colorectal dis 2011_ p536

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Systematic review doi:10.1111/j.1463-1318.2010.02538.x Quality of life, health-related quality of life and health status in patients having restorative proctocolectomy with ileal pouch- anal anastomosis for ulcerative colitis: a systematic review J. T. Heikens*†, J. de Vries‡§ and C. J. H. M. van Laarhoven* *Department of Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands, †Department of Surgery, St Elisabeth Hospital, Tilburg, the Netherlands, ‡Centre of Research on Psychology in Somatic diseases, Tilburg University, Tilburg, the Netherlands and §Department of Medical Psychology, St Elisabeth Hospital, Tilburg, the Netherlands Received 10 August 2010; accepted 23 August 2010; Accepted Article online 22 December 2010 Abstract Aim There are numerous studies on quality of life (QoL), health-related quality of life (HRQoL), and health status (HS) in patients undergoing surgery for ulcerative colitis. A systematic review of published literature was conducted to establish the quality of these studies and to determine QoL, HRQoL, and HS in patients after ileal pouch-anal anastomosis for ulcerative colitis. Method All published studies describing QoL, HRQoL, and HS in adult patients in combination with ileal pouch-anal anastomosis for ulcerative colitis were reviewed systematically. No time or language limitations were applied. Relevance was established on the basis of three pre-specified selection criteria: 1) ileal pouch-anal anastomosis was performed for ulcerative colitis, 2) QoL, HRQoL, and HS were reported as outcome of the study and 3) studies reported a minimum follow-up after surgery for 12 months. Outcome variables were results of QoL, HRQoL, and HS, characteristics of the study population, pouch construction, duration of follow-up, and time of assessment in months before and after restorative surgery. Descriptive data synthesis was performed by tabulation displaying the methodolo- gical quality, study characteristics and conclusions on QoL, HRQoL, and HS measurements in the studies. Results The review included 33 studies comprising 4790 patients. Three were graded to be of high quality, 23 of moderate quality and seven of low quality. All reported improved HS and the majority reported improved HRQoL. However, none of the studies reported on QoL. Conclusion The HRQoL and HS of patients with ulcerative colitis improved 12 months after restorative proctocolectomy with an ileal pouch-anal anastomosis and were indistinguishable from the HRQoL and HS of the normal healthy population. Keywords Quality of life, health-related quality of life, health status, ileal pouch-anal anastomosis, ulcerative colitis, systematic review Introduction From the late 1970s improved medical and surgical treatment has resulted in improved outcomes for patients with ulcerative colitis (UC) [1–6]. Since its introduction in 1978, restorative proctocolectomy with an ileal pouch- anal anastomosis (IPAA) has been considered as the procedure of choice for patients with UC requiring surgery [7]. Over time, the aim of surgery has shifted from reducing mortality to decreasing morbidity and improving quality of life (QoL) [8]. The patient’s QoL, health-related quality of life (HRQoL) and health status (HS) are increasingly recog- nized as important outcomes of medical treatment and they have become important indicators of the quality of health care, especially in patients with chronic disease [9]. These measures help clinicians in management decisions and improve the doctor–patient relationship and patient care [10,11]. As restorative surgery after proctocolec- tomy is considered ‘QoL surgery’, QoL, HRQoL and HS are the main end-points by which the effectiveness of treatment is judged [12]. Correspondence to: Joost Heikens, MD, Department of Surgery, Radboud University Nijmegen Medical Centre, route 690, Geert Grooteplein-Zuid 10, 6525 GA Nijmegen, the Netherlands. E-mail: [email protected] Ó 2011 The Authors 536 Colorectal Disease Ó 2011 The Association of Coloproctology of Great Britain and Ireland. 14, 536–544

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  • Systematic review doi:10.1111/j.1463-1318.2010.02538.x

    Quality of life, health-related quality of life and health statusin patients having restorative proctocolectomy with ileal pouch-anal anastomosis for ulcerative colitis: a systematic review

    J. T. Heikens*, J. de Vries and C. J. H. M. van Laarhoven*

    *Department of Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands, Department of Surgery, St Elisabeth Hospital, Tilburg,the Netherlands, Centre of Research on Psychology in Somatic diseases, Tilburg University, Tilburg, the Netherlands and Department of MedicalPsychology, St Elisabeth Hospital, Tilburg, the Netherlands

    Received 10 August 2010; accepted 23 August 2010; Accepted Article online 22 December 2010

    Abstract

    Aim There are numerous studies on quality of life

    (QoL), health-related quality of life (HRQoL), and

    health status (HS) in patients undergoing surgery for

    ulcerative colitis. A systematic review of published

    literature was conducted to establish the quality of thesestudies and to determine QoL, HRQoL, and HS in

    patients after ileal pouch-anal anastomosis for ulcerative

    colitis.

