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I had been under the impression at the

presentation in Manchester

that the RCTs would be carried out by the existing evaluation team – but that

maybe, was just a misconception on my part.

An important question for me is, what

would the control/comparison groups look like and how much consistency could be

achieved across these sites given that the nature and organisation of family

health support varies across the country (and also practitioners are not

working to a manual in the highly organised way that the family nurses are in

the intervention groups will be doing). In my view these need to be

conducted at least as pragmatic trials, perhaps with three arms so that one of

the comparators is ‘ordinary existing service provision what that is in

each are’, another midwifery and health visiting working to set but

consistent minimum standards and then the intervention group. I would

also like to see inclusion of data collection methods that can pick up the many

different informal sources of guidance and support expectant and new parents seek

for themselves.

Kate Billingham in Manchester did infer that they certainly

wanted the new FNP sites to be spread across the country because of doing the

RCT.

From:

[mailto: ] On Behalf Of Cowley

Sent: 25 January 2008 21:03

Cc:

pafsinterestgroup

Subject: evaluating

the Family Nurse Partnership

Along with the second tranche of money to roll out the

FNP pilots

(intensive home visiting, Olds programme) , is a government

commitment to commissioning an RCT evaluation. I have no idea how

much or who will get the tender, but would be interested to know what

colleagues feel should be taken into account in that study?

best wishes

sarahcowley183btinternet

http://myprofile.cos.com/S124021COn

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Thank you for your thoughts, .  Anyone else?  On 25 Jan 2008, at 22:18, Whittaker wrote:I had been under the impression at the presentation in Manchester that the RCTs would be carried out by the existing evaluation team – but that maybe, was just a misconception on my part.  An important question for me is, what would the control/comparison groups look like and how much consistency could be achieved across these sites given that the nature and organisation of family health support varies across the country (and also practitioners are not working to a manual in the highly organised way that the family nurses are in the intervention groups will be doing).  In my view these need to be conducted at least as pragmatic trials, perhaps with three arms so that one of the comparators is ‘ordinary existing service provision what that is in each are’, another midwifery and health visiting working to set but consistent minimum standards and then the intervention group.  I would also like to see inclusion of data collection methods that can pick up the many different informal sources of guidance and support expectant and new parents seek for themselves. Kate Billingham in Manchester did infer that they certainly wanted the new FNP sites to be spread across the country because of doing the RCT.  From: [mailto: ] On Behalf Of CowleySent: 25 January 2008 21:03 Cc: pafsinterestgroup Subject: evaluating the Family Nurse Partnership Along with the second tranche of money to roll out the FNP pilots (intensive home visiting, Olds programme) , is a government commitment to commissioning an RCT evaluation. I have no idea how much or who will get the tender, but would be interested to know what colleagues feel should be taken into account in that study?best wishessarahcowley183btinternethttp://myprofile.cos.com/S124021COnNo virus found in this incoming message.Checked by AVG Free Edition.Version: 7.5.516 / Virus Database: 269.19.11/1244 - Release Date: 25/01/2008 19:44No virus found in this outgoing message.Checked by AVG Free Edition.Version: 7.5.516 / Virus Database: 269.19.11/1244 - Release Date: 25/01/2008 19:44 sarahcowley183@...http://myprofile.cos.com/S124021COn

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apologies, but my brain is switched off as its Saturday, but what is RCT? ragrds kathy From: kwhittaker1@...Date: Fri, 25 Jan 2008 22:18:45 +0000Subject: RE: evaluating the Family Nurse Partnership

I had been under the impression at the

presentation in Manchester

that the RCTs would be carried out by the existing evaluation team – but that

maybe, was just a misconception on my part.

An important question for me is, what

would the control/comparison groups look like and how much consistency could be

achieved across these sites given that the nature and organisation of family

health support varies across the country (and also practitioners are not

working to a manual in the highly organised way that the family nurses are in

the intervention groups will be doing). In my view these need to be

conducted at least as pragmatic trials, perhaps with three arms so that one of

the comparators is ‘ordinary existing service provision what that is in

each are’, another midwifery and health visiting working to set but

consistent minimum standards and then the intervention group. I would

also like to see inclusion of data collection methods that can pick up the many

different informal sources of guidance and support expectant and new parents seek

for themselves.

