Evidence map›Paper›PMID 24386076›Full record

ArticlePloS one2013

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 Thornton, Norman Waugh, Leslie Walker, TOMBOLA Group

Open access · goldAbstract readComparative Study
In one paragraph

Article in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Observational
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
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  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 3 countries.

Linda SharpNational Cancer Registry Ireland, Cork Airport Business Park, Kinsale Road, Cork, Ireland.
Seonaidh CottonObstetrics & Gynaecology, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, Scotland.
Julian LittleDepartment of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Nicola M GrayCentre of Academic Primary Care, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, Scotland.
Margaret CruickshankObstetrics & Gynaecology, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, Scotland.
Louise SmartDepartment of Pathology, Aberdeen Royal Infirmary, Aberdeen, Scotland.
Alison ThorntonCentre of Academic Primary Care, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, Scotland.
Norman WaughMedical School, University of Warwick, Coventry, England.
Leslie WalkerUniversity of Hull, Hull, England.
TOMBOLA Group
University of Aberdeen · GBAberdeen Royal Infirmary · GBNational Cancer Registry · IEUniversity of Hull · GBUniversity of Ottawa · CAUniversity of Warwick · GB

Funding

Medical Research Council G9700808
6 · The paper itself

Abstract

backgroundLarge 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.

methodsWomen 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.

resultsThere 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.

conclusionsThere 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 registrationControlled-Trials.com ISRCTN 34841617.

Indexed as

AdultAnxietyCervix UteriColposcopyDepressionFemaleHumansMiddle AgedRandomized Controlled Trials as TopicUterine Cervical DiseasesVaginal Smears

Identifiers

PMID24386076
PMCPMC3875419
OpenAlexW2010336628

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.