Writing a Research Protocol

What is a Research Protocol?

A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical evaluation of the data, and organization of a clinical research project.

A well-written protocol will facilitate the process of obtaining institutional and ethical approval for your research and increase your chances of obtaining funding for your project.

A Good Research Protocol

- Forces the investigators to clarify their thoughts and to think about all aspects of the study, conduct, analysis of the data.

- Forms guidelines for a team working on research – help ensure study is performed similarly by different people over time

- is essential if study involves research on human subjects or on experimental animals, in order to get institution institution’s ethical approval

- is an essential component of a research proposal submitted for funding

- is used to start writing a manuscript when study completed

Developing a Research Protocol

Start with a good question - one for which the answer matters either to other researchers in the field, practicing clinicians, or patients

Convert the question to a hypothesis by asserting a position

Construct the protocol

Generate measures of exposure (treatments) and outcome

Test the hypothesis by making a comparison in two or more groups

Develop a plan for data collection and management

Determine the statistical methods for analysis, consult with statistician

Estimate the magnitude of expected difference between the two groups, as a basis for determining sample size (power calculation)

Assess feasibility of the study:

Can enough people be obtained for the study?

Can the outcome events be observed and suitably analyzed?

Research Protocol Format

Project title

Project summary

Project description

Rationale

Objectives

Subjects to study: Inclusion/ Exclusion criteria

Methodology

Data management and analysis

Sample size needed for the study

Ethical considerations

Risks and Benefits of the study

Recruitment plans, Compensation (if any)

Informed Consent, Approvals (DRB and IEC)

References

I] Project Title

Should be descriptive of the study, but concise

Clear, non-ambiguous

Arouse interest

Keep it short and Simple and Sweet

II] Project Summary

Why is the project necessary?

What do you aim to do?

What methods will you use for carrying out the project?

What will be the project outputs?

What is the projected impact of the project?

(An approximate word count: 500 words)

III] Project Rationale (Research Question)

Sets the stage for why the research project should be done. Cite appropriate references.

The condition to be studied

Treatments currently available, note gaps present

Specific treatment to be studied

Preliminary data for treatment in the condition to be studied

Purpose of the study

Discuss the anticipated results and potential pitfalls.

Describe the significance of the research including potential benefit for individual subjects or society at large.

IV] Research Objectives (Aims)

The purpose of the study (research questions and / or study objectives) should be clearly and precisely stated.

Objectives should be simple, specific, and stated in advance of performing the research.

In experimental designs, objectives will be stated as hypotheses to be tested.

Be short but complete and Be specific.

Objectives should be attainable, measurable and realistic

V] Procedures

A. Research Design

The research design should be identified and should be appropriate to answer the research question(s) under study.

Describe the type of research proposed (e.g. experimental, correlational, survey, qualitative) and specific study design that will be used (e.g. pre-test /post / test control group design, cross-sectional design; prospective longitudinal cohort design; phase III double-blind randomized control group design).

The research design, methods and procedures should help answer your research question(s) as written in your study objectives and aims

B. Sample/ Subjects/ Participants

Describe the sampling approach. For experimental designs, include justification for sample size determination.

Identify the procedures that will be used to recruit, screen, and follow study volunteers.

Specifically define the study sample (number of subjects to be enrolled, characteristics of subjects to be included in and excluded from the research).

In intervention studies, how will subjects be allocated to the treatment and comparison groups?

What are the criteria for discontinuation?

C. Measurement/ Instrumentation/ Intervention

Identify the variables of interest and study endpoints (where applicable).

Justify measurement techniques selected.

Provide validity and reliability data for selected measures.

If an intervention is performed, a description is given of the drugs available, or devices to be used, and whether they are already commercially available, or are in phases of development

D. Detailed study procedures

Methods for study data collection and for avoiding / minimizing subject risks should be included.

Include a timeline for subject evaluations and the duration of subject participation in the project.

Identify the plans the proposed safeguards for subject confidentiality (plans for coding data and for securing written and electronic subject records).

Indicate how long personal information will be stored once the study is completed.

Methods will vary with the research approach used (qualitative, quantitative).

The selected methods should be sufficiently described to justify the use of the approach for answering the defined research question.

