OBJETIVOS ESPECÍFICOS DEL PLAN ESTRATÉGICO DE DESARROLLO INSTITUCIONAL

To establish a population based longitudinal birth cohort study conducting a bi-annual assessment of respiratory symptoms of preschool children using the LRSQ from birth to the age of five in Liverpool.

Primary objective: To describe parent reported respiratory symptoms in a population based birth cohort followed longitudinally form birth to five years old using the LRSQ.

Secondary objectives: To examine any association between differences in respiratory symptoms in groups of preschool children with different social and environmental risk and protective factors.

Figure 2.4 Exposure variables • Nursery Attendance

• Persons sharing the child’s bedroom • Number of siblings living in a

household

• Maternal smoking during pregnancy (any)

• Smoking by any household member in the last 3 months regardless of location

• Chronic co-morbidities • Family history of atopy Figure 2.3 Demographics • Sex of child • Age of child • Date of Birth • Postcode • Ethnicity of child • Gestation at birth

• Birth Weight (kg or lb/oz) • Mother’s highest

qualification

• Breastfeeding duration (weeks/months) Bias

To minimise withdrawals from the study patients will be given three

reminders, two via email and one by telephone contact after initial email of the questionnaire. Recall bias is not considered to be a problem, as the questionnaire requires parents to report respiratory symptoms in the last three months and this recall period has been validated for this questionnaire. In the three previous studies parents have not fully completed the

questionnaire, which may introduce reporting bias. Using the online questionnaire may help, as software prompts parents to complete all

questions and can give options for null responses rather than leaving ‘blanks’ on paper.

Proposed Study Size

We plan a maximum recruitment strategy from the Liverpool Women’s Hospital where there are approximately 8,000 births each year. We estimate that approximately one in four mothers will complete the postcard provided. The questionnaire currently has a 13% return rate therefore we expect

approximately 260 patients to participate in the study each year. Comparison of demographic data for those participating with census data will allow a check for recruitment bias.

Statistical Methods

The results from questionnaires on Adobe Forms Central will be uploaded to SPSS and analysed using the SPSS Statistical software. Rolling cumulative data analysis will be performed for the duration of five years.

Univariate and multivariate analyses using linear regression analysis will be used to compare domain scores of the LRSQ scores with exposures such as maternal smoking etc. Fishers exact test will be used to determine whether there is any relation between two categorical variables. Structural equation analysis and multinomial regression analysis will also be used to assess any relationship between exposure/demographic variables and respiratory

symptoms. Cronbach’s alpha coefficients will be calculated to re-assess internal validity. In this study missing data is most likely to result from failure to respond.

Data Sources: Patient Demographic Service

Data will also be collected from linked hospital episode data.

Data management

Data will be collected from questionnaire answers via the Adobe Forms Central Software and linked directly to the programme SPSS for analysis.

Consent

Mothers providing their contact details on the study information postcard implies consent to be contacted. The consent of mothers of patients will be sought when the first questionnaire is emailed or posted to participants. Mothers who are willing to participate will click on the embedded link to the questionnaire will be directed to a screen detailing more information about the study. After reading this they will be given the option to either not to participate and unsubscribe to emails, to contact the research team with any queries or to consent by clicking a button online and inserting their initials. After consenting to take part, mothers will be directed to the questionnaire. Mothers who opted for the postal questionnaire will be asked to complete a consent form alongside the initial questionnaire.

Patients and parents of patients at participating practices have the

opportunity to opt out of the scheme at registration and any point thereafter by either contacting the research team or clicking a button on the email sent containing the LRSQ. [In studies involving postal questionnaires where the burdens are insignificant and sensitive topics are not involved, the REC will normal regard the return of the questionnaire as adequate evidence of consent (IRAS guidance 2012)].

Ethical Issues

This study received REC ethical approval by proportionate review on 08/05/2012. (REC Reference: 12/EM/0194)

This study also received REC approval of minor amendments on the 08/11/2012.

This allowed use of the QR barcode on the postcard for recruitment ant the use of a poster with the QR code for recruitment and advertisement of the study at the Liverpool Women’s Hospital. No physical intervention will take place.

Data protection and Confidentiality

The LRSQ database will include a unique study ID but no direct identifiers. The study ID and contact details will be kept in an encrypted data file in a secure server hosted by the University of Liverpool. Recruitment postcards will be archived securely at the Institute f Child Health, University of

Liverpool. The questionnaire has only been validated in an English Language format. There is no capacity in this student project to develop and validate the LRSQ in other languages.

Risks to Patient

There are few anticipated risks for research participants in this study. Possible risks include a breach in confidentiality with regards to contact details of patients and any personal data. Precautions will be taken to

minimize the risk of this data will be stored very carefully. No identifiable data will be included in publications. Security data measures that will be taken include encrypting data with passwords, coding medical conditions and limiting access to study data.

An additional foreseeable risk identified is the risk of sending emails and questionnaires to parents of deceased children. Measures that could be taken include linking to the National mortality database via the Patient Demographic Service (PDS). The Alder Hey Children’s NHS Foundation Trust's IT department will perform weekly batch searches linking to SPINE via the Patient Demographic Service. This, however, is not a foolproof method as there will be delays between the PDS being notified by the community and by Alder Hey Children’s Hospital.

Benefits to patients

There are no direct benefits to research participants taking part in this study. However there we hope that this study will benefit future preschool children by enabling us to identify risk factors associated with particular respiratory symptoms.

Risks / benefits to study

If too few participants are recruited this would compromise the results of the study. There is also the risk of loosing patients to long-term follow-up. If patients are lost the data will still be included in the results.

Research governance

The University of Liverpool will be lead sponsor and the Liverpool Women’s NHS Foundation Trust will co-sponsor for the study.

The proposed study will be undertaken in accordance with the University of Liverpool’s research governance procedures.

Dr MG Semple (Liverpool University), Professor Ben Shaw (Liverpool Women’s) will be joint guarantors for analysis and reports.

The Research Team Miss Rosanna Pickles Miss Bethan Griffiths

Dr MG Semple (Chief Investigator) Professor Ben Shaw

Dr Kevin Southern Dr Paul McNamara

Figure 2.5: LRBCS Study Method