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MapMySmoke - Primary Care Validation

  • December 2016
DOI:10.13140/RG.2.2.22312.16649
  • Conference: The University of St Andrews Digital Health Initiative Forum
  • At: The University of St Andrews
Authors:
Thomas W Kelsey at University of St Andrews
Thomas W Kelsey
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Abstract

Since smartphones can log spatial, as well as quantitative and qualitative data related to smoking behaviour, we can support smokers by first understanding their smoking behaviour and then sending dynamic support messages post-quit.
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MapMySmoke
A Context Aware Mobile Phone Application
Targeted at Smoking Cessation
Tom Kelsey
School of Computer Science
University of St Andrews
https://tom.home.cs.st-andrews.ac.uk
twk@st-andrews.ac.uk
Tom Kelsey Digital Health Initiative Forum 20 Dec 2016 1 / 16
My Research Background
The late effects of treatment on the fertility of survivors of
childhood cancer (1, 2, 6)
Normative models in reproductive endocrinology &
physiology (3, 4, 5, 9, 10)
Normative models of the human ovarian reserve (7, 8)
Selected recent references are at the end of this presentation
Tom Kelsey Digital Health Initiative Forum 20 Dec 2016 2 / 16
The Team
Rob Schick – School of Mathematics & Statistics
Gerry Humphris – School of Medicine
Tom Kelsey – School of Computer Science
John Marston – Primary Care physician, Fife
Kay Sampson – Tobacco Co-ordinator, Fife Health & Social
Care Partnership
Funding from NHS Fife R & D, the Fife Health and Social Care
Partnership, and the EPSRC Impact Acceleration Account.
Tom Kelsey Digital Health Initiative Forum 20 Dec 2016 3 / 16
Objectives
With the increasing availability of smartphones, we sought to
investigate whether:
An app could be deployed with smokers intending to quit
An app would increase understanding of individual and
population level smoking behavoiour
Knowledge of craving and smoking behaviour helps
smokers quit
App-based delivery of support messages could better
support individual quit attempts
Tom Kelsey Digital Health Initiative Forum 20 Dec 2016 4 / 16
Background
∼11,000 people die in Scotland each year from smoking related
causes.
While quitting smoking is relatively easy, maintaining a quit
attempt is very difficult. Pharmaceutical treatments improve
abstinence rates, however they do not address the spatial aspects
of smoking behaviour.
Since smartphones can log spatial, as well as quantitative and
qualitative data related to smoking behaviour, we can support
smokers by first understanding their smoking behaviour and
then sending dynamic support messages post-quit.
Tom Kelsey Digital Health Initiative Forum 20 Dec 2016 5 / 16
Screenshots from the MapMySmoke app
One data entry screen and two visual summaries
Tom Kelsey Digital Health Initiative Forum 20 Dec 2016 6 / 16
Methods
We have built a
smartphone app
that works on Android and iOS
platforms.
The deployment of this app within a clinical NHS setting has two
distinct phases:
1
a two-week logging phase where pre-quit patients log all of
their smoking and craving events
2a post-quit phase where users receive dynamic support
messages and can continue to log craving events, and
should they occur, relapse events.
Tom Kelsey Digital Health Initiative Forum 20 Dec 2016 7 / 16
Methods
Following the initial logging phase, patients will consult with
their GP to review their smoking patterns and to outline an
individualised quit-attempt plan.
We will deploy the app through two feasibility studies within
NHS Fife with 10 and 100 patients, respectively. Phase I
recruitment was done through Dr Kyle & Partners Surgery in
Pittenweem.
Phase II recruitment will be supervised by NHS Fife Tobacco
Services.
Tom Kelsey Digital Health Initiative Forum 20 Dec 2016 8 / 16
Initial Results
We have successfully deployed the MapMySmoke app in a
clinical setting within NHS Fife.
MapMySmoke collects real-time data on smoking and craving
behaviour.
Initial feedback indicates that use of the app helps make patients
more aware and helps them resist cravings.
Tom Kelsey Digital Health Initiative Forum 20 Dec 2016 9 / 16
Initial Results
The 10 consented patients have logged 124 craving events and
261 smoking events.
Patients using the MapMySmoke app have reported positive
feedback to Dr. Marston:
“The app is very useful in highlighting smoking behaviour–in
particular I found the heatmap the most helpful.”
