Diagnostic pilot study of an evaluation scale - 11th ECET Congress Bologna 2011
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DIAGNOSTIC PILOT STUDY OF AN EVALUATION SCALE OF THE REVERTION SYMPTOMS AFTER AN ANTERIOR RESECTION OF THE RECTUM Gaetano Militello (Ostomy Care Nurse, Wound Care Expert, U.S.L. 4, Misericordia e Dolce Hospital, Prato – Italy) Mario Antonini (Ostomy Care Nurse, Wound Care Expert, U.S.L. 11, San Giuseppe Hospital, Empoli – Italy) Sonia Fligor (Nurse, University of Florence – Italy) Cristina Lippi (Nurse, U.S.L. 4, Misericordia e Dolce Hospital, Prato – Italy) Giuliano Quaresimini (Surgeon Assistant, Misericordia e Dolce Hospital, Prato – Italy) INTRODUCTION The pilot study objective is to validate a scale for secondary symptoms of the revertion after the anterior rectum resection. As this problem seems to be scarcely evaluated in a correct scientific way. A systematic bibliographical research highlighted that also the Cochrane shows two aspects: ano-rectal physiologic measurements are not directly comparable among different studies because of the huge variability of the technology and the evaluation methods of the ano-rectal function used by different centers. Moreover they cannot be directly connected to the clinical outcomes. For these reasons such measurements should be considerate as substitute endpoints. According to any research guidelines, indication from the research a standard related to the outcomes of the intestinal function should be defined to facilitate the comparison among different studies of different rehabilitation techniques. METHODS AND MATERIALS A diagnostic blind research has been done to define the following essential data of the test: - Accuracy; - Reproducibility. In case of lack of any other bibliographical indications, the clinical evaluation should be considered the gold standard. Patients were selected from colo-proctological centers of Prato and Empoli USL (Local Sanitary Units). INCLUSION CRITERIA The patients involved have had a revertion surgery after anterior resection of the rectum and they were all out-patients. EXCLUSION CRITERIA Patients that had a different type of resection; patients that were not reversed, patients that had not been followed by the mentioned centers, patients with privious fecal incontinence for different reasons than the ones takent into consideration in this study;, patients that used drugs that can cause fecal incontinence or severe disorders of the intestinal alvum. Sample units: 20 patients. RESULTS In order to evaluate the validiy of the scale we firstly gave a definition of Cut-off levels by comparing the evaluation results of the scale with the data of the clinical evaluation done by the clinician and by elaborating matrix tables regarding to each cut-off value. The scale presented two Cut-Offs: the first (light-medium) the second (medium-severe). Then sensitivity, specificity, Vp+, Vp-, LR+, LR- have been evaluated. The evaluation of the Cut-Off was done using the Youden Index. The evaluation of the reproducibility was done through the K of Choen. K of Choen of 92% shoul be considered as remarkable reproducibility. As there are several other scales to measure incontinence, the values of their validation have been searched in order to compare them with the section of the Prato scale section regarding the incontinence. This was done to understand if the use of a single scale is correct or if it’s better to evaluate the incontinence with another scale and the other symptoms with this scale if we should use this scale only. A systematic bibliographical research has given unexpeted results, as the validation of the above-mentioned scales was done just for some of them; moreover, in those cases, only the agreement among helth care professionals was considered. No data about sensitivity and specificity were. In a study R of Parson was evaluated to demonstrate a connection between scale values and clinical data, but the same Chocrane stated that this index tent to overestimate the real value. DISCUSSION The pilot study seems to show positive results but reproducibility must be held