Recognizing the value of software: a software citation guide.

Software is as integral as a research paper, monograph, or dataset in terms of facilitating the full understanding and dissemination of research. This article provides broadly applicable guidance on software citation for the communities and institutions publishing academic journals and conference proceedings. We expect those communities and institutions to produce versions of this document with software examples and citation styles that are appropriate for their intended audience. This article (and those community-specific versions) are aimed at authors citing software, including software developed by the authors or by others. We also include brief instructions on how software can be made citable, directing readers to more comprehensive guidance published elsewhere. The guidance presented in this article helps to support proper attribution and credit, reproducibility, collaboration and reuse, and encourages building on the work of others to further research.

Evaluating midwifery-led antenatal care: using a programme logic model to identify relevant outcomes.

BACKGROUND: a range of initiatives has been introduced in Ireland and internationally in recent years to establish midwifery-led models of care, generally aimed at increasing the choices available for women for maternity care. A midwifery-led antenatal clinic was first established at the study site (a large urban maternity hospital in Dublin) and extended over recent years. This paper reports on the design of an evaluation of these midwives clinics, in particular the use of a programme logic model to select outcomes to be included in the evaluation. AIMS AND OBJECTIVES: the programme logic model is used to identify the theory of a programme and is an integrative framework for the design and analysis of evaluations using qualitative and quantitative methods. Through an inclusive approach, the aim was to identify the most relevant outcomes to be included in the evaluation, by identifying and linking programme (midwifery-led antenatal clinic) outcomes to the goals, inputs and processes involved in the production of these outcomes. METHODS: the process involved a literature review, a review of policy documents and previous reviews of the clinics, interviews with midwives, obstetricians and managers to identify possible outcomes, a focus group with midwives, obstetricians, managers and women who had attended the clinics to refine and prioritise outcomes, and a follow-up survey to refine and prioritise the outcomes identified and to identify sources of data on each outcome. FINDINGS: seven categories of outcomes were identified: (1) choice, (2) relationship/interaction with caregiver, (3) experience of care, (4) preparation and education for childbirth and parenthood, (5) effectiveness of care, (6) organisational outcomes, and (7) programme viability. A range of sources of information was identified for each outcome, including existing documentation and data, chart audit, survey of women, and interviews and focus groups with midwives, obstetricians, managers and women. CONCLUSIONS: the programme logic model provided an inclusive, systematic and transparent approach to identifying relevant outcomes to be included in the evaluation. The information obtained has been used since to design the evaluation project, which is currently being concluded.

Determinants of weight gain in the action to control cardiovascular risk in diabetes trial.

OBJECTIVE: Identify determinants of weight gain in people with type 2 diabetes mellitus (T2DM) allocated to intensive versus standard glycemic control in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. RESEARCH DESIGN AND METHODS: We studied determinants of weight gain over 2 years in 8,929 participants (4,425 intensive arm and 4,504 standard arm) with T2DM in the ACCORD trial. We used general linear models to examine the association between each baseline characteristic and weight change at the 2-year visit. We fit a linear regression of change in weight and A1C and used general linear models to examine the association between each medication at baseline and weight change at the 2-year visit, stratified by glycemia allocation. RESULTS: There was significantly more weight gain in the intensive glycemia arm of the trial compared with the standard arm (3.0 ± 7.0 vs. 0.3 ± 6.3 kg). On multivariate analysis, younger age, male sex, Asian race, no smoking history, high A1C, baseline BMI of 25-35, high waist circumference, baseline insulin use, and baseline metformin use were independently associated with weight gain over 2 years. Reduction of A1C from baseline was consistently associated with weight gain only when baseline A1C was elevated. Medication usage accounted for <15% of the variability of weight change, with initiation of thiazolidinedione (TZD) use the most prominent factor. Intensive participants who never took insulin or a TZD had an average weight loss of 2.9 kg during the first 2 years of the trial. In contrast, intensive participants who had never previously used insulin or TZD but began this combination after enrolling in the ACCORD trial had a weight gain of 4.6-5.3 kg at 2 years. CONCLUSIONS: Weight gain in ACCORD was greater with intensive than with standard treatment and generally associated with reduction of A1C from elevated baseline values. Initiation of TZD and/or insulin therapy was the most important medication-related factor associated with weight gain.

