The document discusses various study designs used in hand therapy research. It provides an overview of qualitative and quantitative research approaches and different types of observational and experimental study designs such as cohort studies, case-control studies, cross-sectional studies, randomized controlled trials, and their examples. Factors to consider while selecting an appropriate study design such as the research question, aims, sample size, time, cost, and level of evidence are also highlighted.

1. 02/01/2016
1
Punita V. Solanki
MSc (O.T.), YFT‐ISSA, Level I PIA Trainer, ADCR‐ACE
Consultant Occupational Therapist, Mumbai
Mobile: +91‐9820621352
Email id: therapistindia@gmail.com
Study Designs in Hand
Therapy Research
3rd Annual National Conference of Society for
Hand Therapy, India,
13th September 2014, Saturday
Thane, Mumbai
Table of Contents
1. Research Pathway to Study Design
2. Study Design Selection based on Research Question.
3. Common Terms Used in Research Studies.
4. Types of Study Designs with Examples.
5. Types of Controls Used in Experimental Studies.
6. Types of Randomization & Blinding.
7. Level of Evidence & Grades of Recommendations.
8. Quiz
Disclaimer
The presentation is entirely the effort of the
presenter, based on the past and present experiences
in clinical research; academic training and from
thorough literature search on the related topic.
The company, organization and the hospitals where
the presenter is associated, has no bearing with the
presentation. It is entirely the view of the presenter
based on the existing evidence.

2. 02/01/2016
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Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Research Pathway to Selection of Study Design
Study Design
Hypothesis
Specific Research Question
Research Problem
Review of Literature
Novel Idea
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Study Design Selection
The clinical question determines which
study designs are appropriate. So first
select the research objective and aim of the
study and then choose the study design.
One clinical question can be answered
by more than one study design.
No single study design can answer all
the clinical questions.
No single study design fits all the needs
& circumstances of the research.
Punita V. Solanki
Occupational
Therapist
Study Design Selection
The Clinical Research Question
The Study Aims & Objectives
Sample Population & Sample Size Availability
Time & Cost Concerns
Ethical Concerns
How, When & Where the Study findings are to be
Used.
Concerns about the Robustness of the Study for
its efficacy (internal validity) and its effectiveness
(external validity) for application of findings in
general population.
Factors affecting the selection of study design
could be many and they are:
13th September 2014
3rd Annual National
Conference of SHT,
India

3. 02/01/2016
3
Classification of Medical Research
*1, sometimes known as experimental research; *2, analogous term: interventional; *3, analogous term: noninterventional or nonexperimental
Punita V. Solanki
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Research Method Approaches
13th September 2014
3rd Annual National
Conference of SHT,
India
Qualitative
Research Method
Approach
Quantitative
Research Method
Approach
Mixed Methods
Research
Approach
Ethnography
Observational
Descriptive Research
Sequential
Procedures
Grounded Theory
Observational
Analytical Research
Concurrent
Procedures
Case Study
Experimental/Interv
entional Research
Transformative
Procedures
Phenomenological
Research
Narrative Research
Source: Research Design: Qualitative, Quantitative and Mixed Methods Approaches. John
W. Creswell. Second Edition. 2003. Sage Publications . In Chapter 1: A Framework for
Design.
Punita V. Solanki
Occupational
Therapist
Qualitative Versus Quantitative Study Designs
13th September 2014
3rd Annual National
Conference of SHT,
India
 Understands theory
 Favors Fieldwork
 Interview/Observation
 Discovering frameworks
 Textual (words)
 Theory (Hypothesis)
generating
 Quality of informant is
more important
 Subjective
 Embedded knowledge
 Multiple sources of
evidence (triangulation)
 Models of analysis: text
or words of interviewees
 Open (Inductive) Vs Pre‐
Structured (Deductive)
 Predicts theory
 Favors Laboratory work
 Test/Scale/Score/Survey
 Existing frameworks
 Numerical
 Theory (Hypothesis)
testing (experimental)
 Sample size core issue in
reliability of data
 Objective
 From Public
 Single‐criterion outcome
(albeit multidimensional)
 Model of analysis:
parametric, non‐parametric
 Observational Vs
Experimental/Interventional
Qualitative: Quantitative:

