Vaccine 34 (2016) 6047–6056
Contents lists available at ScienceDirect
Vaccine journal homepage: www.elsevier.com/locate/vaccine
Preterm birth: Case definition & guidelines for data collection, analysis, and presentation of immunisation safety data q Julie-Anne Quinn a,b, Flor M. Munoz c, Bernard Gonik d, Lourdes Frau e, Clare Cutland f, Tamala Mallett-Moore g, Aimee Kissou h, Frederick Wittke i, Manoj Das j, Tony Nunes k, Savia Pye l, Wendy Watson m, Ana-Maria Alguacil Ramos n, Jose F. Cordero o, Wan-Ting Huang p, Sonali Kochhar q, Jim Buttery a,b,⇑, The Brighton Collaboration Preterm Birth Working Group 1 a
SAEFVIC, Murdoch Childrens Research Institute, Victoria, Australia Infection and Immunity, Monash Children’s Hospital, Department of Paediatrics, The Ritchie Centre, Hudson Institute, Monash University, Australia c Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA d Department of Obstetrics and Gynecology, Wayne State University, Detroit, MI, USA e LMF Pharmacoepidemiology, New York, USA f Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Department of Science and Technology National Research Foundation, Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa g Global Pharmacovigilance, Sanofi Pasteur, Swiftwater, Philadelphia, USA h Department of Pediatrics, Souro Sanou Teaching Hospital, Bobo-Dioulasso, Burkina Faso i Debiopharm International SA, Lausanne, Switzerland j INCLEN Trust International, India k Optum Epidemiology, Providence, RI, USA l Communicable Disease Prevention and Control, Nova Scotia, Canada m Pfizer Inc, Collegeville, PA, USA n Dirección General de Salud Pública, Avd Cataluña n°21, 46020 Valencia, Spain o University of Puerto Rico Graduate School of Public Health, Medical Sciences Campus, San Juan 00935, Puerto Rico p Taiwan Centers for Disease Control, Taipei, Taiwan q Global Healthcare Consulting, India b
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Article history: Available online 13 October 2016 Keywords: Preterm birth Adverse event Antenatal Immunisation Guidelines Case definition
a b s t r a c t Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm globally, disproportionately affecting low and middle income countries (LMIC). It contributes directly to estimated one million neonatal deaths annually and is a significant contributor to childhood morbidity. However, in many clinical settings, the information available to calculate completed weeks of gestation varies widely. Accurate dating of the last menstrual period (LMP), as well as access to clinical and ultrasonographic evaluation are important components of gestational age assessment antenatally. This case definition assign levels of confidence to categorisation of births as preterm, utilising assessment modalities which may be available across different settings. These are designed to enable systematic safety evaluation of vaccine clinical trials and postimplementation programmes of immunisations in pregnancy. Ó 2016 Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Disclaimer: The findings, opinions and assertions contained in this consensus document are those of the individual scientific professional members of the working group. They do not necessarily represent the official positions of each participant’s organisation (e.g., government, university, or corporation). Specifically, the findings and conclusions in this paper are those of the authors and do not necessarily represent the views of their respective institutions. ⇑ Corresponding author at: Monash Children’s Hospital, Victoria, Australia. Tel.: +61 3 95944828. E-mail address: [email protected] (J. Buttery). 1 Brighton Collaboration homepage: http://www.brightoncollaboration.org.
1. Preamble 1.1. Need for developing case definitions and guidelines for data collection, analysis, and presentation for preterm birth as an adverse event following immunisation Preterm birth has been defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants
http://dx.doi.org/10.1016/j.vaccine.2016.03.045 0264-410X/Ó 2016 Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
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are born preterm, with resulting complications. It is the principal cause of an estimated one million neonatal deaths annually and a significant contributor to childhood morbidities. Low and middle income countries (LMIC) carry a higher burden of disease attributed to preterm birth. The World Health Organisation (WHO) defines preterm birth as any birth before 37 completed weeks of gestation, or fewer than 259 days since the first day of the woman’s last menstrual period (LMP). This is further subdivided on the basis of gestational age (GA): extremely preterm (28 weeks – third trimester ultrasound. *No LMP date: If menstrual dates are unknown, the ultrasoundestablished dates will be used for gestational age dating or 2nd trimester fundal height and/or newborn physical examination. Pregnancy symptoms– nausea, fatigue, tender swollen breasts, frequent urination. Antenatal Physical Examination– pelvic bimanual examination confirming enlarged uterus [63]. Newborn Physical Examination– New Ballard Score – physical and neurological assessment – Appendix 1. Fundal Height(FH) in cms – Appendix 2. Birth Weight (BW) in grams – Appendix 2.
