervention alone or to placebo. The treatment effect observed in the calcium+vitamin D+hormone therapy combination group may be additive rather than synergistic. For clinicians and patients deciding to begin calcium+vitamin D supplementation, current use
Hak, AE; Bak, AAA; Lindemans, J; Planellas, J; Bennink, HJTC; Hofman, A; Grobbee, DE; Witteman, JCM
Serum homocysteine levels may be lowered by hormone replacement therapy, but randomized controlled trial data are scarce. We performed a single center randomized placebo-controlled trial to assess the 6 months effect of hormone replacement therapy compared with placebo on fasting serum homocysteine
Outpatient 60-hour day-and-night glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or sensor-augmented pump therapy in adults with type 1 diabetes: An open-label, randomised, crossover, controlled trial.
Haidar, Ahmad; Messier, Virginie; Legault, Laurent; Ladouceur, Martin; Rabasa-Lhoret, Rémi
To assess whether the dual-hormone (insulin and glucagon) artificial pancreas reduces hypoglycaemia compared to the single-hormone (insulin alone) artificial pancreas in outpatient settings during the day and night. In a randomized, three-way, crossover trial we compared the dual-hormone artificial pancreas, the single-hormone artificial pancreas and sensor-augmented pump therapy (control) in 23 adults with type 1 diabetes. Each intervention was applied from 8 AM Day 1 to 8 PM Day 3 (60 hours) in outpatient free-living conditions. The primary outcome was time spent with sensor glucose levels below 4.0 mmol/L. A P value of less than .017 was regarded as significant. The median difference between the dual-hormone system and the single-hormone system was -2.3% (P = .072) for time spent below 4.0 mmol/L, -1.3% (P = .017) for time below 3.5 mmol/L, and -0.7% (P = .031) for time below 3.3 mmol/L. Both systems reduced (P artificial pancreas had the lowest risk of hypoglycaemia, but the differences were not statistically significant. Larger studies are needed. © 2017 John Wiley & Sons Ltd.
Kopple, Joel D; Cheung, Alfred K; Christiansen, Jens Sandahl
Adult maintenance hemodialysis (MHD) patients experience high mortality and morbidity and poor quality of life (QoL). Markers of protein-energy wasting are associated with these poor outcomes. The OPPORTUNITY™ Trial examined whether recombinant human growth hormone (hGH) reduces mortality...
Kopple, Joel D; Cheung, Alfred K; Christiansen, Jens Sandahl
Adult maintenance hemodialysis (MHD) patients experience high mortality and morbidity and poor quality of life (QoL). Markers of protein-energy wasting are associated with these poor outcomes. The OPPORTUNITY™ Trial examined whether recombinant human growth hormone (hGH) reduces mortality...
Blencowe, Natalie S; Brown, Julia M; Cook, Jonathan A; Metcalfe, Chris; Morton, Dion G; Nicholl, Jon; Sharples, Linda D; Treweek, Shaun; Blazeby, Jane M
Until recently, insufficient attention has been paid to the fact that surgical interventions are complex. This complexity has several implications, including the way in which surgical interventions are described and delivered in trials. In order for surgeons to adopt trial findings, interventions need to be described in sufficient detail to enable accurate replication; however, it may be permissible to allow some aspects to be delivered according to local practice. Accumulating work in this area has identified the need for general guidance on the design of surgical interventions in trial protocols and reports. Key issues to consider when designing surgical interventions include the identification of each surgical intervention and their components, who will deliver the interventions, and where and how the interventions will be standardised and monitored during the trial. The trial design (pragmatic and explanatory), comparator and stage of innovation may also influence the extent of detail required. Thoughtful consideration of surgical interventions in this way may help with the interpretation of trial results and the adoption of successful interventions into clinical practice.
Montgomery, Paul; Mayo-Wilson, Evan; Hopewell, Sally; Macdonald, Geraldine; Moher, David; Grant, Sean
Understanding randomized controlled trials of complex social and psychological interventions requires a detailed description of the interventions tested and the methods used to evaluate them. However, randomized controlled trial reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. We explain how reporting guidelines have improved the quality of reports in medicine, and describe the ongoing development of a new reporting guideline for randomized controlled trials: an extension of the Consolidated Standards of Reporting Trials for social and psychological interventions. We invite readers to participate in the project by visiting our Web site, to help us reach the best-informed consensus on these guidelines ( http://tinyurl.com/consort-study ).
Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.
Fjeldsoe Brianna S
Full Text Available Abstract Background With an increasing research focus on multiple health behaviour change interventions, a methodological issue requiring further investigation is whether or not to employ pre-trial behavioural screening to exclude participants who are achieving a pre-specified level of one or more behaviours. Behavioural screening can be used to direct limited resources to participants most in need of a behaviour change intervention; but may reduce the representativeness of the sample and limit comparability with trials that do not employ pre-trial behavioural screening. Furthermore, the impact of this type of screening on intervention participation and intervention effects is unknown. Methods Data for this study come from the Logan Healthy Living Program, a randomised, controlled telephone counselling lifestyle intervention trial which did not employ behavioural screening prior to randomisation. Screening for physical activity, diet or the combination was simulated using baseline trial data. To examine the impact of behavioural screening on intervention participation (in terms of participant characteristics, intervention dose received and retention, characteristics of participants included an excluded under the various screening scenarios were compared. To examine the impact of behavioural screening on intervention effects, results from the main trial analysis were compared with results obtained from the same analyses performed separately for each of the screened groups. Results Simulated pre-trial behavioural screening impacted minimally on intervention dose received and trial retention rate. Beyond the anticipated effect of reducing baseline levels of the behaviours being screened for, behavioural screening affected baseline levels of behaviours not targeted by screening, and participants' demographic and health-related characteristics. Behavioural screening impacted on intervention effects in ways that were anticipated and positive, but also
Liu, G; Liang, L; Bray, G A; Qi, L; Hu, F B; Rood, J; Sacks, F M; Sun, Q
The role of thyroid hormones in diet-induced weight loss and subsequent weight regain is largely unknown. To examine the associations between thyroid hormones and changes in body weight and resting metabolic rate (RMR) in a diet-induced weight loss setting. Data analysis was conducted among 569 overweight and obese participants aged 30-70 years with normal thyroid function participating in the 2-year Prevention of Obesity Using Novel Dietary Strategies (POUNDS) LOST randomized clinical trial. Changes in body weight and RMR were assessed during the 2-year intervention. Thyroid hormones (free triiodothyronine (T3), free thyroxine (T4), total T3, total T4 and thyroid-stimulating hormone (TSH)), anthropometric measurements and biochemical parameters were assessed at baseline, 6 months and 24 months. Participants lost an average of 6.6 kg of body weight during the first 6 months and subsequently regained an average of 2.7 kg of body weight over the remaining period from 6 to 24 months. Baseline free T3 and total T3 were positively associated, whereas free T4 was inversely associated, with baseline body weight, body mass index and RMR. Total T4 and TSH were not associated with these parameters. Higher baseline free T3 and free T4 levels were significantly associated with a greater weight loss during the first 6 months (Pweight. Comparing extreme tertiles, the multivariate-adjusted weight loss±s.e. was -3.87±0.9 vs -5.39±0.9 kg for free T3 (Ptrend=0.02) and -4.09±0.9 vs -5.88±0.9 kg for free T4 (Ptrend=0.004). The thyroid hormones did not predict weight regain in 6-24 months. A similar pattern of associations was also observed between baseline thyroid hormones and changes in RMR. In addition, changes in free T3 and total T3 levels were positively associated with changes in body weight, RMR, body fat mass, blood pressure, glucose, insulin, triglycerides and leptin at 6 months and 24 months (all Pweight loss setting, higher baseline free T3 and free T4
Full Text Available In dairy cows and buffaloes, summer heat stress (HS reduces milk yield and delays return to pregnancy leading to financial loss. Clues for effective interventions against summer infertility (SI lie in understanding the underlying mechanisms. This article reviews current knowledge on the mechanisms of bovine SI and their implication for hormonal management. Under HS dairy animals encounter anestrous, silent cycles and repeat breeding which extend their open period. These effects are attributed mainly to HS induced disturbances in luteinizing hormone (LH secretion, follicular dominance and estrogen secretion, ovulation and oocyte competence, luteal development and progesterone secretion, utero-placental function and embryo-fetal development. Hormonal timed artificial insemination protocols and LH support around estrous improved summer pregnancy rates by avoiding need for estrus detection, assisting follicular development and ovulation, enhancing quality oocytes and stimulating luteal function. Progesterone supplementation to enhance embryonic development did not produce significant improvement in summer pregnancy rates. There is need for evaluating integrated approaches combining hormones, metabolic modifier and cyto-protective agents.
Mohr, D.C.; Schueller, S.M.; Riley, W.T.; Brown, C.H.; Cuijpers, P.; Duan, N.; Kwasny, M.J.; Stiles-Shields, C.; Cheung, K.
In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down
Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P
The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible. The Cell Phone Intervention for You study was a National Heart, Lung, and Blood Institute-sponsored, controlled, 24-month randomized clinical trial comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (body mass index≥25 kg/m2) young adults. Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, adaptive intervention design, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The adaptive intervention design strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. Adaptive intervention design was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. The cell phone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive-providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools
Full Text Available Abstract Background Preventive drugs require long-term trials to show their effectiveness or harms and often a lot of changes occur during post-marketing studies. The purpose of this article is to describe the research process in a long-term randomized controlled trial and discuss the impact and consequences of changes in the research environment. Methods The Estonian Postmenopausal Hormone Therapy trial (EPHT, originally planned to continue for five years, was planned in co-operation with the Women's International Study of Long-Duration Oestrogen after Menopause (WISDOM in the UK. In addition to health outcomes, EPHT was specifically designed to study the impact of postmenopausal hormone therapy (HT on health services utilization. Results After EPHT recruited in 1999–2001 the Women's Health Initiative (WHI in the USA decided to stop the estrogen-progestin trial after a mean of 5.2 years in July 2002 because of increased risk of breast cancer and later in 2004 the estrogen-only trial because HT increased the risk of stroke, decreased the risk of hip fracture, and did not affect coronary heart disease incidence. WISDOM was halted in autumn 2002. These decisions had a major influence on EPHT. Conclusion Changes in Estonian society challenged EPHT to find a balance between the needs of achieving responses to the trial aims with a limited budget and simultaneously maintaining the safety of trial participants. Flexibility was the main key for success. Rapid changes are not limited only to transiting societies but are true also in developed countries and the risk must be included in planning all long-term trials. The role of ethical and data monitoring committees in situations with emerging new data from other studies needs specification. Longer funding for preventive trials and more flexibility in budgeting are mandatory. Who should prove the effectiveness of an (old drug for a new preventive indication? In preventive drug trials companies may
Costa, Leonardo Oliveira Pena; Moseley, Anne M; Sherrington, Catherine; Maher, Christopher G; Herbert, Robert D; Elkins, Mark R
The objective of this study was to identify core journals in physical therapy by identifying those that publish the most randomized controlled trials of physical therapy interventions, provide the highest-quality reports of randomized controlled trials, and have the highest journal impact factors. This study was an audit of a bibliographic database. All trials indexed in the Physiotherapy Evidence Database (PEDro) were analyzed. Journals that had published at least 80 trials were selected. The journals were ranked in 4 ways: number of trials published; mean total PEDro score of the trials published in the journal, regardless of publication year; mean total PEDro score of the trials published in the journal from 2000 to 2009; and 2008 journal impact factor. The top 5 core journals in physical therapy, ranked by the total number of trials published, were Archives of Physical Medicine and Rehabilitation, Clinical Rehabilitation, Spine, British Medical Journal (BMJ), and Chest. When the mean total PEDro score was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, Journal of the American Medical Association (JAMA), Stroke, Spine, and Clinical Rehabilitation. When the mean total PEDro score of the trials published from 2000 to 2009 was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, JAMA, Lancet, BMJ, and Pain. The most highly ranked physical therapy-specific journals were Physical Therapy (ranked eighth on the basis of the number of trials published) and Journal of Physiotherapy (ranked first on the basis of the quality of trials). Finally, when the 2008 impact factor was used for ranking, the top 5 journals were JAMA, Lancet, BMJ, American Journal of Respiratory and Critical Care Medicine, and Thorax. There were no significant relationships among the rankings on the basis of trial quality, number of trials, or journal impact factor. Physical therapists who are trying to keep up-to-date by reading the best
Sperduto, R D; Hu, T S; Milton, R C; Zhao, J L; Everett, D F; Cheng, Q F; Blot, W J; Bing, L; Taylor, P R; Li, J Y
To determine whether the vitamin/mineral supplements used in two cancer intervention trials affected the risk of developing age-related cataracts. Two randomized, double-masked trials with a duration of 5 to 6 years and end-of-trial eye examinations. Rural communes in Linxian, China. In trial 1, 2141 participants aged 45 to 74 years, and, in trial 2, 3249 participants aged 45 to 74 years. Multivitamin/mineral supplement or matching placebo in trial 1; factorial design to test the effect of four different vitamin/mineral combinations in trial 2 (retinol/zinc, riboflavin/niacin, ascorbic acid/molybdenum, and selenium/alpha-tocopherol/beta carotene). Prevalence of nuclear, cortical, and posterior subcapsular cataracts in treatment groups at end of trials. In the first trial, there was a statistically significant 36% reduction in the prevalence of nuclear cataract for persons aged 65 to 74 years who received the supplements. In the second trial, the prevalence of nuclear cataract was significantly lower in persons receiving riboflavin/niacin compared with persons not receiving these vitamins. Again, persons in the oldest group, 65 to 74 years, benefited the most (44% reduction in prevalence). No treatment effect was noted for cortical cataract in either trial. Although the number of posterior subcapsular cataracts was very small, there was a statistically significant deleterious effect of treatment with riboflavin/niacin. Findings from the two trials suggest that vitamin/mineral supplements may decrease the risk of nuclear cataract. Additional research is needed in less nutritionally deprived populations before these findings can be translated into general nutritional recommendations.
Wallberg, B; von Schoultz, E; Bolund, C; Bergh, J; Wilking, N
Objectives To investigate the attitudes of breast cancer patients who accepted or declined participation in a randomized trial with hormone replacement therapy that might increase their risk of recurrence (the Stockholm trial). Methods A total of 115 patients free from breast cancer recurrence were interviewed; 57 were participants and 58 were non-participants in the Stockholm trial. Patients answered five questionnaires regarding information needs (two), attitudes to participation in trials (two) and patient role in treatment decisions (one). Results Participants in the Stockholm trial had a lower risk of breast cancer recurrence (measured by node-positive disease and tumor size) and were older than non-participants. Their information needs were the same. Participants in the trial were more prepared to accept uncertainty, to have an altruistic attitude, to accept risks including an increased risk of recurrence of breast cancer, if their quality of life or general health was improved. Most patients preferred a collaborative role in relation to their physician but participants often wanted more influence than they had in treatment decisions. Conclusion A patient's decision to accept or decline participation in the Stockholm trial was influenced by her objective risk of breast cancer recurrence and reflected her attitude to risk, uncertainty and preference to be active in treatment decisions.
Wagman, Jennifer A; Paul, Amy; Namatovu, Fredinah; Ssekubugu, Robert; Nalugoda, Fred
We identify complexities encountered, including unanticipated crossover between trial arms and inadequate 'standard of care' violence services, during a cluster randomized trial (CRT) of a community-level intimate partner violence (IPV) and HIV prevention intervention in Uganda. Concepts in public health ethics - beneficence, social value of research, fairness, standard of care, and researcher responsibilities for post-trial benefits - are used to critically reflect on lessons learned and guide discussion on practical and ethical challenges of violence intervention CRTs. Existing ethical guidelines provide incomplete guidance for responding to unexpected crossover in CRTs providing IPV services. We struggled to balance duty of care with upholding trial integrity, and identifying and providing appropriate standard of care. While we ultimately offered short-term IPV services to controls, we faced additional challenges related to sustaining services beyond the 'short-term' and post-trial. Studies evaluating community-level violence interventions, including those combined with HIV reduction strategies, are limited yet critical for developing evidence-based approaches for effectively preventing IPV. Although CRTs are a promising design, further guidance is needed to implement trials that avoid introducing tensions between validity of findings, researchers' responsibilities to protect participants, and equitable distribution of CRT benefits.
Ortiz, Miriam; Witt, Claudia M; Binting, Sylvia; Helmreich, Cornelia; Hummelsberger, Josef; Pfab, Florian; Wullinger, Michael; Irnich, Dominik; Linde, Klaus; Niggemann, Bodo; Willich, Stefan N; Brinkhaus, Benno
Background In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial’s participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers a...
Liang Feng; Han Fang-lei; Qi Shuang
Purpose: to explore the effects of music intervention on haemodynamics and endocrine hormone level of senile patients. Methods: choosing ASA II-III level and selecting 60 senile patients performed with intraspinal anesthesia; randomly dividing them into the intervention group and control group with 30 cases in each group. Both the two groups of patients completed the SAS before entering the operating room. When the patients of the intervention group entered the operating room, selected music ...
Roth, Mara Y; Shih, Grace; Ilani, Niloufar; Wang, Christina; Page, Stephanie T; Bremner, William J; Swerdloff, Ronald S; Sitruk-Ware, Regine; Blithe, Diana L; Amory, John K
Fifty percent of pregnancies in the United States are unintended despite numerous contraceptive methods available to women. The only male contraceptive methods, vasectomy and condoms, are used by 10% and 16% of couples, respectively. Prior studies have shown efficacy of male hormonal contraceptives in development, but few have evaluated patient acceptability and potential use if commercially available. The objective of this study is to determine if a transdermal gel-based male hormonal contraceptive regimen, containing testosterone and Nestorone® gels, would be acceptable to study participants as a primary contraceptive method. As part of a three-arm, 6-month, double-blind, randomized controlled trial of testosterone and nestorone gels at two academic medical centers, subjects completed a questionnaire to assess the acceptability of the regimen. Of the 99 men randomized, 79 provided data for analysis. Overall, 56% (44/79) of men were satisfied or extremely satisfied with this gel-based method of contraception, and 51% (40/79) reported that they would recommend this method to others. One third of subjects (26/79) reported that they would use this as their primary method of contraception if it were commercially available today. However, men with concerns about sexually transmitted disease were significantly less satisfied than men without such concerns (p=0.03). A majority of the men who volunteered to participate in this trial of an experimental male hormonal contraceptive were satisfied with this transdermal male hormonal contraceptive. If commercially available, a combination of topical nesterone and testosterone gels could provide a reversible, effective method of contraception that is appealing to men. A substantial portion of men report they would use this transdermal male contraceptive regimen if commercially available. This method would provide a novel, reversible method of contraception for men, whose current choices are limited to condoms and vasectomy
Kostis, John B; Wilson, Alan C; Shindler, Daniel M; Cosgrove, Nora M; Lacy, Clifton R
Weight loss and sodium reduction programs are effective in treating hypertension, but there is little information about the persistence of the benefit after discontinuation of the intervention. The Trial of Nonpharmacologic Interventions in the Elderly (TONE) was a four-center controlled clinical trial of weight loss, reduced sodium intake, or both in maintaining normotension after withdrawal of antihypertensive drug therapy in older men and women whose hypertension was controlled with a single antihypertensive medication. Information on maintenance of normotension without need for drug therapy was obtained on 222 of 223 participants at the Robert Wood Johnson Medical School clinical center on average of 48.4 months (range 45 to 54 months) after the end of TONE. At the end of TONE follow-up, 43% of participants in the combined intervention group were off medication compared with 25% in the usual care group (P = .011). At 48 months after the end of TONE and discontinuation of contact of the participants with the clinical center, 23% of the combined intervention group v 7% in the usual care group were off medication (P = .012). Some benefits of structured dietary intervention appears to persist long term in a significant number of patients after discontinuation of the intervention.
Full Text Available TransCon growth hormone is a sustained-release human growth hormone prodrug under development in which unmodified growth hormone is transiently linked to a carrier molecule. It is intended as an alternative to daily growth hormone in the treatment of growth hormone deficiency. This was a multi-center, randomized, open-label, active-controlled trial designed to compare the safety (including tolerability and immunogenicity, pharmacokinetics and pharmacodynamics of three doses of weekly TransCon GH to daily growth hormone (Omnitrope. Thirty-seven adult males and females diagnosed with adult growth hormone deficiency and stable on growth hormone replacement therapy for at least 3 months were, following a wash-out period, randomized (regardless of their pre-study dose to one of three TransCon GH doses (0.02, 0.04 and 0.08 mg GH/kg/week or Omnitrope 0.04 mg GH/kg/week (divided into 7 equal daily doses for 4 weeks. Main outcomes evaluated were adverse events, immunogenicity and growth hormone and insulin-like growth factor 1 levels. TransCon GH was well tolerated; fatigue and headache were the most frequent drug-related adverse events and reported in all groups. No lipoatrophy or nodule formation was reported. No anti-growth hormone-binding antibodies were detected. TransCon GH demonstrated a linear, dose-dependent increase in growth hormone exposure without accumulation. Growth hormone maximum serum concentration and insulin-like growth factor 1 exposure were similar after TransCon GH or Omnitrope administered at comparable doses. The results suggest that long-acting TransCon GH has a profile similar to daily growth hormone but with a more convenient dosing regimen. These findings support further TransCon GH development.
Kalkman, Shona; Kim, Scott Y H; van Thiel, Ghislaine J M W; Grobbee, Diederick E; van Delden, Johannes J M
Pragmatic trials evaluate the comparative benefits, risks, and burdens of health care interventions in real-world conditions. Such studies are now recognized as valuable to the perimarketing stage of drug development and evaluation, with early pragmatic trials (EPTs) being explored as a means to generate real-world evidence at the time of regulatory market approval. In this article, we present an analysis of the ethical issues involved in informed consent for EPTs, in light of the generally recognized concern that traditional ethical rules governing randomized clinical trials, such as lengthy informed consent procedures, could threaten the "real world" nature of such trials. Specifically, we examine to what extent modifications (waivers or alterations) to regulatory consent for EPTs would be ethical. We first identify broadly accepted necessary conditions for modifications of informed consent (namely, the research involves no more than minimal risk of harm, the research is impracticable with regulatory consent, and the alternative to regulatory consent does not violate legitimate patient expectations) and then apply those criteria to the premarket and early postmarket contexts. The analysis shows that neither waivers nor alterations of regulatory consent for premarket EPTs will be ethically permissible. For postmarket EPTs with newly approved interventions, waivers of consent will be ethically problematic, but some studies might be conducted in an ethical manner with alterations to regulatory consent. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
Huisjes Anjoke JM
Full Text Available Abstract Background Around 80% of intrauterine growth restricted (IUGR infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term. Methods/design The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ. Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term. The study aims to include 325 patients per arm. Discussion This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term. Trial registration Dutch Trial Register and ISRCTN
Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P
Background/Aims The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this manuscript is to describe the design and development of the intervention tested in the Cell Phone Intervention for You (CITY) study and to highlight the importance of adaptive intervention design (AID) that made it possible. The CITY study was an NHLBI-sponsored, controlled 24-month randomized clinical trial (RCT) comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (BMI ≥ 25 kg/m2) young adults. Methods Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, AID, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The AID strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. AID was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. Results The cellphone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive – providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools for self-tracking and receiving tailored feedback. The intervention changed over two years to
Christopher, Paul P; Appelbaum, Paul S; Truong, Debbie; Albert, Karen; Maranda, Louise; Lidz, Charles
Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials. This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control) in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50), and willingness to participate in the clinical trial. 154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female); 74 (48.1%) had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004) in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017). Willingness to participate in the hypothetical trial was not significantly different (p = 0.603) between intervention (52.1%, 95% CI [40.2% to 62.4%]) and control (56.3%, 95% CI [45.3% to 66.6%] groups. An enhanced educational intervention augmenting
Hansen, Lars Jørgen; Olivarius, Niels de Fine; Beich, Anders
intervention, problem drinking, randomized controlled trial, family practice, marketing of health services......intervention, problem drinking, randomized controlled trial, family practice, marketing of health services...
Maki, P M; Gast, M J; Vieweg, A J; Burriss, S W; Yaffe, K
To evaluate the effects of hormone therapy (HT) on cognition and subjective quality of life (QoL) in recently postmenopausal women with cognitive complaints. Cognitive Complaints in Early Menopause Trial (COGENT) was a randomized, double-blind, placebo-controlled, multicenter, pilot study of 180 healthy postmenopausal women aged 45 to 55 years, randomly assigned to receive either placebo or conjugated equine estrogen 0.625 mg/medroxyprogesterone acetate 2.5 mg for 4 months. Outcome measures included memory, subjective cognition, QoL, sexuality, and sleep, which were assessed at baseline and month 4. The study was terminated before the expected final sample size of 275 due to a decrease in enrollment coinciding with the publication of findings from the Women's Health Initiative. There were no differences between groups on any cognitive or QoL measures, except for an increase in sexual interest and thoughts with HT. Modest negative effects on short- and long-term verbal memory approached significance (p or=0.45, this study suggests potential modest negative effects on verbal memory that are consistent with previous hormone therapy trials in older women.
Full Text Available Abstract Background The Screen Time Weight-loss Intervention Targeting Children at Home (SWITCH trial tested a family intervention to reduce screen-based sedentary behaviour in overweight children. The trial found no significant effect of the intervention on children’s screen-based sedentary behaviour. To explore these null findings, we conducted a pre-planned process evaluation, focussing on intervention delivery and uptake. Methods SWITCH was a randomised controlled trial of a 6-month family intervention to reduce screen time in overweight children aged 9–12 years (n = 251. Community workers met with each child’s primary caregiver to deliver the intervention content. Community workers underwent standard training and were monitored once by a member of the research team to assess intervention delivery. The primary caregiver implemented the intervention with their child, and self-reported intervention use at 3 and 6 months. An exploratory analysis determined whether child outcomes at 6 months varied by primary caregiver use of the intervention. Results Monitoring indicated that community workers delivered all core intervention components to primary caregivers. However, two thirds of primary caregivers reported using any intervention component “sometimes” or less frequently at both time points, suggesting that intervention uptake was poor. Additionally, analyses indicated no effect of primary caregiver intervention use on child outcomes at 6 months, suggesting the intervention itself lacked efficacy. Conclusions Poor uptake, and the efficacy of the intervention itself, may have played a role in the null findings of the SWITCH trial on health behaviour and body composition. Trial registration The trial was registered in the Australian and New Zealand Clinical Trials Registry (no. ACTRN12611000164998 ; registration date: 10/02/2011.
Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A
To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (pmusic days (pmusic during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright Â© 2016 Elsevier Ltd. All rights reserved.
Full Text Available Context: Hormone replacement therapy (HRT is the most widely used treatment for controlling the effects of menopause. This type of therapy causes some drug-related problems (DRP, which requires monitoring to control the negative effects and ensure patient adherence to therapy. Aims: Perform a pharmacotherapeutic monitoring and educate to menopausal patients in HRT of a community pharmacy from the city of Antofagasta. Methods: A 98-menopausal patients underwent a pharmaceutical intervention to identify the PRM and its resolution. It was applied to them a survey before and after educational activities about this disease and HRT to determine the knowledge on the subject. Results: During the pharmacotherapeutic monitoring was determined that 55% of patients using combined HRT. 62 DRPs were detected, of which 43 were resolved (69%; the most were Patient-Pharmacist (73%. The better resolution DRP were DRP 4(b “frequency of inadequate administration” and DRP 2(a “no medical indication”. At baseline, 90% had an inadequate level of knowledge about the disease and THR, 8% intermediate, and only 2% adequate. After the implementation of the education strategy, the level of knowledge increased, achieving at the end of the study only intermediate (10% and adequate (90% levels. Conclusions: The results confirm the importance of pharmaceutical intervention for the identification and resolution of DRP and the requirement to establish educational strategies to increase the knowledge about menopause and HRT in menopausal patients.
Brooke M Winzer
Full Text Available To investigate the feasibility and safety of a 24-week exercise intervention, compared to control, in males with Barrett's oesophagus, and to estimate the effect of the intervention, compared to control, on risk factors associated with oesophageal adenocarcinoma development.A randomized controlled trial of an exercise intervention (60 minutes moderate-intensity aerobic and resistance exercise five days/week over 24 weeks; one supervised and four unsupervised sessions versus attention control (45 minutes stretching five days/week over 24 weeks; one supervised and four unsupervised sessions in inactive, overweight/obese (25.0-34.9 kg/m2 males with Barrett's oesophagus, aged 18-70 years. Primary outcomes were obesity-associated hormones relevant to oesophageal adenocarcinoma risk (circulating concentrations of leptin, adiponectin, interleukin-6, tumour necrosis factor-alpha, C-reactive protein, and insulin resistance [HOMA]. Secondary outcomes included waist circumference, body composition, fitness, strength and gastro-oesophageal reflux symptoms. Outcomes were measured at baseline and 24-weeks. Intervention effects were analysed using generalised linear models, adjusting for baseline value.Recruitment was difficult in this population with a total of 33 participants recruited (target sample size: n = 80; 97% retention at 24-weeks. Adherence to the exercise protocol was moderate. No serious adverse events were reported. A statistically significant intervention effect (exercise minus control was observed for waist circumference (-4.5 [95% CI -7.5, -1.4] cm; p < 0.01. Effects on primary outcomes were not statistically significant.This small, exploratory trial provides important information to inform future trial development including recruitment rates and estimates of effect sizes on outcomes related to oesophageal adenocarcinoma risk. Future trials should investigate a combined dietary and exercise intervention to achieve greater weight loss in this
Hoffmann, Tammy C.; Erueti, Chrissy; Glasziou, Paul P.
Objectives To evaluate the completeness of descriptions of non-pharmacological interventions in randomised trials, identify which elements are most frequently missing, and assess whether authors can provide missing details. Design Analysis of consecutive sample of randomised trials of non-pharmacological interventions. Data sources and study selection All reports of randomised trials of non-pharmacological interventions published in 2009 in six leading general medical journals; 133 trial repo...
Patel, Rita; Oken, Emily; Bogdanovich, Natalia; Matush, Lidia; Sevkovskaya, Zinaida; Chalmers, Beverley; Hodnett, Ellen D; Vilchuck, Konstantin; Kramer, Michael S; Martin, Richard M
The PROmotion of Breastfeeding Intervention Trial (PROBIT) is a multicentre, cluster-randomized controlled trial conducted in the Republic of Belarus, in which the experimental intervention was the promotion of increased breastfeeding duration and exclusivity, modelled on the Baby-friendly hospital initiative. Between June 1996 and December 1997, 17,046 mother-infant pairs were recruited during their postpartum hospital stay from 31 maternity hospitals, of which 16 hospitals and their affiliated polyclinics had been randomly assigned to the arm of PROBIT investigating the promotion of breastfeeding and 15 had been assigned to the control arm, in which breastfeeding practices and policies in effect at the time of randomization was continued. Of the mother-infant pairs originally recruited for the study, 16,492 (96.7%) were followed at regular intervals until the infants were 12 months of age (PROBIT I) for the outcomes of breastfeeding duration and exclusivity; gastrointestinal and respiratory infections; and atopic eczema. Subsequently, 13,889 (81.5%) of the children from these mother-infant pairs were followed-up at age 6.5 years (PROBIT II) for anthropometry, blood pressure (BP), behaviour, dental health, cognitive function, asthma and atopy outcomes, and 13,879 (81.4%) children were followed to the age of 11.5 years (PROBIT III) for anthropometry, body composition, BP, and the measurement of fasted glucose, insulin, adiponectin, insulin-like growth factor-I, and apolipoproteins. The trial registration number for Current Controlled Trials is ISRCTN37687716 and that for ClinicalTrials.gov is NCT01561612. Proposals for collaboration are welcome, and enquires about PROBIT should be made to an executive group of the study steering committee (M.S.K., R.M.M., and E.O.). More information, including information about how to access the trial data, data collection documents, and bibliography, is available at the trial website (http
Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first
Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first national randomised
Full Text Available Hormone replacement therapy (HRT is frequently prescribed to healthy women to ameliorate menopausal symptoms. HRT is used long term (≥ 1 year to prevent chronic disease in older women. The objective of this study was to review the benefits and risks of HRT and studies of menopause or HRT in Taiwan via a MEDLINE search. Recommendations are provided for future HRT research in Taiwan. Randomized, double-blind, placebo-controlled clinical trials are considered the gold standard of scientific evidence. A MEDLINE literature search (January 1966-July 2002 identified 23 papers on trials (≥ 1 year that met the inclusion criteria. The results showed that various HRT regimens used for more than 1 year caused more harm than good in healthy menopausal women and that there was no benefit for women with coronary artery disease, Alzheimer's disease, hysterectomy, hysterosalpingooophorectomy, and ischemic stroke. None of this research was conducted in Taiwan. A MEDLINE search using the key words “estrogen replacement therapy and menopause in Taiwan” identified 16 studies. There was only one, short-term, HRT trial. No evidence suggested benefits from long-term HRT in menopausal women in Taiwan.
Noyes, Jane; Hendry, Margaret; Lewin, Simon; Glenton, Claire; Chandler, Jackie; Rashidian, Arash
To compare the contribution of "trial-sibling" and "unrelated" qualitative studies in complex intervention reviews. Researchers are using qualitative "trial-sibling" studies undertaken alongside trials to provide explanations to understand complex interventions. In the absence of qualitative "trial-sibling" studies, it is not known if qualitative studies "unrelated" to trials are helpful. Trials, "trial-sibling," and "unrelated" qualitative studies looking at three health system interventions were identified. We looked for similarities and differences between the two types of qualitative studies, such as participants, intervention delivery, context, study quality and reporting, and contribution to understanding trial results. Reporting was generally poor in both qualitative study types. We detected no substantial differences in participant characteristics. Interventions in qualitative "trial-sibling" studies were delivered using standardized protocols, whereas interventions in "unrelated" qualitative studies were delivered in routine care. Qualitative "trial-sibling" studies alone provided insufficient data to develop meaningful transferrable explanations beyond the trial context, and their limited focus on immediate implementation did not address all phenomena of interest. Together, "trial-sibling" and "unrelated" qualitative studies provided larger, richer data sets across contexts to better understand the phenomena of interest. Findings support inclusion of "trial-sibling" and "unrelated" qualitative studies to explore complexity in complex intervention reviews. Copyright © 2016 Elsevier Inc. All rights reserved.
Full Text Available Abstract Background Lifestyle risk factors, in particular smoking, nutrition, alcohol consumption and physical inactivity (SNAP are the main behavioural risk factors for chronic disease. Primary health care (PHC has been shown to be an effective setting to address lifestyle risk factors at the individual level. However much of the focus of research to date has been in general practice. Relatively little attention has been paid to the role of nurses working in the PHC setting. Community health nurses are well placed to provide lifestyle intervention as they often see clients in their own homes over an extended period of time, providing the opportunity to offer intervention and enhance motivation through repeated contacts. The overall aim of this study is to evaluate the impact of a brief lifestyle intervention delivered by community nurses in routine practice on changes in clients' SNAP risk factors. Methods/Design The trial uses a quasi-experimental design involving four generalist community nursing services in NSW Australia. Services have been randomly allocated to an 'early intervention' group or 'late intervention' (comparison group. 'Early intervention' sites are provided with training and support for nurses in identifying and offering brief lifestyle intervention for clients during routine consultations. 'Late intervention site' provide usual care and will be offered the study intervention following the final data collection point. A total of 720 generalist community nursing clients will be recruited at the time of referral from participating sites. Data collection consists of 1 telephone surveys with clients at baseline, three months and six months to examine change in SNAP risk factors and readiness to change 2 nurse survey at baseline, six and 12 months to examine changes in nurse confidence, attitudes and practices in the assessment and management of SNAP risk factors 3 semi-structured interviews/focus with nurses, managers and clients
Full Text Available BACKGROUND: Hormone replacement therapy (HRT is widely used to controlling menopausal symptoms and prevent adverse cardiovascular events. However, the benefit and risk of HRT on cardiovascular outcomes remains controversial. METHODOLOGY AND PRINCIPAL FINDINGS: We systematically searched the PubMed, EmBase, and Cochrane Central Register of Controlled Trials databases for obtaining relevant literature. All eligible trials reported on the effects of HRT on cardiovascular outcomes. We did a random effects meta-analysis to obtain summary effect estimates for the clinical outcomes with use of relative risks calculated from the raw data of included trials. Of 1903 identified studies, we included 10 trials reporting data on 38908 postmenopausal women. Overall, we noted that estrogen combined with medroxyprogesterone acetate therapy as compared to placebo had no effect on coronary events (RR, 1.07; 95%CI: 0.91-1.26; P = 0.41, myocardial infarction (RR, 1.09; 95%CI: 0.85-1.41; P = 0.48, stroke (RR, 1.21; 95%CI: 1.00-1.46; P = 0.06, cardiac death (RR, 1.19; 95%CI: 0.91-1.56; P = 0.21, total death (RR, 1.06; 95%CI: 0.81-1.39; P = 0.66, and revascularization (RR, 0.95; 95%CI: 0.83-1.08; P = 0.43. In addition, estrogen therapy alone had no effect on coronary events (RR, 0.93; 95%CI: 0.80-1.08; P = 0.33, myocardial infarction (RR, 0.95; 95%CI: 0.78-1.15; P = 0.57, cardiac death (RR, 0.86; 95%CI: 0.65-1.13; P = 0.27, total mortality (RR, 1.02; 95%CI: 0.89-1.18; P = 0.73, and revascularization (RR, 0.77; 95%CI: 0.45-1.31; P = 0.34, but associated with a 27% increased risk for incident stroke (RR, 1.27; 95%CI: 1.06-1.53; P = 0.01. CONCLUSION/SIGNIFICANCE: Hormone replacement therapy does not effect on the incidence of coronary events, myocardial infarction, cardiac death, total mortality or revascularization. However, it might contributed an important role on the risk of incident stroke.
Deary, Vincent; McColl, Elaine; Carding, Paul; Miller, Tracy; Wilson, Janet
Medically unexplained loss or alteration of voice-functional dysphonia-is the commonest presentation to speech and language therapists (SLTs). Besides the impact on personal and work life, functional dysphonia is also associated with increased levels of anxiety and depression and poor general health. Voice therapy delivered by SLTs improves voice but not these associated symptoms. The aims of this research were the systematic development of a complex intervention to improve the treatment of functional dysphonia, and the trialling of this intervention for feasibility and acceptability to SLTs and patients in a randomised pilot study. A theoretical model of medically unexplained symptoms (MUS) was elaborated through literature review and synthesis. This was initially applied as an assessment format in a series of patient interviews. Data from this stage and a small consecutive cohort study were used to design and refine a brief cognitive behavioural therapy (CBT) training intervention for a SLT. This was then implemented in an external pilot patient randomised trial where one SLT delivered standard voice therapy or voice therapy plus CBT to 74 patients. The primary outcomes were of the acceptability of the intervention to patients and the SLT, and the feasibility of changing the SLT's clinical practice through a brief training. This was measured through monitoring treatment flow and through structured analysis of the content of intervention for treatment fidelity and inter-treatment contamination. As measured by treatment flow, the intervention was as acceptable as standard voice therapy to patients. Analysis of treatment content showed that the SLT was able to conduct a complex CBT formulation and deliver novel treatment strategies for fatigue, sleep, anxiety and depression in the majority of patients. On pre-post measures of voice and quality of life, patients in both treatment arms improved. These interventions were acceptable to patients. Emotional
Garbutt Jane M
Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications
Full Text Available Abstract Background For postmenopausal women, the main reason to start hormone therapy (HT is to reduce menopausal symptoms and to improve quality of life (QOL. The aim of this study was to analyse the impact of HT on different aspects of symptom experience and QOL during a randomised trial. A total of 1823 postmenopausal women were recruited into the Estonian Postmenopausal Hormone Therapy (EPHT trial in 1999–2001. Women were randomised to blind HT, open-label HT, placebo or non-treatment arm. After one year in the trial, a questionnaire was mailed and 1359 women (75% responded, 686 in the HT arms and 673 in the non-HT arms. Mean age at filling in the questionnaire was 59.8 years. The questionnaire included Women's Health Questionnaire (WHQ to assess menopause specific QOL of middle-aged women together with a 17-item questionnaire on symptoms related to menopause, a question about painful intercourse, and a question about women's self-rated health. Results After one year in the trial, fewer women in the HT arms reported hot flashes, trouble sleeping, and sweating on the symptom questionnaire. According to WHQ, women in the HT arms had fewer vasomotor symptoms, sleep problems, and problems with sexual behaviour, but more menstrual symptoms; HT had no effect on depression, somatic symptoms, memory, attractiveness, or anxiety. A smaller proportion of women reported painful intercourse in the HT arms. There were no significant differences between the trial arms in women’s self-rated subjective health. Conclusions The results from the EPHT trial confirm that HT is not justified for treating symptoms, other than vasomotor symptoms, among postmenopausal women. WHQ proved to be a useful and sensitive tool to assess QOL in this age group of women.
Natalie L Rasgon
Full Text Available The objective of this study was to examine the effects of estrogen-based hormone therapy (HT on regional cerebral metabolism in postmenopausal women (mean age = 58, SD = 5 at risk for development of dementia. The prospective clinical trial design included pre- and post-intervention neuroimaging of women randomized to continue (HT+ or discontinue (HT- therapy following an average of 10 years of use. The primary outcome measure was change in brain metabolism during the subsequent two years, as assessed with fluorodeoxyglucose-18 positron emission tomography (FDG-PET. Longitudinal FDG-PET data were available for 45 study completers. Results showed that women randomized to continue HT experienced relative preservation of frontal and parietal cortical metabolism, compared with women randomized to discontinue HT. Women who discontinued 17-β estradiol (17βE-based HT, as well as women who continued conjugated equine estrogen (CEE-based HT, exhibited significant decline in metabolism of the precuneus/posterior cingulate cortical (PCC area. Significant decline in PCC metabolism was additionally seen in women taking concurrent progestins (with either 17βE or CEE. Together, these findings suggest that among postmenopausal subjects at risk for developing dementia, regional cerebral cortical metabolism is relatively preserved for at least two years in women randomized to continue HT, compared with women randomized to discontinue HT. In addition, continuing unopposed 17βE therapy is associated specifically with preservation of metabolism in PCC, known to undergo the most significant decline in the earliest stages of Alzheimer's disease.ClinicalTrials.gov NCT00097058.
Stiles, Carla R; Biondo, Patricia D; Cummings, Greta; Hagen, Neil A
Robust recommendations on the reporting of methods and results of clinical trials such as therapeutic intervention trials are widely used, such as the Consolidated Standards of Reporting Trials (CONSORT) recommendation. There has not been agreement on analogous publication standards for educational intervention trials, making interpretation of educational intervention studies difficult. The purpose of this report is to describe common deficiencies in reporting of educational intervention trials for cancer pain control, and to offer suggestions for authors to consider as they plan their studies, and report and publish research findings for educational interventions that use randomized controlled trials and other educational trial methodologies. A systematic review of published knowledge translation intervention trials intended to improve cancer pain was undertaken, of which most were educational interventions. Many educational intervention clinical trials designed to improve management of cancer pain appeared methodologically weak, and their results were more difficult to interpret because of reporting deficiencies. In the course of the review, patterns of deficiencies in reporting of methods and trial results were documented. Deficiencies in reporting were compared with the CONSORT recommendations for reporting clinical trials, and parallel recommendations were drafted for educational intervention trials. Patterns of deficiency in reporting cancer pain educational intervention trials were synthesized into seven domains, generically applicable to a range of study designs. Draft recommendations intended to address these deficiencies were constructed to improve communication of educational research results. Development of a standardized reporting template for clinical trials in cancer pain educational interventions could advance knowledge transfer research and thereby increase effectiveness of national and international cancer control policy designed to support cancer
Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E
To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials...
Volkova, Ekaterina; Li, Nicole; Dunford, Elizabeth; Eyles, Helen; Crino, Michelle; Michie, Jo; Ni Mhurchu, Cliona
.... The Food Label Trial (FLT) smartphone app was developed to enable conducting fully automated trials, delivering intervention remotely, and collecting individual-level data on food purchases for two nutrition-labeling...
Taleb, Nadine; Emami, Ali; Suppere, Corinne; Messier, Virginie; Legault, Laurent; Ladouceur, Martin; Chiasson, Jean-Louis; Haidar, Ahmad; Rabasa-Lhoret, Rémi
The aim of this study was to assess whether the dual-hormone (insulin and glucagon) artificial pancreas reduces hypoglycaemia compared with the single-hormone (insulin alone) artificial pancreas during two types of exercise. An open-label randomised crossover study comparing both systems in 17 adults with type 1 diabetes (age, 37.2 ± 13.6 years; HbA1c, 8.0 ± 1.0% [63.9 ± 10.2 mmol/mol]) during two exercise types on an ergocycle and matched for energy expenditure: continuous (60% [Formula: see text] for 60 min) and interval (2 min alternating periods at 85% and 50% [Formula: see text] for 40 min, with two 10 min periods at 45% [Formula: see text] at the start and end of the session). Blocked randomisation (size of four) with a 1:1:1:1 allocation ratio was computer generated. The artificial pancreas was applied from 15:30 hours until 19:30 hours; exercise was started at 18:00 hours and announced 20 min earlier to the systems. The study was conducted at the Institut de recherches cliniques de Montréal. During single-hormone control compared with dual-hormone control, exercise-induced hypoglycaemia (plasma glucose artificial pancreas outperformed the single-hormone artificial pancreas in regulating glucose levels during announced exercise in adults with type 1 diabetes. ClinicalTrials.gov NCT01930110 FUNDING: : Société Francophone du Diabète and Diabète Québec.
Full Text Available Introduction: Hirsutism is a common disorder that has remarkable physical and mental effects on individuals. No appropriate diet has yet specified for individuals with hirsutism. The present study was carried out to examine the effect of high-fibre, low-caloric balanced diet on some related hormone levels in obese or overweight women with hirsutism who had referred to clinics affiliated with Shiraz University of Medical Sciences. Materials and Methods: The present study was a clinical trial that was carried out on 47 obese or overweight women with hirsutism in 2014. The women were randomly assigned to an intervention group and a control group that, respectively, consumed a high-fiber, low-caloric balanced diet and a normal diet for 3 months. A demographic characteristics questionnaire and a researcher-designed diet questionnaire were filled out by the two groups before the intervention. Before and 12 weeks after the intervention, body mass index (BMI was measured and blood samples (on the 3–5 days of menstruation were collected. Factors of luteinizing hormone, follice stimulating hormone, sex hormone binding globulin, dehydroepiandrosterone sulfate, low-density lipoproteins, high-density lipoproteins (HDL, fasting blood sugar (FBS, CHOL, prolactin, triglycerides, insulin, 17-hydroxyprogesterone, and free androstenedione testosterone were measured. The collected data were analyzed through t-test, Chi-square, and intergroup analysis using SPSS 22.0. Results: The mean age of the participating women was 27.23 ± 5.42 years. After the study, the level of FBS and insulin in the intervention group dropped while they increased in the control group. Moreover, the postintervention level of BMI in the intervention group on average decreased 1.89 units while it rose by 0.3 units in the control group, and there was a significant difference between the two groups (P < 0.001. Conclusion: The results of the present study showed that consuming high-fiber diet
Sarah Mummah; Thomas N Robinson; Maya Mathur; Sarah Farzinkhou; Stephen Sutton; Christopher D Gardner
Background Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials...
Hariohm, K; Jeyanthi, S; Kumar, J Saravan; Prakash, V
Amongst several barriers to the application of quality clinical evidence and clinical guidelines into routine daily practice, poor description of interventions reported in clinical trials has received less attention. Although some studies have investigated the completeness of descriptions of non-pharmacological interventions in randomized trials, studies that exclusively analyzed physical therapy interventions reported in published trials are scarce. To evaluate the quality of descriptions of interventions in both experimental and control groups in randomized controlled trials published in four core physical therapy journals. We included all randomized controlled trials published from the Physical Therapy Journal, Journal of Physiotherapy, Clinical Rehabilitation, and Archives of Physical Medicine and Rehabilitation between June 2012 and December 2013. Each randomized controlled trial (RCT) was analyzed and coded for description of interventions using the checklist developed by Schroter et al. Out of 100 RCTs selected, only 35 RCTs (35%) fully described the interventions in both the intervention and control groups. Control group interventions were poorly described in the remaining RCTs (65%). Interventions, especially in the control group, are poorly described in the clinical trials published in leading physical therapy journals. A complete description of the intervention in a published report is crucial for physical therapists to be able to use the intervention in clinical practice. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.
Callahan Christopher M
Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared
Strahorn, Joshua; Serpell, Benjamin G; McKune, Andrew; Pumpa, Kate L
Strahorn, J, Serpell, BG, McKune, A, and Pumpa, KL. Effect of physical and psychosocial interventions on hormone and performance outcomes in professional rugby union players: a systematic review. J Strength Cond Res 31(11): 3158-3169, 2017-This systematic review investigates the acute effects of physical or psychosocial interventions on testosterone and cortisol responses in elite male rugby union players, and the subsequent association with physical performance areas (e.g., strength, power, sprint performance) or key performance indicators (e.g., coach-identified skills). Medline (via EBSCO), SPORTDiscus, Web of Science, InformIT, ProQuest, Cochrane, and Scopus were searched for relevant articles. Nine articles met the inclusion criteria, with 6 articles examining the effect of speed, strength or power training, and the remaining 3 psychosocial interventions. Quality assessment of the articles as determined by their PEDro score was either 6 or 7 out of 11. This review found that both physical and psychosocial interventions can alter testosterone and cortisol, and physical performance areas important for rugby union are affected by these changes. The limited literature in the field supports the notion that physical interventions of short duration and high intensity, and psychosocial interventions that create a positive environment may elicit a hormonal response that is associated with favorable performance outcomes. Studies that reported psychosocial interventions suggest that testosterone and cortisol may be altered in elite rugby players without metabolic stress, something of great interest to elite athletes and coaches who are looking to elicit a performance advantage without increasing athlete load. Overall, this review identified that when the testosterone responses to an intervention are notably greater than that of cortisol, favorable outcomes are likely. Further research is required to improve our understanding on how to best manipulate training to induce
Full Text Available OBJECTIVE: In an effort to understand how results of human clinical trials are made public, we analyze a large set of clinical trials registered at ClinicalTrials.gov, the world's largest clinical trial registry. MATERIALS AND METHODS: We considered two trial result artifacts: (1 existence of a trial result journal article that is formally linked to a registered trial or (2 the deposition of a trial's basic summary results within the registry. RESULTS: The study sample consisted of 8907 completed, interventional, phase 2-or-higher clinical trials that were completed in 2006-2009. The majority of trials (72.2% had no structured trial-article link present. A total of 2367 trials (26.6% deposited basic summary results within the registry. Of those, 969 trials (10.9% were classified as trials with extended results and 1398 trials (15.7% were classified as trials with only required basic results. The majority of the trials (54.8% had no evidence of results, based on either linked result articles or basic summary results (silent trials, while a minimal number (9.2% report results through both registry deposition and publication. DISCUSSION: Our study analyzes the body of linked knowledge around clinical trials (which we refer to as the "trialome". Our results show that most trials do not report results and, for those that do, there is minimal overlap in the types of reporting. We identify several mechanisms by which the linkages between trials and their published results can be increased. CONCLUSION: Our study shows that even when combining publications and registry results, and despite availability of several information channels, trial sponsors do not sufficiently meet the mandate to inform the public either via a linked result publication or basic results submission.
Cockayne, S; Adamson, J.; Clarke, A.; Corbacho, B; Fairhurst, C; Green, L; Hewitt, CE; Hicks, K.; Keenan, A-M; Lamb, SE; McInstosh, C; Menz, HB; Redmond, A; Richardson, Z.; Rodgers, S.
Background\\ud \\ud Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention.\\ud \\ud Design\\ud \\ud Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls pr...
Bird, Lydia; Arthur, Antony; Cox, Karen
The development, implementation and evaluation of any new health intervention is complex. This paper uses experiences from the design, implementation and evaluation of a rehabilitation programme to shed light on, and prompt discussion around, some of the complexities involved in such an undertaking. Semi-structured interviews were conducted with 15 trial participants and five members of staff at the conclusion of a trial evaluating a rehabilitation programme aimed at promoting recovery after stem cell transplantation. This study identified a number of challenges relating to the development and evaluation of complex interventions. The difficulty of providing a standardised intervention that was acceptable to patients was highlighted in the participant interviews. Trial participants and some members of staff found the concept of equipoise and randomisation challenging and there was discord between the psychosocial nature of the intervention and the predominant bio-medical culture in which the research took place. A lack of scientific evidence as to the efficacy of an intervention does not preclude staff and patients holding strong views about the benefits of an intervention. The evaluation of complex interventions should, where possible, facilitate not restrict that complexity. Within the local environment where the trial is conducted, acquiescence from those in positions of authority is insufficient; commitment to the trial is required.
Full Text Available Abstract Background The development, implementation and evaluation of any new health intervention is complex. This paper uses experiences from the design, implementation and evaluation of a rehabilitation programme to shed light on, and prompt discussion around, some of the complexities involved in such an undertaking. Methods Semi-structured interviews were conducted with 15 trial participants and five members of staff at the conclusion of a trial evaluating a rehabilitation programme aimed at promoting recovery after stem cell transplantation. Results This study identified a number of challenges relating to the development and evaluation of complex interventions. The difficulty of providing a standardised intervention that was acceptable to patients was highlighted in the participant interviews. Trial participants and some members of staff found the concept of equipoise and randomisation challenging and there was discord between the psychosocial nature of the intervention and the predominant bio-medical culture in which the research took place. Conclusions A lack of scientific evidence as to the efficacy of an intervention does not preclude staff and patients holding strong views about the benefits of an intervention. The evaluation of complex interventions should, where possible, facilitate not restrict that complexity. Within the local environment where the trial is conducted, acquiescence from those in positions of authority is insufficient; commitment to the trial is required.
