It is not clear which research misconduct policies are adopted by biomedical journals. This study assessed the prevalence and content policies of the most influential biomedical journals on misconduct and procedures for handling and responding to allegations of misconduct.
We conducted a cross-sectional study of misconduct policies of 399 high-impact biomedical journals in 27 biomedical categories of the Journal Citation Reports in December 2011. Journal websites were reviewed for information relevant to misconduct policies.
Of 399 journals, 140 (35.1%) provided explicit definitions of misconduct. Falsification was explicitly mentioned by 113 (28.3%) journals, fabrication by 104 (26.1%), plagiarism by 224 (56.1%), duplication by 242 (60.7%) and image manipulation by 154 (38.6%). Procedures for responding to misconduct were described in 179 (44.9%) websites, including retraction, (30.8%) and expression of concern (16.3%). Plagiarism-checking services were used by 112 (28.1%) journals. The prevalences of all types of misconduct policies were higher in journals that endorsed any policy from editors’ associations, Office of Research Integrity or professional societies compared to those that did not state adherence to these policy-producing bodies. Elsevier and Wiley-Blackwell had the most journals included (22.6% and 14.8%, respectively), with Wiley journals having greater a prevalence of misconduct definition and policies on falsification, fabrication and expression of concern and Elsevier of plagiarism-checking services.
Only a third of top-ranking peer-reviewed journals had publicly-available definitions of misconduct and less than a half described procedures for handling allegations of misconduct. As endorsement of international policies from policy-producing bodies was positively associated with implementation of policies and procedures, journals and their publishers should standardize their policies globally in order to increase public trust in the integrity of the published record in biomedicine.
Smokers earn less than non-smokers, but much is still unknown about the source(s) of the smoker’s wage gap. We build on the work of Bhattacharya and Bundorf (2009), who provide evidence that obese workers receive lower wages on account of their higher expected healthcare costs. Similarly, we find that smokers who hold employer-sponsored health insurance (ESI) receive significantly lower wages than their non-smoking peers, while smokers who are not insured through their employer endure no such wage penalty. Our results have two implications: first, the incidence of smokers’ elevated medical costs appears to be borne by smokers themselves in the form of lower wages. Second, differences in healthcare costs between smokers and non-smokers are a significant source of the smoker’s wage gap.
Smoking; Wages; Employer-sponsored health insurance; Compensating differential
CONSORT, Consolidated Standards of Reporting Trials; ICMJE, International Committee of Medical Journal Editors; MPIP, Medical Publishing Insights and Practices
Employers may be loath to fund vaccination programs without understanding the economic consequences. We developed a decision analytic computational simulation model including dynamic transmission elements that determined the cost-benefit of employer-sponsored workplace vaccination from the employer's perspective. Implementing such programs was relatively inexpensive (<$35/vaccinated employee) and, in many cases, cost saving across diverse occupational groups in all seasonal influenza scenarios. Such programs were cost-saving for a 20% serologic attack rate pandemic scenario (−$15 to −$995) per vaccinated employee) and a 30% serologic attack rate pandemic scenario (range −$39 to −$1,494 per vaccinated employee) across all age and major occupational groups.
Influenza; Workplace; Vaccination
We evaluated the safety of coronary reactivity testing (CRT) in symptomatic women with evidence of myocardial ischemia and no obstructive coronary artery disease (CAD).
Microvascular coronary dysfunction (MCD) in women with no obstructive CAD portends an adverse prognosis of 2.5% annual major adverse cardiovascular event (MACE) rate. The diagnosis of MCD is established by invasive CRT, yet the risk of CRT is unknown.
We evaluated 293 symptomatic women with ischemia and no obstructive CAD, who underwent CRT at three experienced centers. Microvascular function was assessed using a Doppler wire and injections of adenosine, acetylcholine, and nitroglycerin in the left coronary artery. CRT-related serious adverse events (SAE), adverse events (AE), and follow-up MACE (death, nonfatal myocardial infarction (MI), nonfatal stroke, or hospitalization for heart failure) were recorded.