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2.2. Prematurity and assessment of gestational age Level 1: (highest level of certainty) 1. Certain LMP* or intrauterine insemination (IUI) date or embryo transfer (ET) date with confirmatory 1st trimester scan (13 6/7 weeks). OR 2. 1st trimester scan (13 6/7 weeks).
Level 2A 1. Certain LMP* with 2nd trimester scan (14 0/7 weeks to 27 6/7 weeks). If LMP and U/S do not correlate, default to U/S GA assessment. OR 2. Certain LMP* with 1st trimester physical examination.
Level 2B Uncertain LMP with 2nd trimester scan (14 0/7 weeks to 27 6/7 weeks). Level 3A 1. Certain LMP with 3rd trimester scan – 28 0/7 weeks +. OR 2. Certain LMP with confirmatory 2nd trimester FH. OR 3. Certain LMP with birth weight. OR 4. Uncertain LMP with 1st trimester physical examination.
Level 3B 1. Uncertain LMP with FH. OR 2. Uncertain LMP with newborn physical assessment. OR 3. Uncertain LMP with Birth weight. 3. Guidelines for data collection, analysis and presentation of preterm birth It was the consensus of the Brighton Collaboration Working Group for Preterm Birth to recommend the following guidelines to enable meaningful and standardised collection, analysis, and presentation of information about Preterm Birth. However, implementation of all guidelines might not be possible in all settings. The availability of information may vary depending upon resources, geographical region, and whether the source of information is a prospective clinical trial, a post-marketing surveillance or epidemiological study, or an individual report of Preterm Birth. Also, as explained in more detail in the overview paper in this volume, these guidelines have been developed by this working group for guidance only, and are not to be considered a mandatory requirement for data collection, analysis, or presentation.
collected for the specific study question and setting. The guidelines are not intended to guide the primary reporting of Preterm Birth to a surveillance system or study monitor. Investigators developing a data collection tool based on these data collection guidelines also need to refer to the criteria in the case definition, which are not repeated in these guidelines. Guidelines numbers below have been developed to address data elements for the collection of adverse event information as specified in general drug safety guidelines by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use [99], and the form for reporting of drug adverse events by the Council for International Organisations of Medical Sciences [100]. These data elements include an identifiable reporter and patient, one or more prior immunisations, and a detailed description of the adverse event, in this case, Preterm Birth following maternal immunisation. The additional guidelines have been developed as guidance for the collection of additional information to allow for a more comprehensive understanding of Preterm Birth following maternal immunisation. 3.1.1. Source of information/reporter For all cases and/or all study participants, as appropriate, the following information should be recorded: (1) Date of report. (2) Name and contact information of person reporting2 and/or diagnosing the Preterm Birth as specified by country-specific data protection law. (3) Name and contact information of the investigator or clinician responsible for the subject, as applicable. (4) Relation to the patient (e.g., immuniser [clinician, nurse], family member [indicate relationship], other). 3.1.2. Vaccinee/control 3.1.2.1. Demographics. For all cases and/or all study participants, as appropriate, the following information should be recorded: (5) Case/study participant identifiers (e.g., first name initial followed by last name initial) or code (or in accordance with country-specific data protection laws). (6) Date of birth, age, and sex. (7) For infants: gestational age and birth weight. 3.1.2.2. Clinical and immunisation history. For all cases and/or all study participants, as appropriate, the following information regarding the immunised woman should be recorded: (8) Past medical history, including hospitalisations, underlying diseases/disorders, pre-immunisation signs and symptoms including identification of indicators for, or the absence of, a history of allergy to vaccines, vaccine components or medications; food allergy; allergic rhinitis; eczema; asthma. (9) Any medication history (other than treatment for the event described) prior to, during, and after immunisation including prescription and non-prescription medication as well as medication or treatment with long half-life or long term effect (e.g., immunoglobulins, blood transfusion and immunosuppressants). (10) Immunisation history (i.e. previous immunisations and any adverse event following immunisation (AEFI)), in particular occurrence of Preterm Birth after a previous immunisation.