under control in case of: - Other valuators will be involved - The sample selection includes more patients with light symptomatology. This research is also oriented to start the validation of the scale about to the incontinence, as it’s the only study conducted with a methodology suggested by Cochrane, also for this the preliminary results are good. PRATO EVALUATION SCALE INCONTINENCE OTHER SYMPTOMS DATE Flatulence Liquid Stools Solid Stools Bloating Bleeding Rectal spasm Pain Perineal Lesions SF R SF R SF R Trace True Weak Strong SOMETIME 1 2 3 5 6 8 1 1 2 2 1 2 Present 4 DAILY 6 5 7 9 10 12 2 3 5 5 3 5 No lesion 0 ABSENT 0 0 0 0 0 0 0 TOTAL Signature Cut-off 0 7 16 0 7 16 38 38 valore di cut valore di cut- off off VP VP grave grave VN VN lieve lieve VP VP media media Cut-off 7 Valore I.C. 95% Sensibility 1,000 1,000 1,000 Specificity 0,94 0,849 1,02196623 VPP 0,82 0,59025087 1,04611277 VPN 1,00 1,00000000 1,00000000 LR + 15,50 4,05667414 59,22339135 LR - 0,00 Accuracy 0,95 Prob. Pre-test (prevalence) 0,225 Pre-test odds 0,290 Post –test odds 4,500 Prob. Post-test 0,818 Cut-off 16 Valore I.C. 95% Sensibility 0,83 0,661 1,005 Specificity 0,91 0,788 1,029 VPP 0,88 0,729 1,035 VPN 0,87 0,731 1,007 LR + 9,17 2,406 34,919 LR - 0,18 0,064 0,369 Accuracy 0,450 Prob. Pre-test (prevalence) 0,818 Pre-test odds 7,500 Post –test odds 0,882 Prob. Post-test 0,450 Drug treatment for fecal incontinence in adults By: Cheetam, Mark J, Brazzelli, Miriam, Norton, Christine C, Glazener, Cathryn MA, Cochrane Database of systematic Reviews, Issue 4. • Numero di persone che non raggiungono una completa continenza • Numero di persone che non migliora • Frequenza dell’incontinenza (diario o self-report) • Grado di incontinenza (ad esempio, il peso delle feci) • Valutazione incontinenza • Episodi di urgenza fecale • Misurazioni fisiologiche anorettali Electrical stimulation for fecal incontinence in adults By: Hosker G, Cody JD, Norton CC, Cochrane Database of Systematic Reviews, Issue 4. SINTOMI DEL PAZIENTE: - Incontinenza descrizione - Frequenza dell’incontinenza - Punteggio incontinenza (non viene definito come misurarla) - Verificarsi di effetti negativi Misurazioni della fisiologia anorettale. Plugs for containing faecal incontinence By: Deutekom M, Dobben A, Cochrane Database of Systematic Reviews, Issue 4. SINTOMI DEL PAZIENTE: - La frequenza di incontinenza delle feci o flatus (diario o self-report) - Grado di incontinenza (ad esempio, il peso delle feci) VALUTAZIONE INCONTINENZA: - Episodi di urgenza anale. MISURE FISICHE: - Realizzazione di pseudo-continenza (continenza solo mentre indossa un tampone) - Per quanto tempo lo indossa e frequenza d’uso - Tasso di perdita - Controllo degli odori. Reconstructive Techniques after Rectal Resection for Rectal Cancer By: Carl J, Brown, Fenech, Darlene, McLeod, Robin S, Cochrane Database of Systematic Reviews. - Numero di movimenti intestinali al giorno. - Urgenza, definita come l’incapacità di rimandare la defecazione. - L’incontinenza fecale, misurata da uno strumento adeguato (non vengono definite le scare che possono essere considerate adeguate. - L’evacuazione incompleta, definita dalla sensazione di tenesmo residua dopo la defecazione. L’uso di farmaci anti-diarrea, definito come la continua dipendenza da farmaci costipativi. Bilateral sacral spinal nerve rectum resection . Matzel KE, Stadelmaier U, Bittorf B, Hohenefellner, Hohenfellner - Frequenza episodi di inocntinenza - Soddisfazione del paziente (non specificato come valutata) - Manometria (pressione di compressione, pressione a riposo, soglie per la prima percezione, massimo volume tollerabile - Cleveland Clinic Continence Score. Kaspar Z’graggen, Christoph A. Maurer, Stefan Birrer, Daniel Giachinoi, Beatrice Kem MD, Markus W, Buchler, A new surgical Concept for Rectal Replacement aftewr low anterior resection. The transverse Coloplasty Pouch Annals of Surgery Vol. 234, N. 6, 780-2001 Lippicott Williams & Williams % Wilins, Inc. - Frequenza dei movimenti intestinali nelle 24 ore (range) - Urgenza - Frammentazione delle feci - Incontinenza (non viene indicata la modalità di valutazione.