Effect of intensive versus standard blood pressure control on depression and health-related quality of life in type 2 diabetes: the ACCORD trial.

OBJECTIVE: We tested the hypothesis that intensive (systolic blood pressure [SBP] <120 mmHg) rather than standard (SBP 130-139 mmHg) blood pressure (BP) control improves health-related quality of life (HRQL) in those with type 2 diabetes. RESEARCH DESIGN AND METHODS: Subjects were 1,028 ACCORD (Action to Control Cardiovascular Risk in Diabetes) BP trial HRQL substudy participants who completed baseline and one or more 12-, 36-, or 48-month HRQL evaluations. Multivariable linear regression assessed impact of BP treatment assignment on change in HRQL. RESULTS: Over 4.0 years of follow-up, no significant differences occurred in five of six HRQL measures. Those assigned to intensive (vs. standard) BP control had statistically significant worsening of the Medical Outcomes Study 36-item short-form health survey (SF36) physical component scores (-0.8 vs. -0.2; P = 0.02), but magnitude of change was not clinically significant. Findings persisted across all prespecified subgroups. CONCLUSIONS: Intensive BP control in the ACCORD trial did not have a clinically significant impact, either positive or negative, on depression or patient-reported HRQL.

Depression predicts all-cause mortality: epidemiological evaluation from the ACCORD HRQL substudy.

OBJECTIVE: Depression affects up to 20-25% of adults with type 2 diabetes and may increase all-cause mortality, but few well-designed studies have examined the effects of depression on the full range of cardiovascular disease outcomes in type 2 diabetes. RESEARCH DESIGN AND METHODS: A total of 2,053 participants in the ACCORD (Action to Control Cardiovascular Risk in Diabetes) Health-Related Quality of Life substudy completed the Patient Health Questionnaire (PHQ)-9 measure of depression symptoms at baseline and 12, 36, and 48 months. Cox proportional hazards regression models were used to estimate hazard ratios (HRs) (95% CI) for the time-varying impact of depression on protocol-defined clinical outcomes with and without adjustment for demographic, trial-related, clinical, and behavioral variables. RESULTS: In fully adjusted models, depression was not significantly related to the ACCORD primary composite outcome (cardiovascular death, nonfatal heart attack, or stroke) (HR 1.53 [95% CI 0.85-2.73]) or to the ACCORD microvascular composite outcome (0.93 [0.53-1.62]), but all-cause mortality was significantly increased both in those with PHQ-assessed probable major depression (2.24 [1.24-4.06]) and PHQ score of ≥ 10 (1.84 [1.17-2.89]). The effect of depression on all-cause mortality was not related to previous cardiovascular events or to assignment to intensive or standard glycemia control. Probable major depression (by PHQ-9) had a borderline impact on the ACCORD macrovascular end point (1.42 [0.99-2.04]). CONCLUSIONS: Depression increases the risk of all-cause mortality and may increase the risk of macrovascular events among adults with type 2 diabetes at high risk for cardiovascular events.

Baseline comparison of three health utility measures and the feeling thermometer among participants in the Action to Control Cardiovascular Risk in Diabetes trial.

