\u25cf What do we want to do
\nEach of these points can be covered in a couple of sentences or each can have a paragraph
\ndedicated to it.
\nMake sure you conclude the introduction with a couple of sentences (or a paragraph)
\nproviding a high-level overview of your proposed study.
\nSample: With a surge of COVID-19 patients needing care, HMH hospitals adopted the
\nSociety of Critical Care Medicine tiered staffing model for ICU, telemetry, and
\nmedical-surgical units. After the 2009 Australian H1N1 pandemic, researchers explored the
\nlived experience of ICU nurses revealing themes related to staffing such as the challenge of
\nhaving the appropriate skill mix, the need to work overtime, and staff having to take on new
\nroles (Corley, Hammond, & Fraser, 2010). There is a gap in the literature regarding nurse
\nstaffing or how staffing ratios were altered in hospitals during pandemics, epidemics or
\nillness outbreaks. The purpose of this study is to describe the staffing models used in acute
\ncare hospitals during the COVID-19 pandemic. With a better understanding of experiences
\nduring the COVID-19 pandemic, the results from this study will assist nurse leaders and
\nhealthcare administrators in developing a systematic action plan with evidence-based staffing
\nmodels for future outbreaks and epidemics. <\/div>\n
2 \u2013 Background
\n2.1. Background\/literature review (Please provide references and add references in APA
\nformat in the reference list at the end of this document)
\nThe background should offer an overview of the available literature.
\nPlease make sure that you discuss the literature that supports YOUR proposed study. You
\ncan discuss 1-2 more general reference papers in the beginning but make sure that you
\nfocus on similar studies or studies demonstrating a gap.
\nYou might also want to: <\/div>\n
\u25cf Describe and provide the results of animal studies, laboratory studies and pilot
\nstudies done in the USA or elsewhere, and clinical studies conducted abroad. <\/div>\n
\u25cf Summarize the known and potential risks and benefits, if any, to human subjects.
\nConclude your background by identifying the gap and explaining in one sentence how you
\nare going to fill it.
\nMake sure your background is not unnecessarily long (such as a thesis) as long. A protocol
\nonly needs to include the background to allow the reader\/reviewer to familiarize with the
\narea. <\/div>\n
<\/p>\n
Review of Literature (ROL)<\/p>\n<\/div>\n
\u25cf Include existing literature published within the past 3-5 years. <\/div>\n
\u25cf The literature review can include peer-reviewed scientific journal articles,
\nnew\/revised standards of practice\/clinical practice guidelines\/best practices, and
\nstatutes\/regulations if applicable. <\/div>\n
\u25cf Citations\/references older than 5 years may be included if it is a landmark study
\nor theoretical framework. <\/div>\n
\u25cf Discuss literature that supports your proposed study. <\/div>\n
\u25cf Discuss 1-2 more general reference papers in the beginning but make sure that
\nyou focus on similar studies or studies demonstrating a gap. <\/div>\n
\u25cf Try to avoid a structure where each paragraph summarizes one single study. <\/div>\n
\u25cf Summarize and present studies reporting similar findings or studies on similar
\npopulations together <\/div>\n
\u25cf Try to be critical and discuss their limitations especially if you are planning to
\nbase your study on doing something already done but better! <\/div>\n
\u25cf The ROL should be succinct for proposal submission. It is not a school
\nproject\/dissertation that requires a 10-15 page long literature review. <\/div>\n
\u25cf Summarize the known and potential risks and benefits, if any, to human
\nsubjects. <\/div>\n
\u25cf Conclude your ROL by identifying the gap and explaining in one sentence how
\nyou intend to address it with this work. This will give you a good justification for
\nwhy you are proposing a study<\/div>\n
<\/p>\n
3 \u2013 Rationale, Objectives and Hypothesis
\nThe rationale for the study, the investigator\u2019s goals, and\/or the hypothesis to be tested
\nshould be stated here. Objectives should be broken down by primary and secondary which
\nwill then lead to your primary\/secondary variables.