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Transcript of Diagnostic pilot study of an evaluation scale - 11th ECET Congress Bologna 2011
DIAGNOSTIC PILOT STUDY OF AN EVALUATION SCALE OF THE REVERTION SYMPTOMS AFTERAN ANTERIOR RESECTION OF THE RECTUM
Gaetano Militello (Ostomy Care Nurse, Wound Care Expert, U.S.L. 4, Misericordia e Dolce Hospital, Prato – Italy)Mario Antonini (Ostomy Care Nurse, Wound Care Expert, U.S.L. 11, San Giuseppe Hospital, Empoli – Italy)Sonia Fligor (Nurse, University of Florence – Italy)Cristina Lippi (Nurse, U.S.L. 4, Misericordia e Dolce Hospital, Prato – Italy)Giuliano Quaresimini (Surgeon Assistant, Misericordia e Dolce Hospital, Prato – Italy)
INTRODUCTION
The pilot study objective is to validate a scale for secondary symptoms of the revertion after theanterior rectum resection. As this problem seems to be scarcely evaluated in a correct scientificway. A systematic bibliographical research highlighted that also the Cochrane shows two aspects:ano-rectal physiologic measurements are not directly comparable among different studiesbecause of the huge variability of the technology and the evaluation methods of the ano-rectalfunction used by different centers. Moreover they cannot be directly connected to the clinicaloutcomes. For these reasons such measurements should be considerate as substitute endpoints.According to any research guidelines, indication from the research a standard related to theoutcomes of the intestinal function should be defined to facilitate the comparison amongdifferent studies of different rehabilitation techniques.
METHODS AND MATERIALS
A diagnostic blind research has been done to define the following essential data of the test:- Accuracy;- Reproducibility.In case of lack of any other bibliographical indications, the clinical evaluation should be consideredthe gold standard.
Patients were selected from colo-proctological centers of Prato and Empoli USL (Local SanitaryUnits).INCLUSION CRITERIAThe patients involved have had a revertion surgery after anterior resection of the rectum and theywere all out-patients.EXCLUSION CRITERIAPatients that had a different type of resection; patients that were not reversed, patients that hadnot been followed by the mentioned centers, patients with privious fecal incontinence fordifferent reasons than the ones takent into consideration in this study;, patients that used drugsthat can cause fecal incontinence or severe disorders of the intestinal alvum. Sample units: 20patients.
RESULTS
In order to evaluate the validiy of the scale we firstly gave a definition of Cut-off levels bycomparing the evaluation results of the scale with the data of the clinical evaluation done by theclinician and by elaborating matrix tables regarding to each cut-off value. The scale presentedtwo Cut-Offs: the first (light-medium) the second (medium-severe). Then sensitivity, specificity,Vp+, Vp-, LR+, LR- have been evaluated. The evaluation of the Cut-Off was done using theYouden Index.The evaluation of the reproducibility was done through the K of Choen. K of Choen of 92% shoulbe considered as remarkable reproducibility.As there are several other scales to measure incontinence, the values of their validation havebeen searched in order to compare them with the section of the Prato scale section regardingthe incontinence. This was done to understand if the use of a single scale is correct or if it’sbetter to evaluate the incontinence with another scale and the other symptoms with this scale ifwe should use this scale only.A systematic bibliographical research has given unexpeted results, as the validation of theabove-mentioned scales was done just for some of them; moreover, in those cases, only theagreement among helth care professionals was considered.No data about sensitivity and specificity were.In a study R of Parson was evaluated to demonstrate a connection between scale values andclinical data, but the same Chocrane stated that this index tent to overestimate the real value.
DISCUSSION
The pilot study seems to show positive results but reproducibility must be held under control incase of:- Other valuators will be involved- The sample selection includes more patients with light symptomatology.This research is also oriented to start the validation of the scale about to the incontinence, as it’sthe only study conducted with a methodology suggested by Cochrane, also for this the preliminaryresults are good.