Grant, Sean P.; Mayo-Wilson, Evan; Melendez-Torres, G. J.; Montgomery, Paul
Background Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. Objective/Design We conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials. Data Sources (1) To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2) To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. Eligibility (1) Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2) Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes. Results (1) We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2) Our review of trials (n = 239) revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information) and abstracts (55%); information about blinding (15%), sequence generation (23%), and allocation concealment (17%); and details about actual delivery of experimental (43%) and control interventions (34%), participant uptake (25%), and service environment (28%). Only 11 of 40 journals referenced reporting guidelines in “Instructions to Authors.” Conclusion Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely
Grant, Sean P; Mayo-Wilson, Evan; Melendez-Torres, G J; Montgomery, Paul
Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. We conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials. (1) To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2) To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. ELIGIBILITY: (1) Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2) Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes. (1) We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2) Our review of trials (n = 239) revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information) and abstracts (55%); information about blinding (15%), sequence generation (23%), and allocation concealment (17%); and details about actual delivery of experimental (43%) and control interventions (34%), participant uptake (25%), and service environment (28%). Only 11 of 40 journals referenced reporting guidelines in "Instructions to Authors." Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely missing from trial publications; most leading journals in social and
Pinto, Rafael Zambelli; Elkins, Mark R; Moseley, Anne M; Sherrington, Catherine; Herbert, Robert D; Maher, Christopher G; Ferreira, Paulo H; Ferreira, Manuela L
Clinical trial registration has several putative benefits: prevention of selective reporting, avoidance of duplication, encouragement of participation, and facilitation of reviews. Previous surveys suggest that most trials are registered. However, these surveys examined only trials in journals with high impact factors, which may bias the results. This study examined the completeness of clinical trial registration and the extent of selective reporting of outcomes in a random sample of published randomized trials in physical therapy. This was a retrospective cohort study in which 200 randomized trials of physical therapy interventions were randomly selected from those published in 2009 and indexed in the Physiotherapy Evidence Database (PEDro), regardless of the publishing journal. Evidence of registration was sought for each trial in the study, on clinical trial registers, and by contacting authors. The proportion of randomized trials that were registered was 67/200 (34%). This proportion was significantly lower than among the trials in journals with high impact factors, where the proportion was 75% (odds ratio=7.4, 95% confidence interval=2.6-21.4). Unambiguous primary outcomes (ie, method and time points of measurement clearly defined in the trial registry entry) were registered for 32 trials, and registration was adequate (ie, prospective with unambiguous primary outcomes) for 5/200 (2.5%) trials. Selective outcome reporting occurred in 23 (47%) of the 49 trials in which selective reporting was assessable. The inclusion of only English-language trials prevents generalization of the results to non-English-language trials. Registration of randomized trials of physical therapy interventions is rarely adequate. Consequently, the putative benefits of registration are not being fully realized.
Nguyen, Hoa L; Allison, Jeroan J; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Nguyen, Cuong K; Dang, Diem M; Phan, Ngoc T; Vu, Nguyen C; Nguyen, Quang P; Goldberg, Robert J
Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" intervention, "We Talk about Our Hypertension," and a didactic intervention. The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. ClinicalTrials.gov, NCT02483780.
Full Text Available Purpose: to explore the effects of music intervention on haemodynamics and endocrine hormone level of senile patients. Methods: choosing ASA II-III level and selecting 60 senile patients performed with intraspinal anesthesia; randomly dividing them into the intervention group and control group with 30 cases in each group. Both the two groups of patients completed the SAS before entering the operating room. When the patients of the intervention group entered the operating room, selected music would be played in a continuous loop immediately till the end of the operation while the doctors of the control group just told the patient to relax without music or other special treatment. Recording and comparing the SAS scores, SBP, HR and salivary cortisol concentration of the two groups before and after intervention. Results: the SAS scores, SBP, HR and salivary cortisol concentration of the intervention group were significantly decreased compared with the value before intervention and the differences within and between the groups were significant (P < 0.05. Conclusion: music intervention can effectively reduce the preoperative anxiety, ease intranperative tension and maintain the stability of hemodynamics, so it is beneficial for senile parents to live through the perianesthesia period.
Bloom, Sarah E.; Lambert, Joseph M.; Dayton, Elizabeth; Samaha, Andrew L.
Previous studies have focused on whether a trial-based functional analysis (FA) yields the same outcomes as more traditional FAs, and whether interventions based on trial-based FAs can reduce socially maintained problem behavior. We included a full range of behavior functions and taught 3 teachers to conduct a trial-based FA with 3 boys with…
Widmer, R Jay; Allison, Thomas G; Lennon, Ryan; Lopez-Jimenez, Francisco; Lerman, Lilach O; Lerman, Amir
Digital health interventions (DHI) have been shown to improve intermediates of cardiovascular health, but their impact on cardiovascular (CV) outcomes has not been fully explored. The aim of this study was to determine whether DHI administered during cardiac rehabilitation (CR) would reduce CV-related emergency department (ED) visits and rehospitalizations in patients after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). We randomized patients undergoing CR following ACS and PCI to standard CR (n=40) or CR+DHI (n=40) for 3 months with 3 patients withdrawing from CR prior to initiation in the treatment arm and 6 in the control group. The DHI incorporated an online and smartphone-based CR platform asking the patients to report of dietary and exercise habits throughout CR as well as educational information toward patients' healthy lifestyles. We obtained data regarding ED visits and rehospitalizations at 180 days, as well as other metrics of secondary CV prevention at baseline and 90 days. Baseline demographics were similar between the groups. The DHI+CR group had improved weight loss compared to the control group (-5.1±6.5 kg vs. -0.8±3.8 kg, respectively, P=.02). Those in the DHI+CR group also showed a non-significant reduction in CV-related rehospitalizations plus ED visits compared to the control group at 180 days (8.1% vs 26.6%; RR 0.30, 95% CI 0.08-1.10, P=.054). The current study demonstrated that complementary DHI significantly improves weight loss, and might offer a method to reduce CV-related ED visits plus rehospitalizations in patients after ACS undergoing CR. The study suggests a role for DHI as an adjunct to CR to improve secondary prevention of CV disease. This trial is registered at clinicaltrials.gov (NCT01883050). Copyright © 2017 Elsevier Inc. All rights reserved.
Fernandes, Alan Lins; Lopes-Silva, João Paulo; Bertuzzi, Rômulo; Casarini, Dulce Elena; Arita, Danielle Yuri; Bishop, David John; Lima-Silva, Adriano Eduardo
The aim of this study was to determine the effect of time of day on performance, pacing, and hormonal and metabolic responses during a 1000-m cycling time-trial. Nine male, recreational cyclists visited the laboratory four times. During the 1st visit the participants performed an incremental test and during the 2nd visit they performed a 1000-m cycling familiarization trial. On the 3rd and 4th visits, the participants performed a 1000-m TT at either 8 am or 6 pm, in randomized, repeated-measures, crossover design. The time to complete the time trial was lower in the evening than in the morning (88.2±8.7 versus 94.7±10.9 s, respectively, pevening (ptime of day for insulin, cortisol, and total and free testosterone concentration, which were all higher in the morning (+60%, +26%, +31% and +22%, respectively, pevening (pevening trials (p>0.05), but the norepinephrine response to the exercise was increased in the morning (+46%, pevening trials (p>0.05). Our findings suggest that performance was improved in the evening, and it was accompanied by an improved hormonal and metabolic milieu.
Andrea Rodrigues Vasconcelos
Full Text Available Steroid hormones, such as sex hormones and glucocorticoids, have been demonstrated to play a role in different cellular processes in the central nervous system, ranging from neurodevelopment to neurodegeneration. Environmental factors, such as calorie intake or fasting frequency, may also impact on such processes, indicating the importance of external factors in the development and preservation of a healthy brain.The hypothalamic-pituitary-adrenal axis and glucocorticoid activity play a role in neurodegenerative processes, including in disorders such as in Alzheimer´s and Parkinson´s diseases. Sex hormones have also been shown to modulate cognitive functioning. Inflammation is a common feature in neurodegenerative disorders, and sex hormones/glucocorticoids can act to regulate inflammatory processes. Intermittent fasting can protect the brain against cognitive decline that is induced by an inflammatory stimulus. On the other hand, obesity increases susceptibility to inflammation, whilst metabolic syndromes, like diabetes, are associated with neurodegeneration. Consequently, given that gonadal and/or adrenal steroids may significantly impact on the pathophysiology of neurodegeneration, via their effect on inflammatory processes, this review focuses on how environmental factors, like calorie intake and intermittent fasting, acting through their modulation of steroid hormones, impact on inflammation that contributes to cognitive and neurodegenerative processes.
Song, Mi-Kyung; Ward, Sandra E
Baseline assessments and repeated measures are an essential part of educational and psychosocial intervention trials, but merely measuring an outcome of interest can modify that outcome, either by the measurement process alone or by interacting with the intervention to strengthen or weaken the intervention effects. Assessment effects can result in biased estimates of intervention effects and may not be controlled by the usual two-group randomized controlled trial design. In this paper, we review the concept of assessment effects and other related phenomena, briefly describe study designs that estimate assessment effects separately from intervention effects and discuss their strengths and limitations, review evidence regarding the strength of assessment effects in intervention trials targeting behavior change, and discuss implications for intervention research. © 2015 Wiley Periodicals, Inc.
Vaginal, endometrial, and reproductive hormone findings: randomized, placebo-controlled trial of black cohosh, multibotanical herbs, and dietary soy for vasomotor symptoms: the Herbal Alternatives for Menopause (HALT) Study.
Reed, Susan D; Newton, Katherine M; LaCroix, Andrea Z; Grothaus, Louis C; Grieco, Verena S; Ehrlich, Kelly
To evaluate vaginal, endometrial, and reproductive hormone effects of three herbal regimens compared with placebo and hormone therapy (HT). This was a 1-year, randomized, double-blind, placebo-controlled trial of 351 women, ages 45 to 55, with two or more vasomotor symptoms per day. Women were randomly assigned to (1) black cohosh, (2) a multibotanical containing black cohosh, (3) the same multibotanical plus dietary soy counseling, (4) HT, or (5) placebo. Women were ineligible if they had used HT in the previous 3 months or menopausal herbal therapies in the previous month. Data on vaginal cytology and dryness were collected (at baseline and 3 and 12 mo). Daily menstrual diaries were maintained by 313 women with a uterus, and abnormal bleeding was evaluated. Serum estradiol, follicle-stimulating hormone, luteinizing hormone, and steroid hormone-binding globulin were assessed (baseline and 12 mo) among 133 postmenopausal women. Gynecologic outcomes of the five groups were compared. The five groups did not vary in baseline vaginal cytology profiles, vaginal dryness, menstrual cyclicity, or hormone profiles. The HT group had a lower percentage of parabasal cells and vaginal dryness than the placebo group at 3 and 12 months (P < 0.05). Abnormal bleeding occurred in 53 of 313 (16.9%) women. There were no differences in frequency of abnormal bleeding between any of the herbal and placebo groups, whereas women in the HT group had a greater risk than those in the placebo group (P < 0.001). Among postmenopausal women, HT significantly decreased follicle-stimulating hormone and increased estradiol; none of the herbal interventions showed significant effects on any outcomes at any time point. Black cohosh, used alone or as part of a multibotanical product with or without soy dietary changes, had no effects on vaginal epithelium, endometrium, or reproductive hormones.
Martin, Gina S; Tapsell, Linda C; Batterham, Marijka J; Russell, Kenneth G
Investigation of relative bias in diet history measurement during dietary intervention trials. Retrospective analysis of human dietary data from two randomised controlled trials examining modified fat diets in the prevention and treatment of type II diabetes mellitus. Wollongong, Australia. Thirty-five overweight, otherwise healthy subjects in trial 1 and 56 subjects with diabetes in trial 2. Diet history interviews and three-day weighed food records administered at one-month intervals in trial 1 and three-month intervals in trial 2. In a cross-sectional bias analysis, graphs of the association between bias and mean dietary intake showed that bias decreased in higher carbohydrate consumers in trial 1 (r = -0.344, P bias did not change over time in either trial. There were no significant differences in bias magnitudes between the trials, with the exception of monounsaturated fat measurement where bias was significantly greater and more positive in trial 2, indicating overestimation of monounsaturated fat intake with the diet history. Subjects in control and intervention groups underestimated energy, fat, saturated fat and alcohol intakes with the diet history in both trials. Overweight and obese individuals appeared to make the greatest contribution to the overall underestimation of saturated fat intake by the diet history regardless of whether they were in the control or intervention group and whether they were healthy or had diabetes. Bias in diet history measurement appears to be macronutrient-specific, with energy, fat and saturated fat consistently underreported in the interview by subjects with and without diabetes and in both intervention and control groups in a dietary intervention trial. Relative bias analysis appears to be an informative tool in quality control for dietary intervention trials when biochemical markers are unavailable.
Nicolaisen, Anne; Gilså Hansen, Dorte; Mariet, Hagedoorn,
Hand-in-Hand. Psychological Intervention for Women Newly Diagnosed with Cancer and their Partners. A Randomized Controlled Trial.......Hand-in-Hand. Psychological Intervention for Women Newly Diagnosed with Cancer and their Partners. A Randomized Controlled Trial....
Nicolaisen, Anne; Gilså Hansen, Dorte; Hariet, Hagedoorn,
Hand-in-Hand. Psychological Intervention for Women Newly Diagnosed with Cancer and their Partners. A Randomized Controlled Trial......Hand-in-Hand. Psychological Intervention for Women Newly Diagnosed with Cancer and their Partners. A Randomized Controlled Trial...
Dolecheck, K A; Silvia, W J; Heersche, G; Wood, C L; McQuerry, K J; Bewley, J M
The objective of this study was to compare the reproductive performance of cows inseminated based on automated activity monitoring with hormone intervention (AAM) to cows from the same herds inseminated using only an intensive timed artificial insemination (TAI) program. Cows (n=523) from 3 commercial dairy herds participated in this study. To be considered eligible for participation, cows must have been classified with a body condition score of at least 2.50, but no more than 3.50, passed a reproductive tract examination, and experienced no incidences of clinical, recorded metabolic diseases in the current lactation. Within each herd, cows were balanced for parity and predicted milk yield, then randomly assigned to 1 of 2 treatments: TAI or AAM. Cows assigned to the TAI group were subjected to an ovulation synchronization protocol consisting of presynchronization, Ovsynch, and Resynch for up to 3 inseminations. Cows assigned to the AAM treatment were fitted with a leg-mounted accelerometer (AfiAct Pedometer Plus, Afimilk, Kibbutz Afikim, Israel) at least 10 d before the end of the herd voluntary waiting period (VWP). Cows in the AAM treatment were inseminated at times indicated by the automated alert system for up to 90 d after the VWP. If an open cow experienced no AAM alert for a 39±7-d period (beginning at the end of the VWP), hormone intervention in the form of a single injection of either PGF2α or GnRH (no TAI) was permitted as directed by the herd veterinarian. Subsequent to hormone intervention, cows were inseminated when alerted in estrus by the AAM system. Pregnancy was diagnosed by ultrasound 33 to 46 d after insemination. Pregnancy loss was determined via a second ultrasound after 60 d pregnant. Timed artificial insemination cows experienced a median 11.0 d shorter time to first service. Automated activity-monitored cows experienced a median 17.5-d shorter service interval. No treatment difference in probability of pregnancy to first AI, probability
Kantarci, Kejal; Tosakulwong, Nirubol; Lesnick, Timothy G; Zuk, Samantha M; Gunter, Jeffrey L; Gleason, Carey E; Wharton, Whitney; Dowling, N Maritza; Vemuri, Prashanthi; Senjem, Matthew L; Shuster, Lynne T; Bailey, Kent R; Rocca, Walter A; Jack, Clifford R; Asthana, Sanjay; Miller, Virginia M
To investigate the effects of hormone therapy on brain structure in a randomized, double-blinded, placebo-controlled trial in recently postmenopausal women. Participants (aged 42-56 years, within 5-36 months past menopause) in the Kronos Early Estrogen Prevention Study were randomized to (1) 0.45 mg/d oral conjugated equine estrogens (CEE), (2) 50 μg/d transdermal 17β-estradiol, or (3) placebo pills and patch for 48 months. Oral progesterone (200 mg/d) was given to active treatment groups for 12 days each month. MRI and cognitive testing were performed in a subset of participants at baseline, and at 18, 36, and 48 months of randomization (n = 95). Changes in whole brain, ventricular, and white matter hyperintensity volumes, and in global cognitive function, were measured. Higher rates of ventricular expansion were observed in both the CEE and the 17β-estradiol groups compared to placebo; however, the difference was significant only in the CEE group (p = 0.01). Rates of ventricular expansion correlated with rates of decrease in brain volume (r = -0.58; p ≤ 0.001) and with rates of increase in white matter hyperintensity volume (r = 0.27; p = 0.01) after adjusting for age. The changes were not different between the CEE and 17β-estradiol groups for any of the MRI measures. The change in global cognitive function was not different across the groups. Ventricular volumes increased to a greater extent in recently menopausal women who received CEE compared to placebo but without changes in cognitive performance. Because the sample size was small and the follow-up limited to 4 years, the findings should be interpreted with caution and need confirmation. This study provides Class I evidence that brain ventricular volume increased to a greater extent in recently menopausal women who received oral CEE compared to placebo. © 2016 American Academy of Neurology.
Adams, Rebecca N; Mosher, Catherine E; Blair, Cindy K; Snyder, Denise C; Sloane, Richard; Demark-Wahnefried, Wendy
The health benefits of diet and exercise interventions for cancer survivors are well documented. However, little is known regarding demographic and medical predictors of survivors' willingness to participate in diet and exercise intervention trials, study enrollment, intervention adherence, and study completion. To assist in interpreting the generalizability of trial findings and to improve the design of future trials, this study examined predictors of these process measures. An integrative data analysis was performed on data from 3 of the largest home-based diet and exercise intervention trials for cancer survivors (n = 23,841). Demographic and medical factors (ie, sex, race, age, time since diagnosis, and cancer type) were examined as predictors of willingness to participate, study enrollment, intervention adherence, and study completion in the pooled sample. A 99% confidence interval was used to determine statistical significance. Across trials, 11.1% of contacted survivors were willing to participate, and 5.7% were eligible and enrolled. Among enrollees, 53.4% demonstrated ≥75% adherence to the intervention, and 91.1% completed the study. Race (Caucasian vs others), age, time since diagnosis, and cancer type predicted survivors' willingness to participate (P Cancer survivors' demographic and medical characteristics predicted their interest and participation in diet and exercise intervention trials. These findings have implications for the generalizability of results and can help to guide procedures used in future trials to enhance patient representation. © 2014 American Cancer Society.
Adams, Rebecca N.; Mosher, Catherine E.; Blair, Cindy K.; Snyder, Denise C.; Sloane, Richard; Demark-Wahnefried, Wendy
BACKGROUND The health benefits of diet and exercise interventions for cancer survivors are well documented. However, little is known regarding demographic and medical predictors of survivors’ willingness to participate in diet and exercise intervention trials, study enrollment, intervention adherence, and study completion. To assist in interpreting the generalizability of trial findings as well as to improve the design of future trials, we examined predictors of these process measures. METHODS An integrative data analysis was performed on data from three of the largest home-based diet and exercise intervention trials for cancer survivors (N=23,841). Demographic and medical factors (i.e., gender, race, age, time since diagnosis, and cancer type) were examined as predictors of willingness to participate, study enrollment, intervention adherence, and study completion in the pooled sample. A 99% confidence interval was used to determine statistical significance. RESULTS Across trials, 11.1% of contacted survivors were willing to participate and 5.7% were eligible and enrolled. Among enrollees, 53.4% demonstrated ≥75% adherence to the intervention and 91.1% completed the study. Race (Caucasian vs. others), age, time since diagnosis, and cancer type predicted survivors’ willingness to participate (p-valuesCancer survivors’ demographic and medical characteristics predicted their interest and participation in diet and exercise intervention trials. These findings have implications for the generalizability of results and can help guide procedures used in future trials to enhance patient representation. PMID:25155573
Basu, Anna Purna; Pearse, Janice Elizabeth; Rapley, Tim
Open Science is 'the movement to make scientific research, data and dissemination accessible to all levels of an inquiring society'. In the spirit of the Open Science movement, advance publication of protocols for clinical trials is now being advocated by BioMed Central, BMJ Open and others. Simultaneously, participants are becoming increasingly active in their pursuit and sharing of trial- and health- related information. Whilst access to protocols alongside published trial findings has clear benefits, advance publication of trial protocols is potentially problematic for trials of complex behavioural interventions. In this article we explain, with examples, how this could lead to unblinding, 'contamination' between intervention and control groups and deliberate biasing of assessment outcomes by participants. We discuss potential solutions and demonstrate the need for public debate about how this issue is best managed. Triallists may still be underestimating participants' interest in information. This needs to change: joint and open discussions with the public are needed to inform how we should proceed.
Hoffmann, Tammy C; Erueti, Chrissy; Glasziou, Paul P
To evaluate the completeness of descriptions of non-pharmacological interventions in randomised trials, identify which elements are most frequently missing, and assess whether authors can provide missing details. Analysis of consecutive sample of randomised trials of non-pharmacological interventions. All reports of randomised trials of non-pharmacological interventions published in 2009 in six leading general medical journals; 133 trial reports, with 137 interventions, met the inclusion criteria. Using an eight item checklist, two raters assessed the primary full trial report, plus any reference materials, appendices, or websites. Questions about missing details were emailed to corresponding authors, and relevant items were then reassessed. Of 137 interventions, only 53 (39%) were adequately described; this was increased to 81 (59%) by using 63 responses from 88 contacted authors. The most frequently missing item was the "intervention materials" (47% complete), but it also improved the most after author response (92% complete). Whereas some authors (27/70) provided materials or further information, other authors (21/70) could not; their reasons included copyright or intellectual property concerns, not having the materials or intervention details, or being unaware of their importance. Although 46 (34%) trial interventions had further information or materials readily available on a website, many were not mentioned in the report, were not freely accessible, or the URL was no longer functioning. Missing essential information about interventions is a frequent, yet remediable, contributor to the worldwide waste in research funding. If trial reports do not have a sufficient description of interventions, other researchers cannot build on the findings, and clinicians and patients cannot reliably implement useful interventions. Improvement will require action by funders, researchers, and publishers, aided by long term repositories of materials linked to publications.
Jagdeesh N Kulkarni
Full Text Available Objectives: We herein report our experience of double blind randomized clinical trial comparing combined an-drogen blockade vs monotherapy in stage D2 CaP. Patients and Methods: Through June 1999 and May 2001, 100 patients of stage D2 CaP were randomized into placebo (44 and flutamide (42 group after orchiectomy in double blind fashion using the strictest criteria. All men and histological proof of CaP with bone metastasis dem-onstrated on imaging: bone scan and skeletal survey. These patients were further substratified according to number o f bony metastases into high volume disease (HVD>5 sites and low volume disease (LVD< 5 sites. The follow-up was at 3 month intervals. Criteria for decoding were clinical or serological progression and serious adverse effects. Results: Of the 100 patients recruited in the trial, 48 had HVD and 52 LVD. Treatmentwise they were almost equally distributed in flutamide group and placebo group. In the follow-up ranging front 6 to 24 months, 30 out of 100 patients (30% required decoding, reasons for decod-ing were progression of disease in 25 and serious adverse effects in remaining 5. These 25 patients were further analyzed according to treatment group, volume of metas-tasis pre -orchiectomy PSA and Gleason score. We observed that number of bony metastases had impact over the dura-tion of response to hormonal therapy. Discussion: We initiated this simple trial to address the issue of benefit of total androgen blockade over monotherapy in Indian population. In the initial analysis, we observed that treatment group did not make any impact over the response. While subset of prostate cancer with large number of bony metastases has higher propensity to convert into hormone refractory cancer Conclusions: Addition of flutamide did not provide ben-efit. We observed that large number of bony metastases had poor response to hormonal therapy, hence it requires large trial to substantiate this initial observation.
Enright, Kevin; Morton, James; Iga, John; Drust, Barry
There are no data describing the acute hormonal responses to concurrent- training programmes in youth elite soccer players. Therefore, the aim of this study was to describe the total testosterone (T), cortisol (C), and growth hormone (hGH) responses during two same-day concurrent-training (CT) trials in elite soccer players. n=13 youth elite players (age: 17.0±0.2 yrs; height, 1.80±0.07 m; body mass, 73.1±5.7 kg; VO2 max, 64.4±4.8ml-1.kg-1.min-1) from an English premier league soccer club completed two CT trials. 'Trial 1' (CT1); E (10.30h) followed by S (14.00h) and Trial 2 (CT2); strength-training (S) 09.00h followed by a soccer-specific endurance-training session (E) at 10.30h. Venous blood samples were collected at 5 time-points around training and food intake (T1; 08.00h, T2; 09.45h, T3; 12.30h, T4; 13.45h and T5; 15.15h) and analysed for T (nmol/L) and C (nmol/L) and hGH (ug/L). There was no main effects found between exercise conditions for any hormones (T; P=0.22, C; P=0.07, hGH; P=0.21). Effect size analysis revealed a moderate effect for T at T3 (ES=0.63, CT1; 18.4±3.8, CT2; 15.7±4.7 nmol/L-1). A moderate effect for T area under the curve (AUC) was observed between conditions (CT1; 300±76 versus CT2; 244 ± 81 [AU]; ES=0.71). A moderate effect was apparent for C concentrations T4 in (ES=-0.95, CT1; 230±69, CT2; 314±105 nmol/L-1). Moderate effect sizes were observed at T3 and T4 (ES=0.82, CT1; 1.28±1.17, CT2; 0.47±0.75, ES=0.72, CT1; 0.11±0.05, CT2; 0.07±0.06 ug/L-1 respectively). A moderate effect for hGH AUC was observed between trials (CT1; 14±11 versus CT2; 5±9; [AU], ES=-1.08). The organisation of the concurrent-training protocols used in this study has a negligible impact upon the acute T, C and hGH in youth elite soccer players.
Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E
To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. Selective qualitative review. Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment-as-usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. This review highlights the need for a scientific consensus statement on control groups in behavioral trials.
Punthakee, Z; Bosch, J; Dagenais, G
AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs (rosiglit......AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs...
Schmid, Arlene A.; Spangler-Morris, Carrie; Beauchamp, Rachel C.; Wellington, Miranda C.; Hayden, Whitney M.; Porterfield, Hannah S.; Ferguson, Denisha; Callahan, Christopher M.
There is no way to prevent functional declines related to Alzheimer’s Disease (AD). The use of occupational therapy (OT) has been shown to be successful in managing some aspects of AD. We added home-based OT to evidence-based best practice for AD with the aim of delaying functional decline in people with AD. OT was delivered in the home to a caregiver dyad including the person with AD and her/his caregiver. This paper describes the OT intervention for the AD Multiple Intervention Trial, a parallel randomized controlled trial. We include baseline data on the 180 caregiver dyads. PMID:26997685
Ortiz, Miriam; Witt, Claudia M; Binting, Sylvia; Helmreich, Cornelia; Hummelsberger, Josef; Pfab, Florian; Wullinger, Michael; Irnich, Dominik; Linde, Klaus; Niggemann, Bodo; Willich, Stefan N; Brinkhaus, Benno
In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial's participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers and physicians. ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) was a three-armed, randomised, controlled multicentre trial. 422 SAR patients were randomised to semi-standardised acupuncture plus rescue medication (RM, cetirizine), sham acupuncture plus RM or RM alone. We sent a questionnaire to trial physicians in order to evaluate their characteristics regarding their education about and experience in providing acupuncture. During the trial, acupuncturists were asked to diagnose all of their patients according to Chinese Medicine (CM) as a basis for the semi-standardised, individualized intervention in the acupuncture group. Every acupuncture point used in this trial had to be documented after each session Acupuncture was administered in outpatient clinics by 46 (mean age 47 ± 10 years; 24 female/ 22 male) conventionally-trained medical doctors (67% with postgraduate specialization such as internal or family medicine) with additional extensive acupuncture training (median 500 hours (1st quartile 350, 3rd quartile 1000 hours with 73% presenting a B-diploma in acupuncture training (350 hours)) and experience (mean 14 years in practice). The most reported traditional CM diagnosis was 'wind-cold invading the lung' (37%) and 'wind-heat invading the lung' (37%), followed by 'lung and spleen qi deficiency' (9%). The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group (15.7 ± 2.5 vs. 10.0 ± 1.6). The trial interventions were
Ali, Joseph; Andrews, Joseph E; Somkin, Carol P; Rabinovich, C Egla
To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of pragmatic clinical trial interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for pragmatic clinical trials. Specifically, further examination is needed to identify how the types and targets of pragmatic clinical trial interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this article, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of pragmatic clinical trial interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of pragmatic clinical trial interventions and discuss implications for patients, clinicians, and healthcare systems. © The Author(s) 2015.
Roumie, Christianne L; Grogan, Eric L; Falbe, William; Awad, Joseph; Speroff, Theodore; Dittus, Robert S; Elasy, Tom A
Slow adaptation of new information by providers may result in suboptimal care. To evaluate changes in prescriptions for combination hormone replacement therapy (HRT) after a multicomponent intervention to deliver new information to patients and providers. Quasi-experimental study with multiple baselines. Veterans Affairs Tennessee Valley Healthcare System (VA-TVHS). Female veterans age 50 to 79 years who had a prescription filled at the VA-TVHS for combination HRT between 1 January 2002 and 1 July 2002. Discontinuation of HRT. A 3-part intervention consisted of 1) notifying patients who were using combination HRT of the results of the Women's Health Initiative study (patient education component), 2) sending all providers an e-mail with the Women's Health Initiative study results (provider education component), and 3) placing an electronic alert in each eligible patient's chart (provider care component). The alert asked providers to reevaluate the need for combination HRT. The intervention was implemented at different VA-TVHS sites in a stepwise fashion to differentiate intervention effect from media effect. Study follow-up continued through 31 December 2002. The total rate of discontinuation of combination HRT was 70.3% in 2002. The proportion of discontinuation from time of media release until intervention was 23.3%. After initiation of the intervention, an additional 43% of the original cohort discontinued use of HRT; this percentage represents a 59% relative decrease in HRT use among patients. After adjustment for time, the discontinuation rate per day was 4.9 times higher after the multifacted intervention than after the media release (95% CI, 1.8 to 13.1). A true control group is lacking. A multifaceted approach in an integrated health care system with standardized methods of communication is an effective way to implement patient-centered, effective, and timely care with changing medical knowledge.
Tjia, Jennifer; Mazor, Kathleen M; Field, Terry; Doherty, Peter; Spenard, Ann; Gurwitz, Jerry H
To describe factors predictive of nursing home (NH) adherence to a clinical trial intervention. Post hoc analysis of a cluster randomized trial (CRT) evaluating a structured communication intervention to improve nurse-physician telephone communication in NHs. NH. All eligible licensed nursing staff in all participating NHs. Adherence was defined as active participation for at least 3 months of the 12-month trial. NH characteristics hypothesized to affect trial outcomes (profit status, bed size, nursing staff time, NH quality, and leadership turnover) were measured a priori. The association between intervention adherence, NH characteristics and preintervention questionnaire response rate was examined. Of 13 intervention NHs, seven adhered to the intervention. Three factors differentiated adherent from nonadherent NHs: director of nursing turnover (nonadherent NHs 50% vs adherent NHs 0%, P = .03); Centers for Medicare and Medicaid Services (CMS) nurse staffing rating (range: 1-5) (nonadherent NHs mean 3.7 ± 0.5 vs adherent NHs mean 4.3 ± 0.5), P = .048); and questionnaire response rate (nonadherent NHs 15.6 ± 10.0% vs adherent NHs 34.2 ± 12.1%, P = .02). Profit status, bed size, and number of NH deficiencies on state surveys were not significantly associated with intervention adherence. CMS nurse staffing rating, leadership turnover, and questionnaire response rate are associated with adherence to a CRT intervention. Pretrial evaluation of NH staffing rating by CMS and of response to a questionnaire can help investigators improve trial efficiency by screening for NHs likely to adhere to a CRT intervention. © 2011, Copyright the Authors Journal compilation © 2011, The American Geriatrics Society.
Sinha, Yashwant K; Craig, Jonathan C; Sureshkumar, Premala; Hayen, Andrew; Brien, Jo-anne E
To determine whether randomized controlled trials of pharmacologic interventions in children are more likely to be biased than similar trials in adults. Trials involving only children and published in MEDLINE between January 2008 and October 2009 (n=100) were randomly selected and matched, by drug class and therapeutic area, with a similar trial completed in adults. The Cochrane risk of bias tool was used to compare the pediatric and adult trials. The characteristics of adult and pediatric trials included were similar, except that adult studies were more likely to be conducted in Europe and published in specialty journals. Two-thirds of all trials were single center, and 62% had 100 or fewer participants. Many trials had an unclear risk of bias for allocation concealment (65% adult, 52% pediatric). More pediatric trials had a low risk of bias for random sequence generation (59% pediatric, 41% adult, P=.002) and blinding of outcome assessment (63% pediatric, 48% adult, P=.04) than adult trials; however, a sensitivity analysis of trials published since 2008 (and so matched by year of publication) did not confirm this finding, suggesting year of publication was an important confounder. When randomized controlled trials are matched for drug class and therapeutic area, trials involving children display a similar risk of bias. Differences in the risk of bias between pediatric and adult trials are not caused by differences in the capacity of researchers to conduct and report trials of high quality. Copyright © 2014 Elsevier Inc. All rights reserved.
Zourladani, A; Zafrakas, M; Chatzigiannis, B; Papasozomenou, P; Vavilis, D; Matziari, C
To evaluate the effect of an exercise training program combining low-impact dance aerobic, resistance and stretching exercise on physical fitness, hormone and lipid levels of postpartum, primiparous, lactating women. Thirty seven primiparous, lactating women were randomly assigned at 4-6 weeks postpartum to either follow an exercise training program of 50-60 min aerobic, strengthening and stretching exercise, 3 days a week, for 12 weeks (interventional group; n = 20) or no training program at all (control group; n = 17). The following parameters were measured at baseline and 12 weeks later: (1) for evaluation of physical fitness: VO2max, muscular endurance, joint mobility and body fat; (2) for evaluation of the lipidemic profile: triglyceride, total cholesterol, HDL and LDL levels, and (3) levels of hormones associated with lactation: prolactin, estradiol, cortisol, TSH, fT3 and fT4. After completion of the exercise training program, comparisons between the interventional and the control group showed statistically significant mean changes in VO2max (p = 0.003), muscular endurance of the upper extremities (p impact exercise training program appears to improve physical fitness of postpartum women, while it does not seem to affect lipid levels and lactation-associated hormone levels. Hence, implementation of an exercise training program combining low-impact dance aerobic, resistance and stretching exercise is feasible in postpartum, primiparous, lactating women.
Davies, C.; Godwin, J.; Gray, R.; Clarke, M.; Cutter, D.; Darby, S.; McGale, P.; Pan, H. C.; Taylor, C.; Wang, Y. C.; Dowsett, M.; Ingle, J.; Peto, R.; Albain, K.; Anderson, S.; Arriagada, R.; Barlow, W.; Bergh, J.; Bliss, J.; Buyse, M.; Cameron, D.; Carrasco, E.; Correa, C.; Coates, A.; Collins, R.; Costantino, J.; Cuzick, J.; Davidson, N.; Davies, K.; Delmestri, A.; Di Leo, A.; Elphinstone, P.; Evans, V.; Ewertz, M.; Gelber, R.; Gettins, L.; Geyer, C.; Goldhirsch, A.; Gregory, C.; Hayes, D.; Hill, C.; Jakesz, R.; James, S.; Kaufmann, M.; Kerr, A.; MacKinnon, E.; McHugh, T.; Norton, L.; Ohashi, Y.; Paik, S.; Perez, E.; Piccart, M.; Pierce, L.; Pruneri, G.; Pritchard, K.; Raina, V.; Ravdin, P.; Robertson, J.; Rutgers, E.; Shao, Y. F.; Swain, S.; Valagussa, P.; Viale, G.; Whelan, T.; Winer, E.; Wang, Y.; Wood, W.; Abe, O.; Abe, R.; Enomoto, K.; Kikuchi, K.; Koyama, H.; Masuda, H.; Nomura, Y.; Sakai, K.; Sugimachi, K.; Toi, M.; Tominaga, T.; Uchino, J.; Yoshida, M.; Haybittle, J. L.; Leonard, C. F.; Calais, G.; Geraud, P.; Collett, V.; Sayer, J.; Harvey, V. J.; Holdaway, I. M.; Kay, R. G.; Mason, B. H.; Forbes, J. F.; Wilcken, N.; Bartsch, R.; Dubsky, P.; Fesl, C.; Fohler, H.; Gnant, M.; Greil, R.; Lang, A.; Luschin-Ebengreuth, G.; Marth, C.; Mlineritsch, B.; Samonigg, H.; Singer, C. F.; Steger, G. G.; Stöger, H.; Canney, P.; Yosef, H. M. A.; Focan, C.; Peek, U.; Oates, G. D.; Powell, J.; Durand, M.; Mauriac, L.; Dolci, S.; Larsimont, D.; Nogaret, J. M.; Philippson, C.; Piccart, M. J.; Masood, M. B.; Parker, D.; Price, J. J.; Lindsay, M. A.; Mackey, J.; Martin, M.; Hupperets, P. S. G. J.; Bates, T.; Blamey, R. W.; Chetty, U.; Ellis, I. O.; Mallon, E.; Morgan, D. A. L.; Patnick, J.; Pinder, S.; Olivotto, I.; Ragaz, J.; Berry, D.; Broadwater, G.; Cirrincione, C.; Muss, H.; Weiss, R. B.; Abu-Zahra, H. T.; Portnoj, S. M.; Bowden, S.; Brookes, C.; Dunn, J.; Fernando, I.; Lee, M.; Poole, C.; Rea, D.; Spooner, D.; Barrett-Lee, P. J.; Mansel, R. E.; Monypenny, I. J.; Gordon, N. H.; Davis, H. L.; Lehingue, Y.; Romestaing, P.; Dubois, J. B.; Delozier, T.; Griffon, B.; Mace Lesec'h, J.; Rambert, P.; Mustacchi, G.; Petruzelka, L.; Pribylova, O.; Owen, J. R.; Harbeck, N.; Jänicke, F.; Meisner, C.; Schmitt, M.; Thomssen, C.; Meier, P.; Shan, Y.; Wang, X.; Zhao, D. B.; Chen, Z. M.; Howell, A.; Swindell, R.; Burrett, J. A.; Hermans, D.; Hicks, C.; Lay, M.; Albano, J.; de Oliveira, C. F.; Gervásio, H.; Gordilho, J.; Johansen, H.; Mouridsen, H. T.; Gelman, R. S.; Harris, J. R.; Henderson, C.; Shapiro, C. L.; Christiansen, P.; Ejlertsen, B.; Jensen, M.-B.; Møller, S.; Carstensen, B.; Palshof, T.; Trampisch, H. J.; Dalesio, O.; de Vries, E. G. E.; Rodenhuis, S.; van Tinteren, H.; Comis, R. L.; Davidson, N. E.; Robert, N.; Sledge, G.; Solin, L. J.; Sparano, J. A.; Tormey, D. C.; Dixon, J. M.; Forrest, P.; Jack, W.; Kunkler, I.; Rossbach, J.; Klijn, J. G. M.; Treurniet-Donker, A. D.; van Putten, W. L. J.; Rotmensz, N.; Veronesi, U.; Bartelink, H.; Bijker, N.; Bogaerts, J.; Cardoso, F.; Cufer, T.; Julien, J. P.; van de Velde, C. J. H.; Cunningham, M. P.; Huovinen, R.; Joensuu, H.; Costa, A.; Tinterri, C.; Bonadonna, G.; Gianni, L.; Goldstein, L. J.; Bonneterre, J.; Fargeot, P.; Fumoleau, P.; Kerbrat, P.; Luporsi, E.; Namer, M.; Eiermann, W.; Hilfrich, J.; Jonat, W.; Kreienberg, R.; Schumacher, M.; Bastert, G.; Rauschecker, H.; Sauer, R.; Sauerbrei, W.; Schauer, A.; Blohmer, J. U.; Costa, S. D.; Eidtmann, H.; Gerber, B.; Jackisch, C.; Loibl, S.; von Minckwitz, G.; de Schryver, A.; Vakaet, L.; Belfiglio, M.; Nicolucci, A.; Pellegrini, F.; Pirozzoli, M. C.; Sacco, M.; Valentini, M.; McArdle, C. S.; Smith, D. C.; Stallard, S.; Dent, D. M.; Gudgeon, C. A.; Hacking, A.; Murray, E.; Panieri, E.; Werner, I. D.; Segui, M. A.; Galligioni, E.; Lopez, M.; Erazo, A.; Medina, J. Y.; Horiguchi, J.; Takei, H.; Fentiman, I. S.; Hayward, J. L.; Rubens, R. D.; Skilton, D.; Scheurlen, H.; Sohn, H. C.; Untch, M.; Dafni, U.; Markopoulos, C.; Fountzilas, G.; Mavroudis, D.; Klefstrom, P.; Blomqvist, C.; Saarto, T.; Gallen, M.; Margreiter, R.; de Lafontan, B.; Mihura, J.; Roché, H.; Asselain, B.; Salmon, R. J.; Vilcoq, J. R.; Bourgier, C.; Koscielny, S.; Laplanche, A.; Lê, M. G.; Spielmann, M.; A'Hern, R.; Ellis, P.; Kilburn, L.; Yarnold, J. R.; Benraadt, J.; Kooi, M.; van de Velde, A. O.; van Dongen, J. A.; Vermorken, J. B.; Castiglione, M.; Colleoni, M.; Collins, J.; Forbes, J.; Gelber, R. D.; Lindtner, J.; Price, K. N.; Regan, M. M.; Rudenstam, C. M.; Senn, H. J.; Thuerlimann, B.; Bliss, J. M.; Chilvers, C. E. D.; Coombes, R. C.; Hall, E.; Marty, M.; Possinger, K.; Schmid, P.; Wallwiener, D.; Foster, L.; George, W. D.; Stewart, H. J.; Stroner, P.; Borovik, R.; Hayat, H.; Inbar, M. J.; Robinson, E.; Bruzzi, P.; del Mastro, L.; Pronzato, P.; Sertoli, M. R.; Venturini, M.; Camerini, T.; de Palo, G.; Di Mauro, M. G.; Formelli, F.; Amadori, D.; Martoni, A.; Pannuti, F.; Camisa, R.; Cocconi, G.; Colozza, A.; Passalacqua, R.; Aogi, K.; Takashima, S.; Ikeda, T.; Inokuchi, K.; Sawa, K.; Sonoo, H.; Korzeniowski, S.; Skolyszewski, J.; Ogawa, M.; Yamashita, J.; Bastiaannet, E.; van de Water, W.; van Nes, J. G. H.; Christiaens, R.; Neven, P.; Paridaens, R.; van den Bogaert, W.; Braun, S.; Janni, W.; Martin, P.; Romain, S.; Janauer, M.; Seifert, M.; Sevelda, P.; Zielinski, C. C.; Hakes, T.; Hudis, C. A.; Wittes, R.; Giokas, G.; Kondylis, D.; Lissaios, B.; de la Huerta, R.; Sainz, M. G.; Altemus, R.; Camphausen, K.; Cowan, K.; Danforth, D.; Lichter, A.; Lippman, M.; O'Shaughnessy, J.; Pierce, L. J.; Steinberg, S.; Venzon, D.; Zujewski, J. A.; D'Amico, C.; Lioce, M.; Paradiso, A.; Chapman, J.-A. W.; Gelmon, K.; Goss, P. E.; Levine, M. N.; Meyer, R.; Parulekar, W.; Pater, J. L.; Pritchard, K. I.; Shepherd, L. E.; Tu, D.; Ohno, S.; Bass, G.; Brown, A.; Bryant, J.; Dignam, J.; Fisher, B.; Mamounas, E. P.; Redmond, C.; Wickerham, L.; Wolmark, N.; Baum, M.; Jackson, I. M.; Palmer, M. K.; Ingle, J. N.; Suman, V. J.; Bengtsson, N. O.; Emdin, S.; Jonsson, H.; Lythgoe, J. P.; Kissin, M.; Erikstein, B.; Hannisdal, E.; Jacobsen, A. B.; Varhaug, J. E.; Gundersen, S.; Hauer-Jensen, M.; Høst, H.; Nissen-Meyer, R.; Mitchell, A. K.; Robertson, J. F. R.; Ueo, H.; Di Palma, M.; Mathé, G.; Misset, J. L.; Levine, M.; Morimoto, K.; Takatsuka, Y.; Crossley, E.; Harris, A.; Talbot, D.; Taylor, M.; Martin, A. L.; di Blasio, B.; Ivanov, V.; Paltuev, R.; Semiglazov, V.; Brockschmidt, J.; Cooper, M. R.; Falkson, C. I.; Ashley, S.; Makris, A.; Powles, T. J.; Smith, I. E.; Gazet, J. C.; Browne, L.; Graham, P.; Corcoran, N.; Deshpande, N.; di Martino, L.; Douglas, P.; Lindtner, A.; Notter, G.; Bryant, A. J. S.; Ewing, G. H.; Firth, L. A.; Krushen-Kosloski, J. L.; Anderson, H.; Killander, F.; Malmström, P.; Rydén, L.; Arnesson, L.-G.; Carstensen, J.; Dufmats, M.; Fohlin, H.; Nordenskjöld, B.; Söderberg, M.; Carpenter, J. T.; Murray, N.; Royle, G. T.; Simmonds, P. D.; Crowley, J.; Gralow, J.; Green, S.; Hortobagyi, G.; Livingston, R.; Martino, S.; Osborne, C. K.; Ravdin, P. M.; Adolfsson, J.; Bondesson, T.; Celebioglu, F.; Dahlberg, K.; Fornander, T.; Fredriksson, I.; Frisell, J.; Göransson, E.; Iiristo, M.; Johansson, U.; Lenner, E.; Löfgren, L.; Nikolaidis, P.; Perbeck, L.; Rotstein, S.; Sandelin, K.; Skoog, L.; Svane, G.; af Trampe, E.; Wadström, C.; Maibach, R.; Thürlimann, B.; Hakama, M.; Holli, K.; Isola, J.; Rouhento, K.; Saaristo, R.; Brenner, H.; Hercbergs, A.; Yoshimoto, M.; Paterson, A. H. G.; Fyles, A.; Meakin, J. W.; Panzarella, T.; Bahi, J.; Reid, M.; Spittle, M.; Bishop, H.; Bundred, N. J.; Forsyth, S.; Pinder, S. E.; Sestak, I.; Deutsch, G. P.; Kwong, D. L. W.; Pai, V. R.; Senanayake, F.; Boccardo, F.; Rubagotti, A.; Hackshaw, A.; Houghton, J.; Ledermann, J.; Monson, K.; Tobias, J. S.; Carlomagno, C.; de Laurentiis, M.; de Placido, S.; Williams, L.; Broglio, K.; Buzdar, A. U.; Love, R. R.; Ahlgren, J.; Garmo, H.; Holmberg, L.; Liljegren, G.; Lindman, H.; Wärnberg, F.; Asmar, L.; Jones, S. E.; Gluz, O.; Liedtke, C.; Nitz, U.; Litton, A.; Wallgren, A.; Karlsson, P.; Linderholm, B. K.; Chlebowski, R. T.; Caffier, H.
As trials of 5 years of tamoxifen in early breast cancer mature, the relevance of hormone receptor measurements (and other patient characteristics) to long-term outcome can be assessed increasingly reliably. We report updated meta-analyses of the trials of 5 years of adjuvant tamoxifen. We undertook
Savović, J; Jones, He; Altman, Dg
The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...
Alan Lins Fernandes
Full Text Available The aim of this study was to determine the effect of time of day on performance, pacing, and hormonal and metabolic responses during a 1000-m cycling time-trial. Nine male, recreational cyclists visited the laboratory four times. During the 1st visit the participants performed an incremental test and during the 2nd visit they performed a 1000-m cycling familiarization trial. On the 3rd and 4th visits, the participants performed a 1000-m TT at either 8 am or 6 pm, in randomized, repeated-measures, crossover design. The time to complete the time trial was lower in the evening than in the morning (88.2±8.7 versus 94.7±10.9 s, respectively, p0.05, but the norepinephrine response to the exercise was increased in the morning (+46%, p0.05. Our findings suggest that performance was improved in the evening, and it was accompanied by an improved hormonal and metabolic milieu.
... test hormonal therapy in older men with low testosterone levels Testosterone treatment improved sexual function, had smaller effect on walking, vitality. A preliminary study of testosterone therapy in older men with low levels of ...
Full Text Available Abstract Background Sexually transmitted infections (STIs pose a serious public health problem globally. The rapid spread of mobile technology creates an opportunity to use innovative methods to reduce the burden of STIs. This systematic review identified recent randomised controlled trials that employed mobile technology to improve sexual health outcomes. Methods The following databases were searched for randomised controlled trials of mobile technology based sexual health interventions with any outcome measures and all patient populations: MEDLINE, EMBASE, PsycINFO, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, NHS Health Technology Assessment Database, and Web of Science (science and social science citation index (Jan 1999–July 2014. Interventions designed to increase adherence to HIV medication were not included. Two authors independently extracted data on the following elements: interventions, allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. Trials were assessed for methodological quality using the Cochrane risk of bias tool. We calculated effect estimates using intention to treat analysis. Results A total of ten randomised trials were identified with nine separate study groups. No trials had a low risk of bias. The trials targeted: 1 promotion of uptake of sexual health services, 2 reduction of risky sexual behaviours and 3 reduction of recall bias in reporting sexual activity. Interventions employed up to five behaviour change techniques. Meta-analysis was not possible due to heterogeneity in trial assessment and reporting. Two trials reported statistically significant improvements in the uptake of sexual health services using SMS reminders compared to controls. One trial increased knowledge. One trial reported promising results in increasing condom use but no trial
Burns, Kara; Keating, Patrick; Free, Caroline
Sexually transmitted infections (STIs) pose a serious public health problem globally. The rapid spread of mobile technology creates an opportunity to use innovative methods to reduce the burden of STIs. This systematic review identified recent randomised controlled trials that employed mobile technology to improve sexual health outcomes. The following databases were searched for randomised controlled trials of mobile technology based sexual health interventions with any outcome measures and all patient populations: MEDLINE, EMBASE, PsycINFO, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, NHS Health Technology Assessment Database, and Web of Science (science and social science citation index) (Jan 1999-July 2014). Interventions designed to increase adherence to HIV medication were not included. Two authors independently extracted data on the following elements: interventions, allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. Trials were assessed for methodological quality using the Cochrane risk of bias tool. We calculated effect estimates using intention to treat analysis. A total of ten randomised trials were identified with nine separate study groups. No trials had a low risk of bias. The trials targeted: 1) promotion of uptake of sexual health services, 2) reduction of risky sexual behaviours and 3) reduction of recall bias in reporting sexual activity. Interventions employed up to five behaviour change techniques. Meta-analysis was not possible due to heterogeneity in trial assessment and reporting. Two trials reported statistically significant improvements in the uptake of sexual health services using SMS reminders compared to controls. One trial increased knowledge. One trial reported promising results in increasing condom use but no trial reported statistically significant increases in condom
Korsten-Reck, U; Wolfarth, B; Bonk, M; Keul, J; Berg, A
Freiburg Intervention Trial for Obese Children (FITOC) is an interdisciplinary treatment program for obese children, which is established in Freiburg since 1987. Obese children at the age of 8-11 are treated in an eight months intensive period and a follow-up period of 4 months or more. Since 1990 data from 283 children coming out of 15 treatment groups (about 2 groups per year) were collected and analyzed. The program consists of regular physical training (3 times a week), comprehensive nutrition and behaviour training (overall 7 parents evenings each 4 to 6 weeks and 7 cookery courses for the kids in the same time scale). The parents evenings are filled with theoretical and practical information about nutrition as well as background information about the psychological and physiological problems in obese children. In the first examination and the regular control examinations anthropometric, biochemical and exercise physiology data are investigated. In addition, questionnaires for nutrition and behaviour are analysed on a regular basis. At each examination, depending on the progress in therapy, a new orientation with adapted goals will be discussed with the child and the parents. For the growing children a moderate reduction or long term stabilisation of weight will lead to success. Teaching goal for the children in the intensive period is to control themselves and, depending on their specific situation, to establish individual recommendations on a long term basis. The sports program should lead to an increase in self-esteem and a raise in daily energy expenditure. The team includes a physician, a nutritionist, a psychologist and a sports teacher. From 1997 the program was spread to institutions in the surroundings of Freiburg. Training for the external teams is provided for in continuous seminars. Teaching material includes a manual, forms and transparencies. The major goal is to secure quality by continuous training and close interaction between the institutions
Martinez, Joe; Laswell, Emily; Cailor, Stephanie; Ballentine, Jeb
The objective of this study was to describe the interventions and impact made by pharmacists during clinical trials. A specialty contract research organization that used clinical trial research pharmacists to communicate with patients to support clinical trial protocol adherence, retention, and health outcomes performed a retrospective, descriptive analysis of 12 clinical trials that involved 2 noninsulin glucose-lowering medications. Pharmacists called study participants at specific timepoints during the trials as per protocol. During each telephone call, the number and types of interventions were documented. Descriptive statistics (frequencies) were performed to determine the number and type of interventions by call and by patient across all noninsulin glucose-lowering medication drug A and drug B studies. Overall, 25,829 calls were made across all studies. Of these calls, 11,765 calls (45.5%) had at least one intervention that involved 3573 patients (92.3%). The most frequent interventions addressed adverse events (3774 [14.6%]), protocol violations for medication use (3341 [12.9%]), concurrent medications (1630 [5.9%]), and miscellaneous concerns (1269 [4.6%]). The greatest numbers of interventions were high-impact interventions (4772 [18.5%]) (eg, serious adverse events) that would seriously affect trial outcomes and patient adherence. Pharmacists were able to identify, support, and address multiple types of interventions related to medication management during clinical trials, including those related to concurrent medication use, adverse events, and other medication-related issues. These pharmacist interventions can result in better patient outcomes and, ultimately, more reliable study results for review and approval by regulatory agencies. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
Rasmussen, Ole Dahl; Malchow-Møller, Nikolaj; Andersen, Thomas Barnebeck
Recent advances in the use of randomised control trials to evaluate the effect of development interventions promise to enhance our knowledge of what works and why. A core argument supporting randomised studies is the claim that they have high internal validity. The authors argue that this claim i...... microfinance, they argue that a trial registry would also enhance external validity and foster innovative research....
