Psychosocial impact of alternative management policies for low-grade cervical abnormalities

results from the TOMBOLA randomised controlled trial

Linda Sharp (Lead / Corresponding author), Seonaidh Cotton, Julian Little, Nicola M. Gray, Margaret Cruickshank, Louise Smart, Alison Thornton, Norman Waugh, Leslie Walker, on behalf of the TOMBOLA group

    Research output: Contribution to journalArticle

    8 Citations (Scopus)

    Abstract

    BACKGROUND: Large numbers of women who participate in cervical screening require follow-up for minor cytological abnormalities. Little is known about the psychological consequences of alternative management policies for these women. We compared, over 30-months, psychosocial outcomes of two policies: cytological surveillance (repeat cervical cytology tests in primary care) and a hospital-based colposcopy examination.

    METHODS: Women attending for a routine cytology test within the UK NHS Cervical Screening Programmes were eligible to participate. 3399 women, aged 20-59 years, with low-grade abnormal cytology, were randomised to cytological surveillance (six-monthly tests; n = 1703) or initial colposcopy with biopsies and/or subsequent treatment based on colposcopic and histological findings (n = 1696). At 12, 18, 24 and 30-months post-recruitment, women completed the Hospital Anxiety and Depression Scale (HADS). A subgroup (n = 2354) completed the Impact of Event Scale (IES) six weeks after the colposcopy episode or first surveillance cytology test. Primary outcomes were percentages over the entire follow-up period of significant depression (≥ 8) and significant anxiety (≥ 11; "30-month percentages"). Secondary outcomes were point prevalences of significant depression, significant anxiety and procedure-related distress (≥ 9). Outcomes were compared between arms by calculating fully-adjusted odds ratios (ORs) for initial colposcopy versus cytological surveillance.

    RESULTS: There was no significant difference in 30-month percentages of significant depression (OR = 0.99, 95% CI 0.80-1.21) or anxiety (OR = 0.97, 95% CI 0.81-1.16) between arms. At the six-week assessment, anxiety and distress, but not depression, were significantly less common in the initial colposcopy arm (anxiety: 7.9% vs 13.4%; OR = 0.55, 95% CI 0.38-0.81; distress: 30.6% vs 39.3%, OR = 0.67 95% CI 0.54-0.84). Neither anxiety nor depression differed between arms at subsequent time-points.

    CONCLUSIONS: There was no difference in the longer-term psychosocial impact of management policies based on cytological surveillance or initial colposcopy. Policy-makers, clinicians, and women themselves can be reassured that neither management policy has a significantly greater psychosocial cost.

    TRIAL REGISTRATION: Controlled-Trials.com ISRCTN 34841617.

    Original languageEnglish
    Article numbere80092
    Number of pages13
    JournalPLoS ONE
    Volume8
    Issue number12
    DOIs
    Publication statusPublished - 30 Dec 2013

    Fingerprint

    Cytology
    colposcopy
    Colposcopy
    anxiety
    Anxiety
    Randomized Controlled Trials
    odds ratio
    Depression
    cell biology
    Odds Ratio
    Cell Biology
    distress
    Screening
    monitoring
    Biopsy
    testing
    screening
    Administrative Personnel
    biopsy
    Primary Health Care

    Keywords

    • Adult
    • Anxiety
    • Cervix uteri
    • Colposcopy
    • Depression
    • Female
    • Humans
    • Middle aged
    • Randomized controlled trials as topic
    • Uterine cervical diseases
    • Vaginal smears

