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\u00a9 2019 The Authors Health Expectations published by John Wiley & Sons Ltd Background: Showing how engagement adds value for all stakeholders can be an effective motivator for broader implementation of patient engagement. However, it is unclear what methods can best be used to evaluate patient engagement. This paper is focused on ways to evaluate patient engagement at three decision-making points in the medicines research and development process: research priority setting, clinical trial design and early dialogues with regulators and health technology assessment bodies. Objective: Our aim was to review the literature on monitoring and evaluation of patient engagement, with a focus on indicators and methods. Search strategy and inclusion criteria: We undertook a scoping literature review using a systematic search, including academic and grey literature with a focus on evaluation approaches or outcomes associated with patient engagement. No date limits were applied other than a cut-off of publications after July 2018. Data extraction and synthesis: Data were extracted from 91 publications, coded and thematically analysed. Main results: A total of 18 benefits and 5 costs of patient engagement were identified, mapped with 28 possible indicators for their evaluation. Several quantitative and qualitative methods were found for the evaluation of benefits and costs of patient engagement. Discussion and conclusions: Currently available indicators and methods are of some use in measuring impact but are not sufficient to understand the pathway to impact, nor whether interaction between researchers and patients leads to change. We suggest that the impacts of patient engagement can best be determined not by applying single indicators, but a coherent set of measures.
\n \n\n \n \n\u00a9 2017, Copyright \u00a9 Taylor & Francis Group, LLC. The Physician Payments Sunshine Act (PPSA) requires health care product manufacturers to report to the federal government payments more than $10 to physicians. Bringing unprecedented transparency to medicine, PPSA holds great potential for enabling medical stakeholders to manage conflicts of interest (COI) and build patient trust\u2014crucial responsibilities of medical professionalism. The authors conducted six focus groups with 42 physicians in Chicago, IL, San Francisco, CA, and Washington, DC, to explore attitudes and experiences around PPSA. Participants valued the concept of transparency but were wary of the law's design and consequences. They downplayed PPSA's potential and felt it undermined public trust. Showing broad unawareness of COI, they dismissed the notion of industry influence and welcomed company \u201cperks.\u201d Misapprehensions may leave physicians unprepared to advance the opportunities PPSA holds for professionalism. The authors offer recommendations for government and medicine to improve physicians' and other stakeholders' understandings and use of the data.
\n \n\n \n \n\u00a9 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd Background: Despite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials. Objective: To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials. Design: A modified Delphi process including a two round online survey and a stakeholder consensus meeting. Participants: In total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty-seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting. Results: Round 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants. Conclusions: The prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste.
\n \n\n \n \n\u00a9 2020 Elsevier Ltd Background: Failure to report the results of a clinical trial can distort the evidence base for clinical practice, breaches researchers' ethical obligations to participants, and represents an important source of research waste. The Food and Drug Administration Amendments Act (FDAAA) of 2007 now requires sponsors of applicable trials to report their results directly onto ClinicalTrials.gov within 1 year of completion. The first trials covered by the Final Rule of this act became due to report results in January, 2018. In this cohort study, we set out to assess compliance. Methods: We downloaded data for all registered trials on ClinicalTrials.gov each month from March, 2018, to September, 2019. All cross-sectional analyses in this manuscript were performed on data extracted from ClinicalTrials.gov on Sept 16, 2019; monthly trends analysis used archived data closest to the 15th day of each month from March, 2018, to September, 2019. Our study cohort included all applicable trials due to report results under FDAAA. We excluded all non-applicable trials, those not yet due to report, and those given a certificate allowing for delayed reporting. A trial was considered reported if results had been submitted and were either publicly available, or undergoing quality control review at ClinicalTrials.gov. A trial was considered compliant if these results were submitted within 1 year of the primary completion date, as required by the legislation. We described compliance with the FDAAA 2007 Final Rule, assessed trial characteristics associated with results reporting using logistic regression models, described sponsor-level reporting, examined trends in reporting, and described time-to-report using the Kaplan-Meier method. Findings: 4209 trials were due to report results; 1722 (40\u00b79%; 95% CI 39\u00b74\u201342\u00b72) did so within the 1-year deadline. 2686 (63\u00b78%; 62\u00b74\u201365\u00b73) trials had results submitted at any time. Compliance has not improved since July, 2018. Industry sponsors were significantly more likely to be compliant than non-industry, non-US Government sponsors (odds ratio [OR] 3\u00b708 [95% CI 2\u00b752\u20133\u00b777]), and sponsors running large numbers of trials were significantly more likely to be compliant than smaller sponsors (OR 11\u00b784 [9\u00b736\u201314\u00b799]). The median delay from primary completion date to submission date was 424 days (95% CI 412\u2013435), 59 days higher than the legal reporting requirement of 1 year. Interpretation: Compliance with the FDAAA 2007 is poor, and not improving. To our knowledge, this is the first study to fully assess compliance with the Final Rule of the FDAAA 2007. Poor compliance is likely to reflect lack of enforcement by regulators. Effective enforcement and action from sponsors is needed; until then, open public audit of compliance for each individual sponsor may help. We will maintain updated compliance data for each individual sponsor and trial at fdaaa.trialstracker.net. Funding: Laura and John Arnold Foundation.
