119 resultados para Randomized controlled trials


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Purpose of review: The study provides a review of current evidence about the role of complex nonpharmacological strategies in managing the multidimensional components of the breathlessness experience for individuals with life-limiting conditions. Recent findings: Evidence continues to demonstrate the significant impact of breathlessness on patients’ quality of life, day-to-day activity, and physical and psychosocial functioning. Recent evidence also confirms that patients draw on a number of self-initiated actions to cope with breathlessness, although many do not use strategies that are supported by a growing body of evidence from randomized controlled trials. Current literature supports the use of multicomponent, nonpharmacological interventions comprising strategies to improve breathing efficiency and reducing psychological distress to manage breathlessness. However trials of these approaches have mostly been conducted among patients with chronic obstructive pulmonary disease (COPD) or lung cancer, and few studies have investigated the benefits of nonpharmacological for patients in later stages of disease. Further investigation of interventions is required across a broader range of chronic life-limiting conditions. Addressing breathlessness and its co-occurring symptoms (symptom clusters) is also an area for future enquiry. Summary: The experience of breathlessness and strategies adopted by patients to manage the experience highlight the importance of multidimensional approaches to improve outcomes for patients with life-limiting conditions. There is good evidence to support the role of multicomponent, nonpharmacological interventions in reducing breathlessness for patients with COPD and lung cancer, although further studies are required to understand the particular clinical contexts in which such interventions are appropriate.

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Background Women undergoing Cesarean Section (CS) are vulnerable to the adverse effects associated with perioperative core temperature drop, in part due to the tendency for CS to be performed under neuraxial anesthesia, blood and fluid loss, and vasodilation. Inadvertent perioperative hypothermia (IPH) is a common condition that affects patients undergoing surgery of all specialties and is detrimental to all age groups, including neonates. Previous systematic reviews on IPH prevention largely focus on either adult or all ages populations, and have mainly overlooked pregnant or CS patients as a distinct group. Not all recommendations made by systematic reviews targeting all adult patients may be transferable to CS patients. Alternative, effective methods for preventing or managing hypothermia in this group would be valuable. Objectives To synthesize the best available evidence in relation to preventing and/or treating hypothermia in mothers after CS surgery. Types of participants Adult patients over the age of 18 years, of any ethnic background, with or without co-morbidities, undergoing any mode of anesthesia for any type of CS (emergency or planned) at healthcare facilities who have received interventions to limit or manage perioperative core heat loss were included. Types of intervention(s) Active or passive warming methods versus usual care or placebo, that aim to limit or manage core heat loss as applied to women undergoing CS were included. Types of studies Randomized controlled trials (RCTs) that met the inclusion criteria, with reduction of perioperative hypothermia a primary or secondary outcome were considered. Types of outcomes Primary outcome: maternal core temperature measured during the preoperative, intraoperative and postoperative phases of care Secondary outcomes: newborn core temperature at birth, umbilical pH obtained immediately after birth, Apgar scores, length of Post Anesthetic Care Unit (PACU) stay, maternal thermal comfort. Search strategy A comprehensive search was undertaken of the following databases from their inception until May 2012: ProQuest, Web of Science, Scopus, Dissertation and Theses PQDT (via ProQuest), Current Contents, CENTRAL, Mednar, OpenGrey, Clinical Trials. There were no language restrictions. Methodological quality Retrieved papers were assessed for methodological quality by two independent reviewers prior to inclusion using JBI software. Disagreements were resolved via consultation with the third reviewer. An assessment of quality of the included papers was also made in relation to five key quality factors. Data collection Two independent reviewers extracted data from the included papers using a previously piloted customized data extraction tool. Results 12 studies with a combined total of 719 participants were included. Three broad intervention groups were identified; intravenous (IV) fluid warming, warming devices, leg wrapping. IV fluid warming, whether administered intraoperatively or preoperatively, was found to be effective at maintaining maternal (but not neonatal) temperature and preventing shivering, but does not improve thermal comfort. The effectiveness of IV fluid warming on Apgar scores and umbilical pH remains unclear. Warming devices, including forced air warming and under body carbon polymer mattresses, were effective at preventing hypothermia and reduced shivering, however were most effective if applied preoperatively. The effectiveness of warming devices to improve thermal comfort remains unclear. Preoperative forced air warming appears to aid maintenance of neonatal temperature, while intraoperative forced air warming does not. Forced air warming was not effective at improving Apgar scores and the effects for umbilical pH remain unclear. Conclusions Intravenous fluid warming, by any method, improves maternal temperature and reduces shivering for women undergoing CS. Preoperative body warming devices also improve maternal temperature, in addition to reducing shivering.