    Method All published studies describing QoL, HRQoL,

    and HS in adult patients in combination with ileal

    pouch-anal anastomosis for ulcerative colitis werereviewed systematically. No time or language limitations

    were applied. Relevance was established on the basis of

    three pre-specified selection criteria: 1) ileal pouch-anal

    anastomosis was performed for ulcerative colitis, 2)

    QoL, HRQoL, and HS were reported as outcome of the

    study and 3) studies reported a minimum follow-up

    after surgery for 12 months. Outcome variables were

    results of QoL, HRQoL, and HS, characteristics of thestudy population, pouch construction, duration of

    follow-up, and time of assessment in months before

    and after restorative surgery. Descriptive data synthesis

    was performed by tabulation displaying the methodolo-

    gical quality, study characteristics and conclusions on

    QoL, HRQoL, and HS measurements in the studies.

    Results The review included 33 studies comprising

    4790 patients. Three were graded to be of high quality,

    23 of moderate quality and seven of low quality. All

    reported improved HS and the majority reported

    improved HRQoL. However, none of the studies

    reported on QoL.

    Conclusion The HRQoL and HS of patients with

    ulcerative colitis improved 12 months after restorative

    proctocolectomy with an ileal pouch-anal anastomosis

    and were indistinguishable from the HRQoL and HS of

    the normal healthy population.

    Keywords Quality of life, health-related quality of life,

    health status, ileal pouch-anal anastomosis, ulcerative

    colitis, systematic review

    Introduction

    From the late 1970s improved medical and surgical

    treatment has resulted in improved outcomes for patients

    with ulcerative colitis (UC) [16]. Since its introduction

    in 1978, restorative proctocolectomy with an ileal pouch-anal anastomosis (IPAA) has been considered as the

    procedure of choice for patients with UC requiring

    surgery [7]. Over time, the aim of surgery has shifted

    from reducing mortality to decreasing morbidity and

    improving quality of life (QoL) [8].

    The patients QoL, health-related quality of life

    (HRQoL) and health status (HS) are increasingly recog-

    nized as important outcomes of medical treatment and

    they have become important indicators of the quality ofhealth care, especially in patients with chronic disease [9].

    These measures help clinicians in management decisions

    and improve the doctorpatient relationship and patient

    care [10,11]. As restorative surgery after proctocolec-

    tomy is considered QoL surgery, QoL, HRQoL and HS

    are the main end-points by which the effectiveness of

    treatment is judged [12].

    Correspondence to: Joost Heikens, MD, Department of Surgery, Radboud

    University Nijmegen Medical Centre, route 690, Geert Grooteplein-Zuid 10,

    6525 GA Nijmegen, the Netherlands.

    E-mail: [email protected]

    ! 2011 The Authors536 Colorectal Disease ! 2011 The Association of Coloproctology of Great Britain and Ireland. 14, 536544

  • QoL

    QoL is a broad evaluation of human function in a variety of

    domains. The internationally accepted definition of QoL,

    as defined by the World Health Organization Quality of

    Life (WHOQOL) Group, is the individuals perception of

    his or her position in life in the context of the culture and

    value systems in which he or she lives in relation to goals,

    expectations, standards and concerns [13].

    HRQoL

    HRQoL is a part of QoL. It is the patients own

    evaluation of functioning in the physical, psychological

    and social domains [14]. Compared with QoL, HRQoL

    is measured using fewer domains. Hence, evaluation of

    HRQoL is not as extensive as the assessment of QoL.

    HS

    HS refers to the impact that a disease has on a patients

    physical, psychological and social functioning. HS deter-

    mines the patients physical abilities, social activities and

    state of mind. In contrast to QoL and HRQoL in studies

    reporting HS, patients are not asked about their satisfac-tion regarding their functioning [15]. Figure 1 illustrates

    the relationship among HS, HRQoL and QoL.