“I like the app, and found that seeing a representation of my
smoking behaviour is both surprising and helpful.”
“Being asked to log my cravings has helped me resist
smoking.”
Tom Kelsey Digital Health Initiative Forum 20 Dec 2016 10 / 16
Example Smoking Behaviour
Size of circle corresponds to level of satisfaction of each smoking event–larger circle means more satisfaction
Tom Kelsey Digital Health Initiative Forum 20 Dec 2016 11 / 16
Digital Health Science
MapMySmoke provides useful data for the patient & smoking
cessation team to monitor and plan.
Data can also be used to trigger interventions by health
psychology clinicians and/or primary care, who have access to
the entire personalised data.
Anonymised data is available for analysis by non-clinical
researchers investigating population-based issues.
Our privacy, confidentiality & information governance scheme
has been approved by the Public Benefit and Privacy Panel for
Health and Social Care, a governance structure of NHS Scotland.
Tom Kelsey Digital Health Initiative Forum 20 Dec 2016 12 / 16
Context Diagram
Tom Kelsey Digital Health Initiative Forum 20 Dec 2016 13 / 16
Conclusions & Future Work
This is a complex, pragmatic intervention with technological and
clinical components working in unison.
Full release is planned, subject to careful validation of both the
clinical utility and information governance of the app.
Ethical approval & funding is being sought for studies that use
the same underlying technology
1Dental anxiety – with colleagues in Ireland
2Fear of recurrence of cancer – with colleagues in Scotland
Tom Kelsey Digital Health Initiative Forum 20 Dec 2016 14 / 16
References
1: McLaughlin M, et al. Non-growing follicle density is increased following
adriamycin, bleomycin, vinblastine and dacarbazine (ABVD) chemotherapy in
the adult human ovary. Hum Reprod. 2016
2: El Issaoui M, et al. Effect of first line cancer treatment on the ovarian reserve
and follicular density in girls under the age of 18 years. Fertil Steril.
2016;106(7):1757-1762.e1.
3: Andersen CY, et al. Micro-dose hCG as luteal phase support without
exogenous progesterone administration: mathematical modelling of the hCG
concentration in circulation and initial clinical experience. J Assist Reprod
Genet. 2016;33(10):1311-1318.
4: Kelsey TW, et al. A Validated Normative Model for Human Uterine Volume
from Birth to Age 40 Years. PLoS One. 2016 Jun 13;11(6):e0157375.
5: Kelsey TW, et al. A Normative Model of Serum Inhibin B in Young Males.
PLoS One. 2016 Apr 14;11(4):e0153843.
Tom Kelsey Digital Health Initiative Forum 20 Dec 2016 15 / 16
References cont.
6: Wallace WH, et al. Fertility preservation in pre-pubertal girls with cancer: the
role of ovarian tissue cryopreservation. Fertil Steril. 2016;105(1):6-12.
7: McLaughlin M, et al. An externally validated age-related model of mean
follicle density in the cortex of the human ovary. J Assist Reprod Genet.
2015;32(7):1089-95.
8: Depmann M, et al. The Relationship Between Variation in Size of the
Primordial Follicle Pool and Age at Natural Menopause. J Clin Endocrinol
Metab. 2015;100(6):E845-51.
9: Kelsey TW, et al. A validated age-related normative model for male total
testosterone shows increasing variance but no decline after age 40 years. PLoS
One. 2014;9(10):e109346.
10: Kelsey TW, et al. Ovarian volume throughout life: a validated normative
model. PLoS One. 2013;8(9):e71465.
Tom Kelsey Digital Health Initiative Forum 20 Dec 2016 16 / 16
ResearchGate has not been able to resolve any citations for this publication.