\n3.1. Study Rationale\/Problem Statement\/Research question or Study significance
\nExplain in one sentence what the need you intend to cover is. <\/p><\/div>\n
3.2. Hypothesis (if applicable) (Generally not applicable in nursing social-behavioral
\nstudies.)
\nA statement that can be tested with an experiment (usually suggests a relationship).
\nScientists generally base scientific hypotheses on previous observations that cannot
\nsatisfactorily be explained with available scientific theory\/ data. <\/div>\n
3.3. Primary Objective
\nThe main goal you are trying to achieve. It derives from the research question.<\/p>\n
<\/div>\n
3.4. Primary Outcome Variable(s)\/Measure(s) (outcomes corresponding to the stated
\nobjective above)
\nQuantitative measures deriving from the objective(s). Defines the outcomes that the study
\nwill measure. Try to have no more than 2-3 primary outcomes. The rest can be secondary or
\nexplanatory.<\/div>\n
<\/p>\n
Primary Outcome Measure 1
\nTitle:
\nDescription: [Description of the metric used to characterize the specific primary outcome
\nmeasure, if not included in the primary outcome measure title. If a scale is used to assess
\nthe outcome, please list the name of the scale and its range e.g. knowledge will be assessed
\nusing a 9-item scale ranging from 0-9 with 0 being \u201cno previous knowledge\u201d and 9 being
\n\u201cexpert knowledge\u201d.]
\nTimeframe: [Time point(s) at which the measurement is assessed for the specific metric
\nused. The description of the time point(s) of assessment must be specific to the outcome
\nmeasure and is generally the specific duration of time over which each participant is
\nassessed (not the overall duration of the study).]
\nPrimary Outcome Measure 2
\nTitle\/Description\/Timeframe <\/p><\/div>\n
3.5. Secondary Objective(s) (if applicable)
\n3.6. Secondary Outcome Variable(s)\/Measure(s) (if applicable)
\nSecondary Outcome Measures [N\/A if not applicable]
\nSecondary Outcome Measure 1 [for clinical trials, “Secondary outcome measure” means an
\noutcome measure that is of lesser importance than a primary outcome measure, but is part
\nof a pre-specified analysis plan for evaluating the effects of the intervention or interventions
\nunder investigation in a clinical study and is not specified as an exploratory or other
\nmeasure. A clinical study may have more than one secondary outcome measure.]
\nTitle\/Description\/Timeframe <\/div>\n
3.7. Exploratory objective(s) (if applicable) [N\/A if not applicable] <\/div>\n
3.8. Exploratory outcome variable(s) [N\/A if not applicable]
\nExploratory outcome measure 1
\nTitle\/Description\/Timeframe<\/p>\n
<\/div>\n
4 – Study Design
\n4.1 General Design
\nDescribe in a sentence or two the general design of the study. If applicable, make sure you
\nmention whether this is a study with a retrospective AND prospective component, or only
\nprospective, and the type of the protocol (e.g. prospective data \/ sample collection \/clinical
\ntrial\/survey-based\/ quantitative and\/or qualitative), and list control or comparison groups, as
\napplicable.
\nPlease ensure there is a clear distinction between what is taking place as standard of
\ncare (SOC) versus what is done for research purposes.
\nYou might also want to: <\/p>\n
Include a schematic diagram of the study design, procedures and stages as applicable.
\nDescribe the measures taken to minimize\/avoid bias (randomization, blinding).
\nIf data is to be collected, make sure the list of datapoints is listed here or is provided in the
\nappendix (or as a separate attachment).<\/p>\n
<\/div>\n
4.1.1 Study Duration
\nDescribe how long the study is going to last. Take into consideration the time you will need
\nfor the data collection and the time needed for data analysis. Recommend that you allocate
\nextra time for your study because if you have an end date and you have not finished data
\ncollection you will need to submit an amendment to the IRB.
\nIf this is a clinical trial in which patients will be actively involved, make sure you specify the
\nduration for which they will be involved and the time needed to analyze the data collected.