    QoL has been a keyword in the Index Medicus for

    nearly 20 years. Regrettably, different definitions and

    multiple interpretations of QoL, HRQoL and HS are

    currently being used [12]. The increasing number of

    articles published on QoL, HRQoL and HS in patients

    after restorative proctocolectomy for UC, combined with

    the increasing number of operations performed as a result

    of their good long-term results, prompted us to inves-

    tigate the existing literature to try and ascertain the true

    effect of the operation on these variables. This is the first

    study to review all available literature in a systematicmanner. The influence of restorative proctocolectomy on

    QoL, HRQoL and HS in patients with UC was deter-

    mined by combining the results of relevant studies.

    Method

    Search strategy

    The following databases were searched to identify studies

    reporting on QoL, HRQoL and HS after restorative

    proctocolectomy for UC: the Cochrane Database, MED-

    LINE using PubMed as the search engine, Embase, ISI

    Web of Knowledge (Web of Science), CINAHL and

    PsychINFO. We aimed to perform a search without time

    or language limitations. For each database, a specific

    search strategy was devised and adapted to the respectivedatabase. National experts in search strategies were

    consulted to optimize the search for the different

    databases. All keywords suited for the different databases

    were used in a different order to expose the maximum

    amount of hits relevant to the subject. All terms used are

    shown in Table S1.

    Studies published in a language other than English

    were classified according to their English title and abstract.Abstracts of International Meetings were reviewed and

    used to find full-text articles. Only full-text studies were

    included for the purpose of retrieving data because

    abstracts alone do not contain all the information neces-

    sary to score the quality of a study. Assessment of reference

    lists of all selected studies was performed to retrieve

    relevant publications that were not identified in the earlier

    search. Relevant articles were also identified using therelated articles function in PubMed andwere appraised in

    the same order. After completion of the review, the

    literature search was repeated to detect the latest reported

    studies, the most recent being January 2009.

    Selection criteria

    All studies describing aspects of QoL, HRQoL and or HSin adult patients, in combination with restorative procto-

    colectomy for UC, were considered. The titles and

    descriptor terms of all the initial hits from the electronic

    searches were analysed by one reviewer (J.T.H.). Irrelevant

    reports were discarded. The remaining reports were

    inspected by two reviewers (J.T.H. and J.D.V.) who

    graded the abstracts independently and in a different order.

    Quality of life

    Health relatedquality of life

    Health status

    Figure 1 Relationship among quality of life (QoL), health-related quality of life (HRQoL) and health status (HS).

    J. T. Heikens et al. Systematic review of ulcerative colitis

    ! 2011 The AuthorsColorectal Disease ! 2011 The Association of Coloproctology of Great Britain and Ireland. 14, 536544 537

  • Relevance was established on the basis of prespecified

    selection criteria for grading abstracts: (i) if restorative

    proctocolectomy was performed for UC; (ii) if QoL,

    HRQoL and or HS were reported as an outcome of thestudy; and (iii) if studies reported the postoperative period

    for maximal benefit after restorative proctocolectomy.Studies have shown that many patients require as long as

    912 months after surgery to achieve maximal benefit of

    the operation [1618]. Therefore, the minimum follow-

    up period after surgery was taken as 12 months.

    Appraisal of the reviewed studies

    After identifying relevant abstracts, the quality of theselected studies was appraised (by J.T.H. and J.D.V.).

    Approval was based on review of the full texts using a

    checklist of 19 predefined criteria for assessing the

    methodological quality of the studies (Table S2). This

    was tailored to the study and incorporated well-established

    and validated criteria for assessing the quality of trials and

    systematic reviews evaluating QoL, HRQoL and HS [19

    22]. For each item in the checklist, any given study couldreceive one point. If an item was not mentioned or was

    incomplete, no point was assigned. The highest possible

    score was 19. Studies scoring 14 (75%) of the 19 pointswere considered high-quality studies. Those scoring

    between 50 and 75% were considered of medium quality

    and studies scoring < 50% were considered to be low-

    quality studies. A finding was considered consistent if

    75% of studies showed the same trend [23,24].

    Data extraction

    Outcome variables included results of QoL, HRQoL and

    HS questionnaires, characteristics of the study popula-

    tion, number of participants in the study and in the UC

    group, pouch construction (J-, S- or W-pouch), duration

    of follow up and time of assessment (in months beforeand after restorative surgery).

    Data extraction, from the selected full-text articles,

    was conducted independently by J.T.H. and J.D.V.

