- Email: [email protected]
Mental health: needs go beyond RCTs
Correspondence
for example, the perinatal period, in which mind and body are at their most entwined, but also most accessible to change. Although some problems— such as obesity or severe anxiety—will be clear to medical staff, established mental or physical disorders might not present at this time. Often, staff responsible for delivering babies experience concern, confusion, or anxiety about their patient and her family: how are they to know precisely which social, medical, or mental health provision is correct for the pregnant woman and pending offspring? Moreover, the patient’s experience might not be as compartmentalised as the services around her. She could be anxious or afraid yet have somatic symptoms, or physically ill and present with disturbed mood. The authors 1 praise the gold standard of randomised controlled trials (RCT), seeming to suggest that these could eventually answer any question about what to do for a patient in a public health service. However, a clinical judgment of need is not in itself an intervention. What is therefore to be done? Good science can point the way. In the past few decades, many developmental studies have shown links between various perinatal conditions and child health outcomes.2 Even if this knowledge cannot prescribe a proven intervention, it should inform social work, medical, dietetic, 3 and mental health exploration around the time of birth. Reliable predictions can be made that women who are anxious, 4 depressed, frightened, or dependent on drugs will have children who are at increased risk of, for example, depression in their teens, school failure, and social difficulties, as previously described.5 Meanwhile, prevention of excessive weight gain during pregnancy is an example of a complex task that is not always amenable to education or counselling. Although Muktabhant and colleagues6 reported that “none 1832
of the interventions were effective in preventing excessive weight gain in high-risk groups”, this period is possibly the best chance to reduce risk of obesity and metabolic syndrome in the child to be born. The absence of adequate evidence from RCTs for any disorder in the perinatal period is no excuse for clinical indifference to risk, or for delay in assessment at this unique opportunity in the lifecycle. Even if a full range of RCT evidence existed for the earliest interventions, decisions about which treatment to offer will not always be clear from the clinical situation. Yet because of the immense costs of delay, clinical staff are obliged to try to prevent harm. Many observations made by clinicians remain speculative and unspoken, but if each colleague is encouraged to put their views about patients’ problems together, a consensus for action—advice or treatment—can be reached. Without routine opportunities for discussion, the most complex cases are at risk of not getting any help at all, because no one is sure who to ask and each thinks or hopes that another will provide it. To avoid this kind of buck-passing, obstetric and midwifery departments should pilot regular multidisciplinary workshops that include representatives from relevant services—ie, obstetrics and midwifery, general medicine, neonatal paediatrics, dietetics, social work, perinatal mental health, and primary care. Making the best practical use of existing knowledge can also generate testable hypotheses about clinical interventions, which could then be rigorously tested. I declare no competing interests.
Sebastian Kraemer [email protected] Whittington Hospital, London N19 5NF, UK 1
2
Smith G, Wessely S. The future of mental health in the UK: an election manifesto. Lancet 2015; 385: 747–49. Beijers R, Jansen J, Riksen-Walraven M, de Weerth C. Maternal prenatal anxiety and stress predict infant illnesses and health complaints. Pediatrics 2010; 126: e401–09.
3
4
5
6
Catalano PM, Farrell K, Thomas A, et al. Perinatal risk factors for childhood obesity and metabolic dysregulation. Am J Clin Nutr 2009; 90: 1303–13. O’Donnell KJ, Glover V, Barker ED, O’Connor TG. The persisting effect of maternal mood in pregnancy on childhood psychopathology. Dev Psychopathol 2014; 26: 393–403. Kraemer S. Integrated perinatal care. 2015. http://www.rcpsych.ac.uk/pdf/Integrated%20 Perinatal%20Care%20Dr%20Kraemer.pdf (accessed April 21, 2015). Muktabhant B, Lumbiganon P, Ngamjarus C, Dowswell T. Interventions for preventing excessive weight gain during pregnancy. Cochrane Database Syst Rev 2012; 4: CD007145.
