ch 15-19 public health
what is a research protocol
a detailed written description of all the processes and procedures that will be used for data collection and analysis
identifying sample pop, developing questionare and other assessment, and ensuring ethical standards shoudl all occur before
a proposal for grant funding can be finalized and submitted
a population based study uses random sampling method to generate
a sample popualtion that is represenative of some well defined leargger population (to which is usually a pop that is not defined by a disease or exposure status).
at the same time, it is problematic when members of vulnerable populations are systematically excluded from
the resarch
a well defined study question identifies a target populations to which
the results of the study should apply
probability based samplng is usally te preferred option for producing a sample pop that is imilar to ____
the source pop as a whole
the sample population consists of the individuals from
the source population who are invited to participate in the research project
t or f- ascertainment, or other sources of bias can be eliminated or minizmed with carefu planning
true
true or false- hospitals, clinics, ph offices, disease support groups ,etc can help find individuals or groups of individuals to meet study 's case definiiton
true
true or false- however, care must be taken to ensure that the sample pop is not healtheir, sicker, or more or less socially connected than typicl person who meets the case definition
true
true or false- some studies benefi or reuqire the participation and support of whole geographic, cultural, or socail communities and their leaders
true
true or false: depending on the study approach, the componens of the research protocol will vary
true
when there is no significant difference in weight gain in the intervention and control groups, the intervention would be deemed ___. if a more repsreantive study pop had been recruited the intervention mght have been deemd a
unsuccessful, success
a detailed research protocol describes the exact procedures that will be
used for every single step of the project
most research protocols include a detailed schedule for the planned research project. it is therefore helpful to:
-create a list of steps from planning the study through the dissemination of results -create a calender that shows when each of these steps is expected to be intiated and be completed -identify fixed deadlines that must be met such as grant application deadlines and abstract submission dates for conferences where the work may be presented -agree with collaboraters on immediate deadlines for research aks to keep project on track -set up regular meeting times for the research team
a less than 100 percent participation rate is usually not a problem as long as the researcher does these 4 things
- uses acceptable and carefully explained sampling methods -takes appropriate steps to maximize participation rate -recrutis large sample size -reports numbero f potentional participants at each stage
idaelly, a protocol should include
-fully describe all procedures that will be used for data collection and analysis -list anticipated dates of completion for each of the steps in the research process -provide details about the responsibilities of each member of he resarch team -describe mechanism for upadting any part of the research plan if revisions arise after approval of the initial protocol, noting that significant adjustments to the protocol may need to be approved by all relevant research ethics committees before they can be implemented
before initiating datac oolleciton, make suere all preps have been finaized
-have all collaborates approved of their designed roles, responsibilites deadlines? -make sure collaborateds completed reqired training -are all supplies and equp ready? -has the data managment system been tested andfoud to be reliable? -if applicable have the final versions of all study documents )such as informed consent and questionare been approved bt all relevant research ethics committee -if aplicable are all particpating labroatires to begin processing samples?
for the collection of new data from individuals, the researcher needs to
-identify appt way to sample and recruit participants -develop a questionnare and other data collection tools -select methods for gathering and recording responses from partiicpants -prepare an application for a research ethics review committee
4-5-6 of protocol
-precise procedures that will be used to obtain and document inforemd consent or to document refusal to participate - exact questions particpants will be asked nd if intrews will be used to gather info from participants, the instructions for how thos equestions will be asked -the exact ways respones to survey questions will be entered into a computer database, includin gthe methos for recording missing responses
7,8,9,10 of protocol
-precise steps that will be taken to confirm accuracy of entered data -steps taken to maintain confidentiality of personal info thay might be contained in the data set -the plans for data analysis, including the particular statistical tests that will be used to answer the study questions -if applicable, the precise labratory procedures that will be used
for a primary study, the protocol will explain 1-2-3
-the main goal and specific objectives of the study -the desired sample size and the steps that will be taken to acquire an adequate number of participants -specific processes that will be used for contacting and recruiting participants
once a source of cases is identified, a ___ group must be selected
valid control
gantt chart can be very helpful for
visually displaying the research timeleline
the source population is a
welldefined subset of individuals from the target population
sometimes one person, often a senior is designated to be
a adjudicator of delays in the submissions of agreed upon dliverables, disagreements about the interpretation of the protocol or the nature of an assigned task, and other differences of opinion or awkward situations
once a astudy question and a study approach have been selectd, the next step is to create
a detailed research plan
a clinical study that seeks to enroll partiicpants iwth a rare disease may benefit greatly by oartnering with ___ and ____
active disease support, advocacy network
the count can then can be used in the determination of _____ one that might include the entire source pop or a randomly sampled subst of it- and the calculation of participation rates
an appropraite sampling method
a strong protocol provies enough detail that _____
another researcher could easily replicate the study.