Staudacher, Heidi M; Irving, Peter M; Lomer, Miranda C E; Whelan, Kevin
High-quality placebo-controlled evidence for food, nutrient or dietary advice interventions is vital for verifying the role of diet in optimising health or for the management of disease. This could be argued to be especially important where the benefits of dietary intervention are coupled with potential risks such as compromising nutrient intake, particularly in the case of exclusion diets. The objective of the present paper is to explore the challenges associated with clinical trials in dietary research, review the types of controls used and present the advantages and disadvantages of each, including issues regarding placebos and blinding. Placebo-controlled trials in nutrient interventions are relatively straightforward, as in general placebos can be easily produced. However, the challenges associated with conducting placebo-controlled food interventions and dietary advice interventions are protean, and this has led to a paucity of placebo-controlled food and dietary advice trials compared with drug trials. This review appraises the types of controls used in dietary intervention trials and provides recommendations and nine essential criteria for the design and development of sham diets for use in studies evaluating the effect of dietary advice, along with practical guidance regarding their evaluation. The rationale for these criteria predominantly relate to avoiding altering the outcome of interest in those delivered the sham intervention in these types of studies, while not compromising blinding.
MoghaddamHosseini, Vahideh; Nazarzadeh, Milad; Jahanfar, Shayesteh
Fear of childbirth is a problematic mental health issue during pregnancy. But, effective interventions to reduce this problem are not well understood. To examine effective interventions for reducing fear of childbirth. The Cochrane Central Register of Controlled Trials, PubMed, Embase and PsycINFO were searched since inception till September 2017 without any restriction. Randomised controlled trials and quasi-randomised controlled trials comparing interventions for treatment of fear of childbirth were included. The standardized mean differences were pooled using random and fixed effect models. The heterogeneity was determined using the Cochran's test and I(2) index and was further explored in meta-regression model and subgroup analyses. Ten studies inclusive of 3984 participants were included in the meta-analysis (2 quasi-randomized and 8 randomized clinical trials). Eight studies investigated education and two studies investigated hypnosis-based intervention. The pooled standardized mean differences of fear for the education intervention and hypnosis group in comparison with control group were -0.46 (95% CI -0.73 to -0.19) and -0.22 (95% CI -0.34 to -0.10), respectively. Both types of interventions were effective in reducing fear of childbirth; however our pooled results revealed that educational interventions may reduce fear with double the effect of hypnosis. Further large scale randomized clinical trials and individual patient data meta-analysis are warranted for assessing the association. Copyright © 2017 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.
Mummah, Sarah; Robinson, Thomas N.; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D.
Background Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Methods Overweight adults (n=135) aged 18?50 years with BMI=28?40 kg/m2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) an...
P R Srijithesh
Full Text Available The outcome of randomized controlled trials can vary depending on the eligibility criteria of the patients entering into the trial, as well as the heterogeneity of the eligible population and/or the interventions. If the subject population and/or interventions are heterogeneous, the final outcome of the trial depends on the degree of concordance of effects of the subgroups of interventions on the subgroups of the subject population. The considerations that go into the calculation of sample size and determination of the study stopping rules also would affect the nature of the outcome of the study. In this paper we try to examine these phenomena with respect to the recent trials on endovascular therapy in acute ischemic stroke.
Background This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia. Methods/Design This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors. Discussion The trial is supervised by a trial steering committee, and an independent data monitoring committee monitors the trial
Background: Infant attachment security is a protective factor for future mental health, and may be promoted by individual interventions. Given service demands, it is important to determine if a group-based intervention for parents could be used to enhance infant attachment security. Methods: In a randomized trial involving 76 mothers, an 8-session…
VanderWeele, Tyler J.; Hawkley, Louise C.; Thisted, Ronald A.; Cacioppo, John T.
Objective: Clinical scientists, policymakers, and individuals must make decisions concerning effective interventions that address health-related issues. We use longitudinal data on loneliness and depressive symptoms and a new class of causal models to illustrate how empirical evidence can be used to inform intervention trial design and clinical…
Fox, Patrick J.; Vazquez, Laurie; Tonner, Chris; Stevens, Judy A.; Fineman, Norman; Ross, Leslie K.
Using a randomized controlled trial, we tested the efficacy of a fall prevention intervention to reduce falls among adults in a community-based health promotion program. Adults aged 65 and older within two counties were recruited (control n = 257; intervention n = 286). After 12 months, there was a significant decrease in the number of falls in…
Schaaf, Roseann C.; Benevides, Teal; Mailloux, Zoe; Faller, Patricia; Hunt, Joanne; van Hooydonk, Elke; Freeman, Regina; Leiby, Benjamin; Sendecki, Jocelyn; Kelly, Donna
This study evaluated a manualized intervention for sensory difficulties for children with autism, ages 4-8 years, using a randomized trial design. Diagnosis of autism was confirmed using gold standard measures. Results show that the children in the treatment group (n = 17) who received 30 sessions of the occupational therapy intervention scored…
Fletcher-Watson, Sue; Petrou, Alexandra; Scott-Barrett, Juliet; Dicks, Pamela; Graham, Catherine; O'Hare, Anne; Pain, Helen; McConachie, Helen
This study evaluated a technology-based early intervention for social communication skills in pre-schoolers in a randomised controlled trial. Participants were 54 children aged under 6 years with a diagnosis of autism, assigned to either intervention or control conditions. The app engaged children, who played consistently, regardless of…
Villarruel, Antonia M.; Cherry, Carol Loveland; Cabriales, Esther Gallegos; Ronis, David L.; Zhou, Yan
This article reports results of a randomized controlled trial designed to test an intervention to increase parent-adolescent sexual risk communication among Mexican parents. Data were analyzed from parents (n = 791) randomly assigned to an HIV risk reduction or health promotion intervention. Measures were administered at pretest, posttest, and 6-…
Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.
Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…
Beich, A.; Gannik, D.; Saelan, H.
AIMS: Recommendations for routine alcohol screening and brief counselling intervention in primary health care rest on results from intervention efficacy studies. By conducting a pragmatic controlled trial (PCT), we aimed at evaluating the effectiveness of the WHO recommendations for screening......-14 months. Outcome measures focused on patients' acceptance of screening and intervention and their self-reported alcohol consumption. RESULTS: Patient acceptance of screening and intervention -10.3% (N = 794) of the target population (N = 7, 691) explicitly refused screening. All intervention group...
Bricker, Jonathan B.; Liu, Jingmin; Comstock, Bryan A; Peterson, Arthur V.; Kealey, Kathleen A.; Marek, Patrick M.
Only one prior study has examined why adolescent smoking cessation interventions are effective. To address this understudied and important issue, this study examined whether a large adolescent smoking cessation intervention trial’s outcomes were mediated by Social Cognitive Theory processes. In a randomized trial (N = 2,151), counselors proactively delivered a telephone intervention to senior year high school smokers. Mediators and smoking status were self-reported at 12 months post-intervent...
Dunn, Kelly E; Yepez-Laubach, Claudia; Nuzzo, Paul A; Fingerhood, Michael; Kelly, Anne; Berman, Suzan; Bigelow, George E
Opioid overdose (OD) has become a significant public health problem in need of effective interventions. The majority of existing educational interventions target provision of naloxone and are conducted in-person; these elements present logistical barriers that may limit wide-spread implementation. This study developed and evaluated an easily disseminated opioid OD educational intervention and compared computerized versus pamphlet delivery METHODS: Participants (N=76) undergoing opioid detoxification were randomly assigned to receive OD education via a Pamphlet (N=25), Computer (N=24), or Computer+Mastery (N=27) with identical content for all delivery modalities. Primary outcomes were changes from pre- to post-intervention in knowledge of opioid effects, opioid OD symptoms, and recommended opioid OD responses, as well as intervention acceptability. Also assessed at 1 and 3-month follow-ups were retention of knowledge and change in reported OD risk behaviors. Knowledge increased following all three intervention-delivery modalities with few between-group differences observed in knowledge gain or acceptability ratings. Largest gains were in the domain of opioid OD response (from 41.8% to 73.8% mean correct responses; poverdose education delivered by computer or written pamphlet produced sustained increases in knowledge and reduction in a key behavioral risk factor. Results support further evaluation of this educational intervention that can be used alone or to complement naloxone-training programs. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.
Køber, Lars; Rustom, Rana; Wiedmann, Jonas
The high morbidity and mortality rates in hemodialysis (HD) patients are due, at least in part, to their increased risk for cardiovascular diseases (CVD). This prospective study evaluated the effect of growth hormone (GH) on a number of CVD risk markers in adult patients on HD.......The high morbidity and mortality rates in hemodialysis (HD) patients are due, at least in part, to their increased risk for cardiovascular diseases (CVD). This prospective study evaluated the effect of growth hormone (GH) on a number of CVD risk markers in adult patients on HD....
Ndebele Paul M
Full Text Available Abstract Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n=124 obtained low scores (lower than 75% on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used daily examples from the field of Agriculture because Malawi has an agro-based economy. Methods The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18 and intervention arms (n=18. The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study. Results The findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75% during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer’s exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001. Conclusions
Verbakel, Natasha J.; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M
Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial
Volkova, Ekaterina; Li, Nicole; Dunford, Elizabeth; Eyles, Helen; Crino, Michelle; Michie, Jo; Ni Mhurchu, Cliona
There is substantial interest in the effects of nutrition labels on consumer food-purchasing behavior. However, conducting randomized controlled trials on the impact of nutrition labels in the real world presents a significant challenge. The Food Label Trial (FLT) smartphone app was developed to enable conducting fully automated trials, delivering intervention remotely, and collecting individual-level data on food purchases for two nutrition-labeling randomized controlled trials (RCTs) in New Zealand and Australia. Two versions of the smartphone app were developed: one for a 5-arm trial (Australian) and the other for a 3-arm trial (New Zealand). The RCT protocols guided requirements for app functionality, that is, obtaining informed consent, two-stage eligibility check, questionnaire administration, randomization, intervention delivery, and outcome assessment. Intervention delivery (nutrition labels) and outcome data collection (individual shopping data) used the smartphone camera technology, where a barcode scanner was used to identify a packaged food and link it with its corresponding match in a food composition database. Scanned products were either recorded in an electronic list (data collection mode) or allocated a nutrition label on screen if matched successfully with an existing product in the database (intervention delivery mode). All recorded data were transmitted to the RCT database hosted on a server. In total approximately 4000 users have downloaded the FLT app to date; 606 (Australia) and 1470 (New Zealand) users met the eligibility criteria and were randomized. Individual shopping data collected by participants currently comprise more than 96,000 (Australia) and 229,000 (New Zealand) packaged food and beverage products. The FLT app is one of the first smartphone apps to enable conducting fully automated RCTs. Preliminary app usage statistics demonstrate large potential of such technology, both for intervention delivery and data collection. Australian
Julie A Luker
Full Text Available Abstract Background The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phase III stroke rehabilitation trial (AVERT. Methods A descriptive qualitative approach was used. We purposively sampled 53 allied health and nursing staff from 19 acute stroke units in Australia, New Zealand and Scotland. Semi-structured interviews were conducted by phone, voice-internet, or face to face. Digitally recorded interviews were transcribed and analysed by two researchers using rigorous thematic analysis. Results Our analysis uncovered ten important themes that provide insight into the challenges of implementing complex new rehabilitation practices within complex care settings, plus factors and strategies that assisted implementation. Themes were grouped into three main categories: staff experience of implementing the trial intervention, barriers to implementation, and overcoming the barriers. Participation in the trial was challenging but had personal rewards and improved teamwork at some sites. Over the years that the trial ran some staff perceived a change in usual care. Barriers to trial implementation at some sites included poor teamwork, inadequate staffing, various organisational barriers, staff attitudes and beliefs, and patient-related barriers. Participants described successful implementation strategies that were built on interdisciplinary teamwork, education and strong leadership to ‘get staff on board’, and developing different ways of working. Conclusions The AVERT stroke rehabilitation trial required commitment to deliver
Køber, Lars; Rustom, Rana; Wiedmann, Jonas
The high morbidity and mortality rates in hemodialysis (HD) patients are due, at least in part, to their increased risk for cardiovascular diseases (CVD). This prospective study evaluated the effect of growth hormone (GH) on a number of CVD risk markers in adult patients on HD....
Höybye, Charlotte; Pfeiffer, Andreas F H; Ferone, Diego
TransCon growth hormone is a sustained release human growth hormone prodrug in development in which unmodified growth hormone is transiently linked to a carrier molecule. It is intended as an alternative to daily growth hormone in the treatment of growth hormone deficiency. This was a multi-cente...
Fitzgibbon, M. L.; Stolley, M. R.; Schiffer, L.; Braunschweig, C. L.; Gomez, S. L.; Van Horn, L.; Dyer, A.
The preschool years offer an opportunity to interrupt the trajectory toward obesity in black children. The Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial was a group-randomized controlled trial assessing the feasibility and effectiveness of a teacher-delivered weight control intervention for black preschool children. The 618 participating children were enrolled in 18 schools administered by the Chicago Public Schools. Children enrolled in the 9 schools randomized to the intervention group received a 14-week weight control intervention delivered by their classroom teachers. Children in the 9 control schools received a general health intervention. Height and weight, physical activity, screen time, and diet data were collected at baseline and post-intervention. At post-intervention, children in the intervention schools engaged in more moderate-to vigorous physical activity than children in the control schools (difference between adjusted group means=7.46 min/day, p=.02). Also, children in the intervention group had less total screen time (−27.8 min/day, p=.05). There were no significant differences in BMI, BMI Z score, or dietary intake. It is feasible to adapt an obesity prevention program to be taught by classroom teachers. The intervention showed positive influences on physical activity and screen time, but not diet. Measuring diet and physical activity in preschool children remains a challenge, and interventions delivered by classroom teachers require both intensive initial training and ongoing individualized supervision. PMID:21193852
Partnering around cancer clinical trials (PACCT): study protocol for a randomized trial of a patient and physician communication intervention to increase minority accrual to prostate cancer clinical trials.
Eggly, Susan; Hamel, Lauren M; Heath, Elisabeth; Manning, Mark A; Albrecht, Terrance L; Barton, Ellen; Wojda, Mark; Foster, Tanina; Carducci, Michael; Lansey, Dina; Wang, Ting; Abdallah, Rehab; Abrahamian, Narineh; Kim, Seongho; Senft, Nicole; Penner, Louis A
Cancer clinical trials are essential for testing new treatments and represent state-of-the-art cancer treatment, but only a small percentage of patients ever enroll in a trial. Under-enrollment is an even greater problem among minorities, particularly African Americans, representing a racial/ethnic disparity in cancer care. One understudied cause is patient-physician communication, which is often of poor quality during clinical interactions between African-American patients and non-African-American physicians. Partnering Around Cancer Clinical Trials (PACCT) involves a transdisciplinary theoretical model proposing that patient and physician individual attitudes and beliefs and their interpersonal communication during racially discordant clinical interactions influence outcomes related to patients' decisions to participate in a trial. The overall goal of the study is to test a multilevel intervention designed to increase rates at which African-American and White men with prostate cancer make an informed decision to participate in a clinical trial. Data collection will occur at two NCI-designated comprehensive cancer centers. Participants include physicians who treat men with prostate cancer and their African-American and White patients who are potentially eligible for a clinical trial. The study uses two distinct research designs to evaluate the effects of two behavioral interventions, one focused on patients and the other on physicians. The primary goal is to increase the number of patients who decide to enroll in a trial; secondary goals include increasing rates of physician trial offers, improving the quality of patient-physician communication during video recorded clinical interactions in which trials may be discussed, improving patients' understanding of trials offered, and increasing the number of patients who actually enroll. Aims are to 1) determine the independent and combined effects of the two interventions on outcomes; 2) compare the effects of the
Robinson, Hayley; Norton, Sam; Jarrett, Paul; Broadbent, Elizabeth
Psychological stress has been shown to delay wound healing. Several trials have investigated whether psychological interventions can improve wound healing, but to date, this evidence base has not been systematically synthesized. The objective was to conduct a systematic review of randomized controlled trials in humans investigating whether psychological interventions can enhance wound healing. A systematic review was performed using PsychINFO, CINAHL, Web of Science, and MEDLINE. The searches included all papers published in English up until September 2016. The reference lists of relevant papers were screened manually to identify further review articles or relevant studies. Nineteen studies met inclusion criteria and were included in the review. Fifteen of nineteen studies were of high methodological quality. Six studies were conducted with acute experimentally created wounds, five studies with surgical patients, two studies with burn wounds, two studies with fracture wounds, and four studies were conducted with ulcer wounds. Post-intervention standardized mean differences (SMD) between groups across all intervention types ranged from 0.13 to 3.21, favouring improved healing, particularly for surgical patients and for relaxation interventions. However, there was some evidence for publication bias suggesting negative studies may not have been reported. Due to the heterogeneity of wound types, population types, and intervention types, it is difficult to pool effect sizes across studies. Current evidence suggests that psychological interventions may aid wound healing. Although promising, more research is needed to assess the efficacy of each intervention on different wound types. Statement of contribution What is already known on this subject? Psychological stress negatively affects wound healing. A number of studies have investigated whether psychological interventions can improve healing. However, no systematic reviews have been conducted. What does this study add
Kalarchian, Melissa A; Marcus, Marsha D; Courcoulas, Anita P; Cheng, Yu; Levine, Michele D
Studies on the impact of presurgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed. To evaluate whether a presurgery behavioral lifestyle intervention improves weight loss through a 24-month postsurgery period. Bariatric Center of Excellence at a large, urban medical center. Candidates for bariatric surgery were randomized to a 6-month behavioral lifestyle intervention or to 6 months of usual presurgical care. The lifestyle intervention consisted of 8 weekly face-to-face sessions, followed by 16 weeks of face-to-face and telephone sessions before surgery; the intervention also included 3 monthly telephone contacts after surgery. Assessments were conducted 6, 12, and 24 months after surgery. Participants who underwent surgery (n = 143) were 90.2% female and 86.7% White. Average age was 44.9 years, and average body mass index was 47.5 kg/m(2) at study enrollment. At follow-up, 131 (91.6%), 126 (88.1%), 117 (81.8%) patients participated in the 6-, 12-, and 24-month assessments, respectively. Percent weight loss from study enrollment to 6 and 12 months after surgery was comparable for both groups, but at 24 months after surgery, the lifestyle group had significantly smaller percent weight loss compared with the usual care group (26.5% versus 29.5%, respectively, P = .02). Presurgery lifestyle intervention did not improve weight loss at 24 months after surgery. The findings from this study raise questions about the utility and timing of adjunctive lifestyle interventions for bariatric surgery patients. Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
Kalarchian, Melissa A.; Marcus, Marsha D.; Courcoulas, Anita P.; Cheng, Yu; Levine, Michele D.
Background Studies of the impact of pre-surgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed. Objective To evaluate whether a pre-surgery behavioral lifestyle intervention improves weight loss through 24-months post-surgery. Setting Bariatric Center of Excellence at a large, urban medical center. Methods Candidates for bariatric surgery were randomized to a 6-month behavioral lifestyle intervention or to 6 months of usual pre-surgical care. The lifestyle intervention consisted of 8 weekly face-to-face sessions followed by 16 weeks of face-to-face and telephone sessions prior to surgery; the intervention also included 3 monthly telephone contacts after surgery. Assessments were conducted at 6-, 12- and 24-months post-surgery. Results Participants who underwent surgery (n = 143) were 90.2% female and 86.7% White. Average age was 44.9 years, and average BMI was 47.5 kg/m2 at study enrollment. At follow-up, 131 (91.6%), 126 (88.1%), 117 (81.8%) patients participated in the 6-, 12- and 24 month assessments, respectively. Percent weight loss from study enrollment to 6- and 12-months post-surgery was comparable for both groups, but at 24-months post-surgery, the lifestyle group had significantly smaller percent weight loss than the usual care group (26.5% vs. 29.5%, respectively, p = 0.02). Conclusions Pre-surgery lifestyle intervention did not improve weight loss at 24 months post-surgery. Findings raise questions about the utility and timing of adjunctive lifestyle interventions for bariatric surgery patients. PMID:26410538
Lind, Teresa; Bernard, Kristin; Ross, Emily; Dozier, Mary
Exposure to early adversity places young children at risk for behavioral, physiological, and emotional dysregulation, predisposing them to a range of long-term problematic outcomes. Attachment and Biobehavioral Catch-up (ABC) is a 10-session intervention designed to enhance children's self-regulatory capabilities by helping parents to behave in nurturing, synchronous, and non-frightening ways. The effectiveness of the intervention was assessed in a randomized clinical trial, with parents who had been referred to Child Protective Services (CPS) for allegations of maltreatment. Parent-child dyads received either the ABC intervention or a control intervention. Following the intervention, children from the ABC intervention (n=56) expressed lower levels of negative affect during a challenging task compared to children from the control intervention (n=61). Copyright © 2014 Elsevier Ltd. All rights reserved.
Zhang, Melvyn W B; Ho, Roger C M
Smartphones and their accompanying applications are currently widely utilized in various healthcare interventions. Prior to the deployment of these tools for healthcare intervention, typically, proof of concept feasibility studies, as well as randomized trials are conducted to determine that these tools are efficacious prior to their actual implementation. In the field of psychiatry, most of the current interventions seek to compare smartphone based intervention against conventional care. There remains a paucity of research evaluating different forms of interventions using a single smartphone application. In the field of nutrition, there has been recent pioneering research demonstrating how a multi-phasic randomized controlled trial could be conducted using a single smartphone application. Despite the innovativeness of the previous smartphone conceptualization, there remains a paucity of technical information underlying the conceptualization that would support a multi-phasic interventional trial. It is thus the aim of the current technical note to share insights into an innovative server design that would enable the delivery of multi-phasic trials.
Full Text Available Abstract Background Depression is common in residents of Residential and Nursing homes (RNHs. It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents. Method OPERA is a cluster randomised controlled trial. RNHs are randomised to one of two groups with interventions lasting 12 months Intervention group: a depression awareness and physical activity training session for care home staff, plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups. The intervention lasts for one year from randomisation, or Control group: a depression awareness training session for care home staff. Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study. Our primary outcome is the prevalence of depressive symptoms, a GDS-15 score of five or more, in all participants at the end of the one year intervention period. Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to randomisation. Other secondary outcomes include, fear of falling, mobility, fractures, pain, cognition, costs and health related quality of life. We aimed to randomise 77 RNHs. Discussion Home recruitment was completed in May 2010; 78 homes have been randomised. Follow up will finish in May 2011 and results will be available late 2011. Trial Registration [ISRCTN: ISRCTN43769277
Lavinia Ferrante di Ruffano
Full Text Available Abstract Background The most rigorous method for evaluating the effectiveness of diagnostic tests is through randomised trials that compare test-treatment interventions: complex interventions comprising episodes of testing, decision-making and treatment. The multi-staged nature of these interventions, combined with the need to relay diagnostic decision-making and treatment planning, has led researchers to hypothesise that test-treatment strategies may be very challenging to document. However, no reviews have yet examined the reporting quality of interventions used in test-treatment RCTs. In this study we evaluate the completeness of intervention descriptions in a systematically identified cohort of test-treatment RCTs. Methods We ascertained all test-treatment RCTs published 2004–2007, indexed in CENTRAL. Included trials randomized patients to diagnostic tests and measured patient outcomes after treatment. Two raters examined the completeness of test-treatment intervention descriptions in four components: 1 the test, 2 diagnostic decision-making, 3 management decision-making, 4 treatments. Results One hundred and three trials compared 105 control with 119 experimental interventions, most commonly in cardiovascular medicine (35, 34%, obstetrics and gynecology (17%, gastroenterology (14% or orthopedics (10%. A broad range of tests were evaluated, including imaging (50, 42%, biochemical assays (21% and clinical assessment (12%. Only five (5% trials detailed all four components of experimental and control interventions, none of which also provided a complete care pathway diagram. Experimental arms were missing descriptions of tests, diagnostic-decision making, management planning and treatments (36%, 51%, 55% and 79% of trials respectively; control arms were missing the same details in 61%, 66%, 67% and 84% of trials. Conclusion Reporting of test-treatment interventions is very poor, inadequate for understanding the results of these trials, and
Sunay, Didem; Ozdiken, Muruvvet; Arslan, Huseyin; Seven, Ali; Aral, Yalcin
Acupuncture is commonly used to treat menopausal symptoms and other gynaecological conditions. In this study, the authors aimed to investigate whether acupuncture has an effect on menopausal symptoms and to explore whether this effect is related to changes in hormone levels. Materials and methods A total of 53 postmenopausal women were alternately assigned into two treatment groups: acupuncture (n=27) and sham acupuncture (n=26). Menopausal symptoms were assessed using the Menopause Rating Scale (MRS). The serum oestradiol, follicular stimulating hormone (FSH) and luteinising hormone (LH) levels were measured at baseline and again after the first and last sessions. The Student t test was used for normally distributed data and the Wilcoxon signed rank test for not normally distributed data. The group differences in MRS scores were assessed using non-parametric Mann-Whitney U test. After treatment, total MRS, and the somatic and psychological subscale scores were significantly lower in the acupuncture group than the sham group (all p=0.001). The severity of hot flushes was found to be significantly decreased after treatment in acupuncture group (p=0.001). In the acupuncture group LH levels were lower and oestradiol levels were significantly higher than sham group (p=0.046 and p=0.045, respectively) after treatment, but there was no difference in FSH levels. Acupuncture was effective in reducing menopausal complaints when compared to sham acupuncture and can be considered as an alternative therapy in the treatment of menopausal symptoms.
Full Text Available Abstract Background Physical activity shows potential in combating the poor outcomes associated with depression in older people. Meta-analyses show gaps in the research with poor trial design compromising certainty in conclusions and few programmes showing sustained effects. Methods/design The Depression in Late Life: an Intervention Trial of Exercise (DeLLITE is a 12 month randomised controlled trial of a physical activity intervention to increase functional status in people aged 75 years and older with depressive symptoms. The intervention involves an individualised activity programme based on goal setting and progression of difficulty of activities delivered by a trained nurse during 8 home visits over 6 months. The control group received time matched home visits to discuss social contacts and networks. Baseline, 6 and 12 months measures were assessed in face to face visits with the primary outcome being functional status (SPPB, NEADL. Secondary outcomes include depressive symptoms (Geriatric Depression Scale, quality of life (SF-36, physical activity (AHS Physical Activity Questionnaire and falls (self report. Discussion Due to report in 2008 the DeLLITE study has recruited 70% of those eligible and tests the efficacy of a home based, goal setting physical activity programme in improving function, mood and quality of life in older people with depressive symptomatology. If successful in improving function and mood this trial could prove for the first time that there are long term health benefit of physical activity, independent of social activity, in this high risk group who consume excess health related costs. Trial registration Australian and New Zealand Clinical Trials Register ACTRN12605000475640
Gonzales, N.A.; Dumka, L.E.; Millsap, R.E.; Gottschall, A.; McClain, D.B.; Wong, J.J.; Germán, M.; Mauricio, A.M.; Wheeler, L.; Carpentier, F.D.; Kim, S.Y.
Objective This randomized trial of a family-focused preventive intervention for Mexican American (MA) adolescents evaluated intervention effects on adolescent substance use, internalizing and externalizing symptoms, and school discipline and grade records in 8th grade, one year after completion of the intervention. The study also examined hypothesized mediators and moderators of intervention effects. Method Stratified by language of program delivery (English vs. Spanish), the trial included a sample of 516 MA adolescents (50.8% female; M =12.3 years, SD=.54) and at least one caregiver that were randomized to receive a low dosage control group workshop or the 9-week group intervention that included parenting, adolescent coping, and conjoint family sessions. Results Positive program effects were found on all five outcomes at one-year posttest, but varied depending on whether adolescents, parents, or teachers reported on the outcome. Intervention effects were mediated by posttest changes in effective parenting, adolescent coping efficacy, adolescent school engagement, and family cohesion. The majority of direct and mediated effects were moderated by language, with a larger number of significant effects for families that participated in Spanish. Intervention effects also were moderated by baseline levels of mediators and outcomes, with the majority showing stronger effects for families with poorer functioning at baseline. Conclusion Findings support the efficacy of the intervention to decrease multiple problem outcomes for MA adolescents, but also demonstrate differential effects for parents and adolescents receiving the intervention in Spanish vs. English, and depending on their baseline levels of functioning. PMID:22103956
Full Text Available Abstract Background Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. Methods A total of 1260 participants from 44 UK worksites (based within 5 organizations were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form and health outcomes were assessed. Results and discussion Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B = -1.79 mm/Hg and resting heart rate (B = -2.08 beats and significantly increased body mass index (B = .18 units compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. Conclusions The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. Trial registration Current controlled trials ISRCTN08807396
Omayma T. El-Shafie
Full Text Available Objectives: Adrenocorticotropic hormone (ACTH overproduction is usually due to a pituitary tumour which is often not visible on magnetic resonance imaging (MRI. However, ACTH overproduction may be due to an ectopic source. This study aimed to develop a simple non-invasive technique to differentiate these sources. Methods: This study took place in King Faisal Specialist Hospital & Research Centre, Riyadh, Saudi Arabia, and Sultan Qaboos University Hospital, Muscat, Oman, between 1988 and 2012. Serum cortisol levels were measured in nine patients with ACTH-dependent Cushing’s syndrome before and during a 72-hour trial of octreotide. All patients underwent computed tomography (CT scans. MRI scans were performed on six patients. Results: CT scans were abnormal in three patients with ectopic ACTH production. MRI scans showed that three patients had pituitary microadenomas. Serum cortisol levels returned to normal in those with confirmed ectopic ACTH production. No response was found in the other six patients. Conclusion: A 72-hour trial of octreotide is recommended for patients with ACTH-dependent Cushing’s syndrome and a normal pituitary MRI. This trial will be a useful alternative to petrosal sinus sampling.
Pigeot, I; Baranowski, T; De Henauw, S
One of the major research dimensions of the Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS (IDEFICS) study involved the development, implementation and evaluation of a setting-based community-oriented intervention programme for primary prevention of childhood obesity. In this supplement of Obesity Reviews, a compilation of key results of the IDEFICS intervention is packaged in a series of complementary papers. This paper describes the overall design and methods of the IDEFICS intervention in order to facilitate a comprehensive reading of the supplement. In addition, some 'best practice' examples are described. The IDEFICS intervention trial was conducted to assess whether the IDEFICS intervention prevented obesity in young children aged 2 to 9.9 years. The study was a non-randomized, quasi-experimental trial with one intervention matched to one control region in each of eight participating countries. The intervention was designed following the intervention mapping framework, using a socio-ecological theoretical approach. The intervention was designed to address several key obesity-related behaviours in children, parents, schools and community actors; the primary outcome was the prevalence of overweight/obesity according to the IOTF criteria based on body mass index. The aim was to achieve a reduction of overweight/obesity prevalence in the intervention regions. The intervention was delivered in school and community settings over a 2-year period. Data were collected in the intervention and control cohort regions at baseline and 2 years later. This paper offers an introductory framework for a comprehensive reading of this supplement on IDEFICS intervention key results. © 2015 World Obesity.
Kahn, Richard; Bonuck, Karen; Trombley, Michelle
Inappropriate baby bottle use is associated with tooth decay, anemia, and overweight, and it may adversely affect dietary patterns. Parents often do not follow guidance to wean by 18 months of life. We piloted a brief, counseling-based weaning intervention in an urban WIC agency among primarily Hispanic parent/toddler dyads. At baseline (n = 48), toddlers consumed a mean 4.7 bottles/day. At follow-up (n = 39), the intervention group consumed fewer mean bottles/day than controls (0.09 vs 2.0 bottles/day, P < .045). Half the toddlers in the experimental group and one third of the control groups weaned completely. Parents of weaned children were satisfied with the outcome.
Karen J. Sherman
Full Text Available Little guidance is available to assist researchers in developing treatment protocols for research on yoga for health concerns. Because yoga is a complex multifactorial mind-body discipline historically developed for nonmedical purposes, numerous decisions must be made in order to thoughtfully develop such protocols. In this paper, a systematic approach is proposed to assist researchers in selecting an intervention that is appropriate for the condition under consideration and explicitly developed. Researchers need to consider the type or “style” of yoga, the components to include (e.g., breathing exercises, postures as well as the specific protocol for each component, the dose to be delivered (frequency, duration of practice, and the total duration of practice, and issues related to selection of instructors and monitoring the fidelity to the intervention. Each of these domains and the key issues for the development of protocols is discussed. Finally, some areas for further research related to protocol development are recommended.
Full Text Available Abstract Background Increasing evidence suggests the bidirectional interplay between parathyroid hormone and aldosterone as an important mechanism behind the increased risk of cardiovascular damage and bone disease observed in primary hyperparathyroidism. Our primary object is to assess the efficacy of the mineralocorticoid receptor-blocker eplerenone to reduce parathyroid hormone secretion in patients with parathyroid hormone excess. Methods/design Overall, 110 adult male and female patients with primary hyperparathyroidism will be randomly assigned to eplerenone (25 mg once daily for 4 weeks and 4 weeks with 50 mg once daily after dose titration] or placebo, over eight weeks. Each participant will undergo detailed clinical assessment, including anthropometric evaluation, 24-h ambulatory arterial blood pressure monitoring, echocardiography, kidney function and detailed laboratory determination of biomarkers of bone metabolism and cardiovascular disease. The study comprises the following exploratory endpoints: mean change from baseline to week eight in (1 parathyroid hormone(1–84 as the primary endpoint and (2 24-h systolic and diastolic ambulatory blood pressure levels, NT-pro-BNP, biomarkers of bone metabolism, 24-h urinary protein/albumin excretion and echocardiographic parameters reflecting systolic and diastolic function as well as cardiac dimensions, as secondary endpoints. Discussion In view of the reciprocal interaction between aldosterone and parathyroid hormone and the potentially ensuing target organ damage, the EPATH trial is designed to determine whether eplerenone, compared to placebo, will effectively impact on parathyroid hormone secretion and improve cardiovascular, renal and bone health in patients with primary hyperparathyroidism. Trial registration ISRCTN33941607
Symon, Andrew; Pringle, Jan; Downe, Soo; Hundley, Vanora; Lee, Elaine; Lynn, Fiona; McFadden, Alison; McNeill, Jenny; Renfrew, Mary J; Ross-Davie, Mary; van Teijlingen, Edwin; Whitford, Heather; Alderdice, Fiona
Antenatal care models vary widely around the world, reflecting local contexts, drivers and resources. Randomised controlled trials (RCTs) have tested the impact of multi-component antenatal care interventions on service delivery and outcomes in many countries since the 1980s. Some have applied entirely new schemes, while others have modified existing care delivery approaches. Systematic reviews (SRs) indicate that some specific antenatal interventions are more effective than others; however the causal mechanisms leading to better outcomes are poorly understood, limiting implementation and future research. As a first step in identifying what might be making the difference we conducted a scoping review of interventions tested in RCTs in order to establish a taxonomy of antenatal care models. A protocol-driven systematic search was undertaken of databases for RCTs and SRs reporting antenatal care interventions. Results were unrestricted by time or locality, but limited to English language. Key characteristics of both experimental and control interventions in the included trials were mapped using SPIO (Study design; Population; Intervention; Outcomes) criteria and the intervention and principal outcome measures were described. Commonalities and differences between the components that were being tested in each study were identified by consensus, resulting in a comprehensive description of emergent models for antenatal care interventions. Of 13,050 articles retrieved, we identified 153 eligible articles including 130 RCTs in 34 countries. The interventions tested in these trials varied from the number of visits to the location of care provision, and from the content of care to the professional/lay group providing that care. In most studies neither intervention nor control arm was well described. Our analysis of the identified trials of antenatal care interventions produced the following taxonomy: Universal provision model (for all women irrespective of health state or
Anthon, Carl Thomas; Granholm, Anders; Perner, Anders
INTRODUCTION: Evidence exists that unblinded randomised clinical trials (RCTs) overestimate intervention effects compared with blinded RCTs. It has been suggested that this is less pronounced for objective (ie, not subject to interpretation) outcome measures, including mortality. This may not app...... in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement and submit the final paper to an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: PROSPERO, registration number: CRD42017056212....
Osrin, D.; Azad, K.; Fernandez, A.; Manandhar, D. S.; Mwansambo, C. W.; Tripathy, P.; Costello, A. M.
Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common ...
Hopewell, S; McDonald, S; Clarke, M; Egger, M
The inclusion of grey literature (i.e. literature that has not been formally published) in systematic reviews may help to overcome some of the problems of publication bias, which can arise due to the selective availability of data. To review systematically research studies, which have investigated the impact of grey literature in meta-analyses of randomized trials of health care interventions. We searched the Cochrane Methodology Register (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to 20 May 2005), the Science Citation Index (June 2005) and contacted researchers who may have carried out relevant studies. A study was considered eligible for this review if it compared the effect of the inclusion and exclusion of grey literature on the results of a cohort of meta-analyses of randomized trials. Data were extracted from each report independently by two reviewers. The main outcome measure was an estimate of the impact of trials from the grey literature on the pooled effect estimates of the meta-analyses. Information was also collected on the area of health care, the number of meta-analyses, the number of trials, the number of trial participants, the year of publication of the trials, the language and country of publication of the trials, the number and type of grey and published literature, and methodological quality. Five studies met the inclusion criteria. All five studies showed that published trials showed an overall greater treatment effect than grey trials. This difference was statistically significant in one of the five studies. Data could be combined for three of the five studies. This showed that, on average, published trials showed a 9% greater treatment effect than grey trials (ratio of odds ratios for grey versus published trials 1.09; 95% CI 1.03-1.16). Overall there were more published trials included in the meta-analyses than grey trials (median 224 (IQR 108-365) versus 45(IQR 40-102)). Published trials had more participants on average. The most
Kopple, J.D.; Cheung, A.K.; Christiansen, J.S.
, uncontrolled hypertension, chronic use of high-dose glucocorticoids, or immunosuppressive agents and pregnancy. CONCLUSIONS: The OPPORTUNITY Trial is the first large-scale randomized clinical trial in adult MHD patients evaluating the response to GH of such clinical endpoints as mortality, morbidity, markers...... human GH injections, compared with placebo, improve survival in hypoalbuminemic MHD patients. Secondary hypotheses are that GH improves morbidity and health, including number of hospitalized days, time to cardiovascular events, LBM, serum protein and inflammatory marker levels, exercise capacity...
Mauriac, L.; Keshaviah, A; Debled, M; Mouridsen, H; Forbes, Jf; Thürlimann, B; Paridaens, R; Monnier, A.; Láng, I.; Wardley, A; Nogaret, J-M; Gelber, RD; Castiglione-Gertsch, M.; Price, KN; Coates, AS
Background: Aromatase inhibitors are considered standard adjuvant endocrine treatment of postmenopausal women with hormone receptor-positive breast cancer, but it remains uncertain whether aromatase inhibitors should be given upfront or sequentially with tamoxifen. Awaiting results from ongoing randomized trials, we examined prognostic factors of an early relapse among patients in the BIG 1-98 trial to aid in treatment choices. Patients and methods: Analyses included all 7707 eligible patient...
Ravaud, Alain; Hawkins, Robert; Gardner, Jason P
of metastatic sites--were randomly assigned to lapatinib 1,250 mg daily or HT. The primary end point was time to progression (TTP); secondary end points included overall survival (OS), safety, and biomarker analyses. RESULTS: Four hundred sixteen patients were enrolled onto the study. Median TTP was 15.3 weeks......PURPOSE: Lapatinib is an orally reversible inhibitor of epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor 2 (HER-2) tyrosine kinases with demonstrated activity in patients with HER-2-positive breast cancer. In the current phase III open-label trial, lapatinib...... was compared with hormone therapy (HT) in patients with advanced renal cell carcinoma (RCC) that express EGFR and/or HER-2. PATIENTS AND METHODS: Patients with advanced RCC who had experienced disease progression through first-line cytokine therapy--stratified by Karnofsky performance status and number...
Doss, Brian D.; Cicila, Larisa N.; Hsueh, Annie C.; Morrison, Kristen R.; Carhart, Kathryn
The transition to parenthood has been repeatedly identified as a stressful period, with couples reporting difficulties in domains of individual, coparenting, and relationship functioning. Moreover, these difficulties have been shown to impact children’s development. To buffer against these difficulties, numerous effective parenting, couple, and combined interventions have been developed; however, these interventions are typically lengthy, which limits their potential for dissemination. Therefore, in the present study, we developed and tested separate six-hour interventions that focused exclusively on improving either coparenting or relationship functioning. In a randomized control trial, 90 heterosexual couples (180 individuals) were randomly assigned to an information control group, a coparenting intervention, or a relationship intervention and assessed on seven occasions during the two years following birth. Results revealed that women and high-risk men in both the couple and coparenting interventions showed fewer declines in relationship satisfaction (Cohen’s d = 0.53–0.99) and other areas of relationship functioning. Women also reported improved coparenting in both intervention groups (Cohen’s d = 0.47–1.06). Additionally, women in both interventions experienced less perceived stress during the first year after birth. Given similar effects of the two interventions on coparenting and relationship functioning, future dissemination may be enhanced by delivery of coparenting interventions, as coparenting (compared to relationship) interventions seem to attract more interest from couples and are likely easier to integrate into existing services. PMID:25090255
The effect of vitamin D supplementation in combination with low-calorie diet on anthropometric indices and androgen hormones in women with polycystic ovary syndrome: a double-blind, randomized, placebo-controlled trial.
Jafari-Sfidvajani, S; Ahangari, R; Hozoori, M; Mozaffari-Khosravi, H; Fallahzadeh, H; Nadjarzadeh, A
Polycystic ovary syndrome (PCOS) is known as the most common endocrine disorder in reproductive age women. The aim of this studywas to evaluate the effects of vitamin D supplementation in combination with low-calorie diet on anthropometric indices, reproductive hormones and menstrual regularity in overweight and obese PCOS women. In this randomized controlled clinical trial, 60 PCOS women with vitamin D insufficiency were randomly assigned to 12 weeks of either (1) weight-loss intervention + 50,000 IU/week oral vitamin D3 or (2) weight-loss intervention + placebo. At the beginning and end of the study, the anthropometric indices, body composition, 25-hydroxyvitamin D, total testosterone, dehydroepiandrosterone sulfate (DHEAS), sex hormone-binding globulin (SHBG) and free androgen index (FAI) were measured and regularity of menses was compared among the two groups. After 12-week intervention, median of serum 25-hydroxyvitamin D3 significantly increased from 18.5 (10.75-20) ng/ml to 42.69 (34-53.25) ng/ml in vitamin D group compared to placebo group (p PCOS, androgen profile did not change with vitamin D supplementation when combined with low-calorie diet, but menstrual frequency significantly improved. IRCT2016062710826N19.
Figueiras, Maria João; Maroco, João; Monteiro,Rita; Caeiro, Raúl; Neto, David Dias
There is converging evidence that changing beliefs about an illness leads to positive recovery outcomes. However, cardiac misconceptions interventions have been investigated mainly in Angina or Coronary Heart Disease patients, and less in patients following Myocardial Infarction (MI). In these patients, cardiac misconceptions may play a role in the adjustment or lifestyle changes. This article reports a randomized controlled trial of an intervention designed to reduce the strength of misconce...
Powell, John; Newhouse, Nikki; Martin, Angela; Jawad, Sena; Yu, Ly-Mee; Davoudianfar, Mina; Locock, Louise; Ziebland, Sue
The internet is frequently used to share experiences of health and illness, but this phenomenon has not been harnessed as an intervention to achieve health behaviour change. The aim of this study was to determine the feasibility of a randomised trial assessing the effects of a novel, experience-based website as a smoking cessation intervention. The secondary aim was to measure the potential impact on smoking behaviour of both the intervention and a comparator website. A feasibility randomised controlled single-blind trial assessed a novel, experience-based website containing personal accounts of quitting smoking as a cessation intervention, and a comparator website providing factual information. Feasibility measures including recruitment, and usage of the interventions were recorded, and the following participant-reported outcomes were also measured: Smoking Abstinence Self-Efficacy Questionnaire, the single-item Motivation to Stop Scale, self-reported abstinence, quit attempts and health status outcomes. Eligible smokers from two English regions were entered into the trial and given access to their allocated website for two weeks. Eighty-seven smokers were randomised, 65 completed follow-up (75 %). Median usage was 15 min for the intervention, and 5 min for the comparator (range 0.5-213 min). Median logins for both sites was 2 (range 1-20). All participant-reported outcomes were similar between groups. It was technically feasible to deliver a novel intervention harnessing the online sharing of personal experiences as a tool for smoking cessation, but recruitment was slow and actual use was relatively low, with attrition from the trial. Future work needs to maximize engagement and to understand how best to assess the value of such interventions in everyday use, rather than as an isolated 'dose of information'. ISRCTN29549695 DOI 10.1186/ISRCTN29549695 . Registered 17/05/2013.
Briley, Annette L; Barr, Suzanne; Badger, Shirlene; Bell, Ruth; Croker, Helen; Godfrey, Keith M.; Holmes, Bridget; Kinnunen, Tarja I.; Nelson, Scott N.; Oteng-Ntim, Eugene; Patel, Nashita; Robson, Stephen C.; Sandall, Jane; Sanders, Thomas; Sattar, Naveed
Background:\\ud Despite the widespread recognition that obesity in pregnant women is associated with adverse outcomes for mother and child, there is no intervention proven to reduce the risk of these complications. The primary aim of this randomised controlled trial is to assess in obese pregnant women, whether a complex behavioural intervention, based on changing diet (to foods with a lower glycemic index) and physical activity, will reduce the risk of gestational diabetes (GDM) and delivery ...
Dieng, Mbathio; Kasparian, NA; Mireskandari, Shab; Butow, Phyllis; Costa, Daniel; Morton, Rachael; Mann, Graham; Menzies, Scott; Cust, Anne
Introduction Information and psychological needs have been reported as one of the greatest areas of unmet needs for patients with melanoma. To respond to these needs, we developed the Melanoma Care Intervention, a developed psychoeducational intervention for people at high risk of developing another melanoma comprising of a newly developed melanoma educational booklet and individually tailored telephone support sessions provided by trained psychologists. The purpose of this study was to investigate the acceptability and feasibility of the Melanoma Care Intervention. Methods Twenty-four adults (14 men, 10 women, mean age: 58 years, SD: 12.2) at high risk of developing a subsequent primary melanoma were recruited and randomly assigned 1:1 to the intervention (a psychoeducational booklet, a Cancer Council booklet on melanoma and up to five telephone-based sessions with a psychologist) or usual care (Cancer Council booklet only). Acceptability, feasibility, fear of cancer recurrence and secondary psychosocial outcomes were assessed at baseline, 1 and 6 months. Results Satisfaction and perceived benefits were rated highly for all intervention components, particularly the telephone-based psychology sessions (mean satisfaction and benefits: both 9.27 out of 10, SD=2.41). The quality of information and support provided throughout the trial was rated as ‘high’ by the intervention group, with a mean score of 4.6 out of a possible 5 (SD=0.9) and 4.2 (SD=1.2) for the control group. Conclusions The intervention was feasible and acceptable for improving psychological adjustment. Timely access to effective, evidence-based, psychological care is a recognised need for people with melanoma. The intervention is designed to directly address this need in a way that is feasible in a clinical setting, acceptable to patients and health professionals. Trial registration number The trial was registered with the Australian and New Zealand Clinical Trials Registry on 19
Melnick, Alan L; Rdesinski, Rebecca E; Marino, Miguel; Jacob-Files, Elizabeth; Gipson, Teresa; Kuyl, Marni; Dexter, Eve; Olds, David
Women frequently experience barriers to obtaining effective contraceptives from clinic-based providers. Allowing nurses to dispense hormonal methods during home visits may be a way to reduce barriers and improve -effective contraceptive use. Between 2009 and 2013, a sample of 337 low-income, pregnant clients of a nurse home-visit program in Washington State were randomly selected to receive either usual care or enhanced care in which nurses were permitted to provide hormonal contraceptives postpartum. Participants were surveyed at baseline and every three months postpartum for up to two years. Longitudinal Poisson mixed-effects regression analysis was used to examine group differences in gaps in effective contraceptive use, and survival analysis was used to examine time until a subsequent pregnancy. Compared with usual care participants, enhanced care participants had an average of 9.6 fewer days not covered by effective contraceptive use during the 90 days following a first birth (52.6 vs. 62.2). By six months postpartum, 50% of usual care participants and 39% of enhanced care participants were using a long-acting reversible contraceptive (LARC). In analyses excluding LARC use, enhanced care participants had an average of 14.2 fewer days not covered by effective contraceptive use 0-3 months postpartum (65.0 vs. 79.2) and 15.7 fewer uncovered days 4-6 months postpartum (39.2 vs. 54.9). Home dispensing of hormonal contraceptives may improve women's postpartum contraceptive use and should be explored as an intervention in communities where contraceptives are not easily accessible. Copyright © 2016 by the Guttmacher Institute.
Okesene-Gafa, Karaponi; Li, Minglan; Taylor, Rennae S; Thompson, John M D; Crowther, Caroline A; McKinlay, Christopher J D; McCowan, Lesley M E
Maternal obesity is associated with adverse pregnancy outcomes and has lifelong negative implications for offspring health. The Institute of Medicine recommends limited gestational weight gain (GWG) in obese women for optimal maternal and infant outcomes. However, there is a gap regarding an effective and sustainable intervention strategy to achieve this goal. The aim of the healthy mums and babies (HUMBA) demonstration trial is to assess whether a multifaceted nutritional intervention and/or an oral probiotic treatment in obese pregnant women can reduce excessive GWG and optimise pregnancy outcomes. The study is a two by two factorial randomised controlled demonstration trial conducted in Counties Manukau health region, New Zealand, a multi-ethnic region with a high prevalence of obesity. A total of 220 non-diabetic obese women with a singleton pregnancy will be recruited between 12 0 and 17 6 weeks. At recruitment, women are randomised to receive either a culturally tailored multifaceted dietary intervention or routine dietary advice, and either an oral probiotic or placebo capsule. Randomisation is undertaken via a web-based protocol, randomize.net, with a 1:1 ratio using stratification by body mass index (BMI) category (BMI of 30-34.9 or BMI ≥35 kg/m 2 ). The dietary intervention includes 4 customised nutrition education visits by a trained community health worker combined with motivational text messaging. Probiotic capsules consist of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 at a dose of 7 × 10 9 colony-forming units one per day until birth. Probiotic and placebo capsules are identically pre-packed and labelled by a third party, and are prescribed in a double blinded fashion. Research assessments are conducted at enrolment, 28 weeks, 36 weeks, at birth and at 5 months post-delivery. The primary outcomes for the study are proportion of women with excessive GWG and infant birthweight. The HUMBA demonstration trial will assess the
Underwood, Martin; Eldridge, Sandra; Lamb, Sallie; Potter, Rachel; Sheehan, Bartley; Slowther, Anne-Marie; Taylor, Stephanie; Thorogood, Margaret; Weich, Scott
Depression is common in residents of Residential and Nursing homes (RNHs). It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents. OPERA is a cluster randomised controlled trial. RNHs are randomised to one of two groups with interventions lasting 12 months. INTERVENTION GROUP: a depression awareness and physical activity training session for care home staff, plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups. The intervention lasts for one year from randomisation, or a depression awareness training session for care home staff.Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study. Our primary outcome is the prevalence of depressive symptoms, a GDS-15 score of five or more, in all participants at the end of the one year intervention period. Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to randomisation. Other secondary outcomes include, fear of falling, mobility, fractures, pain, cognition, costs and health related quality of life. We aimed to randomise 77 RNHs. Home recruitment was completed in May 2010; 78 homes have been randomised. Follow up will finish in May 2011 and results will be available late 2011. [ISRCTN: ISRCTN43769277].