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Arachidonic acid metabolism through cyclooxygenase (COX) pathways leads to the generation of biologically active eicosanoids. Eicosanoid expression levels vary during development and progression of gastrointestinal (GI) malignancies. COX-2 is the major COX-isoform responsible for G.I. cancer development/progression. COX-2 expression increases during progression from a normal to cancerous state. Evidence from observational studies has demonstrated that chronic NSAID use reduces the risk of cancer development, while both incidence and risk of death due to G.I. cancers were significantly reduced by daily aspirin intake. A number of randomized controlled trials (APC trial, Prevention of Sporadic Adenomatous Polyps trial, APPROVe trial) have also shown a significant protective effect in patients receiving selective COX-2 inhibitors. However, chronic use of selective COX-2 inhibitors at high doses was associated with increased cardiovascular risk, while NSAIDs have also been associated with increased risk. More recently, downstream effectors of COX-signaling have been investigated in cancer development/progression. PGE 2, which binds to both EP and PPAR receptors, is the major prostanoid implicated in the carcinogenesis of G.I. cancers. The role of TXA 2 in G.I. cancers has also been examined, although further studies are required to uncover its role in carcinogenesis. Other prostanoids investigated include PGD 2 and its metabolite 15d-PGJ2, PGF 1α and PGI 2. Targeting these prostanoids in G.I. cancers has the promise of avoiding cardiovascular toxicity associated with chronic selective COX-2 inhibition, while maintaining anti-tumor reactivity.A progressive sequence from normal to pre-malignant to a malignant state has been identified in G.I. cancers. In this review, we will discuss the role of the COX-derived prostanoids in G.I. cancer development and progression. Targeting these downstream prostanoids for chemoprevention and/or treatment of G.I. cancers will also be discussed. Finally, we will highlight the latest pre-clinical technologies as well as avenues for future investigation in this highly topical research field. © 2011 Elsevier B.V.

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Cisplatin and carboplatin are active in previously untreated patients with metastatic breast cancer (MBC) with mean response rates (RRs) of 50 and 32%, respectively. In pretreated patients the RR to cisplatin/carboplatin monotherapy declines markedly to <10%. Cisplatin and carboplatin have been combined with many other cytotoxics. In first-line setting high activity has been observed in combination with taxanes or vinorelbine (RRs consistently ∼60%). It appears that these newer combinations are superior to older regimens with etoposide (RRs 30 to 50%) or 5-fluorouracil (RRs 40 to 60%). Cisplatin-/carboplatin-based regimens with infusional 5-FU and epirubicin/paclitaxel/vinorelbine achieve high RRs of around 60 to 80%. However these regimens are difficult to administer in all patients because they require central venous access for continuous 5-FU infusion. In pretreated MBC the combinations of cisplatin-taxane/vinorelbine/gemcitabine or carboplatin-docetaxel/vinorelbine yield RRs of 40 to 50%, which are higher than those achieved with platinum-etoposide/5-FU. In locally advanced disease cisplatin-based regimens achieve very high RRs (>80%). This would suggest that in chemotherapy-naïve patients platinum-based therapy might have an important role to play. Additionally the synergy demonstrated between platinum compounds, taxanes and herceptin, in preclinical and clinical studies is of immense importance and the results of the two ongoing Breast Cancer International Research Group randomized phase III studies are eagerly awaited. These studies may help clarify the role of platinum compounds in the treatment of metastatic and possibly early breast cancer. © 2003 Elsevier Ltd. All rights reserved.

