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Appendix 6Evidence tables Clinical question 1 Can the relevant cancer or applied treatment lead to somatic, psychological and/or social problems in the initial phase?AuthorYearStudy designLevel/QualitynPopulationResultsParker2003Cross-sectional study351Patients in oncological follow-up in tertiary centre on average 3 years after diagnosis.32% suffered from a depressionQoL reasonably good; average score 43 (general population 50; SD 10)Influencing factors: age +, gender M +, married +, social support + Henningsohn2003Cross-sectional study with control groupC? Period after treatment not reported866♂ after treatment bladder cancer + follow-upAfter cystectomy+conduit, cystectomy+reservoir and neobladder approx 20%19% distress due to ↓ intercourse+orgasm and erection complaints. After radiotherapy, 17% distress due to intenstinal complaints: 16% abdominal pain, 14% defaecation disorders. The most distress as a result of urine retentionHardt2000Prospective study pre-1yr post surgeryB; small study4444 patients alive 1 yr after cystectomyQoL postoperative strong reduction in physical functioning. Also reduction in role limitations and emotional well-being. General satisfaction with life not reducedGerharz1997Retrospective follow-up 2.7 yrs44Patients up to 1 year after cystectomy + urinary diversionQoL reduced, especially in physical functioning. Almost 50% was continent. Decrease in sexual activity (p<0.06)Boini2004Cohort studySF-36 after 15 monthsA2887468 participants in a cancer prevention trial, of which 88 developed cancerLower HRQoL scores for cancer patients, especially in the domains: phys. functioning, physical role functioning and general health domensionsHsiao2007Systematic reviewA1 Searching + selecting +, quality assessm +Men with localised prostate cancerMost frequently reported: urological complaints, sexual dysfunction and intestinal disorders; The diagnosis causes psychological distress with a changed self-awareness, worries about the effects of treatment and distress related to the decision to be made in relation to treatment.Jones2006Systematic reviewA2 Searching + selecting + quality?Women with gynaecological cancerHRQOL is reported specifically per treatmentAuthorYearStudy designLevel/QualitynPopulationResultsHewitt2003Cross-sectional studyB Large representative sample4878Survivors of cancer compared to the general populationSurvivors of cancer more often have a poor health (odds ratio 2.97; CI 2.6, 3.4) and more often psychological problems (OR 2.2; CI 1.7, 2.8)Burgess2005Prospective cohort study + control groupB222Women with breast cancer50% had depression and/or anxiety in the 1st year, 25% in the 2nd decreasing to 15% after 5 years.Stommel2004Prospective cohort studyB860Older cancer patients (breast, lung, colon, prostate)Symptoms of depression decreased after 1 year, but the general well-being did not improve in this periodClinical question 2 Is there effective treatment for these problems, and/or is support justified for other reasons?AuthorYearStudy designLevel/QualitynPopulationResults Newell2002Systematic reviewA2; small trials34 trialsRCTs on the effect psychological intervention has on outcomes of cancer patientsOnly careful conclusions relating to efficacy of some interventions. Also see details of results in the below tableRodin2007Systematic reviewA2; small trials11 trialsRCT’s on the effect of depression in cancer patients2/6 Antidepressants 1 trials + 1/1 benzodiazepine vs. muscle relaxation + 2/4 non-pharmacological +: specialised nurse care after 3 but not after 6 months +orientation programme +Schmitz2007Meta-analysisWeighted mean effect sizesA2; small trials 22 studiesStudies on the effect of interventions designed to increase physical activity on the outcome of adult cancer patients Good tolerance. Mean effect size (ES):Cardioresp. Fitness:3/4 +; ES 0.65( 0.22-1.09)QoL 4/5 + ; ES 0.30?