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

results from the TOMBOLA randomised controlled trial

Linda Sharp*, Seonaidh Cotton, Julian Little, Nicola M. Gray, Margaret Cruickshank, Louise Smart, Alison Jane Thornton, Norman Waugh, Leslie Walker, The TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) Group

*Corresponding author for this work

Research output: Contribution to journalArticle

10 Citations (Scopus)
5 Downloads (Pure)

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

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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

  • 5-year follow-up
  • depression scale
  • hospital anxiety
  • event scale
  • psychological impact
  • long-term
  • colposcopy
  • women
  • borderline
  • cytology

Cite this

Sharp, L., Cotton, S., Little, J., Gray, N. M., Cruickshank, M., Smart, L., ... The TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) Group (2013). Psychosocial impact of alternative management policies for low-grade cervical abnormalities: results from the TOMBOLA randomised controlled trial. PloS ONE, 8(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; Cotton, Seonaidh; Little, Julian; Gray, Nicola M.; Cruickshank, Margaret; Smart, Louise; Thornton, Alison Jane; Waugh, Norman; Walker, Leslie; The TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) Group.

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

Research output: Contribution to journalArticle

Sharp, L, Cotton, S, Little, J, Gray, NM, Cruickshank, M, Smart, L, Thornton, AJ, Waugh, N, Walker, L & The TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) 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
Sharp, Linda ; Cotton, Seonaidh ; Little, Julian ; Gray, Nicola M. ; Cruickshank, Margaret ; Smart, Louise ; Thornton, Alison Jane ; Waugh, Norman ; Walker, Leslie ; The TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) 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.
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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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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 Jane

AU - Waugh, Norman

AU - Walker, Leslie

AU - The TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) Group

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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 - 5-year follow-up

KW - depression scale

KW - hospital anxiety

KW - event scale

KW - psychological impact

KW - long-term

KW - colposcopy

KW - women

KW - borderline

KW - cytology

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 -