    Cite this

    Sharp, Linda ; Cotton, Seonaidh ; Little, Julian ; Gray, Nicola M. ; Cruickshank, Margaret ; Smart, Louise ; Thornton, Alison ; Waugh, Norman ; Walker, Leslie ; on behalf of the TOMBOLA group. / Psychosocial impact of alternative management policies for low-grade cervical abnormalities : results from the TOMBOLA randomised controlled trial. In: PLoS ONE. 2013 ; Vol. 8, No. 12.
    @article{a6468a9814e54d8e8fe33bdd340d49af,
    title = "Psychosocial impact of alternative management policies for low-grade cervical abnormalities: results from the TOMBOLA randomised controlled trial",
    abstract = "BACKGROUND: Large numbers of women who participate in cervical screening require follow-up for minor cytological abnormalities. Little is known about the psychological consequences of alternative management policies for these women. We compared, over 30-months, psychosocial outcomes of two policies: cytological surveillance (repeat cervical cytology tests in primary care) and a hospital-based colposcopy examination.METHODS: Women attending for a routine cytology test within the UK NHS Cervical Screening Programmes were eligible to participate. 3399 women, aged 20-59 years, with low-grade abnormal cytology, were randomised to cytological surveillance (six-monthly tests; n = 1703) or initial colposcopy with biopsies and/or subsequent treatment based on colposcopic and histological findings (n = 1696). At 12, 18, 24 and 30-months post-recruitment, women completed the Hospital Anxiety and Depression Scale (HADS). A subgroup (n = 2354) completed the Impact of Event Scale (IES) six weeks after the colposcopy episode or first surveillance cytology test. Primary outcomes were percentages over the entire follow-up period of significant depression (≥ 8) and significant anxiety (≥ 11; {"}30-month percentages{"}). Secondary outcomes were point prevalences of significant depression, significant anxiety and procedure-related distress (≥ 9). Outcomes were compared between arms by calculating fully-adjusted odds ratios (ORs) for initial colposcopy versus cytological surveillance.RESULTS: There was no significant difference in 30-month percentages of significant depression (OR = 0.99, 95{\%} CI 0.80-1.21) or anxiety (OR = 0.97, 95{\%} CI 0.81-1.16) between arms. At the six-week assessment, anxiety and distress, but not depression, were significantly less common in the initial colposcopy arm (anxiety: 7.9{\%} vs 13.4{\%}; OR = 0.55, 95{\%} CI 0.38-0.81; distress: 30.6{\%} vs 39.3{\%}, OR = 0.67 95{\%} CI 0.54-0.84). Neither anxiety nor depression differed between arms at subsequent time-points.CONCLUSIONS: There was no difference in the longer-term psychosocial impact of management policies based on cytological surveillance or initial colposcopy. Policy-makers, clinicians, and women themselves can be reassured that neither management policy has a significantly greater psychosocial cost.TRIAL REGISTRATION: Controlled-Trials.com ISRCTN 34841617.",
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    author = "Linda Sharp and Seonaidh Cotton and Julian Little and Gray, {Nicola M.} and Margaret Cruickshank and Louise Smart and Alison Thornton and Norman Waugh and Leslie Walker and {on behalf of the TOMBOLA group}",
    year = "2013",
    month = "12",
    day = "30",
    doi = "10.1371/journal.pone.0080092",
    language = "English",
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    Sharp, L, Cotton, S, Little, J, Gray, NM, Cruickshank, M, Smart, L, Thornton, A, Waugh, N, Walker, L & on behalf of the TOMBOLA group 2013, 'Psychosocial impact of alternative management policies for low-grade cervical abnormalities: results from the TOMBOLA randomised controlled trial', PLoS ONE, vol. 8, no. 12, e80092. https://doi.org/10.1371/journal.pone.0080092

    Psychosocial impact of alternative management policies for low-grade cervical abnormalities : results from the TOMBOLA randomised controlled trial. / Sharp, Linda (Lead / Corresponding author); Cotton, Seonaidh; Little, Julian; Gray, Nicola M.; Cruickshank, Margaret; Smart, Louise; Thornton, Alison; Waugh, Norman; Walker, Leslie; on behalf of the TOMBOLA group.

    In: PLoS ONE, Vol. 8, No. 12, e80092, 30.12.2013.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - Psychosocial impact of alternative management policies for low-grade cervical abnormalities

    T2 - results from the TOMBOLA randomised controlled trial

    AU - Sharp, Linda

    AU - Cotton, Seonaidh

    AU - Little, Julian

    AU - Gray, Nicola M.