\n \n\n \n \n\u00a9 2019, Springer Science+Business Media, LLC, part of Springer Nature. Introduction: Bariatric surgery\u2013induced weight loss may reduce resting energy expenditure (REE) and fat-free mass (FFM) disproportionately thereby predisposing patients to weight regain and sarcopenia. Methods: We compared REE and body composition of African-American and Caucasian Roux-en-Y gastric bypass (RYGB) patients after surgery with a group of non-operated controls (CON). REE by indirect calorimetry; skeletal muscle (SM), trunk organs, and brain volumes by MRI; and FFM by DXA were measured at post-surgery visits and compared with CON (N = 84) using linear regression models that adjusted for relevant covariates. Ns in RYGB were 50, 42, and 30 for anthropometry and 39, 27, 17 for MRI body composition at years 1, 2, and 5 after surgery, respectively. Results: Regression models adjusted for age, weight, height, ethnicity, and sex showed REE differences (RYGB minus CON; mean \u00b1 s.e.): year 1 (43.2 \u00b1 34 kcal/day, p = 0.20); year 2 (\u2212 27.9 \u00b1 37.3 kcal/day, p = 0.46); year 5 (114.6 \u00b1 42.3 kcal/day, p = 0.008). Analysis of FFM components showed that RYGB had greater trunk organ mass (~ 0.4 kg) and less SM (~ 1.34 kg) than CON at each visit. REE models adjusted for FFM, SM, trunk organs, and brain mass showed no between-group differences in REE (\u2212 15.9 \u00b1 54.8 kcal/day, p = 0.8; \u2212 46.9 \u00b1 64.9 kcal/day, p = 0.47; 47.7 \u00b1 83.0 kcal/day, p = 0.57, at years 1, 2, and 5, respectively). Conclusions: Post bariatric surgery patients maintain a larger mass of high\u2013metabolic rate trunk organs than non-operated controls of similar anthropometrics. Interpreting REE changes after weight loss requires an accurate understanding of fat-free mass composition at both the organ and tissue levels. Clinical Trial Registration: Long-term Effects of Bariatric Surgery (LABS-2) NCT00465829.
\n \n\n \n \nBackground: Recruitment to paediatric palliative care research is challenging, with high rates of non-invitation of eligible families by clinicians. The impact on sample characteristics is unknown. Aim: To investigate, using mixed methods, non-invitation of eligible families and ensuing selection bias in an interview study about parents experiences of advance care planning (ACP). Design: We examined differences between eligible families invited and not invited to participate by clinicians using (1) field notes of discussions with clinicians during the invitation phase and (2) anonymised information from the services clinical database. Setting: Families were eligible for the ACP study if their child was receiving care from a UK-based tertiary palliative care service (Group A; N = 519) or had died 610 months previously having received care from the service (Group B; N = 73). Results: Rates of non-invitation to the ACP study were high. A total of 28 (5.4%) Group A families and 21 (28.8%) Group B families (\u03c1 < 0.0005) were invited. Familyclinician relationship appeared to be a key factor associated qualitatively with invitation in both groups. In Group A, out-of-hours contact with family was statistically associated with invitation (adjusted odds ratio 5.46 (95% confidence interval 2.1314.00); \u03c1 < 0.0005). Qualitative findings also indicated that clinicians perceptions of families wellbeing, circumstances, characteristics, engagement with clinicians and anticipated reaction to invitation influenced invitation. Conclusion: We found evidence of selective invitation practices that could bias research findings. Non-invitation and selection bias should be considered, assessed and reported in palliative care studies.