Methods should also be described in adequate detail so that IEC members may assess the potential study risks and benefits.

Observations

What observations will be made, how they will be made, and how frequently will they be made.

Make a pilot study where required.

E. Internal Validity

Threats to internal / external validity should be considered.

Identify confounders.

Describe measures that have been taken to avoid study bias.

F. Data Analysis

Specify the analytic techniques the researcher will use to answer the study questions.

Indicate the statistical procedures (e.g. specific descriptive or inferential tests) that will be used and why the procedures are appropriate.

For qualitative data, specify the proposed analytic approaches.

VI] Sample Size

The protocol should provide information and justification on the sample size – the number of patients needed to be studied

A larger sample size than needed to test the research hypothesis Increases the cost and duration of the study and will be unethical if it exposes human subjects to any potential unnecessary risk without additional benefit

A smaller sample size than needed can also be unethical if it exposes human subjects to risk with no benefit to scientific knowledge

Calculation of sample size has been made easy by computer software programs. The principles underlying the estimation of the software sample size should be well understood

VII] Ethical considerations

Risks, Benefits of the study

Recruitment plans

Compensation for subjects in study

Informed Consent and procedure, IEC Approval

Conflict of Interest

Privacy

VIII] GCP Guidelines: https://gcp.nihtraining.com/

IX] Universal Guidelines:

CONSORT - CONsolidated Standards Of Reporting Trials

STROBE - STrengthening the Reporting of OBservational studies in Epidemiology.

X] Others:

Logistics – List of equipment/ tools required

Time Schedule – Gantt Chart

Action Plan – Procedural actions with durations

Budget – Self funded/ Sponsored

XI] Bibliography

Include a reference list of literature cited to support the protocol statement.

Vancouver Format/ APA format

XII] Registration

CTRI – Clinical Trials Registry of India

http://ctri.nic.in/

XIII] Forever Avoid Scientific Misconduct

Gift Authorship

Redundant Publication

Plagiarism

Fabrication

Falsification

References:

1. Fathalla MF. A Practical Guide for Health Researchers. WHO Regional Publications Eastern Mediterranean Series 30

2. Research Protocol. THE OHIO STATE UNIVERSITY Institutional Review Board

3. Parkman H. Writing a Research Protocol. WHO | Recommended format for a Research Protocol. http://www.who.int/rpc/research_ethics/format_rp/en/ [Viewed on Dec 14, 2015]

4. Guidelines on Writing a Research Protocol. Faculty of Health Sciences. University of Pretoria

EVIDENCE BASED PRACTICE IN PHYSIOTHERAPY

EVIDENCE BASED MEDICINE

The term ‘Evidence-based medicine’ (EBM) was coined and defined by Sackett et al in 1996 as

“The conscientious, explicit and judicious use of the current best evidence in making decisions about the care of individual patients”.

This further became known as evidence-based practice which is defined as the integration of best research evidence with clinical expertise and patient values and circumstances' which when applied by practitioners will ultimately lead to improved patient outcome. (Straus et al, 2005)

Best Research Evidence means valid and clinically relevant research with a focus on patient-centered clinical research. Clinical Expertise is the use of clinical skills and experiences while Patient’s Values and Circumstances are the patient’s unique preferences, concerns, and expectations in his or her setting

EBP is not only focused on research studies but uses the experience and expertise of the therapist and the needs of the patient in the best clinical scenarios. It is not only to be used or understood by professionals who routinely participate in research studies and is not a discouragement from trying new treatment.

There may be little or no research on a particular topic or studies with small sample sizes may have lacked the power to demonstrate statistical significance (as later explained in the statistics section). Rothstein in 2001 said “Because RCTs are so difficult, we will always have areas that lack evidence, we will need to find other credible research approaches to supply evidence.  Keep in mind that an absence of evidence is different from negative evidence.  An absence of evidence is not an excuse to ignore the growing body of data available to guide practice.”

(RCT = randomized clinical or controlled trials)

Evidence-based physical therapy (EBPT) has been defined by Herbert, Jamtvedt, Mead & Hagen (2005) as "physiotherapy informed by relevant high quality clinical research"

Relevance of EBP to Physiotherapy practice: [Adapted from Sackett et al (1997) ]

·      You might ask questions about a range of categories of practice:

·      Assessment – how to properly gather and interpret findings?