BACKGROUND: Health utility (HU) measures are used as overall measures of quality of life and to determine quality adjusted life years (QALYs) in economic analyses. We compared baseline values of three HUs including Short Form 6 Dimensions (SF-6D), and Health Utilities Index, Mark II and Mark III (HUI2 and HUI3) and the feeling thermometer (FT) among type 2 diabetes participants in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. We assessed relationships between HU and FT values and patient demographics and clinical variables. METHODS: ACCORD was a randomized clinical trial to test if intensive controls of glucose, blood pressure and lipids can reduce the risk of major cardiovascular disease (CVD) events in type 2 diabetes patients with high risk of CVD. The health-related quality of life (HRQOL) sub-study includes 2,053 randomly selected participants. Interclass correlations (ICCs) and agreement between measures by quartile were used to evaluate relationships between HU's and the FT. Multivariable regression models specified relationships between patient variables and each HU and the FT. RESULTS: The ICCs were 0.245 for FT/SF-6D, 0.313 for HUI3/SF-6D, 0.437 for HUI2/SF-6D, 0.338 for FT/HUI2, 0.337 for FT/HUI3 and 0.751 for HUI2/HUI3 (P < 0.001 for all). Common classification by quartile was found for the majority (62%) of values between HUI2 and HUI3, which was significantly (P < 0.001) higher than between other HUs and the FT: SF-6D/HUI3 = 40.8%, SF-6D/HUI2 = 40.9%, FT/HUI3 = 35.0%, FT/HUI2 = 34.9%, and FT/SF-6D = 31.9%. Common classification was higher between SF-6D/HUI2 and SF-6D/HUI3 (P < 0.001) than between FT/SF-6D, FT/HUI2, and FT/HUI3. The mean difference in HU values per patient ranged from -0.024 ± 0.225 for SF-6D/ HUI3 to -0.124 ± 0.133 for SF-6D/HUI2. Regression models were significant; clinical and demographic variables explained 6.1% (SF-6D) to 7.7% (HUI3) of the variance in HUs. CONCLUSIONS: The agreements between the different HUs were poor except for the two HUI measures; therefore HU values derived different measures may not be comparable. The FT had low agreement with HUs. The relationships between HUs and demographic and clinical measures demonstrate how severity of diabetes and other clinical and demographic factors are associated with HUs and FT measures. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00000620.

Effect of intensive glycemic lowering on health-related quality of life in type 2 diabetes: ACCORD trial.

OBJECTIVE: To compare the effect of intensive versus standard glycemic control strategies on health-related quality of life (HRQL) in a substudy of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. RESEARCH DESIGN AND METHODS: A randomly selected subsample of 2,053 ACCORD participants enrolled in the HRQL substudy was assessed at baseline and 12-, 36-, and 48-month visits. HRQL assessment included general health status (the 36-Item Short Form Health Survey [SF-36]), diabetes symptoms (the Diabetes Symptom Distress Checklist), depression (Patient Health Questionnaire [PHQ]-9), and treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire [DTSQ]). Repeated-measures ANOVA models were used to estimate change in HRQL outcomes by treatment group over 48 months adjusting for model covariates. The effects of early discontinuation of the ACCORD intensive glycemic control arm on study results were explored. RESULTS: A total of 1,956 (95%) completed the self-report HRQL instrument(s) at baseline. The intensive arm had a larger decrease in SF-36 physical health component score than the standard arm (-1.6 vs. -1.1, P = 0.0345). Treatment satisfaction (DTSQ) showed larger improvement with intensive than standard (P = 0.0004). There were no differences in mean scores of the Diabetes Symptom Checklist and PHQ-9. Effects of participant transition following discontinuation of the intensive arm on HRQL were not significant. CONCLUSIONS: The ACCORD trial strategy of intensive glycemic control did not lead to benefits in HRQL and was associated with modest improvement in diabetes treatment satisfaction. Thus patient acceptability was apparently not compromised with intensive and complex interventions such as those used in ACCORD.

Effect of the look AHEAD study intervention on medication use and related cost to treat cardiovascular disease risk factors in individuals with type 2 diabetes.