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Adult soft tissue sarcomas are relatively rare tumours which are curable with radical surgery. Approximately 50% of patients will develop inoperable disease or metastases for which chemotherapy may be inappropriate. Only two cytotoxic agents - doxorubicin and ifosfamide - have activity in > 20% of patients. For both these agents there is evidence of a dose-response relationship. There is currently no good evidence that combination chemotherapy confers a clinical benefit compared with single agents. Outside a clinical trial, standard first-line therapy should be with single agent doxorubicin at a dose intensity ≥ 70 mg2 every 3 weeks. Approximately 25% of patients may be expected to respond to this regimen. There is the suggestion that responses may occur to ifosfamide in patients who progress on doxorubicin. The role of chemotherapy in the adjuvant setting remains uncertain. Several trials have suggested a modest relapse-free and overall survival benefit for the use of post-operative chemotherapy and a recent overview of 14 randomised trials confirms a small though significant benefit. These benefits have to be weighed against the toxicity of chemotherapy. The importance of treating all patients with soft tissue sarcomas in clinical trials is stressed. There is an urgent need to define new active agents to treat this disease.

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Background Postoperative chemotherapy is currently not recommended for resected non-small cell lung cancer in many countries and centers. Recently, results of several large randomized clinical trials were reported with conflicting evidence. Accordingly, we sought to determine whether postoperative chemotherapy is associated with improved survival compared with that after surgical intervention alone. Methods Randomized clinical trials with cisplatin- or uracil plus ftorafur-containing regimens were included and evaluated separately. A systematic review that included randomized clinical trials performed before 1995 was identified and found to be of adequate quality. Further randomized controlled trials were identified by searching MEDLINE, EMBASE, and the Cochrane Controlled Trials Register from 1995 through 2004. In addition, the reference lists of articles and conference abstracts were searched. The logarithm of the hazard ratio and its standard error were calculated, and a fixed-effect model was used to combine the estimates. Results There were 7200 patients enrolled in 19 trials included in the analyses. An overall estimate of 13% relative reduction in mortality (95% confidence interval, 7%-19%) was found. There was 11% relative reduction in mortality associated with postoperative cisplatin (95% confidence interval, 4%-18%; P = .004) and 17% associated with uracil plus ftorafur (95% confidence interval, 5%-27%; P = .006) compared with that after surgical intervention alone. This means that there would be an additional survivor at 5 years for 25 patients treated with cisplatin or for 30 patients treated with uracil plus ftorafur. Conclusions Postoperative chemotherapy is associated with improved survival compared with that after surgical intervention alone. Selected patients with completely resected non-small cell lung cancer should be offered chemotherapy. Copyright © 2004 by The American Association for Thoracic Surgery.

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Background Post-stroke recovery is demanding. Increasing studies have examined the effectiveness of self-management programs for stroke survivors. However no systematic review has been conducted to summarize the effectiveness of theory-based stroke self-management programs. Objectives The aim is to present the best available research evidence about effectiveness of theory-based self-management programs on community-dwelling stroke survivors’ recovery. Inclusion criteria Types of participants All community-residing adults aged 18 years or above, and had a clinical diagnosis of stroke. Types of interventions Studies which examined effectiveness of a self-management program underpinned by a theoretical or conceptual framework for community-dwelling stroke survivors. Types of studies Randomized controlled trials. Types of outcomes Primary outcomes included health-related quality of life and self-management behaviors. Secondary outcomes included physical (activities of daily living), psychological (self-efficacy, depressive symptoms), and social outcomes (community reintegration, perceived social support). Search Strategy A three-step approach was adopted to identify all relevant published and unpublished studies in English or Chinese. Methodological quality The methodological quality of the included studies was assessed using the Joanna Briggs Institute critical appraisal checklist for experimental studies. Data Collection A standardized JBI data extraction form was used. There was no disagreement between the two reviewers on the data extraction results. Data Synthesis There were incomplete details about the number of participants and the results in two studies, which makes it impossible to perform meta-analysis. A narrative summary of the effectiveness of stroke self-management programs is presented. Results Three studies were included. The key issues of concern in methodological quality included insufficient information about random assignment, allocation concealment, reliability and validity of the measuring instruments, absence of intention-to-treat analysis, and small sample sizes. The three programs were designed based on the Stanford Chronic Disease Self-management program and were underpinned by the principles of self-efficacy. One study showed improvement in the intervention group in family and social roles three months after program completion, and work productivity at six months as measured by the Stroke Specific Quality of Life Scale (SSQOL). The intervention group also had an increased mean self-efficacy score in communicating with physicians six months after program completion. The mean changes from baseline in these variables were significantly different from the control group. No significant difference was found in time spent in aerobic exercise between the intervention and control groups at three and six months after program completion. Another study, using SSQOL, showed a significant interaction effect by treatment and time on family roles, fine motor tasks, self-care, and work productivity. However there was no significant interaction by treatment and time on self-efficacy. The third study showed improvement in quality of life, community participation, and depressive symptoms among the participants receiving the stroke self-management program, Stanford Chronic Disease Self-management program, or usual care six months after program completion. However, there was no significant difference between the groups. Conclusions There is inconclusive evidence about the effectiveness of theory-based stroke self-management programs on community-dwelling stroke survivors’ recovery. However the preliminary evidence suggests potential benefits in improving stroke survivors’ quality of life and self-efficacy.