(–0.13-0.73)?Pain 1/1 ES 1.64 (0.43-2.85)Depression 2/5 + ES 0.44 (-0.13-1.01)?Rehse2003Meta-analysisModerate: analysis unclear and unconventional37 studiesControlled studies on the effect of psychosocial interventions on quality of life of cancer patientsNontransparent analysis. No conventional methods used. No insight in efficacy of type of intervention or study designs used. AuthorYearStudy designLevel/QualitynPopulationResultsAllard2001Systematic ReviewA225 studies (4 RCT) involving health care profs: 8 studies (2 RCT) involving pa-tients/ carersStudies (amongst other things, RCTs) on the effect of 'educational interventions'Interventions aimed at health care professionals have little effect on pain perception by patients. Interventions aimed at patients and carers do appear to be effective (also short-term counselling with pain diary)Osborn2006Meta-analysisA2Analysis method unclearSmall non-blinded RCTs15 trials with 1492 patientsStudies on the effect of cognitive behavioural therapy and ‘patient education’ on QoL of adult cancer patientsCBT for depression: SMD 1.21;CI 0.22-2.19; for anxiety: SMD 1.99; CI 0.69-3.31; no effect in the case of pain or physical functioning, with QoL: WMD 0.91; CI 0.38—1.44. Patient education did not have an effect on any outcome. Detailed results for Newell, 2002anxietyMusic therapy; more research required for CBT, individual therapy, etc.depressionNothing, more research for group therapy, structured counselling, etcgeneral or overall effectUnstructured counselling; music therapy. More research voor CBT, structured counselling, etc.stress, distressStructured counselling; more research on CBT, comm. skills training, etcoverall QALStructured or unstructured counsellingcoping/controlGroup therapy; more research on CBT, relaxation therapy+communication skillsvocational or domestic adjustmentnothinginterpersonal or social relationshipsStructured or unstructured counsellingsexual or marital relationshipsMore research for therapist-delivered, individual interventionsnauseaMore research on therapist-delivered interventionsvomitingNo specific intervention recommendedpainMore research on individual therapy, relaxation training, CBT, etc.fatigueNo specific intervention; more research on group therapy and CBToverall physical symptomsNo specific interventionClinical question 3 Is it known how long patients are heavily burdened as a result of these problems (for example, a clearly disturbed ADL function or quality of life experienced), and within what period of time most patients regain their balance?AuthorYearStudy designQuality of studynPopulationResultsHenningsohn2003ACross-sectional study with control groupA2; Period after treatment not reported866444 ♂ after treatment for bladder cancer; 422 controlsAfter cystectomy+conduit, cystectomy+reservoir and neobladder approximately 20% distress due to ↓ intercourse+orgasm and erection complaints. After radiotherapy 17% distress due to intestinal complaints: 16% abdominal pain, 14% defaecation disorders. Most distress due to urine retentionKulaksizoglu2002Prospective cohort studyadequate68Bladder cancer patients after radical cystectomy; follow-up 2? yearsFunctional scores strongly reduced after 3 mths, then improvement until starting level reached after 12 mths; symptom score already high before surgery, after 12 months improvement especially with miction and sexual complaints.Zippe2004Prospective study with 5-year follow-upB49Sexually active ♂♂ after radical cystectomy86% was impotent 5 yr postoperative (erection disorder)Hardt2000Prospective study pre-1 yr post surgeryB; small study4444 patients alive 1 yr after cystectomyQoL postoperative strongly reduced in physical functioning. Also reduction in role limitations and emotional well-being. General satisfaction with life not reducedKulaksizoglu2002Prospective cohort studyB adequate68Bladder cancer patients after radical cystectomy; follow-up 2? yearsFunctional scores strongly reduced after 3 mths, then improvement until starting level reached after 12 mths; symptom score already high preoperatively, improvement after 12 mths especially with miction and sexual complaints.Henningsohn2003Prospective studyB 616303 postcystectomy; 310 controls Psychological well-being 2-10 yr postcystectomy. > 10 yr = controls. Especially sexual dysfunction.Clinical question 4 On the basis of this, what is the most suitable review moment regarding the requirement for follow-up?AuthorYearStudy designQuality of studynPopulationResultsOsse2000Syst review15 InstrumentsPatients with progressive or metastatic cancerNo instrument was complete; spiritual issues and needs of relatives lacking. Instruments especially designed and tested for research.Gilbert2007instrument evaluation315bladder cancer patientsDifferences in QoL demonstrated. BCI responsive for functional differences and differences in complaints in the urinary-, intestinal- and sexual domains. Clinical question 5 Is it possible that health problems will develop at a later point in time as a result of the initial cancer