Expertisecentrum ACC
Uitgangsvraag
Wat is de plaats van behandeling in een hoog-volume centrum versus behandeling in een laag-volume centrum voor patiënten met een adrenocorticaal carcinoom of een vermoeden daarvan?
Aanbeveling
Behandel bij voorkeur patiënten met (verdenking op) een adrenocorticaal carcinoom in een centrum gespecialiseerd in deze ziekte.
Een centrum specificeert zich door te fungeren als (tertiair) verwijscentrum voor deze ziekte met een team van ervaren specialisten in de diagnostiek, therapie en follow up.
Overwegingen
Bijnierschorscarcinoom is een zeer zeldzame ziekte, waarbij de incidentie ligt rond de 1 per 1 miljoen (Kerkhofs, 2013). Gecontroleerde studies bij een dergelijke incidentie zijn praktisch onhaalbaar. De systematische search naar de verschillen tussen hoog- en laagvolume centra in de behandeling, operatief, van bijnierschorscarcinoom resulteerde in negen observationele cohort studies (Anderson, 2018; Barac Nekic, 2022; Bergamini, 2011; Gratian, 2014; Gray, 2021; Greco, 2011; Hermsen, 2012; Kerkhofs, 2013; Lombardi, 2012, MacKinney, 2022).
In deze literatuur werd geen eenduidige definitie gevonden van hoog- en laagvolume centrum. Met de beschreven incidentie van 1 per 1 miljoen is een ‘hoog’ volume centrum nog steeds laag vergeleken met sommige andere tumorsoorten. In de artikelen die specifiek bijnierschorscarcinoom met een getal benoemden was het criterium voor hoog-volume centrum vanaf één per jaar per centrum tot zes per jaar per chirurg, waarbij ook andere bijnieroperaties werden opgenomen met wisselende getallen. Enkele artikelen beschreven als criterium het aantal patiënten behandeld in het centrum, dus in het team voor de ziekte.
Voor twee van de drie cruciale uitkomstmaten (totale overleving en ziektevrije overleving) werden resultaten gerapporteerd (zie tabel 2).
Tabel 2. Resultaten cruciale uitkomstmaten totale overleving en ziektevrije overleving
|
Uitkomstmaat |
Studie |
Hoog-volume versus laag-volume |
Sterkte van bewijs |
Opmerkingen |
|
Totale overleving |
Gratian (2014) |
Voordeel voor hoog-volume centrum, geen klinisch relevant verschil |
Zeer laag |
Overlevingsdata voor patiënten in alle tumor stadia |
|
Hermsen (2012) |
Voordeel voor Dutch Adrenal Network (DAN) centrum, gevonden verschil is klinisch relevant |
Data van Hermsen (2012) en Kerkhofs (2013) overlappen gedeeltelijk. Alleen overlevingsdata voor patiënten met ENSAT tumor stadium I-III |
||
|
Kerkhofs (2013) |
Voordeel voor DAN centrum, gevonden verschil is klinisch relevant |
|||
|
Lombardi (2012) |
Voordeel voor hoog-volume centrum, verschil is klinisch relevant |
Overlevingsdata voor patiënten in alle tumor stadia |
||
|
MacKinney (2022) |
Voordeel voor hoog-volume centrum gevonden, verschil is klinisch relevant |
Overlevingsdata voor patiënten in alle tumor stadia |
||
|
Ziektevrije overleving |
Barac Nekic (2022) |
Voordeel voor hoog-volume centrum, gevonden verschil is klinisch relevant |
Zeer laag |
|
|
Hermsen (2012) |
Voordeel voor Dutch Adrenal Network (DAN) centrum, gevonden verschil is klinisch relevant |
|
||
|
Lombardi (2012) |
Voordeel voor hoog-volume centrum, gevonden verschil is klinisch relevant. |
|
Voor de vier belangrijke uitkomstmaten (R0 resectie status, postoperatieve mortaliteit, complicaties en opnameduur) werden resultaten gerapporteerd. Gezien het risico op bias, de inconsistentie, toepasbaarheid en kleine aantallen in sommige studies, is het voor deze uitkomstmaten lastig om hier conclusies aan te verbinden.
Eén studie rapporteerde R0 resectie status waarbij er een geen klinisch relevant verschil tussen de behandelgroepen gevonden was. Twee studies rapporteerden postoperatieve mortaliteit waarbij er één studie 90 dagen postoperatieve mortaliteit rapporteerde en een klinisch relevant verschil vond in het voordeel van hoog-volume centra voor patiënten met metastasen. De 90 dagen postoperatieve mortaliteit voor patiënten zonder metastasen en 30 dagen postoperatieve mortaliteit, lieten geen klinisch relevant verschil zien tussen hoog- en laag-volume centra. Drie studies rapporteerden complicaties waarbij beide studies geen klinisch relevant verschil vonden tussen de behandelgroepen. Vijf studies rapporteerden opnameduur, waarvan twee studies alleen over bijnierschorscarcinoom en drie over alle bijnieroperaties gingen. Er werden geen klinisch relevante verschillen zijn gevonden bij deze uitkomst.
De bewijskracht voor alle uitkomstmaten gezamenlijk is zeer laag. Observationele studies starten, volgens de GRADE methodiek, op een laag bewijskracht niveau (Schünemann, 2013). Er is daarnaast afgewaardeerd vanwege risico op bias omdat de follow-up periode in sommige gevallen niet beschreven was, mogelijke confounders niet in de analyse zijn meegenomen of er bij een aantal studies de co-interventies en mogelijk verschil tussen de behandelgroepen, niet beschreven zijn. Er kan daarom op basis van de gevonden literatuur geen eenduidige conclusie getrokken worden met betrekking tot het effect van hoog- en laag-volume centra op overleving, resectie status, postoperatieve mortaliteit, kosten of opnameduur.
Naast de beschikbare wetenschappelijke literatuur zijn er ook een aantal overwegingen die meespelen met betrekking tot de keuze voor een behandeling in een hoog-volume centrum of een laagvolume centrum voor patiënten met het zeldzame bijnierschorscarcinoom.
Meestal is het voorafgaand aan de operatie onzeker of de tumor anatomisch gelokaliseerd bij de bijnier, een bijnierschorscarcinoom betreft. In de afweging bij een operatie met vooraf een onzekere diagnose (benigne of maligne bijniertumor) moet vanwege de kans op een bijnierschorscarcinoom de operatie in een voor bijnierschorscarcinoom gespecialiseerd centrum worden verricht, onafhankelijk van de eventuele bewijslast. Het gaat dan niet alleen om de chirurg, maar om het hele team, inclusief endocrinoloog, oncoloog et cetera, met daarbij de organisatie en infrastructuur voor diagnostiek, nabehandeling, (psychosociale) nazorg en palliatieve zorg. Daarnaast moet iedere patiënt, conform SONCOS normeringsrapport, een vast aanspreekpunt c.q. casemanger krijgen.
Waarden en voorkeuren van patiënten (en evt. hun verzorgers)
Patiëntvoorkeur speelt een belangrijke rol in de keuze van de ingreep. Goede informatie over de behandelopties aan de patiënt in een open communicatie is essentieel. In het algemeen, vanuit medische kant, wordt verwijzing naar een bijnier expertise centrum geadviseerd. Het kan zijn dat de patiënt een voorkeur heeft voor een bepaald centrum of kiest voor behandeling dichterbij huis waarbij het gekozen centrum wellicht geen expertise centrum is.
Kosten (middelenbeslag)
Eén studie rapporteerden kosten (Anderson, 2018) waarbij de kosten voor behandeling in een hoog-volume centrum 9,884 dollar zijn (IQR 6,955-15,246) en de kosten voor behandeling in een laag-volume centrum 11,543 dollar zijn (IQR 7,761-19,397). De kosten zijn aangepast aan de inflatie maar volgens het Amerikaanse systeem berekend.
Het is niet mogelijk om deze kosten te generaliseren naar de Nederlandse situatie. Een valide schatting van de kosten voor een operatie en nazorg voor mensen met bijnierschorscarcinoom is op basis van de search niet te maken. De werkelijke kosten per ziekenhuis zullen verschillen, mede afhankelijk van de gemaakte afspraken met de zorgverzekeraar. Op basis van de kosten kan geen aanbeveling worden gedaan ten aanzien van behandelen van patiënten in een hoog- of laagvolume centrum.
Aanvaardbaarheid, haalbaarheid en implementatie
Vanwege de zeldzaamheid van de ziekte bijnierschorscarcinoom zal zowel de mens met de (verdenking) op deze ziekte, als een arts die de diagnose bijnierschorscarcinoom of een verdenking daarop stelt, het beste voor hebben en willen kiezen voor behandeling door een ervaren arts, werkende in een relevant multidisciplinair team.
De algemene normen voor bijnieroperaties, in Nederland gesteld door SONCOS op twintig operaties per jaar per centrum (Platform oncologie - SONCOS, 2023), kunnen niet zonder meer één op één vertaald worden voor operaties voor (verdenking op) bijnierschorscarcinoom. De Soncos-normen van twintig bijnieroperaties per jaar zijn niet met bewijs onderbouwd maar op consensus binnen de chirurgische beroepsgroep gebaseerd. De huidige search geeft hiervoor ook geen bewijs.
De risico’s voor de toekomst om mensen met een bijnierschorscarcinoom niet te laten behandelen in een team van voor deze ziekte ervaren specialisten, ligt in onbekendheid van de arts die een dergelijke bijniertumor ontdekt en zijn of haar verwachting dat een snelle en eenvoudige operatie kan volstaan.
Rationale van de aanbeveling: weging van argumenten voor en tegen de interventies
De bewijslast is te laag om een goed onderbouwde conclusie te geven over het verschil tussen hoog- en laagvolume centra voor de operatie en behandeling van bijnierschorscarcinoom gerelateerd op overleving, mortaliteit, complicaties etc.
Het gebrek aan bewijskracht om specifieke vragen over zeldzame ziekten te beantwoorden is niet onverwacht. De uitkomsten uit de literatuur laten de trend zien dat behandeling van mensen met een bijnierschorscarcinoom in een hoog-volume centrum beter kan zijn dan daarbuiten. Gecombineerd met expert opinion en de geanticipeerde wens van de patiënt om behandeld te worden door een specialist die ervaring heeft met het ziektebeeld, komen wij tot onderstaande aanbeveling.
Onderbouwing
Achtergrond
Het adrenocorticaal carcinoom (ACC) is een zeldzame en agressieve tumor met een mediane overleving van 3-4 jaar (Fassnacht, 2018). Bij patiënten met een ACC is chirurgische resectie de standaard voor een in opzet curatieve behandeling. Vanwege het zeldzame karakter moet volgens de ESMO-EURACAN-richtlijn moet bijnierchirurgie in het kader van een ACC of een vermoeden daarvan bij voorkeur uitgevoerd worden door chirurgen in centra met voldoende expertise en ervaring (Fassnacht, 2020).
In Nederland bestaat een bijniernetwerk waar de ervaring in zeven ziekenhuizen voor het bijnierschorscarcinoom aanwezig is en die in contact staan om bij individuele casus elkaar te ondersteunen. Echter niet elke patiënt met een ACC of een vermoeden daarop wordt in Nederland standaard geopereerd in een centrum dat is aangesloten bij het Bijniernetwerk. De vraag is daarom of chirurgische behandeling in een expertise centrum of hoog-volume centrum leidt tot betere uitkomsten voor de patiënt.
De nabehandeling van het ACC na curatieve resectie, alsmede de behandeling van gemetastaseerde ziekte valt buiten bespreking in deze richtlijn.
Conclusies
Overall survival
|
Very low GRADE |
The evidence is very uncertain about the effect of treatment in a high-volume center on overall survival when compared with treatment in a low-volume center in patients with ACC.
Source: Gratian, 2014; Hermsen, 2012; Kerkhofs, 2013; Lombardi, 2012; MacKinne, 2022 |
Disease-free survival
|
Very low GRADE |
The evidence is very uncertain about the effect of treatment in a high-volume center on disease-free survival when compared with treatment in a low-volume center in patients with ACC.
Source: Barac Nekic, 2022; Hermsen 2012; Lombardi, 2012 |
Progression-free survival
|
No GRADE |
No evidence was found regarding the effect of treatment in a high-volume center on progression-free survival when compared with treatment in a low-volume center in patients with ACC.
|
R0 resection status
|
Very low GRADE |
The evidence is very uncertain about the effect of treatment in a high-volume center on R0 resection status when compared with treatment in a low-volume center in patients with ACC.
Source: Lombardi, 2012; Hermsen, 2012 |
Postoperative mortality
|
Very low GRADE |
The evidence is very uncertain about the effect of treatment in a high-volume center on postoperative mortality when compared with treatment in a low-volume center in patients with ACC.
