13

Adverse Events or Harm

OVERVIEW

The potential for introducing harm or causing adverse event may occur during any form of treatment. The relationship between potential adverse events or harm is traditionally considered relative to pharmacologic agents, and the clinical trial process attempts to ensure the safety of a new drug or medical device. However, rehabilitation may cause adverse events or harm in patients as well. The rehabilitation process includes many phases, such as screening and diagnostic testing, goal setting, one or many intervention, and follow-up evaluation; at each point, there is an opportunity to expose patients to potentially harmful practices or information. For example, a patient may sustain an injury during a particular rehabilitation strategy, or a rehabilitation therapist might focus on a patient’s challenges rather than successes, unintentionally harming the patient’s emotional well being and minimizing the potential for future success. Capturing data about the occurrence of adverse events or harm is important for all types of treatment. The committee reviewed only the randomized controlled trials (RCTs) on cognitive rehabilitation therapy (CRT) for reported information about the potential for adverse events or harm. This chapter includes a discussion of those studies.

POTENTIAL FOR ADVERSE EVENTS OR HARM FROM CRT

None of the RCTs that met inclusion criteria explicitly conceptualized or assessed potential risks of therapy, such as major inconveniences, unintended



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13 Adverse Events or Harm OVERVIEW The potential for introducing harm or causing adverse event may occur during any form of treatment. The relationship between potential adverse events or harm is traditionally considered relative to pharmacologic agents, and the clinical trial process attempts to ensure the safety of a new drug or medical device. However, rehabilitation may cause adverse events or harm in patients as well. The rehabilitation process includes many phases, such as screening and diagnostic testing, goal setting, one or many intervention, and follow-up evaluation; at each point, there is an opportunity to expose patients to potentially harmful practices or information. For example, a patient may sustain an injury during a particular rehabilitation strategy, or a rehabilitation therapist might focus on a patient’s challenges rather than successes, unintentionally harming the patient’s emotional well being and minimizing the potential for future success. Capturing data about the oc- currence of adverse events or harm is important for all types of treatment. The committee reviewed only the randomized controlled trials (RCTs) on cognitive rehabilitation therapy (CRT) for reported information about the potential for adverse events or harm. This chapter includes a discussion of those studies. POTENTIAL FOR ADVERSE EVENTS OR HARM FROM CRT None of the RCTs that met inclusion criteria explicitly conceptualized or assessed potential risks of therapy, such as major inconveniences, unin- 249

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250 COGNITIVE REHABILITATION THERAPY FOR TBI tended negative consequences, or exacerbation of a concomitant condition (e.g., posttraumatic stress disorder). None of the trials reported data about any serious adverse events, including acts of aggression, suicide, or death. Several of the trials that evaluated multi-modal/comprehensive therapy assessed measures such as anxiety and depression that theoretically could be improved or worsened with some forms of CRT (Ruff and Niemann 1990; Salazar et al. 2000; Tiersky et al. 2005; Vanderploeg et al. 2008). Ruff and Niemann’s (1990) small trial included 24 patients with chronic, moderate- severe traumatic brain injury (TBI). The trial compared a multi-modal, structured cognitive outpatient retraining program with therapy focusing on psychosocial functioning and activities of daily living (ADLs). Although the investigators had hypothesized increased emotional distress with cog- nitive rehabilitation, they found neither group perceived any changes in emotional or psychosocial functioning, though individuals in the second group tended to rate themselves more obstreperous after treatment. Salazar et al. (2000) and colleagues’1 single-center trial of patients with TBI in the subacute phase reported increased numbers of patients with major depres- sion (19 at baseline, 27 at 1-year follow-up) and generalized anxiety (10 at baseline, 20 at 1-year follow up) among the 53 active-duty military per- sonnel with moderate-severe TBI randomized to home rehabilitation with telephone support. No such increases were seen among the 67 individuals randomized to intensive in-hospital rehabilitation (depression 18 at base- line and 16 at follow up; anxiety 9 at baseline and follow-up). Incomplete follow-up at 1 year (34 of 53 home rehabilitation patients and 42 of 67 in-hospital rehabilitation patients) and possible differential surveillance and ascertainment limit the interpretation of these findings. Tiersky et al.’s (2005) small, single-blind trial found that individuals with mild TBI in the chronic phase who were randomized to neuro-psychologic reha- bilitation reported less anxiety and depression (measured with SCL-90R) at 3 months than those randomized to a waitlist group. Vanderploeg et al.’s (2008) multi-center trial involving veterans with moderate-severe TBI in the subacute phase who were treated in acute inpatient rehabilitation programs reported no differences in worry, depression, or irritability at 1 year between groups randomized to cognitive didactic versus functional- experiential rehabilitation. RCTs that evaluated single modality interventions most often used modality-specific outcomes and did not assess outcomes that could have detected any psycho-emotional distress related to the rehabilitation therapy. Only the Salazar trial reported estimated costs of CRT. The additional reha- bilitation cost estimated for each patient in the intensive in-hospital group 1 The committee reviewed Salazar et al. 2000, with Braverman et al. 1999 and Warden et al. 2000.

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251 ADVERSE EVENTS OR HARM was $51,840 (based on standard WRAMC physiatry service costs of $864 per day) whereas the home program rehabilitation total cost was $504 per patient (Salazar et al. 2000). CONCLUSIONS: ADVERSE EVENTS OR HARM The committee found that evidence about any potential downsides and risk for harm associated with CRT is scant. Although the limited available evidence suggests no great concern regarding risk for harm, future studies that evaluate CRT should include and report measures that assess such risks. REFERENCES Braverman, S. E., J. Spector, D. L. Warden, B. C. Wilson, T. E. Ellis, M. J. Bamdad, and A. M. Salazar. 1999. A multidisciplinary TBI inpatient rehabilitation programme for active duty service members as part of a randomized clinical trial. Brain Injury 13(6):405–415. Ruff, R. M., and H. Niemann 1990. Cognitive rehabilitation versus day treatment in head- injured adults. Is there an impact on emotional psychosocial adjustment? Brain Injury 4:339–347. Salazar, A. M., D. L. Warden, K. Schwab, J. Spector, S. Braverman, J. Walter, R. Cole, M. M. Rosner, E. M. Martin, J. Ecklund, and R. G. Ellenbogen. 2000. Cognitive rehabilitation for traumatic brain injury: A randomized trial. Journal of the American Medical Associa- tion 283(23):3075–3081. Tiersky, L. A., V. Anselmi, M. V. Johnston, J. Kurtyka, E. Roosen, T. Schwartz, and J. Deluca. 2005. A trial of neuropsychologic rehabilitation in mild-spectrum traumatic brain injury. Archives of Physical Medicine and Rehabilitation 86(8):1565–1574. Vanderploeg, R. D., K. Schwab, W. C. Walker, J. A. Fraser, B. J. Sigford, E. S. Date, S. G. Scott, G. Curtiss, A. M. Salazar, and D. L. Warden. 2008. Rehabilitation of traumatic brain injury in active duty military personnel and veterans: Defense and Veterans Brain Injury Center randomized controlled trial of two rehabilitation approaches. Archives of Physical Medicine and Rehabilitation 89(12):2227–2238. Warden, D. L., A. M. Salazar, E. M. Martin, K. A. Schwab, M. Coyle, and J. Walter. 2000. A home program of rehabilitation for moderately severe traumatic brain injury patients. Journal of Head Trauma Rehabilitation 15(5):1092–1102.

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