Critical Elements in Proposal Writing

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Critical Elements in Proposal Writing

• Dianne Rekow, DDS, PhD
• (for Van Thompson, DDS, PhD)
• New York University
• IADR Vice President

2nd Scientific Conference of The African and
Middle East Region 23rd-25th September 2009-
Mombasa, Kenya Quality Oral Health Care through
Evidence Based Research
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Practice-BasedResearch NetworksNYU
BasedNational Institutes of Health Supported
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• 180 dentists conducting clinical research within
  their own practices
• Practitioner-Investigators trained in the conduct
  of clinical research and protection of human
  subjects
• Studies designed to answer common clinical
  questions
• Study questions posed by PEARL members

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Typical Practitioner-Investigators

• Practitioners
• Often mid-career
• Own the practice
• This approach can also work in dental schools

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Critical Elements in Proposal Writing A case
for discussionObservation Resin
polymerization shrinkage is associated with
post-operative hypersensitivity
POLYMERIZATION SHRINKAGE
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Polymerization shrinkage overcomes bonding a
microfluid flow path being created, leading to
sensitivity? What factors influence this?
Literature documents that gaps exist
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Postoperative hypersensitivity (POH) after
restorative procedures

• Specific Aims
• In a prospective follow-up study, determine the
  incidence and severity of POH as reported by
  subjects who receive Class I resin bonded
  composite restorations at 1, 4, and 13 weeks
  post-op
• Measure the associations between POH and
  restoration width, length, and depth (volume),
  dentin caries activity, lining and bonding
  materials, restorative materials and techniques
• Assess the effects of resin bonded composite
  restorations on patients quality of life (QOL)

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Background and Significance

• Why the study is important?
• For POH study
• Clinicians observe it often and it costs them
  time to eliminate it for patient
• Studies to date do not clearly identify risk
  factors
• Studies to date have limited scope of materials
  and procedures used
• Measurement of POH and tooth sensitivity vary
  widely (difficult to compare across studies)
• POH outcomes/resolution over time not well
  documented

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Preliminary Studies

• What related studies have you been engaged in
  that show that you are qualified to address these
  questions?
• For POH Study
• A survey of Pearl clinicians was conducted to
  determine if there was a meaningful difference in
  the way practitioners approach this clinical
  situation that would be a basis for further study

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Research Design and Methods

• What type of study ? (prospective, retrospective,
  randomized clinical trial, )
• For POH prospective follow up study of Class I
  restorations
• What outcomes are expected?
• For POH
• Sensitivity measured using a 0-10 point scale
  for cold, hot, sweets, chewing, clinching
• Rating of gt 3 on any scale was defined as
  sensitive
• Different exposures restoration volume, dentin
  caries activity, lining and bonding materials,
  restorative materials, restorative technique

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Research Design and Methods (cont)

• How many subjects?
• For POH 25/practice enrolled over 13 weeks
• How long will the study run?
• For POH
• 9 months
• Assumes 40 practices with estimated 20 of Class
  I restorations with some form of POH totals 100
  teeth with POH and 400 asymptomatic teeth for
  comparison

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Research Design and Methods (cont)

• Exactly what is to be done? (What procedures will
  you use?)
• For POH
• Identify patients who meet eligibility criteria
  with 1 or more unrestored posterior teeth with
  occlusal caries diagnosed clinically with or
  without radiographic verification (and more
  details)
• Evaluate pre-operative hypersensitivity using
  analog scale questionnaire (and more details)
• Complete restoration and record details of
  materials and restoration procedures (and more
  details)
• Determine how patient wants to be contacted for
  follow up (phone, e-mail, etc).