We applaud Greg Smith and Simon Wessely’s so-called secret manifesto and its call for evidence to guide mental health policy.1 In their call for evidence, the authors discussed the example of research suggesting that psychological debriefing does more harm than good. However, we propose that their conclusions about debriefing are based more on interpretation than evidence. Psychological debriefing was designed as a group intervention lasting at least 2 h, which was aimed at emergency service and disaster workers at least 24 h after a critical traumatic incident.2 A systematic review3 of 15 randomised controlled trials (RCTs) of debriefing, of which overall quality was described as poor, identified only two studies that seemed to show debriefing to be harmful. Both of these RCTs had design flaws and failed to follow standard debriefing procedure.4 For example, both RCTs offered debriefing to patients admitted to hospital for isolated and unexpected trauma (eg, burns or road traffic accidents). Both RCTs offered debriefing that lasted, on average, 1 h or less, and was delivered sooner than recommended (within 24 h or while patients were undergoing medical treatment). In both RCTs, patients who were debriefed had been more severely injured than the controls. Debriefing had no negative effect on trauma symptoms when initial trauma and injury symptoms were taken into account. The results of a more recent RCT,5 which avoided such design flaws, showed a positive effect for debriefing, www.thelancet.com Vol 385 May 9, 2015
Correspondence
NT reports personal fees from Metropolitan Police and Thames Valley Police, has chaired a group that produced the British Psychological Society’s guidance on debriefing. All other authors declare no competing interests.
*David S J Hawker, Jamie Hacker Hughes, Noreen Tehrani, Debbie M Hawker, William Yule [email protected] InterHealth Worldwide, London SE1 6BD, UK (DSJH, DMH); Anglia Ruskin University, Chelmsford, UK (JHH); Noreen Tehrani Associates, Twickenham, UK (NT); and Kings College London, London, UK (WY) 1
2
3
4
5
Smith G, Wessely S. The future of mental health in the UK: an election manifesto. Lancet 2015; 385: 747–49. Mitchell JT, Everly G. Critical incident stress debriefing: an operations manual for the prevention of traumatic stress among emergency services and disaster workers, 2nd edn (revised). Ellicott City: Chevron, 1996. Rose SC, Bisson J, Churchill R, Wessely S. Psychological debriefing for preventing post traumatic stress disorder (PTSD). Cochrane Database Syst Rev 2002; 2: CD000560. Hawker DM, Durkin J, Hawker DSJ. To debrief or not to debrief our heroes: that is the question. Clin Psychol Psychother 2011; 18: 453–63. Tuckey MR, Scott JE. Group critical incident stress debriefing with emergency services personnel: a randomized controlled trial. Anxiety Stress Coping 2013; 27: 38–54.
A public health approach to hypertension Sonia Angell and colleagues (Feb 28, p 825)1 describe the part played by the Strategic Fund of the Pan American Health Organization (PAHO) in support of the Global Standardized Hypertension Treatment (GSHT) Project, a joint initiative of the US Centers for Disease Control and Prevention (CDC) and PAHO. This contribution to the GSHT Project is consistent with PAHO’s mandates2 and is part of its body of work in hypertension control,3 a condition that affects 250 million people in the Americas. www.thelancet.com Vol 385 May 9, 2015
Created in 2000, and based on PAHO’s experiences managing the Revolving Fund for vaccines, the PAHO Strategic Fund is an effective mechanism to procure drugs and medical technology at reduced prices to treat people with communicable and non-communicable diseases.4,5 As an example of its relevance in the Americas, between 2004, and 2012, the monetary value of antiretrovirals procured for HIV/AIDS through the PAHO Strategic Fund increased by more than 1500 times.6 Participating countries also receive technical cooperation to strengthen their capacity for planning and management of essential medical supplies. The PAHO Strategic Fund has evolved to better respond to the needs of countries and improve access to quality drugs for non-communicable diseases. As a result of an international bidding process and time-bound agreements, PAHO member states are able to procure antihypertensive drugs recommended by the GSHT Project at a unique price for each country.3 This mechanism also applies to drugs for cancer and diabetes. However, the success of the PAHO Strategic Fund depends on a high level of participation by member states, which allows PAHO to negotiate lower prices, thus increasing availability of drugs and providing benefits to larger numbers of people affected. Guaranteeing long-term daily treatment for a billion people with hypertension worldwide7 is extremely complex. Prioritisation of the availability and affordability of a core set of quality-assured drugs to treat hypertension, one of the pillars of the GSHT Project, is highly strategic. As such, the PAHO Strategic Fund represents a model that ensures access to a set of core drugs at competitive prices. Management and sustaining of such a fund is not without challenges— among them, the powerful competing economic interests of manufacturers. Innovative strategies will need to be adopted for advances towards
universal access to health and universal health coverage to ensure access to drugs for all. We declare no competing interests.
