Assessing the transparency of informed consent in feasibility and pilot studies: a single-centre quality assurance study protocol

Introduction Pilot/feasibility studies assess the feasibility of conducting a larger study. Although researchers ought to communicate the feasibility objectives to their participants, many research ethics guidelines do not comment on how informed consent applies to pilot studies. It is unclear whether researchers and research ethics boards clearly communicate the purpose of pilot studies to participants consenting. The primary objective of this study is to assess whether pilot/feasibility studies submitted for ethics approval to a research ethics board transparently communicate the purpose of the study to participants through their informed consent practice. A highly transparent consent practice entails the consent documents communicate: (1) the term ‘pilot’ or ‘feasibility’ in the title; (2) the definition of a pilot/feasibility study; (3) the primary objectives of the study are to assess feasibility; (4) the specific feasibility objectives; and (5) the criteria for the study to successfully lead to the main study. The secondary objectives are to assess whether there is a difference between submitted and revised versions of the consent documents (revisions are made to obtain research ethics approval), to determine factors associated with transparent consent practices and to assess the consistency with which pilot and feasibility studies assess feasibility outcomes as their primary objectives. Methods and analysis This is a retrospective review of informed consent information for pilot/feasibility studies submitted to the Hamilton integrated Research Ethics Board, Canada. We will look at submitted and revised consent documents for pilot/feasibility studies submitted over a 14-year period. We will use descriptive statistics to summarise data, reporting results as percentages with 95% CIs, and conduct logistic regression to determine characteristics associated with transparent consent practices. Ethics and dissemination The study protocol was approved by the Hamilton integrated Research Ethics Board, and the results of this study will be submitted for publication in a peer-reviewed journal

Electronic correlation in the infrared optical properties of the quasi two dimensional κ\kappa-type BEDT-TTF dimer system

The polarized optical reflectance spectra of the quasi two dimensional organic correlated electron system $\kappa$-(BEDT-TTF)$_{2}$Cu[N(CN)$_{2}$]$Y$, $Y =$ Br and Cl are measured in the infrared region. The former shows the superconductivity at $T_{\rm c} \simeq$ 11.6 K and the latter does the antiferromagnetic insulator transition at $T_{\rm N} \simeq$ 28 K. Both the specific molecular vibration mode $\nu_{3}(a_{g})$ of the BEDT-TTF molecule and the optical conductivity hump in the mid-infrared region change correlatively at $T^{*} \simeq$ 38 K of $\kappa$-(BEDT-TTF)$_{2}$Cu[N(CN)$_{2}$]Br, although no indication of $T^{*}$ but the insulating behaviour below $T_{\rm ins} \simeq$ 50-60 K are found in $\kappa$-(BEDT-TTF)$_{2}$Cu[N(CN)$_{2}$]Cl. The results suggest that the electron-molecular vibration coupling on the $\nu_{3}(a_{g})$ mode becomes weak due to the enhancement of the itinerant nature of the carriers on the dimer of the BEDT-TTF molecules below $T^{*}$, while it does strong below $T_{\rm ins}$ because of the localized carriers on the dimer. These changes are in agreement with the reduction and the enhancement of the mid-infrared conductivity hump below $T^{*}$ and $T_{\rm ins}$, respectively, which originates from the transitions between the upper and lower Mott-Hubbard bands. The present observations demonstrate that two different metallic states of $\kappa$-(BEDT-TTF)$_{2}$Cu[N(CN)$_{2}$]Br are regarded as {\it a correlated good metal} below $T^{*}$ including the superconducting state and {\it a half filling bad metal} above $T^{*}$. In contrast the insulating state of $\kappa$-(BEDT-TTF)$_{2}$Cu[N(CN)$_{2}$]Cl below $T_{\rm ins}$ is the Mott insulator.Comment: 8 pages, 7 figure

Progression from external pilot to definitive randomised controlled trial : a methodological review of progression criteria reporting

Objectives: Prespecified progression criteria can inform the decision to progress from an external randomised pilot trial to a definitive randomised controlled trial. We assessed the characteristics of progression criteria reported in external randomised pilot trial protocols and results publications, including whether progression criteria were specified a priori and mentioned in prepublication peer reviewer reports. Study design: Methodological review. Methods: We searched four journals through PubMed: British Medical Journal Open, Pilot and Feasibility Studies, Trials and Public Library of Science One. Eligible publications reported external randomised pilot trial protocols or results, were published between January 2018 and December 2019 and reported progression criteria. We double data extracted 25% of the included publications. Here we report the progression criteria characteristics. Results: We included 160 publications (123 protocols and 37 completed trials). Recruitment and retention were the most frequent indicators contributing to progression criteria. Progression criteria were mostly reported as distinct thresholds (eg, achieving a specific target; 133/160, 83%). Less than a third of the planned and completed pilot trials that included qualitative research reported how these findings would contribute towards progression criteria (34/108, 31%). The publications seldom stated who established the progression criteria (12/160, 7.5%) or provided rationale or justification for progression criteria (44/160, 28%). Most completed pilot trials reported the intention to proceed to a definitive trial (30/37, 81%), but less than half strictly met all of their progression criteria (17/37, 46%). Prepublication peer reviewer reports were available for 153/160 publications (96%). Peer reviewer reports for 86/153 (56%) publications mentioned progression criteria, with peer reviewers of 35 publications commenting that progression criteria appeared not to be specified. Conclusions: Many external randomised pilot trial publications did not adequately report or propose prespecified progression criteria to inform whether to proceed to a future definitive randomised controlled trial

