707 resultados para Study protocol


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Introduction Falls are the most frequent adverse event reported in hospitals. Approximately 30% of in-hospital falls lead to an injury and up to 2% result in a fracture. A large randomised trial found that a trained health professional providing individualised falls prevention education to older inpatients reduced falls in a cognitively intact subgroup. This study aims to investigate whether this efficacious intervention can reduce falls and be clinically useful and cost-effective when delivered in the real-life clinical environment. Methods A stepped-wedge cluster randomised trial will be used across eight subacute units (clusters) which will be randomised to one of four dates to start the intervention. Usual care on these units includes patient's screening, assessment and implementation of individualised falls prevention strategies, ongoing staff training and environmental strategies. Patients with better levels of cognition (Mini-Mental State Examination >23/30) will receive the individualised education from a trained health professional in addition to usual care while patient's feedback received during education sessions will be provided to unit staff. Unit staff will receive training to assist in intervention delivery and to enhance uptake of strategies by patients. Falls data will be collected by two methods: case note audit by research assistants and the hospital falls reporting system. Cluster-level data including patient's admissions, length of stay and diagnosis will be collected from hospital systems. Data will be analysed allowing for correlation of outcomes (clustering) within units. An economic analysis will be undertaken which includes an incremental cost-effectiveness analysis. Ethics and dissemination The study was approved by The University of Notre Dame Australia Human Research Ethics Committee and local hospital ethics committees. Results The results will be disseminated through local site networks, and future funding and delivery of falls prevention programmes within WA Health will be informed. Results will also be disseminated through peer-reviewed publications and medical conferences.

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Objective To evaluate the current management of over-the-counter (OTC) insomnia complaints in Australian community pharmacies using standardized patient methodology. Methods Trained standardized patients visited a sample of 100 randomly selected South East Queensland community pharmacies in June 2011. The standardized patients enacted two OTC insomnia scenarios: a direct product request (DPR) (n = 50) and a symptom-based request (SBR) (n = 50). Results of the interactions were documented immediately after each visit and evaluated using the Pharmaceutical Society of Australia's WHAT STOP GO protocol as a standard comparison. Key findings Of all DPRs, 30% were handled entirely by the pharmacist, 70% of staff enquired about specific symptoms and 28% investigated the cause of insomnia. No staff investigated the frequency of product use. The DPR scenario resulted in a 92% supply of the requested doxylamine product (Restavit). In the SBR scenario, 18% of requests were handled entirely by the pharmacist, 58% of staff enquired about specific symptoms and 44% investigated the cause of insomnia. Staff recommended medicated products (38%), or herbal (78%) or non-drug techniques (18%). Investigation into smoking and alcohol intake was not undertaken in DPR or SBR interactions, while questioning on caffeine intake was undertaken in 2 and 14% of cases respectively. There were no significant differences found in the handling of sleep requests by pharmacists compared to pharmacy assistants. Conclusion The standardized patient methodology was a successful way to assess the community pharmacy counselling provided with OTC sleep requests and suboptimal staff responses were found when compared with recommended practice standards.

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Background Preliminary research shows ginger may be an effective adjuvant treatment for chemotherapy-induced nausea and vomiting but significant limitations need to be addressed before recommendations for clinical practice can be made. Methods/Design In a double–blinded randomised-controlled trial, chemotherapy-naïve patients will be randomly allocated to receive either 1.2 g of a standardised ginger extract or placebo per day. The study medication will be administrated as an adjuvant treatment to standard anti-emetic therapy and will be divided into four capsules per day, to be consumed approximately every 4 hours (300 mg per capsule administered q.i.d) for five days during the first three cycles of chemotherapy. Acute, delayed, and anticipatory symptoms of nausea and vomiting will be assessed over this time frame using a valid and reliable questionnaire, with nausea symptoms being the primary outcome. Quality of life, nutritional status, adverse effects, patient adherence, cancer-related fatigue, and CINV-specific prognostic factors will also be assessed. Discussion Previous trials in this area have noted limitations. These include the inconsistent use of standardized ginger formulations and valid questionnaires, lack of control for anticipatory nausea and prognostic factors that may influence individual CINV response, and the use of suboptimal dosing regimens. This trial is the first to address these issues by incorporating multiple unique additions to the study design including controlling for CINV-specific prognostic factors by recruiting only chemotherapy-naïve patients, implementing a dosing schedule consistent with the pharmacokinetics of oral ginger supplements, and independently analysing ginger supplements before and after recruitment to ensure potency. Our trial will also be the first to assess the effect of ginger supplementation on cancer-related fatigue and nutritional status. Chemotherapy-induced nausea and vomiting are distressing symptoms experienced by oncology patients; this trial will address the significant limitations within the current literature and in doing so, will investigate the effect of ginger supplementation as an adjuvant treatment in modulating nausea and vomiting symptoms. Trial registration

