Begin main content

Intervention

Consumer Intervention: Minimising risks or harms

Definition

Strategies specifically focusing on preventing or managing adverse events of treatment and complications of disease. Interventions can be for ongoing treatment or related to emergency or crisis events. Strategies aim to minimise risks or harms at an individual or at a population level, such as reducing use of antibiotics, or augmenting immunisation uptake.

Effectiveness

There is sufficient evidence that self-management skills for oral anticoagulation therapy decrease most adverse events except major haemorrhages. Conversely, there was sufficient evidence that self-monitoring decreases major haemorrhages but not other adverse events. There is sufficient evidence that continuous labour support reduces use of analgesia or anaesthesia, numbers of instrumental vaginal and caesarean births, labour length, and increases spontaneous vaginal birth without increasing postpartum report of severe labour pain - it is generally effective, however it does not reduce synthetic oxytocin use during labour and maternal perineal trauma. There is some evidence that continuous labour support reduces the number of infants with low 5 minute Apgar score - it is generally effective but it does not change neonatal admission to special care nursery or prolonged neonatal hospital stay.

There is sufficient evidence that continuous subcutaneous insulin infusion (CSII) are effective in improving HbA1c levels and daily insulin requirements as well as some evidence of clinical outcomes. There is some evidence that mortality, adverse events and nocturnal hypoglycaemia are rare and are not different between the CSII and usual multiple daily insulin injection regimes.

Telling patients about adverse effects of medicines does not negatively influence adherence. There is some evidence that pharmacist-led interventions such as discharge planning decrease medicines-related adverse events and mortality, although results were mixed and did not reduce emergency department presentations or hospitalisations; while interventions delivered by other healthcare professionals were generally ineffective. There is little evidence to determine the effectiveness of strategies incorporating education to minimise risks and harms.

For immunisation uptake, there is some evidence that reminder and recall as well as lay health worker interventions improve immunisation uptake and are generally effective, however there are only a small number of these types of interventions investigating coverage of child immunization in low- and middle-income countries.. In contrast, patient reminders combined with outreach are generally ineffective. There is some evidence that effective interventions to improve influenza immunisation coverage include tailored reminders on their own or with telephone invitations; home visits plus vaccination; free vaccination offers; facilitators working with and financial incentives to physicians. However, participant reminders alone are inconsistent and physician reminders alone are generally ineffective. For tuberculosis treatment, as for highly active retroviral therapy for HIV-AIDS, there is some evidence that directly observed therapy is generally ineffective to improve clinical outcomes or treatment completion; and insufficient evidence on the effects of late patient tracers. There is sufficient evidence that delayed antibiotic prescribing decreases antibiotic use but it may also increase supplementary medicines use and effects on clinical outcomes and adverse effects are mixed.

Summary of Overall Findings from Reviews

Summary of Findings Related to Prescribing

45 reviews (24 of high quality) addressing strategies to minimise medicines-related risks and harms were identified, including interventions with implications for individuals and/or the community.

Interventions to individuals:
In one large review, several studies reported that informing patients about medicines adverse effects did not negatively affect adherence (Haynes 2008). There were otherwise few specific strategies targeting individuals, although in five reviews the responsibility for medicines and management resided with patients (Garcia-Alamino 2010, Bhogal 2006, Powell 2002, Bradley 2008, Bainbridge 2006).

Garcia-Alamino 2010 reported that self-management significantly decreased thromboembolic events, mortality, and minor but not major haemorrhages and self-monitoring significantly decreased major haemorrhages but not thromboembolic events, mortality and minor haemorrhages. Both strategies had mixed effects on clinical outcomes; however a significant proportion of people undertaking these strategies were unable to complete treatment, suggesting that self-monitoring and self -management may not be appropriate for everyone.

Reviews comparing asthma self-monitoring and self-management strategies reported conflicting results. In one, symptom monitoring action plans were better than peak flow monitoring for exacerbations requiring acute care in children (Bhogal 2006). Two other reviews assessed self-management education strategies incorporating different combinations of education, medicines review, action plans, instruction, and self-adjustment: one reported no differences between different self-management education strategies for emergency department visits or steroid use in adults (Powell 2002). The other reported fewer emergency department presentations for those patients given self-management education compared with control, but no improvements in medicines use, withdrawals or clinical outcomes in children with history of repeated emergency department visits for asthma (Boyd 2009).