OBJECTIVE: To examine the effect of a lifestyle intervention to produce weight loss and increased physical fitness on use and cost of medications to treat cardiovascular disease (CVD) risk factors in people with type 2 diabetes. RESEARCH DESIGN AND METHODS: Look AHEAD is a multicenter randomized controlled trial of 5,145 overweight or obese individuals with type 2 diabetes, aged 45-76 years. An intensive lifestyle intervention (ILI) involving group and individual meetings to achieve and maintain weight loss through decreased caloric intake and increased physical activity was compared with a diabetes support and education (DSE) condition. Medications prescribed to treat diabetes, hypertension, and hyperlipidemia were compared at baseline and 1 year. Medication costs were conservatively estimated using prices from a national online pharmacy. RESULTS: Participants randomized to an ILI had significantly greater improvements in CVD risk parameters and reduced medication use and cost compared with those assigned to DSE. At 1 year, average number of medications prescribed to treat CVD risk factors was 3.1 +/- 1.8 for the ILI group and 3.6 +/- 1.8 for the DSE group (P < 0.0001), with estimated total monthly medication costs of $143 and $173, respectively (P < 0.0001). DSE participants meeting optimal care goals at 1 year were taking an average of 3.8 +/- 1.6 medications at an estimated cost of $194/month. ILI participants at optimal care required fewer medications (3.2 +/- 1.7) at lower cost ($154/month) (P < 0.001). CONCLUSIONS: At 1 year, ILI significantly improved CVD risk factors, while at the same time reduced medication use and cost. Continued intervention and follow-up will determine whether these changes are maintained and reduce cardiovascular risk.

A luta por responsabilidade das empresas no âmbito das nações unidas e o futuro da agenda de advocacy / Business and human rights: the struggle for accountability in the un and the future direction of the advocacy agenda / Empresas y derechos humanos: la lucha por la rendición de cuentas en la onu y el rumbo futuro de la agenda de incidencia

Nos últimos 40 anos, as Nações Unidas têm tentado de diversas formas elaborar parâmetros mundiais para responsabilizar empresas por violações de direitos humanos. Este artigo descreve a crescente conscientização sobre as violações de direitos humanos envolvendo empresas, bem como detalha os limites de uma abordagem centrada nos Estados para a regulação da conduta das empresas num mundo globalizado. O artigo investiga as razões para o fracasso do Projeto das Nações Unidas de Normas sobre Responsabilidades das Empresas Transnacionais, bem como pondera os pontos positivos e negativos da 'Marco Proteger, Remediar e Respeitar', adotado pelo Conselho de Direitos Humanos das Nações Unidas em 2008. O artigo conclui com a seguinte advertência: se não forem atendidas as demandas por parâmetros globais e remédios efetivos para vitimas de práticas empresariais nocivas, a pressão por mudança só tende a aumentar.

Over the past 40 years the United Nations has made various attempts to develop global standards to hold companies accountable for their involvement in human rights abuses. This article traces the growing awareness of business-related human rights abuses and the limitations of the traditional State-centric approach to regulating corporations in the era of globalisation. It reflects on the reasons for the demise of the Draft UN Norms on the Responsibilities of Transnational Corporations and considers the strengths and weaknesses of 'the Protect, Remedy and Respect Framework' adopted by the Human Rights Council in 2008. The article concludes with a warning that unless the demands for global standards and an effective remedy for those affected by corporate misconduct are addressed, pressure for change is only liable to intensify.

Durante los últimos 40 años, la Organización de Naciones Unidas ha llevado a cabo varios intentos de elaborar estándares globales que permitan hacer responsables a las empresas por su participación en violaciones de derechos humanos. Este artículo describe la creciente toma de conciencia sobre las violaciones de derechos humanos vinculadas a las empresas y las limitaciones que ofrece el enfoque tradicional centrado en el Estado, al momento de regular la conducta de las empresas en la era de la globalización. Reflexiona sobre las razones del decaimiento del Proyecto de Normas de la ONU sobre Responsabilidades de las Empresas Trasnacionales, y evalúa las fortalezas y debilidades del Marco "Proteger, Respetar y Remediar" adoptado por el Consejo de Derechos Humanos el año 2008. El artículo concluye con la advertencia de que a menos que sean atendidas las demandas por estándares globales y por un recurso efectivo para los afectados por malas prácticas empresariales, lo único seguro es que se intensificará la presión para un cambio.

