The Effect of Chronic Kidney Disease on a Physical Activity Intervention: Impact on Physical Function, Adherence, and Safety.

BACKGROUND: Because chronic kidney disease (CKD) is associated with muscle wasting, older adults with CKD are likely to have physical function deficits. Physical activity can improve these deficits, but whether CKD attenuates the benefits is unknown. Our objective was to determine if CKD modified the effect of a physical activity intervention in older adults. METHODS: This is an exploratory analysis of the LIFE-P study, which compared a 12-month physical activity program (PA) to a successful aging education program (SA) in older adults. CKD was defined as a baseline eGFR < 60 mL/min/1.73 m2. We examined the Short Physical Performance Battery (SPPB) at baseline, 6 and 12 months. Secondary outcomes included serious adverse events (SAE) and adherence to intervention frequency. Linear mixed models were adjusted for age, sex, diabetes, hypertension, CKD, intervention, site, visit, baseline SPPB, and interactions of intervention and visit and of intervention, visit, and baseline CKD. RESULTS: The sample included 368 participants. CKD was present in 105 (28.5%) participants with a mean eGFR of 49.2 ± 8.1 mL/min/1.73 m2. Mean SPPB was 7.38 ± 1.41 in CKD participants; 7.59 ± 1.44 in those without CKD (p = 0.20). For CKD participants in PA, 12-month SPPBs increased to 8.90 (95% CI 8.32, 9.47), while PA participants without CKD increased to 8.40 (95% CI 8.01, 8.79, p = 0.43). For CKD participants in SA, 12-month SPPBs increased to 7.67 (95% CI 7.07, 8.27), while participants without CKD increased to 8.12 (95% CI 7.72, 8.52, p = 0.86). Interaction between CKD and intervention was non-significant (p = 0.88). Number and type of SAEs were not different between CKD and non-CKD participants (all p > 0.05). In PA, adherence for CKD participants was 65.5 ± 25.4%, while for those without CKD was 74.0 ± 22.2% (p = 0.12). CONCLUSION: Despite lower adherence, older adults with CKD likely derive clinically meaningful benefits from physical activity with no apparent impact on safety, compared to those without CKD.

Two-year weight-loss maintenance in primary care-based Diabetes Prevention Program lifestyle interventions.

OBJECTIVE: To investigate whether the effects on weight loss and cardiometabolic risk factor reduction of two technology-mediated lifestyle interventions for 15 months in a primary care-based translation trial sustained at 24 months (that is, 9 months after the end of intervention). DESIGN: This study analyzed data from an extended follow-up of participants in the original 'E-LITE' (Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care)-randomized controlled trial, which demonstrated the effectiveness of two adapted Diabetes Prevention Program (DPP) lifestyle interventions compared with usual primary care. SUBJECTS: E-LITE randomized 241 overweight or obese participants with pre-diabetes and/or metabolic syndrome to receive usual care alone (n=81) or usual care plus a coach-led (n=79) or self-directed intervention (n=81). The interventions provided coach-led group behavioral weight-loss treatment or a take-home, self-directed DVD using the same 12-week curriculum, followed by 12 additional months of technology-mediated coach contact and self-monitoring support. Participants received no further intervention after month 15. A blinded assessor conducted 24-month visits by following the measurement protocols of the original trial. Measurements include weight and cardiometabolic risk factors (waist circumference, fasting plasma glucose, resting blood pressure, triglycerides, high- and low-density lipoprotein cholesterol, total cholesterol and triglyceride to high-density lipoprotein cholesterol ratio). RESULTS: At month 24, mean±s.e. changes in body mass index (trial primary outcome) and weight (kg) from baseline were -1.9±0.3 (P=0.001) and -5.4±0.9 (P<0.001) in the coach-led intervention, and -1.6±0.3 (P=0.03) and -4.5±0.9 (P=0.001) in the self-directed intervention, compared with -0.9±0.3 and 2.4±0.9 in the usual care group. In addition, both interventions led to a greater percentage of participants maintaining 7% weight loss and sustained improvements in waist circumference and fasting plasma glucose levels than usual care. CONCLUSION: This study shows sustained benefits of the two primary care-based, technology-mediated DPP lifestyle interventions. The findings warrant replication in long-term studies involving diverse populations.

