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Diabetologia

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Follow-up at 1 year and beyond of women with gestational diabetes treated with insulin and/or oral glucose-lowering agents: a core outcome set using a Delphi survey

  • Delia BogdanetEmail author
  • Catriona Reddin
  • Esther Macken
  • Tomas P. Griffin
  • Narjes Fhelelboom
  • Linda Biesty
  • Shakila Thangaratinam
  • Eugene Dempsey
  • Caroline Crowther
  • Sander GaljaardEmail author
  • Michael Maresh
  • Mary R. Loeken
  • Angela Napoli
  • Eleni Anastasiou
  • Eoin Noctor
  • Harold W. de Valk
  • Mireille N. M. van Poppel
  • Andrea Agostini
  • Cheril Clarson
  • Aoife M. Egan
  • Paula M. O’Shea
  • Declan Devane
  • Fidelma P. Dunne
Open Access
Article

Abstract

Aims/hypothesis

Gestational diabetes mellitus (GDM) is linked with a higher lifetime risk for the development of impaired fasting glucose, impaired glucose tolerance, type 2 diabetes, the metabolic syndrome, cardiovascular disease, postpartum depression and tumours. Despite this, there is no consistency in the long-term follow-up of women with a previous diagnosis of GDM. Further, the outcomes selected and reported in the research involving this population are heterogeneous and lack standardisation. This amplifies the risk of reporting bias and diminishes the likelihood of significant comparisons between studies. The aim of this study is to develop a core outcome set (COS) for RCTs and other studies evaluating the long-term follow-up at 1 year and beyond of women with previous GDM treated with insulin and/oral glucose-lowering agents.

Methods

The study consisted of three work packages: (1) a systematic review of the outcomes reported in previous RCTs of the follow-up at 1 year and beyond of women with GDM treated with insulin and/or oral glucose-lowering agents; (2) a three-round online Delphi survey with key stakeholders to prioritise these outcomes; and (3) a consensus meeting where the final COS was decided.

Results

Of 3344 abstracts identified and evaluated, 62 papers were retrieved and 25/62 papers were included in this review. A total of 121 outcomes were identified and included in the Delphi survey. Delphi round 1 was emailed to 835 participants and 288 (34.5%) responded. In round 2, 190 of 288 (65.9%) participants responded and in round 3, 165 of 190 (86.8%) participants responded. In total, nine outcomes were selected and agreed for inclusion in the final COS: assessment of glycaemic status; diagnosis of type 2 diabetes since the index pregnancy; number of pregnancies since the index pregnancy; number of pregnancies with a diagnosis of GDM since the index pregnancy; diagnosis of prediabetes since the index pregnancy; BMI; post-pregnancy weight retention; resting blood pressure; and breastfeeding.

Conclusions/interpretation

This study identified a COS that will help bring consistency and uniformity to outcome selection and reporting in clinical trials and other studies involving the follow-up at 1 year and beyond of women diagnosed with GDM treated with insulin and/or oral glucose-lowering agents during pregnancy.

Keywords

Core outcome set Gestational diabetes mellitus Insulin Oral hypoglycaemic agents 

Abbreviations

COMET

Core Outcome Measures in Effectiveness Trials Initiative

COS

Core outcome set

COS-STAR

Core Outcome Set STAndards for Reporting

GDM

Gestational diabetes mellitus

IADPSG

International Association of Diabetes in Pregnancy Study Group

SAG

Study advisory group

Introduction

The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide and ranges between 5.2% and 40.4% across countries; this wide variability reflects multiple factors such as BMI, ethnicity, country income, and also the diagnostic criteria used [1]. Based on the International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria, the European prevalence of GDM is approximatively 13% [2, 3]. Medical nutritional therapy (diet and exercise) is the first step in the treatment of GDM [4]. However, if the desired glycaemic goals are not achieved, pharmacological treatment will be required.

