- Email: [email protected]
The HubBle trial: a word of caution
Correspondence
strict fiscal discipline is key. Domestic and international power imbalances that contributed to the crisis in human resources for health will not disappear by framing the human resources for health challenge differently. We declare no competing interests.
*Remco van de Pas, Delphin Kolie, Alexandre Delamou, Wim Van Damme, Sara Van Belle [email protected] Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium (RvdP, AD, WVD, SVB); Centre National de Formation et de Recherche en Santé Rurale de Maferinyah, Forécariah, Guinea (DK, AD); and Department of Public Health, Gamal University of Conakry, Conakry, Guinea (AD) 1
2
3
4
5
Mandeville KL, Lagarde M, Hanson K, Mills A. Human resources for health: time to move out of crisis mode. Lancet 2016; 388: 220–22. WHO. United Nations High-Level Commission on Health Employment and Economic Growth. http://www.who.int/hrh/com-heeg/en/ (accessed Oct 13, 2016). Kentikelenis A, King L, McKee M, Stuckler D. The International Monetary Fund and the Ebola outbreak. Lancet Glob Health 2015; 3: e69–70. Jansen C, Codjia L, Cometto G, Yansané ML, Dieleman M. Realizing universal health coverage for maternal health services in the Republic of Guinea: the use of workforce projections to design health labor market interventions. Risk Manag Healthc Policy 2014; 7: 219–32. Kentikelenis A, Stubbs T, King L. IMF conditionality and development policy space, 1985–2014. Rev Int Polit Econ 2016; 23: 543–82.
Authors’ reply We thank Giorgio Cometto and James Campbell, and Remco van de Pas and colleagues for their insightful responses to our Comment.1 Although we all broadly agree on the need to reframe policy discourse on this issue, we disagree on the following points. First, our call for more realistic and nuanced assessments of local health labour markets does not equate to cessation of advocacy for improved health financing. Encouragement of a higher budgetary allocation to health should remain a cornerstone of global health practice. Arguing that a larger portion of limited health budgets should be spent on the health workforce than at present, however, is less useful. As noted in our Comment,1 the health 2994
workforce currently accounts for around one-third of health budgets— the second largest expenditure after pharmaceuticals. 2 Simply calling for more health workers, without consideration of the impact of recurrent salary costs on budgets, is essentially deprioritising other elements of the health system. As Hernandez-Pena and colleagues2 go on to comment in their study: “The dilemma for governments is how much of the funding [for health], which is currently insufficient, should be devoted to its health workforce.” Second, although the development of a discourse on the positive economic benefits of health sector employment is welcome, fiscal constraints on public sector employment will always exist and might fluctuate according to broader macroeconomic and fiscal circumstances. However, evidence on health financing trends cited by Cometto and Campbell indicates that many low-income and lower middleincome countries will continue to face restricted health budgets in the short-term to medium-term.3 Policy makers therefore need pragmatic information on how to maximise the value of currently available funding for human resources for health, alongside continued efforts to expand health coverage. At worst, a disconnect between normative production and health budget realities can lead to many skilled health professional graduates without jobs, as described in Malawi and Guinea;4 a poor investment by any standards. Better intersectoral dialogue as proposed by van de Pas and colleagues, or moving the responsibility of health worker training from ministries of education to ministries of health, could help support a longerterm perspective in this area. KLM founded and volunteers for a nongovernmental organisation, Medic to Medic, which supports health workers in training in Malawi and Uganda. ML, KH, and AM declare no competing interests.
*Kate L Mandeville, Mylène Lagarde, Kara Hanson, Anne Mills [email protected]
Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, WC1H 9SH, United Kingdom 1
2
3
4
Mandeville K, Lagarde M, Hanson K, Mills A. Human resources for health: time to move out of crisis mode. Lancet 2016; 388: 220–22. Hernandez-Pena P, Poullier J, Van Mosseveld C, et al. Health worker remuneration in WHO Member States. Bull World Health Organ 2013; 91: 808–15. Dieleman JL, Templin T, Sadat N, et al. National spending on health by source for 184 countries between 2013 and 2040. Lancet 2016; 387: 2521–35. Mandeville K, Muula A. Child mortality in Malawi. Lancet Glob Health 2016; 4: e445.