*Pedro Ordunez, Silvana Luciani, Adrian Barojas, James Fitzgerald, Anselm J M Hennis
Sheila Terry/Science Photo Library
as did three RCTs in the systematic review.3 Good RCTs are invaluable, but poor RCTs produce bad evidence. Restating conclusions based on poor evidence makes it harder to gather good evidence and sets back the progress of evidence-based medicine.
[email protected] Pan American Health Organization, Washington, DC 20037, USA 1
2
3
4
5
6
7
Angell SY, De Cock KM, Frieden TR. A public health approach to global management of hypertension. Lancet 2015; 385: 825–27. PAHO. Plan of action for the prevention and control of noncommunicable diseases (NCDs) in the Americas 2013–2019. Washington: Pan American Health Organization, 2014. Ordunez P, Martinez R, Niebylski ML, Campbell NR. Hypertension Prevention and Control in Latin America and the Caribbean. J Clin Hypertens (Greenwich) 2015; published online Feb 28. DOI:10.1111/jch.12518. PAHO. PAHO strategic fund. Washington: Pan American Health Organization, 2014. http:// www.paho.org/hq/index.php?option=com_co ntent&view=category&layout=blog&id=1159& Itemid=452 (accessed March 3, 2014). The Lancet Infectious Diseases. Global harmonisation in vaccine price. Lancet Infect Dis 2015; 15: 249. PAHO. Antiretroviral treatment in the spotlight: a public health analysis in Latin America and the Caribbean 2013. Washington: Pan American Health Organization, 2013. WHO. A global brief on hypertension: silent killer, global public health crisis. Geneva: World Health Organization, 2013.
Sonia Angell and colleagues 1 present constructive ideas to address hypertension globally. However, the daunting challenges of implementation of rapid control of hypertension deserve fuller discourse. The fact that “in the USA, barely half of people with hypertension have their blood pressure at target levels”1 speaks volumes. Moreover emulating single-purpose AIDS programming is largely unrealistic. Undertaking of further multibillion dollar initiatives to establish largely parallel health systems is simply not feasible. And despite huge investment, 2·1 million people are still newly diagnosed with HIV every year, and 1·5 million die from it. 2 Although the major implementation challenges for treatment of hypertension share much with HIV—eg, proper identification of 1833
for example, the perinatal period, in which mind and body are at their most entwined, but also most accessible to change. Although some problems— such as obesity or severe anxiety—will be clear to medical staff, established mental or physical disorders might not present at this time. Often, staff responsible for delivering babies experience concern, confusion, or anxiety about their patient and her family: how are they to know precisely which social, medical, or mental health provision is correct for the pregnant woman and pending offspring? Moreover, the patient’s experience might not be as compartmentalised as the services around her. She could be anxious or afraid yet have somatic symptoms, or physically ill and present with disturbed mood. The authors 1 praise the gold standard of randomised controlled trials (RCT), seeming to suggest that these could eventually answer any question about what to do for a patient in a public health service. However, a clinical judgment of need is not in itself an intervention. What is therefore to be done? Good science can point the way. In the past few decades, many developmental studies have shown links between various perinatal conditions and child health outcomes.2 Even if this knowledge cannot prescribe a proven intervention, it should inform social work, medical, dietetic, 3 and mental health exploration around the time of birth. Reliable predictions can be made that women who are anxious, 4 depressed, frightened, or dependent on drugs will have children who are at increased risk of, for example, depression in their teens, school failure, and social difficulties, as previously described.5 Meanwhile, prevention of excessive weight gain during pregnancy is an example of a complex task that is not always amenable to education or counselling. Although Muktabhant and colleagues6 reported that “none 1832
of the interventions were effective in preventing excessive weight gain in high-risk groups”, this period is possibly the best chance to reduce risk of obesity and metabolic syndrome in the child to be born. The absence of adequate evidence from RCTs for any disorder in the perinatal period is no excuse for clinical indifference to risk, or for delay in assessment at this unique opportunity in the lifecycle. Even if a full range of RCT evidence existed for the earliest interventions, decisions about which treatment to offer will not always be clear from the clinical situation. Yet because of the immense costs of delay, clinical staff are obliged to try to prevent harm. Many observations made by clinicians remain speculative and unspoken, but if each colleague is encouraged to put their views about patients’ problems together, a consensus for action—advice or treatment—can be reached. Without routine opportunities for discussion, the most complex cases are at risk of not getting any help at all, because no one is sure who to ask and each thinks or hopes that another will provide it. To avoid this kind of buck-passing, obstetric and midwifery departments should pilot regular multidisciplinary workshops that include representatives from relevant services—ie, obstetrics and midwifery, general medicine, neonatal paediatrics, dietetics, social work, perinatal mental health, and primary care. Making the best practical use of existing knowledge can also generate testable hypotheses about clinical interventions, which could then be rigorously tested. I declare no competing interests.