GDM is linked with a substantial lifetime risk of developing type 2 diabetes. A meta-analysis conducted on studies published over the last 50 years showed that women with a history of GDM have a higher risk of developing type 2 diabetes (RR 7.4) compared with women with normal glucose tolerance (NGT) in pregnancy [5]. Women with previous GDM are more likely to develop the metabolic syndrome [6] and cardiovascular disorders [7] in later life. Several studies have shown that women with GDM have a higher risk of developing postpartum depression [8, 9]. There is also a growing body of literature associating a history of GDM with the development of tumours, particularly breast and endometrial tumours [10].

Women with GDM should be screened for persistent diabetes or impaired fasting glucose and/or impaired glucose tolerance at 6–12 weeks postpartum using non-pregnancy criteria [11]. However, there is no standardised approach to the long-term follow-up of women with a previous GDM diagnosis. The results of clinical trials evaluating comparable interventions are usually summarised in systematic reviews and meta-analyses that provide the basis for guidelines and treatment recommendations. However, there is little consistency in outcome selection and reporting in clinical trials involving this population. This inconsistency raises concern for possible outcome selection bias, makes significant research synthesis difficult and limits the ability to combine the findings of individual studies into summary estimates. One way to overcome this is to develop a core outcome set (COS).

A COS is the minimum set of outcomes that should be consistently measured and reported in all clinical trials (and other studies). However, this does not restrict researchers from adding additional outcomes. A minimum set of outcomes will provide greater uniformity of reporting in clinical trials and more data to impact meta-analyses. Also, a COS will reduce study heterogeneity and the risk of reporting bias by consistently measuring and reporting these outcomes.

The Core Outcome Measures in Effectiveness Trials (COMET) initiative aims to standardise outcome reporting in trials, facilitates participation of diverse experts undertaking research and minimises duplication of work [12, 13]. The Core Outcome Set STAndards for Reporting (COS-STAR) is a checklist designed to be applicable regardless of the consensus methods used to develop the COS and the various participant groups [14]. The COS-STAR checklist provides guidance for minimal COS study reporting and its purpose is to promote the transparency and completeness of reporting in all COS studies. The CoRe Outcomes in Women’s and Newborn health (CROWN) initiative encourages the development of COSs in women’s and newborns’ health.

The aim of this study was to develop a COS for trials and other studies evaluating the long-term follow-up at 1 year and beyond of women with previous GDM treated with insulin and/oral glucose-lowering agents. This study focuses only on women with GDM treated with insulin and oral glucose-lowering agents as this population has more severe glucose abnormalities and are more likely to progress to type 2 diabetes, obesity and the metabolic syndrome [15, 16].

Methods

This study is registered in the COMET database [17]. Ethical approval for the study was obtained from the Galway University Hospitals Research Ethics Committee (reference CA 1905).

The three work packages of the study were: (1) a systematic review of literature that identified all the outcomes reported in clinical trials that involved the long-term follow-up of this population; (2) a Delphi survey in which all outcomes were scored and prioritised by key stakeholder groups to provide a preliminary list of final outcomes; and (3) a consensus meeting where the final list of outcomes was decided.

Systematic review

Using a broad-based search strategy, the following databases were searched for relevant studies between October 2017 and February 2018: Cochrane Central Register of Controlled Trials (CENTRAL), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PubMed, EMBASE and Web of Science. ClinicalTrials.gov was also searched for relevant ongoing trials. The reference lists of all included studies were searched for additional studies not retrieved from the electronic database search. There was no time restriction on the date of publication of the studies. There was no language restriction applied to the search strategy. Only RCTs and RCT follow-up studies were included in the systematic review (an example of the search strategy is presented in the electronic supplementary material [ESM] Methods).

In step 1, all identified study titles were reviewed and ineligible studies excluded (F.P. Dunne and D. Bogdanet). In step 2, the remaining studies were appraised by two reviewers (F.P. Dunne and D. Bogdanet) who independently assessed the titles and abstracts of each study included at this stage. Full texts of studies meeting the inclusion criteria and studies for which there was uncertainty regarding inclusion at the title/abstract screening stage were retrieved and reviewed independently (F.P. Dunne and D. Bogdanet). The same two authors extracted the data independently, reviewed the data together, assessed consensus and ensured that all outcomes were identified. Following review by F.P. Dunne, D. Devane, D. Bogdanet, L. Biesty, A. M. Egan and P. M. O’Shea (the study advisory group [SAG]), extracted outcomes were grouped under the following domains: laboratory tests, clinical conditions, physiological variables, diet and exercise, psychological variables and other.