The HubBle trial: a word of caution In the HubBle randomised trial, Steven Brown and colleagues (July 23, p 356)1 showed that rubber band ligation (RBL) was more cost-effective than haemorrhoidal artery ligation (HAL), with similar self-reported recurrence for patients with symptomatic internal haemorrhoids. Additionally, patients with RBL resumed daily life more quickly than did those with HAL. Consequently, Brown and colleagues1 speculate that RBL would be preferable to HAL for patients with second-degree and third-degree haemorrhoids. Selection of the procedure, with use of a proctoscope or haemorrhoidectomy, is based on existing evidence and surgeons’ experience and expertise. Selection is also usually independent of the grade of haemorrhoids; however, the grade could affect treatment outcomes. In a Cochrane review,2 no significant difference in recurrence was found between RBL and haemorrhoidectomy for second-degree haemorrhoids (relative risk 1·07 [95% CI 0·94–1·21]), whereas RBL was less effective than was haemorrhoidectomy for third-degree haemorrhoids (1·23 [1·04–1·45]). In a study3 of 701 patients who received RBL and returned for follow-up, the proportion of patients with success were 73·1% for second-degree haemorrhoids and 59·2% for third-degree haemorrhoids. Furthermore, in a 2009 assessment4 of RBL, the proportion of
www.thelancet.com Vol 388 December 17/24/31, 2016
Correspondence
I declare no competing interests.
Tetsuji Fujita [email protected] Department of Surgery, Jikei University School of Medicine, Tokyo 105-8461, Japan 1
2
3
4
5
Brown SR, Tiernan JP, Watson AJ, et al. Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, openlabel, randomised controlled trial. Lancet 2016; 388: 356–64. Shanmugam V, Thaha MA, Rabindranath KS, Campbell KL, Steele RJ, Loudon MA. Rubber band ligation versus excisional haemorrhoidectomy for haemorrhoids. Cochrane Database Syst Rev 2005; 3: CD005034. Iyer VS, Shrier I, Gordon PH. Long-term outcome of rubber band ligation for symptomatic primary and recurrent internal hemorrhoids. Dis Colon Rectum 2004; 47: 1364–70. Forlini A, Manzelli A, Quaresima S, Forlini M. Long-term result after rubber band ligation for haemorrhoids. Int J Colorectal Dis 2009; 24: 1007–10. Giordano P, Overton J, Madeddu F, Zaman S, Gravante G. Transanal hemorrhoidal dearterialization: a systematic review. Dis Colon Rectum 2009; 52V: 1665–71.
I congratulate Steven Brown and colleagues (July 23, p 356)1 for the first study that compares the clinical outcomes and cost-effectiveness of haemorrhoidal artery ligation (HAL) and rubber band ligation (RBL) for the treatment of second-degree and third-degree haemorrhoids. However, considering clinical relevance, I believe their data should be interpreted with caution.
Brown and colleagues 1 argued that repeat RBL is not indicative of recurrence, because RBL is assumed to be a short outpatient procedure with minimal inconvenience; therefore, additional post-hoc analysis was done to investigate the extent to which recurrence differed between an outpatient course of RBL and HAL. 21 (67·7%) of 31 patients from the RBL group who had repeat RBL were reclassified as non-recurrences because they reported being cured or improved at 1 year follow-up from the initial procedure, changing the number of recurrences to 66 (37·5%) of 176 patients in the RBL group, whereas the HAL group remained at 48 (29·8%) of 161 patients (adjusted odds ratio 1·35 [95% CI 0·85–2·15]; p=0·20). In my opinion this analysis is wrong and misleading. The study aimed to follow up patients at 1 year from the original procedure and patients were not followed up beyond that end point of the study. Therefore, any intervention done after the initial procedure would have not reached the required timeframe. Comparison of multiple RBL results that have a follow-up length of less than 12 months with the 12 month follow-up of HAL is illogical and defeats the study objective. Furthermore, if repeat RBL is not considered indicative of failure in the RBL group, the same principle should have been applied to the HAL group and further post-hoc analysis should have been done accordingly. More importantly, the actual number of patients that had further intervention within the 12 month period might not accurately reflect the number needing further intervention. Because patients were reviewed only at 6 weeks and 12 months, I suspect that most patients who received more than one treatment might have already failed at 6 weeks. Likewise, patients who became symptomatic after 6 weeks and required further intervention are likely to not have been treated within the timeframe
