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Direct improvement of quality of life using a tailored quality of life diagnosis and therapy pathway: randomised trial in 200 women with breast cancer

Identifieur interne : 002A52 ( Pmc/Checkpoint ); précédent : 002A51; suivant : 002A53

Direct improvement of quality of life using a tailored quality of life diagnosis and therapy pathway: randomised trial in 200 women with breast cancer

Auteurs : M. Klinkhammer-Schalke [Allemagne] ; M. Koller [Allemagne] ; B. Steinger [Allemagne] ; C. Ehret [Allemagne] ; B. Ernst [Allemagne] ; J C Wyatt [Royaume-Uni] ; F. Hofst Dter [Allemagne] ; W. Lorenz [Allemagne]

Source :

RBID : PMC:3305975

Abstract

Background:

Despite thousands of papers, the value of quality of life (QoL) in curing disease remains uncertain. Until now, we lacked tools for the diagnosis and specific treatment of diseased QoL. We approached this problem stepwise by theory building, modelling, an exploratory trial and now a definitive randomised controlled trial (RCT) in breast cancer, whose results we report here.

Methods:

In all, 200 representative Bavarian primary breast cancer patients were recruited by five hospitals and treated by 146 care professionals. Patients were randomised to either (1) a novel care pathway including diagnosis of ‘diseased' QoL (any QoL measure below 50 points) using a QoL profile and expert report sent to the patient's coordinating practitioner, who arranged QoL therapy consisting of up to five standardised treatments for specific QoL defects or (2) standard postoperative care adhering to the German national guideline for breast cancer. The primary end point was the proportion of patients in each group with diseased QoL 6 months after surgery. Patients were blinded to their allocated group.

Results:

At 0 and 3 months after surgery, diseased QoL was diagnosed in 70% of patients. The QoL pathway reduced rates of diseased QoL to 56% at 6 months, especially in emotion and coping, compared with 71% in controls (P=0.048). Relative risk reduction was 21% (95% confidence interval (CI): 0–37), absolute risk reduction 15% (95% CI: 0.3–29), number needed to treat (NNT)=7 (95% CI: 3–37). When QoL therapy finished after successful treatment, diseased QoL often returned again, indicating good responsiveness of the QoL pathway.

Conclusion:

A three-component outcome system including clinician-derived objective, patient-reported subjective end points and qualitative analysis of clinical relevance was developed in the last 10 years for cancer as a complex intervention. A separate QoL pathway was implemented for the diagnosis and treatment of diseased QoL and its effectiveness tested in a community-based, pragmatic, definitive RCT. While the pathway was active, it was effective with an NNT of 7.


Url:
DOI: 10.1038/bjc.2012.4
PubMed: 22315052
PubMed Central: 3305975


Affiliations:

Links toward previous steps (curation, corpus...)