Delphi method

We conducted a three-round eDelphi survey [18]. This facilitated international participation. Questionnaires were completed online using SurveyMethods software (www.surveymethods.com, SurveyMethods, Dallas, TX, USA, accessed 9 May 2018). Full details of our methods are given in Bogdanet et al (2019) [19] and are described briefly below.

The stakeholder groups comprised: women with a previous diagnosis of GDM, endocrinologists, diabetes nurses, obstetricians, midwives, paediatricians, neonatologists, general practitioners, practice nurses, dietitians, physiotherapists, researchers with expertise in gestational diabetes, policy makers and others (which included clinicians with expertise in gestational diabetes from specialties other than endocrinology and obstetrics, epidemiologists, clinical biochemists and healthcare assistants).

Invitation emails were sent to societies and individual members of the IADPSG, Diabetes Ireland, Irish Endocrine Society (IES), IDF, International Federation of Gynecology and Obstetrics (FIGO), European Board and College of Obstetrics and Gynaecology (EBCOG), Irish Nutrition and Dietetic Institute (INDI), Association of Clinical Biochemists in Ireland (ACBI), Irish Institute of Obstetricians and Gynaecologists, Saolta Healthcare Group (Ireland), EASD, Diabetic Pregnancy Study Group (DPSG) of the EASD and the Royal College of Physicians Ireland (RCPI) (divisions of Endocrinology, Obstetrics and Endocrinology and Paediatrics). All participants were asked to forward the invitation to others whom they regarded as having the required expertise. Additionally, women with a history of GDM were contacted through their clinic by the authors and by additional study participants and, following consent, were forwarded the survey link or given a printed form of the survey. Women with GDM were from a number of clinics; the final group who participated in the consensus meeting were from the Galway clinic.

Study participants gave informed consent prior to the submission of any answers and the following information was also requested: name, email address, sex, stakeholder group and country of residence. Participants were given information about the study and about COSs. Participants were encouraged to complete the eDelphi questionnaire in each round. An email reminder was sent to anyone who did not respond after 7 and 14 days and also 3 days and 1 day before the end of the round.

In the first round of the survey, all the outcomes identified in the systematic review were presented to the participants grouped by domain. The study participants were asked to rate each outcome on a nine-point Likert scale (1–3 limited importance; 4–6 important but not critical, 7–9 critical). We provided all participants with plain English explanations of the outcomes included in the survey. Participants were invited to suggest additional relevant outcomes (no limit to the number of outcomes suggested) using free-text responses. If two or more study participants nominated an outcome, that outcome was included in round 2 of the survey.

All stakeholder groups were grouped into three broader groups, i.e. clinicians, women with a previous diagnosis of GDM and researchers/policy makers. Descriptive statistics were used to summarise the results from round 1. We sent individual results, the results of each stakeholder group and the results of the total group to each study participant. All outcomes including the additional outcomes suggested in round 1 (by two or more participants) were carried forward to round 2. All respondents to round 1 were invited to participate in round 2 and asked to re-rate the outcomes. All outcomes that scored 7–9 on the Likert scale in ≥70% of answers and 1–3 in <15% of answers were carried forward to round 3. Each participant who completed round 2 was emailed their individual results and the results of each stakeholder group and the total group and was invited to participate in round 3 and re-score retained outcomes. Outcomes were classified as ‘consensus in’ (≥70% participants scoring as 7–9 and <15% scoring as 1–3) or ‘consensus out’ (≥70% scoring as 1–3 and <15% scoring as 7–9). The ‘consensus in’ and borderline outcomes were brought forward to the consensus meeting.