Source: Gratian, 2014; MacKinney, 2022 |
Complications
|
Very low GRADE |
The evidence is very uncertain about the effect of treatment in a high-volume center on complications when compared with treatment in a low-volume center in patients with ACC.
Source: Anderson, 2018; Bergamini, 2011; Gray, 2021 |
Costs
|
Very low GRADE |
The evidence is very uncertain about the effect of treatment in a high-volume center on costs when compared with treatment in a low-volume center in patients with ACC.
Source: Anderson, 2018 |
Length of stay
|
Very low GRADE |
The evidence is very uncertain about the effect of treatment in a high-volume center on length of stay when compared with treatment in a low-volume center in patients with ACC.
Source: Anderson, 2018; Gratian, 2014; Gray, 2021; Greco, 2011; MacKinney, 2022 |
Samenvatting literatuur
Description of studies
Anderson (2018) performed a retrospective cohort study using the Healthcare Cost and Utilization Project National Inpatient Sample (NCUP-NIS) dataset. Patients were selected from the HCUP-NIS dataset when they were adult patients and underwent an adrenalectomy between 1998 and 2009 in the United States. A total of 6712 patients were included.
The definition of high- and low volume surgeons was based on the estimated point of annual surgeon volume of adrenalectomies that corresponded to the maximum change in the log odds ratio (OR) of a complication. Restricted Cubic Splines (RCS) was used to examine that point. The identified value was 5.6 (95%CI 3.27-5.96) annual operations. Based on that value, two volume groups were identified. High-volume surgeons had more than six cases per year and low-volume surgeons had six or less cases per year. The high-volume group consisted of 1168 patients and the low-volume group consisted of 5544 patients. Median age in the high-volume group was 56 years (IQR 45-67) and 60 years (IQR 47-70) in the low-volume group. In the high-volume group 395 patients (34%) had a Charleston Morbidity score of two or higher and 2317 patients (42%) in the low-volume group. In the high-volume group 5 patients (5%) and in the low-volume group 2196 patients (40%), were operated in a nonteaching hospital. Groups were not comparable at baseline.
Anderson (2018) used multivariate logistic regression to examine the factors associated with treatment by high-volume surgeon. The primary outcome of this study was incidence of one or more in-hospital complications. Complications were defined by the ICD-9 diagnosis and procedure codes. Secondary outcomes were hospital duration of stay and inflation-adjusted hospital costs.
Barac Nekic (2022) performed a retrospective cohort study using the Croatian ACC registry. Patients were selected from the Croatian ACC registry when they were diagnosed with a European Network for the Study of Adrenal Tumors (ENSAT) stage I-III ACC and receiving surgery between 2008 and 2020. There were no exclusion criteria reported. A center was considered high-volume when the single surgeon who was a urologist, performed more than 20 adrenal surgeries on average per year in the last ten years of which at least two patients per year had ACC.
The high-volume group consisted of 35 patients with a median age of 46 years (IQR 18-77). The low-volume group consisted of 14 patients with a median age of 56.5 years (24-78). Median tumor size in the high-volume group was 80 millimeters (IQR 26-176) and 107.5 millimeters (IQR 70-250) in the low-volume group. Laparoscopic surgery was performed in 71.4 percent in the high-volume group and 28.6 percent in the low-volume group.
Primary outcome of this study was recurrence-free survival (RFS). RFS was calculated from the date of ACC surgery to the date of recurrence or the last imaging follow-up.
Bergamini (2011) performed a prospective cohort study. Patients who were recorded in the Italian Registry of Endoscopic Surgery-Adrenalectomy (IRES-A) between January 2000 and August 2009 and who underwent a laparoscopic adrenalectomy, were included in this study. There were no exclusion criteria reported. The surgical centers were divided in two groups: A referral center with more than 30 laparoscopic adrenalectomies and a non-referral center when there were 30 or less laparoscopic adrenalectomies performed. There was no clear definition of the timeframe in which the number of adrenalectomies had to be performed. The referral center group consisted of 674 patients and the non-referral center consisted of 159 patients. There were no baseline characteristics or prognostic factors reported to provide information on group comparability. The study reported the following outcomes: Complications, intraoperative complications, postoperative surgery-related complications and postoperative nonsurgery-related complications.
Gratian (2014) performed a retrospective cohort study using data from the National Cancer Data Base (NCDB) in the United States between 1998 and 2011. Patients were included with ACC according to the International Classification of Disease for Oncology second and third editions (ICD-O-2/3) for site C74.0-C74.9 and histology 8370.3 (malignant adrenocortical carcinoma) and had no other primary malignancies. Treating facilities were defined as high-volume center when the case load was four or more cases treated per year. A facility was defined as low-volume when the case load was less than four cases treated per year. The high-volume group consisted of 411 patients and the low-volume group consisted of 2354 patients. Median age in the high-volume group was 50 years and in the low-volume group 54 years. Median tumor size in the high-volume group was 11.2 centimeters and in the low-volume group 10.5 centimeters. In the high-volume group, 66 patients (16%) had a Charlson/Deyo comorbidity score of one or more and 603 patients (25.6%) in the low-volume group. The groups were not comparable at baseline. Gratian (2014) reported the outcomes overall survival, 30-day postoperative mortality and length of stay.
Gray (2021) performed a retrospective cohort study using data from the Hospital Episode Statistics (HES) in England. Patients who underwent an unilateral adrenalectomy between 2013 and 2018, were elective readmitted and older than 18 years were included in the study. Data was stratified according to type of procedure, minimally invasive and open procedure. The number of procedures conducted in the year prior to the index procedure was the primary exposure variable. The number of procedures were calculated for each trust (geographically defined catchment area of varying physical size and population) and for each surgeon. Regarding the scope of this review and organization of healthcare in the Netherlands, only outcome data for number of procedures per surgeon, were reported. The threshold according to surgery volume is six, based on the study by Anderson (2018).
In total, 4,189 patients were included in the analysis. 3184 patients (76%) were minimally invasively operated and 1005 patients (24%) were operated using the open procedure. 2622 patients (63%) were operated by a surgeon performing ≥ 6 procedures in the previous year. There are no patient characteristics available for patients operated by a surgeon performing ≥ 6 procedures or < 6 procedures in the previous year.
Gray (2021) reported the outcomes length of stay and complications.
Greco (2011) performed a retrospective cohort study using data from 41 German Urological Centers. Patients who underwent a transperitoneal or retroperitoneal laparoscopic adrenalectomy at the participating centers between 2003 and 2009, were included. The data was stratified according to the surgical approach: Transperitoneal or retroperitoneal. Centers were stratified into three groups according to surgical experience: < 10 laparoscopic adrenalectomies per year (group A), 10-20 laparoscopic adrenalectomies per year (group B) and > 20 laparoscopic adrenalectomies per year (group C). Group A consisted of 73 patients, group B of 91 patients and group C of 199 patients. Mean tumor size for the transperitoneal approach in group A was 2.96 centimeter (SD 1.78), in group B 3.46 centimeter (SD 1.34) and in group C 3.77 centimeter (1.51 SD). Mean tumor size for the retroperitoneal approach was 2.62 centimeter (1.12 SD) in group A, 3.71 centimeter (0.91 SD) in group B and 3.98 centimeter (1.83 SD) in group C. Greco (2011) reported the outcome length of hospital stay.
Hermsen (2012) performed a retrospective cohort study using data from the Dutch Adrenal Network (DAN). Patients older then 16 years, who were treated for histologically confirmed ACC between 1965 and January 2008 in DAN hospitals or non-DAN hospitals with later referral to a DAN hospital, were included. Outcomes were reported for patients treated in a DAN hospital and patients initially treated in a local non-DAN hospital and later directed to a DAN hospital. The DAN hospital group consisted of 89 patients. The non-DAN hospital group consisted of 60 patients. Median age in the DAN group was 48.7 years and in the non-DAN group was 46.1 years. Number of patients with a European Network for the Study of Adrenal Tumors (ENSAT) stage II tumor in the DAN group was 28 (31.5%) and in the non-DAN group 15 (15%). Number of patients with a ENSAT stage III tumor in the DAN group was 34 (38.2%) and in the non-DAN group 17 (28%). Number of patients with a ENSAT stage IV tumor in the DAN group was 25 (28.1%) and in the non-DAN group 27 (45%). Hermsen (2012) reported the outcome overall survival and recurrence-free survival.
Kerkhofs (2013) performed a retrospective cohort study using the data from the Netherlands Cancer Registry. Patients who were diagnosed with ACC between 1st of January 1999 and 31st of December 2008 with primary surgery in a DAN hospital or non-DAN hospital, were included. Pediatric patients were excluded from the analysis. The DAN hospital group consisted of 70 patients and the non-DAN group consisted of 54 patients. Median age in the DAN group was 52 years and in the non-DAN group 57 years. In the DAN group 35 patients (50%) were diagnosed with a ENSAT stage I-II tumor and in the non-DAN group 26 (48%). In the DAN group 11 patients (16%) were diagnosed with ENSAT stage III tumor and 11 patients (20%) in the non-DAN group. Kerkhofs (2013) excluded ENSAT stage IV tumors from the multivariate analysis because for these patients only palliative treatment in possible. Therefore the influence of the covariate ‘surgery’ is not expected to be constant in time or comparable between subgroups. Kerkhofs (2013) reported the outcomes median survival, 1-year survival, 5-year survival and overall survival in patients with ENSAT stage I-III ACC.
The studies of Hermsen (2012) and Kerkhofs (2013) are partially consisting of patients drawn from the same cohort. Both studies report data on overall survival. Kerkhofs (2013) only reports survival data of patients with ENSAT stage I-III ACC. Other outcomes such as 1-year survival, 5-year survival and recurrence-free survival are not reported in both studies. Since the data is not pooled and in consultation with the working group members, data from both studies are reported.
Lombardi (2012) performed a multi-institutional survey in Italy recruiting patients with surgical treatment for ACC between December 2003 and July 2010. Data was compared between two groups: High-volume centers and low-volume centers. A center was considered high-volume if the center recruited 10 or more ACC patients per year. A center was considered low-volume if the recruitment was under 10 ACC patients per year. The high-volume group consisted of 181 patients and the low-volume group consisted of 97 patients. Median age in the high-volume group was 49.2 years and in the low-volume group 50.2 years. Median tumor size in the high-volume group was 104.1 millimeter and 82.8 millimeter in the low-volume group. In total 57 patients (31%) received adjuvant therapy in the high-volume group compared to 13 patients (13%) in the low-volume group. Lombardi (2012) reported the outcomes mean overall survival, which was calculated from the date of diagnosis to the date of death or to the date of the last follow-up, 5-year overall survival rate, mean disease-free survival, which was calculated from the date of diagnosis to the date of diagnosis of tumor recurrence or the date of last follow-up evaluation for patients without recurrence, 5-year disease-free survival rate and R0 resection status. Only univariate analysis for the outcomes were performed.
MacKinney (2022) performed a retrospective cohort study using data from the National Cancer Data Base (NCDB) in the United States. Patients were included when diagnosed with ACC using Primary Site code C74.X and histology codes 8010, 8140 and 8370, between 2004 and 2017. Patients were excluded when treated at more than one reporting facility, receiving palliative surgery, aged under 18 years or treated at a mid-range volume center. Treating facilities were considered high-volume when the center treated fifteen or more ACC cases between 2004 and 2017. Treating facilities were considered low-volume when the center treated seven or less ACC cases between the 2004 and 2017. The high-volume group consisted of 1053 patients and the low-volume group of 1988 patients. Data was stratified according to non-metastatic or metastatic state of the ACC. In the non-metastatic group mean age was 53 years for the high-volume patients and 58 years for the low-volume patients. In the metastatic group mean age was 52 years for the high-volume patients and 58 years for the low-volume patients. MacKinney (2022) reported the outcomes survival, 30-day mortality, 90-day mortality and length of stay.
