Examining the use of process evaluations of randomised controlled trials of complex interventions addressing chronic disease in primary health care-a systematic review protocol

© 2016 The Author(s). Background: Randomised controlled trials (RCTs) of complex interventions in primary health care (PHC) are needed to provide evidence-based programmes to achieve the Declaration of Alma Ata goal of making PHC equitable, accessible and universal and to effectively address the rising burden from chronic disease. Process evaluations of these RCTs can provide insight into the causal mechanisms of complex interventions, the contextual factors, and inform as to whether an intervention is ineffective due to implementation failure or failure of the intervention itself. To build on this emerging body of work, we aim to consolidate the methodology and methods from process evaluations of complex interventions in PHC and their findings of facilitators and barriers to intervention implementation in this important area of health service delivery. Methods: Systematic review of process evaluations of randomised controlled trials of complex interventions which address prevalent major chronic diseases in PHC settings. Published process evaluations of RCTs will be identified through database and clinical trial registry searches and contact with authors. Data from each study will be extracted by two reviewers using standardised forms. Data extracted include descriptive items about (1) the RCT, (2) about the process evaluations (such as methods, theories, risk of bias, analysis of process and outcome data, strengths and limitations) and (3) any stated barriers and facilitators to conducting complex interventions. A narrative synthesis of the findings will be presented. Discussion: Process evaluation findings are valuable in determining whether a complex intervention should be scaled up or modified for other contexts. Publishing this protocol serves to encourage transparency in the reporting of our synthesis of current literature on how process evaluations have been conducted thus far and a deeper understanding of potential challenges and solutions to aid in the implementation of effective interventions in PHC beyond the research setting. Systematic review registration: PROSPERO CRD42016035572

Interstitial lung disease and specialist palliative care access: a healthcare professionals survey

Background Fibrotic interstitial lung disease is an incurable disease with poor prognosis. We aimed to understand factors affecting decisions regarding referrals to specialist palliative care services and to address barriers and facilitators to referrals from healthcare professionals’ perspectives. Methods A survey study of healthcare professionals, including respiratory physicians, interstitial lung disease nurse specialists, respiratory nurse specialists and palliative care physicians, was conducted using a questionnaire, entailing 17 questions. Results Thirty-six respondents, including 15 interstitial lung disease nurse specialists completed the questionnaire. Symptom control, psychological/spiritual support, general deterioration and end-of-life care were the most common reasons for referrals to specialist palliative care services. Most respondents felt confident in addressing palliative care needs and discussing palliative care with patients. A few participants emphasised that experienced respiratory nurse specialists are well placed to provide symptom management and to ensure continuity of patient care. Participants reported that access to palliative care could be improved by increasing collaborative work between respiratory and palliative care teams. Conclusions Most respondents felt that enhancing access to specialist palliative care services would benefit patients. However, palliative care and respiratory care should not be considered as mutually exclusive and multidisciplinary approach is recommended

Nintedanib for non-IPF progressive pulmonary fibrosis: 12-month outcome data from a real-world multicentre observational study

Background Nintedanib slows lung function decline for patients with non-idiopathic pulmonary fibrosis progressive pulmonary fibrosis (PPF) in clinical trials, but the real-world safety and efficacy are not known. Methods In this retrospective cohort study, standardised data were collected from patients in whom nintedanib was initiated for PPF between 2019 and 2020 through an early-access programme across eight centres in the United Kingdom. Rate of lung function change in the 12 months pre- and post-nintedanib initiation was the primary analysis. Symptoms, drug safety, tolerability and stratification by interstitial lung disease subtype and computed tomography pattern were secondary analyses. Results 126 patients were included; 67 (53%) females; mean±sd age 60±13 years. At initiation of nintedanib, mean forced vital capacity (FVC) was 1.87 L (58% predicted) and diffusing capacity of the lung for carbon monoxide (DLCO) was 32.7% predicted. 68% of patients were prescribed prednisolone (median dose 10 mg) and 69% were prescribed a steroid-sparing agent. In the 12 months after nintedanib initiation, lung function decline was significantly lower than in the preceding 12 months: FVC −88.8 mL versus −239.9 mL (p=0.004), and absolute decline in DLCO −2.1% versus −6.1% (p=0.004). Response to nintedanib was consistent in sensitivity and secondary analyses. 89 (71%) out of 126 patients reported side-effects, but 86 (80%) of the surviving 108 patients were still taking nintedanib at 12 months with patients reporting a reduced perception of symptom decline. There were no serious adverse events. Conclusion In PPF, the real-world efficacy of nintedanib replicated that of clinical trials, significantly attenuating lung function decline. Despite the severity of disease, nintedanib was safe and well tolerated in this real-world multicentre study

What information and the extent of information research participants need in informed consent forms: a multi-country survey

Background: The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research. Methods: This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important). Results: Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be \u27moderately important\u27 to \u27very important\u27 for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively). Conclusions: Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF

Geotechnical Engineering Properties of Incinerator Ash Mixes

The incineration of solid waste produces large quantities of bottom and fly ash. Landfilling has been the primary mode of disposal of these waste materials. Shortage in landfill space and the high cost of treatment have, however, prompted the search for alternative uses of these waste materials. This study presents an experimental program that was conducted to determine the engineering properties of incinerator ash mixes for use as construction materials. Incinerator ash mixes were tested as received and around optimum compacted conditions. Compaction curves, shear strength, and permeability values of fly ash, bottom ash, and their various blends were investigated. Bottom ash tends to achieve maximum dry density at much lower water content than does fly ash. The mixes displayed a change in their cohesion and friction angle values when one of the two mix components was altered or as a result of the addition of water. The permeability of bottom ash is quite comparable to that of sand. The permeability of fly ash lies in the range of those values obtained for silts and clays. A 100% bottom ash compacted at the optimum water content has a lower density value and yields a higher friction angle and cohesion values than most construction fills. This would encourage the use of bottom ash as a fill or embankment material because free drainage of water will prevent the buildup of pore water pressures

Uncertainty-Weighted Time Averaging of Mercury Vapour Concentrations in Ambient Air: Application to Measurements in the United Kingdom

Uncertainty-weighted time averaging of total gaseous mercury concentrations in ambient air, with associated robust uncertainties, has been performed for concentrations measured by the U.K. Heavy Metals Monitoring Network between 2007 and 2009. The results have been compared with averages produced using standard time-averaging methods with a view to investigating the properties of the new method and whether it represents an improvement over current practice

Geotechnical Engineering Properties of Incinerator Ash Mixes

The incineration of solid waste produces large quantities of bottom and fly ash. Landfilling has been the primary mode of disposal of these waste materials. Shortage in landfill space and the high cost of treatment have, however, prompted the search for alternative uses of these waste materials. This study presents an experimental program that was conducted to determine the engineering properties of incinerator ash mixes for use as construction materials. Incinerator ash mixes were tested as received and around optimum compacted conditions. Compaction curves, shear strength, and permeability values of fly ash, bottom ash, and their various blends were investigated. Bottom ash tends to achieve maximum dry density at much lower water content than does fly ash. The mixes displayed a change in their cohesion and friction angle values when one of the two mix components was altered or as a result of the addition of water. The permeability of bottom ash is quite comparable to that of sand. The permeability of fly ash lies in the range of those values obtained for silts and clays. A 100% bottom ash compacted at the optimum water content has a lower density value and yields a higher friction angle and cohesion values than most construction fills. This would encourage the use of bottom ash as a fill or embankment material because free drainage of water will prevent the buildup of pore water pressures