Consensus meeting

The consensus meeting involved representatives from each stakeholder group. The participants discussed each outcome brought forward from round 3. If necessary, the outcomes were grouped or renamed in order to facilitate dissemination and usefulness. At the end of the discussion, each participant voted ‘outcome in’ or ‘outcome out’ using the app Poll Everywhere (San Francisco, CA, USA, accessed 27 September 2018) on their electronic device, thus concealing their identity. Outcomes that scored over 70% ‘outcome in’, were included in the final COS.

Results

A total of 3344 titles and abstracts were identified. Following review of the title and/or abstracts, 62 full text papers were retrieved and assessed for eligibility. A further 37 papers were excluded following full text assessment, leaving 25 papers in the review (ESM Table 1). Following data extraction, 121 individual outcomes were identified. Following the SAG meeting, similar outcomes were combined, leaving a final 116 outcomes to be grouped and included in round 1 (ESM Fig. 1).

The first round of the Delphi survey was sent to 835 participants (societies and individual members). At the end of round 1, there were 288 respondents (34.5%) representing 33 countries and five continents (Table 1). A total of 73% of the respondents were female. The distribution of answers throughout the stakeholder groups in each of the three rounds is presented in Table 1. An additional ten outcomes were suggested by two or more study participants and were included in round 2 (ESM Table 2).
Table 1

Characteristics of participants in the Delphi online survey

Variable

Round 1, % (n = 288)

Round 2, % (n = 190)

Round 3, % (n = 165)

Sex (female)

73

73.7

72.1

Experience/background

   

  Diabetes nurse specialist

5.5

6.3

5.5

  Endocrinologist

31.2

35.8

36.4

  Obstetrician

14.2

15.8

17.6

  Paediatrician

1.7

2.1

0.6

  Neonatologist

1.7

1.6

1.2

  Midwife

5.5

4.7

4.8

  General practitioner

3.8

3.1

3

  Practice nurse

0.3

0.5

0.6

  Dietitian

1.7

1

0.6

  Physiotherapist

1

0

0

  Other

11.8

11.6

12.1

  Woman with previous diagnosis of GDM

14.2

10

10.3

  Researcher with expertise in diabetes

5.5

5.8

6.1

  Policy maker

1.4

1.6

0.6

  Clinician

78.9

82.6

83.3

  Health service user

14.2

10

10.3

  Researcher/policy maker

6.9

7.4

6.7

Participant’s country of residence

   

  Albania

0.3

0.5

0.6

  Argentina

7.3

6.8

6.7

  Australia

3.1

4.2

3.6

  Austria

0.7

1.1

1.2

  Belgium

1

0.5

0.6

  Canada

1

1.6

1.8

  Chile

0.3

0.5

0.6

  Croatia

0.7

1.1

1.2

  Czech Republic

0.3

0

0

  Denmark

3.8

4.2

4.8

  France

1.3

2.1

2.4

  Germany

1

0.5

0.6

  Greece

0.7

1.1

0.6

  Hungary

0.3

0

0

  India

0.7

0.5

0.6

  Ireland

49.8

47.4

49

  Israel

0.7

0

0

  Italy

2.1

2.6

2.4

  Jamaica

0.3

0.5

0.6

  Lithuania

1.4

1.6

1.8

  Malta

0.3

0.5

0.6

  The Netherlands

0.7

1.1

0.6

  New Zealand

3.8

4.2

3

  Nigeria

0.3

0.5

0.6

  Poland

0.7

0

0

  Portugal

0.3

0.5

0

  Romania

0.7

1.1

1.2

  Spain

2.1

1.1

1.2

  Sweden

1

1.1

0.6

  UAE

0.7

0.5

0.6

  UK

7.4

6.4

4.8

  USA

4.2

5.8

6.8

  Uruguay

0.3

0.5

0

UAE, United Arab Emirates

Round 2 participants were asked to rate 126 outcomes grouped as described in the Methods section. Round 2 was completed by 65.9% of the round 1 responders (190 participants). Similar to round 1, there was a female predominance among responders (73.7%). The distribution of answers amid stakeholder groups was similar to round 1 (Table 1) (clinicians 82.6%, women with a history of GDM 10%, researchers/policy makers 7.4%). All outcomes that scored 7–9 on Likert scale in ≥70% and 1–3 in <15% by study participants were brought forward to round 3 (n = 34). The percentage of participants who voted 1–3, 4–6 or 7–9 on each outcome at the end of round 2 is presented in Table 2.
Table 2