Table 4: Definitions of high- and low-volume
|
Study |
Definition high-volume |
Definition low-volume |
|
Anderson (2018) |
≥ 6 adrenalectomies per year per surgeon |
< 6 adrenalectomies per year per surgeon |
|
Barac Nekic (2022) |
> 20 adrenal surgeries on average per year (2 patients with ACC) by single surgeon (urologist) in the last 10 years |
≤ 20 adrenal surgeries on average per year by a urologist or abdominal surgeon in the last 10 years |
|
Bergamini (2011) |
> 30 laparoscopic adrenalectomies per center |
≤ 30 laparoscopic adrenalectomies per center |
|
Gratian (2014) |
≥ 4 patients with adrenal cortical carcinoma treated per year per center |
< 4 patients with adrenal cortical carcinoma treated per year per center |
|
Gray (2021) |
≥ 6 operations per surgeon in the previous year |
< 6 operations per surgeon in the previous year |
|
Greco (2011) |
Group A: < 10 laparoscopic adrenalectomies per year per center Group B: 10-20 laparoscopic adrenalectomies per year per center Group C: > 20 laparoscopic adrenalectomies per year per center |
|
|
Hermsen (2012) |
Dutch Adrenal Network (DAN) hospital |
Local hospitals and later direction to DAN hospital |
|
Kerkhofs (2013) |
DAN hospital |
Non-DAN hospital |
|
Lombardi (2012) |
≥ 10 new ACC patients per year per center |
< 10 new ACC patients per year per center |
|
MacKinney (2022) |
≥ 15 ACC cases per center over 14 years |
≤ 7 ACC cases per center over 14 years |
Results
Overall Survival
Five studies reported overall survival (OS) (Gratian, 2014; Hermsen, 2012; Kerkhofs, 2013; Lombardi, 2012; MacKinney, 2022).
Gratian (2014) reported median OS of 2.0 years in the high-volume group and 1.9 years in the low-volume group (HR: 0.89 [95%CI 0.70-1.12]). This difference is not clinically relevant.
Hermsen (2012) reported OS of 81 months in the high-volume group and 20 months in the low-volume group. This difference is clinically relevant.
The HR for surgery in a DAN hospital compared with no surgery on overall survival was 1.74 (95%CI 1.34-2.26). The overall survival data is partially overlapping with the overall survival data of Kerkhofs (2013).
Kerkhofs (2013) reported 1-year survival of 93% in the high-volume group and 78% in the low-volume group. The 5-year survival was 63% in the high-volume group and 42% in the low-volume group. This difference is clinically relevant.
The HR for surgery at DAN hospital compared with no surgery on overall survival was 1.96 (95%CI 1.01-3.81). The overall survival data is partially overlapping with the overall survival data of Hermsen (2012).
Lombardi (2012) reported mean OS of 63 months in the high-volume group and 32 months in the low-volume group. The 5-year OS rate in the high-volume group was 52.9% and in the low-volume group 44.4%. This difference is clinically relevant.
MacKinney (2022) reported survival in subgroups for metastatic and non-metastatic ACC. In the metastatic group, survival of the high-volume compared to the low-volume group resulted in a HR 0.74 (95%CI 0.64-0.86), favouring the high-volume group. This difference is clinically relevant. In the non-metastatic group, survival of high-volume compared to low-volume group resulted in HR 0.92 (95%CI 0.81-1.05), favouring the high-volume group.
Because of the heterogeneity of the studies and because some studies did not correct for possible confounders, data was not pooled.
Disease-free survival
Three studies reported disease-free survival (Barac Nekic, 2022; Hermsen, 2012; Lombardi, 2012).
Barac Nekic (2022) reported disease recurrence rate and recurrence free survival. In the high-volume group, eight of thirty-five patients (22.9%) had a recurrence and in the low-volume group eight of fourteen patients (57.1%) had a recurrence. The HR for recurrence-free was 4.55 (95%CI 1.16-17.88), favouring the high-volume group. This difference is clinically relevant.
Hermsen (2012) reported mean recurrence free survival of 69 months in the high-volume group and 22 months in the low-volume group. This difference is clinically relevant.
Lombardi (2012) reported a mean disease-free survival of 24 months in the high-volume group and 15 months in the low-volume group. The 5-year disease-free survival rate was 31.8% in the high-volume group and 26.5% in the low-volume group. This difference was clinically relevant
Because of the small number of studies, heterogeneity of the studies and because some studies did not correct for possible confounders, data was not pooled.
Progression-free survival
No studies reported progression-free survival.
R0 resection status
Two studies reported R0 resection status (Lombardi, 2012; Hermsen, 2012). Lombardi (2012) reported R0 resection status in 123 patients (68%) in the high-volume and in 70 patients (72%) in the low-volume group (RR 0.94 [95%CI 0.80-1.10]).
Hermsen (2012) reported R0 resection status in 37 patients (66%) who were operated in a DAN hospital and in 19 patients (34%) who were operated in a non-DAN hospital.
Because of the small number of studies, heterogeneity of the studies and because some studies did not correct for possible confounders, data was not pooled.
Postoperative mortality
Two studies reported postoperative mortality (Gratian, 2014; MacKinney, 2022).
Gratian (2014) reported the 30-day postoperative mortality rate. In the high-volume group the 30-day postoperative mortality rate was 1.9% and in the low-volume group 3.7% (RR 0.59 [95%CI 0.29-1.21]). This difference is not clinically relevant.
MacKinney (2022) reported 30-day and 90-day postoperative mortality for metastatic and non-metastatic ACC. In the metastatic group, the 30-day postoperative mortality rate in the high-volume group was 4.1% and in the low-volume group 4.3%. This difference is not clinically relevant. The 90-day postoperative mortality rate for the metastatic group was 8.3% in the high-volume group and 20.4% in the low-volume group (HR 0.38 [95%CI 0.17-0.84]). This difference is clinically relevant.
In the non-metastatic group, the 30-day postoperative mortality rate for the high-volume group was 2.3% and for the low-volume group 2.4%. This difference is not clinically relevant. The 90-day postoperative mortality rate for the non-metastatic group was 4.7% in the high-volume group and 4.8% in the low-volume group (HR 1.17 [95%CI 0.73-1.90]). This difference is not clinically relevant.
Because of the small number of studies, heterogeneity of the studies and because some studies did not correct for possible confounders, data was not pooled.
Complications
Three studies reported complications (Anderson, 2018; Bergamini, 2011; Gray, 2021).
Anderson (2018) reported any type of complications for 166 patients (14%) in the high-volume group and for 1212 patients (22%) in the low-volume group (OR 0.58 [95%CI 0.43-0.79]). This difference is not clinically relevant.
Bergamini (2011) reported number of complications, intraoperative complications, postoperative surgery and non-surgery related complications. In total, the number of complications was 33 (4.8%) in the high-volume group and 35 (22%) in the low-volume group. This difference is not clinically relevant. Intraoperative complications were reported in fourteen patients (2%) in the high-volume group and for 14 patients (8.2%) in the low-volume group. Postoperative surgery related complications were reported for eight patients (1.2%) in the high-volume group and for four patients (2.5%) in the low-volume group. Postoperative non-surgery related complications were reported for eleven patients (1.6%) in the high-volume group and for eighteen patients (11.3%) in the low-volume group.
Gray (2021) reported adjusted odds ratios for surgeon volume in the 12 months before the index procedure for major post-procedural complications. The complications had to be recorded during index admission or during emergency readmission within 30 days. The reported odds ratios are stratified for minimally invasive and open surgery. The adjusted Odds Ratio (aOR) for complications according to surgeon volume in minimally invasive surgery is 0.99 (95%CI 0.97-1.02) and in open surgery the aOR is 0.96 (95%CI 0.92-1.00). These differences are not clinically relevant.
Because of the small number of studies, heterogeneity of the studies and because some studies did not correct for possible confounders, data was not pooled.
Costs
One study reported costs (Anderson, 2018). Anderson (2018) reported inflated-adjusted costs for treatment in high-volume center versus low-volume center. Anderson (2018) reported median cost of $9,884 (IQR 6,955-15,246) in the high-volume group and $11,543 (IQR 7,761-19,397) in the low-volume group (OR -26.2 [95%CI -39.9- to -12.6).
Length of stay
Five studies reported length of stay (Anderson, 2018; Gratian, 2014; Gray, 2021; Greco, 2011; MacKinney, 2022).
Anderson (2018) reported a median duration of stay in the high-volume group of three days (IQR 2-6) and six days (IQR 3-9) in the low-volume group. This difference is clinically relevant.
Gratian (2014) reported median length of stay of five days in the high-volume group and five days in the low-volume group. This difference is not clinically relevant.
Gray (2021) reported adjusted odds ratios for surgeon volume in the 12 months before the index procedure for length of stay greater than the upper quartile. The reported odds ratios are stratified for minimally invasive and open surgery. The adjusted Odds Ratio (aOR) for length of stay according to surgeon volume in minimally invasive surgery is 0.99 (95%CI 0.97-1.01) and in open surgery the aOR is 0.98 (95%CI 0.95-1.01). These differences are not clinically relevant.
Greco (2011) reported mean hospital stay for transperitoneal laparoscopic adrenalectomy (LA) and retroperitoneal LA for three groups stratified according to experience. For the transperitoneal LA, group A (< 10 LA) reported mean hospital stay of 7.83 days (2.99 SD), group B (10-20 LA) reported 7.08 days (2.06 SD) and group C (>20 LA) reported 6.98 days (2.06 SD). The differences are not clinically relevant. Regarding the retroperitoneal LA, group A (<10 LA) reported 7.63 days (1.73 SD), group B (10-20 LA) reported 6.21 days (1.66 SD) and group C (>20 LA) reported 6.82 days (1.75 SD). The differences are not clinically relevant.
MacKinney (2022) reported median length of stay for metastatic and non-metastatic ACC. Median length of stay in the metastatic group was six days for the high-volume group and six days for the low-volume group. Median length of stay in the non-metastatic group was five days for the high-volume group and four days for the low-volume group. Regarding both groups, differences were not clinically relevant.
Because of the heterogeneity of the studies and because some studies did not correct for possible confounders, data could was not pooled.
Level of evidence of the literature
The level of evidence of observational cohort studies is considered low according to the GRADE methodology. Therefore, the level of evidence of these cohort studies starts at low GRADE.
Overall survival
The level of evidence regarding the outcome measure overall survival was downgraded by one level because of study limitations (-1; risk of bias regarding adequate follow-up and participant selection). Therefore the evidence was graded as very low.
Disease-free survival
The level of evidence regarding the outcome measure disease-free survival was downgraded by two levels because of study limitations (-1; risk of bias regarding assessment of exposure and selection of participants) and number of included patients (-1; imprecision because of low sample size and small number of events per arm). Therefore the evidence was graded as very low.
Progression-free survival
The level of evidence regarding the outcome measure progression-free survival could not be assessed with GRADE. None of the studies reported the outcome measure progression-free survival.
R0 resection status
The level of evidence regarding the outcome measure R0 resection status was downgraded by one level because of number of included patients (-1; imprecision because of low sample size and small number of events per arm). Therefore the evidence was graded as very low.
Postoperative mortality
The level of evidence regarding the outcome measure postoperative mortality was downgraded by two levels because of study limitations (-1; risk of bias regarding reporting of follow-up) and number of included patients (-1; imprecision because of low sample size and small number of events per arm). Therefore the evidence was graded as very low.
Complications
The level of evidence regarding the outcome measure complications was downgraded by two levels because of study limitations (-1; risk of bias regarding confounding, reporting of follow-up and unknown co-interventions) and number of included patients (-1; imprecision because of low sample size and small number of events per arm). Therefore the evidence was graded at very low.
Costs
The level of evidence regarding the outcome measure costs was downgraded by two levels because of study limitations (-1; risk of bias regarding follow-up and unkown co-interventions) and number of included patients (-1; imprecision because of low sample size). Therefore the evidence was graded at very low.
Length of stay
The level of evidence regarding the outcome measure length of stay was downgraded by two levels because of study limitations (-2; risk of bias regarding selection of participants, confounding, adequate follow-up and unknown co-interventions). Therefore the evidence was graded at very low.
Zoeken en selecteren
A systematic review of the literature was performed to answer the following question:
Is there a benefit of adrenocortical carcinoma (ACC) surgery in a high-volume center when compared to ACC surgery in a low-volume center, for example in regards to overall survival, disease-free survival, progression-free survival, R0 resection, postoperative mortality, complications and length of stay for patients with (suspected) ACC?
|
P (Patients) |
Patients with (suspected) adrenocortical carcinoma (ACC) |
|
I (Intervention) |
Surgical treatment for ACC in a high-volume center |
|
C (Control) |
Treatment for ACC in a low-volume center |
|
O (Outcomes) |
Overall survival, disease-free survival, progression-free survival, R0 resection, postoperative mortality, complications, and length of stay |
Relevant outcome measures
The guideline development group considered overall survival, disease-free survival, and progression-free survival as critical outcome measures for decision making and R0 resection, postoperative mortality, complications, and length of stay as important outcome measures for decision making.