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Aim To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Background Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Design Pragmatic randomized controlled trial at one site with 260 participants. Methods This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Discussion Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce.

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Thraustochytrids have become of considerable industrial and scientific interest in the past decade due to their health benefits. They have been proven to be the principle source in marine and estuarine fish diets with high percentage of long chain (LC) or polyunsaturated fatty acids (PUFA). Therefore, the oil extracted from fish for human document.forms[0].elements[13].select();consumption is rich in PUFA with high omega-3 fatty acid content. Docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) of all of the omega-3 fatty acids, are considered beneficial essential oils for humans with a wide range of health benefits. These include brain and neural development in infants, general wellbeing of adults and drug delivery through precursor molecules. They have become one of the most extensively studied organisms for industrial oil preparations as PUFA extraction from fish becomes less profitable. Many forms of these Thraustochytrid oils are being trialled for human consumption all over the world. In Australia, there has been little research performed on these organisms in the past ten years. A few Australian studies have been conducted in the form of comparative studies related to PUFA production within the related genera, but not focussed on their identification or cellular and genomic characterisation. Therefore, the main aim of this study was to investigate the morphological and genetic characteristics of Australian Thraustochytrids in order to aid in their identification and characterisation, as well as to better understand the effect of environmental conditions in the regulation of PUFA production. It was also noted that there was a knowledge gap in the preservation and total genomic DNA extraction of these organisms for the purposes of scientific research. The cryopreservation of these organisms for studies around the world follows existing generic methods. However, it is well understood that many of these generic methods attract not only high costs for chemicals, but also uses considerable storage space and other resources, all of which can be improved with new or modified approaches. In this context, a simple and inexpensive bead preservation method is described, without compromising the storage shelf life. We also describe, for the first time, the effects of culture age on the successful cryopreservation of Thraustochytrids. It was evident in the literature that DNA and RNA extractions for molecular and genetic studies of Thraustochytrids follow the classical phenol-chloroform extraction methods. It was also observed that modern protocols failed to avoid the use of phenol-chloroform rather than improving preparation and cell disruption. In order to provide a high quantity and quality DNA extraction, a modified protocol has been introduced that employs the use of modern commercial extraction kits and standard laboratory equipment. Thraustochytrids have been shown to be highly conserved in their 18S rDNA gene sequences, which is used as the current standard for identification. It was demonstrated that the 18S rDNA gene sequence limits the recognition of closely related genera or within the genera from each member. Therefore, it was proposed that another profile, such as a randomly amplified polymorphic DNA (RAPD) based profiling system, be tested for use in the characterisation of Thraustochytrids. The RAPD profiles were shown to provide a unique DNA fingerprint for each isolate and small variations in their genome were able to be detected. This method involved the use of a minimum number of standard arbitrary primers and with an increase in the number of different primers used, a very high discrimination between organisms could be achieved. However, the method was not suitable for taxonomic purposes because the results did not correlate with other taxonomic features such as morphology. Another knowledge gap was found with respect to Australian Thraustochytrid growth characteristics, in that these had not been recorded and published. In order to rectify this, a record of colony and microscopic features of 12 selected isolates was performed. The results of preliminary studies indicated that further microbiological and biochemical studies are needed for full characterisation of these organisms. This information is of great importance to bio-prospecting of new Thraustochytrids from Australian ecosystems and would allow for their accurate identification, and so permit the prediction of their PUFA capability by comparison with related genera/species. It was well recognized that environmental stress plays a role in the PUFA production and is mainly due to the reactive oxygen species as abiotic stress (Chiou et al., 2001; Okuyama et al., 2008; Shabala et al., 2009; Shabala et al., 2001). In this aspect, this study makes the first attempt towards better understanding of this phenomenon by way of the use of real-time PCR for the detection of environmental effects on the regulation of PUFA production. Three main environmental conditions including temperature, pH and oxygen availability were monitored as stress inducers. In summary, this study provides novel approaches for the preservation and handling of Thraustochytrids, their molecular biological features, taxonomy, characterisation and responses to environmental factors with respect to their oil production enzymes. The information produced from this study will prove to be vital for both industrial and scientific investigations in the future.