·      Causes of the problem – how to identify them?

·      Deciding what the problem is – where the symptoms/signs indicate a range of possible problems how do you decide which is most likely?

·      How to select and interpret tests used to identify problems and to monitor patient progress?

·      How to estimate the likely clinical progression of a condition/illness and any likely complications?

·      How to select interventions that do more good than harm and that are worth the effort and cost of doing them?

·      How to reduce the chance of the problem reoccurring or how to promote health?

·      How to keep up to date; improve your skills; and run a more effective/efficient rehab team?

·      How best to understand the perceptions of individuals and groups e.g. service users and carers

Goals of EBPT

Following Evidence Based Practice Procedures Helps To:

·      Make Sure That All Decisions Made For Patient Care Take Into Account "The Best Available Evidence"

·      Better Plan and Evaluate Service Delivery

·      Better Analyze Research Studies and Direct Those Findings To Better Care

·      Take Better Measurement and Do Interpretation Of Outcomes To Provide The Best Care Possible

·      Provide Better Patient Information

·      Better Understand the Reasons For Lack Of Compliance by Patients In Relation To Their PT Care

·      Accurately Gauge The Relationship Between Patients And Physical Therapists And Its Effect On Health-related Outcomes.

·      Develop Theories Based On Evidence In Practice.

Why is EBP important?

·      Clinical decisions can be clearly explained and justified to clients and their families

·      Demonstrate interventions are clinically and cost effective to colleagues, managers and administration

·      Maintaining and improving therapists’ knowledge base and the evidence base of for the future

Guiding Steps to Practice EBP: (Straus et al, 2005)

It is foremost important to analyze what we know and what we do not know, in relation to improving our clinical practice. Also it is essential to form answerable questions to address any gaps in our knowledge. EBP helps us to Search for and find the best research evidence to address our questions and also to critically appraise the information, based on its validity, impact or size of effect, and applicability.

EPB helps us Integrate information gathered from the best research evidence with clinical expertise and the patient’s values and circumstances and Evaluate the effectiveness of any intervention taken based on steps 1-4, and the effectiveness and efficiency of the process

Two Fundamental Principles of EBP

1. “Evidence alone is never sufficient to make a clinical decision”

Consider risks and benefits, costs, inconvenience, alternative treatment strategies, patient preferences/values and circumstances.

2. “EBM posits a hierarchy of evidence to guide clinical decision making”

Not all research is equal in terms of relevance and statistical support, however, that does not mean lower level evidence is not worthwhile. 

(Guyatt and Rennie use the term Evidence-Based Medicine, EBM; Guyatt and Rennie, 2002)

PHILOSOPHY OF EVIDENCE-BASED PRACTICE:

PROCESS / STEPS OF EVIDENCE-BASED PRACTICE

A] Ask: (Formation of Clinical Question)

i) Background Questions: Usually consist of two components, A question root (who, what, where, when, why, how) with a verb and A condition, (test, treatment, or other health care concern)

E.g.: What is Osteoarthritis?

ii) Clinical question/ Foreground question: Using the PICO Model. PICO is an acronym for the four parts of a well-articulated clinical question:

P = Problem and/ or Patient

I = Intervention (or exposure)

C = Comparison (if relevant)

O = Outcome (including time if relevant)

[T = Time factor]

Find: Formulate the Search Strategy

PARTS OF THE QUESTION	CLINICAL SCENARIO	KEYWORDS
PROBLEM / PATIENT POPULATION	Patients undergoing Total Knee Replacement	Total Knee Replacement
INTERVENTION	Post-Operative Physical therapy	Post-Operative Physical therapy
COMPARISON (IF ANY)	Post-Operative Physical therapy	None
OUTCOME	Prevents Complications	Prevent complications
TYPE OF STUDY	Randomized controlled trial	Randomized controlled trial

Formation of Clinical Questions Used to Search for EBP: (Guyatt and Rennie, 2002)

·   Question Type: Categorization is useful for writing the question and statistical analysis