Background Cigarette smoking is the major risk factor for chronic obstructive pulmonary disease (COPD). But a fewer smoking cessation measures were conducted in communities for smokers with COPD in China. The aim of our study was to assess the preventive effects of behavioral interventions for smoking cessation and potential impact factors in smokers with COPD in China. Methods In a randomised controlled smoking cessation trial 3562 patients with COPD who were current smoker were allocated to intervention group received behavioral intervention and control group received the usual care for two years. The primary efficacy endpoint was the complete and continuous abstinence from smoking from the beginning of month 24 to the end of month 30. Participants were followed up at month 48. Results Continuous smoking abstinence rates from month 24 to 30 were significantly higher in participants receiving behavioral intervention than in those receiving usual care (46.4% vs 3.4%, p intervention than in those control group. Family members or family physicians/nurses smoking were first identified to influence smoking cessation. Conclusions Behavioral intervention doubled the smoking cessation rate in patients with COPD and was complied well by the general practitioners. The family members and family physicians/nurses smoking were the main risk factors for smoking cessation. Trial registration Chinese Clinical Trials Registration (ChiCTR-TRC-12001958). PMID:23802809
Müssener, Ulrika; Bendtsen, Marcus; Karlsson, Nadine; White, Ian R; McCambridge, Jim; Bendtsen, Preben
Most smoking efforts targeting young people have so far been focused on prevention of initiation, whereas smoking cessation interventions have largely been targeted towards adult populations. Thus, there is limited evidence for effective smoking cessation interventions in young people, even though many young people want to quit smoking. Mobile communication technology has the potential to reach large numbers of young people and recent text-based smoking cessation interventions using phones have shown promising results. The study aims to evaluate a newly developed text-based smoking cessation intervention for students in colleges and universities in Sweden. The design is a randomised controlled trial (RCT) with a delayed/waiting list intervention control condition. The trial will be performed simultaneously in all colleges and universities served by 25 student health care centres in Sweden. Outcomes will be evaluated after 4 months, with 2 cessation primary outcomes and 4 secondary outcomes. After outcome evaluation the control group will be given access to the intervention. The study will examine the effectiveness of a stand-alone SMS text-based intervention. The intervention starts with a motivational phase in which the participants are given an opportunity to set a quit date within 4 weeks of randomisation. This first phase and the subsequent core intervention phase of 12 weeks are totally automated in order to easily integrate the intervention into the daily routines of student and other health care settings. As well as providing data for the effectiveness of the intervention, the study will also provide data for methodological analyses addressing a number issues commonly challenging in Internet-based RCTs. For example, an extensive follow-up strategy will be used in order to evaluate the use of repeated attempts in the analysis, and in particular to explore the validity of a possible missing not at random assumption that the odds ratio between the primary
Normansell, Rebecca; Holmes, Rebecca; Victor, Christina; Cook, Derek G; Kerry, Sally; Iliffe, Steve; Ussher, Michael; Fox-Rushby, Julia; Whincup, Peter; Harris, Tess
Trials in primary care to increase physical activity (PA) typically experience poor recruitment rates and may not recruit those with lower PA levels and who are most in need of the intervention. Despite the well-publicised benefits of physical activity, the majority of adults in the UK remain inactive and, therefore, at greater risk of many health problems. Our aim was to investigate the reasons for non-participation in the PACE-UP trial, which is a primary care pedometer-based walking intervention. This is important for successful recruitment and retention in future PA trials and programmes. We conducted semi-structured audio-recorded telephone interviews with 30 participants, aged 45-75 years, purposively sampled from those declining participation in the PACE-UP trial. Recruitment continued until data saturation and a demographically balanced sample was achieved. Interviews were transcribed verbatim, coded and subjected to thematic analysis. Interviewees supported walking as suitable exercise for most people in this age group, recognised the importance of this type of research and general practice as an appropriate setting. Key reasons for declining were: the perception of being already 'too active'; existing medical conditions; work; travel and other commitments. Less frequently cited reasons included reluctance to be randomised, the intervention's duration, wearing a pedometer, perceived inappropriateness of trial literature and a preference for a different kind of PA or for a group activity. Whilst most interviewees perceived themselves to be sufficiently active, an important minority did not participate due to existing medical conditions and other commitments. Recruitment to future PA trials might be improved by tailoring activity to compensate for medical problems, and adapting PA interventions to fit around work and travel commitments. Ensuring that patient-targeted literature is succinct and inclusive and that equipment is user-friendly are also important
Full Text Available Abstract Background Mother's diet during pregnancy is important, since plant lignans and their metabolites, converted by the intestinal microflora to enterolignans, are proposed to possess multiple health benefits. Aim of our study was to investigate whether a dietary intervention affects lignan concentrations in the serum of pregnant women. Methods A controlled dietary intervention trial including 105 first-time pregnant women was conducted in three intervention and three control maternity health clinics. The intervention included individual counseling on diet and on physical activity, while the controls received conventional care. Blood samples were collected on gestation weeks 8-9 (baseline and 36-37 (end of intervention. The serum levels of the plant lignans 7-hydroxymatairesinol, secoisolariciresinol, matairesinol, lariciresinol, cyclolariciresinol, and pinoresinol, and of the enterolignans 7-hydroxyenterolactone, enterodiol, and enterolactone, were measured using a validated method. Results The baseline levels of enterolactone, enterodiol and the sum of lignans were higher in the control group, whereas at the end of the trial their levels were higher in the intervention group. The adjusted mean differences between the baseline and end of the intervention for enterolactone and the total lignan intake were 1.6 ng/ml (p = 0.018, 95% CI 1.1-2.3 and 1.4 ng/mg (p = 0.08, 95% CI 1.0-1.9 higher in the intervention group than in the controls. Further adjustment for dietary components did not change these associations. Conclusion The dietary intervention was successful in increasing the intake of lignan-rich food products, the fiber consumption and consequently the plasma levels of lignans in pregnant women. Trial registration ISRCTN21512277, http://www.isrctn.org
Full Text Available Abstract Background Human papillomavirus (HPV infection has been causally linked to six cancers, and many disproportionately affect minorties. This study reports on the development and effectiveness of an intervention aimed at increasing HPV vaccine uptake among African American and Hispanic pediatric patients in safety-net clinics. Methods Formative research, community engagement, and theory guided development of the intervention. A clustered, non-randomized controlled pragmatic trial was conducted in four clinics providing healthcare for the underserved in Tennessee, U.S., with two intervention sites and two usual care sites. Patients aged 9-18 years (N = 408 and their mothers (N = 305 enrolled, with children clustered within families. The intervention consisted of two provider/staff training sessions and provision of patient education materials, consisting of a video/flyer promoting HPV vaccine. Medical records were reviewed before/after the initial visit and after 12 months. Results At the initial visit, provision of patient education materials and provider recommendation were higher at intervention sites versus usual care sites, and receipt of HPV vaccine was higher at intervention sites (45.4% versus 32.9% but not significantly after adjusting for patient’s age and mother’s education. Provider recommendation, but not education materials, increased the likelihood of vaccine receipt at the initial visit, although over one-third of intervention mothers cited the flyer/video as motivating vaccination. Completion of the 3-dose series at follow-up was lower in the intervention arm. Conclusions Future interventions should combine patient education, intensive provider/staff education, and patient reminders. Research should compare patient education focusing on HPV vaccine only versus all adolescent vaccines. Trial registration Retrospectively registered with ClinicalTrials.gov NCT02808832 , 9/12/16
Owen, Jason E; O'Carroll Bantum, Erin; Pagano, Ian S; Stanton, Annette
Web and mobile technologies appear to hold promise for delivering evidence-informed and evidence-based intervention to cancer survivors and others living with trauma and other psychological concerns. Health-space.net was developed as a comprehensive online social networking and coping skills training program for cancer survivors living with distress. The purpose of this study was to evaluate the effects of a 12-week social networking intervention on distress, depression, anxiety, vigor, and fatigue in cancer survivors reporting high levels of cancer-related distress. We recruited 347 participants from a local cancer registry and internet, and all were randomized to either a 12-week waiting list control group or to immediate access to the intervention. Intervention participants received secure access to the study website, which provided extensive social networking capabilities and coping skills training exercises facilitated by a professional facilitator. Across time, the prevalence of clinically significant depression symptoms declined from 67 to 34 % in both conditions. The health-space.net intervention had greater declines in fatigue than the waitlist control group, but the intervention did not improve outcomes for depression, trauma-related anxiety symptoms, or overall mood disturbance. For those with more severe levels of anxiety at baseline, greater engagement with the intervention was associated with higher levels of symptom reduction over time. The intervention resulted in small but significant effects on fatigue but not other primary or secondary outcomes. Results suggest that this social networking intervention may be most effective for those who have distress that is not associated with high levels of anxiety symptoms or very poor overall psychological functioning. The trial was registered with the ClinicalTrials.gov database ( ClinicalTrials.gov #NCT01976949).
Madurasinghe, V W; Sohanpal, Ratna; James, Wai; Steed, Liz; Eldridge, Sandra; Taylor, Sjc; Griffiths, C; Walton, Robert
UK government policy aims to strengthen the role of community pharmacies in health promotion. Thus, we conducted feasibility studies for an intervention to enhance delivery of the NHS Smoking Cessation Service. The overall aims were to assess acceptability and feasibility of conducting the intervention in community pharmacies and piloting this with a cluster randomised trial. Specific objectives were (1) to estimate likely participation rates of pharmacies and stop smoking advisors, (2) to establish the potential impact of the training intervention on throughput and retention of smokers in smoking services, (3) to establish potential impact on smoking cessation outcomes, (4) to optimise logistics for conducting a cluster randomised trial in the next phase of the research programme and (5) to consider the feasibility of collecting pharmacy and service user data. In this cluster randomised parallel group pilot trial, 12 community pharmacies in East London were allocated to intervention or usual practice using simple randomisation (allocation ratio 2:1). Data were analysed descriptively. Twelve of 54 (22.2%, 95% CI 12.0% to 35.6%) pharmacies and 20 of 23 (87.0%, 95% CI 66.4% to 97.2%) advisors invited, agreed to participate. Over 5 months, 302 smokers in intervention pharmacies (mean per pharmacy 43.1, 95% CI: -4.3 to 90.5) and 319 in usual practice pharmacies (mean per pharmacy 79.8, 95% CI: 19.0 to 140.5) joined the service. 51 of 621 smokers (6.3% in intervention vs 10.0% in usual practice) consented to provide additional data on smoking cessation. 17 of 19 smokers that consented were retained at 4 weeks in intervention arm (89.5%, 95% CI: 66.9% to 98.7%) and 24 of 32 in usual practice (75.0%, 95% CI: 56.6% to 88.5%). 10 of 19 in the intervention arm (52.6%, 95% CI: 28.9% to 75.6%) stopped smoking compared to 7 of 32 in usual practice arm (21.9%, 95% CI: 9.3% to 40.0%). The pilot was useful in providing insights on how best to conduct the definitive trial and
Wangberg, Silje C; Nilsen, Olav; Antypas, Konstantinos; Gram, Inger Torhild
Studies suggest that tailored materials are superior to nontailored materials in supporting health behavioral change. Several trials on tailored Internet-based interventions for smoking cessation have shown good effects. There have, however, been few attempts to isolate the effect of the tailoring component of an Internet-based intervention for smoking cessation and to compare it with the effectiveness of the other components. The study aim was to isolate the effect of tailored emails in an Internet-based intervention for smoking cessation by comparing two versions of the intervention, with and without tailored content. We conducted a two-arm, randomized controlled trial of the open and free Norwegian 12-month follow-up, fully automated Internet-based intervention for smoking cessation, slutta.no. We collected information online on demographics, smoking, self-efficacy, use of the website, and participant evaluation at enrollment and subsequently at 1, 3, and 12 months. Altogether, 2298 self-selected participants aged 16 years or older registered at the website between August 15, 2006 and December 7, 2007 and were randomly assigned to either a multicomponent, nontailored Internet-based intervention for smoking cessation (control) or a version of the same Internet-based intervention with tailored content delivered on the website and via email. Of the randomly assigned participants, 116 (of 419, response rate = 27.7%) in the intervention group and 128 (of 428, response rate = 29.9%) in the control group had participated over the 12 months and responded at the end of follow-up. The 7-day intention-to-treat abstinence rate at 1 month was 15.2% (149/982) among those receiving the tailored intervention, compared with 9.4% (94/999) among those who received the nontailored intervention (P Internet-based intervention for smoking cessation seems to increase the success rates in the short term, but not in the long term.
Turrisi, Rob; Larimer, Mary E; Mallett, Kimberly A; Kilmer, Jason R; Ray, Anne E; Mastroleo, Nadine R; Geisner, Irene Markman; Grossbard, Joel; Tollison, Sean; Lostutter, Ty W; Montoya, Heidi
The current study is a multisite randomized alcohol prevention trial to evaluate the efficacy of both a parenting handbook intervention and the Brief Alcohol Screening and Intervention for College Students (BASICS) intervention, alone and in combination, in reducing alcohol use and consequences among a high-risk population of matriculating college students (i.e., former high school athletes). Students (n = 1,275) completed a series of Web-administered measures at baseline (in the summer before starting college) and follow-up (after 10 months). Students were randomized to one of four conditions: parent intervention only, BASICS only, combined (parent and BASICS), and assessment-only control. Intervention efficacy was tested on a number of outcome measures, including peak blood alcohol concentration, weekly and weekend drinking, and negative consequences. Hypothesized mediators and moderators of intervention effect were tested. The overall results revealed that the combined-intervention group had significantly lower alcohol consumption, high-risk drinking, and consequences at 10-month follow-up, compared with the control group, with changes in descriptive and injunctive peer norms mediating intervention effects. The findings of the present study suggest that the parent intervention delivered to students before they begin college serves to enhance the efficacy of the BASICS intervention, potentially priming students to respond to the subsequent BASICS session.
Bunner, Anne E; Agarwal, Ulka; Gonzales, Joseph F; Valente, Francesca; Barnard, Neal D
Limited evidence suggests that dietary interventions may offer a promising approach for migraine. The purpose of this study was to determine the effects of a low-fat plant-based diet intervention on migraine severity and frequency. Forty-two adult migraine sufferers were recruited from the general community in Washington, DC, and divided randomly into two groups. This 36-week crossover study included two treatments: dietary instruction and placebo supplement. Each treatment period was 16 weeks, with a 4-week washout between. During the diet period, a low-fat vegan diet was prescribed for 4 weeks, after which an elimination diet was used. Participants were assessed at the beginning, midpoint, and end of each period. Significance was determined using student's t-tests. Worst headache pain in last 2 weeks, as measured by visual analog scale, was initially 6.4/10 cm (SD 2.1 cm), and declined 2.1 cm during the diet period and 0.7 cm during the supplement period (p=0.03). Average headache intensity (0-10 scale) was initially 4.2 (SD 1.4) per week, and this declined by 1.0 during the diet period and by 0.5 during the supplement period (p=0.20). Average headache frequency was initially 2.3 (SD 1.8) per week, and this declined by 0.3 during the diet period and by 0.4 during the supplement period (p=0.61). The Patient's Global Impression of Change showed greater improvement in pain during the diet period (pnutritional approach may be a useful part of migraine treatment, but that methodologic issues necessitate further research. Clinicaltrials.gov, NCT01699009 and NCT01547494.
McCain, Nancy L.; Gray, D. Patricia; Elswick, R. K., Jr.; Robins, Jolynne W.; Tuck, Inez; Walter, Jeanne M.; Rausch, Sarah M.; Ketchum, Jessica McKinney
Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of…
Hantson, Julie; Wang, Pan Pan; Grizenko-Vida, Michael; Ter-Stepanian, Marina; Harvey, William; Joober, Ridha; Grizenko, Natalie
Objective: The objective of this study was to evaluate the effectiveness of a 2-week therapeutic summer day camp for children with ADHD, which included a social skills training program and parent psychoeducation and training program. This was an open-label, nonrandomized Phase I Clinical Intervention Trial. Method: Parents completed the Weiss…
Bello, Segun; Wei, Maoling; Hilden, Jørgen
Med, Google Scholar and Web of Science Citation Index for studies that assessed whether supposedly indistinguishable interventions (experimental and control) in randomized clinical drug trials could be distinguished based on physical properties (e.g. appearance or smell). Two persons decided on study...
Meulenbeek, Petrus Antonius Maria
EFFECTIVENESS OF AN EARLY INTERVENTION FOR PANIC SYMPTOMS: RANDOMIZED CONTROLLED TRIAL Peter Meulenbeek¹,3,4, Godelief Willemse², Filip Smit²,3, Pim Cuijpers²,3 ¹ GGNet, the Netherlands; UTwente ² Trimbos instituut, Netherlands Institute of Mental Health and Addiction ³ Vrije Universiteit van
Houston, J. Brian; First, Jennifer; Spialek, Matthew L.; Sorenson, Mary E.; Mills-Sandoval, Toby; Lockett, McKenzie; First, Nathan L.; Nitiéma, Pascal; Allen, Sandra F.; Pfefferbaum, Betty
Objective: The purpose of this pilot study was to evaluate the Resilience and Coping Intervention (RCI) with college students. Participants: College students (aged 18-23) from a large Midwest US university who volunteered for a randomized controlled trial during the 2015 spring semester. Methods: College students were randomly assigned to an…
Savović, Jelena; Jones, Hayley E; Altman, Douglas G
Published evidence suggests that aspects of trial design lead to biased intervention effect estimates, but findings from different studies are inconsistent. This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta-analyses conta...
Mummah, Sarah; Robinson, Thomas N; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D
Abstract Background Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Methods Overweight adults ...
Verbakel, N.J.; Langelaan, M.; Verheij, T.J.M.; Wagner, C.; Zwart, D.L.M.
Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial
Verbakel, N.J.; Langelaan, M.; Verheij, T.J.M.; Wagner, C.; Zwart, D.L.M.
Background A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting A three-arm cluster randomised trial was
Phillips, Beth M.; Tabulda, Galiya; Ingrole, Smriti A.; Webb Burris, Pam; Sedgwick, T. Kayla; Chen, Shiyi
Purpose: The present article reports on the implementation and results of a randomized intervention trial targeting the literate language skills of prekindergarten children without identified language disorders but with low oral language skills. Method: Children (N = 82; 45 boys and 37 girls) were screened-in and randomized to a business-as-usual…
Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.
Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…
White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence
Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30…
Ebbels, Susan H.; van der Lely, Heather K. J.; Dockrell, Julie E.
Purpose: The authors aimed to establish whether 2 theoretically motivated interventions could improve use of verb argument structure in pupils with persistent specific language impairment (SLI). Method: Twenty-seven pupils with SLI (ages 11;0-16;1) participated in this randomized controlled trial with "blind" assessment. Participants were randomly…
M.J.E. Van Der Heijden (Marianne J. E.); S.O. Araghi (Sadaf Oliai); J. Jeekel (Hans); I.K.M. Reiss (Irwin); M.G.M. Hunink (Myriam); M. Van Dijk (Monique)
textabstractObjective: Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the
Duff, Fiona J; Hulme, Charles; Grainger, Katy; Hardwick, Samantha J; Miles, Jeremy N V; Snowling, Margaret J
Intervention studies for children at risk of dyslexia have typically been delivered preschool, and show short-term effects on letter knowledge and phoneme awareness, with little transfer to literacy. This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children identified by research criteria as being at risk of dyslexia (n = 56), and their school-identified peers (n = 89). An Experimental group received two 9-week blocks of daily intervention delivered by trained teaching assistants; the Control group received 9 weeks of typical classroom instruction, followed by 9 weeks of intervention. Following mixed effects regression models and path analyses, small-to-moderate effects were shown on letter knowledge, phoneme awareness and taught vocabulary. However, these were fragile and short lived, and there was no reliable effect on the primary outcome of word-level reading. This new intervention was theoretically motivated and based on previous successful interventions, yet failed to show reliable effects on language and literacy measures following a rigorous evaluation. We suggest that the intervention may have been too short to yield improvements in oral language; and that literacy instruction in and beyond the classroom may have weakened training effects. We argue that reporting of null results makes an important contribution in terms of raising standards both of trial reporting and educational practice. © 2014 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.
Wilson Graeme B
Full Text Available Abstract Background Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care. Methods The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742 attending their booking appointment with a community midwife (n = 31 in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C. Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120. Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention. As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention
John A Cunningham
Full Text Available Personalized feedback is a promising self-help for problem gamblers. Such interventions have shown consistently positive results with other addictive behaviours, and our own pilot test of personalized normative feedback materials for gamblers yielded positive findings. The current randomized controlled trial evaluated the effectiveness, and the sustained efficacy, of the personalized feedback intervention materials for problem gamblers.Respondents recruited by a general population telephone screener of Ontario adults included gamblers with moderate and severe gambling problems. Those who agreed to participate were randomly assigned to receive: 1 the full personalized normative feedback intervention; 2 a partial feedback that contained all the feedback information provided to those in condition 1 but without the normative feedback content (i.e., no comparisons provided to general population gambling norms; or 3 a waiting list control condition. The primary hypothesis was that problem gamblers who received the personalized normative feedback intervention would reduce their gambling more than problem gamblers who did not receive any intervention (waiting list control condition by the six-month follow-up.The study found no evidence for the impact of normative personalized feedback. However, participants who received, the partial feedback (without norms reduced the number of days they gambled compared to participants who did not receive the intervention. We concluded that personalized feedback interventions were well received and the materials may be helpful at reducing gambling. Realistically, it can be expected that the personalized feedback intervention may have a limited, short term impact on the severity of participants' problem gambling because the intervention is just a brief screener. An Internet-based version of the personalized feedback intervention tool, however, may offer an easy to access and non-threatening portal that can be used to
Adamsen, Lis; Quist, Morten; Andersen, Christina
OBJECTIVE: To assess the effect of a multimodal group exercise intervention, as an adjunct to conventional care, on fatigue, physical capacity, general wellbeing, physical activity, and quality of life in patients with cancer who were undergoing adjuvant chemotherapy or treatment for advanced dis...... disease. The intervention reduced fatigue and improved vitality, aerobic capacity, muscular strength, and physical and functional activity, and emotional wellbeing, but not quality of life. TRIAL REGISTRATION: Current Controlled trials ISRCTN05322922.......OBJECTIVE: To assess the effect of a multimodal group exercise intervention, as an adjunct to conventional care, on fatigue, physical capacity, general wellbeing, physical activity, and quality of life in patients with cancer who were undergoing adjuvant chemotherapy or treatment for advanced...... and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Medical Outcomes Study Short Form (MOS SF-36), Leisure Time Physical Activity Questionnaire, muscular strength (one repetition maximum), maximum oxygen consumption (Vo(2)max). Statistical methods The general linear model was used...
Appel, L J; Espeland, M; Whelton, P K; Dolecek, T; Kumanyika, S; Applegate, W B; Ettinger, W H; Kostis, J B; Wilson, A C; Lacy, C
National and international policy-making organizations advocate nonpharmacologic therapies to reduce blood pressure (BP). However, data to support such recommendations in older persons are virtually nonexistent. The Trials of Nonpharmacologic Intervention in the Elderly (TONE) is a randomized, controlled trial that will test whether weight loss or a reduced sodium (Na) intake or both can maintain satisfactory BP control, without unacceptable side effects, after withdrawal of antihypertensive drug therapy. Medication-treated hypertensives (aged 60 to 80 years) with a systolic BP less than 145 mm Hg and a diastolic BP less than 85 mm Hg who are taking one antihypertensive medication are randomly assigned to one of four groups: (1) weight loss alone, (2) reduced Na intake alone, (3) combined weight loss and reduced Na intake, or (4) usual life-style (control group). Overweight participants are randomized to one of these four groups, while nonoverweight individuals are assigned to either the reduced Na intake or the usual life-style group. The interventions, tailored to the needs of older persons, use behavioral approaches to accomplish intervention-specific goals (weight loss > or = 10 lb, daily Na intake mEqa). Three months after the start of intervention, antihypertensive drug therapy is withdrawn. The primary trial end point is a BP of 150/90 mm Hg or higher, resumption of antihypertensive drug therapy, or the occurrence of a BP-related clinical complication during 2 to 3 years of follow-up. It is anticipated that TONE findings may identify an effective and acceptable nonpharmacologic approach to control hypertension in the increasingly large number of older persons treated with antihypertensive drug therapy.
Bernard, Paquito; Carayol, Marion; Gourlan, Mathieu; Boiché, Julie; Romain, Ahmed Jérôme; Bortolon, Catherine; Lareyre, Olivier; Ninot, Gregory
A meta-analysis of randomized controlled trials (RCTs) has recently showed that theory-based interventions designed to promote physical activity (PA) significantly increased PA behavior. The objective of the present study was to investigate the moderators of the efficacy of these theory-based interventions. Seventy-seven RCTs evaluating theory-based interventions were systematically identified. Sample, intervention, methodology, and theory implementation characteristics were extracted, coded by three duos of independent investigators, and tested as moderators of interventions effect in a multiple-meta-regression model. Three moderators were negatively associated with the efficacy of theory-based interventions on PA behavior: intervention length (≥14 weeks; β = -.22, p = .004), number of experimental patients (β = -.10, p = .002), and global methodological quality score (β = -.08, p = .04). Our findings suggest that the efficacy of theory-based interventions to promote PA could be overestimated consequently due to methodological weaknesses of RCTs and that interventions shorter than 14 weeks could maximize the increase of PA behavior.
K.D. Allen (Kelli); S.M. Bierma-Zeinstra (Sita); N.E. Foster (Nadine); Y.M. Golightly (Yvonne); G. Hawker (Gillian)
textabstractRigorous implementation research is important for testing strategies to improve the delivery of effective osteoarthritis (OA) interventions. The objective of this manuscript is to describe principles of implementation research, including conceptual frameworks, study designs and
Gilfoyle, David; Mortensen, Eva; Christoffersen, Eva Dam; Leff, Jonathan A; Beckert, Michael
TransCon growth hormone (GH) is a sustained-release inactive prodrug consisting of unmodified GH transiently bound to an inert carrier molecule designed to release fully active GH over a one-week period. This was a first-in-man phase 1 randomized trial was to evaluate the safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of TransCon GH as compared to equivalent doses of daily GH (Omnitrope) or placebo in healthy adults. Forty-four healthy male adults were randomized to 4 cohorts of 11 subjects, distributed in a 7:2:2 ratio (TransCon GH: Omnitrope: placebo). A single injection of 4 possible TransCon GH doses (i.e., 0.04, 0.08, 0.16, or 0.24mg GH/kg/wk) or two different Omnitrope doses (i.e., 0.08 or 0.16mg GH/kg/wk divided into 7 equal daily doses) were administered with subjects evaluated for adverse events, immunogenicity, and GH and insulin-like growth factor-1 (IGF-1) levels. TransCon GH was well tolerated; no serious adverse events occurred, no injection site reaction differences between TransCon GH, Omnitrope, or placebo were identified, no nodules or lipoatrophy were reported, and no anti-GH binding antibodies or ECG changes were detected. Overall, the exposure of GH (Cmax) and IGF-1 (AUC0-168h) following administration of equivalent doses of TransCon GH and Omnitrope were similar. GH and IGF-1 kinetics showed a dose-proportional increase following a single SC administration of TransCon GH and indicated that the prodrug is suitable for weekly administration. These results support advancement of TransCon GH to pediatric and adult GHD trials. Clinical trial registration numbers: NCT01010425 (clinicaltrials.gov). Copyright © 2017 Elsevier Ltd. All rights reserved.
Full Text Available Abstract Background Guidelines recommend multifactorial intervention programmes to prevent falls in older adults but there are few randomised controlled trials in a real life health care setting. We describe the rationale, intervention, study design, recruitment strategies and baseline characteristics of participants in a randomised controlled trial of a multifactorial falls prevention programme in primary health care. Methods Participants are patients from 19 primary care practices in Hutt Valley, New Zealand aged 75 years and over who have fallen in the past year and live independently. Two recruitment strategies were used – waiting room screening and practice mail-out. Intervention participants receive a community based nurse assessment of falls and fracture risk factors, home hazards, referral to appropriate community interventions, and strength and balance exercise programme. Control participants receive usual care and social visits. Outcome measures include number of falls and injuries over 12 months, balance, strength, falls efficacy, activities of daily living, quality of life, and physical activity levels. Results 312 participants were recruited (69% women. Of those who had fallen, 58% of people screened in the practice waiting rooms and 40% when screened by practice letter were willing to participate. Characteristics of participants recruited using the two methods are similar (p > 0.05. Mean age of all participants was 81 years (SD 5. On average participants have 7 medical conditions, take 5.5 medications (29% on psychotropics with a median of 2 falls (interquartile range 1, 3 in the previous year. Conclusion The two recruitment strategies and the community based intervention delivery were feasible and successful, identifying a high risk group with multiple falls. Recruitment in the waiting room gave higher response rates but was less efficient than practice mail-out. Testing the effectiveness of an evidence based intervention in a
Renjith, Vishnu; Pai, Aparna; Radhakrishnan, Kurupath; Nayak, Baby S; Devi, Elsa Sanatombi; Ladd, Elissa; George, Anice
To describe a randomized controlled trial protocol that evaluates the effectiveness of a multicomponent intervention in improving the outcomes (quality of life, disability, intensity, frequency and duration) of patients with migraine. Migraine affects various facets of Quality of Life and results in moderate to high levels of disability among migraineurs. Migraine pain can be intense and unremitting that can interfere with the daily routine and reduce the ability to think and function normally. Many people can lower their risk of a migraine by simply avoiding stress, getting enough sleep, eating regularly and by avoiding triggers. Hence, the present study aims at evaluating the effectiveness of a multicomponent intervention in managing migraine headaches. The multicomponent intervention includes behavioural lifestyle modification program and sessions of pranayama (a form of yogic breathing exercise). The study is a prospective, randomized, controlled, single-blinded trial with parallel arms. The study participants are randomized to intervention and control arms. The participants randomized to the intervention arm would receive the specific multicomponent intervention based on the protocol. The participants in the control arm would receive routine care. They are followed up for 24 weeks and the outcomes are assessed. Various studies report that non-pharmacological therapies and integrative therapies play a major role in the management of migraine headaches. The findings of the study are expected to open up new horizons in health care arena emphasizing the use of non-pharmacological therapy for less focused areas of primary care health problems such as migraine. The trial is registered with the Clinical Trials Registry India (CTRI). The CTRI India is one of the primary registries in the WHO registry network (Ctri.nic.in, ). CTRI reference ID: CTRI/2015/10/006282. © 2017 John Wiley & Sons Ltd.
Full Text Available Abstract Background There is still debate as to which features, types or components of primary care interventions are associated with improved depression outcomes. Previous reviews have focused on components of collaborative care models in general practice settings. This paper aims to determine the effective components of depression care in primary care through a systematic examination of both general practice and community based intervention trials. Methods Fifty five randomised and controlled research trials which focused on adults and contained depression outcome measures were identified through PubMed, PsycInfo and the Cochrane Central Register of Controlled Trials databases. Trials were classified according to the components involved in the delivery of treatment, the type of treatment, the primary focus or setting of the study, detailed features of delivery, and the discipline of the professional providing the treatment. The primary outcome measure was significant improvement on the key depression measure. Results Components which were found to significantly predict improvement were the revision of professional roles, the provision of a case manager who provided direct feedback and delivered a psychological therapy, and an intervention that incorporated patient preferences into care. Nurse, psychologist and psychiatrist delivered care were effective, but pharmacist delivery was not. Training directed to general practitioners was significantly less successful than interventions that did not have training as the most important intervention. Community interventions were effective. Conclusion Case management is important in the provision of care in general practice. Certain community models of care (education programs have potential while others are not successful in their current form (pharmacist monitoring.
Full Text Available Abstract Background Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups
Lou, Peian; Zhu, Yanan; Chen, Peipei; Zhang, Pan; Yu, Jiaxi; Zhang, Ning; Chen, Na; Zhang, Lei; Wu, Hongmin; Zhao, Jing
Cigarette smoking is the major risk factor for chronic obstructive pulmonary disease (COPD). But a fewer smoking cessation measures were conducted in communities for smokers with COPD in China. The aim of our study was to assess the preventive effects of behavioral interventions for smoking cessation and potential impact factors in smokers with COPD in China. In a randomised controlled smoking cessation trial 3562 patients with COPD who were current smoker were allocated to intervention group received behavioral intervention and control group received the usual care for two years. The primary efficacy endpoint was the complete and continuous abstinence from smoking from the beginning of month 24 to the end of month 30. Participants were followed up at month 48. Continuous smoking abstinence rates from month 24 to 30 were significantly higher in participants receiving behavioral intervention than in those receiving usual care (46.4% vs 3.4%, p intervention than in those control group. Family members or family physicians/nurses smoking were first identified to influence smoking cessation. Behavioral intervention doubled the smoking cessation rate in patients with COPD and was complied well by the general practitioners. The family members and family physicians/nurses smoking were the main risk factors for smoking cessation. Chinese Clinical Trials Registration (ChiCTR-TRC-12001958).
Full Text Available BACKGROUND: Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled intervention trial was conducted in a general population of South Africa to test this hypothesis. METHODS AND FINDINGS: A total of 3,274 uncircumcised men, aged 18-24 y, were randomized to a control or an intervention group with follow-up visits at months 3, 12, and 21. Male circumcision was offered to the intervention group immediately after randomization and to the control group at the end of the follow-up. The grouped censored data were analyzed in intention-to-treat, univariate and multivariate, analyses, using piecewise exponential, proportional hazards models. Rate ratios (RR of HIV incidence were determined with 95% CI. Protection against HIV infection was calculated as 1 - RR. The trial was stopped at the interim analysis, and the mean (interquartile range follow-up was 18.1 mo (13.0-21.0 when the data were analyzed. There were 20 HIV infections (incidence rate = 0.85 per 100 person-years in the intervention group and 49 (2.1 per 100 person-years in the control group, corresponding to an RR of 0.40 (95% CI: 0.24%-0.68%; p < 0.001. This RR corresponds to a protection of 60% (95% CI: 32%-76%. When controlling for behavioural factors, including sexual behaviour that increased slightly in the intervention group, condom use, and health-seeking behaviour, the protection was of 61% (95% CI: 34%-77%. CONCLUSION: Male circumcision provides a degree of protection against acquiring HIV infection, equivalent to what a vaccine of high efficacy would have achieved. Male circumcision may provide an important way of reducing the spread of HIV infection in sub-Saharan Africa. (Preliminary and partial results were presented at the International AIDS Society 2005 Conference, on 26 July 2005, in Rio de Janeiro, Brazil..
Shah, Rashmee U; Winkleby, Marilyn A; Van Horn, Linda; Phillips, Lawrence S; Eaton, Charles B; Martin, Lisa W; Rosal, Milagros C; Manson, Joann E; Ning, Hongyan; Lloyd-Jones, Donald M; Klein, Liviu
The purpose of this study is to estimate the effect of education and income on incident heart failure (HF) hospitalization among post-menopausal women. Investigations of socioeconomic status have focused on outcomes after HF diagnosis, not associations with incident HF. We used data from the Women's Health Initiative Hormone Trials to examine the association between socioeconomic status levels and incident HF hospitalization. We included 26,160 healthy, post-menopausal women. Education and income were self-reported. Analysis of variance, chi-square tests, and proportional hazards models were used for statistical analysis, with adjustment for demographics, comorbid conditions, behavioral factors, and hormone and dietary modification assignments. Women with household incomes women with household incomes >$50,000 a year (16.7/10,000 person-years; p Women with less than a high school education had higher HF hospitalization incidence (51.2/10,000 person-years) than college graduates and above (25.5/10,000 person-years; p women with the lowest income levels had 56% higher risk (hazard ratio: 1.56, 95% confidence interval: 1.19 to 2.04) than the highest income women; women with the least amount of education had 21% higher risk for incident HF hospitalization (hazard ratio: 1.21, 95% confidence interval: 0.90 to 1.62) than the most educated women. Lower income is associated with an increased incidence of HF hospitalization among healthy, post-menopausal women, whereas multivariable adjustment attenuated the association of education with incident HF. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Lindemann, Kristina; Kok, Peey-Sei; Stockler, Martin; Jaaback, Ken; Brand, Alison
We sought to summarize the evidence for interventions aiming at enhanced recovery after surgery (ERAS) in ovarian cancer through a systematic review. We searched MEDLINE, EMBASE, and The Cochrane Library for studies testing ERAS interventions in patients undergoing surgery for ovarian cancer. Study selection and data extraction were done independently by 2 reviewers with disagreements resolved by discussion with a senior, third reviewer. We identified 25 studies including 1648 participants with ovarian cancer. Nine observational studies addressed ERAS protocols. Four of them were prospective, and 3 included historical controls. The other 16 studies reported single interventions, for example, early feeding, omission of pelvic drains, early orogastric tube removal, Doppler-guided fluid management, and patient-controlled epidural analgesia. Early feeding protocols were tested in 7 of the 12 randomized trials. Early feeding appeared to be safe and was associated with significantly faster recovery of bowel function. Few studies have specifically studied ERAS interventions in ovarian cancer. All studies on protocols including multiple interventions were susceptible to bias. Early feeding is the intervention that is best supported by randomized trials. Application of evidence for ERAS derived from nonovarian cancer is challenged by the differences not only in the scope of surgery but also in ovarian cancer patients' comorbidities. Postoperative morbidity is particularly high in these patients because of their poor nutritional status, perioperative fluids shifts, and long operating times. These patients may also show excessive response to surgical stress. Innovative, randomized trials are needed to reliably determine the feasibility, safety, and effectiveness of specific ERAS interventions in ovarian cancer.
van Balkom Anton
Full Text Available Abstract Background Panic disorder (PD is a common, severe and persistent mental disorder, associated with a high degree of distress and occupational and social disability. A substantial proportion of the population experiences subthreshold and mild PD and is at risk of developing a chronic PD. A promising intervention, aimed at preventing panic disorder onset and reducing panic symptoms, is the 'Don't Panic' course. It consists of eight sessions of two hours each. The purpose of this study is to evaluate the effectiveness of this early intervention – based on cognitive behavioural principles – on the reduction of panic disorder symptomatology. We predict that the experimental condition show superior clinical and economic outcomes relative to a waitlisted control group. Methods/design A pragmatic, pre-post, two-group, multi-site, randomized controlled trial of the intervention will be conducted with a naturalistic follow-up at six months in the intervention group. The participants are recruited from the general population and are randomized to the intervention or a waitlist control group. The intervention is offered by community mental health centres. Included are people over 18 years of age with subthreshold or mild panic disorder, defined as having symptoms of PD falling below the cut-off of 13 on the Panic Disorder Severity Scale-Self Report (PDSS-SR. Primary outcomes are panic disorder and panic symptoms. Secondary outcomes are symptoms of agoraphobia, anxiety, cognitive aspects of panic disorder, depressive symptoms, mastery, health-related quality of life, and cost-effectiveness. We will examine the following variables as potential mediators: cognitive aspects of panic disorder, symptoms of agoraphobia, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics, panic disorder, agoraphobia, treatment credibility and mastery. Discussion This study was designed to evaluate the (cost effectiveness of an
McEachan, Rosemary R C; Lawton, Rebecca J; Jackson, Cath; Conner, Mark; Meads, David M; West, Robert M
Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B=-1.79 mm/Hg) and resting heart rate (B=-2.08 beats) and significantly increased body mass index (B=.18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. © 2011 McEachan et al; licensee BioMed Central Ltd.
Mutale, Wilbroad; Stringer, Jeffrey; Chintu, Namwinga; Chilengi, Roma; Mwanamwenge, Margaret Tembo; Kasese, Nkatya; Balabanova, Dina; Spicer, Neil; Lewis, James; Ayles, Helen
In many low income countries, the delivery of quality health services is hampered by health system-wide barriers which are often interlinked, however empirical evidence on how to assess the level and scope of these barriers is scarce. A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system. We present the quantitative results of the 12 months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting. The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia. The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations. This paper reports the findings of the follow-up health facility survey that was conducted after 12 months of intervention implementation. Comparisons were made between those facilities in the intervention and control sites. STATA version 12 was used for analysis. The study found significant mean differences between intervention(I) and control (C) sites in the following domains: Training domain (Mean I:C; 87.5.vs 61.1, mean difference 23.3, p = 0.031), adult clinical observation domain (mean I:C; 73.3 vs.58.0, mean difference 10.9, p = 0.02 ) and health information domain (mean I:C; 63.6 vs.56.1, mean difference 6.8, p = 0.01. There was no gender differences in adult service satisfaction. Governance and motivation scores did not differ between control and intervention sites. This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system. Using system wide approaches and triangulating data collection methods seems to be key to successful evaluation of such complex health
Kothe, Emily J; Mullan, Barbara A; Amaratunga, Rajith
The present study sought to test the efficacy of a brief theory-based intervention to promote regular consumption of breakfast, and to expand previous results suggesting that the theory of planned behaviour (TPB) can be meaningfully applied to breakfast consumption. A four-armed randomised controlled trial was conducted. Participants (n=349) were allocated to receive either a (1) positively framed attitude intervention, (2) negatively framed attitude intervention, (3) Perceived Behavioural Control (PBC) intervention, or (4) control task. Attitude, subjective norm, PBC and behaviour were measured at baseline and 4-week follow-up. All three interventions employed persuasive communication and an implementation intention task. The intervention did not result in expected increases in breakfast consumption, or in changes in attitude, subjective norm or PBC. However, baseline attitude, subjective norm and PBC predicted 39.3% of baseline intention. Baseline intention in turn predicted 33% of breakfast consumption at 4 weeks. Change in breakfast consumption was predicted by change in attitude, subjective norm, and PBC between baseline and follow-up. Despite a lack of intervention effects, the TPB provided a good model of breakfast consumption over the four-week follow-up period. By expanding on previous work investigating breakfast consumption using the TPB, this study provides further support for the argument that that theory based interventions could result in meaningful increases in breakfast consumption. Copyright © 2010 Elsevier Ltd. All rights reserved.
Ondersma, Steven J; Svikis, Dace S; Schuster, Charles R
Drug use among parenting women is a significant risk factor for a range of negative child outcomes, including exposure to violence, child maltreatment, and child behavior problems. Implementation of brief interventions with this population may be greatly facilitated by computer-based interventions. Randomized clinical trial with 4-month follow-up. Participants were 107 postpartum women recruited from an urban obstetric hospital primarily serving a low-income population. Women were randomized into assessment only versus assessment plus brief intervention conditions; 76 (71%) returned for follow-up evaluation. A 20-minute, single-session, computer-based motivational intervention (based on motivational interviewing methods), combined with two nontailored mailings and voucher-based reinforcement of attendance at an initial intake/treatment session. Illicit drug use as measured by qualitative urinalysis and self-report. Frequency of illicit drug use other than marijuana increased slightly for the control group, but declined among intervention group participants (pmarijuana use frequency was similar, but did not reach statistical significance. Point-prevalence analysis at follow-up did not show significant group differences in drug use. However, trends under a range of assumptions regarding participants lost to follow-up all favored the intervention group, with most effect sizes in the moderate range (odds ratios 1.4 to 4.7). Results tentatively support the efficacy of this high-reach, replicable brief intervention. Further research should seek to replicate these findings and to further develop the computer as a platform for validated brief interventions.
Sharp, William G; Stubbs, Kathryn H; Adams, Heyward; Wells, Brian M; Lesack, Roseanne S; Criado, Kristen K; Simon, Elizabeth L; McCracken, Courtney E; West, Leanne L; Scahill, Larry D
The aim of this pilot study was to investigate feasibility and preliminary efficacy of an intensive, manual-based behavioral feeding intervention for children with chronic food refusal and dependence on enteral feeding or oral nutritional formula supplementation. Twenty children ages 13 to 72 months (12 boys and 8 girls) meeting criteria for avoidant/restrictive food intake disorder were randomly assigned to receive treatment for 5 consecutive days in a day treatment program (n = 10) or waitlist (n = 10). A team of trained therapists implemented treatment under the guidance of a multidisciplinary team. Parent training was delivered to support generalization of treatment gains. We tracked parental attrition and attendance, as well as therapist fidelity. Primary outcome measures were bite acceptance, disruptions, and grams consumed during meals. Caregivers reported high satisfaction and acceptability of the intervention. Three participants (1 intervention; 2 waitlist) dropped out of the study before endpoint. Of the expected 140 treatment meals for the intervention group, 137 (97.8%) were actually attended. The intervention group showed significantly greater improvements (P treatment gains. Results from this pilot study corroborate evidence from single-subject and nonrandomized studies on the positive effects of behavioral intervention. Findings support the feasibility and preliminary efficacy of this manual-based approach to intervention. These results warrant a large-scale randomized trial to test the safety and efficacy of this intervention.
Zhou, Yuan E; Emerson, Janice S; Levine, Robert S; Kihlberg, Courtney J; Hull, Pamela C
Childcare settings are an opportune location for early intervention programs seeking to prevent childhood obesity. This article reports on a systematic review of controlled trials of obesity prevention interventions in childcare settings. The review was limited to English language articles published in PubMed, Web of Science, and Education Resources Information Center (ERIC) between January 2000 and April 2012. childhood obesity prevention interventions in childcare settings using controlled designs that reported adiposity and behavior outcomes. no interventions, non-childcare settings, clinical weight loss programs, non-English publications. Publications were identified by key word search. Two authors reviewed eligible studies to extract study information and study results. Qualitative synthesis was conducted, including tabulation of information and a narrative summary. Fifteen studies met the eligibility criteria. Seven studies reported improvements in adiposity. Six of the 13 interventions with dietary components reported improved intake or eating behaviors. Eight of the 12 interventions with physical activity components reported improved activity levels or physical fitness. Evidence was mixed for all outcomes. Results should be interpreted cautiously given the high variability in study designs and interventions. Further research needs long-term follow-up, multistrategy interventions that include changes in the nutrition and physical activity environment, reporting of cost data, and consideration of sustainability.
Day, Crispin; Briskman, Jackie; Crawford, Mike J; Harris, Lucy; McCrone, Paul; McMurran, Mary; Moran, Paul; Morgan, Lou; Scott, Stephen; Stahl, Daniel; Ramchandani, Paul; Weaver, Timothy
The Helping Families Programme is a psychoeducational parenting intervention that aims to improve outcomes and engagement for parents affected by clinically significant personality difficulties. This is achieved by working collaboratively with parents to explore ways in which their emotional and relational difficulties impact on parenting and child functioning, and to identify meaningful and realistic goals for change. The intervention is delivered via one-to-one sessions at weekly intervals over a period of 16 weeks. This protocol describes a two-arm parallel RCT in which consenting parents are randomly allocated in a 1:1 ratio to either the Helping Families Programme plus the usual services that the parent may be receiving from their mental health and/or social care providers, or to standard care (usual services plus a brief parenting advice session). The primary clinical outcome will be child behaviour. Secondary clinical outcomes will be child and parental mental health, parenting satisfaction, parenting behaviour and therapeutic alliance. Health economic measures will be collected on quality of life and service use. Outcome measures will be collected at the initial assessment stage, after the intervention is completed and at 6-month follow-up by research staff blind to group allocation. Trial feasibility will be assessed using rates of trial participation at the three time points and intervention uptake, attendance and retention. A parallel process evaluation will use qualitative interviews to ascertain key-workers' and parent participants' experiences of intervention delivery and trial participation. The results of this feasibility study will determine the appropriateness of proceeding to a full-scale trial.
Full Text Available The Helping Families Programme is a psychoeducational parenting intervention that aims to improve outcomes and engagement for parents affected by clinically significant personality difficulties. This is achieved by working collaboratively with parents to explore ways in which their emotional and relational difficulties impact on parenting and child functioning, and to identify meaningful and realistic goals for change. The intervention is delivered via one-to-one sessions at weekly intervals over a period of 16 weeks. This protocol describes a two-arm parallel RCT in which consenting parents are randomly allocated in a 1:1 ratio to either the Helping Families Programme plus the usual services that the parent may be receiving from their mental health and/or social care providers, or to standard care (usual services plus a brief parenting advice session. The primary clinical outcome will be child behaviour. Secondary clinical outcomes will be child and parental mental health, parenting satisfaction, parenting behaviour and therapeutic alliance. Health economic measures will be collected on quality of life and service use. Outcome measures will be collected at the initial assessment stage, after the intervention is completed and at 6-month follow-up by research staff blind to group allocation. Trial feasibility will be assessed using rates of trial participation at the three time points and intervention uptake, attendance and retention. A parallel process evaluation will use qualitative interviews to ascertain key-workers’ and parent participants' experiences of intervention delivery and trial participation. The results of this feasibility study will determine the appropriateness of proceeding to a full-scale trial.
Fletcher-Watson, Sue; Petrou, Alexandra; Scott-Barrett, Juliet; Dicks, Pamela; Graham, Catherine; O'Hare, Anne; Pain, Helen; McConachie, Helen
This study evaluated a technology-based early intervention for social communication skills in pre-schoolers in a randomised controlled trial. Participants were 54 children aged under 6 years with a diagnosis of autism, assigned to either intervention or control conditions. The app engaged children, who played consistently, regardless of developmental level, and was rated highly by parents. There were no significant group differences in parent-report measures post-intervention, nor in a measure of parent-child play at follow-up. Therefore, this intervention did not have an observable impact on real-world social communication skills and caution is recommended about the potential usefulness of iPad(™) apps for amelioration of difficulties in interaction. However, positive attitudes among participants, lack of harms and the potential of apps to deliver therapeutic content at low economic cost suggest this approach is worth pursuing further, perhaps targeting other skill domains. © The Author(s) 2015.
Gallegos, Esther C; Villarruel, Antonia M; Loveland-Cherry, Carol; Ronis, David L; Yan Zhou, Ms
To test the efficacy of a behavioral intervention designed to decrease risk sexual behaviors for HIV/AIDS and unplanned pregnancies in Mexican adolescents. Randomized controlled trial with four follow ups; 832 adolescents recruited from high schools, age 14-17, were randomly assigned to the experimental or control group. The six hour intervention used active learning strategies, and was delivered in two sessions on two consecutive Saturdays. The study was carried out in Monterrey, Mexico, 2002-2005. GEE analysis indicated no differences in sexual relationships intentions between the two conditions, however, the experimental group had higher intentions to use condoms and contraceptives (mean differences 0.15 and 0.16, CI 95%) in the next three months, as compared with the control group. Theoretical variables, such as control beliefs, were significant mediators of the intervention. The behavioral intervention represents an important effort in promoting safe sexual behaviors among Mexican adolescents.
Meichsner, Franziska; Schinköthe, Denise; Wilz, Gabriele
Dementia caregivers often experience loss and grief related to general caregiver burden, physical, and mental health problems. Through qualitative content analysis, this study analyzed intervention strategies applied by therapists in a randomized-controlled trial in Germany to assist caregivers in managing losses and associated emotions. Sequences from 61 therapy sessions that included interventions targeting grief, loss, and change were transcribed and analyzed. A category system was developed deductively, and the intercoder reliability was satisfactory. The identified grief intervention strategies were recognition and acceptance of loss and change,addressing future losses,normalization of grief, and redefinition of the relationship Therapists focused on identifying experienced losses, managing associated feelings, and fostering acceptance of these losses. A variety of cognitive-behavioral therapy-based techniques was applied with each strategy. The findings contribute to understanding how dementia caregivers can be supported in their experience of grief and facilitate the development of a manualized grief intervention. © The Author(s) 2015.
Bricker, Jonathan B.; Liu, Jingmin; Comstock, Bryan A.; Peterson, Arthur V.; Kealey, Kathleen A.; Marek, Patrick M.
Only one prior study has examined why adolescent smoking cessation interventions are effective. To address this understudied and important issue, this study examined whether a large adolescent smoking cessation intervention trial’s outcomes were mediated by Social Cognitive Theory processes. In a randomized trial (N = 2,151), counselors proactively delivered a telephone intervention to senior year high school smokers. Mediators and smoking status were self-reported at 12 months post-intervention-eligibility (88.8% retention). At-least-6-months abstinence was the outcome. Among all enrolled smokers, increased self-efficacy to resist smoking in (a) social & (b) stressful situations together statistically mediated 55.6% of the intervention’s effect on smoking cessation (p smoking in stressful situations statistically mediated 56.9% of the intervention’s effect (p smoking is a possible mediator of the intervention’s effect on smoking cessation. PMID:20853929
Verdurmen, J.E.E.; Koning, I.M.; Vollebergh, W.A.M.; Eijnden, R.J.J.M. van den; Engels, R.C.M.E.
Objective: To examine risk moderation of an alcohol intervention targeting parents and adolescents. Design: A cluster randomized trial including 2937 Dutch early adolescents (m = 12.68 years, SD = 0.51) and their parents randomized over four conditions: parent intervention, student intervention,
Verdurmen, Jacqueline E E; Koning, Ina M.|info:eu-repo/dai/nl/304822329; Vollebergh, Wilma A M|info:eu-repo/dai/nl/090632893; van den Eijnden, Regina J J M|info:eu-repo/dai/nl/17399394X; Engels, Rutger C M E
Objective: To examine risk moderation of an alcohol intervention targeting parents and adolescents. Design: A cluster randomized trial including 2937 Dutch early adolescents (m=12.68. years, SD=0.51) and their parents randomized over four conditions: parent intervention, student intervention,
Poslawsky, Irina E; Naber, Fabiënne BA; Bakermans-Kranenburg, Marian J; van Daalen, Emma; van Engeland, Herman; van IJzendoorn, Marinus H
In a randomized controlled trial, we evaluated the early intervention program Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI) with 78 primary caregivers and their child (16-61 months) with Autism Spectrum Disorder. VIPP-AUTI is a brief attachment-based intervention program, focusing on improving parent-child…
Rosenfeld, R G; Hintz, R L; Johanson, A J; Brasel, J A; Burstein, S; Chernausek, S D; Clabots, T; Frane, J; Gotlin, R W; Kuntze, J
Seventy girls with Turner syndrome, 4 to 12 years of age, were randomly assigned to receive either no treatment (control) or methionyl human growth hormone (0.125 mg/kg three times per week), oxandrolone (0.125 mg/kg/day), or combination hGH plus oxandrolone therapy. Baseline growth rates averaged 4.3 cm/yr, and all were within 2 SD of mean growth velocity for age in girls with Turner syndrome. Sixty-seven girls remained in the study for a minimum of 1 year. Growth rates and growth velocity (in standard deviations for age in girls with Turner syndrome) were control 3.8 cm/yr (-0.1 SD), hGH 6.6 cm/yr (+2.3 SD), oxandrolone 7.9 cm/yr (+3.7 SD), and combination therapy 9.8 cm/yr (+5.4 SD). Mean bone ages advanced 1.0 years (hGH), 1.3 years (oxandrolone), and 1.6 years (combination). However, median increments in height age/bone age (delta HA/delta BA) ratios ranged from 1.0 to 1.1 for treatment groups, compared with 0.8 for the controls. Predicted adult height by the method of Bayley-Pinneau increased 2.5 cm for hGH or oxandrolone alone, and 3.2 cm for combination treatment. These data indicate that both hGH and oxandrolone can significantly stimulate short-term skeletal growth in patients with Turner syndrome, and potentially increase final adult height.