www.thelancet.com Vol 388 December 17/24/31, 2016
of 12 months and, therefore, not captured in the analysis. The need for further intervention might be a good surrogate of failure of the initial procedure, but to assess accurately that specific outcome, a longer follow-up or specifically designed study would be needed. I also have concerns about the high proportion of failure in the HAL group. The proportion recurring of 30% for second-degree and third-degree haemorrhoids remains substantially higher than in the available evidence. In a systematic review,2 myself and colleagues reported the results from about 2000 patients with an overall improvement in haemorrhoidal bleeding and prolapse in more than 90% of patients. These results were achieved without use of plication whereas all the patients in the HubBle trial were routinely treated with mucopexy. These findings have been reproduced in subsequent reviews.3,4 A 2015 meta-analysis5 of randomised controlled trials of HAL also showed no significant difference in recurrence between the HAL and control group (odds ratio 1·07 [95% CI 0·83–1·39]; p=0·60). I acknowledge that current evidence is mostly from observational studies and only a few small prospective trials, making the level of evidence low, yet, inadequate or poor quality evidence cannot be ignored; instead, correct interpretation of data and improvement of specific training to ensure optimal treatment is required. I report personal fees from THD UK, outside the submitted work; and I run the only transanal haemorrhoidal dearterialisation training course accredited by the Royal College of Surgeons of England. I have previously been part of the HubBle Study group.
Pasquale Giordano [email protected] Department of Colorectal Surgery, Barts Health NHS Trust, London E11 1NR, UK 1
Brown SR, Tiernan JP, Watson AJ, et al. Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial. Lancet 2016; 388: 356–64.
Shutterstock
patients with 1 year recurrence was 10% for second-degree haemorrhoids and 25% for third-degree haemorrhoids. In a retrospective study5 of 1996 patients who received HAL, investigators found that HAL was more often done for thirddegree haemorrhoids (57·4%) than for second-degree haemorrhoids (36·3%), with acceptable recurrence for both grades of haemorrhoids.5 These findings suggest that RBL is the best indication for second-degree haemorrhoids, whereas HAL might be more feasible than is RBL for large prolapsing haemorrhoids. Subgroup analysis according to the grade of haemorrhoids would be warranted.
2995
strict fiscal discipline is key. Domestic and international power imbalances that contributed to the crisis in human resources for health will not disappear by framing the human resources for health challenge differently. We declare no competing interests.
*Remco van de Pas, Delphin Kolie, Alexandre Delamou, Wim Van Damme, Sara Van Belle [email protected] Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium (RvdP, AD, WVD, SVB); Centre National de Formation et de Recherche en Santé Rurale de Maferinyah, Forécariah, Guinea (DK, AD); and Department of Public Health, Gamal University of Conakry, Conakry, Guinea (AD) 1
2
3
4
5
Mandeville KL, Lagarde M, Hanson K, Mills A. Human resources for health: time to move out of crisis mode. Lancet 2016; 388: 220–22. WHO. United Nations High-Level Commission on Health Employment and Economic Growth. http://www.who.int/hrh/com-heeg/en/ (accessed Oct 13, 2016). Kentikelenis A, King L, McKee M, Stuckler D. The International Monetary Fund and the Ebola outbreak. Lancet Glob Health 2015; 3: e69–70. Jansen C, Codjia L, Cometto G, Yansané ML, Dieleman M. Realizing universal health coverage for maternal health services in the Republic of Guinea: the use of workforce projections to design health labor market interventions. Risk Manag Healthc Policy 2014; 7: 219–32. Kentikelenis A, Stubbs T, King L. IMF conditionality and development policy space, 1985–2014. Rev Int Polit Econ 2016; 23: 543–82.