CRT-SAEs occurred in 2 women (0.7%) during the procedure: one had coronary artery dissection, and one developed MI associated with coronary spasm. CRT-AEs occurred in 2 women (0.7%) and included one transient air microembolism and one deep venous thrombosis. There was no CRT-related mortality. In the mean follow-up period of 5.4 years, the MACE rate was 8.2%, including 5 deaths (1.7%), 8 non-fatal MIs (2.7%), 8 nonfatal strokes (2.7%), and 11 hospitalizations for heart failure (3.8%).
In women undergoing CRT for suspected MCD, contemporary testing carries a relatively low risk compared to the MACE rate in these women. These results support the use of CRT by experienced operators for establishing definitive diagnosis and assessing prognosis in this at-risk population.
coronary reactivity; microvascular dysfunction; endothelial dysfunction
Background and Purpose
When planning clinical trials, decisions regarding sample size are often based on educated guesses of parameters, that may in fact prove to be over- or underestimates. For example, after initiation of the SPS3 study, published data indicated that the recurrent stroke rates might be lower than initially planned for the study. Failure to account for this could result in an under-powered study. Thus, we performed a sample size re-estimation, and describe the experience herein.
We evaluated different scenarios based on a re-estimated overall event rate, including increasing the sample size and increasing the follow-up time, to determine their impact on both Type I error and the power to detect the initially planned treatment difference.
We found that by increasing the sample size from 2500 to 3000 and by following the patients for one year after the end of recruitment, we would maintain our planned Type I error rate, and increase the power to detect the prespecified clinically meaningful difference to between 67% and 87%, depending on the rate of recruitment.
We successfully implemented this unplanned design modification in the SPS3 study, in order to allow for sufficient power to detect the planned treatment differences.
Clinical Trials Registration Information
Clinical Trials Registration - http://clinicaltrials.gov/show/NCT00059306. Unique identifier: NCT00059306
sample size re-estimation; SPS3; randomized clinical trial
Published results suggests that high adiponectin level may decrease the risk of breast cancer. However, available evidence on breast cancer is conflicting. Therefore a meta-analysis was performed to assess the association between blood adiponectin and breast cancer risk. PubMed database, Web of Science, Elsevier Science, Springer Link and bibliographies of retrieved articles were searched for epidemiological studies published up to March 2013. Meta-analysis was performed on the combined effect values (OR) as well as standardized mean difference (SMD) including 17 studies. Fixed or random effect pooled measure was selected on the basis of homogeneity test among studies. The publication bias was assessed by the Egger’s regression asymmetry test and Begg’s rank correlation test with Begg’s funnel plot. Subgroup analyses and sensitivity analysis were also performed. A total of 13 studies involving 3578 breast cancer cases and 4363 controls contributed to the OR analysis. The high adiponectin level did not significantly affect breast cancer risk (OR=0.902, 95% CI=0.773–1.053). After excluding articles that were the key contributors to between-study heterogeneity, the OR of high adiponectin level was associated with decreased breast cancer risk (OR=0.838, 95% CI=0.744–0.943). There was a significantly association between high adiponectin level and postmenopausal breast cancer women (OR=0.752, 95%CI=0.604-0.936); and it was not associated with premenopausal breast cancer women (OR=0.895, 95%CI=0.638-1.256). The result of pooled measure on SMD was that the high adiponectin level was associated with decreased breast cancer risk (SMD= -0.348, 95% CI= -0.533--0.614) after excluding articles which were the key contributors to between-study heterogeneity. Our findings indicate that high adiponectin level might decrease the risk of postmenopausal breast cancer. More randomized clinical trials and observational studies are needed to confirm this association with underlying biological mechanisms in the future.
Urinary Kidney Injury Molecule 1 (KIM-1) is a proximal tubular injury biomarker for early detection of acute kidney injury (AKI), with variable performance characteristics depending on clinical and population settings.