Links to Exploration step

PMC:3305975

Le document en format XML

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<title>Background:</title>
<p>Despite thousands of papers, the value of quality of life (QoL) in curing disease remains uncertain. Until now, we lacked tools for the diagnosis and specific treatment of diseased QoL. We approached this problem stepwise by theory building, modelling, an exploratory trial and now a definitive randomised controlled trial (RCT) in breast cancer, whose results we report here.</p>
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<p>In all, 200 representative Bavarian primary breast cancer patients were recruited by five hospitals and treated by 146 care professionals. Patients were randomised to either (1) a novel care pathway including diagnosis of ‘diseased' QoL (any QoL measure below 50 points) using a QoL profile and expert report sent to the patient's coordinating practitioner, who arranged QoL therapy consisting of up to five standardised treatments for specific QoL defects or (2) standard postoperative care adhering to the German national guideline for breast cancer. The primary end point was the proportion of patients in each group with diseased QoL 6 months after surgery. Patients were blinded to their allocated group.</p>
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<p>At 0 and 3 months after surgery, diseased QoL was diagnosed in 70% of patients. The QoL pathway reduced rates of diseased QoL to 56% at 6 months, especially in emotion and coping, compared with 71% in controls (
<italic>P</italic>
=0.048). Relative risk reduction was 21% (95% confidence interval (CI): 0–37), absolute risk reduction 15% (95% CI: 0.3–29), number needed to treat (NNT)=7 (95% CI: 3–37). When QoL therapy finished after successful treatment, diseased QoL often returned again, indicating good responsiveness of the QoL pathway.</p>
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<p>A three-component outcome system including clinician-derived objective, patient-reported subjective end points and qualitative analysis of clinical relevance was developed in the last 10 years for cancer as a complex intervention. A separate QoL pathway was implemented for the diagnosis and treatment of diseased QoL and its effectiveness tested in a community-based, pragmatic, definitive RCT. While the pathway was active, it was effective with an NNT of 7.</p>
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<article-id pub-id-type="pii">bjc20124</article-id>
<article-id pub-id-type="doi">10.1038/bjc.2012.4</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Clinical Study</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>Direct improvement of quality of life using a tailored quality of life diagnosis and therapy pathway: randomised trial in 200 women with breast cancer</article-title>
<alt-title alt-title-type="running">QoL diagnosis and therapy in breast cancer</alt-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname>Klinkhammer-Schalke</surname>
<given-names>M</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
<xref ref-type="corresp" rid="caf1">*</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Koller</surname>
<given-names>M</given-names>
</name>
<xref ref-type="aff" rid="aff2">2</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Steinger</surname>
<given-names>B</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Ehret</surname>
<given-names>C</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Ernst</surname>
<given-names>B</given-names>
</name>
<xref ref-type="aff" rid="aff3">3</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Wyatt</surname>
<given-names>J C</given-names>
</name>
<xref ref-type="aff" rid="aff5">5</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Hofstädter</surname>
<given-names>F</given-names>
</name>
<xref ref-type="aff" rid="aff4">4</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Lorenz</surname>
<given-names>W</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
</contrib>
<on-behalf-of>for the Regensburg QoL Study Group
<xref ref-type="author-notes" rid="note1">
<sup>6</sup>
</xref>
</on-behalf-of>
<aff id="aff1">
<label>1</label>
<institution>Tumor Center Regensburg e.V., University Regensburg</institution>
, Regensburg,
<country>Germany</country>
</aff>
<aff id="aff2">
<label>2</label>
<institution>Center for Clinical Trials, University Hospital</institution>
, Regensburg,
<country>Germany</country>
</aff>
<aff id="aff3">
<label>3</label>
<institution>General Practice</institution>
, Regensburg,
<country>Germany</country>
</aff>
<aff id="aff4">
<label>4</label>
<institution>Institute of Pathology, University Regensburg</institution>
, Regensburg,
<country>Germany</country>
</aff>
<aff id="aff5">
<label>5</label>
<institution>Institute for Digital Healthcare, Warwick University</institution>
, Coventry,
<country>UK</country>
</aff>
</contrib-group>
<author-notes>
<corresp id="caf1">
<label>*</label>
E-mail:
<email>monika.klinkhammer-schalke@klinik.uni-regensburg.de</email>
</corresp>
<fn fn-type="present-address" id="note1">
<label>6</label>
<p>See
<xref ref-type="app" rid="app1">Appendix B</xref>
</p>
</fn>
</author-notes>
<pub-date pub-type="ppub">
<day>28</day>
<month>02</month>
<year>2012</year>
</pub-date>
<pub-date pub-type="epub">
<day>07</day>
<month>02</month>
<year>2012</year>
</pub-date>
<pub-date pub-type="pmc-release">
<day>28</day>
<month>2</month>
<year>2012</year>
</pub-date>
<volume>106</volume>
<issue>5</issue>
<fpage>826</fpage>
<lpage>838</lpage>
<history>
<date date-type="received">
<day>12</day>
<month>08</month>
<year>2011</year>
</date>
<date date-type="rev-recd">
<day>03</day>
<month>01</month>
<year>2012</year>
</date>
<date date-type="accepted">
<day>06</day>
<month>01</month>
<year>2012</year>
</date>
</history>
<permissions>
<copyright-statement>Copyright © 2012 Cancer Research UK</copyright-statement>
<copyright-year>2012</copyright-year>
<copyright-holder>Cancer Research UK</copyright-holder>
<license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by-nc-sa/3.0/">