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Use of the hand is vital in working life due to the grabbing and pinching it performs. Spherical grip is the most commonly used, due to similarity to the gripping of a computer mouse. Knowledge of its execution and the involved elements is essential. Analysis of this exertion with surface electromyography devices (to register muscular activity) and accelerometer devices (to register movement values ) can provide multiple variables. Six subjects performed ball gripping and registered real-time electromyography (thenar region, hypothenar region, first dorsal interosseous, flexors of the wrist, flexor carpi ulnaris and extensors of the wrist muscles) and accelerometer (thumb, index, middle, ring, pinky and palm) values. The obtained data was resampled “R software” and processed “Matlab Script” based on an automatic numerical sequence recognition program. Electromyography values were normalized on the basis of maximum voluntary contraction, whilst modular values were calculated for the acceleration vector. After processing and analysing the obtained data and signal, it was possible to identify five stages of movement in accordance with the module vector from the palm. The statistical analysis of the variables was descriptive: average and standard deviations. The outcome variables focus on the variations of the modules of the vector (between the maximum and minimum values of each module and phase) and the maximum values of the standardized electromyography of each muscle. Analysis of movement through accelerometer and electromyography variables can give us an insight into the operation of spherical grip. The protocol and treatment data can be used as a system to complement existing assessments in the hand.

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• Premise of the study: Here we propose a staining protocol using TBO and Ruthenium red in order to reliably identify secondary compounds in the leaves of some species of Myrtaceae. • Methods and results: Leaves of 10 species representing 10 different genera of Myrtaceae were processed and stained using five different combinations of Ruthenium red and TBO. Optimal staining conditions were determined as 1 min of Ruthenium red (0.05% aqueous) and 45 sec of TBO (0.1% aqueous). Secondary compounds clearly identified under this treatment include mucilage in mesophyll, polyphenols in cuticle, lignin in fibers and xylem, tannins and carboxylated polysaccharides in epidermis and pectic substances in primary cell walls. • Conclusions: Potential applications of this protocol include systematic, phytochemical and ecological investigations in Myrtaceae. It might be applicable to other plant families rich in secondary compounds and could be used as preliminary screening method for extraction of these elements.