3.1. Data collection These guidelines represent a desirable standard for the collection of data on availability following immunisation to allow for comparability of data, and are recommended as an addition to data
2 If the reporting centre is different from the vaccinating centre, appropriate and timely communication of the adverse event should occur.
J.-A. Quinn et al. / Vaccine 34 (2016) 6047–6056
3.1.3. Details of the immunisation For all cases and/or all study participants, as appropriate, the following information should be recorded: (11) Date and time of maternal immunisation(s). (12) Description of vaccine(s) (name of vaccine, manufacturer, lot number, dose (e.g., 0.25 mL, 0.5 mL, etc.) and number of dose if part of a series of immunisations against the same disease). (13) The anatomical sites (including left or right side) of all immunisations (e.g., vaccine A in proximal left lateral thigh, vaccine B in left deltoid). (14) Route and method of administration (e.g., intramuscular, intradermal, subcutaneous, and needle-free (including type and size), other injection devices). (15) Needle length and gauge. 3.1.4. The adverse event (16) For all cases at any level of diagnostic certainty and for reported events with insufficient evidence, the criteria fulfilled to meet the case definition should be recorded.
Specifically document (17) Clinical description of signs and symptoms of Preterm Birth in immunised woman and newborn and if there was medical confirmation of the event (i.e. patient seen by physician). (18) Date/time of onset,3 first observation4 and diagnosis,5 end of episode6 and final outcome.7 (19) Concurrent signs, symptoms, and diseases in immunised woman and newborn. (20) Measurement/testing Values and units of routinely measured parameters (e.g., temperature, blood pressure) – in particular those indicating the severity of the event. Method of measurement (e.g., type of thermometer, oral or other route, duration of measurement, etc.). Results of laboratory examinations, surgical and/or pathological findings and diagnoses if present. (21) Treatment given for Preterm Birth to mother and/or newborn, especially specify what medication and dosing, or specific interventions. (22) Outcome8 at last observation.
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(23) Objective clinical evidence supporting classification of the event as ‘‘serious”.9 (24) Exposures other than the immunisation 24 h before and after immunisation (e.g., food, environmental) considered potentially relevant to the reported event. 3.1.5. Miscellaneous/general (25) The duration of surveillance for Preterm Birth should be until the pregnancy has been completed, but specific surveillance may be further predefined based on Biologic characteristics of the vaccine e.g., live attenuated versus inactivated component vaccines. Biologic characteristics of the vaccine-targeted disease. Biologic characteristics of Preterm Birth including patterns identified in previous trials (e.g., early-phase trials). Biologic characteristics of the vaccinee (e.g., nutrition, underlying disease like immunodepressing illness). (26) The duration of follow-up reported during the surveillance period should be predefined likewise. It should aim to continue to resolution of the event. (27) Methods of data collection should be consistent within and between study groups, if applicable. (28) Follow-up of cases should attempt to verify and complete the information collected as outlined in data collection guidelines 1–24. (29) Investigators of patients with Preterm Birth should provide guidance to reporters to optimise the quality and completeness of information provided. (30) Reports of Preterm Birth should be collected throughout the study period regardless of the time elapsed between immunisation and the adverse event. If this is not feasible due to the study design, the study periods during which safety data are being collected should be clearly defined. 3.2. Data analysis The following guidelines represent a desirable standard for analysis of data on Preterm Birth to allow for comparability of data, and are recommended as an addition to data analysed for the specific study question and setting. (31) Reported events should be classified in one of the following five categories including the three levels of diagnostic certainty. Events that meet the case definition should be classified according to the levels of diagnostic certainty as specified in the case definition. Events that do not meet the case definition should be classified in the additional categories for analysis. Event classification in 5 categories10
3 The date and/or time of onset is defined as the time post immunisation, when the first sign or symptom indicative for Preterm Birth occurred. This may only be possible to determine in retrospect. 4 The date and/or time of first observation of the first sign or symptom indicative for Preterm Birth can be used if date/time of onset is not known. 5 The date of diagnosis of an episode is the day post immunisation when the event met the case definition at any level. 6 The end of an episode is defined as the time the event no longer meets the case definition at the lowest level of the definition. 7 E.g., recovery to pre-immunisation health status, spontaneous resolution, therapeutic intervention, persistence of the event, sequelae, death. 8 An AEFI is defined as serious by international standards if it meets one or more of the following criteria: (1) it results in death, (2) is life-threatening, (3) it requires inpatient hospitalisation or results in prolongation of existing hospitalisation, (4) results in persistent or significant disability/incapacity, (5) is a congenital anomaly/ birth defect, (6) is a medically important event or reaction.