Sebastian Kraemer [email protected] Whittington Hospital, London N19 5NF, UK 1
2
Smith G, Wessely S. The future of mental health in the UK: an election manifesto. Lancet 2015; 385: 747–49. Beijers R, Jansen J, Riksen-Walraven M, de Weerth C. Maternal prenatal anxiety and stress predict infant illnesses and health complaints. Pediatrics 2010; 126: e401–09.
3
4
5
6
Catalano PM, Farrell K, Thomas A, et al. Perinatal risk factors for childhood obesity and metabolic dysregulation. Am J Clin Nutr 2009; 90: 1303–13. O’Donnell KJ, Glover V, Barker ED, O’Connor TG. The persisting effect of maternal mood in pregnancy on childhood psychopathology. Dev Psychopathol 2014; 26: 393–403. Kraemer S. Integrated perinatal care. 2015. http://www.rcpsych.ac.uk/pdf/Integrated%20 Perinatal%20Care%20Dr%20Kraemer.pdf (accessed April 21, 2015). Muktabhant B, Lumbiganon P, Ngamjarus C, Dowswell T. Interventions for preventing excessive weight gain during pregnancy. Cochrane Database Syst Rev 2012; 4: CD007145.
We applaud Greg Smith and Simon Wessely’s so-called secret manifesto and its call for evidence to guide mental health policy.1 In their call for evidence, the authors discussed the example of research suggesting that psychological debriefing does more harm than good. However, we propose that their conclusions about debriefing are based more on interpretation than evidence. Psychological debriefing was designed as a group intervention lasting at least 2 h, which was aimed at emergency service and disaster workers at least 24 h after a critical traumatic incident.2 A systematic review3 of 15 randomised controlled trials (RCTs) of debriefing, of which overall quality was described as poor, identified only two studies that seemed to show debriefing to be harmful. Both of these RCTs had design flaws and failed to follow standard debriefing procedure.4 For example, both RCTs offered debriefing to patients admitted to hospital for isolated and unexpected trauma (eg, burns or road traffic accidents). Both RCTs offered debriefing that lasted, on average, 1 h or less, and was delivered sooner than recommended (within 24 h or while patients were undergoing medical treatment). In both RCTs, patients who were debriefed had been more severely injured than the controls. Debriefing had no negative effect on trauma symptoms when initial trauma and injury symptoms were taken into account. The results of a more recent RCT,5 which avoided such design flaws, showed a positive effect for debriefing, www.thelancet.com Vol 385 May 9, 2015
Correspondence
NT reports personal fees from Metropolitan Police and Thames Valley Police, has chaired a group that produced the British Psychological Society’s guidance on debriefing. All other authors declare no competing interests.
*David S J Hawker, Jamie Hacker Hughes, Noreen Tehrani, Debbie M Hawker, William Yule [email protected] InterHealth Worldwide, London SE1 6BD, UK (DSJH, DMH); Anglia Ruskin University, Chelmsford, UK (JHH); Noreen Tehrani Associates, Twickenham, UK (NT); and Kings College London, London, UK (WY) 1
2
3
4
5
Smith G, Wessely S. The future of mental health in the UK: an election manifesto. Lancet 2015; 385: 747–49. Mitchell JT, Everly G. Critical incident stress debriefing: an operations manual for the prevention of traumatic stress among emergency services and disaster workers, 2nd edn (revised). Ellicott City: Chevron, 1996. Rose SC, Bisson J, Churchill R, Wessely S. Psychological debriefing for preventing post traumatic stress disorder (PTSD). Cochrane Database Syst Rev 2002; 2: CD000560. Hawker DM, Durkin J, Hawker DSJ. To debrief or not to debrief our heroes: that is the question. Clin Psychol Psychother 2011; 18: 453–63. Tuckey MR, Scott JE. Group critical incident stress debriefing with emergency services personnel: a randomized controlled trial. Anxiety Stress Coping 2013; 27: 38–54.