\nWhen indicating duration, try to use days, months, years, not specific dates as this may
\nchange depending on when you obtain IRB approval. <\/div>\n
4.1.2 Participant duration
\nExplain how long each participant will remain in the study, including follow-up. <\/div>\n
4.1.3 Number of Study Sites
\nMention the site(s) that will be involved in this study. Include their name and location and
\nspecify if they are HMH\/non-HMH sites.
\nThis is also entered into eResearch in \u201cLocal Research Locations.\u201d <\/div>\n
4.2 Study Population
\nDescribe the participant pool you will choose your participants from and their general
\ncharacteristics. Make sure you specify the type of the participant population (e.g.
\npatients\/students, etc.). <\/div>\n
4.2.1. Number of Participants
\nSpecify the number of participants that will be recruited for your proposed study.
\nFor quantitative studies, recommend that you consult with the statistician to determine the
\nnumber of participants and need for power analysis.
\nFor qualitative studies, typically the number of participants is based on data saturation. <\/div>\n
4.2.2. Eligibility Criteria
\nInclusion Criteria: All eligibility criteria should be listed. (Medical criteria, age, demonstration
\nof disease, ailment, proof of failure using standard therapy, laboratory assessments for
\neligibility, etc.).
\nExclusion Criteria: As applicable: Age limits; minors, pregnant women, mental
\nincompetents; use of other medications concomitantly; subjects with other diseases, severity
\nof illness, etc. <\/div>\n
A comprehensive study cohort inclusion\/exclusion criteria is essential to capture the correct
\npopulation. A good example for a study that used data collected within the SOC would be
\n(especially if you will collaborate with DTS to pull data):
\nStudy Title Example: Investigation of Surgical Outcomes for Patients with Knee
\nOsteoarthritis
\nInclusion Criteria: <\/div>\n
\u25cf Age: Adults aged 50 to 75 years at time of surgery. <\/div>\n
\u25cf Diagnosis Codes: Patients with a confirmed diagnosis of knee osteoarthritis based
\non ICD-10 code M17 (Unilateral primary osteoarthritis of knee) or M18 (Bilateral
\nprimary osteoarthritis of knee) as primary or secondary diagnosis. <\/div>\n
\u25cf Payor: N\/A <\/div>\n
\u25cf Procedure Codes: Patients who have undergone knee arthroscopy for osteoarthritis
\n(CPT code: 29881) <\/div>\n
\u25cf Medications: N\/A <\/div>\n
\u25cf Test\/Lab results: N\/A<\/div>\n
\u25cf Study sites: HUMC <\/div>\n
\u25cf Service: Inpatient or Outpatient
\n\u25cf Date Range: Surgeries performed Jan 1, 2021-Dec 31,2021
\nExclusion Criteria: <\/div>\n
\u25cf Age:Patients below 50 years or above 75 years. <\/div>\n
\u25cf Diagnosis Codes:
\n\u25cb Patients with rheumatoid arthritis (ICD-10 code M05 or M06) primary or
\nsecondary OR
\n\u25cb Patients with post-traumatic knee osteoarthritis (ICD-10 code M17.1) primary
\nor secondary OR
\n\u25cb Patients with secondary osteoarthritis due to other conditions (ICD-10 code
\nM19) as secondary code. <\/div>\n
\u25cf Payor: N\/A <\/div>\n
\u25cf Procedure Codes: Patients who have undergone knee replacement surgery (CPT
\ncodes: 27447, 27486) <\/div>\n
4.2.3. Vulnerable populations (if applicable). Vulnerable populations include children,
\nprisoners, cognitively impaired individuals, economically or educationally disadvantaged
\nindividuals, employees, students. When vulnerable populations are included, indicate what
\nsafeguards are in place to minimize coercion or undue influence to participate.<\/div>\n
<\/p>\n
4.3 Withdrawal criteria <\/p><\/div>\n
\u25cf When and how to withdraw subjects from the study <\/div>\n
\u25cf The type and timing of the data to be collected for withdrawn subjects <\/div>\n
\u25cf Whether and how subjects are to be replaced <\/div>\n
\u25cf The follow-up for subjects withdrawn e.g. procedures that will be followed when
\nsubjects withdraw from the research, including partial withdrawal from procedures
\nwith continued data collection or surveillance (if applicable) <\/div>\n
4.4. Study procedures
\nAll procedures that are STUDY-RELATED must be described here.