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Research Design and Methods (cont)

• Exactly what is to be done? (cont)
• For POH
• Contact subjects 6-7 days post restoration and
  ask them to complete questionnaire (with details
  of how to do that)
• Contact subjects 26-28 days post restorations and
  ask them to complete next questionnaire
• Contact subjects 86-90 days poster restoration
  and ask them to complete next questionnaire
• Clinician records any subject visit for treatment
  of a tooth with POH (and details of what was
  done)
• Details of how non-responding subjects are treated

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POH patient questionnaire asks about

• Tooth sensitivity (on scale included in the
  questionnaire)
• Questions relate to hypersensitivity with eating
  o drinking that are desgiend to distinguish
  between POH with mastication as opposed to
  clinching
• Pain medication
• To determine if patients are taking pain
  medication and why
• Oral health questionnaire
• Measures quality of life related to problems with
  their teeth

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POH baseline dental operational procedures

• Dental caries activity
• Based on visual and tactile examination rated as
• CA1 soft, serous
• CA2 soft, dry
• CA5 firm but discolored
• Preparation depth (with details of how/where)
• Remaining dentin ranking
• In deepest region and closest to pulp horn
• RD1 soft, serious . RD5 solid and normal

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POH baseline dental operational procedures

• Materials used
• Cavity disinfectant, desensitizer, liners,
  bonding agent, restorative material
• Composite placement technique
• Bulk/layer

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Research Design and Methods (cont)

• How will the data be analyzed?
• Sample size and power calculations
• Statistical technique(s) to be used
• For POH
• Assume POH reported in 20 of teeth at 4 weeks
• Logistic regression on lesion depth with sample
  size of 399 subjects achieves 90 power to detect
  a 50 increase in the odds-ratio at a 5 level of
  significance
• A 28 loss to follow up is anticipated from
  earlier experience
• Thus to obtain 4 week data for 400 required
  subjects at 80 power with the reduced completion
  rate, required 110 additional subjects so total
  required is 610 subjects

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Research Design and Methods (cont)

• What criterion are needed for patients to be able
  to be invited to participate?
• For POH
• Only adult dentition through age 60
• At least 1 permanent posterior tooth with
  clinical diagnosis of new Class I caries
  extending into the dentin, with or without
  radiographic confirmation (if more than 1
  occlusal lesion in a quadrant that meets the
  inclusion criteria, the patent is not eligible
  only 1 tooth/quadrant can be treated at a time).
• Eligible teeth 1st and 2nd premolars, 1st and
  2nd molars
• The tooth needing restoration must be occlusion
  with a natural tooth

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Research Design and Methods (cont)

• What criterion are needed for patients to be able
  to be invited to participate?
• For POH (cont)
• A resin-based composite restoration would be the
  standard of care for the lesion
• The tooth must be free of evidence of pulpitis
• The tooth must not be periodontally involved
  (mobility lt2 and no evidence of gingival
  inflammation)
• Subjects must be available for contact for at
  least 13 weeks post-treatment
• Subjects must be willing and able to understand
  and sign the IRB-approved informed consent form

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Research Design and Methods (cont)

• What criterion are needed for patients who are
  not to be included (exclusion criteria)?
• For POH
• Individuals with mixed dentition
• Individuals with Class I lesions that extend more
  than ½ the dentin depth as seen radiographically
• Teeth without an opposing natural tooth
• Teeth with a mobility gt2 or inflamed gingival
  tissue
• Existing restoration(s) on the same tooth
• Teeth with cracks
• Tooth as an abutment for a removable partial
  denture
• Subjects currently undergoing active orthodontic
  treatment

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Research Design and Methods (cont)

• What criterion are needed for patients who are
  not to be included (exclusion criteria)?
• For POH (cont)
• Subjects enrolled in tooth bleaching programs
  within the last month
• Subjects currently taking analgesic medications
  for pain
• Subjects presenting with clinical evidence of
  bruxism
• Subjects with subgingival calculus (unless
  removed at the treatment visit)
• Subjects receiving chairside desensitizing
  therapy
• Subjects undergoing treatment for medical
  disorders that in the PIs opinion could affect
  the patients assessment of POH
• Subjects enrolled in ongoing dental research
  studies

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Research Design and Methods (cont)

• What are the risks and benefits for the subject?
  