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Background: Exercise and adequate self-management capacity may be important strategies in the management of venous leg ulcers. However, it remains unclear if exercise improves the healing rates of venous leg ulcers and if a self-management exercise program based on self-efficacy theory is well adhered to. Method/Design: This is a randomised controlled in adults with venous leg ulcers to determine the effectiveness of a self-efficacy based exercise intervention. Participants with venous leg ulcers are recruited from 3 clinical sites in Australia. After collection of baseline data, participants are randomised to either an intervention group or control group. The control group receive usual care, as recommended by evidence based guidelines. The intervention group receive an individualised program of calf muscle exercises and walking. The twelve week exercise program integrates multiple elements, including up to six telephone delivered behavioural coaching and goal setting sessions, supported by written materials, a pedometer and two follow-up booster calls if required. Participants are encouraged to seek social support among their friends, self-monitor their weekly steps and lower limb exercises. The control group are supported by a generic information sheet that the intervention group also receive encouraging lower limb exercises, a pedometer for self-management and phone calls at the same time points as the intervention group. The primary outcome is the healing rates of venous leg ulcers which are assessed at fortnightly clinic appointments. Secondary outcomes, assessed at baseline and 12 weeks: functional ability (range of ankle motion and Tinetti gait and balance score), quality of life and self-management scores. Discussion: This study seeks to address a significant gap in current wound management practice by providing evidence for the effectiveness of a home-based exercise program for adults with venous leg ulcers. Theory-driven, evidence-based strategies that can improve an individual’s exercise self-efficacy and self-management capacity could have a significant impact in improving the management of people with venous leg ulcers. Information gained from this study will provide much needed information on management of this chronic disease to promote health and independence in this population. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12612000475842 Trial status: Current follow up

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PURPOSE The purposes of this study were to: 1) establish inter-instrument reliability between left and right hip accelerometer placement; 2) examine procedural reliability of a walking protocol used to measure physical activity (PA), and; 3) confirm concurrent validity of accelerometers in measuring PA intensity as compared to the gold standard of oxygen consumption measured by indirect calorimetry. METHODS Eight children (mean age: 11.9; SD: 3.2, 75% male) with CP (GMFCS levels I-III) wore ActiGraph GT3X accelerometers on each hip and the Cosmed K4b^{2} portable indirect calorimeter during two measurement sessions in which they performed the six minute walk test (6MWT) at three self-selected speeds (comfortable/slow, brisk, fast). Oxygen consumption (VO2) and accelerometer step and activity count data were recorded. RESULTS Inter-instrument reliability of ActiGraph GT3X accelerometers placed on left and right hips was excellent (ICC=0.96-0.99, CI_{95}: 0.81-0.99). Reproducibility of the protocol was good/excellent (ICC=0.75-0.95, CI_{95}: 0.75-0.98). Concurrent validity of accelerometer count data and VO2 was fair/good (rho=0.67, p< 0.001). The correlation between step count and VO2 was not significant (rho=0.29, p=0.2). CONCLUSION This preliminary research suggests that ActiGraph GT3X accelerometers are reliable and valid devices to monitor PA during walking in children with CP and may be appropriate in rehabilitation research and clinical practice. ActiGraph GTX3 step counts were not valid for this sample and further research is warranted.

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Aim Large-scale patterns linking energy availability, biological productivity and diversity form a central focus of ecology. Despite evidence that the activity and abundance of animals may be limited by climatic variables associated with regional biological productivity (e.g. mean annual precipitation and annual actual evapotranspiration), it is unclear whether plant–granivore interactions are themselves influenced by these climatic factors across broad spatial extents. We evaluated whether climatic conditions that are known to alter the abundance and activity of granivorous animals also affect rates of seed removal. Location Eleven sites across temperate North America. Methods We used a common protocol to assess the removal of the same seed species (Avena sativa) over a 2-day period. Model selection via the Akaike information criterion was used to determine a set of candidate binomial generalized linear mixed models that evaluated the relationship between local climatic data and post-dispersal seed predation. Results Annual actual evapotranspiration was the single best predictor of the proportion of seeds removed. Annual actual evapotranspiration and mean annual precipitation were both positively related to mean seed removal and were included in four and three of the top five models, respectively. Annual temperature range was also positively related to seed removal and was an explanatory variable in three of the top four models. Main conclusions Our work provides the first evidence that energy and precipitation, which are known to affect consumer abundance and activity, also translate to strong, predictable patterns of seed predation across a continent. More generally, these findings suggest that future changes in temperature and precipitation could have widespread consequences for plant species composition in grasslands, through impacts on plant recruitment.

