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Table 2 Midwives’ perspectives on key study procedures – qualitative responses

From: The treatment of booking gestational diabetes mellitus (TOBOGM) pilot randomised controlled trial

What are your thoughts on the study specifically approaching women in the booking clinic to participate, who have been identified as at risk for GDM? Acceptable • Recruitment strategy is ‘good’, ‘good idea’ or ‘fantastic idea’ (S: 7) No concerns • No concerns regarding the ethics of approaching this group (F: 3) • Neutral or no concerns recruitment (S: 6) Concerns • Consent is an important issue, women should be aware of what their participation would involve e.g. blinding of results, potential withholding of treatment (F: 3, S: 1) • Do not agree with the deliberate recruitment of an at risk population (S: 1)
What do you think about delaying treatment, if needed, to 24 to 28 weeks? Acceptable • Treatment timing is acceptable/appropriate (S: 8) • Acceptable, as standard procedures used to be based on 28 weeks to detect GDM (S: 1, F: 1) • More information/research needed on the outcomes of delayed treatment (S: 2) Concerns • Concern about the legal and ethical issues of providing adequate ‘duty of care’ to patients whose results were withheld due to research participation (F: 2) • Concern that researchers could make a mistake in identifying at-risk patients and delaying treatment (S: 2) • No issue unless GDM is detected earlier, then treatment should not be delayed (S: 3) Not acceptable • Not acceptable, testing and treatment should be made earlier to prevent risk to the mother and foetus e.g. could be too late to treat, to educate mother, prevent complications (S: 4) • Detection and treatment should occur earlier only if risk factors are present (S: 2) • Treatment delay could prevent mothers from experiencing unnecessary anxiety about their pregnancy (F:3) • Unsure (S: 1)
How do you feel about the heel prick test for glucose at one hour old? Acceptable • Midwives were not concerned as it was not part of their workload (F: 2) • Baby’s best interests and health the main priority (S: 1) • Test is needed and therefore there should be no concerns (S: 5) • Not necessary as already part of standard care (S: 4) • Test okay if managed professionally (S: 1) • Test should occur on the basis it will assist in health research (S: 1) Importance of mothers’ consent • Mothers’ consent/refusal must be respected (S: 7) • Mothers’ should be educated and given opportunity to consent, prior to birth (S: 4) • Issues with consent can only be dealt with if there is ‘medical indication’ that test must be done, and a subsequent “refusal of treatment” is put in clinical notes (S: 1) • Concern that test may not be conducted due to mothers’ viewing it as unnecessary despite previously consenting (F: 2) Concerns • Test may not be undertaken due to staff being overworked/too busy (S: 1) • Unnecessary for babies who do not have a diabetic mother (F: 1)
  1. S Survey responses, F Focus group responses