<pmc-comment>author-paid</pmc-comment>
<license-p>This work is licensed under the Creative Commons Attribution-NonCommercial-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/</license-p>
</license>
</permissions>
<abstract>
<sec>
<title>Background:</title>
<p>Despite thousands of papers, the value of quality of life (QoL) in curing disease remains uncertain. Until now, we lacked tools for the diagnosis and specific treatment of diseased QoL. We approached this problem stepwise by theory building, modelling, an exploratory trial and now a definitive randomised controlled trial (RCT) in breast cancer, whose results we report here.</p>
</sec>
<sec>
<title>Methods:</title>
<p>In all, 200 representative Bavarian primary breast cancer patients were recruited by five hospitals and treated by 146 care professionals. Patients were randomised to either (1) a novel care pathway including diagnosis of ‘diseased' QoL (any QoL measure below 50 points) using a QoL profile and expert report sent to the patient's coordinating practitioner, who arranged QoL therapy consisting of up to five standardised treatments for specific QoL defects or (2) standard postoperative care adhering to the German national guideline for breast cancer. The primary end point was the proportion of patients in each group with diseased QoL 6 months after surgery. Patients were blinded to their allocated group.</p>
</sec>
<sec>
<title>Results:</title>
<p>At 0 and 3 months after surgery, diseased QoL was diagnosed in 70% of patients. The QoL pathway reduced rates of diseased QoL to 56% at 6 months, especially in emotion and coping, compared with 71% in controls (
<italic>P</italic>
=0.048). Relative risk reduction was 21% (95% confidence interval (CI): 0–37), absolute risk reduction 15% (95% CI: 0.3–29), number needed to treat (NNT)=7 (95% CI: 3–37). When QoL therapy finished after successful treatment, diseased QoL often returned again, indicating good responsiveness of the QoL pathway.</p>
</sec>
<sec>
<title>Conclusion:</title>
<p>A three-component outcome system including clinician-derived objective, patient-reported subjective end points and qualitative analysis of clinical relevance was developed in the last 10 years for cancer as a complex intervention. A separate QoL pathway was implemented for the diagnosis and treatment of diseased QoL and its effectiveness tested in a community-based, pragmatic, definitive RCT. While the pathway was active, it was effective with an NNT of 7.</p>
</sec>
</abstract>
<kwd-group>
<kwd>quality of life (QoL)</kwd>
<kwd>breast cancer</kwd>
<kwd>definitive RCT</kwd>
<kwd>complex intervention</kwd>
<kwd>effectiveness of the QoL system</kwd>
</kwd-group>
</article-meta>
</front>
<floats-group>
<fig id="fig1">
<label>Figure 1</label>
<caption>
<p>QoL profiles and expert consensus reports of a specific intervention group patient with effective QoL diagnosis and therapy. Female, with primary breast cancer, randomly assigned to QoL diagnosis and treatment group; 50 years, married, one child. Prognostic classification pT1c, SN0, G2, ER
<sup>+</sup>
, PR
<sup>+</sup>
, HER2neu
<sup>−</sup>
. BCT with sentinel node excision followed by radiation and anti-oestrogen treatment in months 3 and 6 with Tamoxifen. Cutoff for diseased/healthy QoL 50 points (grey bar). Global QoL assessed by clinician (1 month) and CP (3 and 6 months): 100, 70, 85 points obtained by the physicians and the values of the patient in the figure, showed good doctor–patient agreement.</p>
</caption>
<graphic xlink:href="bjc20124f1"></graphic>
</fig>
<fig id="fig2">
<label>Figure 2</label>
<caption>
<p>Care pathway for QoL diagnosis and therapy – QoL pathway – tailored to breast cancer patients.</p>
</caption>
<graphic xlink:href="bjc20124f2"></graphic>
</fig>
<fig id="fig3">
<label>Figure 3</label>
<caption>
<p>Diagnosis and therapy of diseased QoL in breast cancer patients: design of a complex intervention.</p>
</caption>
<graphic xlink:href="bjc20124f3"></graphic>
</fig>
<fig id="fig4">
<label>Figure 4</label>
<caption>
<p>Trial profile: flow of patients through each stage of the study. Complete=questionnaire answering the primary end point of the study. In
<xref ref-type="fig" rid="fig6">Figure 6</xref>
, only 83 instead of 85 patients could be analysed in the control group because no data were given for 1/10 QoL dimensions. Since, however, the two patients showed breakdowns in more than one dimension, the primary end point could be analysed and counted in them. Flowchart was constructed according to
<xref ref-type="bibr" rid="bib1">Altman (1996)</xref>
.</p>
</caption>
<graphic xlink:href="bjc20124f4"></graphic>
</fig>
<fig id="fig5">
<label>Figure 5</label>
<caption>
<p>Proportion of patients with diseased QoL following breast cancer surgery and adjuvant therapies: comparison of QoL diagnosis and therapy (QoL pathway) with guideline consistent, traditional postoperative care (control) over 1 year.
<italic>χ</italic>
<sup>2</sup>
-test: !=
<italic>P</italic>
<0.1, x=
<italic>P</italic>
<0.05.</p>
</caption>
<graphic xlink:href="bjc20124f5"></graphic>
</fig>
<fig id="fig6">
<label>Figure 6</label>
<caption>
<p>Number of diseased QoL dimensions per patient 6 months after surgery: Comparison of QoL diagnosis and therapy pathway (dark bars,
<italic>n</italic>
=84) with that of standard postoperative care (light bars,
<italic>n</italic>
=83).</p>
</caption>
<graphic xlink:href="bjc20124f6"></graphic>
</fig>
<fig id="fig7">
<label>Figure 7</label>
<caption>
<p>Proportions of patients with diseased global QoL and single dimensions of QoL: comparison of QoL pathway (▪) with traditional postoperative care (□).
<italic>χ</italic>
<sup>2</sup>
-test: !=
<italic>P</italic>
<0.1, x=
<italic>P</italic>
<0.05, xx=
<italic>P</italic>
<0.01. (a) Period of QoL diagnosis; (b) period of QoL therapy; (c) period of follow-up (maintenance omitted if QoL ⩾50 points).</p>
</caption>
<graphic xlink:href="bjc20124f7"></graphic>
</fig>
<fig id="fig8">
<label>Figure 8</label>
<caption>
<p>Mean values±s.d. for the 10 dimensions of the QoL profile: comparison of QoL pathway (▪) with traditional postoperative care (□). Mann–Whitney
