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Guidelines for inclusion of a new study on the NZPSU Report Card

Introduction

Applications for the inclusion of a study in the New Zealand Paediatric Surveillance Unit (NZPSU) reporting scheme are considered by its Scientific Review Panel (SRP). This document gives detailed guidance on how to complete the NZPSU study application form and the requirements that must be met for a study to be considered.

The SRP will give fair and impartial consideration to all applications, with, where appropriate, the advice of independent referees. The panel may also make inquiries to help avoid duplication or possible conflict with the work of other researchers in the same field. Principal investigators may be invited to a meeting of the SRP to discuss their proposal.

Research workers who are interested in applying for the inclusion of their study are encouraged to first make informal inquiries to the NZPSU, who will be prepared to discuss protocols at the design stage. Formal application should be made on the NZPSU Study Application Form.

Investigators are asked to take into account when planning their study that the process from first discussion to acceptance may take several months. Investigators should also be aware that the timing of inclusion of new studies on the NZPSU card depends on the number and the nature of other studies being conducted. The NZPSU office must receive applications which are ready for submission one month prior to the SRP meeting, to allow time to circulate documents for review. The SRP meets 4 times a year and information on meeting dates is available from the NZPSU office. For conditions of public health importance which require immediate evaluation this process will be accelerated.

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Eligibility

A study is eligible for participation in the scheme if the condition of interest is a relatively rare childhood condition (or a rare complication of a more common disease) of such a low incidence or prevalence as to require ascertainment of cases on a national scale in order to generate sufficient numbers for study. The SRP may also consider inclusion of short-term or geographically limited studies of comparatively more common conditions.

It is important for the success of the scheme that the workload of the mailing list is kept to a minimum. Accordingly, the SRP must be certain that studies conducted through the NZPSU are well designed and worthwhile. The SRP will take into consideration the scientific interest and public health importance of the proposed study, its methodology and the suitability of the condition for ascertainment through the NZPSU scheme. Studies depending on immediate reporting and/or sample collection, or requiring the participation of other specialties, are less likely to be suitable.

Condition means in this context, any definable problem or event normally leading to a child coming under the care of a paediatrician. The condition of interest need not be infectious or a disease.

Child normally implies an upper age limit of 15 years. The SRP wishes to maintain consistency in this respect.

Mailing list refers to all clinicians who are sent the monthly NZPSU report card. This group is comprised of paediatricians, paediatric subspecialists, paediatric general surgeons and other clinicians working predominantly with children.

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Formal requirements

All the usual considerations of confidentiality in medical research apply to information collected through the NZPSU scheme. Any approach to the patient or their family may be made only by the reporting paediatrician.

We currently hold ethical approval for the process of the NZPSU and can request a variation to include new conditions approved by the SRP.

Adequate funding or organisational arrangements must have been obtained for the completion of the research.

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Reports and articles

Investigators are asked to declare that they will acknowledge both the assistance of the NZPSU and the contributors to the NZPSU in any manuscripts submitted for publication. However, the NZPSU does not exercise any control whatsoever over when or where research workers publish their results, nor does it require being included in authorship. Funding for the development of the NZPSU has been generously granted by the Ministry of Health who need to be acknowledged in any publications. The NZPSU requires a copy of published articles and abstracts presented at meetings and information about any other relevant presentations, publications or media interviews.

Regular feedback to reporting clinicians is important to encourage their full co-operation with the scheme. Accordingly, participating investigators are asked to contribute short reports each year and on completion of their project for the NZPSU Annual Report. They are also required to supply periodic reports and review articles as requested.

The SRP would like to remind investigators who are not themselves paediatricians, that the success of the scheme depends on the goodwill of the participants. Submission of articles to the Journal of Paediatrics and Child Health is encouraged.

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Design of questionnaires

The SRP is concerned that questionnaires should be as brief and simple as possible, so as not to impose an excessive burden on the paediatrician. Investigators are welcome to discuss questionnaire design with NZPSU and copies of questionnaires used by existing studies are available on request.