\nRecruitment, consent and any research interventions must be described here. Interventions
\nmight include, but are not limited to: Clinical procedures, surveys, interviews, focus groups
\nand educational interventions. Also include plans to return results to participants and\/or their
\ntreating physician and explain where lab tests will take place (CLIA vs. non-CLIA certified
\nlab). <\/span><\/div>\n\u25cf Describe and explain the study design, including control or comparison groups as
\napplicable. <\/span><\/div>\n\u25cf Provide a description of all research procedures being performed and when they are
\nperformed, including procedures being performed to monitor subjects for safety or
\nminimize risks. <\/span><\/div>\n\u25cf Describe:
\no Procedures performed to lessen the probability or magnitude of risks.
\no The source records that will be used to collect data about subjects.
\n(Attach all surveys, scripts, and data collection forms.) <\/span><\/div>\n\u25cf What data will be collected during the study and how that data will be obtained. <\/span><\/div>\n\u25cf If there are plans for long-term follow-up (once all research related procedures are
\ncomplete), what data will be collected during this period. <\/span><\/div>\n\u25cf If you will conduct genetic or genomic testing as part of your study, please make sure
\nyou specify if you will be using targeted analysis or whole exome\/genome
\nsequencing and ensure consistency between the protocol and the consent form.
\nPlease avoid long explanations of procedures that are standard of care unless it is to explain
\nyour research activities. Please make sure there is a clear distinction between what is the
\nstandard of care and what is done for research purposes.
\n4.4.1. Study discontinuation (if applicable) <\/span><\/div>\n 4.4.2. Concomitant medication (if applicable)<\/span><\/div>\n 4.5. Risks and Benefits <\/span><\/div>\n 4.5.1. Risks<\/span><\/div>\n \u25cf List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the
\nsubjects related to the subjects\u2019 participation in the research. Include a description of
\nthe probability, magnitude, duration, and reversibility of the risks considering physical,
\npsychological, social, legal, and economic risks. <\/div>\n
\u25cf If applicable, indicate which procedures may have risks to the subjects that are
\ncurrently unforeseeable. <\/div>\n
\u25cf If applicable, indicate which procedures may have risks to an embryo or fetus should
\nthe subject be or become pregnant. <\/div>\n
\u25cf If applicable, describe risks to others who are not subjects. <\/div>\n
\u25cf Risks related to breach of confidentiality or data must be described
<\/span><\/div>\n 4.5.2. Benefits
\nIndicate whether there is the prospect of direct benefit to participants or whether there are no
\ndirect benefits to participants. If there are no direct benefits to participants, the potential
\nbenefits to society should be mentioned. Do not include compensation as a benefit to the
\nsubject. <\/div>\n
5 \u2013 Methods
All methods that will be used in the study procedures described above have to be explained
\nhere. The statistical analysis plan has to be included here, including the timing of any
\nplanned interim analysis and the criteria for termination of the trial. In the statistical section
\nyou might also need to include procedures for accounting for missing, unused, or spurious
\ndata and for reporting deviations from the original statistical plan.
\nIf this is a treatment\/diagnostic\/prevention (non drug\/device\/biologic) study, the investigator
\nshould explain the treatment \/diagnosis\/prevention plan and describe any control or
\ncomparison group, as applicable. Baseline diagnostic tests, initial laboratory assessments
\nfor eligibility, any EKGs, physical exams, etc., should be noted. The use of participant
\ndiaries should be noted, the number of visits etc.. <\/span><\/div>\nThe PI (same as quality improvement) should indicate if subjects are to be
\nhospitalized for any part of the study.