Meta-analysis was performed to assess the diagnostic value of urinary KIM-1 in AKI. Relevant studies were searched from MEDLINE, EMBASE, Pubmed, Elsevier Science Direct, Scopus, Web of Science, Google Scholar and Cochrane Library. Meta-analysis methods were used to pool sensitivity and specificity and to construct summary receiver operating characteristic (SROC) curves.
A total of 2979 patients from 11 eligible studies were enrolled in the analysis. Five prospective cohorts, two cross-sectional and four case-control studies were identified for meta-analysis. The estimated sensitivity of urinary KIM-1 for the diagnosis of AKI was 74.0% (95% CI, 61.0%–84.0%), and specificity was 86.0% (95% CI, 74.0%–93.0%). The SROC analysis showed an area under the curve of 0.86(0.83–0.89). Subgroup analysis suggested that population settings and detection time were the key factors affecting the efficiency of KIM-1 for AKI diagnosis.
Various population settings, different definition of AKI and Serum creatinine level used as the standard might have influence on AKI diagnosis. The relatively small number of studies and heterogeneity between them also affected the evaluation.
Urinary KIM-1 may be a promising biomarker for early detection of AKI with considerable predictive value, especially for cardiac surgery patients, and its potential value needs to be validated in large studies and across a broader scope of clinical settings.
Researchers turn to citation tracking to find the most influential articles for a particular topic and to see how often their own published papers are cited. For years researchers looking for this type of information had only one resource to consult: the Web of Science from Thomson Scientific. In 2004 two competitors emerged – Scopus from Elsevier and Google Scholar from Google. The research reported here uses citation analysis in an observational study examining these three databases; comparing citation counts for articles from two disciplines (oncology and condensed matter physics) and two years (1993 and 2003) to test the hypothesis that the different scholarly publication coverage provided by the three search tools will lead to different citation counts from each.
Eleven journal titles with varying impact factors were selected from each discipline (oncology and condensed matter physics) using the Journal Citation Reports (JCR). All articles published in the selected titles were retrieved for the years 1993 and 2003, and a stratified random sample of articles was chosen, resulting in four sets of articles. During the week of November 7–12, 2005, the citation counts for each research article were extracted from the three sources. The actual citing references for a subset of the articles published in 2003 were also gathered from each of the three sources.
For oncology 1993 Web of Science returned the highest average number of citations, 45.3. Scopus returned the highest average number of citations (8.9) for oncology 2003. Web of Science returned the highest number of citations for condensed matter physics 1993 and 2003 (22.5 and 3.9 respectively). The data showed a significant difference in the mean citation rates between all pairs of resources except between Google Scholar and Scopus for condensed matter physics 2003. For articles published in 2003 Google Scholar returned the largest amount of unique citing material for oncology and Web of Science returned the most for condensed matter physics.
This study did not identify any one of these three resources as the answer to all citation tracking needs. Scopus showed strength in providing citing literature for current (2003) oncology articles, while Web of Science produced more citing material for 2003 and 1993 condensed matter physics, and 1993 oncology articles. All three tools returned some unique material. Our data indicate that the question of which tool provides the most complete set of citing literature may depend on the subject and publication year of a given article.