Percentage of round 2 participants (n = 190) scoring each outcome as 1–3, 4–6 or 7–9 on the 9-point Likert scale

Variable

Score 1–3, %

Score 4–6, %

Score 7–9, %

Laboratory tests

   

  75 g OGTT

5

11

84

  Glucose level at 30 min during the 75 g OGTT

53

28

19

  Glucose level at 1 h during the 75 g OGTT

24

23

53

  Glucose level at 2 h during the 75 g OGTT

7

14

79

  Glucose level at 3 h during the 75 g OGTT

58

28

14

  Insulin level at 30 min during the OGTT

53

31

16

  Insulin level at 2 h during the OGTT

39

37

24

  Fasting glucose

3

15

82

  Random glucose

45

36

19

  HbA1c level

4

13

83

  Fasting HbA1c

50

20

30

  Insulin level

38

34

28

  Fasting insulin level

28

36

36

  Insulin to glucose ratio

28

40

32

  Insulinogenic index

30

42

28

  Corrected insulin response

37

40

23

  Insulin sensitivity

25

41

33

  HOMA

29

42

29

  HOMA-IR

26

39

35

  HOMA-β

28

40

32

  Triacylglycerol level

24

36

40

  Fasting triacylglycerol level

12

33

55

  Cholesterol level

21

37

42

  Fasting cholesterol

14

37

49

  HDL

20

36

44

  Fasting HDL

15

38

47

  LDL

20

33

47

  Fasting LDL

16

36

48

  Apo-lipoprotein B

35

46

19

  Oxidised lipoproteins

38

46

16

  ACR

11

37

52

  Insulin growth factor

45

39

16

  IGF-binding protein 3 level

50

37

13

  Paraoxonase

54

33

13

  Leptin

40

40

20

  Adiponectin

39

42

19

  Total circulating adiponectin

43

42

15

  High sensitivity C-reactive protein

35

45

20

  Fibrinogen

47

39

14

  Alanine aminotransferase

23

46

31

  Thyroid stimulating hormone

16

40

44

  Free thyroxine

28

35

37

  Total tissue plasminogen activator antigen

49

39

12

  Cytokines

47

41

12

  Genotype for Pro12Ala polymorphism

57

33

10

  Plasma uric acid

41

38

21

  γ-glutamyl aminotransferase

30

43

27

  Vitamin D

26

42

32

Clinical conditions

   

  Type 2 diabetes

0

3

97

  Insulin-treated type 2 diabetes

3

8

89

  GDM in subsequent pregnancies

0

4

96

  The metabolic syndrome

2

16

82

  Impaired fasting glucose

2

14

84

  Impaired glucose tolerance

2

14

84

  Polycystic ovary syndrome

4

26

70

  Cardiovascular disease

2

17

81

Physiological variables

   

  Weight

1

4

95

  Height

12

12

76

  BMI

1

13

86

  Waist circumference

2

18

80

  Hip circumference

9

34

57

  Waist/hip ratio

7

28

65

  Body fat

8

37

55

  Lean mass

7

45

48

  Post-pregnancy weight retention

2

24

74

  BP

1

11

88

  Resting BP

2

15

83

  Systolic BP

2

12

86

  Diastolic BP

2

12

86

  Resting pulse

6

38

56

Diet and exercise

   

  Coffee intake

22

56

22

  Tea intake

25

55

20

  Alcohol intake

5

32

63

  Protein intake

12

45

43

  Carbohydrate intake

8

27

65

  Fruit intake

10

28

62

  Vegetable intake

9

29

62

  Dairy intake

8

39

52

  Fat intake

10

32

58

  Fibre intake

9

38

53

  Low glycaemic intake

10

35

55

  Unsaturated fat intake

13

32

55

  Saturated fat intake

12

31

57

  Healthy fat intake

14

29

57

  Low fat intake

18

40

42

  Low carbohydrate high-fat diet

17

37

46

  Nutrition composition

13

34

53

  Food frequency

13

29

58

  Portion size

7

27

66

  Total caloric intake

7

26

67

  Sweetened beverage intake

9

23

68

  Physical activity

2

9

89

  Walking/cycling to work

7

23

70

  Time spent sitting

6

23

71

  Time spent sleeping

9

26

65

Psychological variables

   