if exsisting data will be analyzed a ____ must be identified and the ____ and ____ acquired
appropriate data source, data file, supporting materials
when identifying possible participants for a case control study, the first step is to find an ____ and ___ source of cases. all cases must have the same ___, ____, or other health related condition
apprpriate, avaialble, disease, disability
researchers using a convenience sample must avoid the ___ bias that can occur if the convenience sample is not represenative of the source populations as a whole
ascertainment bias
when the source pop is msall, every person who is listed as a member of the source pop can be ____. in thi sistuation, source pop is the same a the sample pop, however, a source pop is often ____ than the sample size required for a study. when the source pop is very large, a portion of he source pop may serve as a ____.
asked to participae in the study, much larger, sample population
when making this ismportant decision, the researcher should consult a reference that specifically addresses the selection of appropriate participants for ___ studies, including the possibiliteis for matching cases to controls
case control
for cohort studies that seek to compare exposed and unexposed ppps, identifying exposed and unexposed participants is similar to the steps for identifying ___ and __ for a case control study
cases and controls
convenience sampling must always be used with ___, since conveneitn sample pops are often systematically different from the ___ and ___ populations they are intended to represent
caution, target, source
when researching demographics, the target population should be of the most recent population ___
census
undestanding specific situations requires testing on those
who actually have expeirencesd
the studys case definition should be very clear about the ___, ___, and ____ that must be present or absent for an individual to be categorized as a case
characteristics, signs and symptoms
vulnerable populatons in health research include ___, some individuals with serious ___, people in __ and some other socially marginalzied populations, and others who may have a limited ability to make an informaed autonomous decision about volunteering to paritcipate in the resarch study
children, health issues,
if the sample is drawn from an entire city _ can be used to dentify at random whole city blocks for inclusion in the sample population, or alternatively sample pop might consist of all residents in city living on every tenth street
cluster sampling
if a list of eevery indiviudal in the source pop is available, a _ can be used to select at random the individuals who will be invited to partiicpate
computer program
identifying source and sample populations for a longitudinal cohort study is similar to the rpocess for idneitfying thse populations for a ____ survery. however, ther eare ssome added concerns abou needing to recruit a stable study pop in oeder to retain as many ___ as possible for the duration of the study
cross sectional, particpants
it should also be detailed enough that the entire methods section of any paper that will result from the prject could be written before -____
data collection begins
when possible, researchers should seek to confirm that the selected sample population has ___ and ___ characteristics similar to those of the broader community the participans are intended to represent
demographic and socioeconomic
the controls must be similar to cases in every way except for their ___
disease status
research projects ten to proceed most smoothly when all research tam members have a shared understanding about
each contributer's roles and responsibilities
all cases and controls must meet the same ____ except for the ones related to disease status
eligibility criterai
having both a case definition and control definiton is helpful so that borderline cases are ____ from serving as either cases or controsl
excluded
true or false- a target pop is never narrow
false
true or false- very feew methods can be used to generate a ample pop that is represenatie subset of a source pop
false- a variety of methods can be used
true or false- convenicen samples usually result in a study pop that is represnative of the target population
false- it rearely does
100 percent participation is very common. nobody will ignore the invitation. nobody wil be ineligible
false- its rare. some will ignore, some will be ineligible
cases ahd controls should be drawn from similar ___ and ___ populations
georgrpahic and socioeconomic
for all study plans, it is helpful to create a protocol that will
guide each step of the data collection and management process
instead a more specific population(sometime called a sampling frame) should be ___. ideally, the source population consists of an enumerate listof population members.