Kate Billingham in Manchester did infer that they certainly

wanted the new FNP sites to be spread across the country because of doing the

RCT.

From:

[mailto: ] On Behalf Of Cowley

Sent: 25 January 2008 21:03

Cc:

pafsinterestgroup

Subject: evaluating

the Family Nurse Partnership

Along with the second tranche of money to roll out the

FNP pilots

(intensive home visiting, Olds programme) , is a government

commitment to commissioning an RCT evaluation. I have no idea how

much or who will get the tender, but would be interested to know what

colleagues feel should be taken into account in that study?

best wishes

sarahcowley183btinternet

http://myprofile.cos.com/S124021COn

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My apologies, Kathy, for lapsing into research jargon and thanks for

reminding me!

An RCT is a Randomised Controlled Trial, where the 'research subjects'

(e.g. teenage mums) are allocated randomly to either an intervention

group, who would get the FNP intensive home visiting, or to a control

group. In the US, the control group got nothing, which is one reason

why this form of intervention gets such good results. For me, that is

the big challenge in this country: what would constitute the 'control

group'? We know there are many places where the core health visiting

service is very minimal and many places where health visitors worry

about their ability to provide as much of a service as they would

like. However, I don't think there are many places where very

vulnerable parents would receive nothing, or even just the minimum

core service. Please let me know if I am wrong here; is there anywhere

where the service s so desperately short that even very vulnerable

parents get very few visits or other contacts?

If I am right and most would get an above-minimum service anyway

(what? monthly visits? more or less often?) there are two problems

for the researchers. First, as says, health visiting services

aspire to being personalised rather than programmed, so there would be

a lot of variation in the control group. Second, if the service is

reasonably good, meaning both control and intervention come out as

fairly similar, the RCT will show no great advantage to eithr. That

is what happened when Walter Barker's first parent visiting programme

was evaluated against 'standard health visiting,' which was (at that

time and in the selected sites) sufficiently comprehensive to show no

great difference between the two. But instead of saying 'Oh good, we

must support standard health visiting,' the study was widely

misinterpreted as showing that the first parent visiting programme was

not effective.

I am not keen on the idea of a control group that would be denied

'usual care,' but if there are places where only a very minimal

service is available for even vulnerable famlies, they could provide a

third comparison group, I suppose, but the idea raises a lot of

worries for me.

best wishes

>

> apologies, but my brain is switched off as its Saturday, but what is

RCT? ragrds kathy

>

>

>

>

> From: kwhittaker1@...

> Date: Fri, 25 Jan 2008 22:18:45 +0000

> Subject: RE: evaluating the Family Nurse Partnership

>

>

>

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> I had been under the impression at the

> presentation in Manchester

> that the RCTs would be carried out by the existing evaluation team �

but that

> maybe, was just a misconception on my part.

>

>

>

> An important question for me is, what

> would the control/comparison groups look like and how much

consistency could be

> achieved across these sites given that the nature and organisation

of family

> health support varies across the country (and also practitioners are not

> working to a manual in the highly organised way that the family

nurses are in

> the intervention groups will be doing). In my view these need to be

> conducted at least as pragmatic trials, perhaps with three arms so

that one of

> the comparators is �ordinary existing service provision what that is in

> each are�, another midwifery and health visiting working to set but

> consistent minimum standards and then the intervention group. I would

> also like to see inclusion of data collection methods that can pick

up the many

> different informal sources of guidance and support expectant and new

parents seek

> for themselves.

>

>

>

> Kate Billingham in Manchester did infer that they certainly

> wanted the new FNP sites to be spread across the country because of

doing the

> RCT.