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BACKGROUND: Diabetes in South Asia represents a different disease entity in terms of its onset, progression, and complications. In the present study, we systematically analyzed the medical research output on diabetes in South Asia. METHODS: The online SciVerse Scopus database was searched using the search terms "diabetes" and "diabetes mellitus" in the article Title, Abstract or Keywords fields, in conjunction with the names of each regional country in the Author Affiliation field. RESULTS: In total, 8478 research articles were identified. Most were from India (85.1%) and Pakistan (9.6%) and the contribution to the global diabetes research output was 2.1%. Publications from South Asia increased markedly after 2007, with 58.7% of papers published between 2000 and 2010 being published after 2007. Most papers were Research Articles (75.9%) and Reviews (12.9%), with only 90 (1.1%) clinical trials. Publications predominantly appeared in local national journals. Indian authors and institutions had the most number of articles and the highest h-index. There were 136 (1.6%) intraregional collaborative studies. Only 39 articles (0.46%) had >100 citations. CONCLUSIONS: Regional research output on diabetes mellitus is unsatisfactory, with only a minimal contribution to global diabetes research. Publications are not highly cited and only a few randomized controlled trials have been performed. In the coming decades, scientists in the region must collaborate and focus on practical and culturally acceptable interventional studies on diabetes mellitus.

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Background There are few data regarding the effectiveness of remote monitoring for older people with heart failure. We conducted a post-hoc sub-analysis of a previously published large Cochrane systematic review and meta-analysis of relevant randomized controlled trials to determine whether structured telephone support and telemonitoring were effective in this population. Methods A post hoc sub-analysis of a systematic review and meta-analysis that applied the Cochrane methodology was conducted. Meta-analyses of all-cause mortality, all-cause hospitalizations and heart failure-related hospitalizations were performed for studies where the mean or median age of participants was 70 or more years. Results The mean or median age of participants was 70 or more years in eight of the 16 (n=2,659/5,613; 47%) structured telephone support studies and four of the 11 (n=894/2,710; 33%) telemonitoring studies. Structured telephone support (RR 0.80; 95% CI=0.63-1.00) and telemonitoring (RR 0.56; 95% CI=0.41-0.76) interventions reduced mortality. Structured telephone support interventions reduced heart failure-related hospitalizations (RR 0.81; 95% CI=0.67-0.99). Conclusion Despite a systematic bias towards recruitment of individuals younger than the epidemiological average into the randomized controlled trials, older people with heart failure did benefit from structured telephone support and telemonitoring. These post-hoc sub-analysis results were similar to overall effects observed in the main meta-analysis. While further research is required to confirm these observational findings, the evidence at hand indicates that discrimination by age alone may be not be appropriate when inviting participation in a remote monitoring service for heart failure.