PRATO EVALUATION SCALE
INCONTINENCE OTHER SYMPTOMS
DATEFlatulence Liquid Stools Solid Stools Bloating Bleeding Rectal
spasm
Pain PerinealLesions
SF R SF R SF R Trace True Weak Strong
SOMETIME 1 2 3 5 6 8 1 1 2 2 1 2 Present4
DAILY 6 5 7 9 10 12 2 3 5 5 3 5 Nolesion
0
ABSENT 0 0 0 0 0 0 0
TOTAL
Signature
Cut-off
0 7 16 0 7 16 3838
valore di cutvalore di cut--offoff
VPVP
gravegrave
VNVN
lievelieve
VPVP
mediamedia
Cut-off 7 Valore I.C. 95%
Sensibility 1,000 1,000 1,000
Specificity 0,94 0,849 1,02196623
VPP 0,82 0,59025087 1,04611277
VPN 1,00 1,00000000 1,00000000
LR + 15,50 4,05667414 59,22339135
LR - 0,00
Accuracy 0,95
Prob. Pre-test(prevalence)
0,225
Pre-test odds 0,290
Post –test odds 4,500
Prob. Post-test 0,818
Cut-off 16 Valore I.C. 95%
Sensibility 0,83 0,661 1,005
Specificity 0,91 0,788 1,029
VPP 0,88 0,729 1,035
VPN 0,87 0,731 1,007
LR + 9,17 2,406 34,919
LR - 0,18 0,064 0,369
Accuracy 0,450
Prob. Pre-test(prevalence)
0,818
Pre-test odds 7,500
Post –test odds 0,882
Prob. Post-test 0,450
Drug treatment for fecal incontinence inadults By: Cheetam, Mark J, Brazzelli,Miriam, Norton, Christine C, Glazener,Cathryn MA, Cochrane Database ofsystematic Reviews, Issue 4.
• Numero di persone che nonraggiungono una completa continenza• Numero di persone che non migliora• Frequenza dell’incontinenza (diario oself-report)• Grado di incontinenza (ad esempio, ilpeso delle feci)• Valutazione incontinenza• Episodi di urgenza fecale• Misurazioni fisiologiche anorettali
Electrical stimulation for fecalincontinence in adults By: Hosker G, CodyJD, Norton CC, Cochrane Database ofSystematic Reviews, Issue 4.
SINTOMI DEL PAZIENTE:- Incontinenza descrizione- Frequenza dell’incontinenza- Punteggio incontinenza (non vienedefinito come misurarla)- Verificarsi di effetti negativiMisurazioni della fisiologia anorettale.
Plugs for containing faecal incontinenceBy: Deutekom M, Dobben A, CochraneDatabase of Systematic Reviews, Issue 4.
SINTOMI DEL PAZIENTE:- La frequenza di incontinenza delle fecio flatus (diario o self-report)- Grado di incontinenza (ad esempio, ilpeso delle feci)VALUTAZIONE INCONTINENZA:- Episodi di urgenza anale.MISURE FISICHE:- Realizzazione di pseudo-continenza(continenza solo mentre indossa untampone)- Per quanto tempo lo indossa efrequenza d’uso- Tasso di perdita- Controllo degli odori.
Reconstructive Techniques after RectalResection for Rectal Cancer By: Carl J,Brown, Fenech, Darlene, McLeod, Robin S,Cochrane Database of Systematic Reviews.
- Numero di movimenti intestinali al giorno.- Urgenza, definita come l’incapacità di rimandare la defecazione.- L’incontinenza fecale, misurata da uno strumento adeguato (non vengono definite le scare che possono essere considerate adeguate.- L’evacuazione incompleta, definita dalla sensazione di tenesmo residua dopo la defecazione.L’uso di farmaci anti-diarrea, definito come la continua dipendenza da farmaci costipativi.
Bilateral sacral spinal nerve rectumresection . Matzel KE, Stadelmaier U,Bittorf B, Hohenefellner, Hohenfellner
- Frequenza episodi diinocntinenza
- Soddisfazione del paziente (nonspecificato come valutata)
- Manometria (pressione dicompressione, pressione a riposo,soglie per la prima percezione,massimo volume tollerabile
- Cleveland Clinic ContinenceScore.
Kaspar Z’graggen, Christoph A. Maurer,Stefan Birrer, Daniel Giachinoi, BeatriceKem MD, Markus W, Buchler, A newsurgical Concept for Rectal Replacementaftewr low anterior resection. Thetransverse Coloplasty Pouch Annals ofSurgery Vol. 234, N. 6, 780-2001 LippicottWilliams & Williams % Wilins, Inc.
- Frequenza dei movimenti intestinali nelle 24 ore (range)- Urgenza- Frammentazione delle feci- Incontinenza (non viene indicata lamodalità di valutazione.