Constructing common cohorts from trials with overlapping eligibility criteria: implications for comparing effect sizes between trials.

BACKGROUND: Comparing findings from separate trials is necessary to choose among treatment options, however differences among study cohorts may impede these comparisons. PURPOSE: As a case study, to examine the overlap of study cohorts in two large randomized controlled clinical trials that assess interventions to reduce risk of major cardiovascular disease events in adults with type 2 diabetes in order to explore the feasibility of cross-trial comparisons METHODS: The Action for Health in Diabetes (Look AHEAD) and The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trials enrolled 5145 and 10,251 adults with type 2 diabetes, respectively. Look AHEAD assesses the efficacy of an intensive lifestyle intervention designed to produce weight loss; ACCORD tests pharmacological therapies for control of glycemia, hyperlipidemia, and hypertension. Incidence of major cardiovascular disease events is the primary outcome for both trials. A sample was constructed to include participants from each trial who appeared to meet eligibility criteria and be appropriate candidates for the other trial's interventions. Demographic characteristics, health status, and outcomes of members and nonmembers of this constructed sample were compared. RESULTS: Nearly 80% of Look AHEAD participants were projected to be ineligible for ACCORD; ineligibility was primarily due to better glycemic control or no early history of cardiovascular disease. Approximately 30% of ACCORD participants were projected to be ineligible for Look AHEAD, often for reasons linked to poorer health. The characteristics of participants projected to be jointly eligible for both trials continued to reflect differences between trials according to factors likely linked to retention, adherence, and study outcomes. LIMITATIONS: Accurate ascertainment of cross-trial eligibility was hampered by differences between protocols. CONCLUSIONS: Despite several similarities, the Look AHEAD and ACCORD cohorts represent distinct populations. Even within the subsets of participants who appear to be eligible and appropriate candidates for trials of both modes of intervention, differences remained. Direct comparisons of results from separate trials of lifestyle and pharmacologic interventions are compromised by marked differences in enrolled cohorts.

Suboptimal control of glycemia, blood pressure, and LDL cholesterol in overweight adults with diabetes: the Look AHEAD Study.

BACKGROUND: The characteristics associated with meeting goals for glycemia, blood pressure (BP), and low-density lipoprotein (LDL) cholesterol for participants with diabetes were examined. METHODS: Baseline information on demographics, medical history, and anthropometry, as well as on hemoglobin A1c, BP, and LDL cholesterol levels, was measured in 5145 participants of Look AHEAD, a multicenter randomized trial performed to determine whether long-term weight loss and increased physical fitness reduce cardiovascular disease (CVD) in overweight and obese individuals with type 2 diabetes. Logistic regression was used to analyze these cross-sectional data to ascertain associations between participant characteristics and attainment of risk factor goals [hemoglobin A1c <7.0%, BP <130/80 mmHg, and LDL <100 mg/dl]. RESULTS: The study population had a mean age of 58.7 years and a mean body mass index of 36.0 kg/m(2). Of the total number of participants, 59.5% were female, 36.8% were of ethnic/racial minority, and 87.3% were on diabetes medications. Upon enrollment, 45.8% had hemoglobin A1c<7.0%, 51.7% had BP<130/80 mmHg, and 37.2% had LDL<100 mg/dl. All three goals were met by only 10.1%. We found consistent evidence for differences in risk factor control by age, gender, race/ethnicity, degree of obesity, education, income, CVD, source of medical care, and medication use. In multivariable analysis, African-American race, increasing degree of obesity, insulin use, and nonutilization of a lipid-lowering agent were associated with not meeting all risk factor goals. CONCLUSION: These data demonstrate that numerous baseline characteristics are associated with suboptimal control of these cardiovascular risk factors among overweight and obese adults with diabetes.