Authors’ reply We thank Giorgio Cometto and James Campbell, and Remco van de Pas and colleagues for their insightful responses to our Comment.1 Although we all broadly agree on the need to reframe policy discourse on this issue, we disagree on the following points. First, our call for more realistic and nuanced assessments of local health labour markets does not equate to cessation of advocacy for improved health financing. Encouragement of a higher budgetary allocation to health should remain a cornerstone of global health practice. Arguing that a larger portion of limited health budgets should be spent on the health workforce than at present, however, is less useful. As noted in our Comment,1 the health 2994
workforce currently accounts for around one-third of health budgets— the second largest expenditure after pharmaceuticals. 2 Simply calling for more health workers, without consideration of the impact of recurrent salary costs on budgets, is essentially deprioritising other elements of the health system. As Hernandez-Pena and colleagues2 go on to comment in their study: “The dilemma for governments is how much of the funding [for health], which is currently insufficient, should be devoted to its health workforce.” Second, although the development of a discourse on the positive economic benefits of health sector employment is welcome, fiscal constraints on public sector employment will always exist and might fluctuate according to broader macroeconomic and fiscal circumstances. However, evidence on health financing trends cited by Cometto and Campbell indicates that many low-income and lower middleincome countries will continue to face restricted health budgets in the short-term to medium-term.3 Policy makers therefore need pragmatic information on how to maximise the value of currently available funding for human resources for health, alongside continued efforts to expand health coverage. At worst, a disconnect between normative production and health budget realities can lead to many skilled health professional graduates without jobs, as described in Malawi and Guinea;4 a poor investment by any standards. Better intersectoral dialogue as proposed by van de Pas and colleagues, or moving the responsibility of health worker training from ministries of education to ministries of health, could help support a longerterm perspective in this area. KLM founded and volunteers for a nongovernmental organisation, Medic to Medic, which supports health workers in training in Malawi and Uganda. ML, KH, and AM declare no competing interests.
*Kate L Mandeville, Mylène Lagarde, Kara Hanson, Anne Mills [email protected]
Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, WC1H 9SH, United Kingdom 1
2
3
4
Mandeville K, Lagarde M, Hanson K, Mills A. Human resources for health: time to move out of crisis mode. Lancet 2016; 388: 220–22. Hernandez-Pena P, Poullier J, Van Mosseveld C, et al. Health worker remuneration in WHO Member States. Bull World Health Organ 2013; 91: 808–15. Dieleman JL, Templin T, Sadat N, et al. National spending on health by source for 184 countries between 2013 and 2040. Lancet 2016; 387: 2521–35. Mandeville K, Muula A. Child mortality in Malawi. Lancet Glob Health 2016; 4: e445.
The HubBle trial: a word of caution In the HubBle randomised trial, Steven Brown and colleagues (July 23, p 356)1 showed that rubber band ligation (RBL) was more cost-effective than haemorrhoidal artery ligation (HAL), with similar self-reported recurrence for patients with symptomatic internal haemorrhoids. Additionally, patients with RBL resumed daily life more quickly than did those with HAL. Consequently, Brown and colleagues1 speculate that RBL would be preferable to HAL for patients with second-degree and third-degree haemorrhoids. Selection of the procedure, with use of a proctoscope or haemorrhoidectomy, is based on existing evidence and surgeons’ experience and expertise. Selection is also usually independent of the grade of haemorrhoids; however, the grade could affect treatment outcomes. In a Cochrane review,2 no significant difference in recurrence was found between RBL and haemorrhoidectomy for second-degree haemorrhoids (relative risk 1·07 [95% CI 0·94–1·21]), whereas RBL was less effective than was haemorrhoidectomy for third-degree haemorrhoids (1·23 [1·04–1·45]). In a study3 of 701 patients who received RBL and returned for follow-up, the proportion of patients with success were 73·1% for second-degree haemorrhoids and 59·2% for third-degree haemorrhoids. Furthermore, in a 2009 assessment4 of RBL, the proportion of
www.thelancet.com Vol 388 December 17/24/31, 2016
Correspondence
I declare no competing interests.
Tetsuji Fujita [email protected] Department of Surgery, Jikei University School of Medicine, Tokyo 105-8461, Japan 1
2
3
4
5
Brown SR, Tiernan JP, Watson AJ, et al. Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, openlabel, randomised controlled trial. Lancet 2016; 388: 356–64. Shanmugam V, Thaha MA, Rabindranath KS, Campbell KL, Steele RJ, Loudon MA. Rubber band ligation versus excisional haemorrhoidectomy for haemorrhoids. Cochrane Database Syst Rev 2005; 3: CD005034. Iyer VS, Shrier I, Gordon PH. Long-term outcome of rubber band ligation for symptomatic primary and recurrent internal hemorrhoids. Dis Colon Rectum 2004; 47: 1364–70. Forlini A, Manzelli A, Quaresima S, Forlini M. Long-term result after rubber band ligation for haemorrhoids. Int J Colorectal Dis 2009; 24: 1007–10. Giordano P, Overton J, Madeddu F, Zaman S, Gravante G. Transanal hemorrhoidal dearterialization: a systematic review. Dis Colon Rectum 2009; 52V: 1665–71.