A public health approach to hypertension Sonia Angell and colleagues (Feb 28, p 825)1 describe the part played by the Strategic Fund of the Pan American Health Organization (PAHO) in support of the Global Standardized Hypertension Treatment (GSHT) Project, a joint initiative of the US Centers for Disease Control and Prevention (CDC) and PAHO. This contribution to the GSHT Project is consistent with PAHO’s mandates2 and is part of its body of work in hypertension control,3 a condition that affects 250 million people in the Americas. www.thelancet.com Vol 385 May 9, 2015
Created in 2000, and based on PAHO’s experiences managing the Revolving Fund for vaccines, the PAHO Strategic Fund is an effective mechanism to procure drugs and medical technology at reduced prices to treat people with communicable and non-communicable diseases.4,5 As an example of its relevance in the Americas, between 2004, and 2012, the monetary value of antiretrovirals procured for HIV/AIDS through the PAHO Strategic Fund increased by more than 1500 times.6 Participating countries also receive technical cooperation to strengthen their capacity for planning and management of essential medical supplies. The PAHO Strategic Fund has evolved to better respond to the needs of countries and improve access to quality drugs for non-communicable diseases. As a result of an international bidding process and time-bound agreements, PAHO member states are able to procure antihypertensive drugs recommended by the GSHT Project at a unique price for each country.3 This mechanism also applies to drugs for cancer and diabetes. However, the success of the PAHO Strategic Fund depends on a high level of participation by member states, which allows PAHO to negotiate lower prices, thus increasing availability of drugs and providing benefits to larger numbers of people affected. Guaranteeing long-term daily treatment for a billion people with hypertension worldwide7 is extremely complex. Prioritisation of the availability and affordability of a core set of quality-assured drugs to treat hypertension, one of the pillars of the GSHT Project, is highly strategic. As such, the PAHO Strategic Fund represents a model that ensures access to a set of core drugs at competitive prices. Management and sustaining of such a fund is not without challenges— among them, the powerful competing economic interests of manufacturers. Innovative strategies will need to be adopted for advances towards
universal access to health and universal health coverage to ensure access to drugs for all. We declare no competing interests.
*Pedro Ordunez, Silvana Luciani, Adrian Barojas, James Fitzgerald, Anselm J M Hennis
Sheila Terry/Science Photo Library
as did three RCTs in the systematic review.3 Good RCTs are invaluable, but poor RCTs produce bad evidence. Restating conclusions based on poor evidence makes it harder to gather good evidence and sets back the progress of evidence-based medicine.
[email protected] Pan American Health Organization, Washington, DC 20037, USA 1
2
3
4
5
6
7
Angell SY, De Cock KM, Frieden TR. A public health approach to global management of hypertension. Lancet 2015; 385: 825–27. PAHO. Plan of action for the prevention and control of noncommunicable diseases (NCDs) in the Americas 2013–2019. Washington: Pan American Health Organization, 2014. Ordunez P, Martinez R, Niebylski ML, Campbell NR. Hypertension Prevention and Control in Latin America and the Caribbean. J Clin Hypertens (Greenwich) 2015; published online Feb 28. DOI:10.1111/jch.12518. PAHO. PAHO strategic fund. Washington: Pan American Health Organization, 2014. http:// www.paho.org/hq/index.php?option=com_co ntent&view=category&layout=blog&id=1159& Itemid=452 (accessed March 3, 2014). The Lancet Infectious Diseases. Global harmonisation in vaccine price. Lancet Infect Dis 2015; 15: 249. PAHO. Antiretroviral treatment in the spotlight: a public health analysis in Latin America and the Caribbean 2013. Washington: Pan American Health Organization, 2013. WHO. A global brief on hypertension: silent killer, global public health crisis. Geneva: World Health Organization, 2013.
Sonia Angell and colleagues 1 present constructive ideas to address hypertension globally. However, the daunting challenges of implementation of rapid control of hypertension deserve fuller discourse. The fact that “in the USA, barely half of people with hypertension have their blood pressure at target levels”1 speaks volumes. Moreover emulating single-purpose AIDS programming is largely unrealistic. Undertaking of further multibillion dollar initiatives to establish largely parallel health systems is simply not feasible. And despite huge investment, 2·1 million people are still newly diagnosed with HIV every year, and 1·5 million die from it. 2 Although the major implementation challenges for treatment of hypertension share much with HIV—eg, proper identification of 1833