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

> From:

> [mailto: ] On

Behalf Of Cowley

>

> Sent: 25 January 2008 21:03

>

>

>

> Cc:

> pafsinterestgroup

>

> Subject: evaluating

> the Family Nurse Partnership

>

>

>

>

>

>

>

>

>

>

>

> Along with the second tranche of money to roll out the

> FNP pilots

>

> (intensive home visiting, Olds programme) , is a government

>

> commitment to commissioning an RCT evaluation. I have no idea how

>

> much or who will get the tender, but would be interested to know what

>

> colleagues feel should be taken into account in that study?

>

>

>

> best wishes

>

>

>

>

>

>

>

> sarahcowley183@...

>

> http://myprofile.cos.com/S124021COn

>

>

>

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>

>

>

>

>

>

>

> No virus found in this incoming message.

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Hi

I think you’re absolutely right

about vulnerable families already getting more than core health visiting. I know

here in Norwich

we are very good at identifying vulnerable pregnant women both by midwives and

health visitors, thereby activating a pre-birth protocol, to ensure we work in

a multi-agency way to try to support and meet the needs of these families. This

often requires a referral to children’s services and several

professionals being involved.

The health visitor would be very likely to

have more than one antenatal contact and weekly contact with the vulnerable

family in the early weeks/months following the birth but it would also be

dependant on the other pressing needs of the HV caseload. Home care, Home Start

and Embrace Young Mum workers may also be in contact with the family.

In our main areas of deprivation the HV’s

hold smaller caseloads than the non-deprived areas, which works okay until you

get long-term sickness and maternity leave reducing the staffing levels. However

we would still be keen to look at the FNP because it would automatically allow

the women who fit the criteria identified in the pilots to get the extra

support, without having to go down the section 17/47 route or involving too

many other professionals.

Helen

From:

[mailto: ] On

Behalf Of senatehvsn1

Sent: 26 January 2008 13:32

Subject: Re:

evaluating the Family Nurse Partnership

My apologies, Kathy, for lapsing into research jargon

and thanks for

reminding me!

An RCT is a Randomised Controlled Trial, where the 'research subjects'

(e.g. teenage mums) are allocated randomly to either an intervention

group, who would get the FNP intensive home visiting, or to a control

group. In the US,

the control group got nothing, which is one reason

why this form of intervention gets such good results. For me, that is

the big challenge in this country: what would constitute the 'control

group'? We know there are many places where the core health visiting

service is very minimal and many places where health visitors worry

about their ability to provide as much of a service as they would

like. However, I don't think there are many places where very

vulnerable parents would receive nothing, or even just the minimum

core service. Please let me know if I am wrong here; is there anywhere

where the service s so desperately short that even very vulnerable

parents get very few visits or other contacts?

If I am right and most would get an above-minimum service anyway

(what? monthly visits? more or less often?) there are two problems

for the researchers. First, as says, health visiting services

aspire to being personalised rather than programmed, so there would be

a lot of variation in the control group. Second, if the service is

reasonably good, meaning both control and intervention come out as

fairly similar, the RCT will show no great advantage to eithr. That

is what happened when Walter Barker's first parent visiting programme

was evaluated against 'standard health visiting,' which was (at that

time and in the selected sites) sufficiently comprehensive to show no

great difference between the two. But instead of saying 'Oh good, we

must support standard health visiting,' the study was widely

misinterpreted as showing that the first parent visiting programme was

not effective.

I am not keen on the idea of a control group that would be denied

'usual care,' but if there are places where only a very minimal

service is available for even vulnerable famlies, they could provide a

third comparison group, I suppose, but the idea raises a lot of

worries for me.

best wishes

>

> apologies, but my brain is switched off as its Saturday, but what is

RCT? ragrds kathy

>

>

>

>

> From: kwhittaker1@...

> Date: Fri, 25 Jan 2008 22:18:45 +0000

> Subject: RE: evaluating the Family Nurse Partnership

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

> I had been under the impression at the

> presentation in Manchester

> that the RCTs would be carried out by the existing evaluation team �

but that

> maybe, was just a misconception on my part.