    Scoring characteristics had to be clearly stated in the

    study, otherwise it was excluded. If data were incomplete,

    the corresponding author was contacted to supply the

    missing information.

    For studies reporting an overlap of patients from thesame centre, only the highest quality study was included.

    If two or more studies described the same patient

    population, data were combined to extract all informa-

    tion. If, at any stage during the analysis, there was

    disagreement between the initial reviewers, a third

    reviewer (C.V.L.) joined the discussion and disagree-

    ments were solved by consensus.

    Data analysis

    Data were analysed by tabulation displaying the meth-

    odological quality, study characteristics and conclusionson QoL, HRQoL and HS measurements in the studies.

    Results

    Search results

    Thirty-three studies evaluating QoL, HRQoL and HS,

    including 4790 patients, were retrieved from the data-

    bases. These are shown in Fig. 2. Most studies used datafrom an existing database, a cross-sectional study, a case

    Reports identifiedthrough database

    searching and othersources (n = 10 565)

    Records screened onthe basis of title andabstract (n = 246)

    Full-text articlesassessed for eligibility

    (n = 64)

    Studies included inqualitative and

    quantitative synthesis(n = 33)

    Full-text articlesexcluded (n = 31)

    Records excluded onthe basis of title andabstract (n = 182)

    Records excluded by title review (n = 10 319)

    Figure 2 Flow chart of studies identified by the literaturesearch.

    Systematic review of ulcerative colitis J. T. Heikens et al.

    ! 2011 The Authors538 Colorectal Disease ! 2011 The Association of Coloproctology of Great Britain and Ireland. 14, 536544

  • Table

    1Results,based

    onthecriteriainTableS2,ofmethodologicalassessmentofqualityoflife(Q

    oL),health-related

    qualityoflife(H

    RQoL)andhealthstatus(H

    S)inpatientswithan

    ilealpouch-analanastomosis(IPAA)forulcerativecolitis(U

    C).

    Reference

    AB

    CD

    EF

    GH

    IJ

    KL

    MN

    OP

    QR

    STotal

    Conclusion

    McLeodetal.[40]

    )+

    )+

    +)

    ++

    ++

    ++

    ++

    ++

    ++

    +16

    Surgeryisusuallysuccessfulin

    improvingHRQoL

    Polle

    etal.[17]

    ++

    )+

    +)

    ++

    +)

    ++

    ++

    ++

    ++

    +16

    HSandHRQoLim

    prove

    afterIPAA

    Thirlbyetal.[16]

    ++

    )+

    +)

    ++

    ))

    )+

    ++

    ++

    ++

    +14

    HSim

    provespostoperativelyandiscomparableto

    that

    ofthegeneralpopulation

    Delaney

    etal.[32]

    ))

    )+

    ++

    )+

    ))

    ++

    ++

    ++

    )+

    +12

    Prudentcase

    selectionallowsacceptableHRQoL

    inpatientsofallages

    Hahnloseretal.[33]

    ))

    )+

    ++

    ++

    ))

    ++

    ++

    +)

    +)

    +12

    HSispreserved

    afterIPAA

    Heuschen

    etal.[35]

    +)

    )+

    +)

    ++

    ))

    ++

    +)

    ++

    ++

    )12

    HSiscomparableto

    healthycontrolsifpostoperative

    complicationsareavoided

    Scarpaetal.[49]

    )+

    )+

    +)

    ++

    ))

    +)

    ++

    +)

    ++

    +12

    HSisinfluencedbydrugs,stoolfrequency,pouchitis,

    ageat

    diagnosisand

    postoperativepelviccomplications

    BerndtssonandOresland[28]

    ))

    )+

    +)

    ++

    ))

    )+

    ++

    ++

    +)

    +11

    GeneralHSandHRQoLdid

    notchangeafterIPAA

    Carmonetal.[31]

    )+

    )+

    +)

    ++

    ))

    +)

    +)

    ++

    ++

    )11

    HSiscomparablewiththat

    ofthegeneralpopulation

    Muiretal.[42]

    ))

    ++

    +)

    )+

    ))

    )+

    ++

    ++

    +)

    +11

    HSim

    provedafterIPAA

    Robbetal.[47]

    )+

    )+

    )+

    +)

    )+

    +)

    +)

    ++

    +)

    +11

    IPAAincreasesHSsignificantlyandapproximates

    that

    foundin

    thegeneralpopulation

    Youngetal.[55]