Full Text Available Abstract Background Identifying critical life transitions in people’s physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited, and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group. Methods This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum with two assessment points at 6 weeks (3.5 months postpartum and 3 months (5 months postpartum and a final follow-up assessment at 6 months (8 months postpartum. The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity. Results A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures. Discussion If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform
Briley, Annette L; Barr, Suzanne; Badger, Shirlene; Bell, Ruth; Croker, Helen; Godfrey, Keith M; Holmes, Bridget; Kinnunen, Tarja I; Nelson, Scott M; Oteng-Ntim, Eugene; Patel, Nashita; Robson, Stephen C; Sandall, Jane; Sanders, Thomas; Sattar, Naveed; Seed, Paul T; Wardle, Jane; Poston, Lucilla
Despite the widespread recognition that obesity in pregnant women is associated with adverse outcomes for mother and child, there is no intervention proven to reduce the risk of these complications. The primary aim of this randomised controlled trial is to assess in obese pregnant women, whether a complex behavioural intervention, based on changing diet (to foods with a lower glycemic index) and physical activity, will reduce the risk of gestational diabetes (GDM) and delivery of a large for gestational age (LGA) infant. A secondary aim is to determine whether the intervention lowers the long term risk of obesity in the offspring. Multicentre randomised controlled trial comparing a behavioural intervention designed to improve glycemic control with standard antenatal care in obese pregnant women.Inclusion criteria; women with a BMI ≥30 kg/m2 and a singleton pregnancy between 15+0 weeks and 18+6 weeks' gestation. Exclusion criteria; pre-defined, pre-existing diseases and multiple pregnancy. Randomisation is on-line by a computer generated programme and is minimised by BMI category, maternal age, ethnicity, parity and centre. Intervention; this is delivered by a health trainer over 8 sessions. Based on control theory, with elements of social cognitive theory, the intervention is designed to improve maternal glycemic control. Women randomised to the control arm receive standard antenatal care until delivery according to local guidelines. All women have a 75 g oral glucose tolerance test at 27+0- 28+6 weeks' gestation.Primary outcome; Maternal: diagnosis of GDM, according to the International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria. Neonatal; infant LGA defined as >90th customised birth weight centile.Sample size; 1546 women to provide 80% power to detect a 25% reduction in the incidence of GDM and a 30% reduction in infants large for gestational age. All aspects of this protocol have been evaluated in a pilot randomised controlled trial
Eades, Sandra J; Sanson-Fisher, Rob W; Wenitong, Mark; Panaretto, Katie; D'Este, Catherine; Gilligan, Conor; Stewart, Jessica
To determine the effectiveness of an intensive quit-smoking intervention on smoking rates at 36 weeks' gestation among pregnant Aboriginal and Torres Strait Islander women. Randomised controlled trial. Pregnant Aboriginal and Torres Strait Islander women (n = 263) attending their first antenatal visit at one of three Aboriginal community-controlled health services between June 2005 and December 2009. A general practitioner and other health care workers delivered tailored advice and support to quit smoking to women at their first antenatal visit, using evidence-based communication skills and engaging the woman's partner and other adults in supporting the quit attempts. Nicotine replacement therapy was offered after two failed attempts to quit. The control ("usual care") group received advice to quit smoking and further support and advice by the GP at scheduled antenatal visits. Self-reported smoking status (validated with a urine cotinine measurement) between 36 weeks' gestation and delivery. Participants in the intervention group (n = 148) and usual care group (n = 115) were similar in baseline characteristics, except that there were more women who had recently quit smoking in the intervention group than the control group. At 36 weeks, there was no significant difference between smoking rates in the intervention group (89%) and the usual care group (95%) (risk ratio for smoking in the intervention group relative to usual care group, 0.93 [95% CI, 0.86-1.08]; P = 0.212). Smoking rates in the two groups remained similar when baseline recent quitters were excluded from the analysis. An intensive quit-smoking intervention was no more effective than usual care in assisting pregnant Aboriginal and Torres Strait Islander women to quit smoking during pregnancy. Contamination of the intervention across groups, or the nature of the intervention itself, may have contributed to this result. Australian New Zealand Clinical Trials Registry ACTRN12609000929202.
Allen, Kelli D; Yancy, William S; Bosworth, Hayden B; Coffman, Cynthia J; Jeffreys, Amy S; Datta, Santanu K; McDuffie, Jennifer; Strauss, Jennifer L; Oddone, Eugene Z
Management of osteoarthritis requires both medical and behavioral strategies, but some recommended therapies are underused. To examine the effectiveness of a combined patient and provider intervention for improving osteoarthritis outcomes. Cluster randomized clinical trial with assignment to osteoarthritis intervention and usual care groups. (ClinicalTrials.gov: NCT01130740). Department of Veterans Affairs Medical Center in Durham, North Carolina. 30 providers (clusters) and 300 outpatients with symptomatic hip or knee osteoarthritis. The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved delivery of patient-specific osteoarthritis treatment recommendations to primary care providers through the electronic medical record. The primary outcome was total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months. Secondary outcomes were WOMAC function and pain subscale scores, physical performance (Short Physical Performance Battery), and depressive symptoms (Patient Health Questionnaire-8). Linear mixed models that were adjusted for clustering of providers assessed between-group differences in improvement in outcomes. At 12 months, WOMAC scores were 4.1 points lower (indicating improvement) in the osteoarthritis intervention group versus usual care (95% CI, -7.2 to -1.1 points; P = 0.009). WOMAC function subscale scores were 3.3 points lower in the intervention group (CI, -5.7 to -1.0 points; P = 0.005). WOMAC pain subscale scores (P = 0.126), physical performance, and depressive symptoms did not differ between groups. Although more patients in the osteoarthritis intervention group received provider referral for recommended osteoarthritis treatments, the numbers who received them did not differ. The study was conducted in a single Veterans Affairs medical center. The combined patient and provider intervention resulted in
Weiser, Sheri D; Bukusi, Elizabeth A; Steinfeld, Rachel L; Frongillo, Edward A; Weke, Elly; Dworkin, Shari L; Pusateri, Kyle; Shiboski, Stephen; Scow, Kate; Butler, Lisa M; Cohen, Craig R
Food insecurity and HIV/AIDS outcomes are inextricably linked in sub-Saharan Africa. We report on health and nutritional outcomes of a multisectoral agricultural intervention trial among HIV-infected adults in rural Kenya. This is a pilot cluster randomized controlled trial. The intervention included a human-powered water pump, a microfinance loan to purchase farm commodities, and education in sustainable farming practices and financial management. Two health facilities in Nyanza Region, Kenya were randomly assigned as intervention or control. HIV-infected adults 18 to 49 years' old who were on antiretroviral therapy and had access to surface water and land were enrolled beginning in April 2012 and followed quarterly for 1 year. Data were collected on nutritional parameters, CD4 T-lymphocyte counts, and HIV RNA. Differences in fixed-effects regression models were used to test whether patterns in health outcomes differed over time from baseline between the intervention and control arms. We enrolled 72 and 68 participants in the intervention and control groups, respectively. At 12 months follow-up, we found a statistically significant increase in CD4 cell counts (165 cells/μl, P < 0.001) and proportion virologically suppressed in the intervention arm compared with the control arm (comparative improvement in proportion of 0.33 suppressed, odds ratio 7.6, 95% confidence interval: 2.2-26.8). Intervention participants experienced significant improvements in food security (3.6 scale points higher, P < 0.001) and frequency of food consumption (9.4 times per week greater frequency, P = 0.013) compared to controls. Livelihood interventions may be a promising approach to tackle the intersecting problems of food insecurity, poverty and HIV/AIDS morbidity.
Wohl, David A; Golin, Carol E; Knight, Kevin; Gould, Michele; Carda-Auten, Jessica; Groves, Jennifer S; Napravnik, Sonia; Cole, Stephen R; White, Becky L; Fogel, Cathie; Rosen, David L; Mugavaro, Michael J; Pence, Brian W; Flynn, Patrick M
HIV-infected individuals transitioning from incarceration to the community are at risk for loss of viral suppression. We compared the effects of imPACT, a multidimensional intervention to promote care engagement after release, to standard care on sustaining viral suppression after community re-entry. This trial randomized 405 HIV-infected inmates being released from prisons in Texas and North Carolina with HIV-1 RNA levels HIV-1 RNA HIV-1 RNA 0.99). Higher rates of HIV suppression and medical care engagement than expected based on previous literature were observed among HIV-infected patients with suppressed viremia released from prison. Randomization to a comprehensive intervention to motivate and facilitate HIV care access after prison release did not prevent loss of viral suppression. A better understanding of the factors influencing prison releasees' linkage to community care, medication adherence, and maintenance of viral suppression is needed to inform policy and other strategic approaches to HIV prevention and treatment.
Full Text Available To investigate whether carrying out various interventions part way through the day influences comfort in symptomatic daily disposable (DD contact lens wearers.A subject-masked, randomized, controlled clinical trial was conducted in thirty symptomatic soft lens wearers who wore their habitual DD contact lenses bilaterally for 12 h on two separate days. Five hours after lens application, one of the following three interventions or a control was performed on each eye: replacing the existing lens with a new lens; removing and reapplying the same lens; performing a 'scleral swish'; and no action (control. Comfort scores were recorded using SMS text messages every hour following lens application using a 0 (causes pain to 100 (excellent comfort scale. Comfort scores before lens application, at 6 mins post-application, and at 6 mins post-intervention were also recorded.There was a significant reduction in comfort from pre-lens application to 6 mins post-application for all groups (all p0.05. After the intervention, comfort continued to decline (p<0.0001 with slightly lower mean scores for the control group compared to the new lens group (p = 0.003. Change in comfort relative to pre-intervention (5 h was similar for all groups (p = 0.81. There was no difference in comfort at 12 h between groups (p = 0.83.This work has confirmed that comfort shows a continual and significant decline over a 12-h wearing period in symptomatic DD contact lens wearers. None of the interventions investigated had any significant impact on end-of-day comfort. These data suggest discomfort in lens wearers is more heavily influenced by changes to the ocular environment rather than to the lens itself.Controlled-Trials.com ISRCTN10419752 http://www.controlled-trials.com/ISRCTN10419752.
Pockley A Graham
Full Text Available Abstract Background The success of a human intervention trial depends upon the ability to recruit eligible volunteers. Many trials fail because of unrealistic recruitment targets and flawed recruitment strategies. In order to predict recruitment rates accurately, researchers need information on the relative success of various recruitment strategies. Few published trials include such information and the number of participants screened or approached is not always cited. Methods This paper will describe in detail the recruitment strategies employed to identify older adults for recruitment to a 6-month randomised controlled dietary intervention trial which aimed to explore the relationship between diet and immune function (The FIT study. The number of people approached and recruited, and the reasons for exclusion, will be discussed. Results Two hundred and seventeen participants were recruited to the trial. A total of 7,482 letters were sent to potential recruits using names and addresses that had been supplied by local Family (General Practices. Eight hundred and forty three potential recruits replied to all methods of recruitment (528 from GP letters and 315 from other methods. The eligibility of those who replied was determined using a screening telephone interview, 217 of whom were found to be suitable and agreed to take part in the study. Conclusion The study demonstrates the application of multiple recruitment methods to successfully recruit older people to a randomised controlled trial. The most successful recruitment method was by contacting potential recruits by letter on NHS headed note paper using contacts provided from General Practices. Ninety percent of recruitment was achieved using this method. Adequate recruitment is fundamental to the success of a research project, and appropriate strategies must therefore be adopted in order to identify eligible individuals and achieve recruitment targets. Trial registration number ISRCTN45031464.
Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A
If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as 'core', 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.
Cunningham, John Alastair
Alcohol problems are a serious public health concern, and few problem drinkers ever seek treatment. The Internet is one means of promoting access to care, but more research is needed to test the best types of interventions to employ. Evaluation of Internet-based interventions that contain a variety of research-validated cognitive-behavioral tools, which have been shown to be helpful to those with more severe alcohol concerns, should be a priority. To evaluate whether providing access to an extended Internet intervention for alcohol problems offers additional benefits in promoting reductions in alcohol consumption compared with a brief Internet intervention. The hypothesis for the current trial was that respondents who were provided with access to an extended Internet intervention (the Alcohol Help Center [AHC]) would display significantly improved drinking outcomes at 6-month follow-up, compared with respondents who were provided with access to a brief Internet intervention (the Check Your Drinking [CYD] screener). A single-blinded randomized controlled trial with a 6-month follow-up. A general population sample of problem drinkers was recruited through newspaper advertisements in a large metropolitan city. Baseline and follow-up data were collected by postal mail. A volunteer sample of problem drinkers of legal drinking age with home access to the Internet were recruited for the trial. Of 239 potential respondents recruited in 2010, 170 met inclusion criteria (average age 45 years; 101/170, 59.4% male; average Alcohol Use Disorders Identification Test [AUDIT] score of 22). Follow-up rates were 90.0% (153/170) with no adverse effects of the interventions reported. A repeated-measures multivariate analysis of variance of the outcome measures using an intent-to-treat approach found a significantly greater reduction in amount of drinking among participants provided access to the AHC than among participants provided access to the CYD (P = .046). The provision of the
Full Text Available Abstract Background In the rural areas of sub-Saharan Africa, the majority of young children affected by malaria have no access to formal health services. Home treatment through mothers of febrile children supported by mother groups and local health workers has the potential to reduce malaria morbidity and mortality. Methods A cluster-randomized controlled effectiveness trial was implemented from 2002–2004 in a malaria endemic area of rural Burkina Faso. Six and seven villages were randomly assigned to the intervention and control arms respectively. Febrile children from intervention villages were treated with chloroquine (CQ by their mothers, supported by local women group leaders. CQ was regularly supplied through a revolving fund from local health centres. The trial was evaluated through two cross-sectional surveys at baseline and after two years of intervention. The primary endpoint of the study was the proportion of moderate to severe anaemia in children aged 6–59 months. For assessment of the development of drug efficacy over time, an in vivo CQ efficacy study was nested into the trial. The study is registered under http://www.controlled-trials.com (ISRCTN 34104704. Results The intervention was shown to be feasible under program conditions and a total of 1.076 children and 999 children were evaluated at baseline and follow-up time points respectively. Self-reported CQ treatment of fever episodes at home as well as referrals to health centres increased over the study period. At follow-up, CQ was detected in the blood of high proportions of intervention and control children. Compared to baseline findings, the prevalence of anaemia (29% vs 16%, p P. falciparum parasitaemia, fever and palpable spleens was lower at follow-up but there were no differences between the intervention and control group. CQ efficacy decreased over the study period but this was not associated with the intervention. Discussion The decreasing prevalence of malaria
Full Text Available Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention.Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness.In the primary analysis were 484 (98.2% intervention and 507 (98.1% control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16. The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05 as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01. There was an increase (p = 0.02 in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY difference 0.0129, 95% CI -0.0050 to 0.0314 and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained.There was a small reduction in falls. The intervention may be cost-effective.ISRCTN ISRCTN68240461.
Cockayne, Sarah; Adamson, Joy; Clarke, Arabella; Corbacho, Belen; Fairhurst, Caroline; Green, Lorraine; Hewitt, Catherine E; Hicks, Kate; Kenan, Anne-Maree; Lamb, Sarah E; McIntosh, Caroline; Menz, Hylton B; Redmond, Anthony C; Richardson, Zoe; Rodgers, Sara; Vernon, Wesley; Watson, Judith; Torgerson, David J
Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention. Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness. In the primary analysis were 484 (98.2%) intervention and 507 (98.1%) control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05) as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01). There was an increase (p = 0.02) in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314) and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained. There was a small reduction in falls. The intervention may be cost-effective. ISRCTN ISRCTN68240461.
Northouse, Laurel L; Katapodi, Maria C; Song, Lixin; Zhang, Lingling; Mood, Darlene W
Family caregivers of cancer patients receive little preparation, information, or support to perform their caregiving role. However, their psychosocial needs must be addressed so they can maintain their own health and provide the best possible care to the patient. The purpose of this article is to analyze the types of interventions offered to family caregivers of cancer patients, and to determine the effect of these interventions on various caregiver outcomes. Meta-analysis was used to analyze data obtained from 29 randomized clinical trials published from 1983 through March 2009. Three types of interventions were offered to caregivers: psychoeducational, skills training, and therapeutic counseling. Most interventions were delivered jointly to patients and caregivers, but they varied considerably with regard to dose and duration. The majority of caregivers were female (64%) and Caucasian (84%), and ranged in age from 18 to 92 years (mean age, 55 years). Meta-analysis indicated that although these interventions had small to medium effects, they significantly reduced caregiver burden, improved caregivers' ability to cope, increased their self-efficacy, and improved aspects of their quality of life. Various intervention characteristics were also examined as potential moderators. Clinicians need to deliver research-tested interventions to help caregivers and patients cope effectively and maintain their quality of life. Copyright 2010 American Cancer Society, Inc.
Williams, Andrew E; Stevens, Victor J; Albright, Cheryl L; Nigg, Claudio R; Meenan, Richard T; Vogt, Thomas M
We assessed the effectiveness of a worksite management intervention (the 3W program) for overweight and obese hotel employees. The program was tested in a 2-year cluster-randomized trial involving 30 hotels that employed nearly 12,000 individuals. All participating hotels were on Oahu, Hawaii. The intervention was implemented within hotel worksites. Participants were included in the analysis if they had an initial body mass index (BMI) ≥ 25, were assessed at least twice, were not missing other data needed for the analysis, and did not switch to employment at a hotel in a different experimental condition. Of the 6519 employees we assessed, data from 1207 individuals (intervention: 598; control: 610) met these criteria and contributed to the analysis. The intervention had two components: (1) group meetings and (2) a workplace environment intervention. Weight and waist to height ratio (WHtR) were measured at three annual assessments. The effect of the intervention on change in BMI and WHtR was estimated in hierarchical mixed regression models using full maximum likelihood to estimate model parameters. The effects on change in BMI and WHtR were in the expected direction but were not statistically significant. The 3W program was not effective. The low intensity of the intervention may have contributed to its ineffectiveness.
Boyde, M; Peters, R; New, N; Hwang, R; Ha, T; Korczyk, D
A variety of educational interventions have been implemented to assist patients with heart failure to maintain their own health, develop self-care behaviours and decrease readmissions. The purpose of this study was to determine the effectiveness of a multimedia educational intervention for patients with heart failure in reducing unplanned hospital readmissions. The study, a randomised controlled trial in a large tertiary referral hospital in Australia, recruited 200 patients. Patients diagnosed with heart failure were randomly allocated 1:1 to usual education or a multimedia educational intervention. The multimedia approach began with an individual needs assessment to develop an educational plan. The educational intervention included viewing a DVD, and verbal discussion supported by a written manual with a teach-back evaluation strategy. The primary outcome was all-cause unplanned hospital readmission at 28 days, three months and 12 months post-recruitment. The secondary outcomes were changes in knowledge and self-care behaviours at three months and 12 months post-recruitment. At 12 months, data on 171 participants were analysed. There were 24 participants who had an unplanned hospital readmission in the intervention group compared to 44 participants in the control group ( p=0.005). The self-care educational intervention reduced the risk of readmission at 12 months by 30% (relative risk: 0.703; 95% confidence interval: 0.548-0.903). A targeted multimedia educational intervention can be effective in reducing all-cause unplanned readmissions for people with heart failure.
Torres, Olga Herminia; Gil, Eva; Comas, Maria Teresa; Saez, Maria Encarnación; Clotet, Sandra; Ramirez, Hector David; Mateo, Miriam; Ruiz, Domingo
The main objective of this study is to determine whether a multidimensional intervention applied to elderly patients admitted to hospital due to pneumonia reduces re-admissions and emergency department visits in the year after the intervention. This is a single-centre non-pharmacological randomised clinical trial with a parallel design. Three hundred and fourteen patients will be included (157 in each arm). Eligible patients will be ≥65 years old and with a Barthel index ≥60 that are admitted to hospital due to pneumonia. Participants will be randomised to multidimensional intervention or to control group. Two months after hospital discharge the intervention group will receive a geriatric intervention, carried out by a nurse and a physician. It will include assessment of co-morbidities, nutritional, functional and cognitive status, and immunisation. The control group will receive conventional follow-up. The number of re-admissions, visits to the emergency department, functional status, survival, and institutionalisation will be evaluated one year after intervention. If the intervention shows an improvement in the studied outcomes, it would allow us to improve individual outcomes, and indirectly reduce healthcare costs using a relatively simple, standardised tool. Copyright © 2015 SEGG. Published by Elsevier Espana. All rights reserved.
Gould, Rebecca L; Coulson, Mark C; Patel, Natasha; Highton-Williamson, Elizabeth; Howard, Robert J
The use of benzodiazepines has been advised against in older people, but prevalence rates remain high. To review the evidence for interventions aimed at reducing benzodiazepine use in older people. We conducted a systematic review, assessment of risk of bias and meta-analyses of randomised controlled trials of benzodiazepine withdrawal and prescribing interventions. Ten withdrawal and eight prescribing studies met the inclusion criteria. At post-intervention, significantly higher odds of not using benzodiazepines were found with supervised withdrawal with psychotherapy (odds ratio (OR) = 5.06, 95% CI 2.68-9.57, Pwithdrawal with prescribing interventions (OR = 1.43, 95% CI 1.02-2.02, P = 0.04) in comparison with the control interventions treatment as usual (TAU), education placebo, withdrawal with or without drug placebo, or psychotherapy alone. Significantly higher odds of not using benzodiazepines were also found for multifaceted prescribing interventions (OR = 1.37, 95% CI 1.10-1.72, P = 0.006) in comparison with control interventions (TAU and prescribing placebo). Supervised benzodiazepine withdrawal augmented with psychotherapy should be considered in older people, although pragmatic reasons may necessitate consideration of other strategies such as medication review.
Ng, Anthony C-F; Cheng, K-F; Leung, P-C
BYSH, a herbal formula, was evaluated for efficacy and safety in a pilot study for patients with advanced hormone refractory prostate cancer (HRPC). The pilot study was designed as a single-center open-label trial. Patients with HRPC were treated with BYSH for 24 weeks. The primary end point was the changes in serum prostate-specific antigen (PSA) level. Safety parameters such as liver and renal functions were monitored during the study period. Ten patients were eligible for the study. Most of them had stable PSA levels while taking BYSH. However, at the end of the BYSH treatment, the level of PSA increased. The median survival from diagnosis of HRPC was 16.4 months. Liver and renal functions remained normal. BYSH was well tolerated and no patient reported adverse events during the study period. Although it is inappropriate to make a conclusion based on the pilot study results, the trend of improvement is obvious. Further investigations should be conducted to demonstrate its clinical benefits. We have also briefly reviewed some plant products which are patented and also available in market.
Trussell, James; Portman, David
Despite several drawbacks, the Pearl Index continues to be the most widely used statistical measure of contraceptive failure. However, Pearl indices reported in studies of newer hormonal contraceptives appear to be increasing. We searched PubMed and Medical Intelligence Solutions databases for prospective trials evaluating oral contraceptive (OC) efficacy to examine potential factors that could contribute to increasing Pearl indices. Numerous potential factors were identified, including an increased rate of failures of newer OCs, deficiencies in methods of calculating contraceptive failure rates, differences in study design and changes in patient populations resulting in increased rates of contraceptive failures due to the inappropriate or inconsistent use of the method. The two most likely important contributors to the increase in Pearl indices are more frequent pregnancy testing with more sensitive tests and less adherent study populations. Because study populations appear to be increasingly representative of the likely actual users once the product is marketed, we can expect to see even higher failure rates in ongoing and future studies. This result poses challenges for companies and regulatory agencies. Copyright © 2013 Elsevier Inc. All rights reserved.
van der Heijden, Marianne J E; Oliai Araghi, Sadaf; Jeekel, Johannes; Reiss, Irwin K M; Hunink, M G Myriam; van Dijk, Monique
Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the possible benefits of music interventions on premature infants' well-being. We searched 13 electronic databases and 12 journals from their first available date until August 2016. Included were all RCTs published in English with at least 10 participants per group, including infants born prematurely and admitted to the NICU. Interventions were either recorded music interventions or live music therapy interventions. All control conditions were accepted as long as the effects of the music intervention could be analysed separately. A meta-analysis was not possible due to incompleteness and heterogeneity of the data. After removal of duplicates the searches retrieved 4893 citations, 20 of which fulfilled the inclusion/exclusion criteria. The 20 included studies encompassed 1128 participants receiving recorded or live music interventions in the NICU between 24 and 40 weeks gestational age. Twenty-six different outcomes were reported which we classified into three categories: physiological parameters; growth and feeding; behavioural state, relaxation outcomes and pain. Live music interventions were shown to improve sleep in three out of the four studies and heart rate in two out of the four studies. Recorded music improved heart rate in two out of six studies. Better feeding and sucking outcomes were reported in one study using live music and in two studies using recorded music. Although music interventions show promising results in some studies, the variation in quality of the studies, age groups, outcome measures and timing of the interventions across the studies makes it difficult to draw strong conclusions on the effects of music in premature infants.
Marianne J E van der Heijden
Full Text Available Neonatal intensive care units (NICU around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the possible benefits of music interventions on premature infants' well-being.We searched 13 electronic databases and 12 journals from their first available date until August 2016. Included were all RCTs published in English with at least 10 participants per group, including infants born prematurely and admitted to the NICU. Interventions were either recorded music interventions or live music therapy interventions. All control conditions were accepted as long as the effects of the music intervention could be analysed separately. A meta-analysis was not possible due to incompleteness and heterogeneity of the data.After removal of duplicates the searches retrieved 4893 citations, 20 of which fulfilled the inclusion/exclusion criteria. The 20 included studies encompassed 1128 participants receiving recorded or live music interventions in the NICU between 24 and 40 weeks gestational age. Twenty-six different outcomes were reported which we classified into three categories: physiological parameters; growth and feeding; behavioural state, relaxation outcomes and pain. Live music interventions were shown to improve sleep in three out of the four studies and heart rate in two out of the four studies. Recorded music improved heart rate in two out of six studies. Better feeding and sucking outcomes were reported in one study using live music and in two studies using recorded music.Although music interventions show promising results in some studies, the variation in quality of the studies, age groups, outcome measures and timing of the interventions across the studies makes it difficult to draw strong conclusions on the effects of music in premature infants.
SOARES CLÁUDIO DE NOVAES
Full Text Available BACKGROUND: Untreated GH-deficient adults have a diversity of dysfunctions (e.g. reduced muscle strength, emotional instability during stress, depressive symptoms that may cause deleterious effects on quality of life, and may be positively influenced by recombinant human growth hormone (rh-GH therapy. AIM: To evaluate the impact of a clinical intervention with rh-GH therapy on GH - deficient adults. METHOD: The physical, psychiatric and neuropsychological status of 9 GH-deficient adults was determined before and after the administration of rh-GH (0.250 IU/Kg/week in a double blind placebo-controlled trial for six months. Patients then received rh-GH for a further period of 6 months and their status was re-evaluated. RESULTS: Rh-GH was significant better than placebo at 6th month (p<0.05, producing increased serum Insulin like growth factor-I (IGF-1 levels, reduced body mass index (BMI and body fat, increased lean body mass and water, reduced waist/hip ratio and increased energy expenditure. The rh-GH therapy was also significantly better than placebo on depressive features as measured by the Hamilton Depression Scale (17-items (p= 0.0431 and the Beck Depression Inventory (p= 0.0431. Neuropsychological evaluations showed significant improvements in measures of Attention: Digit Backward (p= 0.035,Verbal Fluency (FAS (p= 0.02 and Cognitive Efficiency (WAIS-R tests: Vocabulary (p= 0.027 , Picture Arrangements (p= 0.017, and Comprehension (p= 0.01 following rh-GH therapy. CONCLUSION: The clinical, psychiatric, and neuropsychological impairments of untreated GH-deficient adults can be decreased by rh-GH therapy.
Gladstone, Tracy G; Marko-Holguin, Monika; Rothberg, Phyllis; Nidetz, Jennifer; Diehl, Anne; DeFrino, Daniela T; Harris, Mary; Ching, Eumene; Eder, Milton; Canel, Jason; Bell, Carl; Beardslee, William R; Brown, C Hendricks; Griffiths, Kathleen; Van Voorhees, Benjamin W
The high prevalence of major depressive disorder in adolescents and the low rate of successful treatment highlight a pressing need for accessible, affordable adolescent depression prevention programs. The Internet offers opportunities to provide adolescents with high quality, evidence-based programs without burdening or creating new care delivery systems. Internet-based interventions hold promise, but further research is needed to explore the efficacy of these approaches and ways of integrating emerging technologies for behavioral health into the primary care system. We developed a primary care Internet-based depression prevention intervention, Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training (CATCH-IT), to evaluate a self-guided, online approach to depression prevention and are conducting a randomized clinical trial comparing CATCH-IT to a general health education Internet intervention. This article documents the research framework and randomized clinical trial design used to evaluate CATCH-IT for adolescents, in order to inform future work in Internet-based adolescent prevention programs. The rationale for this trial is introduced, the current status of the study is reviewed, and potential implications and future directions are discussed. The current protocol represents the only current, systematic approach to connecting at-risk youth with self-directed depression prevention programs in a medical setting. This trial undertakes the complex public health task of identifying at-risk individuals through mass screening of the general primary care population, rather than solely relying on volunteers recruited over the Internet, and the trial design provides measures of both symptomatic and diagnostic clinical outcomes. At the present time, we have enrolled N = 234 adolescents/expected 400 and N = 186 parents/expected 400 in this trial, from N = 6 major health systems. The protocol described here provides a model
Gage Brian F
Full Text Available Abstract Background There is currently much interest in pharmacogenetics: determining variation in genes that regulate drug effects, with a particular emphasis on improving drug safety and efficacy. The ability to determine such variation motivates the application of personalized drug therapies that utilize a patient's genetic makeup to determine a safe and effective drug at the correct dose. To ascertain whether a genotype-guided drug therapy improves patient care, a personalized medicine intervention may be evaluated within the framework of a randomized controlled trial. The statistical design of this type of personalized medicine intervention requires special considerations: the distribution of relevant allelic variants in the study population; and whether the pharmacogenetic intervention is equally effective across subpopulations defined by allelic variants. Methods The statistical design of the Clarification of Optimal Anticoagulation through Genetics (COAG trial serves as an illustrative example of a personalized medicine intervention that uses each subject's genotype information. The COAG trial is a multicenter, double blind, randomized clinical trial that will compare two approaches to initiation of warfarin therapy: genotype-guided dosing, the initiation of warfarin therapy based on algorithms using clinical information and genotypes for polymorphisms in CYP2C9 and VKORC1; and clinical-guided dosing, the initiation of warfarin therapy based on algorithms using only clinical information. Results We determine an absolute minimum detectable difference of 5.49% based on an assumed 60% population prevalence of zero or multiple genetic variants in either CYP2C9 or VKORC1 and an assumed 15% relative effectiveness of genotype-guided warfarin initiation for those with zero or multiple genetic variants. Thus we calculate a sample size of 1238 to achieve a power level of 80% for the primary outcome. We show that reasonable departures from these
Pechmann, C; K. Delucchi; Lakon, CM; Prochaska, JJ
Background We evaluated a novel Twitter-delivered intervention for smoking cessation, Tweet2Quit, which sends daily, automated communications to small, private, self-help groups to encourage high-quality, online, peer-to-peer discussions. Design A 2-group randomised controlled trial assessed the net benefit of adding a Tweet2Quit support group to a usual care control condition of nicotine patches and a cessation website. Participants Participants were 160 smokers (4 cohorts of 40/cohort), age...
Lou, Peian; Zhu, Yanan; Chen, Peipei; Zhang, Pan; YU, Jiaxi; Zhang, Ning; Chen, Na; Zhang, Lei; Wu, Hongmin; Zhao, Jing
Background Cigarette smoking is the major risk factor for chronic obstructive pulmonary disease (COPD). But a fewer smoking cessation measures were conducted in communities for smokers with COPD in China. The aim of our study was to assess the preventive effects of behavioral interventions for smoking cessation and potential impact factors in smokers with COPD in China. Methods In a randomised controlled smoking cessation trial 3562 patients with COPD who were current smoker were allocated to...
Mummah, Sarah; Robinson, Thomas N; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D
Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Overweight adults (n=135) aged 18-50 years with BMI=28-40 kg/m 2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) and randomly assigned to either the stand-alone, theory-based Vegethon mobile app (enabling goal setting, self-monitoring, and feedback and using "process motivators" including fun, surprise, choice, control, social comparison, and competition) or a wait-listed control condition. The primary outcome was daily vegetables servings, measured by an adapted Harvard food frequency questionnaire (FFQ) 8 weeks post-randomization. Daily vegetable servings from 24-hour dietary recalls, administered by trained, certified, and blinded interviewers 5 weeks post-randomization, was included as a secondary outcome. All analyses were conducted according to principles of intention-to-treat. Daily vegetable consumption was significantly greater in the intervention versus control condition for both measures (adjusted mean difference: 2.0 servings; 95% CI: 0.1, 3.8, p=0.04 for FFQ; and 1.0 servings; 95% CI: 0.2, 1.9; p=0.02 for 24-hour recalls). Baseline vegetable consumption was a significant moderator of intervention effects (p=0.002) in which effects increased as baseline consumption increased. These results demonstrate the efficacy of a mobile app to increase vegetable consumption among overweight adults. Theory-based mobile interventions may present a low-cost, scalable, and effective approach to improving dietary behaviors and preventing associated chronic diseases. ClinicalTrials.gov NCT01826591. Registered 27 March 2013.
Prestwich, A; Conner, MT; Lawton, RJ; Ward, JK; Ayres, K; McEachan, RRC
OBJECTIVE: The research tested the efficacy of partner- and planning-based interventions to reduce dietary fat intake over a 6-month period. DESIGN: Randomized controlled, blinded, parallel trial. METHODS: A computer randomization feature was used to allocate council employees (N = 427, of which 393 completed baseline measures) to one of four conditions (partner + implementation intentions, partner-only, implementation intentions, and control group) before they completed measures at baseline ...
Adamsen, Lis; Quist, Morten; Andersen, Christina; M?ller, Tom; Herrstedt, J?rn; Kronborg, Dorte; Baadsgaard, Marie T; Vistisen, Kirsten; Midtgaard, Julie; Christiansen, Birgitte; Stage, Maria; Kronborg, Morten T; R?rth, Mikael
Objective To assess the effect of a multimodal group exercise intervention, as an adjunct to conventional care, on fatigue, physical capacity, general wellbeing, physical activity, and quality of life in patients with cancer who were undergoing adjuvant chemotherapy or treatment for advanced disease. Design Randomised controlled trial. Setting Two university hospitals in Copenhagen, Denmark. Participants 269 patients with cancer; 73 men, 196 women, mean age 47 years (range 20-65) representing...
Full Text Available Abstract Background Interventions are needed which can successfully modify more than one disease risk factor at a time, but much remains to be learned about the acceptability, feasibility, and effectiveness of multiple risk factor (MRF interventions. To address these issues and inform future intervention development, we conducted a randomized pilot trial (n = 52. This study was designed to assess the feasibility and acceptability of the Step Up program, a MRF cognitive-behavioral program designed to improve participants' mental and physical well-being by reducing depressive symptoms, promoting smoking cessation, and increasing physical activity. Methods Participants were recruited from a large health care organization and randomized to receive usual care treatment for depression, smoking, and physical activity promotion or the phone-based Step Up counseling program plus usual care. Participants were assessed at baseline, three and six months. Results The intervention was acceptable to participants and feasible to offer within a healthcare system. The pilot also offered important insights into the optimal design of a MRF program. While not powered to detect clinically significant outcomes, changes in target behaviors indicated positive trends at six month follow-up and statistically significant improvement was also observed for depression. Significantly more experimental participants reported a clinically significant improvement (50% reduction in their baseline depression score at four months (54% vs. 26%, OR = 3.35, 95% CI [1.01- 12.10], p = 0.05 and 6 months (52% vs. 13%, OR = 7.27, 95% CI [1.85 - 37.30], p = 0.004 Conclusions Overall, results suggest the Step Up program warrants additional research, although some program enhancements may be beneficial. Key lessons learned from this research are shared to promote the understanding of others working in this field. Trial registration The trial is registered with ClinicalTrials.gov (NCT00644995.
Ziaei, Saeideh; Masoumi, Raziyeh; Faghihzadeh, Soghrat
Introduction Many postmenopausal women who are on hormone replacement therapy discontinue medications due to vaginal bleeding. Tibolone, a synthetic steroid, has minimal stimulatory effect on the endometrium. The aim of this study was to assess the effects of continuous HRT regimen and tibolone on the onset of vaginal bleeding and vaginal maturation value. Materials and Methods A total of 150 healthy women in postmenopausal period were randomly enrolled in this controlled clinical trial. Pati...
Maddison, Ralph; Marsh, Samantha; Foley, Louise; Epstein, Leonard H; Olds, Timothy; Dewes, Ofa; Heke, Ihirangi; Carter, Karen; Jiang, Yannan; Mhurchu, Cliona Ni
Screen-based activities, such as watching television (TV), playing video games, and using computers, are common sedentary behaviors among young people and have been linked with increased energy intake and overweight. Previous home-based sedentary behaviour interventions have been limited by focusing primarily on the child, small sample sizes, and short follow-up periods. The SWITCH (Screen-Time Weight-loss Intervention Targeting Children at Home) study aimed to determine the effect of a home-based, family-delivered intervention to reduce screen-based sedentary behaviour on body composition, sedentary behaviour, physical activity, and diet over 24 weeks in overweight and obese children. A two-arm, parallel, randomized controlled trial was conducted. Children and their primary caregiver living in Auckland, New Zealand were recruited via schools, community centres, and word of mouth. The intervention, delivered over 20 weeks, consisted of a face-to-face meeting with the parent/caregiver and the child to deliver intervention content, which focused on training and educating them to use a wide range of strategies designed to reduce their child's screen time. Families were given Time Machine TV monitoring devices to assist with allocating screen time, activity packages to promote alternative activities, online support via a website, and monthly newsletters. Control participants were given the intervention material on completion of follow-up. The primary outcome was change in children's BMI z-score from baseline to 24 weeks. Children (n = 251) aged 9-12 years and their primary caregiver were randomized to receive the SWITCH intervention (n = 127) or no intervention (controls; n = 124). There was no significant difference in change of zBMI between the intervention and control groups, although a favorable trend was observed (-0.016; 95% CI: -0.084, 0.051; p = 0.64). There were also no significant differences on secondary outcomes, except for a trend towards
Hattar, Anne; Hagger, Martin S; Pal, Sebely
Overweight and obesity are major health problems worldwide. This protocol describes the HEALTHI (Healthy Eating and Active LifesTyle Health Intervention) Program, a 12-week randomised-controlled weight-loss intervention that adopts two theory-based intervention techniques, mental imagery and implementation intentions, a behaviour-change technique based on planning that have been shown to be effective in promoting health-behaviour change in previous research. The effectiveness of goal-reminder text messages to augment intervention effects will also be tested. The trial will determine the effects of a brief, low cost, theory-based weight-loss intervention to improve dietary intake and physical activity behaviour and facilitate weight-loss in overweight and obese individuals. Overweight or obese participants will be randomly allocated to one of three conditions: (1) a psycho-education plus an implementation intentions and mental imagery condition; (2) a psycho-education plus an implementation intentions and mental imagery condition with text messages; or (3) a psycho-education control condition. The intervention will be delivered via video presentation to increase the intervention's applicability in multiple contexts and keep costs low. We hypothesise that the intervention conditions will lead to statistically-significant changes in the primary and secondary outcome variables measured at 6 and 12 weeks post-intervention relative to the psycho-education control condition after controlling for baseline values. The primary outcome variable will be body weight and secondary outcome variables will be biomedical (body mass, body fat percentage, muscle mass, waist-hip circumference ratio, systolic and diastolic blood pressure, low-density lipoprotein, high-density lipoprotein, total cholesterol, triglycerides, blood glucose and insulin levels), psychological (quality of life, motivation, risk perception, outcome expectancy, intention, action self-efficacy, maintenance self
Full Text Available Nilesh J Goswami,1 Mitch DeKoven,2 Andreas Kuznik,3 Jack Mardekian,3 Michelle R Krukas,2 Larry Z Liu,3,4 Patrick Bailey,1 Cynthia Deitrick,5 John Vincent3 1Prairie Heart Cardiovascular Consultants, Springfield, IL, USA; 2Health Economics and Outcomes Research, IMS Health, Alexandria, VA, USA; 3Pfizer Inc, New York, NY, USA; 4Weill Cornell Medical College, Cornell University, New York, NY, USA; 5Prairie Heart Education and Research Cooperative, Springfield, IL, USA Background: This trial evaluated the effectiveness of an integrated intervention program that included a 3-to-5-minute nurse counseling session, copay relief cards, and a monthly newsletter on adherence to atorvastatin treatment. Methods and results: A prospective, integrated (composed of nurse counseling, adherence tip sheet, copay relief card, opportunity to enroll in 12-week cholesterol management program randomized interventional study was designed involving patients >21 years of age who were prescribed atorvastatin at a large single-specialty cardiovascular physician practice in Illinois from March 2010 to May 2011. Data from the practice's electronic medical record were matched/merged to IMS Health's longitudinal data. A total of 500 patients were enrolled (125 in the control arm; 375 in the intervention arm. After data linkage, 53 control patients and 155 intervention patients were included in the analysis. Results: Mean age was 67.8 years (control and 69.5 years (intervention; 67.9% and 58.7%, respectively, were male. The mean 6-month adherence rate was 0.82 in both arms. The mean proportion of days covered for both the new-user control and intervention groups was the same, averaging 0.70 day (standard deviation [SD], 0.27 day; for continuing users, the proportion of days covered for the control group was 0.83 (SD, 0.24 and for the intervention group was 0.84 (SD, 0.22. For continuing users, the control group had mean persistent days of 151.6 (SD, 50.2 compared with 150.9 days
Full Text Available This study aimed to evaluate the effect of a lay health worker (LHW telephone intervention on completing a series of hepatitis B virus (HBV vaccinations among foreign-born Asian Americans in the Baltimore-Washington Metropolitan area.During the period of April 2013 and March 2014, we recruited Asian Americans who were 18 years of age and older in the community-based organizations. Of the 645 eligible participants, 600 (201 Chinese, 198 Korean, 201 Vietnamese completed a pretest survey and received hepatitis B screening. Based on the screening results, we conducted a randomized controlled trial among those unprotected (HBsAg-/HBsAB- by assigning them either to an intervention group (n = 124 or control group (n = 108. The intervention group received a list of resources by mails for where to get free vaccinations as well as reminder calls for vaccinations from trained LHWs, while the control group received only list of resources by mail. Seven months after mailing the HBV screening results, trained LHWs followed up with all participants by phone to ask how many of the recommended series of 3 vaccinations they had received: none, 1 or 2, or all 3 (complete. Their self-reported vaccinations were verified with the medical records. Multinomial logistic regressions were used to examine the effect of the LHW intervention. Process evaluation was conducted by asking study participants in the intervention group to evaluate the performance of the LHWs.After seven months, those in the intervention group were more likely to have 1 or more vaccines than the control group, compared to the no vaccination group (OR = 3.04, 95% CI, 1.16, 8.00. Also, those in the intervention group were more likely to complete a series of vaccinations than the control group, compared to the no vaccination group (OR = 7.29, 95% CI 3.39, 15.67. The most important barrier preventing them from seeking hepatitis B vaccinations was lack of time to get the vaccination. The most important
Mouthaan, Joanne; Sijbrandij, Marit; de Vries, Giel-Jan; Reitsma, Johannes B; van de Schoot, Rens; Goslings, J Carel; Luitse, Jan S K; Bakker, Fred C; Gersons, Berthold P R; Olff, Miranda
targeting high-risk individuals who are more likely to benefit from the intervention. International Standard Randomized Controlled Trial Number (ISRCTN): 57754429; http://www.controlled-trials.com/ISRCTN57754429 (Archived by WebCite at http://webcitation.org/6FeJtJJyD).
Lancaster, G A; Campbell, M J; Eldridge, S; Farrin, A; Marchant, M; Muller, S; Perera, R; Peters, T J; Prevost, A T; Rait, G
Trials carried out in primary care typically involve complex interventions that require considerable planning if they are to be implemented successfully. The role of the statistician in promoting both robust study design and appropriate statistical analysis is an important contribution to a multi-disciplinary primary care research group. Issues in the design of complex interventions have been addressed in the Medical Research Council's new guidance document and over the past 7 years by the Royal Statistical Society's Primary Health Care Study Group. With the aim of raising the profile of statistics and building research capability in this area, particularly with respect to methodological issues, the study group meetings have covered a wide range of topics that have been of interest to statisticians and non-statisticians alike. The aim of this article is to provide an overview of the statistical issues that have arisen over the years related to the design and evaluation of trials in primary care, to provide useful examples and references for further study and ultimately to promote good practice in the conduct of complex interventions carried out in primary care and other health care settings. Throughout we have given particular emphasis to statistical issues related to the design of cluster randomised trials.
Osrin, David; Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M
Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of - and responsibility for - group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.
Noonan, Curtis W; Semmens, Erin O; Smith, Paul; Harrar, Solomon W; Montrose, Luke; Weiler, Emily; McNamara, Marcy; Ward, Tony J
Household air pollution due to biomass combustion for residential heating adversely affects vulnerable populations. Randomized controlled trials to improve indoor air quality in homes of children with asthma are limited, and no such studies have been conducted in homes using wood for heating. Our aims were to test the hypothesis that household-level interventions, specifically improved-technology wood-burning appliances or air-filtration devices, would improve health measures, in particular Pediatric Asthma Quality of Life Questionnaire (PAQLQ) scores, relative to placebo, among children living with asthma in homes with wood-burning stoves. A three-arm placebo-controlled randomized trial was conducted in homes with wood-burning stoves among children with asthma. Multiple preintervention and postintervention data included PAQLQ (primary outcome), peak expiratory flow (PEF) monitoring, diurnal peak flow variability (dPFV, an indicator of airway hyperreactivity) and indoor particulate matter (PM) PM2.5. Relative to placebo, neither the air filter nor the woodstove intervention showed improvement in quality-of-life measures. Among the secondary outcomes, dPFV showed a 4.1 percentage point decrease in variability [95% confidence interval (CI)=-7.8 to -0.4] for air-filtration use in comparison with placebo. The air-filter intervention showed a 67% (95% CI: 50% to 77%) reduction in indoor PM2.5, but no change was observed with the improved-technology woodstove intervention. Among children with asthma and chronic exposure to woodsmoke, an air-filter intervention that improved indoor air quality did not affect quality-of-life measures. Intent-to-treat analysis did show an improvement in the secondary measure of dPFV. ClincialTrials.gov NCT00807183. https://doi.org/10.1289/EHP849.
Ewald, H; Kirby, J.; Rees, K; W. Robertson
Background An effective and cost-effective treatment is required for the treatment of childhood obesity. Comparing parent-only interventions with interventions including the child may help determine this. Methods A systematic review of published and ongoing studies until 2013, using electronic database and manual searches. Inclusion criteria: randomized controlled trials, overweight/obese children aged 5-12 years, parent-only intervention compared with an intervention that included the child,...
Gautam, Om Prasad; Schmidt, Wolf-Peter; Cairncross, Sandy; Cavill, Sue; Curtis, Valerie
In this study, we report on the results of a trial of an intervention to improve five food hygiene behaviors among mothers of young children in rural Nepal. This novel intervention targeted five behaviors; cleanliness of serving utensils, handwashing with soap before feeding, proper storage of cooked food, and thorough reheating and water treatment. Based on formative research and a creative process using the Behavior-Centered Design approach, an innovative intervention package was designed and delivered over a period of 3 months. The intervention activities included local rallies, games, rewards, storytelling, drama, competitions linking with emotional drivers of behavior, and “kitchen makeovers” to disrupt behavior settings. The effect of the package on behavior was evaluated via a cluster-randomized before–after study in four villages with four villages serving as controls. The primary outcome was the difference in the mean cluster level proportions of mothers directly observed practicing all five food hygiene behaviors. The five targeted food hygiene behaviors were rare at baseline (composite performance of all five behaviors in intervention 1% [standard deviation (SD) = 2%] and in control groups 2% [SD = 2%]). Six weeks after the intervention, the target behaviors were more common in the intervention than in the control group (43% [SD = 14%] versus 2% [SD = 2%], P = 0.02) during follow-up. The intervention appeared to be equally effective in improving all five behaviors in all intervention clusters. This study shows that a theory-driven, systematic approach employing emotional motivators and modifying behavior settings was capable of substantially improving multiple food hygiene behaviors in Nepal. PMID:28719285
Theise, Rachelle; Huang, Keng-Yen; Kamboukos, Dimitra; Doctoroff, Greta L; Dawson-McClure, Spring; Palamar, Joseph J; Brotman, Laurie Miller
The current study examined whether parent psychological resources (parenting stress, depression, and social support from friends and family) moderated the effects of early family preventive intervention on parenting among high-risk families. Ninety-two preschool-age children (M age = 3.94 years) at familial risk for conduct problems participated in a randomized controlled trial of a family intervention to prevent conduct problems. The majority of families were African American or Latino and experienced multiple stressors associated with poverty and familial antisocial behavior. Families were randomized to a 22-session group-based intervention or to a no-intervention, assessment-only control condition. Parents reported on their psychological resources (parenting stress, depression and social support from friends and family) at baseline. Parenting (responsive, harsh, stimulation for learning) was assessed through self-report and observational measures four times over 24 months. Previously-reported intervention effects on responsive parenting and stimulation for learning were moderated by depression and social support from friends, respectively, such that benefits were concentrated among those at greatest risk (i.e., depressed, limited support from friends). The intervention effect on harsh parenting was not moderated by any of the parent psychological resources examined, such that parents with high and low resources benefited comparably. Consideration of moderators of preventive intervention effects on parenting provides important information about intervention impact among families experiencing multiple barriers to engagement and effective parenting. Findings suggest that parents with diminished psychological resources are just as likely to benefit. Family-focused, group-based intervention is promising for strengthening parenting among the highest risk families.
Bhatia, R Sacha; Dudzinski, David M; Malhotra, Rajeev; Milford, Creagh E; Yoerger Sanborn, Danita M; Picard, Michael H; Weiner, Rory B
This study sought to prospectively study the impact of an appropriate use criteria (AUC)-based educational intervention on outpatient transthoracic echocardiography (TTE) ordering by physicians-in-training. AUC were developed in response to concerns about inappropriate utilization. It is unknown whether an educational intervention can reduce inappropriate outpatient TTE. We conducted a randomized control trial in which physicians-in-training were randomized to an AUC-based educational intervention or a control group at an academic medical center in Boston, Massachusetts. The primary endpoints were the rates of inappropriate and appropriate TTE. For the cardiology physicians-in-training, the proportion of inappropriate TTE was significantly lower in the intervention than in the control group (13% vs. 34%, p intervention group was significantly higher than that of the control group (81% vs. 58%, p intervention group was 2.7 (95% confidence interval [CI]: 1.5 to 5.1, p = 0.002) relative to the control group. The internal medicine physicians-in-training ordered a small number of TTE overall, and there was a trend toward significant odds of ordering an appropriate TTE in the intervention group relative to the control group (odds ratio [OR]: 8.1, 95% CI: 0.95 to 69.0, p = 0.055). Six clinical scenarios accounted for 75% of all inappropriate TTE, with the 3 most common inappropriate indications being routine surveillance (educational and feedback intervention reduced the proportion of inappropriate outpatient TTE and increased the proportion of appropriate outpatient TTE. (Educational Intervention to Reduce Outpatient Inappropriate Transthoracic Echocardiograms; NCT01944202). Copyright © 2014. Published by Elsevier Inc.
Cabezas, Carmen; Advani, Mamta; Puente, Diana; Rodriguez-Blanco, Teresa; Martin, Carlos
To evaluate the effectiveness in primary care of a stepped smoking cessation intervention based on the transtheoretical model of change. Cluster randomized trial; unit of randomization: basic care unit (family physician and nurse who care for the same group of patients); and intention-to-treat analysis. All interested basic care units (n = 176) that worked in 82 primary care centres belonging to the Spanish Preventive Services and Health Promotion Research Network in 13 regions of Spain. A total of 2,827 smokers (aged 14-85 years) who consulted a primary care centre for any reason, provided written informed consent and had valid interviews. The outcome variable was the 1-year continuous abstinence rate at the 2-year follow-up. The main variable was the study group (intervention/control). Intervention involved 6-month implementation of recommendations from a Clinical Practice Guideline which included brief motivational interviews for smokers at the precontemplation-contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help and reinforcing intervention in the maintenance stage. Control group involved usual care. Among others, characteristics of tobacco use and motivation to quit variables were also collected. The 1-year continuous abstinence rate at the 2-year follow-up was 8.1% in the intervention group and 5.8% in the control group (P = 0.014). In the multivariate logistic regression, the odds of quitting of the intervention versus control group was 1.50 (95% confidence interval = 1.05-2.14). A stepped smoking cessation intervention based on the transtheoretical model significantly increased smoking abstinence at a 2-year follow-up among smokers visiting primary care centres. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.
Andersen, Anette; Krølner, Rikker; Bast, Lotus Sofie; Thygesen, Lau Caspar; Due, Pernille
Uptake of smoking in adolescence is still of major public health concern. Evaluations of school-based programmes for smoking prevention show mixed results. The aim of this study was to examine the effect of X:IT, a multi-component school-based programme to prevent adolescent smoking. Data from a Danish cluster randomized trial included 4041 year-7 students (mean age: 12.5) from 51 intervention and 43 control schools. Outcome measure 'current smoking' was dichotomized into smoking daily, weekly, monthly or more seldom vs do not smoke. Analyses were adjusted for baseline covariates: sex, family socioeconomic position (SEP), best friend's smoking and parental smoking. We performed multilevel, logistic regression analyses of available cases and intention-to-treat (ITT) analyses, replacing missing outcome values by multiple imputation. At baseline, 4.7% and 6.8% of the students at the intervention and the control schools smoked, respectively. After 1 year of the intervention, the prevalence was 7.9% and 10.7%, respectively. At follow-up, 553 students (13.7%) did not answer the question on smoking. Available case analyses: crude odds ratios (OR) for smoking at intervention schools compared with control schools: 0.65 (0.48-0.88) and adjusted: 0.70 (0.47-1.04). ITT analyses: crude OR for smoking at intervention schools compared with control schools: 0.67 (0.50-0.89) and adjusted: 0.61 (0.45-0.82). Students at intervention schools had a lower risk of smoking after a year of intervention in year 7. This multi-component intervention involving educational, parental and context-related intervention components seems to be efficient in lowering or postponing smoking uptake in Danish adolescents. © The Author 2015; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.
Boote, Jonathan; Julious, Steven; Horspool, Michelle; Elphick, Heather; Smithson, W Henry; Norman, Paul
Aims We describe how patient and public involvement (PPI) was integrated into the design of an intervention for a randomised controlled trial (RCT) based within primary care. The RCT, known as the PLEASANT trial, aimed to reduce unscheduled medical contacts in children with asthma associated with start of the new school year in September with a simple postal intervention, highlighting the importance of maintaining asthma medication for helping to prevent increased asthma exacerbations. PPI is a key feature of UK health research policy, and is often a requirement of funding from the National Institute for Health Research. There are few detailed accounts of PPI in the design and conduct of clinical trials in the PPI literature for researchers to learn from. We held PPI consultation events to determine whether the proposed intervention for the trial was acceptable to children with asthma and their parents, and to ascertain whether enhancements should be made. Two PPI consultation events were held with children with asthma and their parents, prior to the research commencing. Detailed field notes were taken by the research team at each consultation event. Findings At the first consultation event, parents and children endorsed the trial's rationale, made suggestions to the wording of the trial intervention letter, and made recommendations about to whom the letter should be sent out. At the second consultation event, parents discussed the timing of the intervention, commented on the lay summary of the Research Ethics Application, and were invited to join the trial's steering committee, while the children selected a logo for the study. PPI has resulted in enhancements to the PLEASANT study's intervention. A further PPI consultation event is scheduled for the end of the trial, in order for children with asthma and their parents to contribute to the trial's dissemination strategy.