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Background Despite the widely recognised importance of sustainable health care systems, health services research remains generally underfunded in Australia. The Australian Centre for Health Services Innovation (AusHSI) is funding health services research in the state of Queensland. AusHSI has developed a streamlined protocol for applying and awarding funding using a short proposal and accelerated peer review. Method An observational study of proposals for four health services research funding rounds from May 2012 to November 2013. A short proposal of less than 1,200 words was submitted using a secure web-based portal. The primary outcome measures are: time spent preparing proposals; a simplified scoring of grant proposals (reject, revise or accept for interview) by a scientific review committee; and progressing from submission to funding outcomes within eight weeks. Proposals outside of health services research were deemed ineligible. Results There were 228 eligible proposals across 4 funding rounds: from 29% to 79% were shortlisted and 9% to 32% were accepted for interview. Success rates increased from 6% (in 2012) to 16% (in 2013) of eligible proposals. Applicants were notified of the outcomes within two weeks from the interview; which was a maximum of eight weeks after the submission deadline. Applicants spent 7 days on average preparing their proposal. Applicants with a ranking of reject or revise received written feedback and suggested improvements for their proposals, and resubmissions composed one third of the 2013 rounds. Conclusions The AusHSI funding scheme is a streamlined application process that has simplified the process of allocating health services research funding for both applicants and peer reviewers. The AusHSI process has minimised the time from submission to notification of funding outcomes.

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There is an increasing need in biology and clinical medicine to robustly and reliably measure tens-to-hundreds of peptides and proteins in clinical and biological samples with high sensitivity, specificity, reproducibility and repeatability. Previously, we demonstrated that LC-MRM-MS with isotope dilution has suitable performance for quantitative measurements of small numbers of relatively abundant proteins in human plasma, and that the resulting assays can be transferred across laboratories while maintaining high reproducibility and quantitative precision. Here we significantly extend that earlier work, demonstrating that 11 laboratories using 14 LC-MS systems can develop, determine analytical figures of merit, and apply highly multiplexed MRM-MS assays targeting 125 peptides derived from 27 cancer-relevant proteins and 7 control proteins to precisely and reproducibly measure the analytes in human plasma. To ensure consistent generation of high quality data we incorporated a system suitability protocol (SSP) into our experimental design. The SSP enabled real-time monitoring of LC-MRM-MS performance during assay development and implementation, facilitating early detection and correction of chromatographic and instrumental problems. Low to sub-nanogram/mL sensitivity for proteins in plasma was achieved by one-step immunoaffinity depletion of 14 abundant plasma proteins prior to analysis. Median intra- and inter-laboratory reproducibility was <20%, sufficient for most biological studies and candidate protein biomarker verification. Digestion recovery of peptides was assessed and quantitative accuracy improved using heavy isotope labeled versions of the proteins as internal standards. Using the highly multiplexed assay, participating laboratories were able to precisely and reproducibly determine the levels of a series of analytes in blinded samples used to simulate an inter-laboratory clinical study of patient samples. Our study further establishes that LC-MRM-MS using stable isotope dilution, with appropriate attention to analytical validation and appropriate quality c`ontrol measures, enables sensitive, specific, reproducible and quantitative measurements of proteins and peptides in complex biological matrices such as plasma.