Specific points that should be borne in mind are:

  • Two A4 pages are usually adequate for the questionnaire. Reasons for requiring a longer questionnaire must be outlined in the application.
  • The New Zealand Paediatric Surveillance Unit should be included in the headings of questionnaires and covering letters along with the name of the chief investigator's research base.
  • Note on the example questionnaire the inclusion of:
    • Patient's NHI, date of birth and gender and Month/Year of report
    • Specialist terms or abbreviations which may not be familiar to paediatricians should be explained in full.
    • Respondents should be asked to return the questionnaire even if they are unable to complete all items.
    • Please do not ask the clinician detailed questions in the questionnaire which are more appropriate to a follow-up study. Remember a short questionnaire will maximise compliance.

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Application form

Download the NZPSU application form (Word)

Completing the application form

1. Condition to be studied

Give the accepted name of the condition followed by the recognised abbreviation.

2. Case definition

Give a clear case definition for the condition of interest. Any specialist terms or abbreviations which will not be familiar to clinicians on the mailing list should be explained in full.

3. Reporting instructions

Clinicians should be asked to report all cases seen in the last month. You need to state the desired age limits (usually up to 15 years except for neonatal conditions). Incident not prevalent cases are preferred. Please give reasons if prevalent case ascertainment is requested. In special circumstances you may give reporting instructions for the first month of surveillance which are different to the instructions for subsequent months. For example, for a condition which first appears on the card in March the initial reporting instructions may be all cases seen in the last three (3) months.

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Investigators

Give the names, appointments and institutions of the investigators involved in the study. Indicate clearly (a) the principal contact for correspondence and (b) the contact for reporting of cases, if different. In both cases give full postal address, telephone number and fax number.

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Statement of research questions

Give a clear statement of the specific research question(s) which will be answered by this study.

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Proposed starting date

In choosing a starting date, please remember that the report card is sent to respondents at the end of each month for cases seen during that month.

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Proposed duration of study

The SRP recognises that two or more years of surveillance of a very rare condition may be required to provide adequate cases for study. A study will normally be accepted for an initial period of one year. Continuation thereafter is subject to annual review by the SRP, bearing in mind the progress of the study, the number of new proposals received, and the importance of ascertainment through the NZPSU as opposed to any other means available to the investigators. Justification of the proposed duration should be included in the supporting statement.

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Background information

Give a brief review of the background to the proposal, draw attention to the state of current knowledge, including incidence and prevalence, and show why use of the NZPSU is appropriate. References should be given at the end of the application.

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Why are these research questions important?

Please include information, as outlined on the form, which indicates the ways in which this study will contribute to scientific knowledge, affect clinical management of the condition and/or inform service planning and provision.

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Research methods

Please provide the information requested in this section. The SRP needs to be convinced that the methods used in the study are essential to answer the study research questions and that the methods are practically possible and will not overburden the mailing list.

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Ethical approval

The NZPSU will provide you with a copy of approved variation(s) to the overall ethics approval. If you have separate local approval, please state the research ethics committee to which the proposal has been submitted and the date on which approval was given and provide a copy to the NZPSU.

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Funding and organisational arrangements

Give a brief outline of arrangements made to allow completion of the study, such as administrative, scientific and computing support. The SRP requires that studies have sufficient staff to ensure that questionnaires are mailed to notifying clinicians within two weeks of the NZPSU contacting the study group about a case notification. Sufficient staffing to enable follow-up of questionnaires which are not returned is also necessary. A detailed budget is not required.

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Checklist for application submission

  • Electronic, signed copy of the completed application form
  • Electronic copy of the letter to notifying clinicians
  • Electronic copy of the proposed questionnaire
  • Electronic copy of any additional information sheets which will need to be sent to clinicians, such as information about specimens to be sent and instructions for their transport

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