  Quality of life

3

18

79

  Eating behaviour

6

24

70

  Adverse emotional status

4

28

68

  Mental health status

4

23

73

  Anxiety

4

30

66

  Depression

4

23

73

  Activity to enhance mood

8

28

64

  Postnatal depression

5

15

80

Other

   

  Smoking status

4

7

89

  Quality adjusted life year

6

30

64

  Healthcare costs

11

30

59

  Lost productivity due to absence from work

11

39

50

  Sickness resulting in absence from work

11

37

52

  Satisfaction with research participation

15

41

44

  Number of pregnancies since the index pregnancy

6

17

77

  Health insurance

25

38

37

  Income

20

40

40

  Menopause status

17

35

48

  Miscarriage after the index pregnancy

11

29

60

  Breastfeeding in the index pregnancy

5

16

79

  Breastfeeding at 1 year post delivery

10

28

62

  Plans for future pregnancies

10

24

66

  Employment status

21

35

44

  Return to work after pregnancy

18

41

41

  Current medications

5

21

74

  Oral contraceptive use

14

23

63

  Contraception method

16

27

57

  Hormone replacement therapy

16

30

44

  Hysterectomy

25

35

40

  Oophorectomy

26

37

47

  Genital malignancies

20

30

40

Round 3 was completed by 165 participants (86.8%). Similar to round 2, outcomes were brought forward when 70% or more participants scored the outcome as 7–9 and <15% participants scoring as 1–3. In total, 30 outcomes went through the consensus meeting (ESM Table 3).

Consensus meeting

The consensus meeting involved 20 participants, a chairperson and an administrator. The stakeholder groups included four women with a history of gestational diabetes, one diabetes nurse specialist, two midwives, one policy maker, two paediatricians, one clinical biochemist, two researchers in the area of diabetes in pregnancy, one epidemiologist, two obstetricians and four endocrinologists. The participants represented ten countries and three continents. Before the discussion on each outcome, the participants were shown the previous voting results on that particular outcome by the total group and by each stakeholder group. Each outcome was discussed and there was agreement that some items should be grouped and/or rephrased. Therefore, ‘75 g oral glucose tolerance test’, ‘Blood glucose level at 2 h during the 75 g oral glucose tolerance test’, ‘Fasting glucose’ and ‘HbA1c blood levels’ were combined into ‘Assessment of glycaemic status’. ‘Type 2 diabetes’ became ‘Diagnosis of type 2 diabetes since the index pregnancy’. ‘GDM in subsequent/future pregnancies’ became ‘Number of pregnancies with a diagnosis of GDM since the index pregnancy’. ‘Impaired fasting glucose’ and ‘Impaired glucose tolerance’ were combined into ‘Diagnosis of prediabetes since the index pregnancy’ and ‘Breastfeeding after the index pregnancy’ became ‘Breastfeeding’.

Following discussion, the panel voted on each outcome to determine whether it should or should not be included in the final set. The final COS included nine outcomes and is presented in Table 3, together with the percentage of participants that voted ‘consensus in’.
Table 3

Final outcomes to be included in the COS

Outcome

Votes for the outcome to be included in the final COS, %

Assessment of glycaemic status

100

Diagnosis of T2DM since the index pregnancy

90

Number of pregnancies since the index pregnancy

100

Number of pregnancies with a diagnosis of GDM since the index pregnancy

100

Diagnosis of prediabetes since the index pregnancy

100

BMI

100

Post-pregnancy weight retention

95

Resting BP

100

Breastfeeding

75

T2DM, type 2 diabetes mellitus

Discussion

This study used robust methods to develop the first COS relevant to the follow-up of women with previous gestational diabetes treated with insulin and/or glucose-lowering agents. A Delphi consensus panel with 20 representatives from ten countries agreed on nine outcomes to be included in the final COS. It is advised that all studies in this area use this COS to facilitate comparison among studies and limit heterogeneity and reporting bias. The application of agreed methods in developing a COS and the participation of multiple stakeholder groups assure the wide applicability and dissemination of this COS.