<italic>U</italic>
-test !=
<italic>P</italic>
<0.10, x=
<italic>P</italic>
<0.05. Global QoL
<italic>P</italic>
=0.018, Emotion
<italic>P</italic>
=0.030 and
<italic>P</italic>
=0.060, respectively, Fatigue
<italic>P</italic>
=0.051. (a) Period of QoL diagnosis; (b) period of QoL therapy; (c) period of follow-up (maintenance omitted if QoL ⩾50 points).</p>
</caption>
<graphic xlink:href="bjc20124f8"></graphic>
</fig>
<table-wrap id="tbl1">
<label>Table 1</label>
<caption>
<title>Concept and terminology of disease-related QoL and diseased QoL used in outcome assessment of complex interventions for breast cancer</title>
</caption>
<table frame="hsides" rules="groups" border="1">
<colgroup>
<col align="left"></col>
<col align="left"></col>
</colgroup>
<tbody valign="top">
<tr>
<td align="left" valign="top" charoff="50">Disease-related QoL</td>
<td align="left" valign="top" charoff="50">Health, disease and QoL are key concepts in medicine (
<xref ref-type="bibr" rid="bib56">Wulff, 2002</xref>
), but their definitions should be derived from empirically testable and clinically relevant attributes (
<xref ref-type="bibr" rid="bib31">Lorenz
<italic>et al</italic>
, 1999</xref>
;
<xref ref-type="bibr" rid="bib29">Lorenz and Koller, 2002</xref>
;
<xref ref-type="bibr" rid="bib56">Wulff, 2002</xref>
;
<xref ref-type="bibr" rid="bib49">Velikova
<italic>et al</italic>
, 2004</xref>
). Health is neither absence of disease nor an aggregate amount of disease states. Disease as the vehicle of clinical experience (
<xref ref-type="bibr" rid="bib56">Wulff, 2002</xref>
) has its own, characteristic (molecular, clinical, physical and psychosocial) specificity (
<xref ref-type="bibr" rid="bib31">Lorenz
<italic>et al</italic>
, 1999</xref>
;
<xref ref-type="bibr" rid="bib6">Bowling, 2001</xref>
). QoL as part of the outcome construct is again specifically related to this disease concept. For example, in sepsis, emotional distress (depression, sickness behaviour) is associated with cytokine expression in specific brain areas (
<xref ref-type="bibr" rid="bib4">Bauhofer
<italic>et al</italic>
, 2004</xref>
). Clinically measured QoL is related to the total concept of disease. Hence, QoL  – is assessed in a specifically diagnosed disease, including the critical model of Wulff (
<xref ref-type="bibr" rid="bib31">Lorenz
<italic>et al</italic>
, 1999</xref>
;
<xref ref-type="bibr" rid="bib56">Wulff, 2002</xref>
)  – entails self-perception and self-report in three domains: somatic, psychological and social  – includes health- and therapy-related expectations and coping  – is influenced by basic psychosocial variables such as negative affect  – is part of a three-component outcome model (
<xref ref-type="bibr" rid="bib31">Lorenz
<italic>et al</italic>
, 1999</xref>
;
<xref ref-type="bibr" rid="bib26">Koller and Lorenz, 2002</xref>
;
<xref ref-type="bibr" rid="bib29">Lorenz and Koller, 2002</xref>
) For each attribute in this definition, at least one empirical (prospective) trial is available and usable</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50">Diseased QoL</td>
<td align="left" valign="top" charoff="50">As part of the disease concept, QoL is not just a measurement, but has a medical/clinical value. ‘Diseased' characterises QoL as negative medical value, ‘healed' QoL is the corresponding positive result of therapeutic improvement. The cutoff point between disease and health for any dimension in the QoL profile is <50 points in scales of 0–100 (worst–optimal QoL)  – It is not yet defined by a gold standard, but by face validity using 4-point Likert scales (
<xref ref-type="bibr" rid="bib26">Koller and Lorenz, 2002</xref>
)  – by psychological theories on adaptation level and social comparison (
<xref ref-type="bibr" rid="bib26">Koller and Lorenz, 2002</xref>
),  – by asking patients at which value in a range of 0–100 they would approach their doctor (iatrotropy;
<xref ref-type="bibr" rid="bib26">Koller and Lorenz, 2002</xref>
) and  – by a change in global QoL as a general dimension if QoL in a specific dimension (in 1/10 in the QoL profile) declined below a value of 50 as the lowest in the range of the normal German population (
<xref ref-type="bibr" rid="bib22">Klinkhammer-Schalke
<italic>et al</italic>
, 2008b</xref>
)</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn id="t1-fn1">
<p>Abbreviation: QoL=quality of life.</p>
</fn>
<fn id="t1-fn2">
<p>Methodology: Definitions in medicine according to
<xref ref-type="bibr" rid="bib34">Popper
<italic>et al</italic>
(1998)</xref>
: combine attributes, but only from empirical studies. Presentation of attributes: use meta-levels according to
<xref ref-type="bibr" rid="bib38">Reichenbach (1947</xref>
,
<xref ref-type="bibr" rid="bib39">1951</xref>
).</p>
</fn>
</table-wrap-foot>
</table-wrap>
<table-wrap id="tbl2">
<label>Table 2</label>
<caption>
<title>QoL therapy procedures showing the best possible effectiveness for the five therapeutic options to cure diseased QoL in the context of the care pathway</title>
</caption>
<table frame="hsides" rules="groups" border="1">
<colgroup>
<col align="left"></col>
<col align="left"></col>
<col align="left"></col>
<col align="left"></col>
<col align="left"></col>
<col align="left"></col>
</colgroup>
<thead valign="bottom">
<tr>
<th align="left" valign="top" charoff="50">
<bold>Procedure</bold>
</th>
<th align="left" valign="top" charoff="50">
<bold>1. Physiotherapy</bold>
</th>
<th align="left" valign="top" charoff="50">
<bold>2. Psychotherapy</bold>
</th>
<th align="left" valign="top" charoff="50">
<bold>3. Social support</bold>
</th>
<th align="left" valign="top" charoff="50">
<bold>4. Pain therapy</bold>
</th>
<th align="left" valign="top" charoff="50">
<bold>5. Nutrition and fitness</bold>
</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td align="left" valign="top" charoff="50">Definition of therapeutic option and methods
<xref ref-type="fn" rid="t2-fn3">a</xref>
</td>
<td align="left" valign="top" charoff="50">Physical decongestive therapy of upper limb by manual lymph drainage with sequential compression therapy</td>