>

>

>

> An important question for me is, what

> would the control/comparison groups look like and how much

consistency could be

> achieved across these sites given that the nature and organisation

of family

> health support varies across the country (and also practitioners are not

> working to a manual in the highly organised way that the family

nurses are in

> the intervention groups will be doing). In my view these need to be

> conducted at least as pragmatic trials, perhaps with three arms so

that one of

> the comparators is �ordinary existing service provision what that is in

> each are�, another midwifery and health visiting working to set but

> consistent minimum standards and then the intervention group. I would

> also like to see inclusion of data collection methods that can pick

up the many

> different informal sources of guidance and support expectant and new

parents seek

> for themselves.

>

>

>

> Kate Billingham in Manchester

did infer that they certainly

> wanted the new FNP sites to be spread across the country because of

doing the

> RCT.

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

> From:

>

[mailto: ]

On

Behalf Of Cowley

>

> Sent: 25 January 2008 21:03

>

>

>

> Cc:

> pafsinterestgroup

>

> Subject: evaluating

> the Family Nurse Partnership

>

>

>

>

>

>

>

>

>

>

>

> Along with the second tranche of money to roll out the

> FNP pilots

>

> (intensive home visiting, Olds programme) , is a government

>

> commitment to commissioning an RCT evaluation. I have no idea how

>

> much or who will get the tender, but would be interested to know what

>

> colleagues feel should be taken into account in that study?

>

>

>

> best wishes

>

>

>

>

>

>

>

> sarahcowley183@...

>

> http://myprofile.cos.com/S124021COn

>

>

>

>

>

>

>

>

>

>

>

>

>

>

> No virus found in this incoming message.

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25/01/2008 19:44

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> __________________________________________________________

> Free games, great prizes - get gaming at Gamesbox.

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I would share your thoughts but would also add that the scope for confounders and contamination in an RCT of this kind will be huge given the range and variation of parenting support that is otherwise available. I would have thought the only way that this could be managed would be through a cluster randomised trial so that the pilot sites are randomised to the trial rather than individual parents and the control sites would be in areas completely separate from the pilot sites. It surely would need to be supported by some really good qualitative data to provide some sort of explanatory model for whatever is found in the trial. I would also add that whatever is being funded should be at a realistic cost for an RCT as these tend to be seriously under-funded for complex interventions. I have heard nothing about this being tendered outside of the existing evaluation team so would be interested to know more. My understanding was that the outcome measures are already determined by previous Olds research, is that right?

Sally

Thank you for your thoughts, .  Anyone else? 

On 25 Jan 2008, at 22:18, Whittaker wrote:

I had been under the impression at the presentation in Manchester that the RCTs would be carried out by the existing evaluation team – but that maybe, was just a misconception on my part. 

 

An important question for me is, what would the control/comparison groups look like and how much consistency could be achieved across these sites given that the nature and organisation of family health support varies across the country (and also practitioners are not working to a manual in the highly organised way that the family nurses are in the intervention groups will be doing).  In my view these need to be conducted at least as pragmatic trials, perhaps with three arms so that one of the comparators is ‘ordinary existing service provision what that is in each are’, another midwifery and health visiting working to set but consistent minimum standards and then the intervention group.  I would also like to see inclusion of data collection methods that can pick up the many different informal sources of guidance and support expectant and new parents seek for themselves.

 

Kate Billingham in Manchester did infer that they certainly wanted the new FNP sites to be spread across the country because of doing the RCT.

 

 

From: [mailto: ] On Behalf Of Cowley

Sent: 25 January 2008 21:03

Cc: pafsinterestgroup

Subject: evaluating the Family Nurse Partnership

 

Along with the second tranche of money to roll out the FNP pilots

(intensive home visiting, Olds programme) , is a government

commitment to commissioning an RCT evaluation. I have no idea how

much or who will get the tender, but would be interested to know what

colleagues feel should be taken into account in that study?

best wishes

sarahcowley183@... <mailto:sarahcowley183%40btinternet.com>

http://myprofile.cos.com/S124021COn <http://myprofile.cos.com/S124021COn>

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sarahcowley183@...

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Professor of Nursing

Director, CRIPACC

University of Hertfordshire

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01707 285990 (Admin)

Co-convenor, ICCHNR, www.icchnr.org

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Hello and all

I completely agree with regarding the control groups. I also

think they will need to be vary mindful of the outcome measures used.