The working group defined the following differences as a minimal clinically (patient) important difference:
Dichotomous outcomes (relative risk, odds ratio):
- Overall survival: Absolute difference >5% or absolute difference >3% and Hazard Ratio (HR) <0.75 (BOM, 2018)
- Disease-free survival: Absolute difference >5%, or absolute difference >3% and HR <0.7 (BOM, 2018)
- Progression-free survival: Absolute difference >5% or absolute difference >3% and Hazard Ratio (HR) <0.7 (BOM, 2018)
- R0 resection: Absolute difference >5% or absolute difference >3% and Hazard Ratio (HR) <0.7
- Postoperative mortality: Absolute difference >5% or absolute difference >3% and Hazard Ratio (HR) <0.7
- Complications: Absolute difference >5% for lethal complications, or >25% for serious complications
Continuous outcomes (mean difference):
- Length of stay: Mean difference > 2 days
Search and select (Methods)
The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms until 1-3-2022. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 283 hits. Studies were selected based on the following criteria:
- The study population had to meet the criteria as defined in the PICO;
- The intervention and comparison had to be as defined in the PICO;
- Reported at least one of the outcomes as defined in the PICO;
- Research type: Systematic review, randomized-controlled trial or other comparative (observational) research;
- Articles written in English or Dutch
Sixteen studies were initially selected based on title and abstract screening. After reading the full text, six studies were excluded (see the table with reasons for exclusion under the tab Methods), and ten studies were included.
Results
Ten studies were included in the analysis of the literature. Important study characteristics and results are summarized in the evidence tables. The assessment of the risk of bias is summarized in the risk of bias tables.
Referenties
- Anderson KL Jr, Thomas SM, Adam MA, Pontius LN, Stang MT, Scheri RP, Roman SA, Sosa JA. Each procedure matters: threshold for surgeon volume to minimize complications and decrease cost associated with adrenalectomy. Surgery. 2018 Jan;163(1):157-164. doi: 10.1016/j.surg.2017.04.028. Epub 2017 Nov 6. PMID: 29122321.
- Barac Nekic A, Knezevic N, Zibar Tomsic K, Kraljevic I, Balasko A, Skoric Polovina T, Solak M, Dusek T, Kastelan D, Croatian Acc Study Group. The Effect of Surgeon Expertise on the Outcome of Patients with Adrenocortical Carcinoma. J Pers Med. 2022 Jan 13;12(1):100. doi: 10.3390/jpm12010100. PMID: 35055415; PMCID: PMC8780290.
- Bergamini C, Martellucci J, Tozzi F, Valeri A. Complications in laparoscopic adrenalectomy: the value of experience. Surg Endosc. 2011 Dec;25(12):3845-51. doi: 10.1007/s00464-011-1804-0. Epub 2011 Jun 17. PMID: 21681621.
- BOM. PASKWIL-criteria 2018: adjuvante behandeling. Available from: https://www.nvmo.org/over-de-adviezen/
- Fassnacht M, Dekkers OM, Else T, Baudin E, Berruti A, de Krijger R, Haak HR, Mihai R, Assie G, Terzolo M. European Society of Endocrinology Clinical Practice Guidelines on the management of adrenocortical carcinoma in adults, in collaboration with the European Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2018 Oct 1;179(4):G1-G46. doi: 10.1530/EJE-18-0608. PMID: 30299884.
- Fassnacht M, Assie G, Baudin E, Eisenhofer G, de la Fouchardiere C, Haak HR, de Krijger R, Porpiglia F, Terzolo M, Berruti A; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Adrenocortical carcinomas and malignant phaeochromocytomas: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020 Nov;31(11):1476-1490. doi: 10.1016/j.annonc.2020.08.2099. Epub 2020 Aug 27. PMID: 32861807.
- Schünemann H, Brozek J, Guyatt G, Oxman A. Introduction to GRADE Handbook. 2013. https://gdt.gradepro.org/app/handbook/handbook.html
- Gratian L, Pura J, Dinan M, Reed S, Scheri R, Roman S, Sosa JA. Treatment patterns and outcomes for patients with adrenocortical carcinoma associated with hospital case volume in the United States. Ann Surg Oncol. 2014 Oct;21(11):3509-14. doi: 10.1245/s10434-014-3931-z. Epub 2014 Jul 29. PMID: 25069860; PMCID: PMC4515350.
- Greco F, Hoda MR, Rassweiler J, Fahlenkamp D, Neisius DA, Kutta A, Thüroff JW, Krause A, Strohmaier WL, Bachmann A, Hertle L, Popken G, Deger S, Doehn C, Jocham D, Loch T, Lahme S, Janitzky V, Gilfrich CP, Klotz T, Kopper B, Rebmann U, Kälbe T, Wetterauer U, Leitenberger A, Rassler J, Kawan F, Inferrera A, Wagner S, Fornara P. Laparoscopic adrenalectomy in urological centres - the experience of the German Laparoscopic Working Group. BJU Int. 2011 Nov;108(10):1646-51. doi: 10.1111/j.1464-410X.2010.10038.x. Epub 2011 Apr 6. PMID: 21470358.
- Hermsen IG, Kerkhofs TM, den Butter G, Kievit J, van Eijck CH, Nieveen van Dijkum EJ, Haak HR; Dutch Adrenal Network. Surgery in adrenocortical carcinoma: Importance of national cooperation and centralized surgery. Surgery. 2012 Jul;152(1):50-6. doi: 10.1016/j.surg.2012.02.005. PMID: 22703895.
- Kerkhofs TM, Verhoeven RH, Bonjer HJ, van Dijkum EJ, Vriens MR, De Vries J, Van Eijck CH, Bonsing BA, Van de Poll-Franse LV, Haak HR; Dutch Adrenal Network. Surgery for adrenocortical carcinoma in The Netherlands: analysis of the national cancer registry data. Eur J Endocrinol. 2013 Jun 7;169(1):83-9. doi: 10.1530/EJE-13-0142. PMID: 23641018.
- Kerkhofs TM, Verhoeven RH, Van der Zwan JM, Dieleman J, Kerstens MN, Links TP, Van de Poll-Franse LV, Haak HR. Adrenocortical carcinoma: a population-based study on incidence and survival in the Netherlands since 1993. Eur J Cancer. 2013 Jul;49(11):2579-86. doi: 10.1016/j.ejca.2013.02.034. Epub 2013 Apr 3. PMID: 23561851.
- Lombardi CP, Raffaelli M, Boniardi M, De Toma G, Marzano LA, Miccoli P, Minni F, Morino M, Pelizzo MR, Pietrabissa A, Renda A, Valeri A, De Crea C, Bellantone R. Adrenocortical carcinoma: effect of hospital volume on patient outcome. Langenbecks Arch Surg. 2012 Feb;397(2):201-7. doi: 10.1007/s00423-011-0866-8. Epub 2011 Nov 9. PMID: 22069043.
- MacKinney EC, Holoubek SA, Khokar AM, Kuchta KM, Moo-Young TA, Prinz RA, Winchester DJ. Treatment differences at high volume centers and low volume centers in non-metastatic and metastatic adrenocortical carcinoma. Am J Surg. 2022 Mar;223(3):582-586. doi: 10.1016/j.amjsurg.2022.01.004. Epub 2022 Jan 20. PMID: 35151433.
- Platform oncologie - SONCOS. Multidisciplinaire normering oncologische zorg in Nederland. Soncos normeringsrapport. 2023; 11.
Evidence tabellen
Evidence table for intervention studies (randomized controlled trials and non-randomized observational studies)
Research question: What is the effect of adrenocortical carcinoma (ACC) surgery performed in a high-volume or expert center when compared to ACC surgery in a different center on overall survival, disease-free survival, progression-free survival, R0 resection, postoperative mortality, complications and length of stay for patients with (suspected) ACC?
|
Study reference |
Study characteristics |
Patient characteristics 2 |
Intervention (I) |
Comparison / control (C) 3
|
Follow-up |
Outcome measures and effect size 4 |
Comments |
|
Anderson, 2018 |
Type of study: Retrospective cohort study
Database and country: Hospital setting, HCUP-NIS database, USA
Funding and conflicts of interest: Not reported |
Inclusion criteria: - Adult patients who underwent adrenalectomy from 1998-2009 in the US
Exclusion criteria: - Patients from Arizona, Colorado, Kentucky, Michigan, Missouri, New Jersey, Oregon, Tennessee and Washington
N total at baseline: Intervention: 1168 Control: 5544
Important prognostic factors2: Median Age in years (IQR): I: 56 (45-67) C: 60 (47-70)
Race, white n: I: 913 (78%) C: 3866 (70%)
Race, black n: I: 80 (7%) C: 629 (11%)
Race, Hispanic n: I: 56 (5%) C: 431 (8%)
Race, other n: I: 56 (5%) C: 261 (5%)
Gender, Female n: I: 602 (52%) C: 2779 (50%)
Charleston Comorbidity score ³ 2, n: I: 395 (34%) C: 2317 (42%)
Primary insurance, Private n: I: 698 (60%) C: 2525 (46%)
Hospital type, nonteaching, n: I: 45 (5%) C: 2196 (40%)
Groups not comparable at baseline
|
Describe intervention: Patients treated by surgeons who performed ³ 6 adrenalectomy cases per year
|
Describe control: Patients treated by surgeons who performed < 6 adrenalectomy cases per year.
|
Length of follow-up: Not reported
Loss-to-follow-up: Not reported
Incomplete outcome data: Not reported
|
Outcome measures and effect size (include 95%CI and p-value if available):
Any complication I: N=166 (14%) C: N=1212 (22%) OR (95%CI) : 0.58 (0.43-0.79)
Inflated-adjusted costs, median (IQR): I: $ 9884 (6955-15246) C: $ 11543 (7761-19397) OR (95%CI): -26.2 (-39.9—12.6)
Duration of stay, median days (IQR): I: 3 (2-6) C: 6 (3-9) RR (95%CI): 0.69 (0.59-0.80) |
Authors conclusion: This study illustrates that patients who undergo adrenalectomy by a high- volume surgeon (≥6 cases/year) were less likely, on average, to experience a complication, have a prolonged hospital duration of stay, and incur greater costs for their treatment compared with if they had the procedure by a low-volume surgeon whose median case volume was just one case annually. This study performed an Restricted Cubic Splines method and bootstrap simulation to estimate the point of annual surgeon volume that corresponds to the maximum change in log OR of a complication. After establishing the volume groups high (³6) versus low (<6), multivariate logistic regression was also used to examine the adjusted association between low- versus high-volume surgeons and the incidence of any postoperative complication.
A priori covariates were identified to adjust for in the regression analysis.
There was no clear definition of length of follow-up in which complications could appear. |
|
Barac Nekic, 2022 |
Type of study: Retrospective cohort study
Database and country: Croatian ACC Registry, Croatia
Funding and conflicts of interest: Research received no external funding and authors declared no conflict of interest |
Inclusion criteria: - Patients with European Network for the Study of Adrenal Tumors (ENSAT) stage I-III ACC - Patients who received adrenal surgery between 2008 and 2020.
Exclusion criteria: No exclusion criteria reported
N total at baseline: Intervention: 35 Control: 14
Important prognostic factors2: Median Age in years (IQR): I: 46 (18-77) C: 56.5 (24-78)
Gender, Female, n: I: 24 (69%) C: 10 (71%)
Median tumor size in mm (IQR): I: 80 (26-176) C: 107.5 (70-250)
ENSAT tumor stage I, n: I: 6 (17%) C: 0 (0%)
ENSAT tumor stage II, n: I: 21 (60%) C: 10 (71%)
ENSAT tumor stage III, n: I: 8 (23%) C: 4 (29%)
Laparoscopic surgery, n: I: 25 (71.4%) C: 4 (28.6%)
Groups not comparable at baseline
|
Describe intervention: Adrenal surgery by a single surgeon who was a urologist in a high-volume center. Centers were considered high-volume if they had an average of > 20 adrenal surgeries per year per surgeon in the last 10 years, of which at least two patients per year had ACC. |
Describe control: Adrenal surgery by a urologist or abdominal surgeon in a low-volume center.
|
Length of follow-up: Median length of follow-up in months (IQR): I: 62 (5-147) C: 61.5 (5-165)
Loss-to-follow-up: I: N=0 (0%) C: N=0 (0%)
Incomplete outcome data: I: N=0 (0%) C: N=0 (0%)
|
Outcome measures and effect size (include 95%CI and p-value if available):
Disease recurrence I: N=8 (22.9%) C: N=8 (57.1%)
Recurrence-free survival HR 4.55 (95%CI 1.16-17.88)
|
Authors conclusion: The results of this study showed that ACC surgery performed in expert centers was associated with a better oncological outcome in terms of lower risk of disease recurrence and a tendency towards improved survival rate. Groups are not comparable at baseline. Patients in the low-volume group had larger tumors (tumor size) and there were less laparoscopic adrenalectomies performed in the low-volume group. There was no clear definition of low-volume surgeries. |
|
Bergamini, 2011 |
Type of study: Prospective cohort study
Database and country: Italian Registry of Endoscopic Surgery-Adrenalectomy (IRES-A), Italy
Funding and conflicts of interest: Researchers reported no conflict of interest to be disclosed and no financial support to be obtained. |
Inclusion criteria: - Patients who were recorded in the IRES-A database from January 2000 until august 2009 - Patients who underwent laparoscopic adrenalectomy - Completion of informed consent
Exclusion criteria: No exclusion criteria reported
N total at baseline: Intervention: 674 Control: 159
Important prognostic factors2: Gender, Female: Total, n: 521 (63%)
No information on group comparability. |
Describe intervention: Laparoscopic adrenalectomy in a referral center with > 30 adrenalectomies. |
Describe control: Laparoscopic adrenalectomy in a non-referral center with £ 30 adrenalectomies. |
Length of follow-up: Not reported
Loss-to-follow-up: Not reported
Incomplete outcome data: Not reported
|
Outcome measures and effect size (include 95%CI and p-value if available):
Number of complications: I: N=33 (4.8%) C: N=35 (22%)
Intraoperative complications: I: N=14 (2%) C: N=13 (8.2%)
Postoperative surgery-related complications: I: N=8 (1.2%) C: N=4 (2.5%)
Postoperative nonsurgery-related complications: I: N=11 (1.6%) C: N=18 (11.3%) |
Authors conclusion: The opinion of these authors is that the inexperience of a surgeon may be a relevant factor in the occurrence of these adverse events. The main risk factors, for the occurrence of complications during laparoscopic adrenalectomy appear to be surgical inexperience, the age and BMI of the patient, the dimension of the mass, and pheochromocytoma. There are no baseline characteristics for the subgroups referral and non-referral center.
