HSH708 AT4 Endah Setyaningsih Final

7/31/2019 HSH708 AT4 Endah Setyaningsih Final

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Endah Setyaningsih 1800596468

Assignment 2

HSH708 Health Economic and Program Evaluation

6 November 2008

An Appropriate Study Design for Evaluating

Hospital in the Home (HITH) Program

Endah Setyaningsih

800596468

Deakin University


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I. Introduction

Evaluation is a fundamental activity to measure the effectiveness of a

program or individual performance(Owen & Rogers, 1999). Evaluation can be

defined as critically and justify reasons for selected course of action (Owen,

2006; Owen & Rogers, 1999, p. 1). Ernest House (cited in Owen & Rogers

1999) suggests that evaluation consists of many aspects from collecting data,

identifying relevant value, finding a suitable study design or measures for the

dimensions, validating the standards and finally, evaluative conclusion.

In addition, the study design can be classified as epidemiological designs and

other designs (Dunt, 2004). Based on epidemiology, as mentioned at Bonita,

Beaglehole, and Kjellstrom (2006), there are two types of studies which are

observational studies (i.e. case control and cohort study) and experimental

studies (i.e. randomized controlled trial [RCT], cluster randomized controlled

trial, and field trial). The other types of study are, the two-period cross-over

trial, the community trial, interrupted time series design, and program

monitoring (before, during and after) including secular trends (Dunt, 2004).

A study design could help investigators to identify or measure the connection

between exposure and outcome (Dunt, 2004). However, each study has

strengths and weaknesses that should be considered before implementing in

the program evaluation, such as evaluating hospital in the home (HITH)

program (Bonita et al., 2006). Therefore, after briefly describing HITH

programs and discuss exclusion of some study designs, this paper will


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discuss three study designs for evaluating HITH and purpose the most

appropriate study design which may be suitable for evaluating the program.

II. Program description

Recently, numerous people in the society are experiencing a long period of

chronic disease and require long term treatments. Therefore, it is important to

develop some effective alternatives to tackle this problem. There is an

efficient alternative that has been offered by some hospitals such as treatment

of acute hospital services in patients home or HITH. There are wide ranges of

home treatment that has been demonstrated namely, osteomyelitis,

pneumonia, pyelonephritis, celluitis, pelvic inflammatory disease, subacute

bacterial, endocarditis, and many post-operative wound infections, chronic

obstructive airways disease, diabetes, AIDS-related disease, and

chemotherapy.

Moreover, this alternative solution also provides various levels of action, in

particular qualify and eligible staff for those disease categories and adequate

emergency preparedness that might be needed by the patients. Therefore, to

assess the effectiveness of this program, management ask evaluators to find

an appropriate study design for conducting research evaluation. The mains

objectives are:

1. the health outcomes for patients in a HITH program

2. the safety of HITH programs


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3. the accessibility of HITH care to patients and their families

4. costs of HITH programs

From these objectives, it is clear which study designs can be used or cannot

be used. Case-control is not appropriate to examine the time relationship

between exposures and outcomes, because the study begin from the

outcomes (Farmer & Lawrenson, 2004). Moreover, they explain that case-

control cannot measure multiple outcomes or where the objectives of the

study are more then one. Another study is community trial design, it is

excluded because the objectives of the study focus on individuals than

community (Dunt, 2004). Moreover, conducting community trial is impossible

for HITH programs because it needs a lot of communities involvement.

Interrupted time series design is also excluded because this is more

appropriate when the objectives of the study encompass individual and

community objectives (Dunt, 2004). Therefore, the following paper will discuss

three study designs that could be implemented to assess the objectives of

HITH programs.

III. Study Design

As describe above, the HITH program aims more on individuals (patient) -

health outcome of the HITH patients, costs, safety and acceptability. Yet,

those objectives also might also have impact on hospitals management or

patients families. In order to these various objectives, there are some study

designs that could be employed to evaluate the HITH program, such as

randomised control trial, cohort, and two-period cross-over trial.


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III.1. Randomised Control Trial (RCT)

Randomised control trial (RCT) is an experimental study that can indentify the

effects of a specific intervention (Bonita et al., 2006). They also explain that

the participants or the subjects in the study population are randomised

allocated to receive intervention (study group) and not receive intervention

(control group), and then follow-up to identify which ones progress to

developing the disease or outcomes.