I am sure that Olds has pre-set measures for evaluation but

these are almost certainly long term. I guess the evaluation team

will need to conside shorter term and interim measures as well. I

wonder if parents might be invloved in identifying some of the desired

outcomes (short and long term)?

What do others think ?

Quoting Cowley <sarahcowley183@...>:

> Thank you for your thoughts, . Anyone else?

>

>

> On 25 Jan 2008, at 22:18, Whittaker wrote:

>

>>

>> I had been under the impression at the presentation in Manchester

>> that the RCTs would be carried out by the existing evaluation team

>> – but that maybe, was just a misconception on my part.

>>

>>

>>

>> An important question for me is, what would the control/comparison

>> groups look like and how much consistency could be achieved across

>> these sites given that the nature and organisation of family

>> health support varies across the country (and also practitioners

>> are not working to a manual in the highly organised way that the

>> family nurses are in the intervention groups will be doing). In

>> my view these need to be conducted at least as pragmatic trials,

>> perhaps with three arms so that one of the comparators is

>> ‘ordinary existing service provision what that is in each are’,

>> another midwifery and health visiting working to set but

>> consistent minimum standards and then the intervention group. I

>> would also like to see inclusion of data collection methods that

>> can pick up the many different informal sources of guidance and

>> support expectant and new parents seek for themselves.

>>

>>

>>

>> Kate Billingham in Manchester did infer that they certainly wanted

>> the new FNP sites to be spread across the country because of doing

>> the RCT.

>>

>>

>>

>>

>>

>>

>>

>> From: [mailto:SENATE-

>> HVSN ] On Behalf Of Cowley

>> Sent: 25 January 2008 21:03

>>

>> Cc: pafsinterestgroup

>> Subject: evaluating the Family Nurse Partnership

>>

>>

>>

>> Along with the second tranche of money to roll out the FNP pilots

>> (intensive home visiting, Olds programme) , is a government

>> commitment to commissioning an RCT evaluation. I have no idea how

>> much or who will get the tender, but would be interested to know what

>> colleagues feel should be taken into account in that study?

>>

>> best wishes

>>

>>

>>

>> sarahcowley183@...

>> http://myprofile.cos.com/S124021COn

>>

>>

>>

>> No virus found in this incoming message.

>> Checked by AVG Free Edition.

>> Version: 7.5.516 / Virus Database: 269.19.11/1244 - Release Date:

>> 25/01/2008 19:44

>>

>>

>> No virus found in this outgoing message.

>> Checked by AVG Free Edition.

>> Version: 7.5.516 / Virus Database: 269.19.11/1244 - Release Date:

>> 25/01/2008 19:44

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>>

>>

>

> sarahcowley183@...

> http://myprofile.cos.com/S124021COn

--

Malone

mary.malone@...