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Occupational
Therapist
Quantitative Study Designs
Treatment Assigned
No Yes
Observational Study Experimental or
Interventional Study
Comparator
Randomized
No Yes
No Yes
Descriptive Study
Analytical Study
Non RCT
RCT
13th September 2014
3rd Annual National
Conference of SHT,
India
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Occupational
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Types of Quantitative Study Designs:
Observational:
Descriptive
• Case Report
• Case Series
Observational:
Analytical
• Cohort
• Case Control
• Cross
Sectional
Experimental
or
Interventional
• Single Group
• Parallel
• Cross Over
• Factorial
• Withdrawal
• Latin Square
• Sub Groups
• Pilot Groups
• Group
Allocation
Randomization
& Blinding
Methods to Reduce Bias in
Experimental Studies:
13th September 2014
3rd Annual National
Conference of SHT,
India
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Occupational
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Other Types of Study Designs:
Audits
Surveys
Economic Analysis (Cost Analysis, Cost
Effectiveness Analysis, Cost‐Benefit
Analysis, Cost‐Utility Analysis)
Systematic Reviews & Meta‐Analysis
Narrative Reviews
13th September 2014
3rd Annual National
Conference of SHT,
India

5. 02/01/2016
5
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Therapist
Common Terms Used to Describe Studies:
Longitudinal
Cross Sectional
Prospective (Before & After Design)
Retrospective
Retrospective ‐ Prospective
Ecological
Explanatory
Pragmatic
Cluster
Efficacy
Effectiveness
Randomization
Blinding
Controls
Placebo/Sham
13th September 2014
3rd Annual National
Conference of SHT,
India
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India Observational Study
Designs
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Observational Descriptive Study Designs
The researcher is looking at
what is happening to a group of
people
Does the researcher have a
control group with which to
compare these people?
IF No: Observational
Descriptive Study Design
What is Happening in the Study?
Example: Case Report and Case Series (Useful for generating ideas
for research projects). Researcher reports what was observed in one
person or in a group of people

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Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Observational Analytical Study Designs
What is Happening in the Study?
The researcher is looking at
what is happening to a group
of people
Does the researcher have a
control group with which to
compare these people?
IF YES: Observational
Analytical Study Design
Researcher reports the similarities and differences between
two or more groups of people.
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
• Something happened to
the people. The
researcher wants to
observe the outcome.
Cohort
Study
• The outcome is already
known. The researcher
wants to know why some
people got this outcome.
Case
Control
Study
• The researcher already
knows what happened to
the people and what the
outcome was.
Cross
Sectional
Study
Observational Analytical Study Designs
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Cohort Study Design
PAST PRESENT FUTURE
Subjects Exposed
to Risk Factor
Matched Controls Not
Exposed to Risk Factor
Follow Up
Everyone to
See Who
Gets the
Outcome

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Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Cohort Study Design: Example
PAST PRESENT FUTURE
Professional Computer Users
Exposed to Risk of Repetitive
Reaching Tasks
Professional Computer Users
not Exposed to Risk of
Repetitive Reaching Tasks
Follow Up
Everyone to
assess the
symptoms of
Repetitive
Strain Injuries
of Upper Limb
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Case Control Study Design
PAST PRESENT FUTURE
Subjects with the
Outcome
Matched Controls
without the Outcome
Look Back to
See Which
Risk Factors
They Have
Been
Exposed To.
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Case Control Study Design: Example
PAST PRESENT FUTURE
Subjects with CMC
Joint OA
Matched Controls
without CMC Joint OA
Look Back to
See Which Work
Related Risk
Factors They
Have Been
Exposed To.

8. 02/01/2016
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Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Survey: One Time Assessment.
Subjects are questioned for the presence of risk
factors and outcomes.
Useful for establishing Prevalence.
Establish Association but Not Causality.
Are cheap, simple and ethically safe.
Large study sample required.
Cross Sectional Study Design
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
The groups can be unequal, confounders can be
asymmetrically distributed and recall bias is a
problem.
Used to collect information on a Sample of the
Population.
Special kind of Survey: Example: Census.
Academic Perspective: Can be a chosen study
design for dissertation study [Which has limited
Time Duration for the Conduct of the Study]
Cross Sectional Study Design
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Example:
1. Prevalence of Repetitive Stress Injuries of Upper
Limbs in Secondary School Children, who are
Computer Users, as assessed by one time
Questionnaire.
2. Severity of CMC Joint Osteoarthritis amongst the
Adult Female Chefs Aged 20 to 40 years into daily
professional catering business as assessed on a one
time Questionnaire.
Cross Sectional Study Design