Bradley (2008) reported mixed effects on adverse events and clinical outcomes for specialist epilepsy care models, including self-management education, patient adverse event reporting or patient held reminders. In Bainbridge (2006), patient-controlled analgesia had mixed effects including increased analgesic consumption and improved longer term (48 hr) pain control, but no consistent effects on adverse effects, severe pain, mortality, or treatment discontinuation.
Misso (2010) reported that continuous subcutaneous insulin infusion was effective in improving HbA1c levels and daily insulin requirements as well as some evidence of reducing severe, but not non-severe, hypoglycaemic events. There is some evidence that mortality, adverse events and nocturnal hypoglycaemia are rare and no different between the CSII and usual multiple daily insulin injection regimes.

Interventions targeting interactions between health care professionals and consumers reported mixed results. In Royal (2008), pharmacist-led medicines review decreased adverse events and mortality, although results were mixed; and there were no consistent effects on service use outcomes. Interventions delivered by professionals other than pharmacists, or complex interventions to prevent medicines-related falls also had inconsistent effects. Shepperd (2010) showed that pharmacy discharge planning resulted in some reduction in medicines errors and improved adherence, although these effects were also inconsistent.

Education had little or no effect on outcomes: asthma education in emergency settings did not reduce emergency department presentations or improve clinical outcomes (Tapp 2007). There was too little evidence to decide on the effects of action plans for chronic obstructive pulmonary disease (COPD) which incorporated education (Turnock 2005). Delivering education and treatment in outpatient rather than inpatient settings did not change diabetes complication rates in children (Clar 2007).

Public health interventions:
Continuous labour support significantly reduced any analgesia (including regional analgesia) or anaesthesia use as well as negative rating of birth experiences, labour length, numbers of instrumental vaginal and caesarean births and increased spontaneous vaginal birth without increasing postpartum report of severe labour pain; however, the use of synthetic oxytocin during labour and perineal trauma were not significantly changed. Continuous labour support reduced the number of infants with low 5 minute Apgar score but did not alter the incidence of prolonged neonatal hospital stay and admission to the special care nursery (Hodnett 2011).

For immunisation uptake, several interventions were promising. Reminders and recall interventions (including person-to-person calls, letters, autodialer computer reminders, postcards plus telephone calls, home visits, patient tailored reminders and financial incentives and provider reminders or facilitators working with providers) and lay health worker interventions all significantly improved immunisation rates (Jacobson 2005, Lewin 2010, Thomas 2010); whereas patient reminders with outreach did not (Jacobson 2005). Interventions to improve coverage of child immunization in low- and middle-income countries reported positive effects for single studies of information campaigns, facility based education alone or in combination with redesigned immunisation cards and evidence-based discussion with community groups (Oyo-Ita 2011).

For emerging antibiotic resistance, delayed prescribing reduced antibiotic use, but had mixed effects on adverse effects, supplementary medicines use and clinical outcomes (Spurling 2007). Directly observed therapy for highly active antiretroviral therapy for HIV-AIDS did not improve adherence, clinical outcomes and the prevention of development of resistance mutations (Ford 2009). In addition, there is insufficient evidence to determine the optimal monitoring strategy (virologic, immunologic, and/or clinical) for anti-retroviral therapy as results on clinical and virologic outcomes have been mixed (Chang 2010).
For tuberculosis eradication, single studies reporting outcomes found that interventions incorporating late patient tracers to follow up patients not attending for treatment significantly improved medicines use outcomes (treatment completion, interruption and failure) (Lui 2008). Lay health worker interventions improved cure rates for combined new and retreated smear-positive tuberculosis patient groups, although the effects on cure rates for new smear-positive patients alone, combined cure and treatment-completion groups or on completion of preventive therapy were mixed (Lewin 2010). There were no consistent, significant differences in tuberculosis treatment completion or cure with directly observed therapy (Volmink 2007).