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Thank you , Sally, , and Helen; all your comments were extremely useful and helpful.I was attending an 'expert group' discussion today, about how the tender document should be put together.  I am not sure of dates or amounts of money, but there will be a call for proposals  coming out at some point.  The call for the next tranche of pilot sites has already happened and one of the criteria will be that they must be prepared to participate in the evaluation study.  Also, there is no expectation that Birkbeck will get the main evaluation programme, although obviously they will be in a very good position to bid for it.  They have been conducting the initial implementation study, testing Olds' instruments and evaluating the process of setting up the pilots.  It was an interesting discussion.  There was a good mixture of questioning as well as enthusiasm for the programme, and a heavy emphasis on immediately measurable outcomes for obvious political reasons.  However, there was also a lot of awareness among the academics about the complexities of implementation and the impact on other services.  Although the consensus was for an RCT, there was quite a debate about whether to randomise by individuals or, as Sally suggests, by area (cluster trials).  There was also a clear view that there would be a lot of questions that could not be answered by an RCT alone, so qualitative research would need to be built in.There are two or three more steps to go; the product of this discussion will be taken up by the research wing of the civil service (presumably in DCSF, but maybe DH); they will formulate a draft tender.  Olds and Hall are acting as expert advisers throughout (unlike 'occasional invitees' like me).  Presumably there will be more rounds of discussions, so no way of knowing at this stage exactly what will come out.   In due course the tender will be advertised, but we were not given any dates or indication of how much funding.  best wishes On 27 Jan 2008, at 11:42, Sally Kendall wrote:I would share your thoughts but would also add that the scope for confounders and contamination in an RCT of this kind will be huge given the range and variation of parenting support that is otherwise available. I would have thought the only way that this could be managed would be through a cluster randomised trial so that the pilot sites are randomised to the trial rather than individual parents and the control sites would be in areas completely separate from the pilot sites. It surely would need to be supported by some really good qualitative data to provide some sort of explanatory model for whatever is found in the trial. I would also add that whatever is being funded should be at a realistic cost for an RCT as these tend to be seriously under-funded for complex interventions. I have heard nothing about this being tendered outside of the existing evaluation team so would be interested to know more. My understanding was that the outcome measures are already determined by previous Olds research, is that right?Sally  Thank you for your thoughts, .  Anyone else?  On 25 Jan 2008, at 22:18, Whittaker wrote:I had been under the impression at the presentation in Manchester that the RCTs would be carried out by the existing evaluation team – but that maybe, was just a misconception on my part.  An important question for me is, what would the control/comparison groups look like and how much consistency could be achieved across these sites given that the nature and organisation of family health support varies across the country (and also practitioners are not working to a manual in the highly organised way that the family nurses are in the intervention groups will be doing).  In my view these need to be conducted at least as pragmatic trials, perhaps with three arms so that one of the comparators is ‘ordinary existing service provision what that is in each are’, another midwifery and health visiting working to set but consistent minimum standards and then the intervention group.  I would also like to see inclusion of data collection methods that can pick up the many different informal sources of guidance and support expectant and new parents seek for themselves. Kate Billingham in Manchester did infer that they certainly wanted the new FNP sites to be spread across the country because of doing the RCT.  From: [mailto: ] On Behalf Of CowleySent: 25 January 2008 21:03 Cc: pafsinterestgroup Subject: evaluating the Family Nurse Partnership Along with the second tranche of money to roll out the FNP pilots (intensive home visiting, Olds programme) , is a government commitment to commissioning an RCT evaluation. I have no idea how much or who will get the tender, but would be interested to know what colleagues feel should be taken into account in that study?best wishessarahcowley183btinternet<mailto:sarahcowley183%40btinternet.com> http://myprofile.cos.com/S124021COn<http://myprofile.cos.com/S124021COn> No virus found in this incoming message.Checked by AVG Free Edition.Version: 7.5.516 / Virus Database: 269.19.11/1244 - Release Date: 25/01/2008 19:44No virus found in this outgoing message.Checked by AVG Free Edition.Version: 7.5.516 / Virus Database: 269.19.11/1244 - Release Date: 25/01/2008 19:44 sarahcowley183btinternethttp://myprofile.cos.com/S124021COn      Professor'>http://myprofile.cos.com/S124021COn      Professor of NursingDirector, CRIPACCUniversity of Hertfordshire 01707 28638001707 285990 (Admin)Co-convenor, ICCHNR, www.icchnr.orghttp://www.healthintransition2009.org.auCo-editor, Primary Health Care Research and Developmenthttp://journals.cambridge.org/action/displayJournal?jid=PHC sarahcowley183@...http://myprofile.cos.com/S124021COn

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Many thanks for the update . It will be interesting to see what develops

From: [mailto: ] On Behalf Of CowleySent: 28 January 2008 21:16 Subject: Re: evaluating the Family Nurse Partnership

Thank you , Sally, , and Helen; all your comments were extremely useful and helpful.

I was attending an 'expert group' discussion today, about how the tender document should be put together. I am not sure of dates or amounts of money, but there will be a call for proposals coming out at some point. The call for the next tranche of pilot sites has already happened and one of the criteria will be that they must be prepared to participate in the evaluation study. Also, there is no expectation that Birkbeck will get the main evaluation programme, although obviously they will be in a very good position to bid for it. They have been conducting the initial implementation study, testing Olds' instruments and evaluating the process of setting up the pilots.