\nIf this is not a treatment study, the PI should list measures to be used, tests, interviews,
\nvideotaping, and the amount of time the participant will be involved in each component of the <\/p>\n
study. All tools, surveys etc. that are going to be used should be explained here. Also include
\nhow they have been created and validated. <\/p><\/div>\n
The PI should make clear which methodologies are standard clinical care and which are
\nexperimental: e.g. if lumbar punctures are to be performed, it should be clear which, if any,
\nwould have been performed off study. <\/p>\n
Any monitoring should be described. The PI should also discuss reasons for dropping any
\nparticipant from the study. (Relapse, lack of patient compliance, etc.).
\nIf applicable also include:<\/p><\/div>\n
\u25cf Assessment of efficacy (specification of the efficacy parameters; methods and timing
\nfor assessing, recording, and analyzing efficacy parameters). <\/div>\n
\u25cf Assessment of safety (specification of safety parameters; the methods and timing for
\nassessing, recording, and analyzing safety parameters; procedures for eliciting
\nreports of and for recording and reporting adverse events and intercurrent illnesses;
\nthe type and duration of the follow-up of subjects after adverse events).<\/p>\n
<\/div>\n
5.1. Screening <\/div>\n
5.2. Recruitment, enrollment and retention (including screen failures as applicable)
\nFlyers, patient handouts, etc. require IRB approval and should be attached as an Appendix. <\/div>\n
5.3. Study intervention (including schedule of events and study visits) <\/div>\n
5.4. Assignment \/ randomization (if applicable) <\/div>\n
5.5. Section of instruments (to include for all studies with a social behavioral
\nintervention) <\/div>\n
Describe the tools that will be used, validation\/piloting and applicable copyright.
\nIf the tool was home developed, explain if and how it was piloted. If the tool is copyright
\nprotected, please make sure you have obtained permission before using it for research
\npurposes. <\/div>\n
Describe the purpose of each tool\/instrument\/scale, number of items, scale of
\nmeasurement, reliability and validity. Include who created the tool and if you have
\npermission to utilize. Include a sample of each tool\/instrument\/scale in Appendix <\/div>\n
5.6. Follow-up and end-of study (if applicable) <\/div>\n
5.7. Statistical Method <\/div>\n
5.7.1. Sample size calculation and justification <\/div>\n
Justification can include a statistical sample size calculation (with methods and results) or a
\ndescription of the number of eligible participants seen in your practice during the study
\nperiod. <\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"
1 \u2013 Introduction The introduction should cover the following: \u25cf Why is this topic important \u25cf What do we know (what’s been done before) \u25cf What don\u2019t we know (gap) \u25cf What do we want to do Each of these points can be covered in a couple of sentences or each can […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","template":"","meta":[],"disciplines":[13],"paper_types":[],"tagged":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.writemyessays.app\/blog\/wp-json\/wp\/v2\/questions\/31171"}],"collection":[{"href":"https:\/\/www.writemyessays.app\/blog\/wp-json\/wp\/v2\/questions"}],"about":[{"href":"https:\/\/www.writemyessays.app\/blog\/wp-json\/wp\/v2\/types\/questions"}],"author":[{"embeddable":true,"href":"https:\/\/www.writemyessays.app\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.writemyessays.app\/blog\/wp-json\/wp\/v2\/comments?post=31171"}],"version-history":[{"count":0,"href":"https:\/\/www.writemyessays.app\/blog\/wp-json\/wp\/v2\/questions\/31171\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.writemyessays.app\/blog\/wp-json\/wp\/v2\/media?parent=31171"}],"wp:term":[{"taxonomy":"disciplines","embeddable":true,"href":"https:\/\/www.writemyessays.app\/blog\/wp-json\/wp\/v2\/disciplines?post=31171"},{"taxonomy":"paper_types","embeddable":true,"href":"https:\/\/www.writemyessays.app\/blog\/wp-json\/wp\/v2\/paper_types?post=31171"},{"taxonomy":"tagged","embeddable":true,"href":"https:\/\/www.writemyessays.app\/blog\/wp-json\/wp\/v2\/tagged?post=31171"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}