Increasing rates of antimicrobial-resistant infections and the dwindling pipeline of new agents necessitate judicious, evidence-based antimicrobial prescribing. Clinical trials represent a vital resource for establishing evidence of safety and efficacy, which are crucial to guiding antimicrobial treatment decisions. The objective of this study was to comprehensively evaluate the characteristics of antimicrobial research studies registered in ClinicalTrials.gov. Primary outcome measures, funding sources, inclusion criteria and the reporting of study results were evaluated for 16 055 antimicrobial studies registered in ClinicalTrials.gov as of mid 2012. Interventional studies accounted for 93% of registered antimicrobial studies. Clinical trials of drugs (82%) and biologics (9%) were most common. Antibacterial, antiviral and antifungal studies accounted for 43%, 41% and 16% of drug trials, respectively. Among interventional drug trials, 73% featured randomised allocation to study arms and 71% included measures of safety and/or efficacy as primary endpoints. Children were eligible for enrolment in 26% of studies. Among the studies, 60% were sponsored primarily by non-profit organisations, 30% by industry and 10% by the federal government. Only 7% of studies reported results; however, 71% of these were sponsored primarily by industry. Antimicrobial studies commonly incorporated elements of high-quality trial design, including randomisation and safety/efficacy endpoints. Publication of study results and updating of ClinicalTrials.gov should be encouraged for all studies, with particular attention paid to research sponsored by non-profit organisations and governmental agencies. Leveraging the application of these data to guide the careful selection of antimicrobial agents will be essential to preserve their utility for years to come.
Antibiotic; Antibacterial; Antiviral; Antifungal; Anti-infective agents
Approximately 170 million inhabitants of the American continent live at risk of malaria transmission. Although the continent’s contribution to the global malaria burden is small, at least 1 to 1.2 million malaria cases are reported annually. Sixty per cent of the malaria cases occur in Brazil and the other 40% are distributed in 20 other countries of Central and South America. Plasmodium vivax is the predominant species (74.2 %) followed by P. falciparum (25.7 %) and P. malariae (0.1%), and no less than 10 Anopheles species have been identified as primary or secondary malaria vectors. Rapid deforestation and agricultural practices are directly related to increases in Anopheles species diversity and abundance, as well as in the number of malaria cases. Additionally, climate changes profoundly affect malaria transmission and are responsible for malaria epidemics in some regions of South America. Parasite drug resistance is increasing, but due to bio-geographic barriers there is extraordinary genetic differentiation of parasites with limited dispersion. Although the clinical spectrum ranges from uncomplicated to severe malaria cases, due to the generally low to middle transmission intensity, features such as severe anemia, cerebral malaria and other complications appear to be less frequent than in other endemic regions and asymptomatic infections are a common feature. Although the National Malaria Control Programs (NMCP) of different countries differ in their control activities these are all directed to reduce morbidity and mortality by using strategies like health promotion, vector control and impregnate bed nets among others. Recently, international initiatives such as the Malaria Control Program in Andean-country Border Regions (PAMAFRO) (implemented by the Andean Organism for Health (ORAS) and sponsored by The Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM)) and The Amazon Network for the Surveillance of Antimalarial Drug Resistance (RAVREDA) (sponsored by the Pan American Health Organization/World Health Organization (PAHO/WHO) and several other partners), have made great investments for malaria control in the region. We describe here the current status of malaria in a non-Amazonian region comprising several countries of South and Central America participating in the Centro Latino Americano de Investigación en Malaria (CLAIM), an International Center of Excellence for Malaria Research (ICEMR) sponsored by the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID).
malaria; Plasmodium falciparum; Plasmodium vivax; malaria elimination; epidemiology; Latin America
Factors that have led to the increasing popularity of medical travel include the high cost of healthcare, long wait times for certain procedures, the ease and affordability of international travel, and improvements in both technology and standards of care in many countries.
The present study aims to elaborate the factors that attract international cardiac patients to India, to document the proportion of the admissions into the paediatric cardiac ward who are international patients, and to identify the sources of funding of the international patients.
This was a prospective, cross-sectional, and analytical study carried out between May 2009 and October 2009 in the paediatric cardiac care unit of a large tertiary care cardiac centre in India paediatric wards. Structured questionnaires were administered.
A total of 1372 patients were admitted during the study period, of which 155 (11.3%) were patients from countries outside India. Majority of the patients were from Malaysia (45%), Nigeria (23%), and Tanzania (15%). The age ranged from 1 month to 39 years with an average of 61 months. The male to female ratio was 1:1.4 and the majority of subjects (72.5%) were in social classes 3 and 4. cheaper cost and better expertise was the prominent reason for choosing India. More than half of the respondents were either sponsored by the government or self-funded. For patients from Nigeria 53% (9) were sponsored by self (parent), 29% (5) by non-governmental organisations (NGO), 12% (2) by the parent employer, and 6% (1) by the government.