Consensus and contention regarding redundant publications in clinical research: cross-sectional survey of editors and authors.

OBJECTIVES: To examine the perspectives of journal editors and authors on overlapping and redundant publications in clinical research. DESIGN: Pretested cross-sectional survey, containing both forced choice and open ended questions, administered by mail to the senior editors (N=99) and one randomly selected author (N=99) from all journals in the Abridged Index Medicus (1996) that published clinical research. MAIN MEASUREMENTS: The views of editors and authors about the extent of redundant publications, why they occur, how to prevent and respond to cases, and when the publication of overlapping manuscripts is justified. RESULTS: Seventy two per cent (N=71) of editors and 65% (N=64) of authors completed the survey. There was consensus between both groups that redundant publications occur because authors feel the pressure to publish and journals do not do enough to publicise, criticise, and punish cases, and that the publication of most types of overlapping articles is unacceptable. Sixty seven per cent of authors but only 31% of editors felt, however, that it was justified to publish an overlapping article in a non-peer reviewed symposium supplement, and 68% of editors but 39% of authors supported imposing restrictions on guilty authors' future submissions. In written comments, 15% to 30% of both groups emphasised that it was justified to publish overlapping articles when there were different or non-English-speaking audiences, new data, strengthened methods, or disputed findings. CONCLUSIONS: Editors, authors, and other academic leaders should together develop explicit guidelines that clarify points of contention and ambiguity regarding overlapping manuscripts.

Disclosure of researcher contributions: a study of original research articles in The Lancet.

BACKGROUND: Authorship disputes and abuses have increased in recent years. In response to a proposal that researcher contributions be specified for readers, The Lancet began disclosing such contributions at the end of original articles. OBJECTIVE: To analyze the descriptions researchers use for their contributions and to determine how the order of names on the byline corresponds to these contributions, whether persons listed on the byline fulfill a lenient version of the criteria for authorship specified by the International Committee of Medical Journal Editors (the Vancouver Group), and whether the contributions of persons listed as contributors overlap with the contributions of those who are acknowledged. DESIGN: Descriptive study. MEASUREMENTS: A taxonomy of researchers' contributions was developed and applied to researchers' self-reported contributions to original research articles published in The Lancet from July to December 1997. RESULTS: Contributors lists occupied little page space (mean, 2.5 cm of column length). Placement on the byline did not indicate the specific category of task performed, although the first-contributor position corresponded to a significantly greater number of contributions (mean numbers of contributions: first-contributor position, 3.23; second-contributor position, 2.51; third-contributor position, 2.20; and fourth-contributor position, 2.51) (P < 0.01). Forty-four percent of contributors on the byline did not fulfill a lenient version of the Vancouver Group's criteria for authorship. Sixty percent of the most common categories of activities described on contributors lists overlapped with those on acknowledgements lists. CONCLUSIONS: Publication of lists that specify contributions to research articles is feasible and seems to impart important information. The criteria for authorship outlined by the Vancouver Group do not seem to be congruent with the self-identified contributions of researchers.

When authorship fails. A proposal to make contributors accountable.

A published article is the primary means whereby new work is communicated, priority is established, and academic promotion is determined. Publication depends on trust and requires that authors be held to standards of honesty, completeness, and fairness in their reporting, and to accountability for their statements. The system of authorship, while appropriate for articles with only 1 author, has become inappropriate as the average number of authors of an article has increased; as the work of coauthors has become more specialized and relationships between them have become more complex; and as both credit and, even more, responsibility have become obscured and diluted. Credit and accountability cannot be assessed unless the contributions of those named as authors are disclosed to readers, so the system is flawed. We argue for a radical conceptual and systematic change, to reflect the realities of multiple authorship and to buttress accountability. We propose dropping the outmoded notion of author in favor of the more useful and realistic one of contributor. This requires disclosure to readers of the contributions made to the research and to the manuscript by the contributors, so that they can accept both credit and responsibility. In addition, certain named contributors take on the role of guarantor for the integrity of the entire work. The requirement that all participants be named as contributors will eliminate the artificial distinction between authors and acknowledgees and will enhance the integrity of publication.