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Background Procedural sedation and analgesia (PSA) is used to attenuate the pain and distress that may otherwise be experienced during diagnostic and interventional medical or dental procedures. As the risk of adverse events increases with the depth of sedation induced, frequent monitoring of level of consciousness is recommended. Level of consciousness is usually monitored during PSA with clinical observation. Processed electroencephalogram-based depth of anaesthesia (DoA) monitoring devices provide an alternative method to monitor level of consciousness that can be used in addition to clinical observation. However, there is uncertainty as to whether their routine use in PSA would be justified. Rigorous evaluation of the clinical benefits of DoA monitors during PSA, including comprehensive syntheses of the available evidence, is therefore required. One potential clinical benefit of using DoA monitoring during PSA is that the technology could improve patient safety by reducing sedation-related adverse events, such as death or permanent neurological disability. We hypothesise that earlier identification of lapses into deeper than intended levels of sedation using DoA monitoring leads to more effective titration of sedative and analgesic medications, and results in a reduction in the risk of adverse events caused by the consequences of over-sedation, such as hypoxaemia. The primary objective of this review is to determine whether using DoA monitoring during PSA in the hospital setting improves patient safety by reducing the risk of hypoxaemia (defined as an arterial partial pressure of oxygen below 60 mmHg or percentage of haemoglobin that is saturated with oxygen [SpO2] less than 90 %). Other potential clinical benefits of using DoA monitoring devices during sedation will be assessed as secondary outcomes. Methods/design Electronic databases will be systematically searched for randomized controlled trials comparing the use of depth of anaesthesia monitoring devices with clinical observation of level of consciousness during PSA. Language restrictions will not be imposed. Screening, study selection and data extraction will be performed by two independent reviewers. Disagreements will be resolved by discussion. Meta-analyses will be performed if suitable. Discussion This review will synthesise the evidence on an important potential clinical benefit of DoA monitoring during PSA within hospital settings.

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Background After being discharged from hospital following the acute management of a fragility fracture, older adults may re-present to hospital emergency departments in the post-discharge period. Early re-presentation to hospital, which includes hospital readmissions, and emergency department presentations without admission, may be considered undesirable for individuals, hospital institutions and society. The identification of modifiable risk factors for hospital re-representation following initial fracture management may prove useful for informing policy or practice initiatives that seek to minimise the need for older adults to re-present to hospital early after they have been discharged from their initial inpatient care. The purpose of this systematic review is to identify correlates of hospital re-presentation in older patients who have been discharged from hospital following clinical management of fragility fractures. Methods/Design The review will follow the PRISMA-P reporting guidelines for systematic reviews. Four electronic databases (Pubmed, CINAHL, Embase, and Scopus) will be searched. A suite of search terms will identify peer-reviewed articles that have examined the correlates of hospital re-presentation in older adults (mean age of 65 years or older) who have been discharged from hospital following treatment for fragility fractures. The Effective Public Health Practice Project Quality Assessment Tool for Quantitative Studies will be used to assess the quality of the studies. The strength of evidence will be assessed through best evidence synthesis. Clinical and methodological heterogeneity across studies are likely to impede meta-analyses. Discussion The best evidence synthesis will outline correlates of hospital re-presentations in this clinical group. This synthesis will take into account potential risks of bias for each study, while permitting inclusion of findings from a range of quantitative study designs. It is anticipated that findings from the review will be useful in identifying potentially modifiable risk factors that have relevance in policy, practice and research priorities to improve the management of patients with fragility fractures. Systematic Review Registration PROSPERO CRD42015019379

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Background There has been growing interest in mixed species plantation systems because of their potential to provide a range of socio-economic and bio-physical benefits which can be matched to the diverse needs of smallholders and communities. Potential benefits include the production of a range of forest products for home and commercial use; improved soil fertility especially when nitrogen fixing species are included; improved survival rates and greater productivity of species; a reduction in the amount of damage from pests or disease; and improved biodiversity and wildlife habitats. Despite these documented services and growing interest in mixed species plantation systems, the actual planting areas in the tropics are low, and monocultures are still preferred for industrial plantings and many reforestation programs because of perceived higher economic returns and readily available information about the species and their silviculture. In contrast, there are few guidelines for the design and management of mixed-species systems, including the social and ecological factors of successful mixed species plantings. Methods This protocol explains the methodology used to investigate the following question: What is the available evidence for the relative performance of different designs of mixed-species plantings for smallholder and community forestry in the tropics? This study will systematically search, identify and describe studies related to mixed species plantings across tropical and temperate zones to identify the social and ecological factors that affect polyculture systems. The objectives of this study are first to identify the evidence of biophysical or socio-economic factors that have been considered when designing mixed species systems for community and smallholder forestry in the tropics; and second, to identify gaps in research of mixed species plantations. Results of the study will help create guidelines that can assist practitioners, scientists and farmers to better design mixed species plantation systems for smallholders in the tropics.