Transparency of informed consent in pilot and feasibility studies is inadequate: a single-center quality assurance study

Background Pilot and feasibility studies (PAFS) often have complex objectives aimed at assessing feasibility of conducting a larger study. These may not be clear to participants in pilot studies. Methods Here, we aimed to assess the transparency of informed consent in PAFS by investigating whether researchers communicate, through patient information leaflets and consent forms, key features of the studies. We collected this data from original versions of these documents submitted for ethics approval and the final approved documents for PAFS submitted to the Hamilton Integrated Research Ethics Board, Canada. Results One hundred eighty-four PAFS, submitted for ethics approval from 2004 to 2020, were included, and we found that of the approved consent documents which were provided to participants, 83.2% (153) stated the terms “pilot” or “feasibility” in their title, 12% (22) stated the definition of a pilot/feasibility study, 42.4% (78) of the studies stated their intent to assess feasibility, 19.6% (36) stated the specific feasibility objectives, 1.6% (3) stated the criteria for success of the pilot study, and 0.5% (1) stated all five of these criteria. After ethics review, a small increase in transparency occurred, ranging from 1.6 to 2.8% depending on the criteria. By extracting data from the protocols of the PAFS, we found that 73.9% (136) stated intent to assess feasibility, 71.2% (131) stated specific feasibility objectives, and 33.7% (62) stated criteria for success of the study to lead to a larger study. Conclusion The transparency of informed consent in PAFS is inadequate and needs to be specifically addressed by research ethics guidelines. Research ethics boards and researchers ought to be made aware and mindful of best practices of informed consent in the context of PAFS

Shop stewards’ leadership, left-wing activism and collective workplace union organisation

Providing an account of the dynamic interrelationship between shop steward leadership and membership interaction, Ralph Darlington focuses particular attention on the much-neglected crucial role that left-wing political activists can play in shaping the nature of collective workplace relations

Molecular composition of recycled organic wastes, as determined by solid-state ¹³C NMR and elemental analyses

Using solid state ¹³C NMR data and elemental composition in a molecular mixing model, we estimated the molecular components of the organic matter in 16 recycled organic (RO) wastes representative of the major materials generated in the Sydney basin area. Close correspondence was found between the measured NMR signal intensities and those predicted by the model for all RO wastes except for poultry manure char. Molecular nature of the organic matter differed widely between the RO wastes. As a proportion of organic C, carbohydrate C ranged from 0.07 to 0.63, protein C from <0.01 to 0.66, lignin C from <0.01 to 0.31, aliphatic C from 0.09 to 0.73, carbonyl C from 0.02 to 0.23, and char C from 0 to 0.45. This method is considered preferable to techniques involving imprecise extraction methods for RO wastes. Molecular composition data has great potential as a predictor of RO waste soil carbon and nutrient outcomes

Dry Season Rice Yield Responses to Nitrogen Fertilizer in Central Myanmar

Rice crop yields in central Myanmar are considered to be relatively low due to inadequate applications of fertilizer, and particularly of nitrogen (N). In this study, replicated field experiments were conducted at two sites, Taungoo and Yezin, in Central Myanmar to determine the crop yield responses to N fertilizer for dry season irrigated rice in 2017. The two field experiments were identical in design and conducted at the same time. The experiments had a randomized complete block design with 3 replicates of 8 treatments. The 8 treatments included 6 rates of N fertilizer (0, 30, 77.6, 100, 130, and 160 kg N/ha), applied as two split surface-broadcast applications at 10 days after transplant (10DAT) and at crop panicle initiation (PI) in accordance with local farmer practice. In addition a urea deep placement (UDP) treatment with placement of 2.7 g urea briquettes at IFDC-recommended spacing and soil depth at a N rate of 77.6 kg N/ha was included, as well as a nil input control. All treatments except for the nil input control received basal applications of P, K, S, and Zn. Mean grain yields at Taungoo ranged from 3.54 t/ha (0 kg N/ha) to 5.24 t/ha (160 kg N/ha) whilst at Yezin they ranged from 6.78 t/ha (0 kg N/ha) to 8.15 t/ha (130 kg N/ha). The Taungoo site may represent a typical low-fertility farm site whereas the Yezin site had a more fertile soil. The 77.6 kg N/ha application rate was found to result in a 33% increase (i.e. +1.18 t/ha) in grain yield (P<0.05) at the Taungoo site and a 12 % increase (i.e. + 0.84 t/ha) at the Yezin site (P<0.05) indicating benefits from this N fertilizer rate, depending on economic analysis. At the Taungoo site the UDP treatment (77.6 kg N/ha) produced yields consistently higher than the comparable 77.6 kg N/ha surface broadcast treatment, with a UDP mean yield of 5.23 vs 4.72 t/ha for surface broadcast. However, analysis of variance (ANOVA) found this not to be significant at P=0.05, with a t-test estimating P=0.054 for this comparison. This is sufficient to encourage further research on UDP in this environment. Yield response curves were derived for N fertilizer applications from the experimental data from the two experiment sites. The Taungoo site yield response curve for N was thought to be more applicable to the general soil fertility levels of rice farms in central Myanmar. This paper presents the first results from these experiments which will be expanded on as the full dataset including soil and plant analysis is obtained

A demographic analysis of first marriages in England and Wales 1950-1980

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