RCT could be implied to assess the effectiveness of HITH programs. For

example, eligible participants are randomised allocated by the evaluators, first

group is going to receive HITH (study group) and the second group is not

going to receive HITH (control group), then follow-up for few months. Eligible

participants mean that the patients are decided after they have done several

checked by medical professionals and then classify as acute or subacute. For

example, acute patients can been seen from urinary tracts, subacute can be

seen from deep venous thrombosis (DVT) (Caplan et al., 1999). Thus, the

patients are followed up by nurse or other practitioners to find out, (1) patients

health outcomes, (2) safety, (3) costs differences, and (4) the acceptability of

the HITH program to families and the patients.

The patients health outcomes parameter can be seen by looking several

factors such as internal or external physical conditions. Additionally, the

satisfaction of the patients will be followed up using phone call. There will be a

questioned that should be answered by the patients and families with four


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indicators (excellent, good, fair and poor). Below figure 1 is the schematic

diagram presents RCT for HITH programs.

Figure1. Randomised control trial for HITH programs

RCT as a gold standard of study design has some benefits, in particular can

investigate multiple outcomes as seen in figure 1. This is due to the starting

point of the study; it starts from the exposure (HITH program) rather then

outcomes (Bonita et al., 2006; Dunt, 2004). Moreover, it can minimise biases

and confounding factors because of random allocation to intervention or

Population

HITHprograms(interventio

n group)

No HITHprograms

(controlgroup)

Better health outcomes

Satisfaction includessafety, costs andacceptability (indicators excellent, good, fair andpoor)

No difference orremind the same

No difference orremind the same


Satisfaction includessafety, costs and

acceptability (indicators excellent, good, fair andpoor)

Randomised(after assessed bymedical professional,then classify acute orsubacute)


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control groups (Bonita et al., 2006). Thus, the validity and power of the results

is high (Hennekens, CA & Buring, JA., 1987). It is necessary because it will

support management with strong evidence when they decide introducing

HITH programs for the first time to the public.

However, RCT has two major weaknesses such as ethical issues and sample

size that should be considered by the evaluators. Ethical issue becomes a

major problem because associated with it being an experiment (Bonita et al.,

2006). For instance, by allocating the patients to receive home treatment or

hospital treatment based on evaluators willingness seem unethical. The

patients or the patients families who are suppose to decide whether they

want home treatment or hospital treatment.

In addition, a proper RCT needs massive sample size in order to reduce

confounder effects (Bonita et al., 2006). If the sample size is sufficient,

randomisation will ensure that all common or uncommon confounders are

equally distributed between the groups (Aschengrau & Seage, 2008).

However, there might insufficient patients that could participate in this study,

due to have been introduced the HITH programs.

Beside those two major concerns, there are other issues of conducting RCT

for HITH programs, particularly loss to follow-up or withdrawal that can

influence the power of the results as well. If the study design conducted in a

long period of time, there is possibility that patients move to others place or

does not want to participate anymore before the end of the result. In addition,


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Strong evidence is needed to conduct RCT (Bonita et al., 2006). Even though,

several HITH programs are well demonstrated for the patients such as in

chemotherapy and diabetes and AIDS related diseases, this is not enough. It

needs strong evidenced-based for undertaking the study, as it is an

experiment (Bonita et al., 2006).

III.2. Cohort Study Design

Cohort study is one from two observational studies that has mentioned in the

earlier. Cohort study can be classified as follow-up or incidence studies,

because it begin with a group of individual according their exposure status

and follow-up until develop outcomes (Bonita et al., 2006). The Study is also

able to examine one or multiple outcomes from single exposure or risk factor

(Aschengrau & Seage, 2008). This study design is similar with RCT, yet the

participants are not randomly allocated by investigators or evaluators.

Therefore, cohort study design could be employed to examine the four

objectives of HITH programs. Based the strict criteria that has been justified

by medical professionals, subjects are defined according exposed and

unexposed groups (HITH treatment and hospital treatment respectively). The

exposures then followed over the time to find out the health outcomes, safety,

acceptability and costs of HITH programs.