• For POH
• Anticipate minimal risk since standard clinical
  procedures are to be used
• One new bite wing radiograph is to be taken if
  pre-existing one is more than 1 year old
  (consistent with standards of care)
• All other risks are those normally involved in
  routine dental office examinations and treatment
  of caries

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Research Design and Methods (cont)

• What are the limitations of the study?
• For POH
• No study limitations are anticipated

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Research Design and Methods (cont)

• What special training and calibration, if any,
  will participating investigators be given?
• For POH
• Since the study is to be conducted in real
  world dental offices, key areas of training are
  provided as part of the PEARL training and
  certification core
• Interpretation of initial bite wing
• Questionnaire completion so they can instruct
  subjects
• Data collection and recording
• Cavity preparation measurements
• Human subjects training
• How to obtain informed consent

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Research Design and Methods (cont)

• What compensation will be given?
• For POH
• For the practice each practice was compensated
  for each patient enrolled
• Pearl provides case binders, report forms, and
  documents
• Normal fees for standard procedures for Class I
  restorations
• For patients
• When all questionnaires are completed, the
  patient will receive a 10 gift care for each
  post-operative questionnaire completed

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Research Design and Methods (cont)

• How will you disseminate the results?
• For POH
• To the Pearl practitioners through meetings
• To the dental and research community through
  publications and presentations
• (As a note data sharing requirements for model
  organisms is much more complex)

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Human Subjects Research

• How will you ensure that human
• subjects are treated appropriately?
• For POH
• This study will ensure compliance with
  regulations related to protection of human
  subjects, specifically
• Each practice that participates must be certified
  as having completed human subjects training
• Data confidentiality will be maintained
  (details given as is what will be done if data
  is accidently released)
• How will children, women, and members of minority
  groups participate?
• For POH representation is expected to reflect
  population

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Vertebrate Animal Research

• How will you ensure that animal subjects are
  treated appropriately?
• For POH No animals will be used in this study
• How will children, women, and members of minority
  groups participate?

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So what did the study find?

• 613 patients 682 teeth
• 12 premolars
• 88 molars
• Approx even distribution by quadrant

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Changes in Hypersensitivity Score
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245
50
220
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Increased sensitivity Sensitivity Decreased
sensitivity No sensitivity
85
170
94
Not hypersensitive at baseline
Hypersensitive at baseline
Baseline not-hypersensitive teeth at 4 weeks
Baseline hypersensitive teeth at 4 weeks
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Restorative Techniques
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Study findings

• What didnt influence appreciable POH (score of
  gt3)
• Resin Bonded Composites - partially reduce
  appreciable POH over baseline values
• Cavity depth
• Cavity volume
• Cavity liner (CaOH or RMGI/GI) vs. dentin bonding
  agent alone
• Self etch vs. total etch dentin bonding agents

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Study findings

• What did influence appreciable POH
• Use of chlorhexidine gluconate containing
  antimicrobial prior to restorative techniques
• Significant at 1 week BUT TRANSIENT and not
  significant by 4 weeks

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Study findings factor to note

• Appreciable POH was as high as 45 of patients at
  4 weeks in some practices and as low as 5 in
  others (with the same materials and techniques)!
• This is now the basis for a new study

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Thank you and now your questions
If you would like a copy of the
protocol Dianne.rekow_at_nyu.edu
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Transfer of Research into Dental Practice
Original Research
variable
Submission
Total Elapsed Time
0.5 year
Acceptance
0.6 year
Publication
0.3 year
Bibliographic Databases
6-13 years
Review, Paper, Textbook
9.3 years
16.7 - 23.4 Years
Implementation
E.A. Balas, S.A.Boren. Managing Clinical
Knowledge for Health Care Improvement. Yearbook
of Medical Informatics 2000