or the cancer treatment, and is it plausible that these long-term problems can be treated more effectively if detected earlier? Which sub-scenario (late effects) is appropriate on the basis of these considerations?AuthorYearStudy designLevel/ QualitynPopulationResultsAllareddy2006Prospective cohort study259Bladder cancer patients 8 yrs after diagnosis High scores on QoL. After radical cystectomy: 89% impotent; in the case of intact bladder 32%.Hart1999224Bladder cancer patients 1-23 yrs after radical cystectomyQoL generally good. Most problems with urinary diversion & sexual dysfunction.Clinical questions 6 through to 9 (answered for bladder carcinoma)6. At which point in time can new cancer manifestations (local or regional recurrences, distant metastases or second primary tumours) occur?7. Is there effective treatment for these cancer manifestations, and does treatment efficacy increase with earlier detection of the cancer? 8. Which diagnostics are the most suited to diagnosing treatable new cancer manifestations at an early stage in an accurate manner?9. Which scenario for early detection is appropriate on the basis of these considerations? Authors / year ? Level of evidence Study type ? Population (incl. sample size) Inclusion criteria Intervention duration and dose Control (golden standard, reference test) ? Outcome Result /conclusionComments, notesMalkowicz 2007 - review - - - - - - - Bochner 2003 - review - - - - - - - Westney 1998 C Observat. Retro. 33 Radical cystectomy for UCC?followed by local recurrence ? ? ? - ? ? ? - ? ? ? - Prognosis of pat. with local recurrence is poor despite therapy. Syst. chemo offers good palliation ? ? ? - Bajorin 1998 ? Phase II trial 30 Untreated patients with advanced UCC bladder Ifosfamide 1.5 g/m2/d for a duration of 3 days. Paclitaxel 200 mg/m2 over 3 hours. Cisplatin 70 mg/m2 on day 1 of every 28-day treatment cycle. Max. of 6 cycles ? ? ? - Efficacy - no response, partial response and complete response Toxicity ITP (ifosfamide, paclitaxel and cisplatin) is an active, well- tolerated combination in untreated patients with advanced UCC. ? Sanderson 2007 C Observat. Prospect. 1069 Radical cystectomy voor UCC blaas ? - ? - ? Lifelong risk of recurrence in upper urinary tract. Greatest risk factor is tumor in urethra. Screening does not detect tumours before symptoms develop. ? Stein 2001 C Observat. Retro. 1054 Radical cystectomy + PLND for UCC of the bladder ? - ? - Survival ? Frequency local & distant recurrence 5-year disease-free and overall survival 68% and 66% respectively. Chance of recurrence dependent on pathologic subgroup. ? ? Authors / year ? Level of evidence Study type ? Population (incl. sample size) Inclusion criteria Intervention duration and dose Control (golden standard, reference test) ? Outcome Result /conclusionComments, notesHuguet 2003 C Observat. Retro. 5 Urethral recurrence after cystectomy with orthotopic bladder replacement ? - ? - ? Urethral recurrence after orthotopic bladder replacement rarely occurs. Conservative treatment is an option in the case of superficial recurrences. ? Nieder 2004 C Observat. Retro. 226 Radical cystoprostatectomy ? - ? - ? Risk of urethral recurrence is <4%. Lower risk in case of orthotopic neobladder (0.9%) than supravesical diversion (6.4%). Delayed urethrectomy (i.e. after cystectomy) does not impact survival. ? Lin 2003 C Observat. Retro. 24 Urethrectomy due to urethral recurrence after radical cystoprostatectomy as a result of UCC ? - ? - (Impact of early detection of urethral recurrence on the) Overall survival No significant difference in survival between patients that have/have not been screened with urethral washings ? Sherwood 2006 ? 6 case reports + review ? - ? - ? - ? - ? - ? - ? Slaton 1999 C Observat. Retro. 382 Radical cystectomy for N0-2, M0 UCC bladder ? ? ? Stage-specific follow-up schedule after radical cystectomy can reduce costs and detect recurrences and complications in an efficient manner? Hautmann 2006 ? Meta-analysis (? according to pubmed) > 1300 Orthotopic bladder substitution ? ? Frequency urethral recurrence and recurrence upper urinary tract and long-term metabolic disorders Respectively 1.5-5% 2-3% low ? Kuroda 2002 C Observat. Retro. 351 Radical cystectomy for bladder Ca. ? ? ? Stage-specific follow-up schedule after radical cystectomy can reduce costs and detect recurrences and complications in an efficient manner. ? ................
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