9 To determine the appropriate category, the user should first establish, whether a reported event meets the criteria for the lowest applicable level of diagnostic certainty, e.g., Level three. If the lowest applicable level of diagnostic certainty of the definition is met, and there is evidence that the criteria of the next higher level of diagnostic certainty are met, the event should be classified in the next category. This approach should be continued until the highest level of diagnostic certainty for a given event could be determined. Major criteria can be used to satisfy the requirement of minor criteria. If the lowest level of the case definition is not met, it should be ruled out that any of the higher levels of diagnostic certainty are met and the event should be classified in additional categories four or five. 10 If the evidence available for an event is insufficient because information is missing, such an event should be categorised as ‘‘Reported Preterm Birth with insufficient evidence to meet the case definition”.
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Event meets case definition (1) Level 1: Criteria as specified in the Preterm Birth case definition. (2) Level 2: Criteria as specified in the Preterm Birth case definition. (3) Level 3: Criteria as specified in the Preterm Birth case definition. Event does not meet case definition Additional categories for analysis (4) Reported Preterm Birth with insufficient evidence to meet the case definition.11 (5) Not a case of Preterm Birth.
(32) The interval between immunisation and reported Preterm Birth could be defined as the date/time of immunisation to the date/time of onset12 of the newborn delivery. If few cases are reported, the concrete time course could be analysed for each; for a large number of cases, data can be analysed in the following increments: Subjects with preterm birth by interval to presentation Interval*
Contents lists available at ScienceDirect
Vaccine journal homepage: www.elsevier.com/locate/vaccine
Preterm birth: Case definition & guidelines for data collection, analysis, and presentation of immunisation safety data q Julie-Anne Quinn a,b, Flor M. Munoz c, Bernard Gonik d, Lourdes Frau e, Clare Cutland f, Tamala Mallett-Moore g, Aimee Kissou h, Frederick Wittke i, Manoj Das j, Tony Nunes k, Savia Pye l, Wendy Watson m, Ana-Maria Alguacil Ramos n, Jose F. Cordero o, Wan-Ting Huang p, Sonali Kochhar q, Jim Buttery a,b,⇑, The Brighton Collaboration Preterm Birth Working Group 1 a
SAEFVIC, Murdoch Childrens Research Institute, Victoria, Australia Infection and Immunity, Monash Children’s Hospital, Department of Paediatrics, The Ritchie Centre, Hudson Institute, Monash University, Australia c Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA d Department of Obstetrics and Gynecology, Wayne State University, Detroit, MI, USA e LMF Pharmacoepidemiology, New York, USA f Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Department of Science and Technology National Research Foundation, Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa g Global Pharmacovigilance, Sanofi Pasteur, Swiftwater, Philadelphia, USA h Department of Pediatrics, Souro Sanou Teaching Hospital, Bobo-Dioulasso, Burkina Faso i Debiopharm International SA, Lausanne, Switzerland j INCLEN Trust International, India k Optum Epidemiology, Providence, RI, USA l Communicable Disease Prevention and Control, Nova Scotia, Canada m Pfizer Inc, Collegeville, PA, USA n Dirección General de Salud Pública, Avd Cataluña n°21, 46020 Valencia, Spain o University of Puerto Rico Graduate School of Public Health, Medical Sciences Campus, San Juan 00935, Puerto Rico p Taiwan Centers for Disease Control, Taipei, Taiwan q Global Healthcare Consulting, India b
a r t i c l e
i n f o
Article history: Available online 13 October 2016 Keywords: Preterm birth Adverse event Antenatal Immunisation Guidelines Case definition
a b s t r a c t Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm globally, disproportionately affecting low and middle income countries (LMIC). It contributes directly to estimated one million neonatal deaths annually and is a significant contributor to childhood morbidity. However, in many clinical settings, the information available to calculate completed weeks of gestation varies widely. Accurate dating of the last menstrual period (LMP), as well as access to clinical and ultrasonographic evaluation are important components of gestational age assessment antenatally. This case definition assign levels of confidence to categorisation of births as preterm, utilising assessment modalities which may be available across different settings. These are designed to enable systematic safety evaluation of vaccine clinical trials and postimplementation programmes of immunisations in pregnancy. Ó 2016 Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Disclaimer: The findings, opinions and assertions contained in this consensus document are those of the individual scientific professional members of the working group. They do not necessarily represent the official positions of each participant’s organisation (e.g., government, university, or corporation). Specifically, the findings and conclusions in this paper are those of the authors and do not necessarily represent the views of their respective institutions. ⇑ Corresponding author at: Monash Children’s Hospital, Victoria, Australia. Tel.: +61 3 95944828. E-mail address: [email protected] (J. Buttery). 1 Brighton Collaboration homepage: http://www.brightoncollaboration.org.