·   Therapy: Evaluates the effects of various treatments or interventions

·   Harm (not frequently investigate in PT literature): Evaluates the effects of various treatments or modalities on function, morbidity, mortality

·   Diagnosis:  Evaluates a tool or test’s ability to distinguish among certain conditions

·   Prognosis:  Evaluates the course of a certain condition

Level of Evidence in Medical Literature:

Level	Criteria
I	Evidence obtained from high-quality diagnostic studies, prognostic or prospective studies, cohort studies or randomized controlled trials, meta analyses or systematic reviews (critical appraisal score > 50% of criteria).
II	Evidence obtained from lesser-quality diagnostic studies, prognostic or prospective studies, cohort studies or randomized controlled trials, meta analyses or systematic reviews (eg, weaker diagnostic criteria and reference standards, improper randomization, no blinding, <80% follow-up) (critical appraisal score <50% of criteria).
III	Case-controlled studies or retrospective studies
IV	Case studies and case series
V	Expert opinion (Discussions, Seminars, Blogs etc)

Hierarchy of Evidence for Treatment Decisions: (Guyatt and Rennie, 2002)

Greatest (Top) to Least (Bottom)

1.      Meta-analysis of randomized controlled trial

2.      Systematic review of randomized trials

3.      Single randomized trial

4.      Systematic review of observational studies addressing patient-important outcomes

5.      Single observational study addressing patient-important outcomes

6.      Physiological studies (studies of blood pressure, cardiac output, exercise capacity, bone density, and so forth)

7.      Unsystematic clinical observations

Hierarchy of Evidence (Evidence Pyramid)

Recommendation Grades:

Grade	Recommendation	Quality of Evidence
A	Strong	A preponderance of level I studies, but least 1 level I study directly on the topic support the recommendation.
B	Moderate	A preponderance of level II studies but at least 1 level II study directly on topic support the recommendation.
C	Weak	A single level II study at less than 25% critical appraisal score or a preponderance of level III and IV studies, including statements of consensus by content experts support the recommendation.
D	Theoretical/ foundational	A preponderance of evidence from animal or cadaver studies, from conceptual/theoretical models/principles, or from basic science/bench research, or published expert opinion in peer-reviewed journals supports the recommendation.
P	Best practice	Recommended practice based on current clinical practice norms, exceptional situations where validating studies have not or cannot be performed and there is a clear benefit, harm, or cost, and/or the clinical experience of the guideline development group.
R	Research	There is an absence of research on the topic, or higher-quality studies conducted on the topic disagree with respect to their conclusions. The recommendation is based on these conflicting or absent studies.

B] ACQUIRE

Evidence Search: Sources of Information - Where to find the research evidence, once the foreground question is developed?

·   Internet/ World Wide Web

·   Textbooks

·   Specific Journal Subscriptions

·   Internet Sources for Medical Information

I) INTERNET/ WORLD WIDE WEB:

This category is related to general search engines, not specific medical information journal search sources or health-related texts and journals available on the web.

·      Provides a rapid and abundant source of information

·      Be careful, not all sites and sources of information meet EBP guidelines

·      Consider the reputability of the source and the information found.

Examples: MD Consult (fee), Google Scholar (free for the search).

Some articles found may be free, others may have a fee.

II) TEXTBOOKS:

·      Often more useful for answering general background questions

·      Books in print (hard-copy) may exclude valuable recent information, due to the time taken to compile, edit, and publish texts

·      If utilizing a text, use one that is updated frequently and well referenced, so you can access more details if necessary

·      Many texts that are internet-based are becoming more evidence-based and may be an increasing source of information for foreground questions in the future.

Examples of internet-based texts (Guyatt and Rennie recommend UpToDate and Clinical Evidence as becoming more evidence-based): emedicine (free), UpToDate (fee), Clinical Evidence (fee)

III) Specific Journal Subscriptions:

Browsing a specific journal may be beneficial if specific to your field of practice. However, it mostly likely will leave out many applicable articles published in other journals. Browsing through full text journals to find a specific article with appropriate quality and relevance often takes considerable time (Straus et al, 2005)

IV) Internet Sources for Medical Information:

·      Systematic Reviews or Meta-analysis - MEDLINE, Cochrane Library

·      Critically-Appraised Topics - DynaMed, UpToDate

·      Critically-Appraised Articles - ACP Journal Club

·      Randomized Controlled Trials - Original articles (search MEDLINE)

·      Cohort Studies - Original articles (search MEDLINE)

·      Case-Controlled Studies etc. - Original articles (search MEDLINE)

·      Background Info/Expert Opinion - Books, editorials

KEY DATABASES

PUBMED (www.ncbi.nlm.nih.gov/PubMed).

