D4 Patient Report: Treatment Options for a Patient with Schizophrenia

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INTRODUCTION

Background

Schizophrenia is a chronic and disabling psychiatric disease with profound heterogeneity of its clinical presentations. It can be characterized by the occurrence of a variety of symptoms, which may be broadly categorized as positive symptoms, negative symptoms, and cognitive impairments. Positive symptoms are psychological processes that do not normally occur in healthy persons. These can include delusions, hallucinations, and abnormal thoughts and behaviors behaviors (Fischer et al. 2012). Converse to positive symptoms, a negative symptom is the absence of a normal process. For instance, a person with schizophrenia may display flattened affect, decreased expressiveness, and a lack of energy (Kirkpatrick 2006).

Patients with schizophrenia have about a 50% chance of suffering hallucinations (Thomas, 2007). Of these, auditory hallucinations are most common. Patients may report hearing voices or noises which have no physical explanation. Fortunately, auditory hallucinations frequently are responsive to antipsychotic medication. Approximately 80% of persons with schizophrenia have delusions (Andreasen, 1991). Delusions may be divided by whether they are plausible or absolutely impossible. A false belief that has no possibility of being true would be categorized as a bizarre delusion, whereas one that could have a logical explanation would be categorized as non-bizarre. Patients suffering hallucinations frequently have accompanying delusional beliefs which explain the hallucinations (Bernard, 2012).

Depressive disorders commonly co-occur with schizophrenia, and they are associated with less favorable outcomes than schizophrenia without depression. Over the course of the disease, half of all patients with schizophrenia will experience comorbid depression (Buckley, 2008). Some symptoms of depression overlap with the negative symptoms of schizophrenia, including flattening of affect, apathy, and anhedonia. Cognitive impairments associated with schizophrenia can include slowed processing speed, reduced working memory, and impaired social perception (Dickinson 2004).

Schizophrenia is commonly managed with perphenazine, a high-potency first-generation antipsychotic. Its use and the use of similar first-generation antipsychotics carries a high incidence of several side effects. These can include daytime sedation and hypotension. However, of greatest concern is the risk of inducing extrapyramidal side effects which can include lasting or permanent tardive dyskinesia. First generation antipsychotics cause an approximately 15% risk of drug-associated tardive dyskinesia, presenting as akathisia, rigidity, bradykinesia, tremor, and dystonia (Kane, 1982).

As an alternative to first-generation antipsychotics, many newer medications have been proposed as alternatives. Such drugs are frequently termed second-generation antipsychotics, also known as atypical antipsychotics. Their main benefit is a reduced risk of extrapyramidal side effects. This is theorized to be due to a weaker affinity to the dopamine receptors which they block, causing quicker dissociation (Kapur 2000).

Significance

Schizophrenia has a prevalence estimated at 1% worldwide (McGrath, 2008). This prevalence combined with schizophrenia’s severity make it one of the diseases with the greatest global burden (World Health Organization, 1996). More males are diagnosed with schizophrenia than females, with a ratio of 1.4 to 1 (Abel, 2010). Age of onset typically occurs between the ages of 18 to 25 in men, and in women, either from 25 to 35 or around the onset of menopause (American Psychiatric Association, 2013).

Mental illnesses such as schizophrenia are associated with a significant reduction in the utilization of dental care. This is thought to be due to factors which can include lack of motivation, impaired communication, and elevated occurrence of specific dental phobias (Teng, 2016). Furthermore, more than 80% of persons with schizophrenia smoke tobacco, and many use other harmful substances, especially alcohol and cannabis (Keltner, 2006).

Presentation of patient

Patient AM is a 78 year old African-American female. Her chief complaint is “I want a nice smile.” Interview of the patient reveals that she has been dissatisfied with the esthetics of her partial edentulism. She has been undergoing treatment for both schizophrenia and for depression for over twenty years, although she believes that she had suffered symptoms of both since she was in her late twenties. Her schizophrenia is medically managed with perphenazine, and she participates regularly in a psychosocial rehabilitation program.

The patient interview reveals that the condition of her mental health caused her to neglect her oral health for much of her adult life. At the present time, she has made close connections with women from her church who reach out to one another regularly, and she credits them with having gone more than five years without any of the episodes of depression that she has previously suffered. She expressed that she is overall satisfied with her current psychiatric management, although she reports still occasionally suffering non-bizarre delusions.