9. 02/01/2016
9
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Observational Study Design Selection
Based on Time Availability
Punita V. Solanki
Occupational
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13th September 2014
3rd Annual National
Conference of SHT,
India
 Cause to Effect
 Starts with Exposure
 Tests Disease
Frequency
 Large Sample Size
 Long Term Follow Up
 Expensive
 Less Recall Bias
 Greater Level of
Evidence (Level: 2)
 Prospective
 Effect to Cause
 Starts with Disease
 Tests Cause
Frequency
 Small Sample Size
 Short Term Follow Up
 Inexpensive
 Recall Bias +
 Lower Level of
Evidence (Level: 3)
 Retrospective
Cohort Versus Case Control Study Designs
Cohort Study Design Case Control Study Design
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India Experimental/
Interventional Study
Designs

10. 02/01/2016
10
Punita V. Solanki
Occupational
Therapist
What is happening in the study?
The researcher has introduced a treatment
to some or all of the people and is looking
at what the effects are
Were the people who received the new
treatment chosen at random?
YES No
RCT NRCT
13th September 2014
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India
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Single Group Study Design (Interventional Study)
Enrollment:
Baseline
Treatment
Screening
Example: Population: Infants with Club Hand Deformity
Intervention: Novel Club Hand Splint
Comparator: None
Outcome: Functional Hand Score
Study Design: Single Group Study
13th September 2014
3rd Annual National
Conference of SHT,
India
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Occupational
Therapist
Parallel Groups Study Design
Enrollment:
Run In Period
Randomization
Rx: A
Rx: B
Baseline
Example: Population: Infants with Club Hand Deformity
Intervention: Novel Club Hand Splint (Rx: A)
Comparator: Resting Pan Splint (Rx: B)
Outcome: Functional Hand Score
Study Design: Parallel Group Study
13th September 2014
3rd Annual National
Conference of SHT,
India

11. 02/01/2016
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Punita V. Solanki
Occupational
Therapist
Cross Over Study Design
Enrollment:
Baseline
Randomization
Wash Out Period
Screening
Rx: A
Rx: B Rx: B
Rx: A
Example: Population: Male Adults with HTN & DM
Intervention: Conventional Exercises (Rx: A)
Comparator: Conventional Exercises with
Isokinetic Hand Training (Rx: B)
Outcome: Hand Strength; Functional Endurance
Study Design: Cross Over Study
13th September 2014
3rd Annual National
Conference of SHT,
India
Punita V. Solanki
Occupational
Therapist
Parallel Versus Cross Over Study Design
 Between Patients
 More Variability
 Less Sensitive
 More Patients
 Robust
 No Wash Out Period
 No Test Retest Effect
 No Need for Stable
Disease
 Within Patients
 Less Variability
 More Sensitive
 Fewer Patients
 Less Robust
 Wash Out Period
 Test Retest Effect
 Must have Similar
Baseline & Stable
Disease
Parallel Study Cross Over Study 13th September 2014
3rd Annual National
Conference of SHT,
India
Punita V. Solanki
Occupational
Therapist
Factorial Study Design
Exercise Therapy +
Stimulator (Rx: B)
YES Placebo B0
Exercise
Therapy +
Manual
Therapy
(Rx: A)
YES Group I
Rx: A + B
Group II
Rx: A + B0
Placebo
A0
Group III
Rx: A0+ B
Group IV
Rx: A0 + B0
E.g.: Population: Adult Industrial Male Workers with Hand Injury
Intervention: Exercise Therapy + Manual Therapy (Rx: A) &
Exercise Therapy + Placebo MT (Rx: A0)
Comparator: Exercise Therapy + Stimulator (Rx: B) & Exercise
Therapy + Placebo Stimulator (Rx: B0)
Outcome: Perdue Dexterity Test & the Time to Return to Work
Study Design: Factorial Study
13th September 2014
3rd Annual National
Conference of SHT,
India

12. 02/01/2016
12
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Factorial Study Design
E.g.: Population: Adult Industrial Male Workers with Hand Injury
Intervention: Exercise Therapy + Manual Therapy(Rx: A) &
Exercise Therapy + Placebo MT (Rx: A0)
Comparator: Exercise Therapy + Stimulator (Rx: B) & Exercise
Therapy + Placebo Stimulator (Rx: B0)
Outcome: Perdue Dexterity Test & the Time to Return to Work
Study Design: Factorial Study
Enrollment: Baseline
Randomization
Run In
Period/Screening
Rx: A + B
Rx: A0 + B0
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Withdrawal Study Design
Treatment A
Group I: Continued on
Treatment A
Group II: Withdrawn
From Treatment A
Advantages:
• Easy access to subjects.
• Show whether proven treatment remains beneficial.
Disadvantages:
• Selected population.
• Different stages of disease.
E.g. Population: Adults with CMC Joint OA; Intervention:
Intra‐articular Therapy; Comparator: Subjects
withdrawn from the study; Outcome: Effect on Articular
Cartilage as assessed on MRI & Study Design:
Withdrawal Study Design
13th September 2014
3rd Annual National
Conference of SHT,
India
Punita V. Solanki
Occupational
Therapist
Latin Square Study Design
Example: Population: Adults with Upper Limb CRPS
Intervention: Drug A (3 Formulations: 1, 2 & 3)
Comparator: Drug B & C (3 Formulations: 1, 2 & 3)
Outcome: Pain Assessment on VAS, Functional Score & Effect
on QoL.
Study Design: Latin Square Study Design
Volume
Number
Period 1 Period 2
Period 3
1 A B C
2 B C A
3 C A B
13th September 2014
3rd Annual National
Conference of SHT,
India