The wide applicability of the study was one of the main reasons why the outcomes ‘75 g oral glucose tolerance test’, ‘Blood glucose level at 2 h during the 75 g oral glucose tolerance test’, ‘Fasting glucose’ and ‘HbA1c blood levels’ were combined into ‘Assessment of glycaemic status’; in so doing, the COS permits researchers the opportunity to assess glycaemic status according to their own national guidelines and resources. In addition, this COS identifies ‘what is to be collected’ and not ‘how it is to be collected’, which will be the subject of future work. Similarly, ‘Impaired fasting glucose’ and ‘Impaired glucose tolerance’ were combined as ‘Diagnosis of prediabetes since the index pregnancy’ to give the COS a worldwide applicability in light of the variability in diagnostic tools and criteria. However, while we would recommend that collection and reporting of all outcomes in the COS is mandatory, researchers can choose to collect any additional outcomes required for their study, including specific indices of glycaemic control.

Of importance, the COS consensus meeting had representation from a variety of health professionals/specialties, both local and international, and included women with a previous diagnosis of GDM. This stakeholder composition permitted both the health professionals and women to bring their experience and perspectives to the issues under discussion. Each participant was able to have an understanding of what was important to the other person and what was feasible. Ultimately, this resulted in shared decision-making in a study that will impact future research of women with gestational diabetes.

There are some limitations to our study. Currently, there are no methods for sample size calculation for this type of study. To minimise the potential for selection bias, participants were invited through international organisations and personal professional email lists. Only participants who completed each survey round were recorded. From the totality of initial emails sent before round 1, we had a 35% response. This response rate, however, included participants from 33 countries and five continents. We had a 34% drop-off rate between round 1 and round 2, but, impressively, 87% of participants who completed round 2 also completed round 3. There was a low response rate among primary care physicians (3.5%).

Another potential limitation of this study is the large number of items to be scored in rounds 1 and 2 of the online Delphi survey, which may have impacted negatively on the survey response rate.

We had a large percentage of international participants, including individuals from high-income, upper- and lower-middle-income countries. However, low-income countries were under-represented, and this may limit the generalisability of this COS to certain parts of the world. The participants at the consensus meeting tried to overcome this by rephrasing or combining outcomes in order to increase the worldwide applicability of the COS.

The access to service users was limited by data protection laws, so participants were recruited through the clinical facilities. Despite this, 30% of respondents in round 1 were international service users. At the consensus meeting, 50% of service user participants were non-Irish. We sought international participation for the COS to have global relevance. The service user representatives made important suggestions on all the outcomes discussed at the consensus meeting. Anonymous voting (via the electronic app during this meeting) aimed to prevent participants feeling compelled to vote in a certain way. It has been advocated that the views of health service users should be given greater value in the development of a COS [20] as outcomes reported for clinical studies might not reflect endpoints that are meaningful for them. Examples exist where health service users identified an outcome important to them as a group that might not have been considered by clinicians [21, 22, 23]. However, the responses from health service users and the responses from other stakeholder groups were generally concordant.

The strengths of the study include our use of robust methods in the COS development, including adherence to the COS-STAR statement, the thoroughness of the systematic review (six databases were searched for relevant studies), the high number of participants and the diversity of stakeholder groups participating at each stage of the COS.

Recent review papers have shown the degree of outcome reporting bias among studies, with the main outcome not being reported in up to 47% of the studies and inadequately reported in up to 76% of the studies reviewed [24, 25, 26]. Therefore, there is a cogent argument for creating and disseminating a COS to harmonise outcome reporting.