It was an interesting discussion. There was a good mixture of questioning as well as enthusiasm for the programme, and a heavy emphasis on immediately measurable outcomes for obvious political reasons. However, there was also a lot of awareness among the academics about the complexities of implementation and the impact on other services. Although the consensus was for an RCT, there was quite a debate about whether to randomise by individuals or, as Sally suggests, by area (cluster trials). There was also a clear view that there would be a lot of questions that could not be answered by an RCT alone, so qualitative research would need to be built in.

There are two or three more steps to go; the product of this discussion will be taken up by the research wing of the civil service (presumably in DCSF, but maybe DH); they will formulate a draft tender. Olds and Hall are acting as expert advisers throughout (unlike 'occasional invitees' like me). Presumably there will be more rounds of discussions, so no way of knowing at this stage exactly what will come out. In due course the tender will be advertised, but we were not given any dates or indication of how much funding.

best wishes

On 27 Jan 2008, at 11:42, Sally Kendall wrote:

I would share your thoughts but would also add that the scope for confounders and contamination in an RCT of this kind will be huge given the range and variation of parenting support that is otherwise available. I would have thought the only way that this could be managed would be through a cluster randomised trial so that the pilot sites are randomised to the trial rather than individual parents and the control sites would be in areas completely separate from the pilot sites. It surely would need to be supported by some really good qualitative data to provide some sort of explanatory model for whatever is found in the trial. I would also add that whatever is being funded should be at a realistic cost for an RCT as these tend to be seriously under-funded for complex interventions. I have heard nothing about this being tendered outside of the existing evaluation team so would be interested to know more. My understanding was that the outcome measures are already determined by previous Olds research, is that right?Sally Thank you for your thoughts, . Anyone else? On 25 Jan 2008, at 22:18, Whittaker wrote:

I had been under the impression at the presentation in Manchester that the RCTs would be carried out by the existing evaluation team – but that maybe, was just a misconception on my part. An important question for me is, what would the control/comparison groups look like and how much consistency could be achieved across these sites given that the nature and organisation of family health support varies across the country (and also practitioners are not working to a manual in the highly organised way that the family nurses are in the intervention groups will be doing). In my view these need to be conducted at least as pragmatic trials, perhaps with three arms so that one of the comparators is ‘ordinary existing service provision what that is in each are’, another midwifery and health visiting working to set but consistent minimum standards and then the intervention group. I would also like to see inclusion of data collection methods that can pick up the many different informal sources of guidance and support expectant and new parents seek for themselves. Kate Billingham in Manchester did infer that they certainly wanted the new FNP sites to be spread across the country because of doing the RCT.

From: [mailto: ] On Behalf Of CowleySent: 25 January 2008 21:03 Cc: pafsinterestgroup Subject: evaluating the Family Nurse Partnership Along with the second tranche of money to roll out the FNP pilots (intensive home visiting, Olds programme) , is a government commitment to commissioning an RCT evaluation. I have no idea how much or who will get the tender, but would be interested to know what colleagues feel should be taken into account in that study?best wishessarahcowley183btinternet<mailto:sarahcowley183%40btinternet.com> http://myprofile.cos.com/S124021COn<http://myprofile.cos.com/S124021COn> No virus found in this incoming message.Checked by AVG Free Edition.Version: 7.5.516 / Virus Database: 269.19.11/1244 - Release Date: 25/01/2008 19:44No virus found in this outgoing message.Checked by AVG Free Edition.Version: 7.5.516 / Virus Database: 269.19.11/1244 - Release Date: 25/01/2008 19:44 sarahcowley183btinternethttp://myprofile.cos.com/S124021COn Professor of NursingDirector, CRIPACCUniversity of Hertfordshire 01707 28638001707 285990 (Admin)Co-convenor, ICCHNR, www.icchnr.orghttp://www.healthintransition2009.org.auCo-editor, Primary Health Care Research and Developmenthttp://journals.cambridge.org/action/displayJournal?jid=PHC

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http://myprofile.cos.com/S124021COn

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