There is a need for local development of facilities and training of personnel in specialised areas of healthcare to provide succour for a significant number of nationals who might otherwise have suffered and possibly have even died of their ailment. There is also the added advantage that such facilities would save foreign currency and help boost our economy.
International patients; Medical tourism
The ethics of research continue to attract considerable debate, particularly when that research is sponsored by partners from the North and carried out in the South. Ethical research should contribute to social value in the country where research is being carried out, but there is significant debate around how this might be achieved and who is responsible. The literature suggests that researchers might employ two inter-related strategies to maximise social value: collaborative partnerships with policy makers and communities from the outset of research, and dissemination of research results to participants, policy makers and implementers once the research is over. These areas have received relatively little empirical attention. In this study, we carried out 40 in-depth interviews to explore the role of collaborative partnerships in health research priority setting, and the way in which research findings are disseminated to aid policy making and implementation in Kenya. Interviewees included policy makers, researchers, policy implementers and representatives of organisations funding health reforms in Kenya. Two policy issues were drawn upon as tracers wherever possible: (1) the introduction of Artemesinin- based Combination Therapies (ACTs), an anti-malarial treatment policy; and (2) Haemophilus influenzae (Hib) vaccine for the prevention of pneumococcal diseases among children.
The findings point to significant gaps in the ‘research to policy to practice’ pathway, particularly for national research institutions with a focus on clinical/biomedical research. These gaps reflect poorly effective partnerships among stakeholders and limit the potential social value of much research. While more investment is needed to establish strong structures for promoting and directing collaboration and partnership, how to target this investment is not entirely clear, especially in the context of the considerable power of the global health agenda and the research financing tied to it.
Kenya; Ethics; Social value; Research benefits; Collaborative research
Mucormycosis is an emergent and threatening invasive fungal invasion underdiagnosed by clinicians due to lack of awareness and aspecific clinical picture. The authors describe a clinical case of a diabetic and cirrhotic patient who developed rhino-orbital-cerebral and pulmonary mucormycosis, non-responsive to treatment. Typical gaps in the management of this deadly disease are addressed. There is a strong need for novel therapies and an expectation that sponsors will recognize the critical need for randomized clinical trials.
Mucormycosis; Diabetes; High mortality; Delays; Hyperbaric medicine; Randomized clinical trials
Cytomegalovirus end-organ disease can be prevented by giving ganciclovir when viraemia is detected in allograft recipients. Values of viral load correlate with development of end-organ disease and are moderated by pre-existing natural immunity. Our aim was to determine whether vaccine-induced immunity could do likewise.
We undertook a phase-2 randomised placebo controlled trial in adults awaiting kidney or liver transplantation at the Royal Free Hospital, London, UK. Exclusion criteria were pregnancy, receipt of blood products (except albumin) in the previous 3 months, and simultaneous multiorgan transplantation. 70 patients seronegative and 70 seropositive for cytomegalovirus were randomly assigned from a scratch-off randomisation code in a 1:1 ratio to receive either cytomegalovirus glycoprotein-B vaccine with MF59 adjuvant or placebo, each given at baseline, 1 month and 6 months later. If a patient was transplanted, no further vaccinations were given and serial blood samples were tested for cytomegalovirus DNA by real-time quantitative PCR (rtqPCR). Any patient with one blood sample containing more than 3000 cytomegalovirus genomes per mL received ganciclovir until two consecutive undetectable cytomegalovirus DNA measurements. Safety and immunogenicity were coprimary endpoints and were assessed by intention to treat in patients who received at least one dose of vaccine or placebo. This trial is registered with ClinicalTrials.gov, NCT00299260.