The patient was diagnosed with hypertension in 1995, which is well controlled with amlodipine and hydrochlorothiazide along with diet and exercise. Blood pressure was measured as 117 / 75 mmHg, with pulse rate of 57 bpm. She occasionally feels faint when transitioning from seated to standing, so she must be raised slowly from the dental chair and allowed to acclimate in order to prevent orthostatic hypotension. Her perphenazine use likely contributes to her orthostatic hypotension.

The patient’s primary care physician informs her that her bone density is excellent. However, she suffers knee pain associated with osteoarthritis, for which she receives steroid injections every six months. The patient also complains of gastroesophageal reflux disease, which is moderate and usually occurs when she lies down after eating. She controls this by eating at least two hours before bed, and by taking ranitidine, an antihistamine antacid. The patient reports an allergy to penicillin with a reaction consistent with urticaria. She also has mild eczema, for which she is prescribed hydrocortisone cream.

The patient is a never-married retiree who lives with unrelated roommates. She reports never having used alcohol, and that although she tried cigarettes a few times as a teenager she never developed a smoking habit, despite the high rate of substance abuse among persons with schizophrenia. She is active in her church community, enjoys walking for exercise when the weather is mild, and spends time with her nieces, nephews, and their children. She reports that she currently brushes with fluoridated toothpaste and flosses twice daily, and also uses a non-fluoridated mouthwash once daily. Her home care has been good, with no signs of gingivitis and minimal deposits of calculus. She writes in a planner that she carries with her, and has not missed or been late to any over her nearly ten appointments, although she does not own any type of telephone.

Extraoral exam is within normal limits. Intraoral exam reveals racial pigmentation of gingiva, with cheeks and tongue appearing dry and saliva frothy. She carries a water bottle with her to each visit, stating that she sips from it frequently due to dry-mouth. This xerostomia may be a side effect of her thiazide antihypertensive.

The patient has class 1 occlusion, but is missing teeth 1, 4, 7, 11-13, 16, 17, 19, 20, and 29-32. Even so, she states that she has no difficulty eating. Crowns are present on teeth 7, 8, and 9 as well as class 1 and 2 amalgam restorations on all of her posterior teeth. No teeth display mobility or furcal involvement, and two sites have probing depths of 4mm with no bleeding on probing. On the initial visit it was noted that her teeth had been prepared with rest seats. When asked, the patient complained that she had partial dentures made more than ten years ago, but that they had never fully seated on her teeth and so she never wore them. She also presented with a sensitive buccal abrasion of #21. It was determined that the best course of treatment for patient AM would comprise prophylaxis with oral hygiene instruction, a restoration of #21, and then removable partial dentures for her maxilla and mandible.

Purpose

A dentist’s responsibility is not limited to the mouth. For many patients, dentists are either the most frequent, or only healthcare provider that they see regularly (Hendricson, 2001). It is therefore incumbent upon dentists to ensure that each patient receives adequate care for their general health. Many conditions including mental health disturbances can have a reciprocal relationship with dental health, whereby improvement in one leads to a corresponding improvement  in the other (Casamassimo, 2000). The purpose of this report is to explore the two most common options for management of patient AM’s positive symptoms of schizophrenia: treatment with psychosocial rehabilitation paired with either a first generation antipsychotic or an atypical antipsychotic drug.

LITERATURE REVIEW

Search strategy

Given concern for the risk of lasting extrapyramidal side effects, a safer and no less effective alternative therapy was sought for management of the patient’s positive symptoms of schizophrenia. The clinical question was formulated as follows:

“Is there a difference in efficacy of second generation antipsychotics compared to perphenazine for the treatment of schizophrenia?”.

The PICO structure for this literature search is:

P: Patients with schizophrenia

I: Second generation antipsychotics

C: perphenazine

O: Improvement of symptoms

The decision to search PubMed only for Clinical Trials and Meta-Analyses was made in the interest of using only articles with a high potential for determining causation. Using a PubMed search for the terms ((perphenazine) AND schizophrenia), limiting results to Clinical Trials and Systematic Reviews on human subjects from the last 10 years yielded 49 articles. Screening them by title and abstract to only include articles that compared perphenazine medication to second-generation antipsychotic medication with the primary outcome being a quality-of-life scale left 5 articles: 2 meta-analyses and 3 randomized controlled trials. Literature appraisal was performed on the three randomized controlled trials.