<td align="left" valign="top" charoff="50">Individual, experiential psychotherapy and cognitive behavioural interventions for adjustment disorders</td>
<td align="left" valign="top" charoff="50">Network nodes for social counselling (financial security, well-being, partnership, children, homecare, profession) organised in quality circle</td>
<td align="left" valign="top" charoff="50">Combination of drugs (WHO analgesic ladder) with non-drug measures, for example, psychotherapy and disease-modifying therapies</td>
<td align="left" valign="top" charoff="50">Combination of self-help groups: counselling for diet and ambulatory sports training programmes, all enrolled in quality circles</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50">Level of evidence for an effective outcome measure
<xref ref-type="fn" rid="t2-fn4">b</xref>
</td>
<td align="left" valign="top" charoff="50">1 Questionable effective (
<xref ref-type="bibr" rid="bib36">Preston
<italic>et al</italic>
, 2009</xref>
)</td>
<td align="left" valign="top" charoff="50">1 Effective for QoL (
<xref ref-type="bibr" rid="bib33">Newell
<italic>et al</italic>
, 2002</xref>
)</td>
<td align="left" valign="top" charoff="50">4 GCP Effectiveness not tested</td>
<td align="left" valign="top" charoff="50">1 Effective for pain (
<xref ref-type="bibr" rid="bib20">Hanks
<italic>et al</italic>
, 2001</xref>
)</td>
<td align="left" valign="top" charoff="50">4 GCP Effectiveness not tested (
<xref ref-type="bibr" rid="bib5">Beliveau and Gingras, 2005</xref>
)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50">Methodological standard achieved in local consensus of recommendations
<xref ref-type="fn" rid="t2-fn5">c</xref>
</td>
<td align="left" valign="top" charoff="50">Formal consensus, Nominal Group Process (
<xref ref-type="bibr" rid="bib30">Lorenz
<italic>et al</italic>
, 2001</xref>
)</td>
<td align="left" valign="top" charoff="50">Informal consensus, decisions, cases analysed in quality circle</td>
<td align="left" valign="top" charoff="50">Informal consensus within quality circle</td>
<td align="left" valign="top" charoff="50">Informal consensus, locally tailored guidelines, in quality circle</td>
<td align="left" valign="top" charoff="50">Informal consensus, developed only within QoL unit</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn id="t2-fn1">
<p>Abbreviations: GCP=good clinical practice; QoL=quality of life.</p>
</fn>
<fn id="t2-fn2">
<p>General sources of information (
<xref ref-type="bibr" rid="bib30">Lorenz
<italic>et al</italic>
, 2001</xref>
).</p>
</fn>
<fn id="t2-fn3">
<label>a</label>
<p>German national guideline for breast cancer (
<ext-link ext-link-type="uri" xlink:href="http://www.AWMF.de">http://www.AWMF.de</ext-link>
) in 2009.</p>
</fn>
<fn id="t2-fn4">
<label>b</label>
<p>Scottish Intercollegiate Guidelines Network (SIGN) grading system in 1999.</p>
</fn>
<fn id="t2-fn5">
<label>c</label>
<p>German guideline manual in 2001 (
<xref ref-type="bibr" rid="bib30">Lorenz
<italic>et al</italic>
, 2001</xref>
).</p>
</fn>
</table-wrap-foot>
</table-wrap>
<table-wrap id="tbl3">
<label>Table 3</label>
<caption>
<title>Influence of treatment combinations on QoL outcome at 6 and 12 months</title>
</caption>
<table frame="hsides" rules="groups" border="1">
<colgroup>
<col align="left"></col>
<col align="left"></col>
<col align="center"></col>
<col align="center"></col>
<col align="center"></col>
</colgroup>
<thead valign="bottom">
<tr>
<th colspan="2" align="center" valign="top" charoff="50">
<bold>Treatment combinations</bold>
<hr></hr>
</th>
<th colspan="3" align="center" valign="top" charoff="50">
<bold>Rates of diseased QoL/total patients in each treatment combination</bold>
<hr></hr>
</th>
</tr>
<tr>
<th align="left" valign="top" charoff="50">
<bold>Description</bold>
</th>
<th align="left" valign="top" charoff="50">
<bold>Combination</bold>
</th>
<th align="center" valign="top" charoff="50">
<bold>Rates</bold>
</th>
<th align="center" valign="top" charoff="50">
<bold>%</bold>
</th>
<th align="center" valign="top" charoff="50">
<bold>
<italic>χ</italic>
<sup>2</sup>
test</bold>
</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td colspan="5" align="left" valign="top" charoff="50">
<italic>At 6 months</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Chemo</td>
<td align="left" valign="top" charoff="50">BCT+
<bold>CT</bold>
+RT+ET
<italic>vs</italic>
BCT+
<bold>no CT</bold>
+RT+ET</td>
<td align="char" valign="top" char="." charoff="50">26/35
<italic>vs</italic>
18/40</td>
<td align="char" valign="top" char="." charoff="50">74%
<italic>vs</italic>
45%</td>
<td align="char" valign="top" char="." charoff="50">
<italic>P</italic>
=0.01
<sup>*</sup>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Operation</td>
<td align="left" valign="top" charoff="50">
<bold>BCT</bold>
+CT+RT+ET
<italic>vs</italic>
<bold>ME</bold>
+CT+RT+ET</td>
<td align="char" valign="top" char="." charoff="50">26/35
<italic>vs</italic>
4/9</td>
<td align="char" valign="top" char="." charoff="50">74%
<italic>vs</italic>
44%</td>
<td align="char" valign="top" char="." charoff="50">
<italic>P</italic>
=0.09</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="5" align="left" valign="top" charoff="50">
<italic>At 12 months</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Chemo</td>
<td align="left" valign="top" charoff="50">BCT+
<bold>CT</bold>
+RT+ET
<italic>vs</italic>
BCT+
<bold>no CT</bold>
+RT+ET</td>
<td align="char" valign="top" char="." charoff="50">41/87
<italic>vs</italic>
16/32</td>
<td align="char" valign="top" char="." charoff="50">47%
<italic>vs</italic>
50%</td>
<td align="char" valign="top" char="." charoff="50">
<italic>P</italic>
=0.78</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Operation</td>
<td align="left" valign="top" charoff="50">
<bold>BCT</bold>
+CT+RT+ET
<italic>vs</italic>
<bold>ME</bold>
+CT+RT+ET</td>
<td align="char" valign="top" char="." charoff="50">41/87
<italic>vs</italic>
19/25</td>
<td align="char" valign="top" char="." charoff="50">47%
<italic>vs</italic>
76%</td>
