VAST Clinical Trial NCT01972945 redacted database results

Response to this request is long overdue. By law, under all circumstances, Birmingham Women's and Children's NHS Foundation Trust should have responded by now (details). You can complain by requesting an internal review.

Katharine Tylko-Hill

Dear Birmingham Women's and Children's NHS Foundation Trust,

Under the Freedom of Information Act (2000) please may I request

1) The full database of results from the VAST Vaginoscopy Against Standard Treatment: Clinical Trial NCT01972945 with any patients' or staff names redacted.

2) A full description of the novel system of collecting procedural pain scores and patient acceptability on an iPad mini, including the written explanation given to participating patients as to how to respond.

3) The number of patients who were invited to join the trial but declined to undergo outpatient hysteroscopy and opted from the outset for GA, epidural, IV sedation with analgesia, etc.

4) When the results are to be posted on clinicaltrials.gov and on any other clinical trial databases.

Thank you very much for your kind help.

Yours faithfully,

Katharine Tylko-Hill

FREEDOMOFINFORMATION (BIRMINGHAM WOMEN'S AND CHILDREN'S NHS FOUNDATION TRUST), Birmingham Women's and Children's NHS Foundation Trust

Dear Ms Tylko-Hill

Please accept this email as formal acknowledgement of your request for information received on 18/08/2020​.

This request will be processed in accordance with the Freedom of Information Act 2000 and unless you are otherwise informed, your request will be processed within a maximum of twenty working days from receipt.

At this moment we are unaware of any fees, charges or exemptions likely to be applied to your request. However, if during the course of processing your application it becomes clear that fees will apply, we will inform you of this. In the event that costs are applicable, no information will be provided unless the costs are paid within three months of us informing you. In the event that some or all of the information you have requested is exempt from disclosure, we will inform you of this.

We will also contact you if during the process it emerges that we do not have sufficient detail to locate the information or we are unclear exactly what it is that you have requested.

In the meantime if you wish to discuss any aspect of your request please feel free to contact us at this email address.

Yours sincerely

FOI Lead/Publication Scheme Co-ordinator
Birmingham Womens and Childrens NHS Foundation Trust
[Birmingham Women's and Children's NHS Foundation Trust request email]​

________________________________________
From: Katharine Tylko-Hill <[FOI #685729 email]>
Sent: 18 August 2020 20:52
To: FREEDOMOFINFORMATION (BIRMINGHAM WOMEN'S AND CHILDREN'S NHS FOUNDATION TRUST)
Subject: Freedom of Information request - VAST Clinical Trial NCT01972945 redacted database results

Dear Birmingham Women's and Children's NHS Foundation Trust,

Under the Freedom of Information Act (2000) please may I request

1) The full database of results from the VAST Vaginoscopy Against Standard Treatment: Clinical Trial NCT01972945 with any patients' or staff names redacted.

2) A full description of the novel system of collecting procedural pain scores and patient acceptability on an iPad mini, including the written explanation given to participating patients as to how to respond.

3) The number of patients who were invited to join the trial but declined to undergo outpatient hysteroscopy and opted from the outset for GA, epidural, IV sedation with analgesia, etc.

4) When the results are to be posted on clinicaltrials.gov and on any other clinical trial databases.

Thank you very much for your kind help.

Yours faithfully,

Katharine Tylko-Hill

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FREEDOMOFINFORMATION (BIRMINGHAM WOMEN'S AND CHILDREN'S NHS FOUNDATION TRUST), Birmingham Women's and Children's NHS Foundation Trust

Thank you for your request for information. We apologise for the slight
delay in replying.

 

The information you seek is publicly available as the trial was published
in BJOG:
[1]https://obgyn.onlinelibrary.wiley.com/do...

 

 

Under the Freedom of Information Act (2000) please may I request

1) The full database of results from the VAST Vaginoscopy Against Standard
Treatment: Clinical Trial NCT01972945 with any patients' or staff names
redacted.

2) A full description of the novel system of collecting procedural pain
scores and patient acceptability on an iPad mini,  including the written
explanation given to participating patients as to how to respond.

3) The number of patients who were invited to join the trial but declined
to undergo outpatient hysteroscopy and opted from the outset for GA,
epidural, IV sedation with analgesia, etc.

4) When the results are to be posted on clinicaltrials.gov and on any
other clinical trial databases.

Thank you very much for your kind help.

Yours faithfully,

Katharine Tylko-Hill

show quoted sections

Katharine Tylko-Hill

Dear FREEDOMOFINFORMATION (BIRMINGHAM WOMEN'S AND CHILDREN'S NHS FOUNDATION TRUST),

Please may I request the full dataset. Only a small portion appears in the BJOG.

Thank you.

Yours sincerely,

Katharine Tylko-Hill