Non-growing follicle density is increased following adriamycin, bleomycin, vinblastine and dacarbazine (ABVD) chemotherapy in the adult human ovary
Article
Full-text available
Study question: Do the chemotherapeutic regimens of ABVD (adriamycin, bleomycin, vinblastine and dacarbazine) or OEPA-COPDAC (combined vincristine, etoposide, prednisone, doxorubicin (OEPA) and cyclophosphamide, vincristine, prednisone, dacarbazine (COPDAC)) used to treat Hodgkin lymphoma (HL), affect the density, morphology and in vitro developmental potential of human ovarian follicles? Summary answer: Ovarian tissue from women treated with ABVD contained a higher density of non-growing follicles (NGFs) per cubic millimetre and increased numbers of multiovular follicles but showed reduced in vitro growth compared with patients with lymphoma who had not received chemotherapy, patients treated with OEPA-COPDAC, age-matched healthy women and age-related model-predicted values. What is known already: Chemotherapy regimens can cause a loss of follicles within the ovary, which depends on the drugs given. Early stage HL is commonly treated by ABVD, a non-alkylating regimen that apparently has ovarian sparing qualities; thus it is important to investigate the histological appearance and distribution of follicles within ABVD-treated ovarian tissue. Study design, size, duration: Thirteen ovarian biopsies were obtained from HL patients (six adolescents and seven adults) and one biopsy from a non-HL patient. Two HL patients and the non-HL patient had received no treatment prior to biopsy collection. The remaining 11 HL patients received one of two regimens: ABVD or OEPA-COPDAC. Tissue was analysed histologically and compared to biopsies from healthy women, and in a subgroup of patients, tissue was cultured for 6 days in vitro. Participants/materials, setting, methods: Ovarian biopsies were obtained from patients undergoing ovarian cryopreservation for fertility preservation and from healthy women at the time of Caesarian section ('obstetric tissue'). Follicle number and maturity were evaluated in sections of ovarian cortical tissue, and compared to an age-related model of mean follicle density and to age-matched contemporaneous biopsies. The developmental potential of follicles was investigated after 6 days of tissue culture. Main results and the role of chance: A total of 6877 follicles were analysed. ABVD-treated tissue contained a higher density of NGFs per cubic millimetre (230 ± 17) (mean ± SEM) than untreated (110 ± 54), OEPA-COPDAC-treated (50 ± 27) and obstetric (20 ± 4) tissue (P < 0.01), with follicle density 9-21 SD higher than predicted by an age-related model. Biovular and binucleated NGFs occurred frequently in ABVD-treated and in adolescent-untreated tissue but were not observed in OEPA-COPDAC-treated or obstetric tissue, although OEPA-COPDAC-treated tissue contained a high proportion of morphologically abnormal oocytes (52% versus 23% in untreated, 22% in ABVD-treated and 25% in obstetric tissue; P < 0.001). Activation of follicle growth in vitro occurred in all groups, but in ABVD-treated samples there was very limited development to the secondary stage, whereas in untreated samples from lymphoma patients growth was similar to that observed in obstetric tissue (untreated; P < 0.01 versus ABVD-treated, NS versus obstetric). Large scale data: N/A LIMITATIONS, REASONS FOR CAUTION: Although a large number of follicles were analysed, these data were derived from a small number of biopsies. The mechanisms underpinning these observations have yet to be determined and it is unclear how they relate to future fertility. Wider implications of the findings: This study confirms that the number of NGFs is not depleted following ABVD treatment, consistent with clinical data that female fertility is preserved. Our findings demonstrate that immature follicle density can increase as well as decrease following at least one chemotherapy treatment. This is the first report of morphological and follicle developmental similarities between ABVD-treated tissue and the immature human ovary. Further experiments will investigate the basis for the marked increase in follicle density in ABVD-treated tissue. Study funding/competing interests: Funded by UK Medical Research Council Grants G0901839 and MR/L00299X/1. The authors have no competing interests.
Micro-dose hCG as luteal phase support without exogenous progesterone administration: mathematical modelling of the hCG concentration in circulation and initial clinical experience
Article
Full-text available
For the last two decades, exogenous progesterone administration has been used as luteal phase support (LPS) in connection with controlled ovarian stimulation combined with use of the human chorionic gonadotropin (hCG) trigger for the final maturation of follicles. The introduction of the GnRHa trigger to induce ovulation showed that exogenous progesterone administration without hCG supplementation was insufficient to obtain satisfactory pregnancy rates. This has prompted development of alternative strategies for LPS. Augmenting the local endogenous production of progesterone by the multiple corpora lutea has been one focus with emphasis on one hand to avoid development of ovarian hyper-stimulation syndrome and, on the other hand, to provide adequate levels of progesterone to sustain implantation. The present study evaluates the use of micro-dose hCG for LPS support and examines the potential advances and disadvantages. Based on the pharmacokinetic characteristics of hCG, the mathematical modelling of the concentration profiles of hCG during the luteal phase has been evaluated in connection with several different approaches for hCG administration as LPS. It is suggested that the currently employed LPS provided in connection with the GnRHa trigger (i.e. 1.500 IU) is too strong, and that daily micro-dose hCG administration is likely to provide an optimised LPS with the current available drugs. Initial clinical results with the micro-dose hCG approach are presented.