<td align="char" valign="top" char="." charoff="50">
<italic>P</italic>
=0.01
<sup>*</sup>
</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn id="t3-fn1">
<p>Abbreviations: BCT=breast conserving therapy; ME=mastectomy; CT=chemotherapy; RT=radiotherapy; ET=endocrine therapy (e.g., Tamoxifen); QoL=quality of life.</p>
</fn>
<fn id="t3-fn2">
<p>Bold letters emphasise subgroups different in treatment.</p>
</fn>
<fn id="t3-fn3">
<p>
<sup>*</sup>
<italic>P</italic>
<0.05.</p>
</fn>
</table-wrap-foot>
</table-wrap>
<table-wrap id="tbl4">
<label>Table 4</label>
<caption>
<title>Activities and communications among members of the care pathway relevant for group comparison and mutual exclusion</title>
</caption>
<table frame="hsides" rules="groups" border="1">
<colgroup>
<col align="left"></col>
<col align="center"></col>
<col align="center"></col>
</colgroup>
<thead valign="bottom">
<tr>
<th align="left" valign="top" charoff="50">
<bold>Activities and communications</bold>
</th>
<th align="center" valign="top" charoff="50">
<bold>Intervention group (QoL pathway)</bold>
</th>
<th align="center" valign="top" charoff="50">
<bold>Control group (standard postoperative care)</bold>
</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td align="left" valign="top" charoff="50">CP and professional therapists trained in treatment options and trial protocol</td>
<td align="center" valign="top" charoff="50">✓</td>
<td align="center" valign="top" charoff="50">✓</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50">CP able to order one or more QoL therapeutic options also in standard care (e.g., physiotherapy)</td>
<td align="center" valign="top" charoff="50">✓</td>
<td align="center" valign="top" charoff="50">✓</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50">Timing and extent of adjuvant therapies with negative influence on QoL (chemotherapy, radiation, endocrine therapy) captured</td>
<td align="center" valign="top" charoff="50">✓</td>
<td align="center" valign="top" charoff="50">✓</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50">CP receives QoL profile and expert report</td>
<td align="center" valign="top" charoff="50">✓</td>
<td align="center" valign="top" charoff="50">−</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50">Onset and duration of any QoL therapies are prompted by profile and expert report</td>
<td align="center" valign="top" charoff="50">✓</td>
<td align="center" valign="top" charoff="50">−</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50">CP is able to communicate with professional therapists and opinion leaders about the meaning of the profile and what should be done</td>
<td align="center" valign="top" charoff="50">✓</td>
<td align="center" valign="top" charoff="50">−</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50">QoL unit calls CP by telephone, 4 weeks after patient's regular follow-up date, asking if anything was done in response to QoL diagnosis</td>
<td align="center" valign="top" charoff="50">✓</td>
<td align="center" valign="top" charoff="50">−</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn id="t4-fn1">
<p>Abbreviations: CP=coordinating practitioner; QoL=quality of life; ✓=present; −=absent.</p>
</fn>
<fn id="t4-fn2">
<p>Activities are present in both groups, contamination occurs and reduces effectiveness.</p>
</fn>
</table-wrap-foot>
</table-wrap>
<table-wrap id="tbl5">
<label>Table 5</label>
<caption>
<title>Rates of therapeutic options in QoL pathway group compared with those in the control group</title>
</caption>
<table frame="hsides" rules="groups" border="1">
<colgroup>
<col align="left"></col>
<col align="char" char="."></col>
<col align="char" char="."></col>
<col align="char" char="."></col>
<col align="char" char="."></col>
</colgroup>
<thead valign="bottom">
<tr>
<th align="left" valign="top" charoff="50"> </th>
<th colspan="4" align="center" valign="top" char="." charoff="50">
<bold>Rates of therapeutic options in each group (
<italic>n</italic>
=92–99)</bold>
<hr></hr>
</th>
</tr>
<tr>
<th align="left" valign="top" charoff="50"> </th>
<th colspan="2" align="center" valign="top" char="." charoff="50">
<bold>3 months</bold>
<hr></hr>
</th>
<th colspan="2" align="center" valign="top" char="." charoff="50">
<bold>6 months</bold>
<hr></hr>
</th>
</tr>
<tr>
<th align="left" valign="top" charoff="50"> </th>
<th align="char" valign="top" char="." charoff="50">
<bold>QoL pathway</bold>
</th>
<th align="char" valign="top" char="." charoff="50">
<bold>Control</bold>
</th>
<th align="char" valign="top" char="." charoff="50">
<bold>QoL pathway</bold>
</th>
<th align="char" valign="top" char="." charoff="50">
<bold>Control</bold>
</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td align="left" valign="top" charoff="50">Any QoL therapy given?</td>
<td align="char" valign="top" char="." charoff="50">42</td>
<td align="char" valign="top" char="." charoff="50">35</td>
<td align="char" valign="top" char="." charoff="50">35</td>
<td align="char" valign="top" char="." charoff="50">39</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50">Coping strategies and counselling</td>
<td align="char" valign="top" char="." charoff="50">21</td>
<td align="char" valign="top" char="." charoff="50">12
<sup>*</sup>
</td>
<td align="char" valign="top" char="." charoff="50">19</td>
<td align="char" valign="top" char="." charoff="50">10</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50">Psychotherapy</td>
<td align="char" valign="top" char="." charoff="50">10</td>
<td align="char" valign="top" char="." charoff="50">1
<sup>**</sup>
</td>
<td align="char" valign="top" char="." charoff="50">3</td>
<td align="char" valign="top" char="." charoff="50">3</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50">Physiotherapy</td>
<td align="char" valign="top" char="." charoff="50">18</td>
<td align="char" valign="top" char="." charoff="50">25</td>
<td align="char" valign="top" char="." charoff="50">16</td>
<td align="char" valign="top" char="." charoff="50">30
<sup>***</sup>
</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn id="t5-fn1">
<p>Abbreviation: QoL=quality of life.</p>