    ))

    )+

    ++

    ++

    ))

    ++

    ++

    +)

    +)

    )11

    Majority

    ofpatientsreportpoorHRQoLafterIPAA

    Cam

    illeri-Brennan

    etal.[30]

    ))

    )+

    +)

    ++

    )+

    ))

    +)

    ++

    ++

    )10

    IPAAandileostomyresultin

    comparablehighlevelsofHS

    Holubar

    andHym

    an[37]

    ))

    )+

    +)

    ++

    ))

    +)

    )+

    ++

    ++

    )10

    Despitechanges

    incontinence

    HSisextrem

    elywellpreserved

    Martinetal.[39]

    )+

    )+

    +)

    ++

    +)

    ))

    )+

    +)

    ++

    )10

    HSafterIPAAiscomparableto

    that

    ofpatientsin

    remissionorwithmild

    symptoms

    Mowschensonetal.[41]

    ))

    )+

    +)

    ++

    +)

    ++

    ++

    +)

    ))

    )10

    Majority

    ofpatientsreportnorm

    alHSafterIPAA

    Paceetal.[44]

    +)

    )+

    +)

    ++

    ))

    )+

    ++

    ++

    ))

    )10

    HSreported

    tobegenerallysatisfying

    Weinrybetal.[25,26]

    )+

    )+

    ))

    ))

    +)

    ++

    +)

    ++

    +)

    +10

    HSisgoodandcomparablein

    ileostomyandIPAApatients

    Coffey

    etal.[18]

    ))

    )+

    +)

    )+

    ))

    ++

    ++

    ++

    ))

    )9

    HRQoLafterIPAAisaffected

    bydiet,timingofintake,

    preoperativediagnosisandpregnancy

    Hauseretal.[34]

    ))

    )+

    +)

    ++

    )+

    +)

    ))

    ++

    +)

    )9

    HSafterIPAAisalso

    determined

    byanxietyand

    extra-intestinalmanifestations

    OBichereetal.[43]

    ))

    )+

    +)

    +)

    )+

    +)

    ))

    ++

    ++

    )9

    Improvedpelvicfunctionreflectsin

    betterHSafterIPAA

    Richardsetal.[46]

    )+

    )+

    ))

    ++

    ))

    +)

    )+

    ++

    +)

    +9

    HSandHRQoLiscomparableto

    thenorm

    alhealthypopulation

    Sagar

    etal.[48]

    )+

    )+

    +)

    ++

    ))

    +)

    )+

    +)

    )+

    )9

    HSafterIPAAisgood

    Seideletal.[50]

    ))

    )+

    +)

    +)

    +)

    +)

    +)

    +)

    ++

    )9

    HSisgoodandin

    themajority

    improved

    Steensetal.[51]

    ))

    )+

    +)

    +)

    +)

    ))

    +)

    ++

    ++

    )9

    HSandHRQoLafterIPAAisonlyslightlydecreased

    Willisetal.[54]

    ))

    )+

    +)

    +)

    +)

    ))

    +)

    ++

    +)

    +9

    PatientswithuneventfulcoursehaveasignificantlybetterHS

    J. T. Heikens et al. Systematic review of ulcerative colitis

    ! 2011 The AuthorsColorectal Disease ! 2011 The Association of Coloproctology of Great Britain and Ireland. 14, 536544 539

  • series or a cohort design. Weinryb et al. [25,26] pre-sented the same population in two different studies and

    the data were combined to extract the relevant informa-

    tion. Thirty-three studies, published between 1985 and

    2008, were included in this analysis [1618,2655].

    Table 1 displays the results of the methodologicalassessment, based on criteria shown in Table S2, as well

    as the general conclusion of the study, according to the

    definitions used in this review. The characteristics of each

    trial are given in Table 2.

    Twenty-nine studies described QoL and four reported

    HRQoL [34,42,49,52] in 4790 patients (2225 male and

    2063 female subjects). Three studies were graded of high

    quality, 23 of moderate quality and seven of low quality(Table 1). Twenty-one (64%) studies used at one or more

    questionnaires to measure Qol, HRQoL and HS: in total,

    24 different established questionnaires were used. Eight

    authors used self-made questionnaires or a question-

    naire without providing information on validation and

    reliability (Table S3).

