This study aims to estimate the cost-effectiveness of oral spironolactone plus routine topical treatment compared with routine topical treatment alone for persistent acne in adult women from a British NHS perspective over 24 weeks.
Economic evaluation undertaken alongside a pragmatic, parallel, double-blind, randomised trial.
Primary and secondary healthcare, community and social media advertising.
Women ≥18 years with persistent facial acne judged to warrant oral antibiotic treatment.
Participants were randomised 1:1 to 50 mg/day spironolactone (increasing to 100 mg/day after 6 weeks) or matched placebo until week 24. Participants in both groups could continue topical treatment.
Cost-utility analysis assessed incremental cost per quality-adjusted life year (QALY) using the EQ-5D-5L. Cost-effectiveness analysis estimated incremental cost per unit change on the Acne-QoL symptom subscale. Adjusted analysis included randomisation stratification variables (centre, baseline severity (investigator’s global assessment, IGA
Spironolactone did not appear cost-effective in the complete case analysis (n=126 spironolactone, n=109 control), compared with no active systemic treatment (adjusted incremental cost per QALY £67 191; unadjusted £34 770). Incremental cost per QALY was £27 879 (adjusted), just below the upper National Institute for Health and Care Excellence’s threshold value of £30 000, where multiple imputation took account of missing data. Incremental cost per QALY for other sensitivity analyses varied around the base-case, highlighting the degree of uncertainty. The adjusted incremental cost per point change on the Acne-QoL symptom subscale for spironolactone compared with no active systemic treatment was £38.21 (complete case analysis).
The results demonstrate a high level of uncertainty, particularly with respect to estimates of incremental QALYs. Compared with no active systemic treatment, spironolactone was estimated to be marginally cost-effective where multiple imputation was performed but was not cost-effective in complete case analysis.
ISRCTN registry (ISRCTN12892056).
To establish research priorities which will support the development and delivery of community pharmacy initiatives for the management of skin conditions.
An iterative, multistage stakeholder consultation consisting of online survey, participant workshops and prioritisation meeting.
All data collection took place online with participants completing a survey (delivered via the JISC Online Survey platform, between July 2021 and January 2022) and participating in online workshops and meetings (hosted on Microsoft Teams between April and July 2022).
174 community pharmacists and pharmacy staff completed the online survey.
53 participants participated in the exploratory workshops (19 community pharmacists, 4 non-pharmacist members of pharmacy staff and 30 members of the public). 4 healthcare professionals who were unable to attend a workshop participated in a one-to-one interview.
29 participants from the workshops took part in the prioritisation meeting (5 pharmacists/pharmacy staff, 1 other healthcare professional and 23 members of the public).
Five broad areas of potential research need were identified in the online survey: (1) identifying and diagnosing skin conditions; (2) skin conditions in skin of colour; (3) when to refer skin conditions; (4) disease-specific concerns and (5) product-specific concerns.
These were explored and refined in the workshops to establish 10 potential areas for research, which will support pharmacists in managing skin conditions. These were ranked in the prioritisation meeting. Among those prioritised were topics which consider how pharmacists work with other healthcare professionals to identify and manage skin conditions.
Survey responses and stakeholder workshops all recognised the potential for community pharmacists to play an active role in the management of common skin conditions. Future research may support this in the generation of resources for pharmacists, in encouraging public take-up of pharmacy services, and in evaluating the most effective provision for dealing with skin conditions.
To explore parents' perceptions/experiences of help-seeking for unsettled baby behaviours, including views and experiences of obtaining advice from primary healthcare professionals.
Semi-structured qualitative interviews.
Recruitment occurred via social media, general practice and health visiting teams. Remote semi-structured interviews were conducted with parents of babies. Babies were under 12 months old at time of interview, and parents had perceived unsettled baby behaviours in their first 4 months of life. Interviews were transcribed and data analysed using reflexive thematic analysis.
Based on interviews with 25 mothers, four main themes were developed. ‘The need for answers’ highlighted parental uncertainty about what constitutes normal baby behaviour, leading to help-seeking from multiple sources. ‘The importance of health professionals’ and ‘Experiencing health professional support’ identified perceptions about limited access, communication, mixed advice and how these influenced parental perception/management of behaviours. ‘Foundations to help-seeking’ highlighted important roles of social support and online help for valued shared experiences, emotional and practical support.
Health professional access and advice are important to parents, despite the increasing role of online help and importance of social support. More support and improved access to reliable sources of information is needed for parents.
Findings will inform future research and clinical practice to address parental uncertainties. Qualitative research with front-line health professionals is necessary.
Findings can inform the development of resources to support professionals/families managing unsettled babies.
Standards for Reporting Qualitative Research.
A public contributor was involved throughout all stages of the research. Emerging findings were discussed at a parent group.
Addressing parental uncertainties is important; about what is normal, non-pharmacological approaches and when pharmacological intervention is required. A digital information/self-management intervention may be useful for parents/clinicians.
To explore parents' experiences of unsettled babies and medical labels.
Qualitative systematic review, thematic synthesis and development of a conceptual model.
Systematic review and thematic synthesis of primary, qualitative research into parents' experiences of unsettled babies <12 months of age. ‘Unsettled’ was defined as perception of excessive crying with additional feature(s) such as vomiting, skin or stool problems. The Critical Appraisal Skills Programme (CASP) checklist was used to assess trustworthiness.
Structured searches completed in CINAHL, Medline, Embase, PsychINFO and CochraneCT on 23 March 2022 and rerun on 14 April 2023.
Ten eligible studies were included across eight countries contributing data from 103 mothers and 24 fathers. Two analytical themes and eight descriptive themes were developed.
Firstly, parents expressed fearing judgement, feeling guilty and out of control as a result of babies' unsettled symptoms and seeking strategies to construct an ‘Identity as a “Good Parent”’.
This desire for positive parenting identity underpinned the second analytical theme ‘Searching for an explanation’ which included seeking external (medical) causes for babies' unsettled behaviours.
Parents can become trapped in a cycle of ‘searching for an explanation’ for their baby's unsettled behaviours, experiencing considerable distress which is exacerbated by feelings of guilt and failure.
Insight gained from this review could inform interventions to support parents, reducing inaccurate medicalization.
Health visiting teams supporting parents with unsettled baby behaviour could focus on supporting a positive parenting identity by managing expectations, normalizing the continuum of infant behaviours, reducing feelings of guilt or uncertainty and helping parents regain a feeling of control.
ENTREQ guidelines were adhered to in the reporting of this review.
Parent input was crucial in the design phase; shaping the language used (e.g., ‘unsettled babies’) and in the analysis sense-checking findings.