Stark, Lori J; Opipari-Arrigan, Lisa; Filigno, Stephanie S; Simon, Stacey L; Leonard, Amanda; Mogayzel, Peter J; Rausch, Joseph; Zion, Cynthia; Powers, Scott W
Usability and pilot testing of a web intervention (BeInCharge.org [BIC]) of behavior plus nutrition intervention for children with cystic fibrosis (CF) ages 4-9 years. Think Aloud methodology was used with five mothers to assess usability and refine the intervention. A pilot trial was then conducted with 10 mothers of children with CF ages 4-9 years randomized to the web-based BIC or a Standard Care Control (STC). Change in weight gain for each group was compared in a pre-to-post design. Mothers rated the usability and clarity of BIC highly. The pilot trial showed children of mothers who received BIC had a significant change in weight pre-to-post-treatment (0.67 kg, p = .04). Change for the STC was not significant (0.41 kg, p = .10). A web-based behavior plus nutrition intervention appears promising in increasing weight gain in children with CF. © The Author 2015. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: email@example.com.
Franklin, James M; Gebski, Val; Poston, Graeme J; Sharma, Ricky A
Interventional oncology is a rapidly growing sub-speciality that aims to develop new disease-modifying treatment options beyond conventional surgical and oncological therapies in several disease settings. The evidence for interventional oncology success is dominated by single-arm studies reporting technical success or clinical efficacy. These studies have successfully resulted in the development of new techniques, but are not sufficient to change clinical practice uniformly across health-care systems. This Review discusses why clinical investigators must incorporate measures of cost-effectiveness and patient-reported outcomes into large-scale studies currently being designed to provide robust evidence for changing clinical practice. In particular, interventional oncology trials could be designed to show that certain treatments may be as effective as the current standard of care, but with significantly less morbidity and with better outcomes for patients with cancer. Innovative trial design and awareness of the challenges from interventional studies in other fields of medicine and surgery are also discussed to demonstrate how this new speciality can make progress. Registry-based models are emerging as an alternative means of deriving cohort data and can be used in parallel with local or national commissioning of new services.
Carla FJ Nooijen
Full Text Available Questions: For people with subacute spinal cord injury, does rehabilitation that is reinforced with the addition of a behavioural intervention to promote physical activity lead to a more active lifestyle than rehabilitation alone? Design: Randomised, controlled trial with concealed allocation, intention-to-treat analysis, and blinded assessors. Participants: Forty-five adults with subacute spinal cord injury who were undergoing inpatient rehabilitation and were dependent on a manual wheelchair. The spinal cord injuries were characterised as: tetraplegia 33%; motor complete 62%; mean time since injury 150 days (SD 74. Intervention: All participants received regular rehabilitation, including handcycle training. Only the experimental group received a behavioural intervention promoting an active lifestyle after discharge. This intervention involved 13 individual sessions delivered by a coach who was trained in motivational interviewing; it began 2 months before and ended 6 months after discharge from inpatient rehabilitation. Outcome measures: The primary outcome was physical activity, which was objectively measured with an accelerometer-based activity monitor 2 months before discharge, at discharge, and 6 and 12 months after discharge from inpatient rehabilitation. The accelerometry data were analysed as total wheeled physical activity, sedentary time and motility. Self-reported physical activity was a secondary outcome. Results: The behavioural intervention significantly increased wheeled physical activity (overall between-group difference from generalised estimating equation 21 minutes per day, 95% CI 8 to 35. This difference was evident 6 months after discharge (28 minutes per day, 95% CI 8 to 48 and maintained at 12 months after discharge (25 minutes per day, 95% CI 1 to 50. No significant intervention effect was found for sedentary time or motility. Self-reported physical activity also significantly improved. Conclusion: The behavioural
Young, Sean D; Cumberland, William G; Nianogo, Roch; Menacho, Luis A; Galea, Jerome T; Coates, Thomas
Social media technologies offer new approaches to HIV prevention and promotion of testing. We examined the efficacy of the Harnessing Online Peer Education (HOPE) social media intervention to increase HIV testing among men who have sex with men (MSM) in Peru. In this cluster randomised controlled trial, Peruvian MSM from Greater Lima (including Callao) who had sex with a man in the past 12 months, were 18 years of age or older, were HIV negative or serostatus unknown, and had a Facebook account or were willing to create one (N=556) were randomly assigned (1:1) by concealed allocation to join intervention or control groups on Facebook for 12 weeks. For the intervention, Peruvian MSM were trained and assigned to be HIV prevention mentors (peer-leaders) to participants in Facebook groups. The interventions period lasted 12 weeks. Participants in control groups received an enhanced standard of care, including standard offline HIV prevention available in Peru and participation in Facebook groups (without peer leaders) that provided study updates and HIV testing information. After accepting a request to join the groups, continued participation was voluntary. Participants also completed questionnaires on HIV risk behaviours and social media use at baseline and 12 week follow-up. The primary outcome was the number of participants who received a free HIV test at a local community clinic. The facebook groups were analysed as clusters to account for intracluster correlations. This trial is registered with ClinicalTrials.gov, number NCT01701206. Of 49 peer-leaders recruited, 34 completed training and were assigned at random to the intervention Facebook groups. Between March 19, 2012, and June 11, 2012, and Sept 26, 2012, and Dec 19, 2012, 556 participants were randomly assigned to intervention groups (N=278) or control groups (N=278); we analyse data for 252 and 246. 43 participants (17%) in the intervention group and 16 (7%) in the control groups got tested for HIV (adjusted
Skår, Silje; Sniehotta, Falko F; Molloy, Gerard J; Prestwich, Andrew; Araújo-Soares, Vera
Brief planning interventions, usually delivered within paper and pencil questionnaires, have been found to be effective in changing health behaviours. Using a double-blind randomised controlled trial, this study examined the efficacy of two types of planning interventions (action plans and coping plans) in increasing physical activity levels when they are delivered via the internet. Following the completion of self-reported physical activity (primary outcome) and theory of planned behaviour (TPB) measures at baseline, students (N = 1273) were randomised into one of four conditions on the basis of a 2 (received instructions to form action plans or not) × 2 (received instructions to form coping plans or not) factorial design. Physical activity (primary outcome) and TPB measures were completed again at two-month follow-up. An objective measure (attendance at the university's sports facilities) was employed 6 weeks after a follow-up for a duration of 13 weeks (secondary outcome). The interventions did not change self-reported physical activity, attendance at campus sports facilities or TPB measures. This might be due to low adherence to the intervention protocol (ranging from 58.8 to 76.7%). The results of this study suggest that the planning interventions under investigation are ineffective in changing behaviour when delivered online to a sample of participants unaware of the allocation to different conditions. Possible moderators of the effectiveness of planning interventions in changing health behaviours are discussed.
Menezes, Mariana Carvalho de; Mingoti, Sueli Aparecida; Cardoso, Clareci Silva; Mendonça, Raquel de Deus; Lopes, Aline Cristine Souza
To analyze the effects of an intervention based on the Transtheoretical Model on anthropometric and dietetic profile among women in the Primary Health Care in Brazil. Randomized controlled trial. The control group participated in physical activity and open group-education regarding nutrition of usual care. The intervention group participated in 10 workshops based on the Transtheoretical Model. Seventy-one women completed the study, with a mean age of 57.9±11.7years. Participants in the intervention group showed an improved body perception, reduced weight and body mass index post-intervention, and lower consumption of calories and foods high in fat. Significant weight reduction in the intervention group was associated with higher per capita income, reduced consumption of protein, reduced consumption of lipids, and the removal of visible fat from red meat and skin from chicken. An intervention based on the Transtheoretical Model promoted reduction in consumption of foods high in calories and fat, with positive effects on weight and body perception. These results provide evidence of the applicability and benefit of the Transtheoretical Model within primary care. Copyright © 2014 Elsevier Ltd. All rights reserved.
van Genugten, Lenneke; van Empelen, Pepijn; Boon, Brigitte; Borsboom, Gerard; Visscher, Tommy; Oenema, Anke
Prevention of weight gain has been suggested as an important strategy in the prevention of obesity and people who are overweight are a specifically important group to target. Currently there is a lack of weight gain prevention interventions that can reach large numbers of people. Therefore, we developed an Internet-delivered, computer-tailored weight management intervention for overweight adults. The focus of the intervention was on making small (100 kcal per day), but sustained changes in dietary intake (DI) or physical activity (PA) behaviors in order to maintain current weight or achieve modest weight loss. Self-regulation theory was used as the basis of the intervention. This study aims to evaluate the efficacy of the computer-tailored intervention in weight-related anthropometric measures (Body Mass Index, skin folds and waist circumference) and energy balance-related behaviors (physical activity; intake of fat, snacks and sweetened drinks) in a randomized controlled trial. The tailored intervention (TI) was compared to a generic information website (GI). Participants were 539 overweight adults (mean age 47.8 years, mean Body Mass Index (BMI) 28.04, 30.9% male, 10.7% low educated) who where recruited among the general population and among employees from large companies by means of advertisements and flyers. Anthropometric measurements were measured by trained research assistants at baseline and 6-months post-intervention. DI and PA behaviors were assessed at baseline, 1-month and 6-month post-intervention, using self-reported questionnaires. Repeated measurement analyses showed that BMI remained stable over time and that there were no statistically significant differences between the study groups (BMI: TI=28.09, GI=27.61, P=.09). Similar results were found for waist circumference and skin fold thickness. Amount of physical activity increased and intake of fat, snacks and sweetened drinks decreased during the course of the study, but there were no differences
Aveyard, Paul; Lewis, Amanda; Tearne, Sarah; Hood, Kathryn; Christian-Brown, Anna; Adab, Peymane; Begh, Rachna; Jolly, Kate; Daley, Amanda; Farley, Amanda; Lycett, Deborah; Nickless, Alecia; Yu, Ly-Mee; Retat, Lise; Webber, Laura; Pimpin, Laura; Jebb, Susan A
Obesity is a common cause of non-communicable disease. Guidelines recommend that physicians screen and offer brief advice to motivate weight loss through referral to behavioural weight loss programmes. However, physicians rarely intervene and no trials have been done on the subject. We did this trial to establish whether physician brief intervention is acceptable and effective for reducing bodyweight in patients with obesity. In this parallel, two-arm, randomised trial, patients who consulted 137 primary care physicians in England were screened for obesity. Individuals could be enrolled if they were aged at least 18 years, had a body-mass index of at least 30 kg/m(2) (or at least 25 kg/m(2) if of Asian ethnicity), and had a raised body fat percentage. At the end of the consultation, the physician randomly assigned participants (1:1) to one of two 30 s interventions. Randomisation was done via preprepared randomisation cards labelled with a code representing the allocation, which were placed in opaque sealed envelopes and given to physicians to open at the time of treatment assignment. In the active intervention, the physician offered referral to a weight management group (12 sessions of 1 h each, once per week) and, if the referral was accepted, the physician ensured the patient made an appointment and offered follow-up. In the control intervention, the physician advised the patient that their health would benefit from weight loss. The primary outcome was weight change at 12 months in the intention-to-treat population, which was assessed blinded to treatment allocation. We also assessed asked patients' about their feelings on discussing their weight when they have visited their general practitioner for other reasons. Given the nature of the intervention, we did not anticipate any adverse events in the usual sense, so safety outcomes were not assessed. This trial is registered with the ISRCTN Registry, number ISRCTN26563137. Between June 4, 2013, and Dec 23, 2014
Andersen, Lars; Jørgensen, Marie Birk; Blangsted, Anne
resistance training (SRT, n = 180), all-round physical exercise (APE, n = 187), and reference intervention (REF, n = 182) with general health counseling. Physical tests were performed and questionnaires answered at pre-, mid-, and postintervention. The main outcome measures were compliance, changes......PURPOSE:: The objective of this study is to investigate the effect of three different workplace interventions on long-term compliance, muscle strength gains, and neck/shoulder pain in office workers. METHODS:: A 1-yr randomized controlled intervention trial was done with three groups: specific...... in maximal muscle strength, and changes in intensity of neck/shoulder pain (scale 0-9) in those with and without pain at baseline. RESULTS:: Regular participation was achieved by 54%, 31%, and 16% of those of the participants who answered the questionnaire in SRT (78%), APE (81%), and REF (80%), respectively...
Background Research in suicide prevention using psychosocial interventions is rapidly advancing. However, randomised controlled trials are published across a range of medical, psychological and sociology journals, and it can be difficult to locate a full set of research studies. In this paper, we present a database of randomised controlled outcome studies on psychosocial interventions targeting suicidal behaviour. The database is updated annually and can be accessed by contacting the corresponding author. Description A comprehensive literature search of the major bibliographical databases (PsycINFO; PubMed; Cochrane Central Register of Controlled Trials) was conducted for articles published between 1800 to July 30 2013, and examined reference lists of previous relevant reviews and included papers to locate additional references. Studies were included if they featured a randomised controlled design in which the effects of a psychosocial intervention were compared to a control condition (no intervention, attention placebo, wait-list, treatment-as-usual [TAU]), another psychosocial intervention or a pharmacological intervention. In total, 12,250 abstracts were identified. Of these, 131 studies met eligibility criteria and were included. Each paper was then coded into categories of participant characteristics (age, gender, formal diagnosis, primary reason for recruitment); details of the intervention (recruitment setting, content, intervention setting, administering individual, delivery type, delivery format, delivery frequency, delivery length); and study characteristics (control and experimental conditions, primary outcome/s, secondary outcome/s, follow-up period). One paper has been published from the database using studies collected and coded prior to 2012. Conclusion The database and listing of 131 studies is available for use by suicide prevention researchers. It provides a strong starting point for systematic reviews and meta-analyses of treatments and
Allen, Kelli D; Oddone, Eugene Z; Coffman, Cynthia J; Jeffreys, Amy S; Bosworth, Hayden B; Chatterjee, Ranee; McDuffie, Jennifer; Strauss, Jennifer L; Yancy, William S; Datta, Santanu K; Corsino, Leonor; Dolor, Rowena J
A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions. To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes. Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109). 10 Duke University Health System community-based primary care clinics. 537 outpatients with symptomatic hip or knee osteoarthritis. The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups. No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care. The study involved 1 health care network. Data on provider referrals were not collected. Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically
Wyers, C E; Reijven, P L M; Evers, S M A A; Willems, P C; Heyligers, I C; Verburg, A D; van Helden, S; Dagnelie, P C
Hip fracture patients can benefit from nutritional supplementation during their recovery. Up to now, cost-effectiveness evaluation of nutritional intervention in these patients has not been performed. Costs of nutritional intervention are relatively low as compared with medical costs. Cost-effectiveness evaluation shows that nutritional intervention is likely to be cost-effective. Previous research on the effect of nutritional intervention on clinical outcome in hip fracture patients yielded contradictory results. Cost-effectiveness of nutritional intervention in these patients remains unknown. The aim of this study was to evaluate cost-effectiveness of nutritional intervention in elderly subjects after hip fracture from a societal perspective. Open-label, multi-centre randomized controlled trial investigating cost-effectiveness of intensive nutritional intervention comprising regular dietetic counseling and oral nutritional supplementation for 3 months postoperatively. Patients allocated to the control group received care as usual. Costs, weight and quality of life were measured at baseline and at 3 and 6 months postoperatively. Incremental cost-effectiveness ratios (ICERs) were calculated for weight at 3 months and quality adjusted life years (QALYs) at 6 months postoperatively. Of 152 patients enrolled, 73 were randomized to the intervention group and 79 to the control group. Mean costs of the nutritional intervention was 613 Euro. Total costs and subcategories of costs were not significantly different between both groups. Based on bootstrapping of ICERs, the nutritional intervention was likely to be cost-effective for weight as outcome over the 3-month intervention period, regardless of nutritional status at baseline. With QALYs as outcome, the probability for the nutritional intervention being cost-effective was relatively low, except in subjects aged below 75 years. Intensive nutritional intervention in elderly hip fracture patients is likely to be cost
McKenzie, Lara B; Roberts, Kristin J; Kaercher, Roxanne M; Collins, Christy L; Comstock, R Dawn; Fernandez, Soledad; Abdel-Rasoul, Mahmoud; Casavant, Marcel J; Mihalov, Leslie
Background Although non-fire-related carbon monoxide (CO) poisoning is almost entirely preventable, over 400 people die and 20 000 people are injured each year in the USA from unintentional CO poisoning. Thus, there is a critical need for evidence-based interventions for preventing CO poisoning and increasing the proper use and installation of CO detectors. Methods A randomised, controlled trial (Project CODE, a Carbon Monoxide Detector Education intervention) with 2-week and 6-month follow-up home observations was conducted in 299 parents of children aged ≤18 years recruited in the emergency department of a level 1 paediatric trauma centre. The intervention group received an educational tool, a spiral-bound, laminated booklet that resembled a CO detector containing theory-based safety messages based on the precaution adoption process model, a plug-in CO detector and 9 V battery. The control group received a one page flyer on CO poisoning prevention. Results Although the difference was not statistically significant, mean CO knowledge score increased at a greater rate for the intervention group than the control group. Intervention group parents were more likely to exhibit ‘safe’ CO detector use than control group parents at the 2-week follow-up (RR: 2.75; 95% CI 2.06 to 3.69) and 6-month follow-up (RR: 2.78; 95% CI 2.06 to 3.76), after adjusting for self-reported CO detector use behaviour at enrolment and annual per capita income. Conclusions An emergency department-delivered intervention containing a theory-based educational tool paired with a CO detector can be an effective method for increasing knowledge about CO poisoning, for prevention and for appropriate use of a CO detector. Trial registration number NCT00959478. PMID:28007971
Chisholm, Katharine Elizabeth; Patterson, Paul; Torgerson, Carole; Turner, Erin; Birchwood, Max
With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors' knowledge. If efficacious the intervention could provide a
Hawkins, Marquis; Braun, Barry; Marcus, Bess H; Stanek, Edward; Markenson, Glenn; Chasan-Taber, Lisa
C-reactive protein (CRP) during pregnancy has been associated with adverse maternal outcomes such as preeclampsia and gestational diabetes mellitus. Randomized trials suggest that exercise programs may be associated with reductions in CRP in non-pregnant populations; however, such studies have not been conducted among pregnant women. The purpose of this study was to evaluate the impact of an individually-tailored motivationally-matched exercise intervention on CRP in pregnant women. The Behaviors Affecting Baby and You study was a randomized controlled trial of prenatal physical activity to prevent the development of gestational diabetes mellitus in women at increased risk. Women were randomized to either a 12-week exercise intervention (n = 84) or a comparison health and wellness intervention (n = 87). High sensitivity CRP (mg/dL) was measured using a commercial immunoassay kit. Physical activity was measured using the Pregnancy Physical Activity Questionnaire. Mixed model analyses were used to evaluate the impact of the intervention on change in CRP using an intent-to-treat approach. CRP decreased (-0.09 mg/dL, 95 % CI: -0.25, 0.07) from pre- to post-intervention in the exercise arm (p = 0.14) and increased (0.08 mg/dL, 95 % CI: -0.07, 0.24) (p = 0.64) in the health and wellness arm; however the between group difference was not statistically significant (p = 0.14). Findings did not differ according to ethnic group or pre-pregnancy body mass index. In a secondary analysis based on self-reported physical activity, women who decreased their time spent in sports/exercise experienced a mean increase in CRP (0.09 mg/dL, 95 % CI: -0.14, 0.33), whereas women who maintained or increased their sports/ exercise experienced a mean decrease in CRP (-0.08 mg/dL, 95 % CI: -0.23, 0.08) (p = 0.046). Findings from this randomized trial in an ethnically and socio-economically diverse population of pregnant women were consistent with a positive impact
Full Text Available Abstract Background Obesity and asthma have reached epidemic proportions in the US. Their concurrent rise over the last 30 years suggests that they may be connected. Numerous observational studies support a temporally-correct, dose-response relationship between body mass index (BMI and incident asthma. Weight loss, either induced by surgery or caloric restriction, has been reported to improve asthma symptoms and lung function. Due to methodological shortcomings of previous studies, however, well-controlled trials are needed to investigate the efficacy of weight loss strategies to improve asthma control in obese individuals. Methods/Design BE WELL is a 2-arm parallel randomized clinical trial (RCT of the efficacy of an evidence-based, comprehensive, behavioral weight loss intervention, focusing on diet, physical activity, and behavioral therapy, as adjunct therapy to usual care in the management of asthma in obese adults. Trial participants (n = 324 are patients aged 18 to 70 years who have suboptimally controlled, persistent asthma, BMI between 30.0 and 44.9 kg/m2, and who do not have serious comorbidities (e.g., diabetes, heart disease, stroke. The 12-month weight loss intervention to be studied is based on the principles of the highly successful Diabetes Prevention Program lifestyle intervention. Intervention participants will attend 13 weekly group sessions over a four-month period, followed by two monthly individual sessions, and will then receive individualized counseling primarily by phone, at least bi-monthly, for the remainder of the intervention. Follow-up assessment will occur at six and 12 months. The primary outcome variable is the overall score on the Juniper Asthma Control Questionnaire measured at 12 months. Secondary outcomes include lung function, asthma-specific and general quality of life, asthma medication use, asthma-related and total health care utilization. Potential mediators (e.g., weight loss and change in physical
Cybulski, Lukasz; Mayo-Wilson, Evan; Grant, Sean
Prospective registration increases the validity of randomized controlled trials (RCTs). In the United States, registration is a legal requirement for drugs and devices regulated by the Food and Drug Administration (FDA), and many biomedical journals refuse to publish trials that are not registered. Trials in clinical psychology have not been subject to these requirements; it is unknown to what extent they are registered. We searched the 25 highest-impact clinical psychology journals that published at least 1 RCT of a health-related psychological intervention in 2013. For included trials, we evaluated their registration status (prospective, retrospective, not registered) and the completeness of their outcome definitions. We identified 163 articles that reported 165 RCTs; 73 (44%) RCTs were registered, of which only 25 (15%) were registered prospectively. Of registered RCTs, only 42 (58%) indicated their registration status in the publication. Only 2 (1% of all trials) were registered prospectively and defined their primary outcomes completely. For the primary outcome(s), 72 (99%) of all registrations defined the domain, 67 (92%) the time frame, and 48 (66%) the specific measurements. Only 19 (26%) and 5 (7%) defined the specific metric and method of aggregation, respectively, for all primary outcomes. Very few reports of RCTs published in clinical psychology journals were registered prospectively and completely. Clinical psychology journals could improve transparency and reproducibility, as well as reduce bias, by requiring complete prospective trial registration for publication and by including trial registration numbers in all reports of RCTs. (PsycINFO Database Record (c) 2016 APA, all rights reserved).
Adams, Marc A; Sallis, James F; Norman, Gregory J; Hovell, Melbourne F; Hekler, Eric B; Perata, Elyse
Physical activity (PA) interventions typically include components or doses that are static across participants. Adaptive interventions are dynamic; components or doses change in response to short-term variations in participant's performance. Emerging theory and technologies make adaptive goal setting and feedback interventions feasible. To test an adaptive intervention for PA based on Operant and Behavior Economic principles and a percentile-based algorithm. The adaptive intervention was hypothesized to result in greater increases in steps per day than the static intervention. Participants (N = 20) were randomized to one of two 6-month treatments: 1) static intervention (SI) or 2) adaptive intervention (AI). Inactive overweight adults (85% women, M = 36.9 ± 9.2 years, 35% non-white) in both groups received a pedometer, email and text message communication, brief health information, and biweekly motivational prompts. The AI group received daily step goals that adjusted up and down based on the percentile-rank algorithm and micro-incentives for goal attainment. This algorithm adjusted goals based on a moving window; an approach that responded to each individual's performance and ensured goals were always challenging but within participants' abilities. The SI group received a static 10,000 steps/day goal with incentives linked to uploading the pedometer's data. A random-effects repeated-measures model accounted for 180 repeated measures and autocorrelation. After adjusting for covariates, the treatment phase showed greater steps/day relative to the baseline phase (pgoal and feedback algorithm is a "behavior change technology" that could be incorporated into mHealth technologies and scaled to reach large populations. ClinicalTrials.gov NCT01793064.
Ciaschini, P M; Straus, S E; Dolovich, L R; Goeree, R A; Leung, K M; Woods, C R; Zimmerman, G M; Majumdar, S R; Spadafora, S; Fera, L A; Lee, H N
falls are the leading causes of accidental death and fragility fractures in older adults. Interventions that assess and reduce falls risk are underutilised. to evaluate the impact of a multifaceted community-based programme aimed at optimising evidence-based management of patients at risk for fall-related fractures. this was a randomised trial performed from 2003 to 2006. community-based intervention in Ontario, Canada. eligible patients were community-dwelling, aged > or =55 years and identified to be at risk for fall-related fractures. A total of 201 patients were allocated to the intervention group or to usual care. components of the intervention included assessment of falls risk, functional status and home environment, and patient education. primary outcome was the implementation of appropriate falls risk assessment at 6 months. Secondary outcomes included falls and fractures at 6 and 12 months. the mean age of participants was 72 years, and 41% had fallen with injury in the previous year. Compared to usual care, the intervention increased the number of referrals made to physiotherapy [21% (21/101) vs 6.0% (6/100); relative risk (RR) 3.47, 95% confidence interval (CI) 1.46-8.22] and occupational therapy [15% (15/101) vs 0%; RR 30.7, 95% CI 1.86 to >500]. At 12 months, the number of falls in the intervention group was greater than in the usual care group [23% (23/101) vs 11% (11/100); RR 2.07, 95% CI 1.07-4.02]. compared to usual care, a multi-faceted intervention increased referrals to physiotherapy and occupational therapy but did not reduce risk of falls. Similar falls reduction interventions cannot be recommended based on the results of this study.
Northouse, Laurel L; Mood, Darlene W; Schafenacker, Ann; Montie, James E; Sandler, Howard M; Forman, Jeffrey D; Hussain, Maha; Pienta, Kenneth J; Smith, David C; Kershaw, Trace
Few intervention studies have been conducted to help couples manage the effects of prostate cancer and maintain their quality of life. The objective of this study was to determine whether a family-based intervention could improve appraisal variables (appraisal of illness or caregiving, uncertainty, hopelessness), coping resources (coping strategies, self-efficacy, communication), symptom distress, and quality of life in men with prostate cancer and their spouses. For this clinical trial, 263 patient-spouse dyads were stratified by research site, phase of illness, and treatment; then, they were randomized to the control group (standard care) or the experimental group (standard care plus a 5-session family intervention). The intervention targeted couples' communication, hope, coping, uncertainty, and symptom management. The final sample consisted of 235 couples: 123 couples in the control group and 112 couples in the experimental group. Data collection occurred at baseline before randomization and at 4 months, 8 months, and 12 months. At 4-month follow-up, intervention patients reported less uncertainty and better communication with spouses than control patients, but they reported no other effects. Intervention spouses reported higher quality of life, more self-efficacy, better communication, and less negative appraisal of caregiving, uncertainty, hopelessness, and symptom distress at 4 months compared with controls, and some effects were sustained to 8 months and 12 months. Men with prostate cancer and their spouses reported positive outcomes from a family intervention that offered them information and support. Programs of care need to be extended to spouses who likely will experience multiple benefits from intervention. 2007 American Cancer Society
Full Text Available Abstract Background Very brief interventions (VBIs for physical activity are promising, but there is uncertainty about their potential effectiveness and cost. We assessed potential efficacy, feasibility, acceptability, and cost of three VBIs in primary care, in order to select the most promising intervention for evaluation in a subsequent large-scale RCT. Methods Three hundred and ninety four adults aged 40–74 years were randomised to a Motivational (n = 83, Pedometer (n = 74, or Combined (n = 80 intervention, delivered immediately after a preventative health check in primary care, or control (Health Check only; n = 157. Potential efficacy was measured as the probability of a positive difference between an intervention arm and the control arm in mean physical activity, measured by accelerometry at 4 weeks. Results For the primary outcome the estimated effect sizes (95 % CI relative to the Control arm for the Motivational, Pedometer and Combined arms were respectively: +20.3 (−45.0, +85.7, +23.5 (−51.3, +98.3, and −3.1 (−69.3, +63.1 counts per minute. There was a73% probability of a positive effect on physical activity for each of the Motivational and Pedometer VBIs relative to control, but only 46 % for the Combined VBI. Only the Pedometer VBI was deliverable within 5 min. All VBIs were acceptable and low cost. Conclusions Based on the four criteria, the Pedometer VBI was selected for evaluation in a large-scale trial. Trial registration Current Controlled Trials ISRCTN02863077 . Retrospectively registered 05/10/2012.
Welch Martha G
Full Text Available Abstract Background The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges. Methods This study is a randomized controlled trial (RCT with blinded assessment comparing Standard Care (SC with a novel Family Nurture Intervention (FNI. FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1 In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2 Outside the isolette during holding and feeding via the Calming Cycle; and 3 through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA, maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group. Discussion The FNI is designed to increase biologically important activities and behaviors that enhance maternally
Background The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU) can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges. Methods This study is a randomized controlled trial (RCT) with blinded assessment comparing Standard Care (SC) with a novel Family Nurture Intervention (FNI). FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA) and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1) In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2) Outside the isolette during holding and feeding via the Calming Cycle; and 3) through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA), maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group). Discussion The FNI is designed to increase biologically important activities and behaviors that enhance maternally-mediated sensory experiences of
Full Text Available Abstract Background To respond to the rapid surge in the incidence of suicide in Japan, which appears to be an ongoing trend, the Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP have launched a multimodal community-based suicide prevention program, NOCOMIT-J. The primary aim of this study is to examine whether NOCOMIT-J is effective in reducing suicidal behavior in the community. Methods/DesignThis study is a community intervention trial involving seven intervention regions with accompanying control regions, all with populations of statistically sufficient size. The program focuses on building social support networks in the public health system for suicide prevention and mental health promotion, intending to reinforce human relationships in the community. The intervention program components includes a primary prevention measures of awareness campaign for the public and key personnel, secondary prevention measures for screening of, and assisting, high-risk individuals, after-care for individuals bereaved by suicide, and other measures. The intervention started in July 2006, and will continue for 3.5 years. Participants are Japanese and foreign residents living in the intervention and control regions (a total of population of 2,120,000 individuals. Discussion The present study is designed to evaluate the effectiveness of the community-based suicide prevention program in the seven participating areas. Trial registration UMIN Clinical Trials Registry (UMIN-CTR UMIN000000460.
Rationale and design of the participant, investigator, observer, and data-analyst-blinded randomized AGENDA trial on associations between gene-polymorphisms, endophenotypes for depression and antidepressive intervention: the effect of escitalopram versus placebo on the combined dexamethasone
Knorr, Ulla; Vinberg, Maj; Klose, Marianne
, a 60% power is obtained to detect a clinically relevant difference in the primary outcome between the intervention and the placebo group. Secondary outcome measures are changes from baseline to four weeks in scores of: 1) cognition and 2) neuroticism. Tertiary outcomes measures are changes from...... hypothesize that potential endophenotypes for depression may be affected by selective serotonin re-uptake inhibitor antidepressants in healthy first-degree relatives of depressed patients. The primary outcome measure is the change in plasma cortisol in the dexamethasone-corticotrophin releasing hormone test...... from baseline to the end of intervention. METHODS: The AGENDA trial is designed as a participant, investigator, observer, and data-analyst-blinded randomized trial. Participants are 80 healthy first-degree relatives of patients with depression. Participants are randomized to escitalopram 10 mg per day...
de Boer, Sanneke P M; van Leeuwen, Maarten A H; Cheng, Jin M; Oemrawsingh, Rohit M; van Geuns, Robert-Jan; Serruys, Patrick W J C; Boersma, Eric; Lenzen, Mattie J
This study examines differences in clinical outcome between trial-participants and non-participants after percutaneous coronary intervention (PCI). This study compromised of 11,931 consecutive patients who underwent PCI in a high volume center, during the period 2000 - 2009. Of these patients, 1787 (15%) participated in an interventional clinical trial with a follow-up period of at least six months. The maximum follow-up duration was 11.8 years, with a median of 3.8 years (IQR: 2.6 - 6.5). Baseline and procedural characteristics differed between trial-participants and non-participants. Trial-participants were more often male, were younger, had more cardiovascular risk factors and were treated more often for stable angina pectoris and single vessel disease. Overall mortality at maximum follow-up was lower for trial-participants compared to non-participants (8.1% versus 17.6%, pclinical trials in the field of interventional cardiology with a follow-up of at least six months differed considerably from non-participants in baseline and procedural characteristics. Trial-participants had better survival than non-participants. In contrast, a two-fold higher incidence of repeat PCI was observed in trial-participants. © 2013.
Renes, J S; Willemsen, R H; Mulder, J C; Bakker-van Waarde, W M; Rotteveel, J; Oostdijk, W; Houdijk, E C A M; Westerlaken, C; Noordam, C; Verrijn Stuart, A A; Odink, R J; de Ridder, M A J; Hokken-Koelega, A C S
Growth hormone (GH) treatment is effective in improving adult height (AH) in short children born SGA. However, there is a wide variation in height gain, even after adjustment for predictive variables. It is therefore important to investigate new factors which can influence the response to GH. To investigate the efficacy of GH treatment (1 mg/m(2/) day) in short SGA children on AH. To assess the relation between spontaneous catch-up growth after birth and growth during puberty on the total height gain SDS to AH. Longitudinal GH trial in 170 children. Median age at start of GH was 7·1 years and height -3·0 SDS. AH was -1·8 SDS (TH-corrected AH -1·1 SDS) in boys and -1·9 SDS (TH-corrected AH -1·3 SDS) in girls. Spontaneous catch-up growth after birth was ≥0·5 SDS in 42% of children. In contrast to expectation, spontaneous catch-up growth was negatively correlated with total height gain SDS during GH (P = 0·009). During puberty, height SDS declined (-0·4 SDS in boys and -0·5 SDS in girls) resulting in a lower total height gain SDS than expected. Pubertal height gain was 25·5 cm in boys and 15·3 cm in girls, significantly lower compared to AGA children (P Growth velocity was comparable to AGA children during the first two years of puberty, but thereafter significantly lower until reaching AH (P children with greater spontaneous catch-up growth after birth show a lower total height gain SDS during GH. Height SDS declines from mid-puberty, due to a marked early deceleration of growth velocity. © 2014 John Wiley & Sons Ltd.
Full Text Available Abstract Background Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services. Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month. Methods/design This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain. The number of patients required is 242 (121 in each arm, all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. Discussion This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity
Maguire, Jonathon L; Birken, Catherine S; Loeb, Mark B; Mamdani, Muhammad; Thorpe, Kevin; Hoch, Jeffrey S; Mazzulli, Tony; Borkhoff, Cornelia M; Macarthur, Colin; Parkin, Patricia C
Vitamin D levels are alarmingly low (respiratory tract infections (URTI), asthma-related hospitalizations and use of anti-inflammatory medication have all been linked with low vitamin D. No study has determined whether wintertime vitamin D supplementation can reduce the risk of URTI and asthma exacerbations, two of the most common and costly illnesses of early childhood. The objectives of this study are: 1) to compare the effect of 'high dose' (2000 IU/day) vs. 'standard dose' (400 IU/day) vitamin D supplementation in achieving reductions in laboratory confirmed URTI and asthma exacerbations during the winter in preschool-aged Canadian children; and 2) to assess the effect of 'high dose' vitamin D supplementation on vitamin D serum levels and specific viruses that cause URTI. This study is a pragmatic randomized controlled trial. Over 4 successive winters we will recruit 750 healthy children 1-5 years of age. Participating physicians are part of a primary healthcare research network called TARGet Kids!. Children will be randomized to the 'standard dose' or 'high dose' oral supplemental vitamin D for a minimum of 4 months (200 children per group). Parents will obtain a nasal swab from their child with each URTI, report the number of asthma exacerbations and complete symptom checklists. Unscheduled physician visits for URTIs and asthma exacerbations will be recorded. By May, a blood sample will be drawn to determine vitamin D serum levels. The primary analysis will be a comparison of URTI rate between study groups using a Poisson regression model. Secondary analyses will compare vitamin D serum levels, asthma exacerbations and the frequency of specific viral agents between groups. Identifying whether vitamin D supplementation of preschoolers can reduce wintertime viral URTIs and asthma exacerbations and what dose is optimal may reduce population wide morbidity and associated health care and societal costs. This information will assist in determining practice and
Duncan, Scott; Goodyear-Smith, Felicity; McPhee, Julia; Zinn, Caryn; Grøntved, Anders; Schofield, Grant
To assess the effects of a family-centered, physical activity and nutrition "brief" intervention (time-limited contact) on body weight and related health outcomes in primary health care patients with an elevated 5-year cardiovascular disease (CVD) risk. This study implemented a cluster randomized controlled trial design with two treatment conditions: a CVD risk assessment and one-time consultation ("usual care" control) and a CVD risk assessment and up to five home sessions that aimed to reduce obesity by encouraging physical activity and healthy eating (intervention). Three hundred and twenty patients aged 35 to 65 years from 16 primary health care clinics in Auckland, New Zealand, participated in the study. Intervention effects on BMI, waist circumference, blood pressure, blood cholesterol, triglycerides, 5-year CVD risk, physical activity, and dietary patterns were assessed using generalized linear mixed models. When compared with the control group, the intervention resulted in a significant but relatively modest decrease in BMI between baseline and the 12-month follow-up (-0.633 kg m(-2) , Padj = 0.048). Significant decreases were also observed for total cholesterol at 4 and 12 months, the total cholesterol to high-density lipoprotein cholesterol ratio at 4 months, 5-year CVD risk at 4 months, and fast food consumption at 12 months. Our findings show that a family-centered brief intervention targeting physical activity and nutrition can generate slightly better obesity-related health outcomes than usual care alone. © 2016 The Obesity Society.
Spittle, Alicia J; Barton, Sarah; Treyvaud, Karli; Molloy, Carly S; Doyle, Lex W; Anderson, Peter J
To examine the child and parental outcomes at school age of a randomized controlled trial of a home-based early preventative care program for infants born very preterm and their caregivers. At term-equivalent age, 120 infants born at a gestational age of intervention (n = 61) or standard care (n = 59) groups. The intervention included 9 home visits over the first year of life focusing on infant development, parental mental health, and the parent-infant relationship. At 8 years' corrected age, children's cognitive, behavioral, and motor functioning and parental mental health were assessed. Analysis was by intention to treat. One hundred children, including 13 sets of twins, attended follow-up (85% follow-up of survivors). Children in the intervention group were less likely to have mathematics difficulties (odds ratio, 0.42; 95% confidence interval [CI], 0.18 to 0.98; P = .045) than children in the standard care group, but there was no evidence of an effect on other developmental outcomes. Parents in the intervention group reported fewer symptoms of depression (mean difference, -2.7; 95% CI, -4.0 to -1.4; P parents in the standard care group. An early preventive care program for very preterm infants and their parents had minimal long-term effects on child neurodevelopmental outcomes at the 8-year follow-up, whereas primary caregivers in the intervention group reported less depression. Copyright © 2016 by the American Academy of Pediatrics.
Zingmark, Magnus; Fisher, Anne G; Rocklöv, Joacim; Nilsson, Ingeborg
The aim of this exploratory randomised controlled trial (RCT) was to evaluate three different occupation-focused interventions for well older people by estimating effect sizes for leisure engagement and ability in activities of daily living (ADL) and thereby identifying the most effective interventions. One hundred and seventy seven persons, 77-82 years old, living alone and without home help, were randomized to a control group (CG), an individual intervention (IG), an activity group (AG), and a one-meeting discussion group (DG). All interventions focused on occupational engagement and how persons can cope with age-related activity restrictions in order to enhance occupational engagement. Data were collected by blinded research assistants at baseline, three, and 12 months. Ordinal outcome data were converted, using Rasch measurement methods, to linear measures of leisure engagement and ADL ability. Standardized between-group effect sizes, Cohen's d, were calculated. While all groups showed a decline in leisure engagement and ADL over time, the IG and the DG were somewhat effective in minimizing the decline at both three and 12 months. However, the effect sizes were small. The findings indicate that occupation-focused interventions intended to minimize a decline in leisure engagement and ADL were sufficiently promising to warrant their further research.
McCusker, Jane; Yaffe, Mark; Faria, Rosana; Lambert, Sylvie; Li, Madeline; Poirier-Bisson, Joannie; Magalhaes, Mona; de Raad, Manon
Supported self-care interventions are a low-intensity treatment for depression that has received little research attention in the cancer population. This is a phase II intervention only study to test the feasibility, acceptability and preliminary effectiveness of a depression self-care intervention for cancer patients who have completed their primary treatment and have moderate depressive symptoms. The self-care intervention was adapted from a successful model for people with chronic physical conditions, following focus groups with cancer care professionals and patients. The support was delivered by telephone by a trained lay coach who provided up to 8 weekly coaching contacts. A variety of recruitment methods were tested; those with the highest yield of eligible subjects per research staff time were electronic mailings to community support group members and social media posting. Sixty-eight people were contacted about the study over an 11-month period, of whom 34 (49%) were eligible; 32 were enrolled (94% recruitment rate); and 25 completed 2-month follow-up (78% retention). The mean severity of PHQ-9 depression decreased significantly from screening to 2 months (12.8 to 7.0, p < .0001). The intervention is a promising treatment option for cancer survivors, demonstrating sufficient effectiveness and feasibility to proceed with a phase III clinical trial. © 2017 John Wiley & Sons Ltd.
Harmsen, Hans; Bernsen, Roos; Meeuwesen, Ludwien; Thomas, Siep; Dorrenboom, Govert; Pinto, David; Bruijnzeels, Marc
Due to worldwide migration to Western countries, physicians are increasingly encountering patients with different ethnic backgrounds. Communication problems can arise as a result of differences in cultural backgrounds and poor language proficiency. To assess the effectiveness of an educational intervention on intercultural communication aimed to decrease inequalities in care provided between Western and non-Western patients. A randomised controlled trial with randomisation at the GP level and outcome measurements at the patient level. General practice in Rotterdam. Thirty-eight Dutch GPs in the Rotterdam region, with at least 25% of inhabitants of non-Western origin, and 2407 visiting patients were invited to participate in the study. A total of 986 consultations were finally included. The GPs were educated about cultural differences and trained in intercultural communication. Patients received a videotaped instruction focusing on how to communicate with their GP in a direct way. The primary outcome measure was mutual understanding and the secondary outcomes were patient's satisfaction and perceived quality of care. The intervention effect was assessed for all patients together, for the 'Western' and 'non-Western' patients, and for patients with different cultural backgrounds separately. An intervention effect was seen 6 months after the intervention, as improvement in mutual understanding (and some improvement in perceived quality of care) in consultations with 'non-Western' patients. A double intervention on intercultural communication given to both physician and patient decreases the gap in quality of care between 'Western' and 'non-Western' patients.
Chi, Ying-Chen; Wu, Chen-Long; Chen, Cheng-Yu; Lyu, Shu-Yu; Lo, Feng-En; Morisky, Donald E
This study sought to assess the effectiveness of a secondhand tobacco smoke (SHS) prevention program based on an expanded Health Belief Model (HBM) incorporating self-efficacy among pregnant women in a hospital setting in Taiwan. This study utilized a two-group longitudinal randomized controlled trial design. Participants in the intervention group (n=50) enrolled in a SHS prevention program based on the HBM, while participants in the comparison group (n=50) received standard government-mandated counseling care. Both groups were given questionnaires as a pre-test, two weeks into the intervention, and one month following the conclusion of the intervention. The questionnaire and intervention were developed based on the understanding gained through a series of in-depth interviews and a focus-group conducted among pregnant women. Exhaled carbon monoxide was also measured and used as a proxy for SHS exposure. Intervention group scores were all significantly higher than comparison group scores (pwomen regarding the harms of SHS while both empowering and equipping them with the tools to confront their family members and effectively reduce their SHS exposure while promoting smoke-free social norms. Copyright © 2014 Elsevier Ltd. All rights reserved.
Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja
Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication. (c) 2015 APA, all rights reserved).
Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula
Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions. Copyright © 2015 Elsevier Inc. All rights reserved.
Spieker, Susan J.; Oxford, Monica L.; Kelly, Jean F.; Nelson, Elizabeth M.; Fleming, Charles B.
We conducted a community based, randomized control trial of Promoting First Relationships (PFR; Kelly, Sandoval, Zuckerman, & Buehlman, 2008) to improve parenting and toddler outcomes for toddlers in state dependency. Toddlers (10 – 24 months; N = 210) with a recent placement disruption were randomized to 10-week PFR or a comparison condition. Community agency providers were trained to use PFR in the intervention for caregivers. From baseline to post-intervention follow-up, observational ratings of caregiver sensitivity improved more in the PFR condition than in the comparison condition, with an effect size for the difference in adjusted means post-intervention of d = .41. Caregiver understanding of toddlers’ social emotional needs and caregiver reports of child competence also differed by intervention condition post-intervention (d = .36 and d = .42) with caregivers in the PFR condition reporting more understanding of toddlers and child competence. Models of PFR effects on within-individual change were significant for caregiver sensitivity and understanding of toddlers. At the 6-month follow-up 61% of original sample dyads were still intact and there were no significant differences on caregiver or child outcomes, although caregivers in the PFR group did report marginally (pchild sleep problems (d = −.34). PMID:22949743
Full Text Available Background : There is a dearth of effective interventions to prevent the development of post-traumatic stress disorder (PTSD. Method : We evaluated the efficacy of a brief dyadic two-session cognitive-behavioral intervention through a controlled trial involving trauma-exposed individuals recruited at the hospital's emergency room. Participants were randomly assigned to either the dyadic intervention group (n=37 or to a waiting list (assessment only group (n=37. Results : In an intent-to-treat analysis, a time-by-group interaction was found, whereby the treated participants had less PTSD symptoms at the post-treatment but not at the pre-treatment compared to controls. Controlling for the improvement observed in the control participants, the intervention yielded a net effect size of d=0.39. Conclusions : A brief, early, and effective intervention can be provided by nurses or social workers in hospital settings, at a fairly low cost to individuals presenting to the emergency room as the result of trauma exposure.
Dunn, Carolyn; Olabode-Dada, Olusola; Whetstone, Lauren; Thomas, Cathy; Aggarwal, Surabhi; Nordby, Kelly; Thompson, Samuel; Johnson, Madison; Allison, Christine
To implement a randomized trial to evaluate the effectiveness of a weight loss program delivered using synchronous distance education compared with a wait-list control group with 6-month follow-up. Adults with a body mass index (BMI) ≥25 were randomized to the intervention (n = 42) or wait-list control group (n = 38). The intervention group participated in a synchronous, online, 15-week weight loss program; weight loss was the primary outcome. Secondary measures included height, BMI, and confidence in ability to be physically active and eat healthy. Assessments occurred at three and four time points in the intervention and control group, respectively. Participants who completed the program lost significantly more weight (1.8 kg) than those in the wait-list control group (0.25 kg) at week 15 [F(1,61) = 6.19, P = 0.02] and had a greater reduction in BMI (0.71 vs. 0.14 kg/m(2) ), [F(1,61) = 7.45, P = 0.01]. There were no significant differences between the intervention and the wait-list control groups for change in confidence in ability to be physically active or eat healthy. Weight loss was maintained at 6 months. Use of synchronous distance education is a promising approach for weight loss. The results of this study will help to inform future research that employs Web-based interventions. © 2015 The Obesity Society.
Yilmaz, G; Demirli Caylan, N; Karacan, C D
Screen time, defined as time spent watching television, DVDs, or videos or playing computer or video games, has been related to serious health consequences in children, such as impaired language acquisition, violent behaviour, tobacco smoking and obesity. Our aim was to determine if a simple intervention aimed at preschool-aged children, applied at the health maintenance visits, in the primary care setting, would be effective in reducing screen time. We used a two group randomized controlled trial design. Two- to 6-year-old children and their parents were randomly assigned to receive an intervention to reduce their screen time, BMI and parental report of aggressive behaviour. At the end of the intervention we made home visits at 2, 6 and 9 months and the parents completed questionnaire. Parents in the intervention group reported less screen time and less aggressive behaviour than those in the control group but there were no differences in BMI z scores. This study shows that a preschool-based intervention can lead to reductions in young children's television/video viewing. © 2014 John Wiley & Sons Ltd.
Pots, Wendy T M; Fledderus, Martine; Meulenbeek, Peter A M; ten Klooster, Peter M; Schreurs, Karlein M G; Bohlmeijer, Ernst T
Depression is a highly prevalent disorder, causing a large burden of disease and substantial economic costs. Web-based self-help interventions seem promising in promoting mental health. To compare the efficacy of a guided web-based intervention based on acceptance and commitment therapy (ACT) with an active control (expressive writing) and a waiting-list control condition (Netherlands Trial Register NTR1296). Adults with depressive symptoms from the general population were randomised to ACT (n = 82), expressive writing (n = 67) or waiting-list control (n = 87). The main outcome was reduction in depressive symptoms assessed with the Center for Epidemiological Studies - Depression scale. Significant reductions in depressive symptoms were found following the ACT intervention, compared with the control group (Cohen's d = 0.56) and the expressive writing intervention (d = 0.36). The effects were sustained at 6-month and 12-month follow-up. Acceptance and commitment therapy as a web-based public mental health intervention for adults with depressive symptoms can be effective and applicable. © The Royal College of Psychiatrists 2016.
Beiwinkel, Till; Eißing, Tabea; Telle, Nils-Torge; Siegmund-Schultze, Elisabeth; Rössler, Wulf
Depression is highly prevalent in the working population and is associated with significant loss of workdays; however, access to evidence-based treatment is limited. This study evaluated the effectiveness of a Web-based intervention in reducing mild to moderate depression and sickness absence. In an open-label randomized controlled trial, participants were recruited from a large-scale statutory health insurance and were assigned to two groups. The intervention group had access to a 12 week Web-based program consisting of structured interactive sessions and therapist support upon request. The wait-list control group had access to unguided Web-based psycho-education. Depressive symptoms were self-assessed at baseline, post-treatment, and follow-up (12 weeks after treatment) using the Patient Health Questionnaire (PHQ-9) and Beck Depression Inventory (BDI-II) as primary outcome measures. Data on sickness absence was retrieved from health insurance records. Intention-to-treat (ITT) analysis and per-protocol (PP) analysis were performed. Of the 180 participants who were randomized, 88 completed the post-assessment (retention rate: 48.8%, 88/180). ITT analysis showed a significant between-group difference in depressive symptoms during post-treatment in favor of the intervention group, corresponding to a moderate effect size (PHQ-9: d=0.55, 95% CI 0.25-0.85, Psignificant effect on one primary outcome (PHQ-9: d=0.61, 95% CI 0.15-1.07, P=.04, and BDI-II: d=0.25 95% CI -0.18 to 0.65, P=.37). Analysis of clinical significance using reliable change index revealed that significantly more participants who used the Web-based intervention (63%, 63/100) responded to the treatment versus the control group (33%, 27/80; P<.001). The number needed to treat (NNT) was 4.08. Within both groups, there was a reduction in work absence frequency (IG: -67.23%, P<.001, CG: -82.61%, P<.001), but no statistical difference in sickness absence between groups was found (P=.07). The Web
Rosário, R; Araújo, A; Padrão, P; Lopes, O; Moreira, A; Abreu, S; Vale, S; Pereira, B; Moreira, P
There is evidence that fruit consumption among school children is below the recommended levels. This study aims to examine the effects of a dietary education intervention program me, held by teachers previously trained in nutrition, on the consumption of fruit as a dessert at lunch and dinner, among children 6-12 years old. This is a randomized trial with the schools as the unit of randomisation. A total of 464 children (239 female, 6-12years) from seven elementary schools participated in this cluster randomized controlled trial. Three schools were allocated to the intervention and four to the control group. For the intervention schools, we delivered professional development training to school teachers (12 sessions of 3 h each). The training provided information about nutrition, healthy eating, the importance of drinking water and healthy cooking activities. After each session, teachers were encouraged to develop classroom activities focused on the learned topics. Sociodemographic was assessed at baseline and anthropometric, dietary intake and physical activity assessments were performed at baseline and at the end of the intervention. Dietary intake was evaluated by a 24-h dietary recall and fruit consumption as a dessert was gathered at lunch and dinner. Intervened children reported a significant higher intake in the consumption of fruit compared to the controlled children at lunch (P = 0.001) and at dinner (P = 0.012), after adjusting for confounders. Our study provides further support for the success of intervention programmes aimed at improving the consumption of fruit as a dessert in children. Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.
Goldfeld, Sharon; Napiza, Natasha; Quach, Jon; Reilly, Sheena; Ukoumunne, Obioha C; Wake, Melissa
Early shared reading and literacy promotion benefits have stimulated international interest in the development of early-years literacy-promotion programs despite limited evidence of effectiveness at a broader population level. To determine whether a population-based primary care literacy promotion intervention during the first 2 years of life improves early markers of subsequent literacy by 2 years of age. This cluster randomized controlled trial took place in 5 relatively disadvantaged areas in Melbourne, Australia. Infants attending their maternal and child health centers were recruited at age 1-2 months. The intervention (4-8, 12, and 18 months) comprised maternal and child health nurses modelling shared reading activities to parents, supported by parent information and free books. Outcomes (at 2 years) included expressive vocabulary (MacArthur Bates Communicative Development Inventory), communication (Communication and Symbolic Behavior Scales), and home literacy environment (StimQ-Toddler). We analyzed the outcomes using random-effects (linear regression) models allowing for clustering. A total of 552 families (87.6%; 324 intervention and 228 control families) of 630 recruited families (66.5% response) were retained to outcome. A total of 97.3% of intervention parents received some (93.7% to all) of the intervention. At 2 years, the trial arms had similar vocabulary (adjusted mean difference: -2.0 [95% confidence interval: -6.2 to 2.2]; P = .36), communication (adjusted mean difference: 0.2 [95% confidence interval: -2.3 to 2.7]; P = .87), and home literacy (adjusted mean difference: -0.4 [95% confidence interval: -1.0 to 0.2]; P = .21). This universal literacy-promotion program was not beneficial in relatively disadvantaged communities by the age of 2 years and may be ineffective. Alternative interpretations may relate to program intensity, reach and/or sleeper effects. Definitive outcomes at 4 years are awaited.