A Validated Normative Model for Human Uterine Volume from Birth to Age 40 Years
Article
Full-text available
Transabdominal pelvic ultrasound and/or pelvic Magnetic Resonance Imaging are safe, accurate and non-invasive means of determining the size and configuration of the internal female genitalia. The assessment of uterine size and volume is helpful in the assessment of many conditions including disorders of sex development, precocious or delayed puberty, infertility and menstrual disorders. Using our own data from the assessment of MRI scans in healthy young females and data extracted from four studies that assessed uterine volume using transabdominal ultrasound in healthy females we have derived and validated a normative model of uterine volume from birth to age 40 years. This shows that uterine volume increases across childhood, with a faster increase in adolescence reflecting the influence of puberty, followed by a slow but progressive rise during adult life. The model suggests that around 84% of the variation in uterine volumes in the healthy population up to age 40 is due to age alone. The derivation of a validated normative model for uterine volume from birth to age 40 years has important clinical applications by providing age-related reference values for uterine volume.
A Normative Model of Serum Inhibin B in Young Males
Article
Full-text available
Inhibin B has been identified as a potential marker of Sertoli cell function in males. The aim of this study is to produce a normative model of serum inhibin B in males from birth to seventeen years. We used a well-defined search strategy to identify studies containing data that can contribute to a larger approximation of the healthy population. We combined data from four published studies (n = 709) and derived an internally validated model with high goodness-of-fit and normally distributed residuals. Our results show that inhibin B increases following birth to a post-natal peak of 270 pg/mL (IQR 210-335 pg/mL) and then decreases during childhood followed by a rise at around 8 years, peaking at a mean 305 pg/mL (IQR 240-445 pg/mL) at around age 17. Following this peak there is a slow decline to the standard mature adult normal range of 170 pg/mL (IQR 125-215 pg/mL). This normative model suggests that 35% of the variation in Inhibin B levels in young males is due to age alone, provides an age-specific reference range for inhibin B in the young healthy male population, and will be a powerful tool in evaluating the potential of inhibin B as a marker of Sertoli cell function in pre-pubertal boys.
The Relationship Between Variation in Size of the Primordial Follicle Pool and Age at Natural Menopause
Article
Full-text available
Menopause has been hypothesized to occur when the non-growing follicle (NGF) number falls below a critical threshold. Age at natural menopause (ANM) can be predicted using NGF numbers and this threshold. These predictions support the use of ovarian reserve tests, reflective of the ovarian follicle pool, in menopause forecasting. To investigate the hypothesis that age-specific NGF numbers reflect age at natural menopause. Histologically derived NGF numbers obtained from published literature (n=218) and distribution of menopausal ages derived from the population based Prospect-EPIC cohort (n=4037) were combined. NGF data were from single ovaries that had been obtained post-natally for various reasons, such as elective surgery or autopsy. From the Prospect-EPIC cohort, women aged 58 years and older with a known ANM were selected. None Main Outcome Measure(s): Conformity between observed age at menopause in the Prospect-EPIC cohort and NGF-predicted age at menopause from a model for age-related NGF decline constructed using a robust regression analysis. A critical threshold for NGF number was estimated by comparing the probability distribution of age at which NGF numbers fall below this threshold with the observed distribution of ANM from the Prospect-EPIC cohort. The distributions of observed age at natural menopause and predicted age at natural menopause showed close conformity. The close conformity observed between NGF-predicted and actual age at natural menopause supports the hypothesis that that the size of the primordial follicle pool is an important determinant for the length of the individual ovarian lifespan and supports the concept of menopause prediction using ovarian reserve tests, such as anti-Müllerian hormone and antral follicle count, as derivatives of the true ovarian reserve.