Reviews listed as "Summary Pending" will be analyzed, summarized and reported at a later date.

The findings will then be incorporated in the overall evidence summaries of the interventions they address.

Reviews Addressing This Intervention Quality Assessment Tool:
AMSTAR Score (of 11 points)
Bhogal S, Zemek R, Ducharme FM. Written action plans for asthma in children. Cochrane Database of Systematic Reviews 2006 3:CD005306. 11 (High)
Garcia-Alamino J, Ward A, Alonso-Coello P, Perera R, Bankhead C, Fitzmaurice D, Heneghan C. Self-monitoring and self-management of oral anticoagulation. Cochrane Database of Systematic Reviews 2010 4:CD003839. 11 (High)
Boyd M, Lasserson TJ, McKean MC, Gibson PG, Ducharme FM, Haby M. Interventions for educating children who are at risk of asthma-related emergency department attendance. Cochrane Database of Systematic Reviews 2009 2:CD001290. 10 (High)
Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database of Systematic Reviews 2008 2:CD000011. 10 (High)
Jacobson VJ, Szilagyi P. Patient reminder and patient recall systems to improve immunization rates. Cochrane Database of Systematic Reviews 2005 3:CD003941. 10 (High)
Lewin S, Munabi-Babigumira S, Glenton C, Daniels K, Bosch-Capblanch X, van Wyk B, Odgaard-Jensen J, Johansen M, Aja G, Zwarenstein M, Scheel I. Lay health workers in primary and community health care for maternal and child health and the management of infectious diseases. Cochrane Database of Systematic Reviews 2010 3:CD004015. 10 (High)
Misso ML, Egberts K, Page M, O'Connor D, Shaw J. Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus. Cochrane Database of Systematic Reviews 2010 1:CD005103. 10 (High)
Thomas RE, Russell M, Lorenzetti D. Interventions to increase influenza vaccination rates of those 60 years and older in the community. Cochrane Database of Systematic Reviews 2010 9:CD005188. 10 (High)
Volmink J, Garner P. Directly observed therapy for treating tuberculosis. Cochrane Database of Systematic Reviews 2007 4:CD003343. 10 (High)
Bainbridge D, Martin JE, Cheng DC. Patient-controlled versus nurse-controlled analgesia after cardiac surgery--a meta-analysis. Canadian Journal of Anaesthesia 2006 53 (5):492-9. 9 (High)
Bradley PM, Lindsay B. Care delivery and self-management strategies for adults with epilepsy. Cochrane Database of Systematic Reviews 2008 1:CD006244. 9 (High)
Chang L, Harris J, Humphreys E. Optimal monitoring strategies for guiding when to switch first-line antiretroviral therapy regimens for treatment failure in adults and adolescents living with HIV in low-resource settings. Cochrane Database of Systematic Reviews 2010 4:CD008494. 9 (High)
Clar C, Waugh N, Thomas S. Routine hospital admission versus out-patient or home care in children at diagnosis of type 1 diabetes mellitus. Cochrane Database of Systematic Reviews 2007 2:CD004099. 9 (High)
Ford N, Nachega J, Engel M, Mills E. Directly observed antiretroviral therapy: a systematic review and meta-analysis of randomised clinical trials. Lancet 2009 374 (9707):2064-71. 9 (High)
Hodnett ED, Gates S, Hofmeyr GJ, Sakala C, Weston J. Continuous support for women during childbirth. Cochrane Database of Systematic Reviews 2011 2:CD003766. 9 (High)
Liu Q, Abba K, Alejandria MM, Balanag VM, Berba RP, Lansang MA. Reminder systems and late patient tracers in the diagnosis and management of tuberculosis. Cochrane Database of Systematic Reviews 2008 4:CD006594. 9 (High)
Powell H, Gibson PG. Options for self-management education for adults with asthma. Cochrane Database of Systematic Reviews 2003 1:CD004107. 9 (High)
Shepperd S, McClaran J, Phillips C, Lannin N, Clemson L, McCluskey A, Cameron I, Barras S. Discharge planning from hospital to home. Cochrane Database of Systematic Reviews 2010 1:CD000313. 9 (High)