There was no exact definition of the timeframe in which the number of adrenalectomies had to be performed to be a referral or non-referral center. |
|
Gratian, 2014 |
Type of study: Retrospective cohort study
Database and country: National Cancer Data Base, United States
Funding and conflicts of interest: Not reported |
Inclusion criteria: - Patients with ACC (ICD-O-2/3 for site C74.0-C74.9 and histology 8370.3) who were recorded from the National Cancer Data Base (NCDB) between 1998 and 2011 - Patients had no other primary malignancies
Exclusion criteria: No exclusion criteria reported
N total at baseline: Intervention: 411 Control: 2354
Important prognostic factors2: Median Age in years (Q1, Q3): I: 50 (41, 60) C: 54 (43, 65)
Gender, Female, n: I: 236 (57.4%) C: 1410 (59.9%)
Median tumor size in cm (Q1, Q3): I: 11.2 (8.0, 16.0) C: 10.5 (7.1, 15.0)
Charlson/Deyo score ³ 1, n: I: 66 (16%) C: 603 (25.6%)
Groups were not comparable at baseline. |
Describe intervention: Treatment at a high-volume center with an annual case load of ³ 4 cases of primary adrenal malignancies treated per year. |
Describe control: Treatment at a low-volume center with an annual case load of < 4 cases of primary adrenal malignancies treated per year. |
Length of follow-up: At least 5-years for outcome Overall Survival
Loss-to-follow-up: Not reported
Incomplete outcome data: Missing data are <5% except for: Charlson/Deyo score: 30% Income: 6% Distant metastasis: 84% Tumor grade: 77%
|
Outcome measures and effect size (include 95%CI and p-value if available):
Median Overall survival: I: 2.0 years C: 1.9 years HR (95%CI): 0.89 (0.70-1.12)
30-day postoperative mortality I: 1.9% C: 3.7%
Median Length of stay: I: 5 days C: 5 days |
Authors conclusion: This study did not find an association between hospital case volume and OS despite more aggressive surgical and adjuvant therapy at high-volume centers.
Groups were not comparable at baseline. In the high-volume group median tumor size was larger. In the low-volume group median age was higher and patients had more comorbidities (Charlson/Deyo score).
|
|
Greco, 2011 |
Type of study: Prospective cohort study
Database and country: 23 German Urological centers, Germany
Funding and conflicts of interest: No declaration of conflict of interest |
Inclusion criteria: - Patients who underwent a transperitoneal or retroperitoneal laparoscopic adrenalectomy (LA) at participating centres between 2003 and 2009
Exclusion criteria: Not reported
N total at baseline: Group A: 73 Group B: 91 Group C: 199
Important prognostic factors2: Transperitoneal LA: Mean Age in years (SD): Group A: 56.12 (1.98) Group B: 62.24 (12.28) Group C: 54.66 (12.65)
Retroperitoneal LA: Group A: 54.12 (13.32) Group B: 41.71 (13.25) Group C: 56.37 (16.14)
Transperitoneal LA Mean tumor size in cm (SD): Group A: 2.96 (1.78) Group B: 3.46 (1.34) Group C: 3.77 (1.51)
Retroperitoneal LA Mean tumor size in cm (SD): Group A: 2.62 (1.12) Group B: 3.71 (0.91) Group C: 3.98 (1.83)
Groups were not comparable at baseline. |
Describe intervention: Centres were stratified into three groups according to experience: - Group A: < 10 laparoscopic adrenalectomies per year - Group B: 10-20 laparoscopic adrenalectomies per year - Group C: > 20 laparoscopic adrenalectomies per year
Data was also stratified according to the surgical approach (transperitoneal or retroperitoneal) |
Describe control: Not applicable |
Length of follow-up: No follow-up reported
Loss-to-follow-up: Not reported
Incomplete outcome data: Not reported
|
Outcome measures and effect size (include 95%CI and p-value if available):
Mean Hospital stay (SD): Transperitoneal LA Group A: 7.83 days (2.99) Group B: 7.08 days (2.06) Group C: 6.98 days (2.06)
Retroperitoneal LA Group A: 7.63 days (1.73) Group C: 6.82 days (1.75)
|
Authors conclusion: According to the present study, LA for malignant adrenal tumors should be performed only in high-volume centers by a surgeon performing >10 LAs/year. Correlation between tumour size and operating time and duration of stay.
No follow-up or missing data reported.
Only urological departments |
|
Hermsen, 2012 |
Type of study: Retrospective cohort study
Database and country: Dutch Adrenal Network, the Netherlands
Funding and conflicts of interest: Not reported |
Inclusion criteria: - Patients who were operated from 1965 until January 2008 in DAN hospitals and patients who were operated in non-DAN hospitals and later directed to a DAN hospital - Age > 16 years - Histologically confirmed ACC - Patients with stage IV ACC who were not operated
Exclusion criteria: - Not reported
N total at baseline: Intervention: 89 Control: 60
Important prognostic factors2: Median Age in years (range): I: 48.7 (21-79) C: 46.1 (16-71)
Tumor ENSAT stage I at diagnosis: C: N=1 (2%)
Tumor ENSAT stage II at diagnosis: I: N=28 (31.5%) C: N=15 (15%)
Tumor ENSAT stage III at diagnosis: C: N=17 (28%)
Tumor ENSAT stage IV at diagnosis: C: N=27 (45%)
Groups were not comparable at baseline. |
Describe intervention: Surgery or treatment for ACC at a Dutch Adrenal Network (DAN) hospital |
Describe control: Surgery or treatment for ACC in a local hospital and later directed to a DAN hospital. |
Length of follow-up: Median follow-up (range): 25 months (0-451)
Loss-to-follow-up: Not reported
Incomplete outcome data: Resection status: N=14 (14%)
|
Outcome measures and effect size (include 95%CI and p-value if available):
Overall survival (local hospital versus DAN hospital): I: 81 months C: 20 months
Multivariate analysis of Surgery at DAN hospital on overall surviva: HR (95%CI): 1.74 (1.34-2.26)
Recurrence-free survival: I: 69 months (range 36-102) C: 22 months (range 0-50) |
Authors conclusion: Treatment in specialized centers offering multidisciplinary approach is beneficial to patients with ACC, because improved survival was observed in patients initially operated within DAN hospitals compared with patients treated in non-DAN hospitals.
The database only contains patients who have been treated in a DAN center at any time during course of their disease. Patients with ENSAT tumor stage IV who did not undergo an operation were also included
|
|
Kerkhofs, 2013 |
Type of study: Retrospective cohort study
Database and country: Netherlands Cancer Registry, the Netherlands
Funding and conflicts of interest: The authors declare no conflict of interest. This research did not receive any specific grant from any funding agency in the public, commercial or not-for-profit sector
|
Inclusion criteria: - Adults who were diagnosed with ACC between 1st January 1999 and 31st December 2008 - Primary surgery in a Dutch Adrenal Network (DAN) hospital or non-DAN hospital
Exclusion criteria: - Pediatric patients
N total at baseline: Intervention: 70 Control: 54
Important prognostic factors2: Median Age in years (range): I: 52 (22-74) C: 57 (28-80)
Gender, Female, n: I: 44 (63%) C: 29 (54%)
Tumor ENSAT stage I-II: C: N=26 (48%)
Tumor ENSAT stage III: I: N=11 (16%) C: N=11 (20%)
Tumor ENSAT stage IV: C: N=9 (17%)
Groups were not comparable at baseline. |
Describe intervention: Primary surgery in a DAN hospital |
Describe control: Primary surgery in a non-DAN hospital |
Length of follow-up: At least 1 year
Loss-to-follow-up: Surgery unspecified: N=15
Incomplete outcome data: I: N=24 (34%) C: N=17 (32%) Reasons: Stage IV ACC was left out of the Cox model because clinically these patients belong to a different category. Only palliative treatment is possible for these patients, therefore the influence of the covariate ‘surgery’ is not expected to be constant in time or comparable in subgroups.
|
Outcome measures and effect size (include 95%CI and p-value if available):
Median survival (95%CI): I: Not reported C: 49 months (24-75)
1-year survival: I: 93% C: 78%
5-year survival: I: 63% C: 42%
Overall survival (non-DAN hospital versus DAN hospital): HR (95%CI): 1.96 (1.01-3.81) |
Authors conclusion: The results of our population-based study confirm that surgical removal of the primary tumor in a DAN hospital is associated with a survival benefit compared with primary surgery in a non-DAN hospital for patients with local or locally advanced ACC. Only survival data for ENSAT stage I-III ACC.
The study included surgical and non-surgical patients |
|
Lombardi, 2012 |
Type of study: Multi-institutional survey
Database and country: Multi-institutional survey data, Italy
Funding and conflicts of interest: No conflict of interest. Funding not reported. |
Inclusion criteria: - Patients with surgical treatment for ACC between December 2003 and July 2010
Exclusion criteria: Not reported
N total at baseline: Intervention: 181 Control: 97
Important prognostic factors2: Median Age in years (range): I: 49.2 (10-81) C: 50.2 (10-81)
Gender, Female, n: I: 109 (60%) C: 56 (57%)
Median tumor size in mm (range): I: 104.1 (30-340) C: 82.8 (30-200)
Tumor ENSAT stage I: C: N=11 (11%)
Tumor ENSAT stage II: C: N=43 (44%)
Tumor ENSAT stage III: I: N=43 (24%) C: N=23 (24%)
Tumor ENSAT stage IV: C: N=14 (14%)
Adjuvant therapy, mitotane: I: N=23 (13%) C: N=3 (3%)
Adjuvant therapy, polychemotherapy (PCT): I: N=10 (6%) C: N=9 (9%) Adjuvant therapy, mitotane + PCT: I: N=24 (13%) C: N=1 (1%)
Groups were not comparable at baseline. |
Describe intervention: Treatment in a high-volume center with an annual case load of ³ 10 ACC patients per center |
Describe control: Treatment in a low-volume center with an annual case load of < 10 ACC patients per center |
Length of follow-up: Mean follow-up time (SD): C: 30.5 months (30.4)
Loss-to-follow-up: I: N=33 (18%) C: N=16 (16%) Reasons (describe): Not reported
Incomplete outcome data: Number of missing cases with follow-up data is reported at loss-to-follow-up.