·   Finding the highest levels of evidence: systematic reviews and meta-analyses faster and easier

·   Providing further analysis of randomized controlled trials

·   When to use Keyword search?

·   Keyword search and limit search results for the past few months. Eg. LUMBAR DISC PROLAPSE

Setting up Evidence-Based Filters Using my NCBI

Filters help sort search results faster. Set up EB filters for systematic reviews, meta-analyses, RCTs, practice guidelines

Cochrane: Cochrane Database of Systematic Reviews

PEDro: (http://www.pedro.org.au/index.html)

·   Physiotherapy evidence-based database, produced by the Centre for Evidence-Based Physiotherapy in Australia

·   Covers RCTs, systematic reviews, clinical practice guidelines in physiotherapy

·   Trials rated for quality

Sources of Information:

·         Internet/World Wide Web,

·         Consider the reputability of the source and the information found.

Google:

“I personally have found Google Scholar very helpful”. (Guyatt and Rennie, 2002)

EBSCOhost:

·   Provider of CINAHL^® (Cumulative Index to Nursing and Allied Health Literature) – CINAHL ^® also available through several other sources

·   Fee for use (Often as a university or health science subscription): http://www.ebscohost.com

·   Similar search strategies to other medical information sources

APTA’s Open Door:

·   Available with APTA membership (login to www.apta.org, look under areas of interest, research subheading)

·   Access to research journal collections including ProQuest, Medline, Cochrane Library, CINAHL® (mostly contains bibliographic records, not full text journals)

·   Suggestions, with links, for free full text (including BioMed Central, Directory of Open Access Journals, Public Library of Science, PubMed Central, and more)

·   Tutorials and searching tips for EBP, along with guidelines for finding full-text articles

·   Information on PT journals and samplings of current research in specific fields

APTA’s Hooked on Evidence:

·   Available with APTA membership (login in to www.apta.org, look under areas of interest, research subheading)

·   Database of article extractions relevant to physical therapists: Peer reviewed information about the methodological quality and level evidence of the included articles

The Guide to Physical Therapist Practice (Text):

·   Provides PTs with comprehensive descriptions of scope of practice

·   Details preferred practice patterns

·   Indications for specific tests and measures and interventions

·   APTA. Guide to Physical Therapist Practice. 2nd ed. American Physical Therapy Association;2001.

Search Strategies

1. Key words

2. Filters

3. Bullions (Search terms): (OR, AND

4. Truncation symbols (*): Associated words

5. MeSH database (Medical Subject Heading)

6. Square brackets: [TiAb], [Au], [Ti]

C] APPRAISAL

Evaluation Criteria – 4 STEPS

1. Credibility (Internal Validity)

2. Transferability (External Validity)

3. Dependability (Reliability)

4. Conformability (Objectivity)

Variables

Variables are characteristic that can be manipulated or observed. They are of 2 types; Independent or Dependent

Measurement Scales/Levels:

]Classification is useful for communication, so that readers are aware of the author’s hypothesis of what situation or intervention (independent variable) will predict or cause a given outcome (dependent variable) (Portney and Watkins, 2000)

Variables: Independent or Dependent: (Portney and Watkins, 2000)

Independent Variable: A variable that is manipulated or controlled by the researcher, presumed to cause or determine another (dependent) variable

Dependent Variable:  A response variable that is assumed to depend on or be caused by another (independent) variable

Variables: Measurement Scales: (Portney and Watkins, 2000)

·   Useful to convey information to the reader about the type of variables observed

·   Necessary to determine what statistical analysis approach should be used to examine relationships between variables

·   From lowest to highest level of measurement, the scales are nominal, ordinal, interval, and ratio

1. Nominal Scales (Classification Scale)

·   Data, with no quantitative value, are organized into categories

·   Categorizes are based on some criterion

·   Categories are mutually exclusive and exhaustive (each piece of data will be assigned to only one category)

·   Only permissible mathematical operation is counting (such as the number of items within each category)

·   Examples:  Gender, Blood Type, Side of Hemiplegic Involvement 

2. Ordinal Scales

·   Data are organized into categories, which are rank-ordered on the basis of a defined characteristic or property.