67 patients received vaccine and 73 placebo, all of whom were evaluable. Glycoprotein-B antibody titres were significantly increased in both seronegative (geometric mean titre 12 537 (95% CI 6593–23 840) versus 86 (63–118) in recipients of placebo recipients; p<0·0001) and seropositive (118 395; 64 503–217 272) versus 24 682 (17 909–34 017); p<0·0001) recipients of vaccine. In those who developed viraemia after transplantation, glycoprotein-B antibody titres correlated inversely with duration of viraemia (p=0·0022). In the seronegative patients with seropositive donors, the duration of viraemia (p=0·0480) and number of days of ganciclovir treatment (p=0·0287) were reduced in vaccine recipients.
Although cytomegalovirus disease occurs in the context of suppressed cell-mediated immunity post-transplantation, humoral immunity has a role in reduction of cytomegalovirus viraemia. Vaccines containing cytomegalovirus glycoprotein B merit further assessment in transplant recipients.
National Institute of Allergy and Infectious Diseases, Grant R01AI051355 and Wellcome Trust, Grant 078332. Sponsor: University College London (UCL).
The present study was aimed to study the requirements of bioequivalence for the registration of pharmaceutical products in the USA, Europe and Canada. Before going into bioequivalence studies it is essential for the pharmaceutical industry to study the guidelines of bioequivalence for the respective country where the industry wants to market its products and thus enter into generic market. This study reviews the requirements of bioequivalence with study parameters such as study design, fasting or fed state studies, volunteers recruitment, study dose, sampling points, analytical method validation parameters, moieties to be measured in plasma, pharmacokinetic parameters, criteria for bioequivalence, GCP requirements etc, which are needed for the pharmaceutical industry to carry out bioequivalence studies and to file ANDA. Test products and reference products are needed for this study. Test products are usually manufactured by a sponsor and reference products are provided by the government laboratories of the respective countries. Sampling points also vary with respect to the regulatory guidelines of these countries. All these countries follow ICH GCP guidelines. The criterion of bioequivalence for these countries is 90% CI 80–125% for Cmax, AUCt, AUC0–∞.
Bioavailability; Bioequivalence; Pharmacokinetics
Federal and state efforts to rebalance long-term services and supports (LTSS) in favor of home and community-based over institutional settings has helped create structural bridges between the historically separated aging and disability LTSS networks by integrating and/or linking aging and disability systems. These changes present new opportunities to study bridging mechanisms and program related outcomes at national and local levels through federally sponsored LTSS initiatives termed Rebalancing programs. Rebalancing programs also offer opportunities to explore and understand the capacity of LTSS networks (age integrated or linked aging and disability systems) to serve aging with disability populations, persons who live with long-term chronic conditions or impairments such as multiple sclerosis, spinal cord injury, intellectual or developmental disabilities. To date, there is limited evidence-based LTSS program and practice knowledge about this heterogeneous population such as met and unment need or interventions to support healthy aging. Efforts that center on bridging the larger fields of aging and disability in order to build new knowledge and engage in knowledge translation and translational research are critical for building capacity to support persons aging with disability in LTSS. Generating the investment in bridging aging and disability research across stakeholder group, including researchers and funders, is vital for these efforts.
aging; disability; long term services and supports; public policy; bridging
To examine how much of the impact of the Centers for Medicare and Medicaid Services’ national coverage decision (NCD) on bariatric surgery was driven by the restriction of reimbursements to Centers of Excellence (COE).
Inpatient care data of those with employer-sponsored insurance plans across United States using the MarketScan Commercial Claims and Encounter Database (2003–2009).
We performed a retrospective cohort study evaluating the impact of the accreditation on subjects with a difference-in-difference approach (removing the temporal changes occurring in non-COEs) on rates of inpatient mortality, 90-day reoperations, complications, readmissions, and total payments.