Summaries of articles

Addington et. al.

This article presents findings from the National Institute of Mental Health (NIMH) Clinical Antipsychotic Trial of Intervention Effectiveness (CATIE) project, a randomized controlled trial on which patients with schizophrenia were assigned to take one of the following antipsychotic medications: perphenazine, olanzapine, risperidone quetiapine, and ziprasidone. Of these, perphenazine is a first-generation antipsychotic, and the remainder are second-generation antipsychotics. Patients were evaluated for presence and severity of depressive symptoms using the Calgary Depression Scale for Schizophrenia (CDSS) at baseline and recall. Patients were excluded if they had suffered tardive dyskinesia, but depression was not one of the inclusion or exclusion criteria.

Each of the interventions was compared to each other over each recall period. Due to the multiple comparisons made in this study, the threshold of significance was made more restrictive by a Hochberg adjustment with three degrees of freedom, dividing a typical ɑ of .05 by three for a significance threshold of P <  .017. For patients presenting with ongoing major depressive episode at baseline, a statistically significantly less symptomatic score was found for quetiapine when compared to risperidone (mean CDSS = 8.52 for quetiapine versus 9.06 for risperidone). No other statistically significant findings were revealed.

While a statistically significant finding was only reported for one of the many comparisons in this study, the authors report that the effect size was quite small. For this reason, the statistically significant difference in efficacy may be clinically insignificant. Furthermore, the authors report that given the high variance of outcomes coupled with substantial loss to follow-up, the sample size of 1,460 patients with schizophrenia lacked adequate statistical power to reveal differences in depression outcomes.

Mohamed et. al.

This study is a randomized controlled trial of the effects of antipsychotics on substance abuse, comparing perphenazine to second-generation antipsychotics for patients with schizophrenia. The second-generation antipsychotics used were olanzapine, risperidone quetiapine, and ziprasidone. Patients with tardive dyskinesia were excluded from the trial, but substance use was not one of the inclusion criteria. The study was performed in a double-blind manner with clinicians also blind to treatment group. Patients were followed for up to 18 months of treatment to monitor their consumption of cigarettes, alcohol, and illicit drugs. The number of cigarettes smoked was self-reported by the patients, and clinicians interviewed the patients to determine their level of alcohol and drug use, reporting these on a standardized five-point Alcohol or Drug Use Scale.

All of the treatment groups displayed a statistically significant reduction over the course of the trial in all three substance use categories. However, the trial uncovered no significant differences in the efficacies of the therapies rendered. A major limitation of this study is that all of the substance use data were collected by surveying the subjects. Self-reporting is notoriously unreliable due to the effects that response bias can have. The results of this study may have been severely confounded by effects such as the subjects’ desire to provide socially desirable responses (Paulhus 1991).

Resnick et. al.

This article presents a randomized controlled trial on patients with schizophrenia, comparing the outcomes of treatment with first and second generation antipsychotics on patients’ employment and on their participation in psychosocial rehabilitation. All patients included in the study were interviewed at baseline and quarterly at each follow-up for 18 months, with trained interviewers completing a Lehman Quality of Life questionnaire. Treatments were administered in a double-blind manner, with interviewers also being blinded to the treatment group.

Any subject who completed at least one follow-up interview was included for analysis. However, many patients were lost to follow up, and the authors do not present figures on loss to follow up, nor do they perform an intention-to-treat analysis. For these reasons, the findings have a high risk of selection bias.

The authors do find a significant improvement in the percentage of participating subjects with paid employment over time for all groups, but no significant differences between the different medications used. However, this may be confounded by a possible association between those patients who experienced better outcomes overall being more likely to remain in the study.

Synthesis of findings

No significant differences have been found in the efficacy of treatment with perphenazine as compared with second generation antipsychotics for the management of schizophrenia on the basis of substance use, symptoms of depression, or participation in employment and rehabilitation. However, similar efficacy coupled with a reduction in side effects may make some of the newer atypical antipsychotics a better choice in some cases.