13. 02/01/2016
13
Punita V. Solanki
Occupational
Therapist
Types of Controls Used in Experimental Studies
No Control Group (Single Group
Interventional Study Design)
Experimental Studies: (Control Group Always
Present)
Historical Controls
Placebo Therapy/Sham Treatment
Standard of Care/Conventional Therapy
Other Treatment Methods (To be proved
superior or inferior to the experimental novel
treatment method)
13th September 2014
3rd Annual National
Conference of SHT,
India
Punita V. Solanki
Occupational
Therapist
Random Number Generation &
Concealed Allocation
There are a variety of techniques to generate a
random sequence that can be used to decide
allocation:
Computer random number generation
Random number tables
Shuffled cards or envelopes.
This ensures that the group assignment cannot be
predicted in advance.
13th September 2014
3rd Annual National
Conference of SHT,
India
Punita V. Solanki
Occupational
Therapist
Random Number Generation &
Concealed Allocation
Concealment means the interventions in the
different arms of the study are kept secret. So the
researchers are unaware of the intervention in the
group to which a subject will be allocated.
Advantage: It avoids both conscious &
subconscious selection of patients into the study. It
prevents selection bias. A good study will have
different investigators recruiting and randomizing
subjects. Alternatively randomization can be done
electronically on internet or with sealed opaque
envelops or coded containers.
13th September 2014
3rd Annual National
Conference of SHT,
India

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Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Types of Randomization
Fixed Randomization: The randomization
methods are defined and allocation sequences are
set up before the start of the study. E.g.: Simple,
Block, Stratified & Randomized Consent. Other
types are Quasi‐Random Allocation, Cluster
Randomization.
Adaptive Randomization: The randomized
groups are adjusted as the study progresses to
account for imbalances in the numbers in the
groups or in response to the outcome data. An
example is minimization.
Randomization reduces:
Selection Bias &
Confounding Bias
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Types of Fixed Randomization
Simple Randomization: Random assignment of
treatments per participant; independently of any
other factors.
Method: Flipping a coin (2 Groups), rolling a die
(> 2 Groups), Random number tables, Computer
generated random numbers.
Advantage: Simple and Practical to implement.
Disadvantage: Unequal distribution of
confounding factors; particularly in small trials.
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Types of Fixed Randomization
Block Randomization: Randomization within
blocks of sequential participants. Some refer to
this method as “Permuted Block Randomization”.
Method: Subjects are put into blocks which when
filled are divided equally into the different arms
of the study. The order of this allocation within
the block is randomly permuted.
Advantage: Equal numbers of patients in each
arm are ensured.

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Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Types of Fixed Randomization
Stratified Randomization: Randomization
within clusters of participants. It has better control
of potentially important prognostic factors (age,
gender, race, clinical centres, geographical regions
etc.)
Method: Subgroups containing confounding factors
are formed. Block randomization takes place within
each subgroup.
Advantage: Confounding factors are equally
distributed in the different arms.
Disadvantage: Impractical in small
studies; so minimization is an
alternative method for achieving
similarity between groups.
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Adaptive Randomization
The probability of being allocated to a certain arm
in the study is adjusted to maintain similarity
between the arms. E.g. Minimization.
Minimization: At the outset of the study it is
decided which factors would be present in equal
numbers in the different arms.
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Types of Blinding
Open Label Study.
Single Blind Study. {Usually the research
participant is blinded}
Double Blind Study. {The investigator and the
research participants are blinded}
Triple Blind Study. {The investigator, research
participant and the statistician are blinded}
Double Blind Double Dummy
Blinding Reduces:
Observation Bias &
Analysis Bias