</fn>
<fn id="t5-fn2">
<p>Comparison of two time intervals (3 and 6 months) and the most important QoL dimensions (global QoL, emotion and arm symptoms).</p>
</fn>
<fn id="t5-fn3">
<p>
<italic>Source</italic>
: Interview of coordinating practitioners by study coordinator 4 weeks after sending the expert report in the QoL pathway group or letter without information for control group patient (for details see
<xref ref-type="bibr" rid="bib24">Klinkhammer-Schalke
<italic>et al</italic>
(2008a))</xref>
.</p>
</fn>
<fn id="t5-fn4">
<p>
<italic>χ</italic>
<sup>2</sup>
-test
<sup>*</sup>
<italic>P</italic>
<0.055;
<sup>**</sup>
<italic>P</italic>
<0.050;
<sup>***</sup>
<italic>P</italic>
<0.020.</p>
</fn>
</table-wrap-foot>
</table-wrap>
<table-wrap id="tbla1">
<label>Table 6</label>
<caption>
<title>Patient characteristics (baseline values) with potential influence on primary end point: distribution in the two experimental groups</title>
</caption>
<table frame="hsides" rules="groups" border="1">
<colgroup>
<col align="left"></col>
<col align="center"></col>
<col align="center"></col>
</colgroup>
<thead valign="bottom">
<tr>
<th align="left" valign="top" charoff="50">
<bold>Characteristics</bold>
</th>
<th align="center" valign="top" charoff="50">
<bold>QoL pathway (
<italic>n</italic>
=99)</bold>
</th>
<th align="center" valign="top" charoff="50">
<bold>Control (
<italic>n</italic>
=100)</bold>
</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td colspan="3" align="left" valign="top" charoff="50">
<italic>(1) Classical medical outcome oriented</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Patients included in each of the five QoL measurements (
<italic>n</italic>
)</td>
<td align="center" valign="top" charoff="50">99/96/95/95/94</td>
<td align="center" valign="top" charoff="50">100/98/97/96/94</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Age at recruitment (years, median (range))</td>
<td align="center" valign="top" charoff="50">58 (31–85)</td>
<td align="center" valign="top" charoff="50">57 (28–85)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> BCT/mastectomy (
<italic>n</italic>
)</td>
<td align="center" valign="top" charoff="50">74/25</td>
<td align="center" valign="top" charoff="50">76/24</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="3" align="left" valign="top" charoff="50">
<italic>Prognostic stage group (UICC in</italic>
%)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> UICC 0</td>
<td align="char" valign="top" char="." charoff="50">2</td>
<td align="char" valign="top" char="." charoff="50">2</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> UICC I</td>
<td align="char" valign="top" char="." charoff="50">45</td>
<td align="char" valign="top" char="." charoff="50">44</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> UICC II (II a and b combined)</td>
<td align="char" valign="top" char="." charoff="50">26</td>
<td align="char" valign="top" char="." charoff="50">32</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> UICC III (III a, b, c combined)</td>
<td align="char" valign="top" char="." charoff="50">25</td>
<td align="char" valign="top" char="." charoff="50">20</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> UICC IV</td>
<td align="char" valign="top" char="." charoff="50">2</td>
<td align="char" valign="top" char="." charoff="50">2</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="3" align="left" valign="top" charoff="50">
<italic>Receptor status positive (in</italic>
%)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Oestrogen</td>
<td align="char" valign="top" char="." charoff="50">86</td>
<td align="char" valign="top" char="." charoff="50">83</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Progesterone</td>
<td align="char" valign="top" char="." charoff="50">82</td>
<td align="char" valign="top" char="." charoff="50">82</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> HER2neu</td>
<td align="char" valign="top" char="." charoff="50">20</td>
<td align="char" valign="top" char="." charoff="50">21</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Mortality rate (%) up to 6 months</td>
<td align="char" valign="top" char="." charoff="50">3</td>
<td align="char" valign="top" char="." charoff="50">1</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Up to 12 months</td>
<td align="char" valign="top" char="." charoff="50">3</td>
<td align="char" valign="top" char="." charoff="50">2</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Significant comorbidity up to 6 months (%)</td>
<td align="char" valign="top" char="." charoff="50">70</td>
<td align="char" valign="top" char="." charoff="50">63</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="3" align="left" valign="top" charoff="50">
<italic>(2) QoL outcome oriented</italic>
(%)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Married, widowed, divorced, other</td>
<td align="center" valign="top" charoff="50">78/13/8/1</td>
<td align="center" valign="top" charoff="50">80/7/7/6</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Children (0/ 1–2/ 3 or more)</td>
<td align="center" valign="top" charoff="50">13/71/15</td>
<td align="center" valign="top" charoff="50">18/64/18</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> House wife or pensioner</td>
<td align="char" valign="top" char="." charoff="50">48</td>
<td align="char" valign="top" char="." charoff="50">48</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Working outside home</td>
<td align="char" valign="top" char="." charoff="50">52</td>
<td align="char" valign="top" char="." charoff="50">52</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Cofatality, up to 6 months</td>
<td align="char" valign="top" char="." charoff="50">6</td>
<td align="char" valign="top" char="." charoff="50">5</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Up to 12 months</td>
<td align="char" valign="top" char="." charoff="50">9</td>
<td align="char" valign="top" char="." charoff="50">7</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Daily living in</td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Urban area (Regensburg)</td>