    High-quality studies

    The three high-quality studies [16,17,40] claimed to

    describe QoL after restorative proctocolectomy in a

    combined total of 117 patients, comprising 64 (55%)

    men and 53 (45%) women (age-range: 3541 years).

    QoL was not measured in any of these studies, however.

    HRQoL was measured in two studies [17,40], and HS

    was measured in two studies (Table S3) [16,17]. Thegeneral conclusion of these studies was that HRQoL and

    HS improve after restorative proctocolectomy and are

    indistinguishable from the general population. All results

    were considered consistent.

    Moderate-quality studies

    In the studies of moderate quality, 23 described 4423patients [18,26,28,3035,37,39,4144,4651,54,55].

    Eighteen reported a combined total of 2070 male and

    1921 female subjects. Five studies did not report gender.

    The average age mentioned in 21 studies ranged from

    31 to 47 years. The median length of follow up was 51

    (range, 12130) months (Table 2).

    QoL was not measured in any of these studies.

    HRQoL was measured in nine studies, and HS wasmeasured in 17. Nine studies used questionnaires that

    were self-made or not specified, and none of these was

    validated (Tables 1 and 2). The general conclusion was

    that HRQoL and HS improves after restorative procto-

    colectomy and is comparable with general levels in

    a healthy population. All results were considered

    consistent.Table

    1(C

    ontinued).

    Reference

    AB

    CD

    EF

    GH

    IJ

    KL

    MN

    OP

    QR

    STotal

    Conclusion

    Bartonetal.[27]

    )+

    )+

    +)

    ))

    +)

    ))

    ))

    ++

    ++

    )8

    HSisgood

    Pezim

    andNicholls

    [45]

    ))

    )+

    +)

    ++

    +)

    +)

    +)

    +)

    ))

    )8

    HSissatisfactory

    Tiainen

    andMatikainen

    [52]

    )+

    )+

    +)

    +)

    ))

    +)

    ))

    ++

    ++

    )8

    HSiscomparablewiththat

    ofthenorm

    alpopulation

    Lecointe-Besanconetal.[38]

    ))

    )+

    +)

    )+

    ))

    ))

    ++

    ))

    ++

    )7

    HRQoLissimilarbetweencontinentandincontinentpatients

    Bruneletal.[29]

    ))

    )+

    ++

    ))

    ))

    )+

    +)

    +)

    ))

    +7

    Restorative

    proctocolectomyim

    provesHRQoL

    Hildebrandtetal.[36]

    ))

    )+

    +)

    )+

    ))

    )+

    )+

    ))

    ))

    )5

    HRQoLwas

    graded

    nineoutoften

    Vendrelletal.[53]

    ))

    )+

    +)

    +)

    ))

    ))

    +)

    +)

    ))

    )5

    HSim

    provesaftersurgery

    AS,criteriaaccordingto

    TableS2;+,criteriapresentin

    thestudyandaw

    arded

    onepoint;),criterianotclearlydefined

    ornotpresentin

    thestudyandaw

    arded

    nopoints;Total,total

    number

    ofpointsaw

    arded

    tothestudyaccordingto

    thecriteriain

    TableS2.

    Systematic review of ulcerative colitis J. T. Heikens et al.

    ! 2011 The Authors540 Colorectal Disease ! 2011 The Association of Coloproctology of Great Britain and Ireland. 14, 536544

  • Table

    2Studycharacteristics.

    Reference

    Characteristics

    Age

    (years)

    nMale

    (n)

    Fem

    ale

    (n)

    Typeofpouch

    (SJ

    W)

    Follow-upperiod

    afterIPAA(m

    onths)

    No.ofUC

    patientsin

    study

    Tim

    eof

    assessment

    McLeodetal.[40]

    36

    37

    23

    14

    i.n.a.

    12

    37

    After

    IPAA

    Polle

    etal.[17]

    35

    53

    19

    34

    J12

    34

    Before

    andafterIPAA

    Thirlbyetal.[16]

    41

    27

    22

    5i.n.a.

    12

    27

    Before

    andafterIPAA

    Delaney

    etal.[32]

    i.n.a.

    1285

    773

    512

    J55

    1285

    After

    IPAA

    Hahnloseretal.[33]

    34

    1885

    862

    1023

    1824J+44S+17W

    130

    1885

    Before

    andafterIPAA

    Heuschen

    etal.[35]

    i.n.a.

    243

    i.n.a.

    i.n.a.