Quach, Jon; Hiscock, Harriet; Ukoumunne, Obioha Chukwunyere; Wake, Melissa
To determine the feasibility of screening for child sleep problems and the efficacy of a behavioral sleep intervention in improving child and parent outcomes in the first year of schooling. A randomized controlled trial was nested in a population survey performed at 22 elementary schools in Melbourne, Australia. Intervention involved 2 to 3 consultations that covered behavioral sleep strategies for children whose screening results were positive for a moderate/severe sleep problem. Outcomes were parent-reported child sleep problem (primary outcome), sleep habits, psychosocial health-related quality of life, behavior, and parent mental health (all at 3, 6, and 12 months) and blinded, face-to-face learning assessment (at 6 months). The screening survey was completed by 1512 parents; 161 (10.8%) reported a moderate/severe child sleep problem, and 108 of 136 (79.2% of those eligible) entered the trial. Sleep problems tended to resolve more rapidly in intervention children. Sleep problems affected 33% of 54 intervention children versus 43% of 54 control children at 3 months (P = .3), 25.5% vs 46.8% at 6 months (P = .03), and 32% vs 33% at 12 months (P = .8). Sustained sleep-habit improvements were evident at 3, 6, and 12 months (effect sizes: 0.33 [P = .03]; 0.51 [P = .003]; and 0.40 [P = .02]; respectively), and there were initial marked improvements in psychosocial scores that diminished over time (effect sizes: 0.47 [P = .02]; 0.41 [P = .09]; and 0.26 [P = .3]; respectively). Better prosocial behavior was evident at 12 months (effect size: 0.35; P = .03), and learning and parent outcomes were similar between groups. School-based screening for sleep problems followed by a targeted, brief behavioral sleep intervention is feasible and has benefits relevant to school transition.
Hooten, W Michael; Townsend, Cynthia O; Hays, J Taylor; Ebnet, Kaye L; Gauvin, Thomas R; Gehin, Jessica M; Laures, Heidi J; Patten, Christi A; Warner, David O
Current evidence suggests it may be difficult for patients with chronic pain to quit smoking and, based on previous formative work, a 7-session individual and group-based cognitive behavioral (CB) intervention was developed. The primary aim of this randomized controlled pilot trial was to test the hypothesis that abstinence at month 6 would be greater among patients with chronic pain who received the CB intervention compared to a control condition. Upon admission to a 3-week interdisciplinary pain treatment (IPT) program, patients were randomized to receive the CB intervention (n=30) or the control condition (n=30). The 7-day point prevalence of self-reported smoking status was assessed at week 3 (upon completion of the 3-week IPT program) and at month 6 in an intent-to-treat analysis. At week 3, 30% (n=9) of patients in the CB condition were abstinent from smoking compared to 10% (n=3) in the control group (P=.104). At month 6, 20% (n=6) of patients who received the CB intervention were abstinent compared to none in the control group (P=.024). At week 3, a significant group by time interaction effect was found where the CB patients experienced greater improvements in self-efficacy from baseline compared to the control group (P=.002). A greater proportion of patients randomized to the CB group completed the IPT program (P=.052). The findings of this pilot trial suggest that integration of a CB-based smoking abstinence intervention into ongoing pain therapy may be an effective treatment for smokers with chronic pain. Copyright © 2013 Elsevier Ltd. All rights reserved.
Carroll, Kathleen M.; Stefanovics, Elina; Rosenheck, Robert A.
Objective Money management has been implemented, often in bundled interventions, as a strategy to counteract spending of public support checks and other funds on drugs and alcohol. The authors conducted a randomized controlled trial of a voluntary money management program as an adjunctive treatment for patients in treatment for mental illness, substance use disorders, or both. In the advisor-teller money manager (ATM) intervention, a money manager stores patients’ checkbooks and automated bank cards, trains patients to manage their own funds, and links spending to activities related to their treatment goals. Methods Eighty-five veterans with recent use of alcohol or cocaine were randomly assigned to 36 weeks of the ATM intervention or a control intervention (completion of a simple financial workbook). Results With ATM, 75% of veterans gave their checkbook to their money manager to hold, and participants attended significantly more therapy sessions than those assigned to the control therapy (mean of 20.6 versus 8.1 sessions). Although participants assigned to ATM did not show significantly greater improvement over time on the primary outcomes (self-reported abstinence from alcohol and cocaine and negative urine tests for cocaine metabolite), they reduced their Addiction Severity Index drug and alcohol use composite scale scores more rapidly than the control group. High rates of abstinence in both groups created a ceiling effect, limiting the power to detect improved abstinence rates. Conclusions In this relatively small trial, ATM, a money management intervention, showed promise in engaging patients, improving their money management, and improving some substance abuse outcomes. PMID:19339325
Rodriguez-Sanchez, Emiliano; Patino-Alonso, Maria C.; Mora-Simon, Sara; Gomez-Marcos, Manuel A.; Perez-Penaranda, Anibal; Losada-Baltar, Andres; Garcia-Ortiz, Luis
Purpose: To assess, in the context of Primary Health Care (PHC), the effect of a psychological intervention in mental health among caregivers (CGs) of dependent relatives. Design and Methods: Randomized multicenter, controlled clinical trial. The 125 CGs included in the trial were receiving health care in PHC. Inclusion criteria: Identifying…
White, Bethany; Madden, Annie; Hellard, Margaret; Kerr, Thomas; Prins, Maria; Page, Kimberly; Dore, Gregory J.; Maher, Lisa
While people who inject drugs are at high risk of hepatitis C virus (HCV) infection and will be the target population for future HCV vaccine trials, little is known about clinical trial literacy (CTL) in this group. We assessed the impact of a brief intervention (BI) designed to improve HCV vaccine
Prentice, Ross L; Zhao, Shanshan; Johnson, Melissa; Aragaki, Aaron; Hsia, Judith; Jackson, Rebecca D; Rossouw, Jacques E; Manson, JoAnn E; Hanash, Samir M
We previously reported mass spectrometry-based proteomic discovery research to identify novel plasma proteins related to the risk of coronary heart disease (CHD) and stroke, and to identify proteins with concentrations affected by the use of postmenopausal hormone therapy. Here we report CHD and stroke risk validation studies for highly ranked proteins, and consider the extent to which protein concentration changes relate to disease risk or provide an explanation for hormone therapy effects on these outcomes. Five proteins potentially associated with CHD (beta-2 microglobulin (B2M), alpha-1-acid glycoprotein 1 (ORM1), thrombospondin-1(THBS1), complement factor D pre-protein (CFD), and insulin-like growth factor binding protein 1 (IGFBP1)) and five potentially associated with stroke (B2M, IGFBP2, IGFBP4, IGFBP6, and hemopexin (HPX)) had high discovery phase significance level ranking and an available ELISA assay, and were included in case-control validation studies within the Women's Health Initiative (WHI) hormone therapy trials. Protein concentrations, at baseline and 1 year following randomization, were assessed for 358 CHD cases and 362 stroke cases, along with corresponding disease-free controls. Disease association, and mediation of estrogen-alone and estrogen plus progestin effects on CHD and stroke risk, were assessed using logistic regression. B2M, THBS1, and CFD were confirmed (P markers, and B2M, IGFBP2, and IGFBP4 were confirmed as novel stroke disease risk markers, while the assay for HPX proved to be unreliable. The change from baseline to 1 year in B2M was associated (P marker for both CHD and stroke. The B2M increase experienced by women during the first year of hormone therapy trial participation conveys cardiovascular disease risk. The increase in IGFBP1 similarly conveys CHD risk, and the magnitude of the IGFBP1 increase following hormone therapy may be a mediator of hormone therapy effects. Plasma THBS1 and CFD are confirmed as CHD risk markers
Danaher, Brian G.; Severson, Herbert H.; Zhu, Shu-Hong; Andrews, Judy A.; Cummins, Sharon E.; Lichtenstein, Edward; Tedeschi, Gary J.; Hudkins, Coleen; Widdop, Chris; Crowley, Ryann; Seeley, John R.
Quitline interventions did not result in additive or synergistic effects, as have been found for smoking. Both interventions were more effective than a self-help control condition in helping motivated smokeless tobacco users quit tobacco. Intervention usage and satisfaction were related to the amount intervention content offered. Usage of the Quitline intervention decreased when offered in combination, though rates of helpfulness and recommendations were higher when offered in combination. Trial Registration Clinicaltrials.gov NCT00820495; http://clinicaltrials.gov/ct2/show/NCT00820495 PMID:25914872
Stanhope, R; Albanese, A; Moyle, L; Hamill, G
The use of optimum conventional growth hormone administration, using a growth hormone vial combined with an Auto Injector, was compared with a pen injection system using a cartridge of growth hormone. In both methods of administration the concentration of growth hormone was 16 IU/ml. Thirty patients (22 boys, eight girls) who had all previously been treated with growth hormone (4 IU/ml) administered using needles and syringes (without an Auto Injector) were randomised into receiving one of either treatment for three months and then crossed over for a further three months. Fourteen patients (10 boys, four girls) initially received KabiVial 16 IU/ml combined with an Auto Injector while 16 patients (12 boys, four girls) were treated with KabiPen 16 IU/ml. Mean age in both groups was 9.6 years. The majority of patients in both groups were treated with a regimen of either 15 or 20 units/m2/week as a daily subcutaneous injection. Of the 30 patients who started in this trial, two who commenced using an Auto Injector refused to change to a pen system and were excluded from further analysis. When scored on a scale of -5 to +5 general convenience when changing from an Auto Injector to the KabiPen decreased from +4.7 to +1.0. When assessed for pain, the Auto Injector group scored +4.7, which decreased to -0.2 (more painful) for the pen. At the end of the trial 23 patients (82%) chose to continue with the KabiVial/Auto Injector combination as they found this less painful and the child did not see the needle or need to insert the needle manually. Five patients (18%) continued with the KabiPen as they considered the device smaller and easier to use. The accuracy of dosing using KabiVial was 100% compared with the range of 88% to 111% using KabiPen as the latter was available only in 0.5 unit increments. No growth hormone was wasted using KabiVial, although a mean of 0.6 units was wasted with every 16 IU cartridge in the KabiPen system. It is concluded that patients should be
Bailey, Donald E; Hendrix, Cristina C; Steinhauser, Karen E; Stechuchak, Karen M; Porter, Laura S; Hudson, Julie; Olsen, Maren K; Muir, Andrew; Lowman, Sarah; DiMartini, Andrea; Salonen, Laurel Williams; Tulsky, James A
We tested an uncertainty self-management telephone intervention (SMI) with patients awaiting liver transplant and their caregivers. Participants were recruited from four transplant centers and completed questionnaires at baseline, 10, and 12 weeks from baseline (generally two and four weeks after intervention delivery, respectively). Dyads were randomized to either SMI (n=56) or liver disease education (LDE; n=59), both of which involved six weekly telephone sessions. SMI participants were taught coping skills and uncertainty management strategies while LDE participants learned about liver function and how to stay healthy. Outcomes included illness uncertainty, uncertainty management, depression, anxiety, self-efficacy, and quality of life. General linear models were used to test for group differences. No differences were found between the SMI and LDE groups for study outcomes. This trial offers insight regarding design for future interventions that may allow greater flexibility in length of delivery beyond our study's 12-week timeframe. Our study was designed for the time constraints of today's clinical practice setting. This trial is a beginning point to address the unmet needs of these patients and their caregivers as they wait for transplants that could save their lives. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
Mostaghel, Elahe A; Lin, Daniel W; Amory, John K; Wright, Jonathan L; Marck, Brett T; Nelson, Peter S; Matsumoto, Alvin M; Bremner, William J; Page, Stephanie T
Male hormonal contraception (MHC) combines hypothalamic-pituitary-gonadal axis blockade with exogenous androgen delivery to maintain extragonadal androgen end-organ effects. Concern exists that MHC may adversely impact prostate health. The objective of the study was to determine the molecular impact of MHC on intraprostatic androgen concentrations and androgen action. This was a single-blind, randomized, placebo-controlled study. The study was conducted at an academic medical center. 32 healthy men aged 25-55 yr participated in the study. Interventions included placebo, daily transdermal testosterone (T) (T-gel), T-gel + depomedroxyprogesterone acetate (T+DMPA), or T-gel + dutasteride daily (T+D) for 12 wk, and prostate biopsy during treatment wk 10. Serum and prostate androgen concentrations and prostate epithelial-cell gene expression were measured. Thirty men completed the study. Serum T levels were significantly increased in T-gel and T+D groups compared with baseline (P < 0.05) but were decreased with the addition of DMPA. Intraprostatic androgens were no different from placebo with T-gel treatment. Addition of DMPA to T resulted in 40% lower intraprostatic dihydrotestosterone (DHT) concentration (P = 0.0273 vs. placebo), whereas combining dutasteride with T resulted in a 90% decrease in intraprostatic DHT (P = 0.0012), 11-fold increased intraprostatic T (P = 0.0011), and 7-fold increased intraprostatic androstenedione (P = 0.0011). Significant differences in global or androgen-regulated prostate epithelial-cell gene expression were not observed. Androgen-regulated gene expression correlated with epithelial-cell androgen receptor and prostatic DHT in placebo, T-gel, and T+DMPA arms and with T and androstenedione levels in the T+D arm. MHC regimens do not markedly alter gene expression in benign prostate epithelium, suggesting they may not alter risk of prostate disease. Longer-term studies examining the impact of MHC on prostate health are needed.
Kasari, Connie; Kaiser, Ann; Goods, Kelly; Nietfeld, Jennifer; Mathy, Pamela; Landa, Rebecca; Murphy, Susan; Almirall, Daniel
This study tested the effect of beginning treatment with a speech-generating device (SGD) in the context of a blended, adaptive treatment design for improving spontaneous, communicative utterances in school-aged, minimally verbal children with autism. A total of 61 minimally verbal children with autism, aged 5 to 8 years, were randomized to a blended developmental/behavioral intervention (JASP+EMT) with or without the augmentation of a SGD for 6 months with a 3-month follow-up. The intervention consisted of 2 stages. In stage 1, all children received 2 sessions per week for 3 months. Stage 2 intervention was adapted (by increased sessions or adding the SGD) based on the child's early response. The primary outcome was the total number of spontaneous communicative utterances; secondary measures were the total number of novel words and total comments from a natural language sample. Primary aim results found improvements in spontaneous communicative utterances, novel words, and comments that all favored the blended behavioral intervention that began by including an SGD (JASP+EMT+SGD) as opposed to spoken words alone (JASP+EMT). Secondary aim results suggest that the adaptive intervention beginning with JASP+EMT+SGD and intensifying JASP+EMT+SGD for children who were slow responders led to better posttreatment outcomes. Minimally verbal school-aged children can make significant and rapid gains in spoken spontaneous language with a novel, blended intervention that focuses on joint engagement and play skills and incorporates an SGD. Future studies should further explore the tailoring design used in this study to better understand children's response to treatment. Clinical trial registration information-Developmental and Augmented Intervention for Facilitating Expressive Language (CCNIA); http://clinicaltrials.gov/; NCT01013545. Copyright © 2014 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.
Díez, Elia; López, Maria J; Marí-Dell'Olmo, Marc; Nebot, Laia; Pérez, Gloria; Villalbi, Joan R; Carreras, Ramon
This study aims to evaluate the effects of a community-based counselling intervention to improve contraception use among immigrant and native residents in deprived neighbourhoods. : Randomized controlled trial. Women aged 14-49 years and men aged 14-39 years from two low-income neighbourhoods with high proportion of immigration in Barcelona (Catalonia, Spain) who had not undergone irreversible contraception and were not planning a pregnancy were recruited (2011-13). A culturally developed and theoretically based brief counselling intervention was delivered in community settings. The primary outcome was the consistent use of effective contraceptive methods (optimal use). Secondary outcomes were the incorrect use of effective methods and the use of less effective methods stratified by sex and migrant status. Differences within subgroups from baseline to the 3-month follow-up were analysed by intention to treat and per protocol. The effects were assessed with adjusted robust Poisson regressions. : The study enrolled and randomized 746 eligible participants. There were no differences between the intervention and control groups in demographic characteristics. Optimal use significantly increased in men, women, immigrants and natives in the intervention group, with no changes in the control group. In the intervention group, inconsistent use of effective methods decreased by 54.9% and that of less effective methods by 47.2%. The overall adjusted prevalence ratio of optimal use in the intervention group versus the control group was 1.138 (95% CI: 1.010-1.284). : This brief counselling intervention increased the consistent use of effective contraception in low-income neighbourhoods with a high proportion of immigration.
Kasari, Connie; Kaiser, Ann; Goods, Kelly; Nietfeld, Jennifer; Mathy, Pamela; Landa, Rebecca; Murphy, Susan; Almirall, Daniel
Objective This study tested the effect of beginning treatment with a speech-generating device in the context of a blended, adaptive treatment design for improving spontaneous, communicative utterances in school-aged, minimally verbal children with autism. Method Sixty-one minimally verbal children with autism, aged 5 to 8 years, were randomized to a blended developmental/behavioral intervention (JASP+EMT) with or without the augmentation of a speech-generating device (SGD) for 6 months with a 3-month follow-up. The intervention consisted of two stages. In Stage 1 all children received two sessions per week for 3 months. Stage 2 intervention was adapted (increased sessions or adding the SGD) based on the child’s early response. The primary outcome was the total number of spontaneous communicative utterances; secondary measures were total number of novel words and total comments from a natural language sample. Results Primary aim results found improvements in spontaneous communicative utterances, novel words, and comments that all favored the blended behavioral intervention that began by including an SGD (JASP+EMT+SGD) as opposed to spoken words alone (JASP+EMT). Secondary aim results suggest that the adaptive intervention beginning with JASP+EMT+SGD and intensifying JASP+EMT+SGD for children who were slow responders led to better post-treatment outcomes. Conclusion Minimally verbal school-aged children can make significant and rapid gains in spoken spontaneous language with a novel, blended intervention that focuses on joint engagement and play skills and incorporates an SGD. Future studies should further explore the tailoring design used in this study to better understand children’s response to treatment. Clinical trial registration information—Developmental and Augmented Intervention for Facilitating Expressive Language (CCNIA); http://clinicaltrials.gov/; NCT01013545. PMID:24839882
Pardavila-Belio, Miren I; García-Vivar, Cristina; Pimenta, Adriano Marçal; Canga-Armayor, Ana; Pueyo-Garrigues, Sara; Canga-Armayor, Navidad
To evaluate the effectiveness of a nurse intervention aimed at helping college student smokers quit smoking. Single-blind, pragmatic randomized controlled trial which compares a multi-component intervention, tailored specifically to college students, with a brief advice session with a 6-month follow-up. This study was conducted at the University of Navarra, Spain. A total of 255 college student smokers (age range = 18-24 years) were randomized to an intervention group (n = 133) or to a control group (n = 122). A multi-component intervention based on the Theory of Triadic Influence of Flay was developed. The intervention consisted of a 50-minute motivational interview conducted by a nurse and online self-help material. The follow-up included a reinforcing e-mail and group therapy. The primary outcome was self-reported abstinence, with biochemical verification at 6 months. The secondary outcomes consisted of the mean number of cigarettes smoked per day, self-reported attempts to quit smoking and stage of change at 6 months. At the 6-month follow-up, the smoking cessation incidence was 21.1% in the intervention group compared with 6.6% in the control group (difference = 14.5 confidence interval = 6.1-22.8; relative risk = 3.41, 95% confidence interval = 1.62-7.20). The difference in the mean number of cigarettes at 6 months was significantly different (difference = -2.2, confidence interval = -3.6 to -0.9). A multi-component intervention tailored to college students and managed by a nurse is effective in increasing smoking cessation among college students. © 2015 Society for the Study of Addiction.
Wennehorst, Katharina; Mildenstein, Klas; Saliger, Brunhild; Tigges, Corinna; Diehl, Hans; Keil, Thomas; Englert, Heike
The prevalence of type 2 diabetes is continuously increasing. This chronic metabolic disorder is difficult to treat and imposes a considerable economic burden on the healthcare system. In view of the fact that type 2 diabetes is primarily caused by behavioral factors, effective preventive strategies are urgently needed. We examined the effects of a holistic lifestyle intervention on clinical and laboratory parameters as well as on the long-term diabetes risk in patients at risk to develop diabetes. We conducted a randomized controlled trial in a primary care setting in Hannover, Germany, with 83 patients diagnosed as (pre)diabetic or at risk for diabetes. CHIP Germany is a 40-hour coaching lifestyle intervention program for the primary and secondary prevention of type 2 diabetes and cardiovascular diseases. The intervention included a comprehensive nutrition and health educational program based on the American CHIP approach. The primary outcome parameter was the body mass index (BMI). Secondary outcome parameters included body weight, blood pressure, fasting glucose, HbA1c, blood lipids, and the FINDRISK score, which assesses long-term diabetes risk. At the final measurement after 12 months, in the intervention group the BMI was reduced by 1.4 versus 0.2 kg/m(2) in controls (p = .119). The mean sustained weight loss after 12 months was -4.1 kg in the intervention group versus -0.8 kg in controls. Furthermore, we found a trend toward a stronger reduction in blood pressure, fasting glucose, and HbA1c as well as an improved FINDRISK score in the intervention group, compared to controls. Although failing to reach statistical significance at the final assessment, this comprehensive lifestyle intervention showed a noticeable reduction in several cardiometabolic risk factors which may facilitate the prevention of diabetes.
Figueiras, Maria João; Maroco, João; Monteiro, Rita; Caeiro, Raúl; Dias Neto, David
There is converging evidence that changing beliefs about an illness leads to positive recovery outcomes. However, cardiac misconceptions interventions have been investigated mainly in Angina or Coronary Heart Disease patients, and less in patients following Myocardial Infarction (MI). In these patients, cardiac misconceptions may play a role in the adjustment or lifestyle changes. This article reports a randomized controlled trial of an intervention designed to reduce the strength of misconceptions in patients after a first MI. The primary outcome was the degree of change in misconceptions and the secondary outcomes were: exercise, smoking status, return to work and mood (anxiety and depression). Patients in the intervention condition (n = 60) were compared with a control group (n = 67) receiving usual care. Both groups were evaluated at baseline and 4, 8 and 12 months after hospital discharge. There was a significant time-by-group interaction for the total score of cardiac misconceptions. Patients in the intervention group significantly decreased their total score of cardiac misconceptions at 4 months compared with the control group and this difference was sustained over time. Patients in the intervention group were also more likely to exercise at the follow-up period after MI than the control group. This intervention was effective in reducing the strength of cardiac misconceptions in MI patients and had a positive impact on health behaviour outcomes. These results support the importance of misconceptions in health behaviours and the utility of belief change interventions in promoting health in patients with Myocardial Infarction.
Full Text Available Abstract Background With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. Methods/Design A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. Discussion The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors
Background With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year , coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. Methods/Design A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. Discussion The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors' knowledge. If efficacious
Full Text Available BACKGROUND: Occupational sedentary behaviour is an important contributor to overall sedentary risk. There is limited evidence for effective workplace interventions to reduce occupational sedentary time and increase light activity during work hours. The purpose of the study was to determine if participatory workplace interventions could reduce total sedentary time, sustained sedentary time (bouts >30 minutes, increase the frequency of breaks in sedentary time and promote light intensity activity and moderate/vigorous activity (MVPA during work hours. METHODS: A randomised controlled trial (ANZCTR NUMBER: ACTN12612000743864 was conducted using clerical, call centre and data processing workers (n = 62, aged 25-59 years in 3 large government organisations in Perth, Australia. Three groups developed interventions with a participatory approach: 'Active office' (n = 19, 'Active Workstation' and promotion of incidental office activity; 'Traditional physical activity' (n = 14, pedometer challenge to increase activity between productive work time and 'Office ergonomics' (n = 29, computer workstation design and breaking up computer tasks. Accelerometer (ActiGraph GT3X, 7 days determined sedentary time, sustained sedentary time, breaks in sedentary time, light intensity activity and MVPA on work days and during work hours were measured before and following a 12 week intervention period. RESULTS: For all participants there was a significant reduction in sedentary time on work days (-1.6%, p = 0.006 and during work hours (-1.7%, p = 0.014 and a significant increase in number of breaks/sedentary hour on work days (0.64, p = 0.005 and during work hours (0.72, p = 0.015; there was a concurrent significant increase in light activity during work hours (1.5%, p = 0.012 and MVPA on work days (0.6%, p = 0.012. CONCLUSIONS: This study explored novel ways to modify work practices to reduce occupational sedentary behaviour
Daly, Niamh; Farren, Maria; McKeating, Aoife; OʼKelly, Ruth; Stapleton, Mary; Turner, Michael J
To evaluate whether an intensive, medically supervised exercise intervention improved maternal glycemia and gestational weight gain in obese pregnant women when compared with routine prenatal care. This randomized controlled trial compared a medically supervised exercise intervention with routine prenatal care. The primary outcome was a reduction in mean maternal fasting plasma glucose in the intervention group by 6.9 mg/dL at the time of a 75-g oral glucose tolerance test at 24-28 weeks of gestation. Secondary outcomes included excessive gestational weight gain. The intervention consisted of 50-60 minutes of exercise: warm-up, resistance or weights, aerobic exercises, and cool-down. All women received routine prenatal care. Power calculation determined that 24 women were required per group to detect a difference of 6.9 mg/dL in fasting plasma glucose between groups based on an independent-sample t test for statistical power of 80% at a type I error rate of 0.05. A sample size of 44 per group was planned to allow a dropout rate of 33%. From November 2013 through August 2015, 88 women were randomized: 44 each to the exercise and control groups. Eight women in the control group and 11 in the intervention group did not complete the trial at 6 weeks postpartum (P=.61), but 43 in each group attended the 24- to 28-week glucose screen. There were no baseline maternal differences between groups. Classes commenced at a mean of 13 4/7±1 2/7 weeks of gestation. In early pregnancy, 51.1% (n=45/88) had an elevated fasting plasma glucose (92-125 mg/dL). There was no difference in the mean fasting plasma glucose at 24-28 weeks of gestation: 90.0±9.0 mg/dL (n=43) compared with 93.6±7.2 mg/dL (n=43) (P=.13) or in the incidence of gestational diabetes mellitus at 24-28 weeks of gestation: 48.8% (n=21/43) compared with 58.1% (n=25/43) (P=.51) in the control and exercise groups, respectively. At 36 weeks of gestation, excessive gestational weight gain greater than 9.1 kg was lower
Whittaker, Robyn; Dorey, Enid; Bramley, Dale; Bullen, Chris; Denny, Simon; Elley, C Raina; Maddison, Ralph; McRobbie, Hayden; Parag, Varsha; Rodgers, Anthony; Salmon, Penny
Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones. This social cognitive theory-based intervention (called "STUB IT") used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques. The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation. A randomized controlled trial was conducted with 6-month follow-up. Participants had to be 16 years of age or over, be current daily smokers, be ready to quit, and have a video message-capable phone. Recruitment targeted younger adults predominantly through radio and online advertising. Registration and data collection were completed online, prompted by text messages. The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date, role model, and timing of messages. Extra messages were available on demand to beat cravings and address lapses. The control group also set a quit date and received a general health video message sent to their phone every 2 weeks. The target sample size was not achieved due to difficulty recruiting young adult quitters. Of the 226 randomized participants, 47% (107/226) were female and 24% (54/226) were Maori (indigenous population of New Zealand). Their mean age was 27 years (SD 8.7), and there was a high level of nicotine addiction. Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8). Feedback from participants indicated that the support provided by the video role models was important and appreciated. This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone. However, there was
Koning, I.M.; Vollebergh, W.A.M.; Smit, F.; Verdurmen, J.E.E.; Eijnden, R.J.J.M. van den; Bogt, T.F.M. ter; Stattin, H.; Engels, R.C.M.E.
Aims To evaluate the effectiveness of two preventive interventions to reduce heavy drinking in first- and second-year high school students. Design and setting Cluster randomized controlled trial using four conditions for comparing two active interventions with a control group from 152 classes of 19
Guillemont, Juliette; Cogordan, Chloé; Nalpas, Bertrand; Nguyen-Thanh, Vi?t; Richard, Jean-Baptiste; Arwidson, Pierre
This study aims to evaluate the effectiveness of a web-based intervention to reduce alcohol consumption among hazardous drinkers. A two-group parallel randomized controlled trial was conducted among adults identified as hazardous drinkers according to the Alcohol Use Disorders Identification Test. The intervention delivers personalized normative…
Krabbenborg, Manon A. M.; Boersma, Sandra N.; van der Veld, William M.; van Hulst, Bente; Vollebergh, Wilma A. M.; Wolf, Judith R. L. M.
Objective: To test the effectiveness of Houvast: a strengths-based intervention for homeless young adults. Method: A cluster randomized controlled trial was conducted with 10 Dutch shelter facilities randomly allocated to an intervention and a control group. Homeless young adults were interviewed when entering the facility and when care ended.…
Bogaerts, A.F.L.; Devlieger, R.; Nuyts, E.; Witters, I.; Gyselaers, W.; Van den Bergh, B.R.H.
Objective: Lifestyle intervention could help obese pregnant women to limit their weight gain during pregnancy and improve their psychological comfort, but has not yet been evaluated in randomized controlled trials. We evaluated whether a targeted antenatal lifestyle intervention programme for obese
Clements, Douglas H.; Sarama, Julie; Spitler, Mary Elaine; Lange, Alissa A.; Wolfe, Christopher B.
This study employed a cluster randomized trial design to evaluate the effectiveness of a research-based intervention for improving the mathematics education of very young children. This intervention includes the "Building Blocks" mathematics curriculum, which is structured in research-based learning trajectories, and congruous…
Full Text Available Abstract Background Recent years have seen publication of a considerable number of clinical trials of preventive interventions against clinical malaria in children. There has been variability in the specification of end-points, case definitions, analysis methods and reporting and the relative lack of standardization complicates the ability to make comparative evaluations between trials. Methods To prepare for a WHO consultation on design issues in malaria vaccine trials, controlled trials of preventive interventions against malaria in children in endemic countries were identified in which clinical malaria, or death, had been one of the main end-points. Trials were included that evaluated the impact of vaccines, insecticide-treated bed nets (ITN, intermittent presumptive or preventive therapy in infants (IPTi or, in one instance, vitamin A supplementation. Methods that had been used in these trials were summarized and compared in order to identify issues that were directly relevant to the design of malaria vaccine trials. Results 29 controlled trials of preventive malaria interventions were identified, of which eight were vaccine trials. Vaccine trials that were designed to detect an effect on clinical malaria all reported the incidence rate of first episodes of clinical malaria as their primary endpoint. Only one trial of a preventive intervention (of ITN was identified that was designed to detect an effect on severe malaria. A group of larger trials were designed to detect an effect of impregnated bed nets or curtains on all-cause mortality as the primary end-point. Key methodological and reporting differences between trials are noted in the text. Two issues have been identified that are of some concern. Firstly, the choice of primary endpoint is not stated in the reports of a number of the trials and, secondly, the relationship between pre-specified analysis plans and trial reports is rarely made clear. Conclusion This article reports an
Li, Nicole; Dunford, Elizabeth; Eyles, Helen; Crino, Michelle; Michie, Jo; Ni Mhurchu, Cliona
Background There is substantial interest in the effects of nutrition labels on consumer food-purchasing behavior. However, conducting randomized controlled trials on the impact of nutrition labels in the real world presents a significant challenge. Objective The Food Label Trial (FLT) smartphone app was developed to enable conducting fully automated trials, delivering intervention remotely, and collecting individual-level data on food purchases for two nutrition-labeling randomized controlled trials (RCTs) in New Zealand and Australia. Methods Two versions of the smartphone app were developed: one for a 5-arm trial (Australian) and the other for a 3-arm trial (New Zealand). The RCT protocols guided requirements for app functionality, that is, obtaining informed consent, two-stage eligibility check, questionnaire administration, randomization, intervention delivery, and outcome assessment. Intervention delivery (nutrition labels) and outcome data collection (individual shopping data) used the smartphone camera technology, where a barcode scanner was used to identify a packaged food and link it with its corresponding match in a food composition database. Scanned products were either recorded in an electronic list (data collection mode) or allocated a nutrition label on screen if matched successfully with an existing product in the database (intervention delivery mode). All recorded data were transmitted to the RCT database hosted on a server. Results In total approximately 4000 users have downloaded the FLT app to date; 606 (Australia) and 1470 (New Zealand) users met the eligibility criteria and were randomized. Individual shopping data collected by participants currently comprise more than 96,000 (Australia) and 229,000 (New Zealand) packaged food and beverage products. Conclusions The FLT app is one of the first smartphone apps to enable conducting fully automated RCTs. Preliminary app usage statistics demonstrate large potential of such technology, both for
McRury, Jonna M; Zolotor, Adam J
To evaluate the efficacy of videotaped instruction of a behavioral intervention to reduce crying among newborns. Mothers of healthy, full-term newborns were recruited from the postpartum unit of a large community hospital for a prospective, randomized, controlled trial of an intervention to reduce infant crying. Mothers participating in the intervention viewed a videotape with instructions involving swaddling, side positioning, white noise, jiggling, and sucking. Mothers in the control group viewed a videotape with instructions for normal newborn care. Intervention was assessed by mean hours per day of infant total crying (fussing, crying, and unsoothable crying) and sleeping as recorded in a diary 3 days a week during the 1st, 4th, 6th, 8th, and 12th weeks of age; the Parenting Stress Index was also used during the 6th and 12th weeks. Fifty-one mother-infant pairs were recruited; 35 completed the study (18 intervention and 17 controls). Sixteen were lost to follow-up. There were no statistically significant differences between the groups in the hours of mean daily total crying or sleeping during the 1st, 4th, 6th, 8th, or 12th weeks of age. For example, during the 6th week of age mean daily total crying was 1.9 hours for infants in the control group versus 2.2 hours for infants in the intervention group (P = .4); sleep was 14.5 hours for infants in the control group versus 14.4 hours for infants in the intervention group (P = .8). During the 12th week mean daily total crying was 1.2 hours for infants in the control group versus 1.8 hours for infants in the intervention group (P = .8) and sleep was 14.1 hours for infants in the control group versus 14.0 hours for infants in the intervention group (P = 1.0). There was no difference between the groups in the Parenting Stress Index during the 6th week of age. The behavioral intervention, when provided via videotape, does not seem to be efficacious in decreasing total crying among normal infants.
Marc A Adams
Full Text Available Physical activity (PA interventions typically include components or doses that are static across participants. Adaptive interventions are dynamic; components or doses change in response to short-term variations in participant's performance. Emerging theory and technologies make adaptive goal setting and feedback interventions feasible.To test an adaptive intervention for PA based on Operant and Behavior Economic principles and a percentile-based algorithm. The adaptive intervention was hypothesized to result in greater increases in steps per day than the static intervention.Participants (N = 20 were randomized to one of two 6-month treatments: 1 static intervention (SI or 2 adaptive intervention (AI. Inactive overweight adults (85% women, M = 36.9 ± 9.2 years, 35% non-white in both groups received a pedometer, email and text message communication, brief health information, and biweekly motivational prompts. The AI group received daily step goals that adjusted up and down based on the percentile-rank algorithm and micro-incentives for goal attainment. This algorithm adjusted goals based on a moving window; an approach that responded to each individual's performance and ensured goals were always challenging but within participants' abilities. The SI group received a static 10,000 steps/day goal with incentives linked to uploading the pedometer's data.A random-effects repeated-measures model accounted for 180 repeated measures and autocorrelation. After adjusting for covariates, the treatment phase showed greater steps/day relative to the baseline phase (p<.001 and a group by study phase interaction was observed (p .017. The SI group increased by 1,598 steps/day on average between baseline and treatment while the AI group increased by 2,728 steps/day on average between baseline and treatment; a significant between-group difference of 1,130 steps/day (Cohen's d = .74.The adaptive intervention outperformed the static intervention for increasing
Mark W. Vander Weg
Full Text Available Abstract Background Tobacco use remains prevalent among Veterans of military service and those residing in rural areas. Smokers frequently experience tobacco-related issues including risky alcohol use, post-cessation weight gain, and depressive symptoms that may adversely impact their likelihood of quitting and maintaining abstinence. Telephone-based interventions that simultaneously address these issues may help to increase treatment access and improve outcomes. Methods This study was a two-group randomized controlled pilot trial. Participants were randomly assigned to an individually-tailored telephone tobacco intervention combining counseling for tobacco use and related issues including depressive symptoms, risky alcohol use, and weight concerns or to treatment provided through their state tobacco quitline. Selection of pharmacotherapy was based on medical history and a shared decision interview in both groups. Participants included 63 rural Veteran smokers (mean age = 56.8 years; 87 % male; mean number of cigarettes/day = 24.7. The primary outcome was self-reported 7-day point prevalence abstinence at 12 weeks and 6 months. Results Twelve-week quit rates based on an intention-to-treat analysis did not differ significantly by group (Tailored = 39 %; Quitline Referral = 25 %; odds ratio [OR]; 95 % confidence interval [CI] = 1.90; 0.56, 5.57. Six-month quit rates for the Tailored and Quitline Referral conditions were 29 and 28 %, respectively (OR; 95 % CI = 1.05; 0.35, 3.12. Satisfaction with the Tailored tobacco intervention was high. Conclusions Telephone-based treatment that concomitantly addresses other health-related factors that may adversely affect quitting appears to be a promising strategy. Larger studies are needed to determine whether this approach improves cessation outcomes. Trial registration ClinicalTrials.gov identifier number NCT01592695 registered 11 April 2012.
Crawford, Jennifer J; Vallance, Jeff K; Holt, Nicholas L; Bell, Gordon J; Steed, Helen; Courneya, Kerry S
To examine the feasibility and preliminary efficacy of an eight-week supervised climbing intervention for gynecologic cancer survivors (GCSs). . A pilot randomized, controlled trial. . The Wilson Climbing Center in Edmonton, Alberta, Canada. . 35 GCSs who had completed cancer therapy. . GCSs were randomized to an eight-week (16 session) supervised wall climbing intervention (WCI) (n = 24) or usual care (UC) (n = 11). . Feasibility outcomes included recruitment rate, adherence rate, skill performance, and safety. Preliminary efficacy outcomes were objective health-related and functional fitness assessed before and after the eight-week intervention using the Senior Fitness Test. . Median adherence to the WCI was 13.5 of 16 sessions. Most GCSs were proficient on 16 of 24 skill assessment items. No serious adverse events were reported. Based on intention-to-treat analyses, the WCI group was superior to the UC group for the 6-minute walk, 30-second chair stand, 30-second arm curls, sit and reach, 8-foot up-and-go, grip strength-right, and grip strength-left assessments. . The Gynecologic Cancer Survivors Wall Climbing for Total Health (GROWTH) Trial demonstrated that an eight-week supervised WCI was safe, feasible, and improved functional fitness in GCSs. Phase II and III trials are warranted to further establish the safety, feasibility, and efficacy of WCIs in cancer survivors. . Oncology nurses may consider a climbing wall as an alternative type of physical activity for improving functional fitness in GCSs.
Hormonal and metabolic effects of polyunsaturated fatty acids in young women with polycystic ovary syndrome: results from a cross-sectional analysis and a randomized, placebo-controlled, crossover trial.
BACKGROUND: Polycystic ovary syndrome (PCOS) is characterized by an adverse metabolic profile. Although dietary changes are advocated, optimal nutritional management remains uncertain. Polyunsaturated fatty acids (PUFAs), particularly long-chain (LC) n-3 (omega-3) PUFAs, improve metabolic health, but their therapeutic potential in PCOS is unknown. OBJECTIVES: We aimed to determine the associations between plasma PUFAs and metabolic and hormonal aspects of PCOS to investigate the efficacy of LC n-3 PUFA supplementation and to support the findings with mechanistic cellular studies. DESIGN: We selected a cross-sectional PCOS cohort (n = 104) and conducted a principal component analysis on plasma fatty acid profiles. Effects of LC n-3 PUFA supplementation on fasting and postprandial metabolic and hormonal markers were determined in PCOS subjects (n = 22) by a randomized, crossover, placebo-controlled intervention. Direct effects of n-6 (omega-6) compared with n-3 PUFAs on steroidogenesis were investigated in primary bovine theca cells. RESULTS: Cross-sectional data showed that a greater plasma n-6 PUFA concentration and n-6:n-3 PUFA ratio were associated with higher circulating androgens and that plasma LC n-3 PUFA status was associated with a less atherogenic lipid profile. LC n-3 PUFA supplementation reduced plasma bioavailable testosterone concentrations (P < 0.05), with the greatest reductions in subjects who exhibited greater reductions in plasma n-6:n-3 PUFA ratios. The treatment of bovine theca cells with n-6 rather than with n-3 PUFAs up-regulated androstenedione secretion (P < 0.05). CONCLUSIONS: Cross-sectional data suggest that PUFAs modulated hormonal and lipid profiles and that supplementation with LC n-3 PUFAs improves androgenic profiles in PCOS. In bovine theca cells, arachidonic acid modulated androstenedione secretion, which suggests an indirect effect of n-3 PUFAs through the displacement of or increased competition with n-6 PUFAs. This trial was
Karen J. Campbell
Full Text Available Abstract Background Understanding how we can prevent childhood obesity in scalable and sustainable ways is imperative. Early RCT interventions focused on the first two years of life have shown promise however, differences in Body Mass Index between intervention and control groups diminish once the interventions cease. Innovative and cost-effective strategies seeking to continue to support parents to engender appropriate energy balance behaviours in young children need to be explored. Methods/Design The Infant Feeding Activity and Nutrition Trial (InFANT Extend Program builds on the early outcomes of the Melbourne InFANT Program. This cluster randomized controlled trial will test the efficacy of an extended (33 versus 15 month and enhanced (use of web-based materials, and Facebook® engagement, version of the original Melbourne InFANT Program intervention in a new cohort. Outcomes at 36 months of age will be compared against the control group. Discussion This trial will provide important information regarding capacity and opportunities to maximize early childhood intervention effectiveness over the first three years of life. This study continues to build the evidence base regarding the design of cost-effective, scalable interventions to promote protective energy balance behaviors in early childhood, and in turn, promote improved child weight and health across the life course. Trial registration ACTRN12611000386932 . Registered 13 April 2011.
Messiah, Antoine; Constant, Aymery; Contrand, Benjamin; Felonneau, Marie-Line; Lagarde, Emmanuel
Prevention tools are challenged by risky behaviors that follow their adoption. Speed increase following helmet use adoption was analyzed among bicyclists enrolled in a controlled intervention trial. Speed and helmet use were assessed by video (2621 recordings, 587 participants). Speeds were similar among helmeted and nonhelmeted female cyclists (16.5 km/h and 16.1 km/h, respectively) but not among male cyclists (helmeted: 19.2 km/h, nonhelmeted: 16.8 km/h). Risk compensation, observed only among male cyclists, was moderate, thus unlikely to offset helmet preventive efficacy.
Danielle E Clarkesmith
Full Text Available BACKGROUND: Stroke prevention in atrial fibrillation (AF, most commonly with warfarin, requires maintenance of a narrow therapeutic target (INR 2.0 to 3.0 and is often poorly controlled in practice. Poor patient-understanding surrounding AF and its treatment may contribute to the patient's willingness to adhere to recommendations. METHOD: A theory-driven intervention, developed using patient interviews and focus groups, consisting of a one-off group session (1-6 patients utilising an "expert-patient" focussed DVD, educational booklet, self-monitoring diary and worksheet, was compared in a randomised controlled trial (ISRCTN93952605 against usual care, with patient postal follow-ups at 1, 2, 6, and 12-months. Ninety-seven warfarin-naïve AF patients were randomised to intervention (n=46, mean age (SD 72.0 (8.2, 67.4% men, or usual care (n=51, mean age (SD 73.7 (8.1, 62.7% men, stratified by age, sex, and recruitment centre. Primary endpoint was time within therapeutic range (TTR; secondary endpoints included knowledge, quality of life, anxiety/depression, beliefs about medication, and illness perceptions. MAIN FINDINGS: Intervention patients had significantly higher TTR than usual care at 6-months (76.2% vs. 71.3%; p=0.035; at 12-months these differences were not significant (76.0% vs. 70.0%; p=0.44. Knowledge increased significantly across time (F (3, 47 = 6.4; p<0.01, but there were no differences between groups (F (1, 47 = 3.3; p = 0.07. At 6-months, knowledge scores predicted TTR (r=0.245; p=0.04. Patients' scores on subscales representing their perception of the general harm and overuse of medication, as well as the perceived necessity of their AF specific medications predicted TTR at 6- and 12-months. CONCLUSIONS: A theory-driven educational intervention significantly improves TTR in AF patients initiating warfarin during the first 6-months. Adverse clinical outcomes may potentially be reduced by improving patients' understanding of the
Meyer, Björn; Weiss, Mario; Holtkamp, Martin; Arnold, Stephan; Brückner, Katja; Schröder, Johanna; Scheibe, Franziska; Nestoriuc, Yvonne
Depression is common among persons with epilepsy (PwE), affecting roughly one in three individuals, and its presence is associated with personal suffering, impaired quality of life, and worse prognosis. Despite the availability of effective treatments, depression is often overlooked and treated inadequately in PwE, in part because of assumed concerns over drug interactions or proconvulsant effects of antidepressants. Internet-administered psychological interventions might complement antidepressant medication or psychotherapy, and preliminary evidence suggests that they can be effective. However, no trial has yet examined whether an Internet intervention designed to meet the needs of PwE can achieve sustained reductions in depression and related symptoms, such as anxiety, when offered as adjunct to treatment as usual. This randomized controlled trial will include 200 participants with epilepsy and a current depressive disorder, along with currently at least moderately elevated depression (Patient Health Questionnaire (PHQ-9) sum score of at least 10). Patients will be recruited via epilepsy treatment centers and other sources, including Internet forums, newspaper articles, flyers, posters, and media articles or advertisements, in German-speaking countries. Main inclusion criteria are: self-reported diagnosis of epilepsy and a depressive disorder, as assessed with a phone-administered structured diagnostic interview, none or stable antidepressant medication, no current psychotherapy, no other major psychiatric disorder, no acute suicidality. Participants will be randomly assigned to either (1) a care-as-usual/waitlist (CAU/WL) control group, in which they receive CAU and are given access to the Internet intervention after 3 months (that is, a CAU/WL control group), or (2) a treatment group that may also use CAU and in addition immediately receives six-month access to the novel, Internet-administered intervention. The primary outcome measure is the PHQ-9, collected
Reynolds, Joanna; DiLiberto, Deborah; Mangham-Jefferies, Lindsay; Ansah, Evelyn K; Lal, Sham; Mbakilwa, Hilda; Bruxvoort, Katia; Webster, Jayne; Vestergaard, Lasse S; Yeung, Shunmay; Leslie, Toby; Hutchinson, Eleanor; Reyburn, Hugh; Lalloo, David G; Schellenberg, David; Cundill, Bonnie; Staedke, Sarah G; Wiseman, Virginia; Goodman, Catherine; Chandler, Clare I R
There is increasing recognition among trialists of the challenges in understanding how particular 'real-life' contexts influence the delivery and receipt of complex health interventions. Evaluations of interventions to change health worker and/or patient behaviours in health service settings exemplify these challenges. When interpreting evaluation data, deviation from intended intervention implementation is accounted for through process evaluations of fidelity, reach, and intensity. However, no such systematic approach has been proposed to account for the way evaluation activities may deviate in practice from assumptions made when data are interpreted. A collective case study was conducted to explore experiences of undertaking evaluation activities in the real-life contexts of nine complex intervention trials seeking to improve appropriate diagnosis and treatment of malaria in varied health service settings. Multiple sources of data were used, including in-depth interviews with investigators, participant-observation of studies, and rounds of discussion and reflection. From our experiences of the realities of conducting these evaluations, we identified six key 'lessons learned' about ways to become aware of and manage aspects of the fabric of trials involving the interface of researchers, fieldworkers, participants and data collection tools that may affect the intended production of data and interpretation of findings. These lessons included: foster a shared understanding across the study team of how individual practices contribute to the study goals; promote and facilitate within-team communications for ongoing reflection on the progress of the evaluation; establish processes for ongoing collaboration and dialogue between sub-study teams; the importance of a field research coordinator bridging everyday project management with scientific oversight; collect and review reflective field notes on the progress of the evaluation to aid interpretation of outcomes; and
Allen Kelli D
Full Text Available Abstract Background Osteoarthritis (OA of the hip and knee are among the most common chronic conditions, resulting in substantial pain and functional limitations. Adequate management of OA requires a combination of medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and the majority of patients with hip and knee OA are overweight and physically inactive. Consequently, interventions at the provider-level and patient-level both have potential for improving outcomes. This manuscript describes two ongoing randomized clinical trials being conducted in two different health care systems, examining patient-based and provider-based interventions for managing hip and knee OA in primary care. Methods / Design One study is being conducted within the Department of Veterans Affairs (VA health care system and will compare a Combined Patient and Provider intervention relative to usual care among n = 300 patients (10 from each of 30 primary care providers. Another study is being conducted within the Duke Primary Care Research Consortium and will compare Patient Only, Provider Only, and Combined (Patient + Provider interventions relative to usual care among n = 560 patients across 10 clinics. Participants in these studies have clinical and / or radiographic evidence of hip or knee osteoarthritis, are overweight, and do not meet current physical activity guidelines. The 12-month, telephone-based patient intervention focuses on physical activity, weight management, and cognitive behavioral pain management. The provider intervention involves provision of patient-specific recommendations for care (e.g., referral to physical therapy, knee brace, joint injection, based on evidence-based guidelines. Outcomes are collected at baseline, 6-months, and 12-months. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function, and
Brendbekken, Randi; Eriksen, Hege R; Grasdal, Astrid; Harris, Anette; Hagen, Eli M; Tangen, Tone
This randomized clinical trial was performed to compare the effect of a new multidisciplinary intervention (MI) programme to a brief intervention (BI) programme on return to work (RTW), fully and partly, at a 12-month and 24-month follow-up in patients on long-term sick leave due to musculoskeletal pain. Patients (n = 284, mean age 41.3 years, 53.9 % women) who were sick-listed with musculoskeletal pain and referred to a specialist clinic in physical rehabilitation were randomized to MI (n = 141) or BI (n = 143). The MI included the use of a visual educational tool, which facilitated patient-therapist communication and self-management. The MI also applied one more profession, more therapist time and a comprehensive focus on the psychosocial factors, particularly the working conditions, compared to a BI. The main features of the latter are a thorough medical, educational examination, a brief cognitive assessment based on the non-injury model, and a recommendation to return to normal activity as soon as possible. The number of patients with full-time RTW developed similarly in the two groups. The patients receiving MI had a higher probability to partly RTW during the first 7 months of the follow-up compared to the BI-group. There were no differences between the groups on full-time RTW during the 24 months. However, the results indicate that MI hastens the return to work process in long-term sick leave through the increased use of partial sick leave. http://www.clinicaltrials.gov with the registration number NCT01346423.
Locher, JL; Vickers, KS; Buys, DR; Ellis, A; Lawrence, JC; Newton, LE; Roth, DL; Ritchie, CS; Bales, CW
Older adults with multiple comorbidities are often undernourished or at high risk for becoming so, especially after a recent hospitalization. Randomized controlled trials of effective, innovative interventions are needed to support evidence-based approaches for solving nutritional problems in this population. Self-management approaches where participants select their own behavioral goals can enhance success of interventions. The purpose of this study was to evaluate the feasibility and effica...
Tan, Pey June; Khoo, Ee Ming; Chinna, Karuthan; Hill, Keith D; Poi, Phillip JH; Tan, Maw Pin
Background In line with a rapidly ageing global population, the rise in the frequency of falls will lead to increased healthcare and social care costs. This study will be one of the few randomized controlled trials evaluating a multifaceted falls intervention in a low-middle income, culturally-diverse older Asian community. The primary objective of our paper is to evaluate whether individually tailored multifactorial interventions will successfully reduce the number of falls among older adult...
Munro, Cindy L; Cairns, Paula; Ji, Ming; Calero, Karel; Anderson, W McDowell; Liang, Zhan
Explore the effect of an automated reorientation intervention on ICU delirium in a prospective randomized controlled trial. Delirium is common in ICU patients, and negatively affects outcomes. Few prevention strategies have been tested. Thirty ICU patients were randomized to 3 groups. Ten received hourly recorded messages in a family member's voice during waking hours over 3 ICU days, 10 received the same messages in a non-family voice, and 10 (control) did not receive any automated reorientation messages. The primary outcome was delirium free days during the intervention period (evaluated by CAM-ICU). Groups were compared by Fisher's Exact Test. The family voice group had more delirium free days than the non-family voice group, and significantly more delirium free days (p = 0.0437) than the control group. Reorientation through automated, scripted messages reduced incidence of delirium. Using identical scripted messages, family voice was more effective than non-family voice. Copyright © 2017 Elsevier Inc. All rights reserved.
Harder-Lauridsen, Nina Majlund; Birk, Nina Marie; Ried-Larsen, Mathias
BACKGROUND: Obesity amongst children is a growing problem worldwide. In contrast to adults, little is known on the effects of controlled weight loss on components of the metabolic syndrome in children. The primary aim of the study was to evaluate the effects of a 20-week exercise and diet guidance...... intervention on body mass index (BMI) in a group of overweight children. Our hypothesis was an observed reduction in BMI and secondarily in body fat content, insulin insensitivity, and other components of the metabolic syndrome in the intervention group. METHODS: School children from Copenhagen were randomly....../day, and fat mass. In addition, similar beneficial metabolic effects were found in the children as shown in adults, e.g. increase in peripheral insulin sensitivity. TRIAL REGISTRATION: Clinicaltrials.gov Identifier number NCT01660789....