Similarly, the exposed group are classified or divided into two group acute

disease or subacute disease which enabling evaluators to assess the

presences of disease response to the treatments. In addition, the basic


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criterion for selecting control group (i.e. hospital treatments) should be equally

susceptible. For example, this required that both groups, study group and

control group are matched in respect of variables such as the patients

disease, age group, sex and other parts that can influence the outcomes

(barker, cooper and Rose, 1998). A schematic diagram of cohort study for

HITH program can be seen in figure 2.

Figure 2 Schematic diagram of cohort study for HITH program

There are several strengths of cohort study that can be used to assess the

four objectives of HITH programs. The strengths are: (1) cohort study design

Source ofpopulation

Expose toHITHprograms

Notexposedto HITHprograms

Opposite outcomes

Opposite outcomes


Satisfaction includes safety,costs and acceptability(indicators excellent, good,fair and poor)


Satisfaction includes safety,costs and acceptability(indicators excellent, good,fair and poor)

(Hospital treatments orother communitytreatments, but matchedsuch as disease, sex and

age)

Acute (pneumonia,urinary tract,infections andcellulitis)Subacute(endocarditic and

oesteomyelitis)


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is very useful for rare exposure (Bonita et al., 2006; Fos & Fine, 2005). HITH

program are classified as a new program or innovation due to management

has not made a decision to introduce the HITH programs to public, thus it

might be rare patients (exposure) that would joint the study. (2) The study is

able to investigate multiple outcomes as mentioned by Aschengrau and

Seage (2008). As a result, this study is suitable for assessing HITH programs

which have more than one outcome, such as patients health outcomes,

safety, acceptability and costs. (3) The most advantage of conducting this

study is able to identify a temporal relationship between exposures and

outcomes (Bonita et al., 2006). This is very powerful and essential element of

a study in order to find out real cause and effects. Thus, it can affect

managements confidence of the program. (4) Moreover, biases are not

generally a problem because the enrolment occurs before the outcomes have

developed (Hennekens & Buring, 1987). Thus, Hospitals management can

introduce HITH programs to the public with full of confidence.

However, there are several limitations of cohort that evaluators should be

considered. Usually, the study needs longer time until the outcomes occurred

and spent a lot of money (expensive) (Bonita et al., 2006), yet, this might not

a major concern. Another weakness is a loss to follow-up due to various

factors such as migration or withdrawal from the study that may cause bias

the results (Farmer & Lawrenson, 2004). In the case of HITH programs, loss

to follow-up may happen due to health conditions of the participants are

getting worst. They might need emergency interventions or sent back to the

hospitals treatments immediately. Thus, basic information of the participants


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and outcomes of those HITH programs cannot be followed-up in detail.

Regardless of the reality that there were some losses followed-up, the results

still valid with benchmark equal or more 80% participants in the study

(Aschengrau & Seage, 2008). Furthermore, in the case of HITH programs

loss to follow-up can be minimised by classifying the exposure group as

mentioned above.

III.3. Two-Period Cross-Over Trial

Similar with RCTs, the two-period cross-over trial adopts an experimental

design (Dunt, 2004). Armitage and Hills (1982) explain that two-period cross-

over trial compares between 2 treatments in each participant, where

participants are assigned randomly to two groups (i.e. group A or group B).

They also suggest that wash out period must be inserted between two

treatment periods. Wash out period must be inserted in order to minimise any

effects of first treatment that could influence second treatment (Dunt, 2004).

This study design might be implied in HITH programs. Here, A and B are two

treatments (i.e. HITH programs = A, and hospital treatment = B) under

comparison. Where treatment A and B will be given to each participant, yet it

will be given in different sequence with wash out period between periods I and

periods II (each period around 12 months). Then, their response of both

treatments such as health outcomes, safety, acceptability and the costs of the

program are compared (see figure 3).


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Figure3 Two-period cross-over trial for HITH program

Group I

Group II

Two-period cross-over trial is commonly used by evaluators due to two main

attractions such as more economical and the comparison 2 programs within

patients (Armitage & Hills, 1982). For instance, each participant provides with

two treatments (HITH and hospital treatment) which responses to treatments

are calculated, as a result it economises in the number of participants or

sample size. Another aspect of economic is because the study needs small

number of participants, it will effect budget allocation (cost effective).