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Background The measurement of severity and control of asthma in both children and adults can be based on subjective or objective measures. It has been advocated that fractional exhaled nitric oxide (FeNO) can be used to monitor airway inflammation as it correlates with some markers of asthma. Interventions for asthma therapies have been traditionally based on symptoms and/or spirometry. Objectives To evaluate the efficacy of tailoring asthma interventions based on exhaled nitric oxide in comparison to clinical symptoms (with or without spirometry/peak flow) for asthma related outcomes in children and adults. Search methods We searched the Cochrane Airways Group Specialised Register of Trials, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and reference lists of articles. The last search was completed in February 2009. Selection criteria All randomised controlled comparisons of adjustment of asthma therapy based on exhaled nitric oxide compared to traditional methods (primarily clinical symptoms and spirometry/peak flow). Data collection and analysis Results of searches were reviewed against pre-determined criteria for inclusion. Relevant studies were independently selected in duplicate. Two authors independently assessed trial quality and extracted data. Authors were contacted for further information with response from one. Main results Two studies have been added for this update, which now includes six (2 adults and 4 children/adolescent) studies; these studies differed in a variety of ways including definition of asthma exacerbations, FeNO cut off levels, the way in which FeNO was used to adjust therapy and duration of study. Of 1053 participants randomised, 1010 completed the trials. In the meta-analysis, there was no significant difference between groups for the primary outcome of asthma exacerbations or for other outcomes (clinical symptoms, FeNO level and spirometry). In post-hoc analysis, a significant reduction in mean final daily dose inhaled corticosteroid per adult was found in the group where treatment was based on FeNO in comparison to clinical symptoms, (mean difference -450 mcg; 95% CI -677 to -223 mcg budesonide equivalent/day). However, the total amount of inhaled corticosteroid used in one of the adult studies was 11% greater in the FeNO arm. In contrast, in the paediatric studies, there was a significant increase in inhaled corticosteroid dose in the FeNO strategy arm (mean difference of 140 mcg; 95% CI 29 to 251, mcg budesonide equivalent/day). Authors' conclusions Tailoring the dose of inhaled corticosteroids based on exhaled nitric oxide in comparison to clinical symptoms was carried out in different ways in the six studies and found only modest benefit at best and potentially higher doses of inhaled corticosteroids in children. The role of utilising exhaled nitric oxide to tailor the dose of inhaled corticosteroids cannot be routinely recommended for clinical practice at this stage and remains uncertain.

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Asthma severity and control can be measured both subjectively and objectively. Traditionally asthma treatments have been individualised using symptoms and spirometry/peak flow. Increasingly treatment tailored in accordance with inflammatory markers (sputum eosinophil counts or fractional exhaled nitric oxide (FeNO) data) is advocated as an alternative strategy. The objective of this review was to evaluate the efficacy of tailoring asthma interventions based on inflammatory markers (sputum analysis and FeNO) in comparison with clinical symptoms (with or without spirometry/peak flow) for asthma-related outcomes in children and adults. Cochrane Airways Group Specialised Register of Trials, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and reference lists of articles were searched. The last searches were in February 2009. All randomised controlled comparisons of adjustment of asthma treatment based on sputum analysis or FeNO compared with traditional methods (primarily clinical symptoms and spirometry/peak flow) were selected. Results of searches were reviewed against predetermined criteria for inclusion. Relevant studies were selected, assessed and data extracted independently by at least two people. The trial authors were contacted for further information. Data were analysed as 'intervention received' and sensitivity analyses performed. Six (2 adults and 4 children/adolescent) studies utilising FeNO and three adult studies utilising sputum eosinophils were included. These studies had a degree of clinical heterogeneity including definition of asthma exacerbations, duration of study and variations in cut-off levels for percentage of sputum eosinophils and FeNO to alter management in each study. Adults who had treatment adjusted according to sputum eosinophils had a reduced number of exacerbations compared with the control group (52 vs. 77 patients with >=1 exacerbation in the study period; p=0.0006). There was no significant difference in exacerbations between groups for FeNO compared with controls. The daily dose of inhaled corticosteroids at the end of the study was decreased in adults whose treatment was based on FeNO in comparison with the control group (mean difference -450.03 mug, 95% CI -676.73 to -223.34; p<0.0001). However, children who had treatment adjusted according to FeNO had an increase in their mean daily dose of inhaled corticosteroids (mean difference 140.18 mug, 95% CI 28.94 to 251.42; p=0.014). It was concluded that tailoring of asthma treatment based on sputum eosinophils is effective in decreasing asthma exacerbations. However, tailoring of asthma treatment based on FeNO levels has not been shown to be effective in improving asthma outcomes in children and adults. At present, there is insufficient justification to advocate the routine use of either sputum analysis (due to technical expertise required) or FeNO in everyday clinical practice.