16. 02/01/2016
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Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Level of Evidence of Various Study Designs
Punita V. Solanki
Occupational
Therapist
Quiz Time
Title 1: Efficacy of pressure therapy in the
management of hand oedema in patients with crush
hand injury ‐ A randomised controlled trial.
Objective: To compare pressure therapy with
conventional therapy in terms of oedema
management and functional improvement.
P: Patients with Crush Hand Injury
I: Pressure Therapy
C: Conventional Therapy
O: Reduction of Oedema and Improvement of Hand
Function
S: RCT
13th September 2014
3rd Annual National
Conference of SHT,
India
Punita V. Solanki
Occupational
Therapist
Quiz Time
Title 2: Efficacy of Static Serial Versus Static
Progressive Hand Splint as an Adjunct to Exercise
Therapy in the Functional Management of Post
Burn Hand Contractures : A 12 month randomised
controlled trial.
P: Patients with Post Burn Hand Contracture
I: Static Serial Splint & Exercise Therapy
C: Static Progressive Splint & Exercise Therapy
O: Improvement of Hand ROM and Function
S: RCT
13th September 2014
3rd Annual National
Conference of SHT,
India

17. 02/01/2016
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Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Quiz Time
Say True or False:
1. Randomized Controlled Trial offers the best evidence for all
clinical research questions
Answer: False
2. To study the incidence and prevalence of sports injuries
amongst the school children we should select RCT study
design.
Answer: False
3. Randomized Controlled Trials offers Level Ib evidence on
analysis.
Answer: True
4. To study the efficacy of a novel occupational therapy
treatment method we should select RCT study design
Answer: True
5. Randomization in an RCT study design reduces observation
bias.
Answer: False
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Quiz Time
Say True or False:
6. Cohort studies are relatively cheap as compared to Case
Control studies
Answer: False
7. Cohort studies require a small sample size as compared to
Case Control studies
Answer: False
8. The best observational study design for studying the
functional outcome in Mucopolysaccharidosis patients
attending the genetic clinic of the hospital with an incidence of
1 in 25,000 born babies, would be Case Control Study?
Answer: True
9. Case Control studies are prospective study designs
Answer: False
10. Cross sectional study design is the best for studying
prevalence of any condition
Answer: True
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Quiz Time
Select the Best Correct Response:
1. Two novel occupational therapy treatment methods were
published independently in a journal. If we plan to compare
these two novel treatment methods in the same study for a
progressive condition, which study design would be the best?
a. Withdrawal Study
b. Parallel Group Study
c. Cross Over Study
d. Factorial Study
KEY: d
2. Two treatment methods are proved to be efficacious in the
management of spine degenerative conditions independently.
If we plan to compare these treatment methods which study
design would be the best?
a. Withdrawal Study
b. Parallel Group Study
c. Cross Over Study
d. Factorial Study
KEY: b

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Punita V. Solanki
Occupational
Therapist
Quiz Time
Select the Best Correct Response:
3. The strongest evidence for causality comes from which of
the following research methods/designs?
a. Experiment
b. Case control study.
c. Correlation study.
d. Ethnography.
KEY: a
4. An investigator takes a sample of healthy individuals,
records their ongoing exposure to the treatment with novel
low temperature thermoplastic splint and relates that to the
subsequent occurrence of skin irritation in the same group.
a. Case‐control study
b. Ecological study
c. Cohort study
d. Cross‐sectional study
KEY: c
13th September 2014
3rd Annual National
Conference of SHT,
India
Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
Quiz Time
Select the Best Correct Response:
5 . Recall Bias is encountered in which of the following
observational study design?
a. Case Series
b. Cohort
c. Cross Sectional
d. Case Control
KEY: d
6. Which of the following is an advantage of a case‐control
study?
a. There is little or no bias in assessment of exposure.
b. Multiple disease outcomes following a selected exposure
can be readily studied.
c. Dependence on recall by subjects in the study minimized.
d. It is possible to determine the true incidence of the disease.
e. It may be used to study etiology of a rare disease
KEY: e
Punita V. Solanki
Occupational
Therapist
Acknowledgements:
I am extremely thankful to my mentor for critically
reviewing my presentation & guiding me with
valuable comments to improvise on my
presentation:
• Dr. Sandeep B. Bavdekar Sir (HOD ‐ Paediatric
Medicine Department at B. Y. L. Nair Hospital & T. N.
Medical College, Mumbai Central).
13th September 2014
3rd Annual National
Conference of SHT,
India

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Punita V. Solanki
Occupational
Therapist
13th September 2014
3rd Annual National
Conference of SHT,
India
References:
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7. Research Design: Qualitative, Quantitative and Mixed Methods
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Presentation Time Duration:
1 Hour