\n \n\n \n \n\u00a9 2018 Article author(s). Objective We set out to document how NHS trusts in the UK record and share disclosures of conflict of interest by their employees. Design Cross-sectional study of responses to a Freedom of Information Act request for Gifts and Hospitality Registers. Setting NHS Trusts (secondary/tertiary care organisations) in England. Participants 236 Trusts were contacted, of which 217 responded. Main outcome measures We assessed all disclosures for completeness and openness, scoring them for achieving each of five measures of transparency. Results 185 Trusts (78%) provided a register. 71 Trusts did not respond within the 28 day time limit required by the FoIA. Most COI registers were incomplete by design, and did not contain the information necessary to assess conflicts of interest. 126/185 (68%) did not record the names of recipients. 47/185 (25%) did not record the cash value of the gift or hospitality. Only 31/185 registers (16%) contained the names of recipients, the names of donors, and the cash amounts received. 18/185 (10%) contained none of: Recipient name, donor name, and cash amount. Only 15 Trusts had their disclosure register publicly available online (6%). We generated a transparency index assessing whether each Trust met the following criteria: Responded on time; provided a register; had a register with fields identifying donor, recipient, and cash amount; provided a register in a format that allowed further analysis; and had their register publicly available online. Mean attainment was 1.9/5; no NHS trust met all five criteria. Conclusion Overall, recording of employees' conflicts of interest by NHS trusts is poor. None of the NHS Trusts in England met all transparency criteria. 19 did not respond to our FoIA requests, 51 did not provide a Gifts and Hospitality Register and only 31 of the registers provided contained enough information to assess employees' conflicts of interest. Despite obligations on healthcare professionals to disclose conflicts of interest, and on organisations to record these, the current system for logging and tracking such disclosures is not functioning adequately. We propose a simple national template for reporting conflicts of interest, modelled on the US 'Sunshine Act'.
\n \n\n \n \n\u00a9 2018 John Wiley & Sons, Ltd. Nosology is the science of defining and classifying diseases. Meta-nosology is the study of how we do this, on what principles nosological practices are based, the quality of the resulting medical taxonomy, and primarily whether/how diseases can be defined better than they are now. In modern Western medicine, there are a wide variety of ways in which diseases are defined and categorized. Examples include by the symptoms they present with (syndromic), their underlying causes (etiological), the biological mechanisms involved (pathogenetic), available treatments, historical precedent, and through diagnostic exclusion. Here, I explore the hypothesis that how we define diseases has an impact on how (and how effectively) we research and treat them. I explore the philosophical implications of this thesis and suggest a direction that the underlying metaphysics of disease definition might follow. I conclude that further research is warranted into whether our current disease definitions could be improved upon.
\n \n\n \n \n\u00a9 Published by the BMJ Publishing Group Limited. Objective To test the effectiveness and safety of a total diet replacement (TDR) programme for routine treatment of obesity in a primary care setting. Design Pragmatic, two arm, parallel group, open label, individually randomised controlled trial. Setting 10 primary care practices in Oxfordshire, UK. Participants 278 adults who were obese and seeking support to lose weight: 138 were assigned to the TDR programme and 140 to usual care. 73% of participants were re-measured at 12 months. Interventions The TDR programme comprised weekly behavioural support for 12 weeks and monthly support for three months, with formula food products providing 810 kcal/day (3389 kJ/day) as the sole food during the first eight weeks followed by reintroduction of food. Usual care comprised behavioural support for weight loss from a practice nurse and a diet programme with modest energy restriction. Main outcome measures The primary outcome was weight change at 12 months analysed as intention to treat with mixed effects models. Secondary outcomes included biomarkers of cardiovascular and metabolic risk. Adverse events were recorded. Results Participants in the TDR group lost more weight (-10.7 kg) than those in the usual care group (-3.1 kg): adjusted mean difference -7.2 kg (95% confidence interval -9.4 to -4.9 kg). 45% of participants in the TDR group and 15% in the usual care group experienced weight losses of 10% or more. The TDR group showed greater improvements in biomarkers of cardiovascular and metabolic risk than the usual care group. 11% of participants in the TDR group and 12% in the usual care group experienced adverse events of moderate or greater severity. Conclusions Compared with regular weight loss support from a practice nurse, a programme of weekly behavioural support and total diet replacement providing 810 kcal/day seems to be tolerable, and leads to substantially greater weight loss and greater improvements in the risk of cardiometabolic disease. Trial registration International Standard Randomised Controlled Trials No ISRCTN75092026.
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