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Background Chronic kidney disease is a global public health problem of increasing prevalence. There are five stages of kidney disease, with Stage 5 indicating end stage kidney disease (ESKD) requiring dialysis or death will eventually occur. Over the last two decades there have been increasing numbers of people commencing dialysis. A majority of this increase has occurred in the population of people who are 65 years and over. With the older population it is difficult to determine at times whether dialysis will provide any benefit over non-dialysis management. The poor prognosis for the population over 65 years raises issues around management of ESKD in this population. It is therefore important to review any research that has been undertaken in this area which compares outcomes of the older ESKD population who have commenced dialysis with those who have received non-dialysis management. Objective The primary objective was to assess the effect of dialysis compared with non-dialysis management for the population of 65 years and over with ESKD. Inclusion criteria Types of participants This review considered studies that included participants who were 65 years and older. These participants needed to have been diagnosed with ESKD for greater than three months and also be either receiving renal replacement therapy (RRT) (hemodialysis [HD] or peritoneal dialysis [PD]) or non-dialysis management. The settings for the studies included the home, self-care centre, satellite centre, hospital, hospice or nursing home. Types of intervention(s)/phenomena of interest This review considered studies where the intervention was RRT (HD or PD) for the participants with ESKD. There was no restriction on frequency of RRT or length of time the participant received RRT. The comparator was participants who were not undergoing RRT. Types of studies This review considered both experimental and epidemiological study designs including randomized controlled trials, non-randomized controlled trials, quasi-experimental, before and after studies, prospective and retrospective cohort studies, case control studies and analytical cross sectional studies. This review also considered descriptive epidemiological study designs including case series, individual case reports and descriptive cross sectional studies for inclusion. This review included any of the following primary and secondary outcome measures: •Primary outcome – survival measures •Secondary outcomes – functional performance score (e.g. Karnofsky Performance score) •Symptoms and severity of end stage kidney disease •Hospital admissions •Health related quality of life (e.g. KDQOL, SF36 and HRQOL) •Comorbidities (e.g. Charlson Comorbidity index).

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Objective. To assess the effectiveness of workplace interventions in improving physical activity. Data Source. EBSCO research database (and all subdatabases). Study Inclusion and Exclusion Criteria. Articles were published from 2000 to 2010 in English, had appropriate designs, and measured employees' physical activity, energy consumption, and/or body mass index (BMI) as primary outcomes. Articles that did not meet the inclusion criteria were excluded. Data Extraction. Data extracted included study design, study population, duration, intervention activities, outcomes, and results. Data Synthesis. Data were synthesized into one table. Results of each relevant outcome including p values were combined. Results. Twelve (60%) of 20 selected interventions reported an improvement in physical activity level, steps, or BMI, and there was one slowed step reduction in the intervention group. Among these, 10 were less than 6 months in duration; 9 used pedometers; 6 applied Internet-based approaches; and 5 included activities targeting social and environmental levels. Seven of 8 interventions with pre-posttest and quasi-experimental controlled design showed improvement on at least one outcome. However, 7 of 12 randomized controlled trials (RCTs) did not prove effective in any outcome. Conclusion. Interventions that had less rigorous research designs, used pedometers, applied Internet-based approaches, and included activities at social and environmental levels were more likely to report being effective than those without these characteristics.

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Background: Type 2 diabetes affects an estimated 347 million people worldwide and often leads to serious complications including blindness, kidney disease, and limb amputation. Comorbid dysphoria is common and is an independent risk factor for poor glycaemic control. Professional support for diabetes self-management and dysphoria has limited availability and involves high costs, especially after regular hours, and in rural and remote areas. Web-based cognitive behavior therapy offers highly accessible, acceptable, and cost-effective support for people with diabetes. This paper describes the development of OnTrack Diabetes, a self-guided, Web-based program to promote improved physical and emotional self-management in people with Type 2 diabetes. Objective: The objective of the study is to describe the development of the OnTrack Diabetes program, which is a self-guided, Web-based program aimed to promote euthymia and improved disease self-management in people with Type 2 diabetes. Methods: Semistructured interviews with 12 general practitioners and 13 patients with Type 2 diabetes identified enablers of and barriers to effective diabetes self-management, requirements for additional support, and potential program elements. Existing resources and research data informed the development of content, and consultants from relevant disciplines provided feedback on draft segments and reviewed the program before release. Using a self-guided delivery format contained costs, in addition to adapting program features and modules from an existing OnTrack program. Results: A separate paper describes the protocol for a randomized controlled trial to provide this required evaluation. Conclusions: Development of the OnTrack Diabetes program demonstrates strategies that help ensure that a program is acceptable to users. The next stages involve testing users’ experiences and examining the program’s effectiveness and cost-effectiveness in randomized controlled trials.