identifiedLOOK AT EX IN BOOK
the study must be sufficienitly ___ to justify gatheting new fata from members of a vulnerable population
important
the case definition should specify both the ___ and ___ criteria
inclusion and exclusion
concerns abou the ___ of adverse effects from study participation must be addressed
increased risks
the approval of community leaders does not negate the requirement to obtain ___ from participants whose individual data will be collected
individual informed consent
a researcher can acquire or generate a list of all members of the source population, which means that the number of _____ in the source pop can be counted
individuals (or households)
the ability of every participant or young chldren and those with sig diminished cog abilities, a legally recognized rep, to provide ____ free from coercion must be assured
informed consent
another option may o be to use the participants of a large ____ study as the source population for both cases and controls
longitudianl cohort
the study population will consist of
mmbers of the sample pop that can be located, who can consent to the participation, and who meet all eligibility criteria
this kind of ____ study design minimizes recall bias because information about past exposures was collected at the time of exposure and is not based on participant's memories. however a chohort study will only yield a sufficient number of cases when the disease being studied is ____
nested case control study, common
a convenience population is ____ based, and is seelcted based on the ease of access to those indiviudals, schools, workplaces, organizations or communities
nonprobability based
researchers attempting to generate a random sample frm the source pp need to avoid the ____ bias that could occur if each individual in the source pop does not have an equal chance of being selected for the sample population
nonrandom sampling
a low respnse rate mat result in a ___ bias, if the members of the sample pop who agree t be ib teh study are systematically different from nonparticipants
nonresponse
these populations should not be selected as the source pop for studies that do not require their -__
participation
however, community buy in for a porject often improves ___, enhavnes the ___, and ensures he study outcomes are ___ to the community
participation rates, cultural competence of the research team, valuabel
a longitudinal study that itneds to recurit and monitor whole villages will be most successful if formal and informal community laders and other local represenatie are actively involved in __, ___, __
planning, recruitment, retention
for all study designs, the protocol should anticipate liekly dilemmas or areas of confusion and address them as compeltely ____
possible
unless the target population is very small, it is usually not
possible to invite all members of the target population to partiicpate in the study
research stuies incluing members of vulnerable populations require extra consideration of the ____ of research to particpants
potential risks
__ must be taken to protect participants from injury
precautions
the internal due dates set by the research team will be somewhat fleible because
predicting how long some steps will take can be difficult
___ and ___ must be included in tests of the safety of pharmaceutical agents beofre they can be approved for wider use
pregnant women, children
univiersities, hospitals, and other instituitions typically require one reseracher to act as the ___, and to accept responsibiltiy for guranteering that
primary invesigatior (Pi) -protocol is followed -budget is managed properly -any adverse outcomes immediately reported to the institutions research ehics committee
including a timeline in the protocol even if it may need to be updated as the project is confuted is a way to
promote steady progress toward completion
for a systemic review, the protocol is ___ but equally ____, it defines the exact criteria for an article's eligibility for inclusion in the review and it spells out exactly how articles that acnnot easily be classified according ot the eligibility criteria will be handed
quite different, detailed
in particiular, the only way to study healt hissues of importance to potentially vulnerable pops is to allow for their particpant in ___
relevant research projects
it may be also helpful to identiffy a process for
resolving conflicts
___ should alwys be a top priority when designing and implementing an experimental study
safety
the individuals identified a the ___ population will be later asked tot aprticipate in the study
sampel
an example of an option better than convenience sampling
sample students from each of the 15 schools such as randomly sampling 20 percent of the students in each high school based on the cassroom they are in during the first period of the day
a cross sectional survey that will collect information from students may require the perission of ___ in addition to the consent of the students and of their parents, and the approval of the research ethics committee
school authorities
if a systemic litereature reviw will be conducted, the ___ must be identified, ____ identified, and ____ from each article extracted into data base
search strategy, eligible articles, and relevant information
although the pi may be doing hte most work, many insutuions allow only __ to serve as official institutionl pis
senior employes (ex- sometimes univieresities require professor to be listed on research project that involves human subjects, even if a stuent is taking lead role in project
controls can be drawn from many types of ___ populations
source
ideally, the researcher will identify a way to confirm that the___ is similar to the ____ nd that the __ piopulation is similar to the -___.
source population, target population, sample, source
in some experiemtnal studies, studies require patitpcants to be exposrd to potentialy risky substances or activires. in such studies, the risk of harm can be reduce by selecting an apprpriate ___ and defining strict __ and ___.
source, inclusion and exclusion criteria
as is true for rcross sectional surveys, experiemntal studies require a __ population that is reasonably represenative of the __ populatin
source, targer
no matter which sampling method used, the goal is to end up with a sample pop tat is represenative of the ___ population, and ideally of the ___ too
source, target population
in a cross sectional survye, the source population must be represantive of the ___ poplation, and the ___ population must be repseprenative of the ___ population
targer, sample, source
the broadest population group is the ___ which the results of the study____
target population, should be applicable
at least 4 types of pops must be considred when preparing to collect data. these include-
target population, source population, sample population, study population
the goal of most cross sectional surveys is to describ a specific ___ population accurately. the results of the survey are often used to make important ___ and ___ decisions.
target, resource, policy
the study population comprises
the eligibile members of the sample population who consent to participate in the study
the protocol should include
the names of the people who have accepted responsibility for particular tasks, the dates they have agreed to work on those assignments, and the mechanisms that will be used to encourage careful and ontime completion of those items (such as emailed reminders sent by the lead researcher in advance of deadlines