    AU - Cruickshank, Margaret

    AU - Smart, Louise

    AU - Thornton, Alison

    AU - Waugh, Norman

    AU - Walker, Leslie

    AU - on behalf of the TOMBOLA group

    PY - 2013/12/30

    Y1 - 2013/12/30

    N2 - BACKGROUND: Large numbers of women who participate in cervical screening require follow-up for minor cytological abnormalities. Little is known about the psychological consequences of alternative management policies for these women. We compared, over 30-months, psychosocial outcomes of two policies: cytological surveillance (repeat cervical cytology tests in primary care) and a hospital-based colposcopy examination.METHODS: Women attending for a routine cytology test within the UK NHS Cervical Screening Programmes were eligible to participate. 3399 women, aged 20-59 years, with low-grade abnormal cytology, were randomised to cytological surveillance (six-monthly tests; n = 1703) or initial colposcopy with biopsies and/or subsequent treatment based on colposcopic and histological findings (n = 1696). At 12, 18, 24 and 30-months post-recruitment, women completed the Hospital Anxiety and Depression Scale (HADS). A subgroup (n = 2354) completed the Impact of Event Scale (IES) six weeks after the colposcopy episode or first surveillance cytology test. Primary outcomes were percentages over the entire follow-up period of significant depression (≥ 8) and significant anxiety (≥ 11; "30-month percentages"). Secondary outcomes were point prevalences of significant depression, significant anxiety and procedure-related distress (≥ 9). Outcomes were compared between arms by calculating fully-adjusted odds ratios (ORs) for initial colposcopy versus cytological surveillance.RESULTS: There was no significant difference in 30-month percentages of significant depression (OR = 0.99, 95% CI 0.80-1.21) or anxiety (OR = 0.97, 95% CI 0.81-1.16) between arms. At the six-week assessment, anxiety and distress, but not depression, were significantly less common in the initial colposcopy arm (anxiety: 7.9% vs 13.4%; OR = 0.55, 95% CI 0.38-0.81; distress: 30.6% vs 39.3%, OR = 0.67 95% CI 0.54-0.84). Neither anxiety nor depression differed between arms at subsequent time-points.CONCLUSIONS: There was no difference in the longer-term psychosocial impact of management policies based on cytological surveillance or initial colposcopy. Policy-makers, clinicians, and women themselves can be reassured that neither management policy has a significantly greater psychosocial cost.TRIAL REGISTRATION: Controlled-Trials.com ISRCTN 34841617.

    AB - BACKGROUND: Large numbers of women who participate in cervical screening require follow-up for minor cytological abnormalities. Little is known about the psychological consequences of alternative management policies for these women. We compared, over 30-months, psychosocial outcomes of two policies: cytological surveillance (repeat cervical cytology tests in primary care) and a hospital-based colposcopy examination.METHODS: Women attending for a routine cytology test within the UK NHS Cervical Screening Programmes were eligible to participate. 3399 women, aged 20-59 years, with low-grade abnormal cytology, were randomised to cytological surveillance (six-monthly tests; n = 1703) or initial colposcopy with biopsies and/or subsequent treatment based on colposcopic and histological findings (n = 1696). At 12, 18, 24 and 30-months post-recruitment, women completed the Hospital Anxiety and Depression Scale (HADS). A subgroup (n = 2354) completed the Impact of Event Scale (IES) six weeks after the colposcopy episode or first surveillance cytology test. Primary outcomes were percentages over the entire follow-up period of significant depression (≥ 8) and significant anxiety (≥ 11; "30-month percentages"). Secondary outcomes were point prevalences of significant depression, significant anxiety and procedure-related distress (≥ 9). Outcomes were compared between arms by calculating fully-adjusted odds ratios (ORs) for initial colposcopy versus cytological surveillance.RESULTS: There was no significant difference in 30-month percentages of significant depression (OR = 0.99, 95% CI 0.80-1.21) or anxiety (OR = 0.97, 95% CI 0.81-1.16) between arms. At the six-week assessment, anxiety and distress, but not depression, were significantly less common in the initial colposcopy arm (anxiety: 7.9% vs 13.4%; OR = 0.55, 95% CI 0.38-0.81; distress: 30.6% vs 39.3%, OR = 0.67 95% CI 0.54-0.84). Neither anxiety nor depression differed between arms at subsequent time-points.CONCLUSIONS: There was no difference in the longer-term psychosocial impact of management policies based on cytological surveillance or initial colposcopy. Policy-makers, clinicians, and women themselves can be reassured that neither management policy has a significantly greater psychosocial cost.TRIAL REGISTRATION: Controlled-Trials.com ISRCTN 34841617.

    KW - Adult

    KW - Anxiety

    KW - Cervix uteri

    KW - Colposcopy

    KW - Depression

    KW - Female

    KW - Humans

    KW - Middle aged

    KW - Randomized controlled trials as topic

    KW - Uterine cervical diseases

    KW - Vaginal smears

    U2 - 10.1371/journal.pone.0080092

    DO - 10.1371/journal.pone.0080092

    M3 - Article

    VL - 8

    JO - PLoS ONE

    JF - PLoS ONE

    SN - 1932-6203

    IS - 12

    M1 - e80092

    ER -