1. Preamble 1.1. Need for developing case definitions and guidelines for data collection, analysis, and presentation for preterm birth as an adverse event following immunisation Preterm birth has been defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants
http://dx.doi.org/10.1016/j.vaccine.2016.03.045 0264-410X/Ó 2016 Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
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are born preterm, with resulting complications. It is the principal cause of an estimated one million neonatal deaths annually and a significant contributor to childhood morbidities. Low and middle income countries (LMIC) carry a higher burden of disease attributed to preterm birth. The World Health Organisation (WHO) defines preterm birth as any birth before 37 completed weeks of gestation, or fewer than 259 days since the first day of the woman’s last menstrual period (LMP). This is further subdivided on the basis of gestational age (GA): extremely preterm (28 weeks – third trimester ultrasound. *No LMP date: If menstrual dates are unknown, the ultrasoundestablished dates will be used for gestational age dating or 2nd trimester fundal height and/or newborn physical examination. Pregnancy symptoms– nausea, fatigue, tender swollen breasts, frequent urination. Antenatal Physical Examination– pelvic bimanual examination confirming enlarged uterus [63]. Newborn Physical Examination– New Ballard Score – physical and neurological assessment – Appendix 1. Fundal Height(FH) in cms – Appendix 2. Birth Weight (BW) in grams – Appendix 2.
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2.2. Prematurity and assessment of gestational age Level 1: (highest level of certainty) 1. Certain LMP* or intrauterine insemination (IUI) date or embryo transfer (ET) date with confirmatory 1st trimester scan (13 6/7 weeks). OR 2. 1st trimester scan (13 6/7 weeks).
Level 2A 1. Certain LMP* with 2nd trimester scan (14 0/7 weeks to 27 6/7 weeks). If LMP and U/S do not correlate, default to U/S GA assessment. OR 2. Certain LMP* with 1st trimester physical examination.
Level 2B Uncertain LMP with 2nd trimester scan (14 0/7 weeks to 27 6/7 weeks). Level 3A 1. Certain LMP with 3rd trimester scan – 28 0/7 weeks +. OR 2. Certain LMP with confirmatory 2nd trimester FH. OR 3. Certain LMP with birth weight. OR 4. Uncertain LMP with 1st trimester physical examination.
Level 3B 1. Uncertain LMP with FH. OR 2. Uncertain LMP with newborn physical assessment. OR 3. Uncertain LMP with Birth weight. 3. Guidelines for data collection, analysis and presentation of preterm birth It was the consensus of the Brighton Collaboration Working Group for Preterm Birth to recommend the following guidelines to enable meaningful and standardised collection, analysis, and presentation of information about Preterm Birth. However, implementation of all guidelines might not be possible in all settings. The availability of information may vary depending upon resources, geographical region, and whether the source of information is a prospective clinical trial, a post-marketing surveillance or epidemiological study, or an individual report of Preterm Birth. Also, as explained in more detail in the overview paper in this volume, these guidelines have been developed by this working group for guidance only, and are not to be considered a mandatory requirement for data collection, analysis, or presentation.