·   Categories exhibit a “greater than-less than” relationship with each other and intervals between categories may not be consistent and may not be known

·   If categories are labeled with a numerical value, the number does not represent a quantity, but only a relative position within a distribution (for example, manual muscle test grades of 0-5)

·   Not appropriate to use arithmetic operations

·   Examples: Pain Scales, Reported Sensation, Military Rank, Amount of Assistance Required (Independent, Minimal…)

3. Interval Scales

·   Data are organized into categories, which are rank-ordered with known and equal intervals between units of measurement

·   Not related to a true zero

·   Data can be added or subtracted, but actual quantities and ratios cannot be interpreted, due to lack of a true zero

·   Examples:  Intelligence testing scores, temperature in degrees centigrade or Fahrenheit, calendar years in AD or BC

4. Ratio Scales

·   Interval score with an absolute zero point (so negative numbers are not possible)

·   All mathematical and statistical operations are permissible

·   Examples:  time, distance, age, weight

Measurement Validity

Measurement Validity examines the “extent to which an instrument measures what it is intended to measure” (Portney and Watkins, 2000)

For example, how accurate is a test or instrument at discriminating, evaluating, or predicting certain items?

Measurement Validity

Validity of Diagnostic Tests

Based on the ability for a test to accurately determine the presence or absence of a condition

Compare the test’s results to known results, such as a gold standard. 

For example, a test determining balance difficulties likely to result in falls could be compared against the number of falls an individual actually experiences within a certain time frame.  A clinical test for a torn ACL could be compared against an MRI.

(Portney and Watkins, 2000)

Measurement Validity: Types

a. Face Validity: Examines if an instrument appears to measure what it is supposed to measure (weakest form of measurement validity)

b. Content Validity: Examines if the items within an instrument adequately comprise the entire content of a given domain reported to be measured by the instrument

c. Construct Validity:  Examines if an instrument can measure an abstract concept

d. Criterion-related Validity: Examines if the outcomes of the instrument can be used as a substitute measure for an established gold standard test.

e. Concurrent Validity:  Examination of Criterion-related Validity, when the instrument being examined and the gold standard are compared at the same time

f. Predictive Validity:  Examination of Criterion-related Validity, when the outcome of the instrument being examined can be used to predict a future outcome determined by a gold standard

Measurement Reliability:

·   Reliability examines a measurement’s consistency and freedom from error

·   Can be thought of as reproducibility or dependability

·   Estimate of how observed scores vary from the actual scores

D] Apply:

·   Using Evidence in Clinical Practice

·   Implementation of the study results

·   Find out the changes / outcome in all aspects

·   Document it

·   Bring into discussion

·   Get a clinical question / problem 

·   For further precision /refinement

Application of EBP to Physiotherapy

·   Interpretation of Evidence

·   Consider the type of study and where the study falls on the hierarchy of evidence.

·   When evaluating the study, ask three questions: Are the Results Valid, What Are the Results, How Can I Apply the Results to Patient Care?

·   Don’t forget to incorporate clinical expertise and patient values and preferences after evaluating any research material.

Interpretation of Evidence For Therapy/Intervention: Validity

·   Are the results valid?

·   Were patients randomized into the groups?

·   Was randomization concealed (blinded or masked)?

·   Were patients analyzed in the groups to which they were randomized?

·   Were patients in the treatment group and control groups similar with respect to known prognostic factors?

·   Did experimental and control groups retain a similar prognosis after the study started?

·   Were clinicians aware of group allocation? 

·   Were outcome assessors aware of group allocation? 

·   Was follow-up complete? 

·   What are the results?

·   How can I apply the results to patient care?

·   Are the likely treatment benefits worth the potential harm and cost? 