HITHprograms

Hospitaltreatment

Washoutperiod

Randomisedhalf studyperiod

Randomisedhalf studyperiod

Period I

12 months

Hospitaltreatment

HITHprograms

Period II

12 months


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Despite economic advantage, the four objectives of HITH programs will

clearly define because the comparisons of treatment are identified within

participants, therefore the participants immediately can express the different

between HITH programs and hospital treatment in terms of their health

outcomes, safety, the costs differences and the acceptability of the program.

However, two-period cross-over trial has some weaknesses. First, the

difficulty to find eligible participants that could be allocated in HITH programs

and hospitals treatment. For example, AIDS-related disease patients might

not eligible for both hospital and HITH treatments. This can be tackled by

using participants that eligible for both treatments, yet it will limit variety of the

diseases. Second, although there is washout period, substantial biases

because first treatment might still there and it will affect the result of the next

treatment. For example, hospital treatments might already cure the patients,

as a result the HITH treatment (second treatment) result are might affected by

hospital treatment.

IV. Recommendation and Conclusion

This paper has presented some discussion about three study design

strategies that can be implied to determine the objectives of HITH programs.

In general, the similarity of these studies is using prospective study design.

Thus, it is able to assess multiple outcomes or objectives. However, there are

some differences on the limitations from those three study designs as in the

following table.


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Table 1- The limitations of three study design

No. Limitations RCT Cohort Two-period cross-over trial

1. Ethical issues ++++ - -

2. sample size ++++ ++ +

3. Duration of the

study

+++ ++ ++

4. Evidence ++++ + +

5. Biases - + ++++

6. Temporal

relationship

++++ ++++ +

+...++++ indicates a general degree of needs form weak to strongest- indicates not need

It is clearly shown from the table above that cohort study is the most feasible

or appropriate to determine the objectives of HITH program. It is more feasible

than other studies because those limitations can be tolerated or controlled as

discussed in point II cohort study design.

Although between cohort and two-period cross-over trial has less limitations

then RCT, biases in two-period cross-over trial are serious problems. This can

reduce the significance of the results. Moreover, two-period cross-over trials

less possible to identify temporal relationship between exposure and

outcomes.


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To conclude, HITH programs are a new innovative program that can be used

as an alternative treatment to improve health outcomes to the patients.

However, it is necessary for policy makers or hospitals management to run

an appropriate research with an appropriate study designs. Thus, when the

program is ready introduced, there will be strong evidence based practiced. In

addition, there is not right and wrong study design, each study designs have

characteristic. Therefore it is essential to understand the character of the case

and the feasibility of the study design before conducting an evaluation.


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References:

Armitage, P., & Hills, M. (1982). The Two-Period Crossover Trial. TheStatistician, 31(2), 119-131.

Aschengrau, A., & Seage, G. R. (2008). Essentials of Epidemiology in Public

Health(2 ed.). London: Jones and Bartlett Publishers

Bonita, R., Beaglehole, R., & Kjellstrom, T. (2006). Basic EpidemiologyGeneva Word Health Organisation

Caplan, G. A., Ward, J. A., Brennan, N. J., Coconis, J., Board, N., & Brown, A.(1999). Hospital in the home: a Randomised controlled trial MJA, 170,156-160.

Dunt, D. (2004). Session Notes for Choosing an Appropriate Study DesignMelbourne

Farmer, R., & Lawrenson, R. (2004). Epidemiology and Public HealthMedicine(5 ed.). Melbourne Blackwell Publishing

Fos, P. J., & Fine, D. J. (2005). Managerial Epidemiology for Health CareOrganisation(2 ed.). San Fransisco: Jossey-Bass.

Hennekens, C. H., & Buring, J. A. (1987). Epidemiology in Medicine USALittle Brown & CO.

Owen, J. M. (2006). Program Evaluation(3rd ed.). NSW: Allen and Uwin.

Owen, J. M., & Rogers, P. J. (1999). Program Evaluation Forms andApproaches(2nd ed.). NSW: Allen and Uwin

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