collected for the specific study question and setting. The guidelines are not intended to guide the primary reporting of Preterm Birth to a surveillance system or study monitor. Investigators developing a data collection tool based on these data collection guidelines also need to refer to the criteria in the case definition, which are not repeated in these guidelines. Guidelines numbers below have been developed to address data elements for the collection of adverse event information as specified in general drug safety guidelines by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use [99], and the form for reporting of drug adverse events by the Council for International Organisations of Medical Sciences [100]. These data elements include an identifiable reporter and patient, one or more prior immunisations, and a detailed description of the adverse event, in this case, Preterm Birth following maternal immunisation. The additional guidelines have been developed as guidance for the collection of additional information to allow for a more comprehensive understanding of Preterm Birth following maternal immunisation. 3.1.1. Source of information/reporter For all cases and/or all study participants, as appropriate, the following information should be recorded: (1) Date of report. (2) Name and contact information of person reporting2 and/or diagnosing the Preterm Birth as specified by country-specific data protection law. (3) Name and contact information of the investigator or clinician responsible for the subject, as applicable. (4) Relation to the patient (e.g., immuniser [clinician, nurse], family member [indicate relationship], other). 3.1.2. Vaccinee/control 3.1.2.1. Demographics. For all cases and/or all study participants, as appropriate, the following information should be recorded: (5) Case/study participant identifiers (e.g., first name initial followed by last name initial) or code (or in accordance with country-specific data protection laws). (6) Date of birth, age, and sex. (7) For infants: gestational age and birth weight. 3.1.2.2. Clinical and immunisation history. For all cases and/or all study participants, as appropriate, the following information regarding the immunised woman should be recorded: (8) Past medical history, including hospitalisations, underlying diseases/disorders, pre-immunisation signs and symptoms including identification of indicators for, or the absence of, a history of allergy to vaccines, vaccine components or medications; food allergy; allergic rhinitis; eczema; asthma. (9) Any medication history (other than treatment for the event described) prior to, during, and after immunisation including prescription and non-prescription medication as well as medication or treatment with long half-life or long term effect (e.g., immunoglobulins, blood transfusion and immunosuppressants). (10) Immunisation history (i.e. previous immunisations and any adverse event following immunisation (AEFI)), in particular occurrence of Preterm Birth after a previous immunisation.
3.1. Data collection These guidelines represent a desirable standard for the collection of data on availability following immunisation to allow for comparability of data, and are recommended as an addition to data
2 If the reporting centre is different from the vaccinating centre, appropriate and timely communication of the adverse event should occur.
J.-A. Quinn et al. / Vaccine 34 (2016) 6047–6056
3.1.3. Details of the immunisation For all cases and/or all study participants, as appropriate, the following information should be recorded: (11) Date and time of maternal immunisation(s). (12) Description of vaccine(s) (name of vaccine, manufacturer, lot number, dose (e.g., 0.25 mL, 0.5 mL, etc.) and number of dose if part of a series of immunisations against the same disease). (13) The anatomical sites (including left or right side) of all immunisations (e.g., vaccine A in proximal left lateral thigh, vaccine B in left deltoid). (14) Route and method of administration (e.g., intramuscular, intradermal, subcutaneous, and needle-free (including type and size), other injection devices). (15) Needle length and gauge. 3.1.4. The adverse event (16) For all cases at any level of diagnostic certainty and for reported events with insufficient evidence, the criteria fulfilled to meet the case definition should be recorded.
Specifically document (17) Clinical description of signs and symptoms of Preterm Birth in immunised woman and newborn and if there was medical confirmation of the event (i.e. patient seen by physician). (18) Date/time of onset,3 first observation4 and diagnosis,5 end of episode6 and final outcome.7 (19) Concurrent signs, symptoms, and diseases in immunised woman and newborn. (20) Measurement/testing Values and units of routinely measured parameters (e.g., temperature, blood pressure) – in particular those indicating the severity of the event. Method of measurement (e.g., type of thermometer, oral or other route, duration of measurement, etc.). Results of laboratory examinations, surgical and/or pathological findings and diagnoses if present. (21) Treatment given for Preterm Birth to mother and/or newborn, especially specify what medication and dosing, or specific interventions. (22) Outcome8 at last observation.