I congratulate Steven Brown and colleagues (July 23, p 356)1 for the first study that compares the clinical outcomes and cost-effectiveness of haemorrhoidal artery ligation (HAL) and rubber band ligation (RBL) for the treatment of second-degree and third-degree haemorrhoids. However, considering clinical relevance, I believe their data should be interpreted with caution.
Brown and colleagues 1 argued that repeat RBL is not indicative of recurrence, because RBL is assumed to be a short outpatient procedure with minimal inconvenience; therefore, additional post-hoc analysis was done to investigate the extent to which recurrence differed between an outpatient course of RBL and HAL. 21 (67·7%) of 31 patients from the RBL group who had repeat RBL were reclassified as non-recurrences because they reported being cured or improved at 1 year follow-up from the initial procedure, changing the number of recurrences to 66 (37·5%) of 176 patients in the RBL group, whereas the HAL group remained at 48 (29·8%) of 161 patients (adjusted odds ratio 1·35 [95% CI 0·85–2·15]; p=0·20). In my opinion this analysis is wrong and misleading. The study aimed to follow up patients at 1 year from the original procedure and patients were not followed up beyond that end point of the study. Therefore, any intervention done after the initial procedure would have not reached the required timeframe. Comparison of multiple RBL results that have a follow-up length of less than 12 months with the 12 month follow-up of HAL is illogical and defeats the study objective. Furthermore, if repeat RBL is not considered indicative of failure in the RBL group, the same principle should have been applied to the HAL group and further post-hoc analysis should have been done accordingly. More importantly, the actual number of patients that had further intervention within the 12 month period might not accurately reflect the number needing further intervention. Because patients were reviewed only at 6 weeks and 12 months, I suspect that most patients who received more than one treatment might have already failed at 6 weeks. Likewise, patients who became symptomatic after 6 weeks and required further intervention are likely to not have been treated within the timeframe
www.thelancet.com Vol 388 December 17/24/31, 2016
of 12 months and, therefore, not captured in the analysis. The need for further intervention might be a good surrogate of failure of the initial procedure, but to assess accurately that specific outcome, a longer follow-up or specifically designed study would be needed. I also have concerns about the high proportion of failure in the HAL group. The proportion recurring of 30% for second-degree and third-degree haemorrhoids remains substantially higher than in the available evidence. In a systematic review,2 myself and colleagues reported the results from about 2000 patients with an overall improvement in haemorrhoidal bleeding and prolapse in more than 90% of patients. These results were achieved without use of plication whereas all the patients in the HubBle trial were routinely treated with mucopexy. These findings have been reproduced in subsequent reviews.3,4 A 2015 meta-analysis5 of randomised controlled trials of HAL also showed no significant difference in recurrence between the HAL and control group (odds ratio 1·07 [95% CI 0·83–1·39]; p=0·60). I acknowledge that current evidence is mostly from observational studies and only a few small prospective trials, making the level of evidence low, yet, inadequate or poor quality evidence cannot be ignored; instead, correct interpretation of data and improvement of specific training to ensure optimal treatment is required. I report personal fees from THD UK, outside the submitted work; and I run the only transanal haemorrhoidal dearterialisation training course accredited by the Royal College of Surgeons of England. I have previously been part of the HubBle Study group.
Pasquale Giordano [email protected] Department of Colorectal Surgery, Barts Health NHS Trust, London E11 1NR, UK 1
Brown SR, Tiernan JP, Watson AJ, et al. Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial. Lancet 2016; 388: 356–64.
Shutterstock
patients with 1 year recurrence was 10% for second-degree haemorrhoids and 25% for third-degree haemorrhoids. In a retrospective study5 of 1996 patients who received HAL, investigators found that HAL was more often done for thirddegree haemorrhoids (57·4%) than for second-degree haemorrhoids (36·3%), with acceptable recurrence for both grades of haemorrhoids.5 These findings suggest that RBL is the best indication for second-degree haemorrhoids, whereas HAL might be more feasible than is RBL for large prolapsing haemorrhoids. Subgroup analysis according to the grade of haemorrhoids would be warranted.
2995