|
Outcome measures and effect size (include 95%CI and p-value if available):
Mean overall survival: I: 63 months C: 32 months
5-year overall survival rate: I: 52.9% C: 44.4%
Mean disease-free survival: I: 24 months C: 15 months
5-year disease-free survival rate: I: 31.8% C: 26.5%
Resection status R0: I: N=123 (68%) C: N=70 (72%)
|
Authors conclusion: Patients that underwent surgery at HVC experienced a better oncologic outcome, with a significantly longer time to recurrence and a lower rate of local recurrence observed. Only univariate analysis for outcomes
Rate of patients with adjuvant therapy and laparoscopic resection were significantly higher in HVC group compared to LVC group. |
|
MacKinney, 2022 |
Type of study: Retrospective cohort study
Database and country: National Cancer Data Base, United States
Funding and conflicts of interest: This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors. Authors have no related conflicts of interest to declare. |
Inclusion criteria: - Patients in the National Cancer Data Base diagnosed with ACC using Primary Site code C74.X and histology codes 8010, 8140 or 8370 between 2004 and 2017
Exclusion criteria: - Patients treated at more than one reporting facility - Patients receiving palliative surgery - Age < 18 years - Patients from centers with a mid-range volume
N total at baseline: Intervention: 1053 Control: 1988
Important prognostic factors2: Non-metastatic group: Mean Age in years (SD): I: 53 (15) C: 58 (16)
Gender, Female, n: I: 416 (57.4%) C: 748 (60.9%)
Charlson Comorbidity Index, 0: I: N=569 (78.5%) C: N=843 (68.6%)
Charlson Comorbidity Index, 1: I: N=111 (15.3%) C: N=276 (22.5%)
Charlson Comorbidity Index, ³ 2: I: N=45 (6.2%) C: N=110 (9%)
Tumor size <5.0 cm: I: N=81 (11.2%) C: N=173 (14.1%)
Tumor size 5.0-9.9 cm: I: N=241 (33.2%) C: N=436 (35.5%)
Tumor size ³ 10.0 cm: I: N=350 (48.3%) C: N=503 (40.9%)
Metastatic group: Mean Age in years (SD): I: 52 (16) C: 58 (15)
Gender, Female, n: I: 193 (58.8%) C: 391 (56.7%)
Charlson Comorbidity Index, 0: I: N=238 (72.6%) C: N=483 (70.1%)
Charlson Comorbidity Index, 1: I: N=61 (18.6%) C: N=131 (19.0%)
Charlson Comorbidity Index, ³ 2: I: N=29 (8.8%) C: N=29 (4.2%)
Tumor size <5.0 cm: I: N=25 (7.6%) C: N=62 (9.0%)
Tumor size 5.0-9.9 cm: I: N=67 (20.4%) C: N=185 (26.9%)
Tumor size ³ 10.0 cm: I: N=175 (53.4%) C: N=296 (43%)
Groups were not comparable at baseline. |
Describe intervention: Patients treated in a high-volume center with ³15 ACC cases from the 2004-2017 time period |
Describe control: Patients treated in a low-volume center with £7 ACC cases from the 2004-2017 time period |
Length of follow-up: Not reported
Loss-to-follow-up: Not reported
Incomplete outcome data: Not reported
|
Outcome measures and effect size (include 95%CI and p-value if available):
Survival – non metastatic group: HR (95%CI): 0.92 (0.81-1.05)
Survival – metastatic group: HR: (95%CI): 0.74 (0.64-0.86)
30-day mortality – non metastatic group: C: N=22 (2.4%)
30-day mortality – metastatic group: C: N=6 (4.3%)
90-day mortality – non metastatic group: I: N=29 (4.7%) C: N=42 (4.8%)
90-day mortality – metastatic group: I: N=10 (8.3%) C: N=28 (20.4%)
Median Length of stay (Q1-Q3) – non metastatic group: C: 4 days (2-7)
Median Length of stay (Q1-Q3) – metastatic group: C: 6 days (3-8)
|
Authors conclusion: NM-ACC having surgery at HVCs and LVCs had similar OS. M-ACC at HVCs had improved OS and 90-day mortality. It may be more important with regards to outcomes for a patient with M-ACC to be treated at a HVC than a patient with NM-ACC. No length of follow-up or missing data reported.
Patients in HVC were more likely to get surgery than patients in LVC. |
Risk of bias table for cohort studies
Research question: What is the effect of adrenocortical carcinoma (ACC) surgery performed in a high-volume or expert center when compared to ACC surgery in a different center on overall survival, disease-free survival, progression-free survival, R0 resection, postoperative mortality, complications and length of stay for patients with (suspected) ACC?
|
Author, year |
Selection of participants
Was selection of exposed and non-exposed cohorts drawn from the same population?
|
Exposure
Can we be confident in the assessment of exposure?
|
Outcome of interest
Can we be confident that the outcome of interest was not present at start of study?
|
Confounding-assessment
Can we be confident in the assessment of confounding factors?
|
Confounding-analysis
Did the study match exposed and unexposed for all variables that are associated with the outcome of interest or did the statistical analysis adjust for these confounding variables?
|
Assessment of outcome
Can we be confident in the assessment of outcome?
|
Follow up
Was the follow up of cohorts adequate? In particular, was outcome data complete or imputed?
|
Co-interventions
Were co-interventions similar between groups?
|
Overall Risk of bias
|
|
Definitely yes, probably yes, probably no, definitely no |
Definitely yes, probably yes, probably no, definitely no |
Definitely yes, probably yes, probably no, definitely no |
Definitely yes, probably yes, probably no, definitely no |
Definitely yes, probably yes, probably no, definitely no |
Definitely yes, probably yes, probably no, definitely no |
Definitely yes, probably yes, probably no, definitely no |
Definitely yes, probably yes, probably no, definitely no |
Low, Some concerns, High |
|
|
Anderson, 2018 |
Definitely yes
Reason: Participants were selected from the NIS dataset |
Probably yes
Reason: Definition of high- and low-volume was obtained from own data using logistic regression with Restricted Cubic Splines |
Probably yes
Reason: Outcome data were obtained from the registry |
Probably yes
Reason: Confouding factors were described and obtained from the dataset. |
Probably yes
Reason: A priori covariates were defined. There was adjustment for covariates in the multivariate logistic regression |
Definetly yes
Reason: Outcomes were defined according to ICD-9 diagnoses and procedure codes |
Probably no
Reason: Follow up period was not specified or reported |
No information
Reason: No information regarding type of surgery or other co-interventions
|
Some concerns (regarding follow-up and co-interventions) |
|
Barac Nekic, 2022 |
Definitely yes
Reason: Participants were drawn from the Croatian ACC registry
|
Probably no
Reason: No clear definition of low-volume surgeries
|
Probably yes
Reason: Outcome data were obtained from the registry
|
Probably yes
Reason: Confouding factors were described and obtained from the dataset.
|
Probably yes
Reason: Regarding outcome recurrence-free survival there was adjustment for confounding factors
|
Definetly yes
Reason: Clear definition regarding recurrence-free survival
|
Probably yes
Reason: Follow-up period was specified, no missing data reported.
|
Probably no
Reason: Co-intervention adjuvant therapy is reported but not similar between groups (60% vs. 42.9%) and no correction in multivariate analysis
|
Some concerns (regarding assessment of exposure and co-interventions) |
|
Bergamini, 2011 |
Definitely yes
Reason: Participants were drawn from the IRES-A registry
|
Probably yes
Reason: Clear definition regarding referral and non-referral centers
|
Probably yes
Reason: Outcome data were obtained from the registry
|
Probably no
Reason: Confounding factors were not specified or described, no baseline characteristich for subgroups referral and non-referral
|
Probably no
Reason: There was no (statistical) adjustment for confounding factors
|
Probably yes
Reason: Clear definitions of outcomes (complications)
|
Probably no
Reason: Follow up period was not specified or reported
|
Probably no
Reason: No information regarding type of surgery or other co-interventions
|
High (regarding confounding, follow up and co-interventions)
|
|
Gratian, 2014 |
Definitely yes
Reason: Participant data was drawn from NHS data
|
Probably yes
Reason: Clear definition regarding high- volume surgeons
|
Probably yes
Reason: Outcome data were obtained from the database
|
Probably yes
Reason: Confounding factors were prespecified, obtained from the database.
|
Probably yes
Reason: There was statistical adjustment for confounding factors for the primary and secondary outcomes
|
Definetly yes
Reason: Clear definition outcomes
|
Probably yes
Reason: Follow-up was specified and adequate for outcome (5-year OS). Missing outcome data was imputed
|
No information
Reason: Co-interventions (chemotherapy, radiotherapy) were reported but not clear if there was adjustment for these factors in multivariate analysis
|
Some concerns (regarding co-interventions)
|
|
Gray, 2021 |
Probably no
Reason: Participant data was drawn from National Cancer Data Base but no clear in- and exclusion criteria and no characteristics available for high- and low-volume surgical group
|
Probably yes
Reason: Clear definition regarding high- and low-volume centers
|
Probably yes
Reason: Outcome data were obtained from the database
|
Probably yes
Reason: Confounding factors (baseline characteristics) were described and obtained from the data base
|
Probably yes
Reason: There was statistical adjustment for confounding factors for the primary outcome
|
Definetly yes
Reason: Clear definition of primary outcome (overall survival)
|
Probably no
Reason: Follow up period was not specified or reported
|
No information
Reason: No information
|
Some concerns (participant selection and follow-up)
|
|
Greco, 2011 |
Probably no
Reason: Database with data from questionnaires of 23 urological departments (only urological) |
Probably yes
Reason: Clear definition regarding experience of laparoscopic adrenalectomies
|
Probably yes
Reason: Outcome data were obtained from the questionnaires
|
Probably yes
Reason: Confounding factors (baseline characteristics) were described and obtained from the questionnaires
|
Probably no
Reason: There was no statistical adjustment for confounding factors
|
Probably yes
Reason: No exact definition of primary outcome measure (hospital stay)
|
Probably no
Reason: There was no follow-up period specified. Missing or incomplete data were not reported
|
Probably no
Reason: Regarding the outcome hospital stay relevant co-interventions were reported (but no statistical adjustment in analysis) for difference in treatment groups
|
High (regarding selection of participants, confoundin, follow-up and co-interventions)
|
|
Hermsen, 2012 |
Definitely no
Reason: The database only contains patients who have been treated in a DAN center at any time during course of disease
|
Probably yes
Reason: Clear definition of DAN or non-DAN hospitals
|
Probably yes
Reason: Outcome data were obtained from the database
|
Probably yes
Reason: Confounding factors (baseline characteristics) were described and obtained from database
|
Probably yes
Reason: There was statistical adjustment for confounding factors for the primary outcome
|
Probably yes
Reason: No exact definition of primary outcome (overall survival)
|
Probably yes
Reason: Follow-up period was specified and adequate for primary outcome (overall survival). Only incomplete outcome data for resection status reported
|
Probably yes
Reason: Relevant co-interventions (adjuvant therapy) were reported, not clear if co-interventions are similar between groups
|
Some concerns (regarding participant selection and co-interventions)
|
|
Kerkhofs, 2013 |
Probably yes
Reason: Netherlands Cancer Registry database
|
Probably yes
Reason: Clear definition of DAN or non-DAN hospitals
|
Probably yes
Reason: Outcome data were obtained from the database
|
Probably yes
Reason: Confounding factors (baseline characteristics) were described and obtained from database
|
Probably yes
Reason: There was statistical adjustment for confounding factors
|
Probably yes
Reason: No exact definition of primary outcome (overall survival)
|
Probably yes
Reason: Follow-up period was specified and adequate for primary outcome (overall survival). Loss-to-follow-up data was reported
|
No information
Reason: No information regarding relevant co-interventions (adjuvant therapy, non-surgery) or similarity in treatment groups
|
Some concerns (regarding co-interventions) |
|
Lombardi, 2012 |
Probably yes
Reason: Multi-institutional survey data
|
Probably yes
Reason: Clear definition of high- and low-volume centers
|
Probably yes
Reason: Outcome data were obtained from the database
|
Probably yes
Reason: Confounding factors (baseline characteristics) were described and obtained from database
|
Probably yes
Reason: There was statistical adjustment for confounding factors
|
Definetly yes
Reason: Clear definition of primary outcome (overall survival)
|
Probably yes
Reason: Follow-up period was specified and adequate for primary outcome (overall survival). Loss-to-follow-up data was reported
|
Probably no
Reason: Co-interventions (laparoscopic resection and adjuvant therapy) were significantly different between treatment groups.
|
Some concerns (regarding co-interventions)
|
|
MacKinney, 2022 |
Probably yes
Reason: Participant data was drawn from National Cancer Data Base
|
Probably yes
Reason: Clear definition of high- and low-volume centers |
Probably yes
Reason: Outcome data were obtained from the database
|
Probably yes
Reason: Confounding factors (baseline characteristics) were described and obtained from database
|
Probably yes
Reason: There was statistical adjustment for confounding factors
|
Probably yes
Reason: No exact definition of primary outcome (survival)
|
Probably no
Reason: No length of follow-up or handling of missing data were reported
|
Probably no
Reason: Co-interventions (surgery and adjuvant therapy) were significantly different between treatment groups.