This is the first study to outline a COS for the long-term follow-up of women with previous GDM. We encourage all investigators undertaking research in this field to report, as a minimum, this COS to reduce reporting bias by allowing evidence synthesis across clinical studies. This will ultimately lead to improvements in the quality of research and delivery of evidence-based healthcare for women with GDM.

Notes

Acknowledgements

We thank all the stakeholders who participated in the Delphi study and consensus meeting. We thank Wellcome and Health Research Board for funding the Irish Clinical Academic Training (ICAT) Programme, of which DB is a training Fellow.

Contribution statement

DB drafted the manuscript, analysed the data and coordinated revisions. All authors participated in and made substantial contribution to the study design or acquisition of data and revised the manuscript critically for important intellectual content. All authors read and approved the final manuscript. DB is responsible for the integrity of the work as a whole.

Funding

The HRB-Trials Methodology Research Network part funded the consensus meeting. TPG is supported by a Hardiman Scholarship from the College of Medicine, Nursing and Health Science, National University of Ireland, Galway, Ireland, and a bursary from the Irish Endocrine Society/Royal College of Physicians of Ireland.

Duality of interest

The authors declare that there is no duality of interest associated with this manuscript.

Supplementary material

125_2019_4935_MOESM1_ESM.pdf (282 kb)
ESM (PDF 281 kb)

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Copyright information

© The Author(s) 2019

Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

Authors and Affiliations

  • Delia Bogdanet
    • 1
    Email author
  • Catriona Reddin
    • 1
  • Esther Macken
    • 1
  • Tomas P. Griffin
    • 1
  • Narjes Fhelelboom
    • 1
  • Linda Biesty
    • 1
  • Shakila Thangaratinam
    • 2
  • Eugene Dempsey
    • 3
  • Caroline Crowther
    • 4
  • Sander Galjaard
    • 5
    Email author
  • Michael Maresh
    • 6
  • Mary R. Loeken
    • 7
    • 8
  • Angela Napoli
    • 9
  • Eleni Anastasiou
    • 10
  • Eoin Noctor
    • 11
  • Harold W. de Valk
    • 12
  • Mireille N. M. van Poppel
    • 13
  • Andrea Agostini
    • 14
  • Cheril Clarson
    • 15
    • 16
  • Aoife M. Egan
    • 17
  • Paula M. O’Shea
    • 1
  • Declan Devane
    • 1
  • Fidelma P. Dunne
    • 1
  1. 1.College of Medicine, Nursing and Health SciencesNational University IrelandGalwayIreland
  2. 2.Queen Mary, University of London, Women’s Health Research UnitLondonUK
  3. 3.INFANT Centre and Department of Paediatrics & Child HealthUniversity College CorkCorkIreland
  4. 4.Liggins InstituteThe University of AucklandAucklandNew Zealand
  5. 5.Department of Obstetrics and Gynaecology, Division of Obstetrics and Prenatal Medicine, Erasmus MCUniversity Medical Centre RotterdamRotterdamthe Netherlands
  6. 6.Department of ObstetricsSt Mary’s Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science CentreManchesterUK
  7. 7.Section of Islet Cell and Regenerative BiologyJoslin Diabetes CenterBostonUSA
  8. 8.Department of MedicineHarvard Medical SchoolBostonUSA
  9. 9.Department of Clinical and Molecular Medicine, Sant’Andrea University HospitalSapienza, University of RomeRomeItaly
  10. 10.Department of Endocrinology, Metabolism and Diabetes CentreAlexandra HospitalAthensGreece
  11. 11.Department of EndocrinologyUniversity Hospital LimerickLimerickIreland
  12. 12.Department of Internal MedicineUniversity Medical Centre UtrechtUtrechtthe Netherlands
  13. 13.Institute of Sport ScienceUniversity of GrazGrazAustria
  14. 14.A.S.L Viterbo Distretto A, Consultorio MontefiasconeRomeItaly
  15. 15.Department of PediatricsUniversity of Western OntarioLondonCanada
  16. 16.Lawson Health Research InstituteLondonCanada
  17. 17.Division of Endocrinology, Diabetes and MetabolismMayo ClinicRochesterUSA

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