Glycemia treatment strategies in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.

There is an independent progressive epidemiologic relation between glycemia and cardiovascular disease (CVD) events; however, whether lowering glucose levels with currently available therapies can reduce CVD events remains unknown. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial is designed to answer this question in high-risk patients with type 2 diabetes mellitus. In ACCORD, 10,251 patients with type 2 diabetes and other CVD risk factors or CVD were randomly allocated to intensive glycemic control, targeting a glycosylated hemoglobin (HbA1c) level <6%, or standard glycemic control, targeting an HbA1c level of 7.0%-7.9%. All participants are provided with diabetes education, glucose-monitoring equipment, and antidiabetic medications. All participants in the intensive glycemic control group are started on > or = 2 classes of agents. Doses are intensified or a new medication class is added every month if HbA1c levels are > or = 6% or if >50% of premeal or postmeal capillary glucose readings are >5.6 mmol/L (100 mg/dL) or >7.8 mmol/L (140 mg/dL), respectively. All drug combinations are permitted, and drugs are reduced only because of side effects or contraindications. Annual training, menus of approaches for intensification, regular electronic messaging, audits of achieved glycemia, and central feedback to sites support glycemic intensification strategies in intensive participants. In participants in the standard glycemic control group, therapy is intensified whenever HbA1c is > or = 8%, and antihyperglycemic drugs that promote hypoglycemia (ie, insulin or insulin secretagogues) are reduced if HbA1c persistently decreases to <7% in the setting of hypoglycemia. ACCORD addresses the hypothesis that aggressive glucose lowering prevents CVD events in patients with type 2 diabetes. It is focused on the levels of glycemia achieved using a variety of strategies, not on the specific therapies used. It will also provide information on how to safely approach near-normal levels of glucose control in clinical practice and evidence to support future clinical guidelines for diabetes management in older adults.

Health-related quality of life and cost-effectiveness components of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: rationale and design.

Diabetes mellitus affects not only life expectancy but also quality of life. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial's health-related quality of life (HRQOL) and cost-effectiveness components will enable the assessment of the relative importance of the various outcomes from the point of view of patients, provide an understanding of the balance between the burdens and benefits of the intervention strategies, and offer valuable insights into adherence. The HRQOL measures used include the Diabetes Symptoms Distress Checklist; the 36-Item Short Form Health Survey, Version 2 (SF-36) (RAND Corporation, Santa Monica, CA); the Patient Health Questionnaire (PHQ) depression measure (Pfizer Inc, New York, NY); the World Health Organization (WHO) Diabetes Treatment Satisfaction Questionnaire (DTSQ); and the EuroQol Feeling Thermometer (EuroQol Group, Rotterdam, Netherlands). The cost-effectiveness analysis (CEA) in ACCORD will provide information about the relative economic efficiency of the different interventions being compared in the trial. Effectiveness will be measured in terms of cardiovascular event-free years gained and quality-adjusted life-years gained (using the Health Utilities Index Mark 3 [HUI-3] [Health Utilities Inc., Dundas, Ontario, Canada] to measure health-state utility). Costs will be direct medical costs assessed from the perspective of a single-payer health system collected by means of patient and clinic cost forms and hospital discharge summaries. The primary HRQOL and CEA hypotheses mirror those in the main ACCORD trial, addressing the effects of the 3 main ACCORD interventions considered separately. There are also secondary (pairwise reference case) comparisons that do not assume independence of treatment effects on HRQOL. CEA will be done on a subsample of 4,311 ACCORD participants and HRQOL on a subsample of 2,053 nested within the CEA subsample. Most assessments will occur through questionnaires at baseline and at 12, 36, and 48 months.