<td align="char" valign="top" char="." charoff="50">76</td>
<td align="char" valign="top" char="." charoff="50">82</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Rural area (Amberg-Sulzbach)</td>
<td align="char" valign="top" char="." charoff="50">24</td>
<td align="char" valign="top" char="." charoff="50">18</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Rates of patients with diseased QoL at 0 and 3 months (single dimension)</td>
<td align="center" valign="top" charoff="50">
<xref ref-type="fig" rid="fig7">Figure 7</xref>
</td>
<td align="center" valign="top" charoff="50">
<xref ref-type="fig" rid="fig7">Figure 7</xref>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="3" align="left" valign="top" charoff="50">
<italic>(3) Classical treatment oriented</italic>
</td>
</tr>
<tr>
<td colspan="3" align="left" valign="top" charoff="50">(Most frequent combinations up to 6 months) (
<italic>n</italic>
)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> BCT + RT + ET</td>
<td align="char" valign="top" char="." charoff="50">21</td>
<td align="char" valign="top" char="." charoff="50">20</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> BCT + CT + RT + ET</td>
<td align="char" valign="top" char="." charoff="50">16</td>
<td align="char" valign="top" char="." charoff="50">19</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> BCT + CT + RT</td>
<td align="char" valign="top" char="." charoff="50">12</td>
<td align="char" valign="top" char="." charoff="50">19</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> BCT + CT</td>
<td align="char" valign="top" char="." charoff="50">12</td>
<td align="char" valign="top" char="." charoff="50">9</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> ME + ET</td>
<td align="char" valign="top" char="." charoff="50">8</td>
<td align="char" valign="top" char="." charoff="50">4</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> BCT alone</td>
<td align="char" valign="top" char="." charoff="50">6</td>
<td align="char" valign="top" char="." charoff="50">4</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> ME + CT + RT + ET</td>
<td align="char" valign="top" char="." charoff="50">6</td>
<td align="char" valign="top" char="." charoff="50">4</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Less frequent combinations</td>
<td align="char" valign="top" char="." charoff="50">18</td>
<td align="char" valign="top" char="." charoff="50">21</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="3" align="left" valign="top" charoff="50">
<italic>(Most frequent combinations up to 12 months</italic>
) (n)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> BCT + CT +RT + ET</td>
<td align="char" valign="top" char="." charoff="50">48</td>
<td align="char" valign="top" char="." charoff="50">42</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> BCT + RT + ET</td>
<td align="char" valign="top" char="." charoff="50">16</td>
<td align="char" valign="top" char="." charoff="50">17</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> ME + CT + RT + ET</td>
<td align="char" valign="top" char="." charoff="50">13</td>
<td align="char" valign="top" char="." charoff="50">13</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> BCT + CT + RT</td>
<td align="char" valign="top" char="." charoff="50">3</td>
<td align="char" valign="top" char="." charoff="50">12
<sup>*</sup>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> ME + ET</td>
<td align="char" valign="top" char="." charoff="50">7</td>
<td align="char" valign="top" char="." charoff="50">4</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Less frequent combinations</td>
<td align="char" valign="top" char="." charoff="50">12</td>
<td align="char" valign="top" char="." charoff="50">12</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="3" align="left" valign="top" charoff="50">
<italic>Treatment completed/ongoing at 6 months</italic>
(n)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Chemotherapy</td>
<td align="center" valign="top" charoff="50">50/5</td>
<td align="center" valign="top" charoff="50">58/9</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Radiotherapy</td>
<td align="center" valign="top" charoff="50">51/12</td>
<td align="center" valign="top" charoff="50">60/18</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Endocrine therapy</td>
<td align="center" valign="top" charoff="50">3/59</td>
<td align="center" valign="top" charoff="50">1/54</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn id="t6-fn1">
<p>Abbreviations: BCT=breast conserving therapy; CT=chemotherapy; ET=endocrine therapy (e.g., Tamoxifen); ME=mastectomy; RT=radiotherapy; QoL=quality of life.</p>
</fn>
<fn id="t6-fn2">
<p>Not frequent=⩽10 per whole trial sample.
<sup>*</sup>
<italic>χ</italic>
<sup>2</sup>
-test
<italic>P</italic>
=0.017.</p>
</fn>
</table-wrap-foot>
</table-wrap>
</floats-group>
</pmc>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Royaume-Uni</li>
</country>
</list>
<tree>
<country name="Allemagne">
<noRegion>
<name sortKey="Klinkhammer Schalke, M" sort="Klinkhammer Schalke, M" uniqKey="Klinkhammer Schalke M" first="M" last="Klinkhammer-Schalke">M. Klinkhammer-Schalke</name>
</noRegion>
<name sortKey="Ehret, C" sort="Ehret, C" uniqKey="Ehret C" first="C" last="Ehret">C. Ehret</name>
<name sortKey="Ernst, B" sort="Ernst, B" uniqKey="Ernst B" first="B" last="Ernst">B. Ernst</name>
<name sortKey="Hofst Dter, F" sort="Hofst Dter, F" uniqKey="Hofst Dter F" first="F" last="Hofst Dter">F. Hofst Dter</name>
<name sortKey="Koller, M" sort="Koller, M" uniqKey="Koller M" first="M" last="Koller">M. Koller</name>
<name sortKey="Lorenz, W" sort="Lorenz, W" uniqKey="Lorenz W" first="W" last="Lorenz">W. Lorenz</name>
<name sortKey="Steinger, B" sort="Steinger, B" uniqKey="Steinger B" first="B" last="Steinger">B. Steinger</name>
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<name sortKey="Wyatt, J C" sort="Wyatt, J C" uniqKey="Wyatt J" first="J C" last="Wyatt">J C Wyatt</name>
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