Spurling GK, Del Mar CB, Dooley L, Foxlee R. Delayed antibiotics for respiratory infections. Cochrane Database of Systematic Reviews 2007 3:CD004417. 9 (High)
Tapp S, Lasserson TJ, Rowe B. Education interventions for adults who attend the emergency room for acute asthma. Cochrane Database of Systematic Reviews 2007 3:CD003000. 9 (High)
Jones A, Fay JK, Ram FSF. Primary care based clinics for asthma. Cochrane Database of Systematic Reviews 2002 1:CD003533. 8 (High)
Oyo-Ita A, Nwachukwu CE, Oringanje C, Meremikwu MM. Interventions for improving coverage of child immunization in low- and middle-income countries. Cochrane Database of Systematic Reviews 2011 7:CD008145. 8 (High)
Royal S, Smeaton L, Avery AJ, Hurwitz B, Sheikh A. Interventions in primary care to reduce medication related adverse events and hospital admissions: systematic review and meta-analysis. Quality & Safety in Health Care 2006 15 (1):23-31. 8 (High)
Turnock AC, Walters EH, Walters JA, Wood-Baker R. Action plans for chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews 2005 4:CD005074. 8 (High)
Bailey EJ, Cates CJ, Kruske SG, Morris PS, Chang AB, Brown N. Culture-specific programs for children and adults from minority groups who have asthma. Cochrane Database of Systematic Reviews 2009 1:CD006580. 7 (Medium)
Bayoumi I, Howard M, Holbrook A, Schabort I. Interventions to improve medication reconciliation in primary care. The Annals of Pharmacotherapy 2009 43 (10):1667-75. 7 (Medium)
Forsetlund L, Eike MC, Gjerberg E, Vist GE. Effect of interventions to reduce potentially inappropriate use of drugs in nursing homes: a systematic review of randomised controlled trials. BMC Geriatrics 2011 11:16. 7
Summary Pending
Golicki DT, Golicka D, Groele L, Pankowska E. Continuous Glucose Monitoring System in children with type 1 diabetes mellitus: a systematic review and meta-analysis. Diabetologia 2008 51 (2):233-40. 7 (Medium)
Pankowska E, Blazik M, Dziechciarz P, Szypowska A, Szajewska H. Continuous subcutaneous insulin infusion vs. multiple daily injections in children with type 1 diabetes: a systematic review and meta-analysis of randomized control trials. Pediatric Diabetes 2009 10 (1):52-8. 7 (Medium)
Roughead EE, Semple SJ, Vitry AI. Pharmaceutical care services: A systematic review of published studies, 1990 to 2003, examining effectiveness in improving patient outcomes. International Journal of Pharmacy Practice 2005 13 (1):53-70. 7 (Medium)
Schuetz P, Chiappa V, Briel M, Greenwald JL. Procalcitonin algorithms for antibiotic therapy decisions: a systematic review of randomized controlled trials and recommendations for clinical algorithms. Archives of Internal Medicine 2011 171 (15):1322-31. 7 (Medium)
Stone EG, Morton SC, Hulscher ME, Maglione MA, Roth EA, Grimshaw JM, Mittman BS, Rubenstein LV, Rubenstein LZ, Shekelle PG. Interventions that increase use of adult immunization and cancer screening services: a meta-analysis. Annals of Internal Medicine 2002 136 (9):641-51. 7 (Medium)
Agarwal R, Bills JE, Hecht TJW, Light RP. Role of Home Blood Pressure Monitoring in Overcoming Therapeutic Inertia and Improving Hypertension Control. Hypertension 2011 57:29-38. 6 (Medium)
Holland R, Desborough J, Goodyer L, Hall S, Wright D, Loke YK. Does pharmacist-led medication review help to reduce hospital admissions and deaths in older people? A systematic review and meta-analysis. British Journal of Clinical Pharmacology 2008 65 (3):303-16. 6 (Medium)
Koshman SL, Charrois TL, Simpson SH, McAlister FA, Tsuyuki RT. Pharmacist care of patients with heart failure: a systematic review of randomized trials. Archives of Internal Medicine 2008 168 (7):687-94. 6 (Medium)