|
Some concerns (regarding follow-up and co-interventions |
Table of excluded studies
|
Reference |
Reason for exclusion |
|
Langenhuijsen J, Birtle A, Klatte T, Porpiglia F, Timsit MO. Surgical Management of Adrenocortical Carcinoma: Impact of Laparoscopic Approach, Lymphadenectomy, and Surgical Volume on Outcomes-A Systematic Review and Meta-analysis of the Current Literature. Eur Urol Focus. 2016 Feb;1(3):241-250. doi: 10.1016/j.euf.2015.12.001. Epub 2015 Dec 24. Erratum in: Eur Urol Focus. 2018 Apr;4(3):461. PMID: 28723392.
|
Separate studies from systematic review were included |
|
Palazzo F, Dickinson A, Phillips B, Sahdev A, Bliss R, Rasheed A, Krukowski Z, Newell-Price J. Adrenal surgery in England: better outcomes in high-volume practices. Clin Endocrinol (Oxf). 2016 Jul;85(1):17-20. doi: 10.1111/cen.13021. Epub 2016 Feb 15. PMID: 26776382.
|
Same database was used as included study (Gray, 2021) |
|
Al-Qurayshi Z, Robins R, Buell J, Kandil E. Surgeon volume impact on outcomes and cost of adrenal surgeries. Eur J Surg Oncol. 2016 Oct;42(10):1483-90. doi: 10.1016/j.ejso.2016.06.392. Epub 2016 Jun 23. PMID: 27378161.
|
Same database was used as included study (Anderson, 2018) |
|
Park HS, Roman SA, Sosa JA. Outcomes from 3144 adrenalectomies in the United States: which matters more, surgeon volume or specialty? Arch Surg. 2009 Nov;144(11):1060-7. doi: 10.1001/archsurg.2009.191. PMID: 19917944.
|
Same database was used as included study (Anderson, 2018) |
|
Hauch A, Al-Qurayshi Z, Kandil E. Factors associated with higher risk of complications after adrenal surgery. Ann Surg Oncol. 2015 Jan;22(1):103-10. doi: 10.1245/s10434-014-3750-2. Epub 2014 May 3. PMID: 24793341.
|
Same database was used as included study (Anderson, 2018) |
|
Fassnacht M, Johanssen S, Fenske W, Weismann D, Agha A, Beuschlein F, Führer D, Jurowich C, Quinkler M, Petersenn S, Spahn M, Hahner S, Allolio B; German ACC Registry Group. Improved survival in patients with stage II adrenocortical carcinoma followed up prospectively by specialized centers. J Clin Endocrinol Metab. 2010 Nov;95(11):4925-32. doi: 10.1210/jc.2010-0803. Epub 2010 Jul 28. PMID: 20668036.
|
No specific comparison between care in high- and low-volume centers |
Verantwoording
Autorisatiedatum en geldigheid
Laatst beoordeeld : 07-05-2024
Laatst geautoriseerd : 07-05-2024
Geplande herbeoordeling : 01-01-2025
Algemene gegevens
De ontwikkeling/herziening van deze richtlijnmodule werd ondersteund door het Kennisinstituut van de Federatie Medisch Specialisten www.demedischspecialist.nl/kennisinstituut) en werd gefinancierd uit de Kwaliteitsgelden Medisch Specialisten (SKMS). De financier heeft geen enkele invloed gehad op de inhoud van de richtlijnmodule.
Samenstelling werkgroep
Voor het ontwikkelen van de richtlijnmodule is in 2021 een multidisciplinaire werkgroep ingesteld, bestaande uit vertegenwoordigers van alle relevante specialismen en patiëntvertegenwoordigers (zie hiervoor de Samenstelling van de werkgroep) die betrokken zijn bij de zorg voor patiënten met bijniertumoren.
Werkgroep
- Prof. dr. M.R. (Menno) Vriens, endocrien oncologisch chirurg, werkzaam in het UMC Utrecht te Utrecht, NVvH (voorzitter)
- Prof. dr. S. (Schelto) Kruijff, endocrien oncologisch chirurg, werkzaam in het UMCG te Groningen, NVvH (voorzitter)
- Prof. dr. R.A. (Richard) Feelders, internist-endocrinoloog, werkzaam in het Erasmus MC te Rotterdam, NIV
- Prof. dr. H.R. (Harm) Haak, internist, werkzaam in het Máxima MC te Eindhoven, NIV
- Drs. J.F. (Julia) Heusdens, anesthesioloog, werkzaam in het UMC Utrecht te Utrecht, NVA
- Prof. dr. R.R. (Ronald) de Krijger, patholoog, werkzaam in het UMC Utrecht/Prinses Máxima Centrum te Utrecht, NVVP
- Drs. J. (Jeroen) Vister, radioloog, werkzaam in het Universitair Medisch Centrum Groningen te Groningen, NVvR
- Dr. M.R. (Max) Dahele, radiotherapeut-oncoloog, werkzaam in het Amsterdam UMC te Amsterdam, NVRO
- Dr. J.F. (Hans) Langenhuijsen, uroloog, werkzaam in het Radboudumc te Nijmegen, NVU
- Dr. B.P.M. (Bernadette) van Nesselrooij, klinisch geneticus, werkzaam in het UMC Utrecht te Utrecht, VKGN
- J.G. (Johan) Beun, manager/coördinator BijnierNET, BijnierNET
- D.D. (Diana) Kwast-Hoekstra, MScN.RN. Verplegingswetenschapper en patientvertegenwoordiger, Bijniervereniging NVACP (tot 31-12-2022)
- Drs. N.T.M. (Nick) van der Meij, verpleegkundig specialist, werkzaam in het UMC Utrecht, te Utrecht, LWEV
Met ondersteuning van
- dr. A. (Anja) van der Hout, adviseur, Kennisinstituut van de Federatie Medisch Specialisten
- drs. S. (Sarah) van Duijn, adviseur, Kennisinstituut van de Federatie Medisch Specialisten
- drs. M. (Miriam) te Lintel Hekkert, adviseur, Kennisinstituut van de Federatie Medisch Specialisten
- drs. I. (Ingeborg) van Dusseldorp, medisch informatiespecialist, Kennisinstituut van de Federatie Medisch Specialisten
Belangenverklaringen
De Code ter voorkoming van oneigenlijke beïnvloeding door belangenverstrengeling is gevolgd. Alle werkgroepleden hebben schriftelijk verklaard of zij in de laatste drie jaar directe financiële belangen (betrekking bij een commercieel bedrijf, persoonlijke financiële belangen, onderzoeksfinanciering) of indirecte belangen (persoonlijke relaties, reputatiemanagement) hebben gehad. Gedurende de ontwikkeling of herziening van een module worden wijzigingen in belangen aan de voorzitter doorgegeven. De belangenverklaring wordt opnieuw bevestigd tijdens de commentaarfase.
Een overzicht van de belangen van werkgroepleden en het oordeel over het omgaan met eventuele belangen vindt u in onderstaande tabel. De ondertekende belangenverklaringen zijn op te vragen bij het secretariaat van het Kennisinstituut van de Federatie Medisch Specialisten.
|
Werkgroeplid |
Functie |
Nevenfuncties |
Gemelde belangen |
Ondernomen actie |
|
Vriens (voorzitter) |
Chirurg UMC Utrecht |
Bestuurslid NVvH (tot mei 2021) |
Geen |
Geen restricties |
|
Kruijff (voorzitter) |
Endocrien chirurg UMCG Groningen |
Geen |
Geen |
Geen restricties |
|
Feelders |
- Professor -internist-endocrinoloog Erasmus MC - Adjunct Professor of Medicine New York University U.S.A. |
- Medisch adviseur NVCAP, onbetaald - Bestuurslid Dutch Adrenal Network, onbetaald - Consultant Recordati, betaald |
Geen |
Geen restricties |
|
Beun |
Coordinator van de Stichting BijnierNET, parttime |
Geen |
Geen |
Geen restricties |
|
Langenhuijsen |
Uroloog Radboudumc, Niijmegen |
Bestuurslid Radboudumc Expertisecentrum Bijnierziekten Voorzitter eUROGEN WS 3 Rare genito-urological cancers en Expertise Area coordinator Adrenal tumours |
ZonMw gefinancieerd onderzoek, DoelmatigheidsOnderzoek "Pentixafor PET/CT vs veneuze bijniervenesampling bij subtypering primair hyperaldosteronisme" i..s.m. PentixaPharm GmBH |
Geen restricties |
|
De Krijger |
- Patholoog, UMC Utrecht, 0,2 fte |
- Board member of Perined, Dutch organization supporting perinatal registries (vacatiegeld) - Council Member European Society of Pathology (onbetaald) - International Panel Member of Wilms tumor panel of SIOP Renal Tumor Study Group (onbetaald) - Chair International (European) pediatrie liver tumor panel (PHITT trial) (onbetaald) - Chairmen Dutch/Belgian working group on Pediatrie Pathology (onbetaald) - Associate editor Pediatrie and Developmental Pathology (onbetaald) - Member editorial board Endocrine Pathology (onbetaald) - Member editorial board Virchows Archiv (onbetaald) - Member editorial board Frontiers in Endocrinology (onbetaald) - Editor-in-Chief Cancers, section Pediatrie Oncology (honorarium) - Member editorial board WHO Endocrine and Neuroendocrine Tumors, 5th edition (onbetaald) |
Geen |
Geen restricties |
|
Heusdens |
Anesthesioloog UMC Utrecht
|
Geen |
Geen |
Geen restricties |
|
Haak |
- Internist- endocrinoloog Maxima MC tot 01-09-2023, daarna nul-aanstelling en pensioen - Hoogleraar acute interne geneeskunde MUMC/UM, tot 01-02-2024 |
- Lid algemeen bestuurd BijnierNET - Voorzitter Bijniernetwerk Nederland D.A.N. - Raad van Toezicht Kempenhaeghe, betaald |
Incidenteel grant van HRA
|
Geen restricties |
|
Dahele |
Radiotherapeut/VHD afdeling radiotherapie Amsterdam UMC (locatie VUmc)
|
Geen |
Onderzoek financiering van: Varian Medical Systems (niet gerelateerd aan bijniertumoren) |
Geen restricties |
|
Van Nesselrooij |
Klinisch Genetica, UMC Utrecht (0,8fte)
|
Secretaris van de VKGN (tot 01-01-2023)
|
Geen |
Geen restricties |
|
Kwast (tot 13-12-2022)
|
Bestuurslid Bijniervereniging NVACP te Nijkerk (onbetaald) (tot 13-12-2022) |
Redactielid Bijniervereniging NVACP (onbetaald) (tot 13-12-2022) |
Geen |
Geen restricties |
|
Vister
|
Radioloog, UMCG
|
Geen |
Geen |
Geen restricties |
|
van der Meij
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Verpleegkundig specialist AGZ, UMC Utrecht, afdeling Endocriene oncologie |
Geen |
Geen |
Geen restricties |
Inbreng patiëntenperspectief
Er werd aandacht besteed aan het patiëntenperspectief door Patiëntenfederatie Nederland, BijnierNET, Bijniervereniging NVACP, Nederlandse Federatie van Kankerpatiënten organisaties (NFK), Nierstichting, Nierpatiëntenvereniging Nederland uit te nodigen voor de invitational conference en afgevaardigden van BijnierNET en Bijniervereniging NVACP in de werkgroep. Het verslag van de invitational conference (zie bijlage) is besproken in de werkgroep. De verkregen input is meegenomen bij het opstellen van de uitgangsvragen, de keuze voor de uitkomstmaten en bij het opstellen van de overwegingen. De conceptrichtlijn is tevens voor commentaar voorgelegd aan de patiëntenorganisaties: Bijniervereniging NVACP, Patiëntenfederatie Nederland, BijnierNET, Nederlandse Federatie van Kankerpatiënten organisaties (NFK), Nierstichting, Nierpatiëntenvereniging Nederland, Nederlandse Hypofyse Stichting en de eventueel aangeleverde commentaren zijn bekeken en verwerkt.
Wkkgz & Kwalitatieve raming van mogelijke substantiële financiële gevolgen
Kwalitatieve raming van mogelijke financiële gevolgen in het kader van de Wkkgz
Bij de richtlijn is conform de Wet kwaliteit, klachten en geschillen zorg (Wkkgz) een kwalitatieve raming uitgevoerd of de aanbevelingen mogelijk leiden tot substantiële financiële gevolgen. Bij het uitvoeren van deze beoordeling zijn richtlijnmodules op verschillende domeinen getoetst (zie het stroomschema op de Richtlijnendatabase).