    J43

    185

    After

    IPAA

    Scarpaetal.[49]

    40

    36

    27

    9i.n.a.

    101

    36

    After

    IPAA

    BerndtssonandOresland[28]

    36

    32

    22

    10

    JofW

    12

    32

    Before

    andafterIPAA

    Carmonetal.[31]

    38

    78

    35

    43

    i.n.a.

    51

    78

    After

    IPAA

    Muiretal.[42]

    38

    20

    10

    10

    J12

    20

    Before

    andafterIPAA

    Robbetal.[47]

    44

    138

    67

    71

    S>>>J+9other

    constructions

    45

    138

    After

    IPAA

    Youngetal.[55]

    38

    48

    i.n.a.

    i.n.a.

    J68

    48

    Before

    andafterIPAA

    Cam

    illeri-Brennan

    etal.[30]

    41

    19

    12

    74S,

    1W,14J

    41

    19

    After

    IPAA

    Holubar

    andHym

    an[37]

    42

    51

    25

    26

    i.n.a.

    85

    51

    After

    IPAA

    Martinetal.[39]

    35

    29

    22

    7J

    46

    29

    After

    IPAA

    Mowschensonetal.[41]

    34

    111

    i.n.a.

    i.n.a.

    J75

    127

    After

    IPAA

    Paceetal.[44]

    35

    13

    85

    J24

    13

    After

    IPAA

    Weinrybetal.[25,26]

    44

    40

    25

    15

    J82

    40

    After

    IPAA

    Coffey

    etal.[18]

    31

    54

    24

    30

    J67

    54

    After

    IPAA

    Hauseretal.[34]

    47

    61

    32

    29

    59J+2kock

    pouch

    80

    61

    After

    IPAA

    OBichereetal.[43]

    43

    30

    i.n.a.

    i.n.a.

    i.n.a.

    13

    30

    After

    IPAA

    Richardsetal.[46]

    34

    56

    32

    24

    i.n.a.

    48

    56

    After

    IPAA

    Sagar

    etal.[48]

    34

    103

    50

    53

    41S,

    50W,14J

    12

    103

    After

    IPAA

    Seideletal.[50]

    31

    55

    30

    25

    i.n.a.

    31

    35

    After

    IPAA

    Steensetal.[51]

    38

    36

    14

    22

    18J17S1W

    67

    31

    After

    IPAA

    Willisetal.[54]

    43

    24

    i.n.a.

    i.n.a.

    J96

    24

    After

    IPAA

    Bartonetal.[27]

    47

    37

    i.n.a.

    i.n.a.

    J33

    37

    After

    IPAA

    Pezim

    andNicholls

    [45]

    34

    51

    31

    24

    53S+2W

    28

    44

    After

    IPAA

    Tiainen

    andMatikainen

    [52]

    40

    68

    32

    36

    J96

    68

    After

    IPAA

    Lecointe-Besanconetal.[38]

    36

    13

    i.n.a.

    i.n.a.

    J31

    13

    After

    IPAA

    Bruneletal.[29]

    45

    27

    16

    11

    J35

    27

    Before

    andafterIPAA

    Hildebrandtetal.[36]

    1736

    52

    3J

    i.n.a.

    5After

    IPAA

    Vendrelletal.[53]

    32

    25

    10

    15

    i.n.a.

    i.n.a.

    25

    After

    IPAA

    i.n.a.,inform

    ationnotavailable;IPAA,ilealpouch-analanastomosis;UC,ulcerativecolitis.

    J. T. Heikens et al. Systematic review of ulcerative colitis

    ! 2011 The AuthorsColorectal Disease ! 2011 The Association of Coloproctology of Great Britain and Ireland. 14, 536544 541

  • Low-quality studies

    Seven studies, describing a total of 226 patients, were

    graded as low quality [27,29,36,38,45,52,53]. Fivereported on 91 male and 89 female subjects. The age-

    range of subjects was 3247 years. The median duration

    of follow up was 33 (range, 2896) months (Table 2).

    QoL was not measured in any of these studies.

    HRQoL was measured in one study and HS was

    measured in two. In four studies questionnaires were

    used that were self-made or not specified, and none was

    validated. Overall, some studies showed overlappingenquiries as a result of the use of multiple questionnaires

    (Table S3). The general conclusion in this population

    was that HRQoL and HS improves after surgery and

    ranges from satisfactory to good. All results were

    considered consistent.