Lau D, Hu J, Majumdar SR, Storie DA, Rees SE, Johnson JA. Interventions to improve influenza and pneumococcal vaccination rates among community-dwelling adults: a systematic review and meta-analysis. Annals of Family Medicine 2012 10 (6):538-546. 6
Summary Pending
Ranji SR, Steinman MA, Shojania KG, Gonzales R. Interventions to reduce unnecessary antibiotic prescribing: a systematic review and quantitative analysis. Medical Care 2008 46 (8):847-62. 6 (Medium)
Winterbottom JB, Smyth RM, Jacoby A, Baker GA. Preconception counselling for women with epilepsy to reduce adverse pregnancy outcome. Cochrane Database of Systematic Reviews 2008 3:CD006645. 6 (Medium)
Castelino R, Bajorek B, Chen T. Targeting suboptimal prescribing in the elderly: a review of the impact of pharmacy services. The Annals of Pharmacotherapy 2009 43 (6):1096-106. 5 (Medium)
Lummis H, Sketris I, Veldhuyzen van ZS. Systematic review of the use of patients' own medications in acute care institutions. Journal of Clinical Pharmacy and Therapeutics 2006 31 (6):541-63. 5 (Medium)
Maglione MA, Stone EG, Shekelle PG. Mass mailings have little effect on utilization of influenza vaccine among Medicare beneficiaries. American Journal of Preventive Medicine 2002 23 (1):43-6. 5 (Medium)
Mollon B, Chong J Jr, Holbrook AM, Sung M, Thabane L, Foster G. Features predicting the success of computerized decision support for prescribing: a systematic review of randomized controlled trials. BMC Medical Informatics and Decision Making 2009 9. 5 (Medium)
Stevenson FA, Cox K, Britten N, Dundar Y. A systematic review of the research on communication between patients and health care professionals about medicines: the consequences for concordance. Health Expectations 2004 7 (3):235-45. 5 (Medium)
Wright J, Emerson A, Stephens M, Lennan E. Hospital inpatient self-administration of medicine programmes: a critical literature review. Pharmacy World & Science 2006 28 (3):140-51. 5 (Medium)
Amico KR, Harman JJ, Johnson BT. Efficacy of antiretroviral therapy adherence interventions: a research synthesis of trials, 1996 to 2004. Journal of Acquired Immune Deficiency Syndromes 2006 41 (3):285-97. 4 (Medium)
Jegu J, Gallini A, Soler P, Montastruc JL, Lapeyre-Mestre M. Slow-release oral morphine for opioid maintenance treatment: a systematic review. British Journal of Clinical Pharmacology 2011 71 (6):832-43. 4 (Medium)
Nishtala PS, McLachlan A, Bell JS, Chen TF. Psychotropic prescribing in long-term care facilities: impact of medication reviews and educational interventions. American Journal of Geriatric Psychiatry 2008 16 (8):621-32. 4 (Medium)
Hawkes SJ, Gomez GB, Broutet N. Early antenatal care: does it make a difference to outcomes of pregnancy associated with syphilis? A systematic review and meta-analysis. PLoS ONE [Electronic Resource] 2013 8 (2):e56713. Summary Pending
Krogsb°ll LT, J°rgensen KJ, Gr°nh°j LC, G°tzsche PC. General health checks in adults for reducing morbidity and mortality from disease. Cochrane Database of Systematic Reviews 2012 10:CD009009. Summary Pending
Lopez LM, Newmann SJ, Grimes DA, Nanda K, Schulz KF. Immediate start of hormonal contraceptives for contraception. Cochrane Database of Systematic Reviews 2012 12:CD006260. Summary Pending
Spurling GK, Del Mar CB, Dooley L, Foxlee R, Farley R. Delayed antibiotics for respiratory infections. Cochrane Database of Systematic Reviews 2013 4:CD004417. Summary Pending
Windmill J, Fisher E, Eccleston C, Derry S, Stannard C, Knaggs R, Moore RA. Interventions for the reduction of prescribed opioid use in chronic non-cancer pain. Cochrane Database of Systematic Reviews 2013 9:CD010323. Summary Pending