30,755 patients (43.9±11.0 years; 79.9% women) had bariatric surgery. 17,896 patients underwent procedures at sites that became COEs (8,455 pre-NCD and 9,441 post-NCD, [+10.4%]) compared to 12,859 at non-COEs (6,534 pre-NCD and 6,325 post-NCD, [-3.3%]). Of the total number of bariatric procedures, laparoscopic Roux-en-Y gastric bypass and laparoscopic adjustable band procedures increased from 42.9% and 3.1% pre-NCD to 64.5% and 19.7% post-NCD, respectively. In the COEs, there were reductions in inpatient mortality (0.3% to 0.1%, p-value=0.02), 90-day reoperations (0.8% to 0.5%, p-value=0.006), complications (36.4% to 27.6%, p-value<0.001), and readmissions (10.8% to 8.8%, p-value<0.001) while payments remained similar ($24,543 ± $40,145 to $24,510 ± $37,769, p-value=0.9). After distinguishing from temporal trends and differences occurring at non-COEs, 90-day reoperation (-0.8%, p-value=0.02) and complication rates (-2.7%, p-value=0.01) were lower at the COEs after the NCD.
The accreditation-based NCD in bariatric surgery was associated with lower rates of reoperations and complications. Such policies may become a powerful tool to improve surgical safety and quality.
Centers of excellence; national coverage decision; Centers for Medicare and Medicaid Services; accreditation; bariatric surgery
The authors of four National Institutes of Health (NIH)-sponsored antibiotic treatment trials of patients with persistent unexplained symptoms despite previous antibiotic treatment of Lyme disease determined that retreatment provides little if any benefit and carries significant risk. Recently, two groups have provided an independent reassessment of these trials and concluded that prolonged courses of antibiotics are likely to be helpful. We have carefully considered the points raised by these groups, along with our own critical review of the treatment trials. Based on this analysis, the conclusion that there is a meaningful clinical benefit to be gained from retreatment of such patients with parenteral antibiotic therapy cannot be justified.
Lyme disease; Borrelia burgdorferi; Post-Lyme disease syndrome; Clinical trials
A longitudinal analysis was conducted among a U.S. national sample of persons affiliated with Alcoholics Anonymous and Narcotics Anonymous living in self-run recovery homes (Oxford Houses). Categorical involvement in a set of 12-step activities (i.e., having a sponsor, reading 12-step literature, doing service work, and calling other members for help) and averaged summary scores of involvement were examined in relation to abstinence and self-efficacy for abstinence. Participants who were categorically involved in all 12-step activities reported significantly higher levels of abstinence and self-efficacy for abstinence at 1 year compared with those who were less involved, whereas averaged summary scores of involvement were not a significant predictor of abstinence. Participants’ number of days in Oxford Houses, but not rates of 12-step meeting attendance, was significantly related to increased abstinence. Findings suggest that categorical involvement in a number of 12-step activities equip persons with substance use disorders with resources for ongoing recovery.
12-Step involvement; Self-efficacy for abstinence; Abstinence; Alcoholics Anonymous; Narcotics Anonymous; Oxford House
Currently, no agents are approved by the United States Food and Drug Administration for either prevention or treatment of acute graft-versus-host disease (GVHD). Since the field lacks formal precedents establishing a comparative basis for assessing the efficacy and safety of new investigational agents, the design of trials to demonstrate overall clinical benefit with statistical certainty remains extremely difficult both for academic and industry sponsors. As a step toward addressing this problem, a panel of experts met on two occasions to reach consensus on recommendations for terminology defining a clinically meaningful primary endpoint in studies assessing treatment for acute GVHD. The panel recommended terminology for “very good partial response” that includes both diagnostic and functional criteria. Assessment of response at day 28 after starting treatment is appropriate for the primary end point, but later time points can be considered. Since treatment agents can be designed for use on a single occasion, on repeated occasions as needed, or continuously, durability of response should not be required as a component in the primary end point of the initial trials, although follow-up trials may be needed in order to define the optimal conditions of use and the associated risks and benefits, and sustained response may be essential for optimal clinical benefit.
acute graft-versus-host disease; clinical trials; endpoints; guidelines