Smith, Gregory C.; Strieder, Frederick; Greenberg, Patty; Hayslip, Bert; Montoro-Rodriguez, Julian
The authors used Andersen’s (2008) behavior model to investigate patterns of enrollment and treatment engagement among 343 custodial grandmothers who participated in a randomized clinical trial of three psychosocial interventions:(a) a behavioral parenting program, (b) a cognitive behavioral coping program, or (c) an information-only condition. Treatment completion was superior to that typically found with birth parents, even though the grandmothers and their target grandchildren both had high levels of mental and physical health challenges. Compliance did not differ significantly by condition but was higher among grandmothers who self-reported less positive affect, were older, and were using mental health professionals. Treatment satisfaction was highest in grandmothers who attended more treatment sessions, reported lower annual family income, had a health problem, and were using mental health professionals. The practice and policy implications of these findings are discussed, especially in terms of strategies for enhancing the engagement of custodial grandfamilies in future psychoeducational interventions. PMID:27667888
Full Text Available Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09–0.25. KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.
Soto-Rodríguez, Anxela; García-Soidán, José Luís; de Toro-Santos, Manuel; Rodríguez-González, Manuel; Arias-Gómez, M Jesús; Pérez-Fernández, María Reyes
To assess whether an educational intervention in women in perimenopausal age with diabetes mellitus, hypertension and/or dyslipidemia could improve aspects of quality of life and exercise. A randomized clinical trial. physical activity, quality of life and weight in women aged 45-60 years (n = 320) at time 0 and 12 months after surgery. intervention group (IG): 3 interactive workshops on cardiovascular disease prevention and control group (CG): information by mail. The IG obtained better scores on the mental component of quality of life one year later (p cardiovascular risk factor improves aspects of quality of life and of healthy habits such as physical activity. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.
Fitzgerald, Sarah; Geaney, Fiona; Kelly, Clare; McHugh, Sheena; Perry, Ivan J.
Background Ambiguity exists regarding the effectiveness of workplace dietary interventions. Rigorous process evaluation is vital to understand this uncertainty. This study was conducted as part of the Food Choice at Work trial which assessed the comparative effectiveness of a workplace environmental dietary modification intervention and an educational intervention both alone and in combination versus a control workplace. Effectiveness was assessed in terms of employees? dietary intakes, nutri...
Higgins, Michaela J; Liedke, Pedro E R; Goss, Paul E
Early hormone-receptor-positive breast cancer is a chronic relapsing disease that can remain clinically silent for many years. The NCIC-CTG MA.17/BIG 1-97 trial randomized disease-free early breast cancer patients who had received five years of adjuvant tamoxifen to either letrozole or placebo and was the first to demonstrate a benefit with extended endocrine therapy. MA.17/BIG 1-97 was stopped at the first interim analysis because disease free survival was strongly prolonged in the letrozole arm. Subsequent subset analyses and longer follow up have shown that this therapy improved survival across all groups, particularly among women with node-positive disease and those that were pre-menopausal at time of study enrolment. The MA.17/BIG 1-97 study should be considered a paradigm for extended adjuvant endocrine therapy in hormone-receptor-positive early breast cancer. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.
Arnold, Shelley S; Barton, Belinda; McArthur, Genevieve; North, Kathryn N; Payne, Jonathan M
To examine the efficacy of a phonics-training program in children with neurofibromatosis type 1 (NF1) and reading difficulties. Thirty children (7-12 years of age) with NF1 completed a double-baseline, 24-week intervention trial. Literacy outcome measures were assessed at 4 time points: (1) at baseline; (2) after an 8-week no-treatment period; (3) immediately post-treatment; and (4) at follow-up 8 weeks post-treatment. Repeated-measures ANOVA were conducted to examine change over time for all outcome measures, and significant main effects were explored with planned comparisons. Predictors of treatment effects were examined by linear regressions. Ninety percent of participants completed the intervention. Intervention-specific improvements were observed across a range of literacy outcomes, including reading accuracy (nonword reading, Cohen d = 1.10; regular-word reading, Cohen d = 0.32), letter-sound knowledge (Cohen d = 0.80), blending (Cohen d = 0.88), repetition of nonsense words (Cohen d = 0.94), phonemic decoding fluency (Cohen d = 0.55), and reading comprehension (Cohen d = 0.31). Improvements were maintained 8 weeks post-treatment. Age (P = .03) and working memory (P = .02) significantly influenced efficacy, with greatest improvements observed in older children with stronger verbal working memory capacity. Home-based, computerized reading intervention was effective in improving the reading and reading-related abilities of children with NF1 and reading difficulty. Australian and New Zealand Clinical Trials Registry: ACTRN12611000779976. Copyright © 2016 Elsevier Inc. All rights reserved.
Adamo, Kristi B; Ferraro, Zachary M; Goldfield, Gary; Keely, Erin; Stacey, Dawn; Hadjiyannakis, Stasia; Jean-Philippe, Sonia; Walker, Mark; Barrowman, Nicholas J
Maternal obesity and/or high gestational weight gain (GWG) are associated with downstream child obesity. Pregnancy represents a critical period for prevention as women are highly motivated and more receptive to behavior change. This pilot study was developed to test the feasibility of intervening with the mother, specifically keeping her GWG within the Institute of Medicine (IOM) limits, with the intended target of preventing obesity in her child downstream. We are testing the practicality of delivering a structured physical activity and nutrition intervention to pregnant women during gestation and then following mom and baby to 24 months of age. This study is a two-arm, parallel group, randomized controlled trial being conducted in Ottawa. Pregnant women, with pregravid BMI >18.5, between 12 and 20 weeks gestation are randomized to one of two groups: intervention (n=30) who receive the MOM trial Handbook (guide to healthy gestation) plus a structured physical activity and nutrition program, or a standard clinical care control group (n=30). The intervention lasts 25-28 weeks (6 months) depending on anticipated delivery date, with follow-up assessment on mother and child at 3, 6, 12 and 24 months post-delivery. Pregnancy, a critical time of growth, development and physiological change, provides an opportunity for early lifestyle intervention. The goal of identifying an effective lifestyle program for the gestational period that leads to healthy fetal development and subsequently normal weight offspring, less likely to develop obesity and its co-morbidities, is unique and could possibly attenuate the inter-generational cycle of obesity. Copyright © 2013 Elsevier Inc. All rights reserved.
Johns, David J; Hartmann-Boyce, Jamie; Jebb, Susan A; Aveyard, Paul
Evidence on the effectiveness of behavioral weight management programs often comes from uncontrolled program evaluations. These frequently make the assumption that, without intervention, people will gain weight. The aim of this study was to use data from minimal intervention control groups in randomized controlled trials to examine the evidence for this assumption and the effect of frequency of weighing on weight change. Data were extracted from minimal intervention control arms in a systematic review of multicomponent behavioral weight management programs. Two reviewers classified control arms into three categories based on intensity of minimal intervention and calculated 12-month mean weight change using baseline observation carried forward. Meta-regression was conducted in STATA v12. Thirty studies met the inclusion criteria, twenty-nine of which had usable data, representing 5,963 participants allocated to control arms. Control arms were categorized according to intensity, as offering leaflets only, a single session of advice, or more than one session of advice from someone without specialist skills in supporting weight loss. Mean weight change at 12 months across all categories was -0.8 kg (95% CI -1.1 to -0.4). In an unadjusted model, increasing intensity by moving up a category was associated with an additional weight loss of -0.53 kg (95% CI -0.96 to -0.09). Also in an unadjusted model, each additional weigh-in was associated with a weight change of -0.42 kg (95% CI -0.81 to -0.03). However, when both variables were placed in the same model, neither intervention category nor number of weigh-ins was associated with weight change. Uncontrolled evaluations of weight loss programs should assume that, in the absence of intervention, their population would weigh up to a kilogram on average less than baseline at the end of the first year of follow-up. © 2016 The Authors Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).
Abrantes, Ana M; Bloom, Erika Litvin; Strong, David R; Riebe, Deborah; Marcus, Bess H; Desaulniers, Julie; Fokas, Kathryn; Brown, Richard A
Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation. The preliminary efficacy of a behavioral exercise intervention that incorporated features designed to address prior limitations was tested in a randomized controlled trial (RCT). Sixty-one smokers (65.6% female, mean age = 47.3 years, smoked a mean of 19.7 cigarettes/day) were randomized to receive either a 12-week exercise intervention or a 12-week health education contact control. Participants in both conditions received an 8-week telephone-delivered, standard smoking cessation protocol (with the transdermal nicotine patch). Follow-ups were conducted at the end of treatment (EOT), 6- and 12-month timepoints. There were no differences between conditions with respect to the number of weekly exercise or health education sessions attended (9.3±2.8 vs. 9.3±3.0, respectively). While not statistically significant, participants in the exercise condition demonstrated higher verified abstinence rates (EOT: 40% vs. 22.6%, odds ratio [OR] = 2.28; 6- and 12-month follow-ups: 26.7% vs. 12.9%, OR = 2.46). Irrespective of treatment condition, higher levels of moderate-to-vigorous exercise were associated with lower levels of depressive symptoms during the intervention. The results of this small RCT point toward the benefit of a behavioral exercise intervention designed to address previous methodological limitations for smoking cessation. Given the potential public health impact of the demonstrated efficacy of exercise for smoking cessation, the continued development and optimization of exercise interventions for smokers through larger RCTs merits pursuit. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: firstname.lastname@example.org.
Lee, Hee; Ghebre, Rahel; Le, Chap; Jang, Yoo Jeong; Sharratt, Monica; Yee, Douglas
Despite the increasing breast cancer incidence and mortality rates, Korean American immigrant women have one of the lowest rates of breast cancer screening across racial groups in the United States. Mobile health (mHealth), defined as the delivery of health care information or services through mobile communication devices, has been utilized to successfully improve a variety of health outcomes. This study adapted the principles of mHealth to advance breast cancer prevention efforts among Korean American immigrant women, an underserved community. Using a randomized controlled trial design, 120 Korean American women aged 40 to 77 years were recruited and randomly assigned to either the mMammogram intervention group (n=60) to receive culturally and personally tailored multilevel and multimedia messages through a mobile phone app along with health navigator services or the usual care control group (n=60) to receive a printed brochure. Outcome measures included knowledge, attitudes, and beliefs about breast cancer screening, readiness for mammography, and mammogram receipt. The feasibility and acceptability of the mMammogram intervention was also assessed. The intervention group showed significantly greater change on scores of knowledge of breast cancer and screening guidelines (P=.01). The intervention group also showed significantly greater readiness for mammography use after the intervention compared with the control group. A significantly higher proportion of women who received the mMammogram intervention (75%, 45/60) completed mammograms by the 6-month follow-up compared with the control group (30%, 18/60; Phttps://clinicaltrials.gov/show/NCT01972048 (Archived by WebCite at https://clinicaltrials.gov/archive/NCT01972048/2013_10_29).
McKenzie, Lara B; Roberts, Kristin J; Kaercher, Roxanne M; Collins, Christy L; Comstock, R Dawn; Fernandez, Soledad; Abdel-Rasoul, Mahmoud; Casavant, Marcel J; Mihalov, Leslie
Although non-fire-related carbon monoxide (CO) poisoning is almost entirely preventable, over 400 people die and 20 000 people are injured each year in the USA from unintentional CO poisoning. Thus, there is a critical need for evidence-based interventions for preventing CO poisoning and increasing the proper use and installation of CO detectors. A randomised, controlled trial (Project CODE, a Carbon Monoxide Detector Education intervention) with 2-week and 6-month follow-up home observations was conducted in 299 parents of children aged ≤18 years recruited in the emergency department of a level 1 paediatric trauma centre. The intervention group received an educational tool, a spiral-bound, laminated booklet that resembled a CO detector containing theory-based safety messages based on the precaution adoption process model, a plug-in CO detector and 9 V battery. The control group received a one page flyer on CO poisoning prevention. Although the difference was not statistically significant, mean CO knowledge score increased at a greater rate for the intervention group than the control group. Intervention group parents were more likely to exhibit 'safe' CO detector use than control group parents at the 2-week follow-up (RR: 2.75; 95% CI 2.06 to 3.69) and 6-month follow-up (RR: 2.78; 95% CI 2.06 to 3.76), after adjusting for self-reported CO detector use behaviour at enrolment and annual per capita income. An emergency department-delivered intervention containing a theory-based educational tool paired with a CO detector can be an effective method for increasing knowledge about CO poisoning, for prevention and for appropriate use of a CO detector. NCT00959478. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Pace, Emma J; Somerville, Nicholas J; Enyioha, Chineme; Allen, Joseph P; Lemon, Latrina C; Allen, Claudia W
Increasing attention is being paid to patients’ experience of hospitalization. BATHE (a brief psychosocial intervention that addresses Background, Affect, Trouble, Handling, and Empathy) has been found to improve patients’ outpatient experiences but has not yet been studied in inpatient settings. This randomized controlled trial (RCT) examined whether daily administration of BATHE would improve patients’ satisfaction with their hospital experience. BATHE is a brief psychosocial intervention designed to reduce distress and strengthen the physician-patient relationship. In February through March 2015 and February through March 2016, 25 patients admitted to the University of Virginia Family Medicine inpatient service were randomized to usual care or to the BATHE intervention. Participants completed a baseline measure of satisfaction at enrollment. Those in the intervention group received the BATHE intervention daily for five days or until discharge. At completion, participants completed a patient satisfaction measure. Daily administration of BATHE had strong effects on patients’ likelihood of endorsing their medical care as “excellent.” BATHE did not improve satisfaction by making patients feel more respected, informed or attended to. Rather, effects on satisfaction were mediated by patients’ perception that their physician showed “a genuine interest in me as a person." Our study suggests that patients are more satisfied with their hospitalization experience when physicians take a daily moment to check in with the patient “as a person” and not just as a medical patient. The brevity of the BATHE intervention indicates that this check-in need not be lengthy or overly burdensome for the already busy inpatient physician.
Karjalainen, Kaija; Malmivaara, Antti; Pohjolainen, Timo; Hurri, Heikki; Mutanen, Pertti; Rissanen, Pekka; Pahkajärvi, Helena; Levon, Heikki; Karpoff, Hanna; Roine, Risto
Randomized controlled trial. To investigate the effectiveness and costs of a mini-intervention, provided in addition to the usual care, and the incremental effect of a work site visit for patients with subacute disabling low back pain. There is lack of data on cost-effectiveness of brief interventions for patients with prolonged low back pain. A total of 164 patients with subacute low back pain were randomized to a mini-intervention group (A), a work site visit group (B), or a usual care group (C). Groups A (n = 56) and B (n = 51) underwent one assessment by a physician plus a physiotherapist. Group B received a work site visit in addition. Group C served as controls (n = 57) and was treated in municipal primary health care. All patients received a leaflet on back pain. Pain, disability, specific and generic health-related quality of life, satisfaction with care, days on sick leave, and use and costs of health care consumption were measured at 3-, 6-, and 12-month follow-ups. During follow-up, fewer subjects had daily pain in Groups A and B than in Group C (Group A Group C, = 0.002; Group B Group C, = 0.030). In Group A, pain was less bothersome (Group A Group C, = 0.032) and interfered less with daily life (Group A Group C, = 0.040) than among controls. Average days on sick leave were 19 in Group A, 28 in Group B, and 41 in Group C (Group A Group C, = 0.019). Treatment satisfaction was better in the intervention groups than among the controls, and costs were lowest in the mini-intervention group. Mini-intervention reduced daily back pain symptoms and sickness absence, improved adaptation to pain and patient satisfaction among patients with subacute low back pain, without increasing health care costs. A work site visit did not increase effectiveness.
Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M
A constructive safety culture is essential for the successful implementation of patient safety improvements. To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. A three-arm cluster randomised trial was conducted in a mixed method study, studying the effect of administering a patient safety culture questionnaire (intervention I), the questionnaire complemented with a practice-based workshop (intervention II) and no intervention (control) in 30 general practices in the Netherlands. The primary outcome, the number of reported incidents, was measured with a questionnaire at baseline and a year after. Analysis was performed using a negative binomial model. Secondary outcomes were quality and safety indicators and safety culture. Mixed effects linear regression was used to analyse the culture questionnaires. The number of incidents increased in both intervention groups, to 82 and 224 in intervention I and II respectively. Adjusted for baseline number of incidents, practice size and accreditation status, the study showed that practices that additionally participated in the workshop reported 42 (95% confidence interval [CI] = 9.81 to 177.50) times more incidents compared to the control group. Practices that only completed the questionnaire reported 5 (95% CI = 1.17 to 25.49) times more incidents. There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups. Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents. It is beneficial to invest in a team-wise effort to improve patient safety. © British Journal of General Practice 2015.
Clanchy, Kelly M; Tweedy, Sean M; Trost, Stewart G
Individuals with brain impairment (BI) are less active than the general population and have increased risk of chronic disease. This controlled trial evaluated the efficacy of a physical activity (PA) intervention for community-dwelling adults with BI. A total of 43 adults with BI (27 male, 16 female; age 38.1 ± 11.9 years; stage of change 1-3) who walked as their primary means of locomotion were allocated to an intervention (n = 23) or control (n = 20) condition. The intervention comprised 10 face-to-face home visits over 12 weeks, including a tailored combination of stage-matched behavior change activities, exercise prescription, community access facilitation, and relapse prevention strategies. The control group received 10 face-to-face visits over 12 weeks to promote sun safety, healthy sleep, and oral health. Primary outcomes were daily activity counts and minutes of moderate-to-vigorous-intensity PA (MVPA) measured with the ActiGraph GT1M at baseline (0 weeks), postintervention (12 weeks) and follow-up (24 weeks). Between-group differences were evaluated for statistical significance using repeated-measures ANOVA. MVPA for the intervention group increased significantly from baseline to 12 weeks (20.8 ± 3.1 to 31.2 ± 3.1 min/d; P = .01), but differences between baseline and 24 weeks were nonsignificant (20.8 ± 3.1 to 25.3 ± 3.2 min/d; P = .28). MVPA changes for the control group were negligible and nonsignificant. Between-group differences for change in MVPA were significant at 12 weeks (P = .03) but not at 24 weeks (P = .49). The 12-week intervention effectively increased adoption of PA in a sample of community-dwelling adults with BI immediately after the intervention but not at follow-up. Future studies should explore strategies to foster maintenance of PA participation. © The Author(s) 2016.
Full Text Available This study examined the impact of a targeted Irish early intervention program on children's emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally.ISRCTN Registry ISRCTN04631728.
Schuna, John M; Swift, Damon L; Hendrick, Chelsea A; Duet, Megan T; Johnson, William D; Martin, Corby K; Church, Timothy S; Tudor-Locke, Catrine
To evaluate the effectiveness of a 3-month treadmill desk intervention in eliciting changes in physical activity and sedentary behavior among overweight/obese office workers. A randomized controlled trial was conducted among overweight/obese office workers (n = 41; mean age = 40.1 ± 10.1 years) at a private workplace. Participants were randomly assigned to a shared-treadmill desk intervention (n = 21) or a usual working condition control group (n = 20). Accelerometer-determined physical activity and sedentary behavior were measured before and after the intervention. Compared with the control group, the intervention group increased daily steps (1622 steps/day; P = 0.013) and light physical activity (1.6 minutes/hour; P = 0.008), and decreased sedentary time (-3.6 minutes/hour; P = 0.047) during working hours. Shared-treadmill desks in the workplace can be effective at promoting favorable changes in light physical activity (specifically 40 to 99 steps/minute) and sedentary behavior among overweight/obese office workers.
Osman, Hibah; Saliba, Matilda; Chaaya, Monique; Naasan, Georges
The postpartum period can be a challenging time particularly for first-time mothers. This study aimed to assess two different interventions designed to reduce stress in the postpartum among first-time mothers. Healthy first-time mothers with healthy newborns were recruited from hospitals in Beirut, Lebanon after delivery. The two interventions were a 20-minute film addressing common stressors in the postpartum period and a 24-hour telephone support hotline. Participants were randomized to one of four study arms to receive either the postpartum support film, the hotline service, both interventions, or a music CD (control). Participants were interviewed at eight to twelve weeks postpartum for assessment of levels of stress as measured by the Cohen Perceived Stress Scale (PSS-10). Of the 632 eligible women, 552 (88%) agreed to participate in the study. Of those, 452 (82%) completed the study. Mean PSS-10 scores of mothers who received the film alone (15.76) or the film with the hotline service (15.86) were significantly lower than that of the control group (18.93) (p-value reduced stress in the postpartum period in first-time mothers. These simple interventions can be easily implemented and could have an important impact on the mental wellbeing of new mothers. The trial was registered with clinicaltrials.gov (identifier # NCT00857051) on March 5, 2009.
Elgmark Andersson, E; Emanuelson, I; Björklund, R; Stålhammar, D A
Positive results from early clinical intervention of mild traumatic brain injury (MTBI) patients by rehabilitation specialists have been reported. Various treatments have been used, but few controlled studies are published. We hypothesised that early rehabilitation of selected MTBI patients would reduce long term sequelae. A randomised controlled trial with one year follow-up. Among 1719 consecutive patients with MTBI, 395 individuals, 16-60 years of age, met the MTBI definition. Exclusion criteria were: previous clinically significant brain disorders and/or a history of substance abuse. The control group (n = 131) received regular care. The intervention group (n = 264) was examined by a rehabilitation specialist. 78 patients were mainly referred to an occupational therapist. The problems were identified in daily activities and in terms of post-concussion symptoms (PCS), an individualised, tailored treatment was given. Primary endpoint was change in rate of PCS and in life satisfaction at one-year follow-up between the groups. No statistical differences were found between the intervention and control groups. Patients who experienced few PCS two to eight weeks after the injury and declined rehabilitation recovered and returned to their pre-injury status. Patients who suffered several PCS and accepted rehabilitation did not recover after one year. In this particular MTBI sample, early active rehabilitation did not change the outcome to a statistically-significant degree. Further studies should focus on patients with several complaints during the first 1-3 months and test various types of interventions.
Gold, Christian; Saarikallio, Suvi; Crooke, Alexander Hew Dale; McFerran, Katrina Skewes
Music forms an important part of the lives and identities of adolescents and may have positive or negative mental health implications. Music therapy can be effective for mental disorders such as depression, but its preventive potential is unknown. The aim of this study was to examine whether group music therapy (GMT) is an effective intervention for young people who may be at risk of developing mental health problems, as indicated via unhealthy music use. The main question was whether GMT can reduce unhealthy uses of music and increase potentials for healthy uses of music, compared to self-directed music listening (SDML). We were also interested in effects of GMT on depressive symptoms, psychosocial well-being, rumination, and reflection. In an exploratory cluster-randomized trial in Australian schools, 100 students with self-reported unhealthy music use were invited to GMT (weekly sessions over 8 weeks) or SDML. Changes in the Healthy-Unhealthy Music Scale (HUMS) and mental health outcomes were measured over 3 months. Both interventions were well accepted. No effects were found between GMT and SDML (all p > 0.05); both groups tended to show small improvements over time. Younger participants benefited more from GMT, and older ones more from SDML (p = 0.018). GMT was associated with similar changes as SDML. Further research is needed to improve the processes of selecting participants for targeted interventions; to determine optimal dosage; and to provide more reliable evidence of effects of music-based interventions for adolescents.
Saitz, Richard; Palfai, Tibor P A; Cheng, Debbie M; Alford, Daniel P; Bernstein, Judith A; Lloyd-Travaglini, Christine A; Meli, Seville M; Chaisson, Christine E; Samet, Jeffrey H
The United States has invested substantially in screening and brief intervention for illicit drug use and prescription drug misuse, based in part on evidence of efficacy for unhealthy alcohol use. However, it is not a recommended universal preventive service in primary care because of lack of evidence of efficacy. To test the efficacy of 2 brief counseling interventions for unhealthy drug use (any illicit drug use or prescription drug misuse)-a brief negotiated interview (BNI) and an adaptation of motivational interviewing (MOTIV)-compared with no brief intervention. This 3-group randomized trial took place at an urban hospital-based primary care internal medicine practice; 528 adult primary care patients with drug use (Alcohol, Smoking, and Substance Involvement Screening Test [ASSIST] substance-specific scores of ≥4) were identified by screening between June 2009 and January 2012 in Boston, Massachusetts. Two interventions were tested: the BNI is a 10- to 15-minute structured interview conducted by health educators; the MOTIV is a 30- to 45-minute intervention based on motivational interviewing with a 20- to 30-minute booster conducted by master's-level counselors. All study participants received a written list of substance use disorder treatment and mutual help resources. Primary outcome was number of days of use in the past 30 days of the self-identified main drug as determined by a validated calendar method at 6 months. Secondary outcomes included other self-reported measures of drug use, drug use according to hair testing, ASSIST scores (severity), drug use consequences, unsafe sex, mutual help meeting attendance, and health care utilization. At baseline, 63% of participants reported their main drug was marijuana, 19% cocaine, and 17% opioids. At 6 months, 98% completed follow-up. Mean adjusted number of days using the main drug at 6 months was 12 for no brief intervention vs 11 for the BNI group (incidence rate ratio [IRR], 0.97; 95% CI, 0.77-1.22) and 12
Sharma, Yogesh; Thompson, Campbell; Miller, Michelle; Shahi, Rashmi; Hakendorf, Paul; Horwood, Chris; Kaambwa, Billingsley
Prevalence of malnutrition in older hospitalized patients is 30%. Malnutrition is associated with poor clinical outcomes in terms of high morbidity and mortality and is costly for hospitals. Extended nutrition interventions improve clinical outcomes but limited studies have investigated whether these interventions are cost-effective. In this randomized controlled trial, 148 malnourished general medical patients ≥60 years were recruited and randomized to receive either an extended nutritional intervention or usual care. Nutrition intervention was individualized and started with 24 h of admission and was continued for 3 months post-discharge with a monthly telephone call whereas control patients received usual care. Nutrition status was confirmed by Patient generated subjective global assessment (PG-SGA) and health-related quality of life (HRQoL) was measured using EuroQoL 5D (EQ-5D-5 L) questionnaire at admission and at 3-months follow-up. A cost-effectiveness analysis was conducted for the primary outcome (incremental costs per unit improvement in PG-SGA) while a cost-utility analysis (CUA) was undertaken for the secondary outcome (incremental costs per quality adjusted life year (QALY) gained). Nutrition status and HRQoL improved in intervention patients. Mean per included patient Australian Medicare costs were lower in intervention group compared to control arm (by $907) but these differences were not statistically significant (95% CI: -$2956 to $4854). The main drivers of higher costs in the control group were higher inpatient ($13,882 versus $13,134) and drug ($838 versus $601) costs. After adjusting outcomes for baseline differences and repeated measures, the intervention was more effective than the control with patients in this arm reporting QALYs gained that were higher by 0.0050 QALYs gained per patient (95% CI: -0.0079 to 0.0199). The probability of the intervention being cost-effective at willingness to pay values as low as $1000 per unit
Wylie, Gavin; Menz, Hylton B; McFarlane, Sarah; Ogston, Simon; Sullivan, Frank; Williams, Brian; Young, Zoe; Morris, Jacqui
Common foot problems are independent risk factors for falls in older people. There is evidence that podiatry can prevent falls in community-dwelling populations. The feasibility of implementing a podiatry intervention and trial in the care home population is unknown. To inform a potential future definitive trial, we performed a pilot randomised controlled trial to assess: (i) the feasibility of a trial of a podiatry intervention to reduce care home falls, and (ii) the potential direction and magnitude of the effect of the intervention in terms of number of falls in care home residents. Informed by Medical Research Council guidance on developing and evaluating complex interventions, we conducted a single blind, pilot randomised controlled trial in six care homes in the East of Scotland. Participants were randomised to either: (i) a three month podiatry intervention comprising core podiatry care, foot and ankle exercises, orthoses and footwear provision or (ii) usual care. Falls-related outcomes (number of falls, time to first fall) and feasibility-related outcomes (recruitment, retention, adherence, data collection rates) were collected. Secondary outcomes included: generic health status, balance, mobility, falls efficacy, and ankle joint strength. 474 care home residents were screened. 43 (9.1%) participants were recruited: 23 to the intervention, 20 to control. Nine (21%) participants were lost to follow-up due to declining health or death. It was feasible to deliver the trial elements in the care home setting. 35% of participants completed the exercise programme. 48% reported using the orthoses 'all or most of the time'. Completion rates of the outcome measures were between 93% and 100%. No adverse events were reported. At the nine month follow-up period, the intervention group per-person fall rate was 0.77 falls vs. 0.83 falls in the control group. A podiatry intervention to reduce falls can be delivered to care home residents within a pilot randomised
van der Kop, Mia L; Muhula, Samuel; Ekström, Anna M; Jongbloed, Kate; Smillie, Kirsten; Abunah, Bonface; Kinagwi, Koki; Kyomuhangi, Lennie B; Gelmon, Lawrence; Ojakaa, David I; Lester, Richard T; Awiti, Patricia O
Background To be consistent with the United Nations' sustainable development goals on gender equality, mobile health (mHealth) programmes should aim to use communications technology to promote the empowerment of women. We conducted a pre-trial analysis of data from the WelTel Retain study on retention in HIV care to assess gender-based differences in phone access, phone sharing and concerns about receiving text messages from a healthcare provider. Methods Between April 2013-June 2015, HIV-positive adults were screened for trial participation at two clinics in urban slums in Nairobi, Kenya. Proportions of men and women excluded from the trial due to phone-related criteria were compared using a chi-square test. Gender-based differences in phone sharing patterns and concerns among trial participants were similarly compared. Results Of 1068 individuals screened, there was no difference in the proportion of men ( n = 39/378, 10.3%) and women ( n = 71/690, 10.3%) excluded because of phone-related criteria ( p-value = 0.989). Among those who shared their phone, women ( n = 52/108, 48.1%) were more likely than men ( n = 6/60, 10.0%) to share with other non-household and household members ( p equally able to participate in a trial of an mHealth intervention. Equitable access in these urban slums may indicate the 'gender digital divide' is narrowing in some settings; however, gender-specific phone sharing patterns and concerns regarding privacy must be fully considered in the development and scale-up of mHealth programmes.
Full Text Available Evidence suggests European American (EA women have two- to five-fold increased odds of having pelvic organ prolapse (POP when compared with African American (AA women. However, the role of genetic ancestry in relation to POP risk is not clear. Here we evaluate the association between genetic ancestry and POP in AA women from the Women's Health Initiative Hormone Therapy trial. Women with grade 1 or higher classification, and grade 2 or higher classification for uterine prolapse, cystocele or rectocele at baseline or during follow-up were considered to have any POP (N = 805 and moderate/severe POP (N = 156, respectively. Women with at least two pelvic exams with no indication for POP served as controls (N = 344. We performed case-only, and case-control admixture-mapping analyses using multiple logistic regression while adjusting for age, BMI, parity and global ancestry. We evaluated the association between global ancestry and POP using multiple logistic regression. European ancestry at the individual level was not associated with POP risk. Case-only and case-control local ancestry analyses identified two ancestry-specific loci that may be associated with POP. One locus (Chromosome 15q26.2 achieved empirically-estimated statistical significance and was associated with decreased POP odds (considering grade ≥2 POP with each unit increase in European ancestry (OR: 0.35; 95% CI: 0.30, 0.57; p-value = 1.48x10-5. This region includes RGMA, a potent regulator of the BMP family of genes. The second locus (Chromosome 1q42.1-q42.3 was associated with increased POP odds with each unit increase in European ancestry (Odds ratio [OR]: 1.69; 95% confidence interval [CI]: 1.28, 2.22; p-value = 1.93x10-4. Although this region did not reach statistical significance after considering multiple comparisons, it includes potentially relevant genes including TBCE, and ACTA1. Unique non-overlapping European and African ancestry-specific susceptibility loci may be
Stow, Ruth; Ives, Natalie; Smith, Christina; Rick, Caroline; Rushton, Alison
Protein energy malnutrition (PEM) predisposes individuals to disease, delays recovery from illness and reduces quality of life. Care home residents in the United Kingdom are especially vulnerable, with an estimated 30 to 42 % at risk. Evidence for nutritional interventions to address PEM in the care home setting is lacking. Widely used techniques include food-based intervention and/or the use of prescribed oral nutritional supplements. To define outcomes and optimise the design for an adequately powered definitive trial to compare the efficacy of established nutritional interventions in this setting, a cluster randomised feasibility trial with a 6-month intervention was undertaken. Care home residents with or at risk of malnutrition were identified across six UK care home sites from September to December 2013. Homes were cluster randomised to standard care (SC), food-based intervention (FB) or oral nutritional supplement intervention (ONS), for 6 months. Key outcomes were trial feasibility and the acceptability of design, allocated interventions and outcome assessments. Anthropometry, dietary intake, healthcare resource usage and participant-reported outcome measures were assessed at baseline and at 3 and 6 months. All six care homes approached were recruited and retained. Of the 110 residents at risk of malnutrition, 85 % entered the trial, and 68 % completed the 6-month intervention. Pre-specified success criteria for feasibility were met for recruitment and retention, intervention acceptability (resident compliance ≥60 %) and measurement of weight, body mass index (BMI), mid-upper arm circumference and dietary intake (data completeness >80 %). Measurement of handgrip strength and triceps skinfold thickness was not found to be feasible in this population. The 95 % confidence interval (CI) data suggested sensitivity to change in dietary intake for weight, BMI and energy intake between baseline and 3 months when each intervention (FB and ONS) was compared with SC
Parry, Sharon; Straker, Leon; Gilson, Nicholas D; Smith, Anne J
Occupational sedentary behaviour is an important contributor to overall sedentary risk. There is limited evidence for effective workplace interventions to reduce occupational sedentary time and increase light activity during work hours. The purpose of the study was to determine if participatory workplace interventions could reduce total sedentary time, sustained sedentary time (bouts >30 minutes), increase the frequency of breaks in sedentary time and promote light intensity activity and moderate/vigorous activity (MVPA) during work hours. A randomised controlled trial (ANZCTR NUMBER: ACTN12612000743864) was conducted using clerical, call centre and data processing workers (n = 62, aged 25-59 years) in 3 large government organisations in Perth, Australia. Three groups developed interventions with a participatory approach: 'Active office' (n = 19), 'Active Workstation' and promotion of incidental office activity; 'Traditional physical activity' (n = 14), pedometer challenge to increase activity between productive work time and 'Office ergonomics' (n = 29), computer workstation design and breaking up computer tasks. Accelerometer (ActiGraph GT3X, 7 days) determined sedentary time, sustained sedentary time, breaks in sedentary time, light intensity activity and MVPA on work days and during work hours were measured before and following a 12 week intervention period. For all participants there was a significant reduction in sedentary time on work days (-1.6%, p = 0.006) and during work hours (-1.7%, p = 0.014) and a significant increase in number of breaks/sedentary hour on work days (0.64, p = 0.005) and during work hours (0.72, p = 0.015); there was a concurrent significant increase in light activity during work hours (1.5%, p = 0.012) and MVPA on work days (0.6%, p = 0.012). This study explored novel ways to modify work practices to reduce occupational sedentary behaviour. Participatory workplace interventions can reduce
view: diet, anthropometry and biochemistry in dependent patients at nutritional risk and to assess the effect of a nutritional education intervention. The design with random allocation, inclusion of all patients, validated methods, caregivers’ education and standardization between nurses allows us to obtain valuable information about nutritional status and prevention. Trial Registration number Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360775
Chau, Elaine M T; Manns, Braden J; Garg, Amit X; Sood, Manish M; Kim, S Joseph; Naimark, David; Nesrallah, Gihad E; Soroka, Steven D; Beaulieu, Monica; Dixon, Stephanie; Alam, Ahsan; Tangri, Navdeep
Early initiation of chronic dialysis (starting dialysis with higher vs lower kidney function) has risen rapidly in the past 2 decades in Canada and internationally, despite absence of established health benefits and higher costs. In 2014, a Canadian guideline on the timing of dialysis initiation, recommending an intent-to-defer approach, was published. The objective of this study is to evaluate the efficacy and safety of a knowledge translation intervention to promote the intent-to-defer approach in clinical practice. This study is a multicenter, 2-arm parallel, cluster randomized trial. The study involves 55 advanced chronic kidney disease clinics across Canada. Patients older than 18 years who are managed by nephrologists for more than 3 months, and initiate dialysis in the follow-up period are included in the study. Outcomes will be measured at the patient-level and enumerated within a cluster. Data on characteristics of each dialysis start will be determined by linkages with the Canadian Organ Replacement Register. Primary outcomes include the proportion of patients who start dialysis early with an estimated glomerular filtration rate greater than 10.5 mL/min/1.73 m2 and start dialysis in hospital as inpatients or in an emergency room setting. Secondary outcomes include the rate of change in early dialysis starts; rates of hospitalizations, deaths, and cost of predialysis care (wherever available); quarterly proportion of new starts; and acceptability of the knowledge translation materials. We randomized 55 multidisciplinary chronic disease clinics (clusters) in Canada to receive either an active knowledge translation intervention or no intervention for the uptake of the guideline on the timing of dialysis initiation. The active knowledge translation intervention consists of audit and feedback as well as patient- and provider-directed educational tools delivered at a comprehensive in-person medical detailing visit. Control clinics are only exposed to guideline
Stevenson, Kay; Jackson, Sue; Shufflebotham, Julie; Roddy, Edward; Foster, Nadine E
This paper describes the development, content and delivery of a physiotherapist- led individualised, supervised and progressed exercise programme for use in a factorial randomised controlled trial testing treatments for subacromial impingement syndrome. To develop the intervention, a survey of community physiotherapists and national guidelines provided the basis for a consensus workshop through which a protocol was developed for the SUPPORT trial physiotherapist-led exercise programme (SUPPORT: SUbacromial impingement syndrome and Pain: a randomised controlled trial Of exeRcise and injection). The protocol included three stages of exercise progression: (1) scapular stability and active exercise with no resistance (2) range of motion exercise with scapular control, isometrics and stretches, and (3) through range resistance exercise. A two day training programme was developed for physiotherapists which included the trial background, current evidence and strategies to improve exercise adherence. Twenty physiotherapists were trained to deliver the exercise intervention. In the SUPPORT trial, 128 participants were randomised to physiotherapist-led exercise. Ninety nine (81%) participants had their first physiotherapy session within 2 to 3 weeks and 71 (56%) received six to eight treatment sessions. Frequently-used exercises were: stage 1 scapular setting with glenohumeral joint (GHJ) flexion to 90°, stage 2 GHJ medial rotation stretch, stage 3 scapular setting through lateral rotation, with resistance bands. We combined clinical and research expertise with national guidance in order to develop a physiotherapist-led, individualised, progressed and supervised exercise intervention for use within a randomised trial. The effectiveness of the intervention is being evaluated within the SUPPORT trial. Trial registration number ISRCTN 42399123. Copyright © 2017 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Full Text Available Abstract Background To demonstrate the use of risk-benefit analysis for comparing multiple competing interventions in the absence of randomized trials, we applied this approach to the evaluation of five anticoagulants to prevent thrombosis in patients undergoing orthopedic surgery. Methods Using a cost-effectiveness approach from a clinical perspective (i.e. risk benefit analysis we compared thromboprophylaxis with warfarin, low molecular weight heparin, unfractionated heparin, fondaparinux or ximelagatran in patients undergoing major orthopedic surgery, with sub-analyses according to surgery type. Proportions and variances of events defining risk (major bleeding and benefit (thrombosis averted were obtained through a meta-analysis and used to define beta distributions. Monte Carlo simulations were conducted and used to calculate incremental risks, benefits, and risk-benefit ratios. Finally, net clinical benefit was calculated for all replications across a range of risk-benefit acceptability thresholds, with a reference range obtained by estimating the case fatality rate - ratio of thrombosis to bleeding. Results The analysis showed that compared to placebo ximelagatran was superior to other options but final results were influenced by type of surgery, since ximelagatran was superior in total knee replacement but not in total hip replacement. Conclusions Using simulation and economic techniques we demonstrate a method that allows comparing multiple competing interventions in the absence of randomized trials with multiple arms by determining the option with the best risk-benefit profile. It can be helpful in clinical decision making since it incorporates risk, benefit, and personal risk acceptance.
Brady, Marian C; Stott, David J; Norrie, John; Chalmers, Campbell; St George, Bridget; Sweeney, Petrina M; Langhorne, Peter
Many interventions delivered within the stroke rehabilitation setting could be considered complex, though some are more complex than others. The degree of complexity might be based on the number of and interactions between levels, components and actions targeted within the intervention. The number of (and variation within) participant groups and the contexts in which it is delivered might also reflect the extent of complexity. Similarly, designing the evaluation of a complex intervention can be challenging. Considerations include the necessity for intervention standardisation, the multiplicity of outcome measures employed to capture the impact of a multifaceted intervention and the delivery of the intervention across different clinical settings operating within varying healthcare contexts. Our aim was to develop and evaluate the implementation of a complex, multidimensional oral health care (OHC) intervention for people in stroke rehabilitation settings which would inform the development of a randomised controlled trial. After reviewing the evidence for the provision of OHC following stroke, multi-disciplinary experts informed the development of our intervention. Using both quantitative and qualitative methods we evaluated the implementation of the complex OHC intervention across patients, staff and service levels of care. We also adopted a pragmatic approach to patient recruitment, the completion of assessment tools and delivery of OHC, alongside an attention to the context in which it was delivered. We demonstrated the feasibility of implementing a complex OHC intervention across three levels of care. The complementary nature of the mixed methods approach to data gathering provided a complete picture of the implementation of the intervention and a detailed understanding of the variations within and interactions between the components of the intervention. Information on the feasibility of the outcome measures used to capture impact across a range of components was
Wolfenden, Luke; Nathan, Nicole; Janssen, Lisa M; Wiggers, John; Reilly, Kathryn; Delaney, Tessa; Williams, Christopher M; Bell, Colin; Wyse, Rebecca; Sutherland, Rachel; Campbell, Libby; Lecathelinais, Christophe; Oldmeadow, Chris; Freund, Megan; Yoong, Sze Lin
Internationally, governments have implemented school-based nutrition policies to restrict the availability of unhealthy foods from sale. The aim of the trial was to assess the effectiveness of a multi-strategic intervention to increase implementation of a state-wide healthy canteen policy. The impact of the intervention on the energy, total fat, and sodium of children's canteen purchases and on schools' canteen revenue was also assessed. Australian primary schools with a canteen were randomised to receive a 12-14-month, multi-strategic intervention or to a no intervention control group. The intervention sought to increase implementation of a state-wide healthy canteen policy which required schools to remove unhealthy items (classified as 'red' or 'banned') from regular sale and encouraged schools to 'fill the menu' with healthy items (classified as 'green'). The intervention strategies included allocation of a support officer to assist with policy implementation, engagement of school principals and parent committees, consensus processes with canteen managers, training, provision of tools and resources, academic detailing, performance feedback, recognition and marketing initiatives. Data were collected at baseline (April to September, 2013) and at completion of the implementation period (November, 2014 to April, 2015). Seventy schools participated in the trial. Relative to control, at follow-up, intervention schools were significantly more likely to have menus without 'red' or 'banned' items (RR = 21.11; 95% CI 3.30 to 147.28; p ≤ 0.01) and to have at least 50% of menu items classified as 'green' (RR = 3.06; 95% CI 1.64 to 5.68; p ≤ 0.01). At follow-up, student purchases from intervention school canteens were significantly lower in total fat (difference = -1.51 g; 95% CI -2.84 to -0.18; p = 0.028) compared to controls, but not in energy (difference = -132.32 kJ; 95% CI -280.99 to 16.34; p = 0.080) or sodium (difference = -46
Morris David W
Full Text Available Abstract Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA Clinical Trials Network (CTN CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI or Health Education Intervention Augmentation (HEI. Both groups will receive TAU (i.e., usual care. The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual sessions
Full Text Available Abstract Background Very low birthweight infants are at risk for deficits in cognitive and language development, as well as attention and behaviour problems. Maternal sensitive behaviour (i.e. awareness of infant cues and appropriate responsiveness to those cues in interaction with her very low birthweight infant is associated with better outcomes in these domains; however, maternal anxiety interferes with the mother's ability to interact sensitively with her very low birthweight infant. There is a need for brief, cost-effective and timely interventions that address both maternal psychological distress and interactive behaviour. The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants. Methods and design Mothers of singleton infants born at weights below 1500 g are recruited in the neonatal intensive care units of 2 tertiary care hospitals, and are randomly assigned to the experimental (Cues intervention or to an attention control (Care condition. The Cues intervention teaches mothers to attend to their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age. Discussion The Cues and Care trial will
Kooijmans, H.; Post, M. W. M.; van der Woude, L. H. V.; de Groot, S.; Stam, H. J.; Bussmann, J. B. J.
Purpose: To evaluate the effectiveness of a 16-week self-management intervention on physical activity level and self-management skills (self-efficacy, proactive coping and problem solving skills) in persons with chronic SCI. Method and design: Multicenter randomized controlled trial (RCT). Eighty
The main aim of this thesis was to evaluate the added benefit of applying specific factors in community-based intervention for child witnesses of interparental violence (IPV) and their parents, by means of a randomized controlled trial (RCT). The results of this RCT showed no additional benefits of
Batch, Bryan C.; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B.; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P.
Background The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. Purpose To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition. Methods A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. Conclusions If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. PMID:24462568
Hagobian, Todd; Smouse, Allison; Streeter, Mikaela; Wurst, Chloe; Schaffner, Andrew; Phelan, Suzanne
Previous studies have shown that women have higher concentrations of the endocrine disruptor bisphenol A (BPA), but an intervention to reduce BPA is lacking in women. To test the hypothesis that an intervention to reduce BPA would decrease urinary BPA concentrations over 3 weeks, 24 women (mean ± standard deviation [SD]; 22.1 ± 2.8 kg/m2 body mass index, 20.9 ± 1.5 years) were randomly assigned to an intervention or control. The intervention included weekly face-to-face meetings to reduce BPA exposures from food, cosmetics, and other packaged products. Women were provided with BPA-free cosmetics, hygiene, glass food/water containers, and daily self-monitored major sources of BPA. Fasting urine BPA and creatinine concentrations, and weight were assessed at study entry and after 3 weeks. A significant (p = 0.04) treatment × time interaction effect was observed on creatinine-adjusted BPA concentrations. From study entry to 3 weeks, women in the intervention significantly decreased geometric mean creatinine-adjusted urinary BPA by -0.71 ng/m, whereas women in the control significantly increased urinary BPA by 0.32 ng/mL (p = 0.04). Additionally, from study entry to 3 weeks, women in the intervention significantly lost weight -0.28 ± 0.44 kg, whereas women in the control significantly gained weight +1.65 ± 0.74 kg (p = 0.03). Changes in creatinine-adjusted BPA concentrations and weight were not significantly related (p = 0.67). In this pilot study, a 3-week intervention decreased urinary BPA concentrations in women. Future clinical trials are needed to confirm these results and to examine whether a similar BPA intervention positively impacts risk markers in the pathogenesis of cardiovascular disease and diabetes.
Green, Carla A; Yarborough, Bobbi Jo H; Leo, Michael C; Yarborough, Micah T; Stumbo, Scott P; Janoff, Shannon L; Perrin, Nancy A; Nichols, Greg A; Stevens, Victor J
The STRIDE study assessed whether a lifestyle intervention, tailored for individuals with serious mental illnesses, reduced weight and diabetes risk. The authors hypothesized that the STRIDE intervention would be more effective than usual care in reducing weight and improving glucose metabolism. The study design was a multisite, parallel two-arm randomized controlled trial in community settings and an integrated health plan. Participants who met inclusion criteria were ≥18 years old, were taking antipsychotic agents for ≥30 days, and had a body mass index ≥27. Exclusions were significant cognitive impairment, pregnancy/breastfeeding, recent psychiatric hospitalization, bariatric surgery, cancer, heart attack, or stroke. The intervention emphasized moderate caloric reduction, the DASH (Dietary Approaches to Stop Hypertension) diet, and physical activity. Blinded staff collected data at baseline, 6 months, and 12 months. Participants (men, N=56; women, N=144; mean age=47.2 years [SD=10.6]) were randomly assigned to usual care (N=96) or a 6-month weekly group intervention plus six monthly maintenance sessions (N=104). A total of 181 participants (90.5%) completed 6-month assessments, and 170 (85%) completed 12-month assessments, without differential attrition. Participants attended 14.5 of 24 sessions over 6 months. Intent-to-treat analyses revealed that intervention participants lost 4.4 kg more than control participants from baseline to 6 months (95% CI=-6.96 kg to -1.78 kg) and 2.6 kg more than control participants from baseline to 12 months (95% CI=-5.14 kg to -0.07 kg). At 12 months, fasting glucose levels in the control group had increased from 106.0 mg/dL to 109.5 mg/dL and decreased in the intervention group from 106.3 mg/dL to 100.4 mg/dL. No serious adverse events were study-related; medical hospitalizations were reduced in the intervention group (6.7%) compared with the control group (18.8%). Individuals taking antipsychotic medications can lose
Walker, Marion F; Thomas, Shirley A; Whitehead, Phillip J; Condon, Laura; Fisher, Rebecca J; Kontou, Eirini; Benford, Penny; Cobley, Christine
Reducing length of hospital stay for stroke survivors often creates a shift in the responsibility of care towards informal carers. Adjustment to the caregiving process is experienced by many carers as overwhelming, complex and demanding and can have a detrimental impact on mental and physical health and well-being. National policy guidelines recommend that carers' needs are considered and addressed; despite this, few interventions have been developed and empirically evaluated. We developed a biopsychosocial intervention in collaboration with carers of stroke survivors. Our aim is to determine whether the intervention can be delivered in a group setting and evaluated using a randomised controlled trial (RCT). Feasibility RCT and nested qualitative interview study. We aim to recruit up to 40 stroke carers within 1 year of the stroke onset. Carers are randomised to usual care or usual care plus biopsychosocial intervention. Each intervention group will consist of five stroke carers. The intervention will focus on: psychoeducation, psychological adjustment to stroke, strategies for reducing unwanted negative thoughts and emotions and problem-solving strategies. The main outcome is the feasibility of conducting an RCT. Carer outcomes at 6 months include: anxiety and depression, quality of life and carer strain. Data are also collected from stroke survivors at baseline and 6 months including: level of disability, anxiety and depression, and quality of life. Favourable ethical opinion was provided by East Midlands - Nottingham2 Research Ethics Committee (14/EMI/1264). This study will determine whether delivery of the biopsychosocial intervention is feasible and acceptable to stroke carers within a group format. It will also determine whether it is feasible to evaluate the effects of the biopsychosocial intervention in an RCT. We will disseminate our findings through peer-reviewed publications and presentations at national and international conferences. ISRCTN
Beukes, Eldré W; Allen, Peter M; Manchaiah, Vinaya; Baguley, David M; Andersson, Gerhard
Managing chronic tinnitus is challenging, and innovative ways to address the resulting health-care burden are required. Internet-based cognitive behavioral therapy (iCBT) for tinnitus shows promise as a cost-effective treatment option. The feasibility and effectiveness of iCBT in the United Kingdom are yet to be explored. Furthermore, it is not known if iCBT can be supported by an audiologist rather than a psychologist. This study aimed to determine the feasibility of guided iCBT using audiological support on tinnitus distress and tinnitus-related comorbidities. Furthermore, it aimed to establish the feasibility of iCBT for tinnitus distress in the United Kingdom, by determining recruitment, attrition, and compliance rates. Finally, it aimed to identify which aspects of the protocol require refinement for subsequent clinical trials. A single-group open trial design was implemented. This study would serve as a prerequisite study, to identify barriers, before undertaking effectiveness trials. Participants consisted of 37 adults (18 males, 19 females), with an age range of between 50 and 59 yr. The mean preintervention tinnitus severity rating was 56.15 (standard deviation = 18.35), which is categorized as "severe tinnitus" as measured by the Tinnitus Functional Index (TFI). Five participants withdrew during the study, and 29 of the remaining participants completed the postintervention questionnaire. The guided iCBT intervention ran over an eight-week period and consisted of 16 obligatory modules and five optional modules. The intervention was designed to be interactive, interesting, and stimulating. A key element was the provision of support from an audiologist throughout the program. Online questionnaires were used throughout the study. These were administered at baseline and postintervention to determine attrition and compliance rates and to facilitate sample size estimates for further clinical trials. Outcome measures for tinnitus severity, hearing handicap
Jørgensen, Marie B; Faber, Anne; Jespersen, Tobias
This study evaluates the implementation of physical coordination training (PCT) and cognitive behavioural training (CBTr) interventions in a randomised controlled trial at nine cleaners' workplaces. Female cleaners (n = 294) were randomised into a PCT, a CBTr or a reference (REF) group. Both 12...... intervention effects, more research on implementation is needed. Trial registration: ISRCTN96241850. Practitioner summary: Both physical coordination training and cognitive behavioural training are potential effective workplace interventions among low educated job groups with high physical work demands....... However, thorough consideration should be given to feasibility in the design of interventions. The optimal intervention should be tailored to closely match the implementation context and be robust and flexible to minimise susceptibility to changes in work organisation....
Pradeep, Archana; Proudlock, Frank Antony; Awan, Musarat; Bush, Glen; Collier, Jacqueline; Gottlob, Irene
Previous reports suggest that adherence to patching is a major issue in amblyopia treatment. We tested with an unmasked randomised controlled clinical trial whether an intense educational/motivational intervention improves adherence when a high-dose regime is prescribed. 62 children with newly diagnosed amblyopia were randomly allocated into two treatment arms with and without educational/motivational intervention material. Both were prescribed patching 10 h/day, 6 days/week for a fixed period of 12 weeks. The intervention arm received an educational/motivational intervention before patching which included information booklets, video, a cartoon story book, sticker charts and a dedicated session with a researcher. The control arm received the usual clinical information. The primary outcome measure was adherence measured using electronic occlusion dose monitors where a success/failure binary outcome was used to account for participants who dropped out of the study defined as patching >4 h/day. Visual outcome, expressed as percentage visual deficit, was measured as secondary outcome. The intervention increased adherence success rate from 45.2% in the control group to 80.6% in the intervention group (p=0.0027). However, visual outcome was not significantly better in the intervention group (p=0.190). Our study shows that an intense educational/motivational intervention can improve adherence to patching to high prescribed doses although no significant improvement in visual outcome was observed. TRIALS REGISTRATION NUMBER: ISRCTN05346737 (International Standard Randomised Controlled Trial Number Register).