Uit de kwalitatieve raming blijkt dat er waarschijnlijk geen substantiële financiële gevolgen zijn, zie onderstaande tabel.
|
Module |
Uitkomst raming |
Toelichting |
|
Module Diagnostiek morbus Conn |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling niet breed toepasbaar is (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
|
Module Behandeling morbus Conn |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling niet breed toepasbaar is (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
|
Module Behandeling Cushing |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling niet breed toepasbaar is (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
|
Module Behandeling feochromocytoom |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling niet breed toepasbaar is (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
|
Module Expertisecentrum ACC |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling niet breed toepasbaar is (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
|
Module Biopsie bij ongedefinieerde retroperitoneale massa |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling niet breed toepasbaar is (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
|
Module Kenmerken CT-scan incidentaloom |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling niet breed toepasbaar is (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
|
Module Autonome cortisol (hyper)secretie (subklinische Cushing) |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling niet breed toepasbaar is (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
|
Module Behandeling bijniermetastasen |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling niet breed toepasbaar is (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
|
Module Minimaal invasieve chirurgie |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling niet breed toepasbaar is (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
|
Module Genetisch testen en chirurgisch beleid |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling niet breed toepasbaar is (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
|
Module Pathologieverslag |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling niet breed toepasbaar is (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
|
Module Radiologieverslag |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling niet breed toepasbaar is (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
|
Module Follow-up |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling niet breed toepasbaar is (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
|
Module Aandacht bijnierschorsinsufficiëntie |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling niet breed toepasbaar is (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
Werkwijze
AGREE
Deze richtlijnmodule is opgesteld conform de eisen vermeld in het rapport Medisch Specialistische Richtlijnen 2.0 van de adviescommissie Richtlijnen van de Raad Kwaliteit. Dit rapport is gebaseerd op het AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II; Brouwers, 2010).
Knelpuntenanalyse en uitgangsvragen
Tijdens de voorbereidende fase inventariseerde de werkgroep de knelpunten in de zorg voor patiënten met bijniertumoren. Tevens zijn er knelpunten aangedragen door de NVvH, NVU, NOV, NVRO, VKGN, Bijniervereniging NVACP, IKNL, NAPA (vakgroep interne geneeskunde), Belangenvereniging Von Hippel-Lindau via een invitational conference. Een verslag hiervan is opgenomen in de bijlage.
Op basis van de uitkomsten van de knelpuntenanalyse zijn door de werkgroep concept-uitgangsvragen opgesteld en definitief vastgesteld.
Uitkomstmaten
Na het opstellen van de zoekvraag behorende bij de uitgangsvraag inventariseerde de werkgroep welke uitkomstmaten voor de patiënt relevant zijn, waarbij zowel naar gewenste als ongewenste effecten werd gekeken. Hierbij werd een maximum van acht uitkomstmaten gehanteerd. De werkgroep waardeerde deze uitkomstmaten volgens hun relatieve belang bij de besluitvorming rondom aanbevelingen, als cruciaal (kritiek voor de besluitvorming), belangrijk (maar niet cruciaal) en onbelangrijk. Tevens definieerde de werkgroep tenminste voor de cruciale uitkomstmaten welke verschillen zij klinisch (patiënt) relevant vonden.
Methode literatuursamenvatting
Een uitgebreide beschrijving van de strategie voor zoeken en selecteren van literatuur is te vinden onder ‘Zoeken en selecteren’ onder Onderbouwing. Indien mogelijk werd de data uit verschillende studies gepoold in een random-effects model. Review Manager 5.4 werd gebruikt voor de statistische analyses. De beoordeling van de kracht van het wetenschappelijke bewijs wordt hieronder toegelicht.
Beoordelen van de kracht van het wetenschappelijke bewijs
De kracht van het wetenschappelijke bewijs werd bepaald volgens de GRADE-methode. GRADE staat voor ‘Grading Recommendations Assessment, Development and Evaluation’ (zie http://www.gradeworkinggroup.org/). De basisprincipes van de GRADE-methodiek zijn: het benoemen en prioriteren van de klinisch (patiënt) relevante uitkomstmaten, een systematische review per uitkomstmaat en een beoordeling van de bewijskracht per uitkomstmaat op basis van de acht GRADE-domeinen (domeinen voor downgraden: risk of bias, inconsistentie, indirectheid, imprecisie en publicatiebias; domeinen voor upgraden: dosis-effect relatie, groot effect en residuele plausibele confounding).
GRADE onderscheidt vier gradaties voor de kwaliteit van het wetenschappelijk bewijs: hoog, redelijk, laag en zeer laag. Deze gradaties verwijzen naar de mate van zekerheid die er bestaat over de literatuurconclusie, in het bijzonder de mate van zekerheid dat de literatuurconclusie de aanbeveling adequaat ondersteunt (Schünemann, 2013; Hultcrantz, 2017).
|
Definitie |
|
|
Hoog |
|
|
Redelijk |
|
|
Laag |
|
|
Zeer laag |
|
Bij het beoordelen (graderen) van de kracht van het wetenschappelijk bewijs in richtlijnen volgens de GRADE-methodiek spelen grenzen voor klinische besluitvorming een belangrijke rol (Hultcrantz, 2017). Dit zijn de grenzen die bij overschrijding aanleiding zouden geven tot een aanpassing van de aanbeveling. Om de grenzen voor klinische besluitvorming te bepalen moeten alle relevante uitkomstmaten en overwegingen worden meegewogen. De grenzen voor klinische besluitvorming zijn daarmee niet één op één vergelijkbaar met het minimaal klinisch relevant verschil (Minimal Clinically Important Difference, MCID). Met name in situaties waarin een interventie geen belangrijke nadelen heeft en de kosten relatief laag zijn, kan de grens voor klinische besluitvorming met betrekking tot de effectiviteit van de interventie bij een lagere waarde (dichter bij het nuleffect) liggen dan de MCID (Hultcrantz, 2017).
Overwegingen (van bewijs naar aanbeveling)
Om te komen tot een aanbeveling zijn naast (de kwaliteit van) het wetenschappelijke bewijs ook andere aspecten belangrijk en worden meegewogen, zoals aanvullende argumenten uit bijvoorbeeld de biomechanica of fysiologie, waarden en voorkeuren van patiënten, kosten (middelenbeslag), aanvaardbaarheid, haalbaarheid en implementatie. Deze aspecten zijn systematisch vermeld en beoordeeld (gewogen) onder het kopje ‘Overwegingen’ en kunnen (mede) gebaseerd zijn op expert opinion. Hierbij is gebruik gemaakt van een gestructureerd format gebaseerd op het evidence-to-decision framework van de internationale GRADE Working Group (Alonso-Coello, 2016a; Alonso-Coello 2016b). Dit evidence-to-decision framework is een integraal onderdeel van de GRADE methodiek.
De aanbevelingen geven antwoord op de uitgangsvraag en zijn gebaseerd op het beschikbare wetenschappelijke bewijs en de belangrijkste overwegingen en een weging van de gunstige en ongunstige effecten van de relevante interventies. De kracht van het wetenschappelijk bewijs en het gewicht dat door de werkgroep wordt toegekend aan de overwegingen, bepalen samen de sterkte van de aanbeveling. Conform de GRADE-methodiek sluit een lage bewijskracht van conclusies in de systematische literatuuranalyse een sterke aanbeveling niet a priori uit en zijn bij een hoge bewijskracht ook zwakke aanbevelingen mogelijk (Agoritsas, 2017; Neumann, 2016). De sterkte van de aanbeveling wordt altijd bepaald door weging van alle relevante argumenten tezamen. De werkgroep heeft bij elke aanbeveling opgenomen hoe zij tot de richting en sterkte van de aanbeveling zijn gekomen.
In de GRADE-methodiek wordt onderscheid gemaakt tussen sterke en zwakke (of conditionele) aanbevelingen. De sterkte van een aanbeveling verwijst naar de mate van zekerheid dat de voordelen van de interventie opwegen tegen de nadelen (of vice versa), gezien over het hele spectrum van patiënten waarvoor de aanbeveling is bedoeld. De sterkte van een aanbeveling heeft duidelijke implicaties voor patiënten, behandelaars en beleidsmakers (zie onderstaande tabel). Een aanbeveling is geen dictaat, zelfs een sterke aanbeveling gebaseerd op bewijs van hoge kwaliteit (GRADE gradering HOOG) zal niet altijd van toepassing zijn, onder alle mogelijke omstandigheden en voor elke individuele patiënt.
|
Implicaties van sterke en zwakke aanbevelingen voor verschillende richtlijngebruikers |
||
|
|
Sterke aanbeveling |
Zwakke (conditionele) aanbeveling |
|
Voor patiënten |
De meeste patiënten zouden de aanbevolen interventie of aanpak kiezen en slechts een klein aantal niet. |
Een aanzienlijk deel van de patiënten zouden de aanbevolen interventie of aanpak kiezen, maar veel patiënten ook niet. |
|
Voor behandelaars |
De meeste patiënten zouden de aanbevolen interventie of aanpak moeten ontvangen. |
Er zijn meerdere geschikte interventies of aanpakken. De patiënt moet worden ondersteund bij de keuze voor de interventie of aanpak die het beste aansluit bij zijn of haar waarden en voorkeuren. |
|
Voor beleidsmakers |
De aanbevolen interventie of aanpak kan worden gezien als standaardbeleid. |
Beleidsbepaling vereist uitvoerige discussie met betrokkenheid van veel stakeholders. Er is een grotere kans op lokale beleidsverschillen. |
Organisatie van zorg
In de knelpuntenanalyse en bij de ontwikkeling van de richtlijnmodule is expliciet aandacht geweest voor de organisatie van zorg: alle aspecten die randvoorwaardelijk zijn voor het verlenen van zorg (zoals coördinatie, communicatie, (financiële) middelen, mankracht en infrastructuur). Randvoorwaarden die relevant zijn voor het beantwoorden van deze specifieke uitgangsvraag zijn genoemd bij de overwegingen.
Commentaar- en autorisatiefase
De conceptrichtlijnmodule werd aan de betrokken (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd ter commentaar. De commentaren werden verzameld en besproken met de werkgroep. Naar aanleiding van de commentaren werd de conceptrichtlijnmodule aangepast en definitief vastgesteld door de werkgroep. De definitieve richtlijnmodule werd aan de deelnemende (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd voor autorisatie en door hen geautoriseerd dan wel geaccordeerd.
Literatuur
Agoritsas T, Merglen A, Heen AF, Kristiansen A, Neumann I, Brito JP, Brignardello-Petersen R, Alexander PE, Rind DM, Vandvik PO, Guyatt GH. UpToDate adherence to GRADE criteria for strong recommendations: an analytical survey. BMJ Open. 2017 Nov 16;7(11):e018593. doi: 10.1136/bmjopen-2017-018593. PubMed PMID: 29150475; PubMed Central PMCID: PMC5701989.
Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016 Jun 28;353:i2016. doi: 10.1136/bmj.i2016. PubMed PMID: 27353417.
Alonso-Coello P, Oxman AD, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Vandvik PO, Meerpohl J, Guyatt GH, Schünemann HJ; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ. 2016 Jun 30;353:i2089. doi: 10.1136/bmj.i2089. PubMed PMID: 27365494.
Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L; AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010 Dec 14;182(18):E839-42. doi: 10.1503/cmaj.090449. Epub 2010 Jul 5. Review. PubMed PMID: 20603348; PubMed Central PMCID: PMC3001530.
Hultcrantz M, Rind D, Akl EA, Treweek S, Mustafa RA, Iorio A, Alper BS, Meerpohl JJ, Murad MH, Ansari MT, Katikireddi SV, Östlund P, Tranæus S, Christensen R, Gartlehner G, Brozek J, Izcovich A, Schünemann H, Guyatt G. The GRADE Working Group clarifies the construct of certainty of evidence. J Clin Epidemiol. 2017 Jul;87:4-13. doi: 10.1016/j.jclinepi.2017.05.006. Epub 2017 May 18. PubMed PMID: 28529184; PubMed Central PMCID: PMC6542664.
Medisch Specialistische Richtlijnen 2.0 (2012). Adviescommissie Richtlijnen van de Raad Kwalitieit. http://richtlijnendatabase.nl/over_deze_site/over_richtlijnontwikkeling.html
Neumann I, Santesso N, Akl EA, Rind DM, Vandvik PO, Alonso-Coello P, Agoritsas T, Mustafa RA, Alexander PE, Schünemann H, Guyatt GH. A guide for health professionals to interpret and use recommendations in guidelines developed with the GRADE approach. J Clin Epidemiol. 2016 Apr;72:45-55. doi: 10.1016/j.jclinepi.2015.11.017. Epub 2016 Jan 6. Review. PubMed PMID: 26772609.
Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from http://gdt.guidelinedevelopment.org/central_prod/_design/client/handbook/handbook.html.
Zoekverantwoording
Zoekacties zijn opvraagbaar. Neem hiervoor contact op met de Richtlijnendatabase.