    Discussion

    As restorative proctocolectomy is considered quality oflife surgery, the aim of the present study was to assess

    measurements of this using QoL, HRQoL and HS scales

    in patients undergoing this operation for UC. All studies

    measured HRQoL and or HS, reporting levels compa-rable to those found in the general population. Despite

    the above aim, QoL was neither actually measured nor

    reported and, furthermore, the methodological quality of

    most studies was moderate to low. Only three studiesqualified as being of high quality. These supported the

    observations that HRQoL and HS improved in patients

    after restorative proctocolectomy for UC and that the

    HRQoL and HS in patients reached levels comparable

    with those in a healthy population. The moderate- and

    low-quality studies led to a similar conclusion.

    One has to be cautious when interpreting the

    conclusions of the studies, for several reasons. First,clinical heterogeneity was present between studies. Sec-

    ond, key characteristics, such as histopathological diag-

    nosis, were not identical in all studies. Third, while in

    patients with UC, restorative proctocolectomy cures the

    patient from disease, this is not the case for patients

    suffering from Crohns disease (CD). CD is one of the

    most important risk factors for pouch failure [5]. Five

    studies reported the postoperative histological diagnosis[29,32,33,47,55]. Fourth, UC and CD are different

    diseases, which may have different effects on QoL,

    HRQoL and HS. Lastly, rehabilitation from disease is a

    process and not a one-off result; hence, the patients

    perceived QoL may differ over time. Therefore, if QoL is

    used as an outcome measure in this population, repeated

    measurements are required [56].

    Furthermore, seven studies reported measuring

    HRQoL and or HS before and after IPAA [16,17,28,29,33,42,55]. Observations on HRQoL and HS measured

    after restorative proctocolectomy can only be drawn in

    relation to the normal population and not if these

    qualities improve or diminish after restorative proctoco-lectomy.

    Most studies used different methods to assess QoL,

    HRQoL and HS and because they were too heteroge-

    neous as a result, it was not possible to pool data.

    Methodological heterogeneity in study design and quality

    was, however, present and grading the quality of the

    different studies made it possible to judge the relative

    importance of the results. We recognize that the use ofquality scoring is controversial because scores constructed

    in an ad hoc manner may lack validity [57]. Despite this,some aspects of study quality have been shown to be

    associated with effect [58]. Thus, key components of

    design, rather than aggregate scores themselves, may be

    important. Because of the substantial heterogeneity

    present in and between these studies, the data necessary

    to perform a meta-analysis could not be obtained.Besides showing that HRQoL and HS after restorative

    proctocolectomy reach levels comparable with those of

    the general population, the systemic review has also

    illustrated that a uniform approach to QoL and its

    measurement is needed. Often HS or HRQoL instru-

    ments were used while titles of articles would refer to QoL

    incorrectly [12]. QoL, HRQoL and HS are different

    entities and therefore are not interchangeable. Taking intoconsideration the HRQoL results of the high-quality

    studies and the consistent results observed in the other

    studies, one might expect that QoL after restorative

    proctocolectomy for UC would also be comparable with

    the general population. This question can only be

    answered by studies examining all the domains of QoL.

    To be able to improve future patient care, evaluation

    of QoL is essential, but it must include many moredomains than HRQoL. Consequently, the QoL ques-

    tionnaire is the most sensitive tool for detecting subtle

    differences in outcome. From the late 1970s, great

    advances have been made in reducing the mortality and

    decreasing the morbidity of restorative proctocolectomy,

    which have resulted in levels of HRQoL and HS

    comparable with those found in the general population.

    Evaluating QoL in greater depth using separate domainscan improve this further.

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    Supporting Information

    Additional Supporting Information may be found in the

    online version of this article:

    Table S1. Keywords used and search strategy forelectronic databases.

    Table S2. List of criteria for assessing the methodo-logical quality of studies on QoL, HRQoL and HS in

    patients with IPAA for UC.Table S3. List of different questionnaires used in

    studies and what they measure.

    Please note: Wiley-Blackwell are not responsible for

    the content or functionality of any supporting materials

    supplied by the authors. Any queries (other than missing

    material) should be directed to the corresponding author

    for the article.

    Systematic review of ulcerative colitis J. T. Heikens et al.

    ! 2011 The Authors544 Colorectal Disease ! 2011 The Association of Coloproctology of Great Britain and Ireland. 14, 536544