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(23) Objective clinical evidence supporting classification of the event as ‘‘serious”.9 (24) Exposures other than the immunisation 24 h before and after immunisation (e.g., food, environmental) considered potentially relevant to the reported event. 3.1.5. Miscellaneous/general (25) The duration of surveillance for Preterm Birth should be until the pregnancy has been completed, but specific surveillance may be further predefined based on Biologic characteristics of the vaccine e.g., live attenuated versus inactivated component vaccines. Biologic characteristics of the vaccine-targeted disease. Biologic characteristics of Preterm Birth including patterns identified in previous trials (e.g., early-phase trials). Biologic characteristics of the vaccinee (e.g., nutrition, underlying disease like immunodepressing illness). (26) The duration of follow-up reported during the surveillance period should be predefined likewise. It should aim to continue to resolution of the event. (27) Methods of data collection should be consistent within and between study groups, if applicable. (28) Follow-up of cases should attempt to verify and complete the information collected as outlined in data collection guidelines 1–24. (29) Investigators of patients with Preterm Birth should provide guidance to reporters to optimise the quality and completeness of information provided. (30) Reports of Preterm Birth should be collected throughout the study period regardless of the time elapsed between immunisation and the adverse event. If this is not feasible due to the study design, the study periods during which safety data are being collected should be clearly defined. 3.2. Data analysis The following guidelines represent a desirable standard for analysis of data on Preterm Birth to allow for comparability of data, and are recommended as an addition to data analysed for the specific study question and setting. (31) Reported events should be classified in one of the following five categories including the three levels of diagnostic certainty. Events that meet the case definition should be classified according to the levels of diagnostic certainty as specified in the case definition. Events that do not meet the case definition should be classified in the additional categories for analysis. Event classification in 5 categories10
3 The date and/or time of onset is defined as the time post immunisation, when the first sign or symptom indicative for Preterm Birth occurred. This may only be possible to determine in retrospect. 4 The date and/or time of first observation of the first sign or symptom indicative for Preterm Birth can be used if date/time of onset is not known. 5 The date of diagnosis of an episode is the day post immunisation when the event met the case definition at any level. 6 The end of an episode is defined as the time the event no longer meets the case definition at the lowest level of the definition. 7 E.g., recovery to pre-immunisation health status, spontaneous resolution, therapeutic intervention, persistence of the event, sequelae, death. 8 An AEFI is defined as serious by international standards if it meets one or more of the following criteria: (1) it results in death, (2) is life-threatening, (3) it requires inpatient hospitalisation or results in prolongation of existing hospitalisation, (4) results in persistent or significant disability/incapacity, (5) is a congenital anomaly/ birth defect, (6) is a medically important event or reaction.
9 To determine the appropriate category, the user should first establish, whether a reported event meets the criteria for the lowest applicable level of diagnostic certainty, e.g., Level three. If the lowest applicable level of diagnostic certainty of the definition is met, and there is evidence that the criteria of the next higher level of diagnostic certainty are met, the event should be classified in the next category. This approach should be continued until the highest level of diagnostic certainty for a given event could be determined. Major criteria can be used to satisfy the requirement of minor criteria. If the lowest level of the case definition is not met, it should be ruled out that any of the higher levels of diagnostic certainty are met and the event should be classified in additional categories four or five. 10 If the evidence available for an event is insufficient because information is missing, such an event should be categorised as ‘‘Reported Preterm Birth with insufficient evidence to meet the case definition”.
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Event meets case definition (1) Level 1: Criteria as specified in the Preterm Birth case definition. (2) Level 2: Criteria as specified in the Preterm Birth case definition. (3) Level 3: Criteria as specified in the Preterm Birth case definition. Event does not meet case definition Additional categories for analysis (4) Reported Preterm Birth with insufficient evidence to meet the case definition.11 (5) Not a case of Preterm Birth.
(32) The interval between immunisation and reported Preterm Birth could be defined as the date/time of immunisation to the date/time of onset12 of the newborn delivery. If few cases are reported, the concrete time course could be analysed for each; for a large number of cases, data can be analysed in the following increments: Subjects with preterm birth by interval to presentation Interval*