A Validated Age-Related Normative Model for Male Total Testosterone Shows Increasing Variance but No Decline after Age 40 Years
Article
Full-text available
The diagnosis of hypogonadism in human males includes identification of low serum testosterone levels, and hence there is an underlying assumption that normal ranges of testosterone for the healthy population are known for all ages. However, to our knowledge, no such reference model exists in the literature, and hence the availability of an applicable biochemical reference range would be helpful for the clinical assessment of hypogonadal men. In this study, using model selection and validation analysis of data identified and extracted from thirteen studies, we derive and validate a normative model of total testosterone across the lifespan in healthy men. We show that total testosterone peaks [mean (2.5-97.5 percentile)] at 15.4 (7.2-31.1) nmol/L at an average age of 19 years, and falls in the average case [mean (2.5-97.5 percentile)] to 13.0 (6.6-25.3) nmol/L by age 40 years, but we find no evidence for a further fall in mean total testosterone with increasing age through to old age. However we do show that there is an increased variation in total testosterone levels with advancing age after age 40 years. This model provides the age related reference ranges needed to support research and clinical decision making in males who have symptoms that may be due to hypogonadism.
Ovarian Volume throughout Life: A Validated Normative Model
Article
Full-text available
The measurement of ovarian volume has been shown to be a useful indirect indicator of the ovarian reserve in women of reproductive age, in the diagnosis and management of a number of disorders of puberty and adult reproductive function, and is under investigation as a screening tool for ovarian cancer. To date there is no normative model of ovarian volume throughout life. By searching the published literature for ovarian volume in healthy females, and using our own data from multiple sources (combined n = 59,994) we have generated and robustly validated the first model of ovarian volume from conception to 82 years of age. This model shows that 69% of the variation in ovarian volume is due to age alone. We have shown that in the average case ovarian volume rises from 0.7 mL (95% CI 0.4-1.1 mL) at 2 years of age to a peak of 7.7 mL (95% CI 6.5-9.2 mL) at 20 years of age with a subsequent decline to about 2.8 mL (95% CI 2.7-2.9 mL) at the menopause and smaller volumes thereafter. Our model allows us to generate normal values and ranges for ovarian volume throughout life. This is the first validated normative model of ovarian volume from conception to old age; it will be of use in the diagnosis and management of a number of diverse gynaecological and reproductive conditions in females from birth to menopause and beyond.
Effect of First Line Cancer Treatment on the Ovarian Reserve and Follicular Density in Girls Under the Age of 18 Years
Article
Objective To study the impact of first-line antineoplastic treatment on ovarian reserve in young girls returning for ovarian tissue cryopreservation (OTC) in connection with a relapse. Design Retrospective case-control study. Setting University hospitals. Patient(s) Sixty-three girls under the age of 18 years who underwent OTC before (group 1: 31 patients) and after (group 2: 32 patients) their initial cancer treatment. Intervention(s) None. Main Outcome Measure(s) Follicular densities (follicles/mm3) measured from an ovarian cortical biopsy before OTC. The ovarian volume (mL) of entire ovaries excised for OTC was also monitored. Result(s) There was no statistically significant difference in the mean age or follicular density between groups 1 and 2 (334 ± 476/mm3 vs. 327 ± 756/mm3). In contrast, the ovarian volume and total number of ovarian cortex chips cryopreserved were statistically significantly lower in patients who received gonadotoxic treatment before OTC (mean ± standard deviation [SD]: ovarian volume, 5.3 ± 3.1 mL vs. 2.9 ± 2.1 mL, respectively; number of cortex chips: 21.3 ± 8.1 vs. 15.2 ± 7.1, respectively). The reduction in the estimated ovarian reserve ranged from 10% to 20% in children to around 30% in adolescent girls (>10 years). Conclusion(s) Girls under the age of 10 tolerate a gonadotoxic insult better than adolescents, who may experience up to a 30% reduction in the ovarian reserve via first-line gonadotoxic treatment, which at present is considered to have little effect on the follicle pool. This information will improve counseling of young female cancer patients in deciding whether to undergo fertility preservation treatment.
Fertility preservation in pre-pubertal girls with cancer: The role of ovarian tissue cryopreservation
Article
  • Dec 2015
With the increasing numbers of survivors of cancer in young people, future fertility and ovarian function are important considerations that should be discussed before treatment commences. Some young people, by nature of the treatment they will receive, are at high risk of premature ovarian insufficiency and infertility. For them, ovarian tissue cryopreservation (OTC) is one approach to fertility preservation that remains both invasive and for young patients experimental. There are important ethical and consent issues that need to be explored and accepted before OTC can be considered established in children with cancer. In this review we have discussed a framework for patient selection which has been shown to be effective in identifying those patients at high risk of premature ovarian insufficiency and who can be offered OTC safely.