Interpretation of Evidence For Diagnosis: Validity

·   Are the Results Valid?

·   Was there a blind comparison with an independent gold standard applied similarly to the treatment group and the control group? 

·   Did the results of the test being evaluated influence the decision to perform the reference standard?

Interpretation of Evidence For Diagnosis: Application

·         What are the results?

·         What likelihood ratios were associated with the range of possible test results? 

·         How can I apply the results to patient care?

·         Are the results applicable to the patient in my practice?

·         Will the results change my management strategy?

·         Will patients be better off as a result of the test?

·         What are the potential risks versus benefits of the test?

E] Evaluate your performance as an EBPT practitioner

Ask yourself:

·      Did you ask an answerable clinical question?

·      Did you find the best external evidence?

·      Did you critically appraise the evidence and evaluate it for its validity and potential usefulness?

·      Did you integrate critical appraisal of the best available external evidence from systematic research with individual clinical expertise in personal daily clinical practice?

·      What were the outcomes of your application of the best evidence for your patient(s)?

PROCESS OF NEW RESEARCH  APPLICABILITY – 4 PHASES

1. Physiological testing

2. Test for harm

3. Test for effects

4. Testing practice

Evidence V/S Experience Based Practice in Physiotherapy

What do you think????

EPB always considers the experience part of the therapist. There is no application of Pure evidence without understanding the details of the conditions based on the experiential understanding of the patient.

IS EVIDENCE ALONE SUFFICIENT    ?????????????????????

·   Benefits

·   Risks

·   Patient values, preferences & expectations

·   Inconvenience

·   Availability

·   Cost effectiveness

·   Ethical & legal issues

CONFLICTS

·   Withdrawal of treatment procedures

·   Funds

·   Reducing the burden of insurance companies

·   Reducing or increasing the therapy sessions

·   Promoting one specific therapy

·   Dominant companies will manipulate & increase the usage through bringing favorable results evidences

Barriers to EBP

·   Some barriers to EBP that have been discussed in literature include:

·   Access and availability to information

·   Limited time

·   Lack of EBP skills

·   Confidence in the value of the evidence

·   Support from management

·   Conflict with client centered philosophy of PT

However, barriers can always be overcome:

·   Develop your own strategies

·   Appear & behave - professional & unique

·   Always be conscious & aware

·   No overconfidence

·   Update yourself

·   Emotional stability

·   Improve your communication skills

·   Identify your strength & weakness

·   Do genuine & professional practice

·   Stop requesting for case references

·   Don’t give clinic / referral pads to other health care professionals

·   Don’t blindly follow the prescription

·   Develop the habit of assessment / case discussion

·   Don’t encourage modality prescription

·   Demand for referral simply as physiotherapy with due respect

·   Keep on improving the infrastructure

·   House visits should not exploit you & your profession

·   Documentation is mandatory - helps in professional & financial growth

·   Patient behaviours & reactions

·   Relationship with patients & team members

References:

1. Donald, A. and Greenhalgh, T. (2000) A Hands-on Guide to Evidence Based Healthcare: Practice and Implementation, Blackwell Science, Oxford.

2. Le May, A. Evidence-base practice, London, Nursing Times Books (1999) .

3. Muir Gray, J.A. Evidence-based Health Care. How to make Health Policy and Management Decisions, Edinburgh, Churchill Livingstone (1997) .

4. Sackett, D.L., Strauss, S.E., Richardson, W.S., Rosenberg, W. and Haynes, R.B. Evidence Based Medicine: How to Practice and Teach EBM, 2^nd edn, Edinburgh, Churchill Livingstone (2000) .

5. Portney LG. Evidence-based practice and clinical decision making: it’s not just the research course anymore. Journal of Physical Therapy Education. 2004;18(3):46-51.

6. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence-based medicine: what it is and what it isn’t. BMJ. 1996;312:71-2.

7. Kaplan SL. Et al Developing Evidence-Based Physical Therapy Clinical Practice Guidelines. Pediatric Physical Therapy. 2013; 257-70

8. Special Acknowledgement:

a. D. Thiagarajan  MPT [Neurosciences]

b. Portea Healthcare