DISCUSSION OF CASE

Ethical dilemma

A significant issue that arose is the need for the patient to make informed consent. A mentally ill patient may or may not be competent to consent. Schizophrenia is known to produce psychiatric symptoms which can include delusions and impaired cognition. Decisional capacity can be impaired to widely differing degrees between individuals, depending on factors such as the severity of the disease, ongoing medical management, and participation in psychosocial rehabilitation programs (Palmer 2005).

Current literature presents several conditions that are necessary to establish capacity to consent. We identified four Necessary Conditions for Informed Consent (Staden 2003) that needed to be confirmed:

  1. a mental disorder should not prevent a patient from understanding what s/he consents to;
  2. a mental disorder should not prevent a patient from choosing decisively for/against the intervention;
  3. a mental disorder should not prevent a patient from communicating his/her consent (presuming that at least reasonable steps have been taken to understand the patient’s communication if present at all), and
  4. a mental disorder should not prevent a patient from accepting the need for a medical intervention.

While the presence of negative symptoms such as avolition reduce patients’ decisional capacity, positive symptoms such as delusions are not significantly associated with any such deficit (Moser, 2002). This indicates that our patient is at a lower risk for incapacity based on her present symptom profile which does not include negative symptoms.

Discussion of the treatment options with the patient included having her explain verbally understanding of the nature of the treatments. She was able to communicate a thorough description in her own words of the procedures involved along with their timeline and prognosis, indicating that she meets criterion 1. Likewise, she had actively sought treatment and expressed modest enthusiasm for new removable prostheses, stating that she wanted to move forward with the treatments. Communication of her consent to treatment verbally and in writing satisfies criteria 2, 3, and 4. Given that the patient meets all of the above criteria and displays no signs of impaired cognition, her consent was determined to be valid and treatment was initiated.

Patient and problem

As of February 2018, the patient has completed the treatment plan without incident. Although she was informed of the need to place clasps on her teeth, she does complain that the appearance of the clasps on the upper right do compromise the appearance of her smile as seen in Figure 1. However, as discussed in advance with the patient and with faculty, these clasps in the esthetic region are necessary for retention of the maxillary appliance. She is satisfied with the fit, comfort, and chewing efficiency of her removable partial dentures. The crowns and restorations, seen in Figure 2, do not present any problems at this time, and the patient is on a six month recall schedule for her low caries risk

CONCLUSION

The heterogeneity of schizophrenia make it both difficult to study and complex to treat. Many trials have experimentally compared perphenazine to second-generation antipsychotics for the management of schizophrenia, but no treatment has emerged as a clear choice applicable to most cases. Despite the high prevalence of schizophrenia and the profound consequences that it can have for those affected by it, safe and effective management of schizophrenia remains an ongoing topic of research. Existing medications and psychosocial interventions cannot be expected to definitively treat schizophrenia, and antipsychotics still pose a risk of severe side effects including tardive dyskinesia.

Patient AM is fortunate to have not suffered any of the more severe symptoms which schizophrenia can manifest, such as hallucinations, bizarre delusions, or disordered cognition. For at least five years her home care has been good and she has been having dental and psychiatric care at regular recare intervals, and it is critical to her oral, mental, and general health that this trend continue. Given the importance of home care and maintenance, it is imperative that all healthcare providers of patients with mental illness implore them to regularly visit the dentist.

The intent of this report is to explore treatment options for management of the patient’s delusions in the context of dentistry and its interaction with general health. Given the current state of research, the answer to the clinical question “Is there a difference in efficacy of second generation antipsychotics compared to perphenazine for the treatment of schizophrenia?” is no. There does not appear to be any clinically significant difference in efficacy between perphenazine, which patient AM currently takes, as compared with any of the investigated second-generation antipsychotic alternatives. However, the potential side effects of any antipsychotic warrant careful monitoring by both dentist and psychiatrist, and second-generation antipsychotics present an acceptable alternative for her in case signs of neurologic side effects are detected.

REFERENCES

  1. Addington, Donald E., et al. “Impact of second-generation antipsychotics and perphenazine on depressive symptoms in a randomized trial of treatment for chronic schizophrenia.” The Journal of clinical psychiatry 72.1 (2011): 75.
  2. American Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM-5®). American Psychiatric Pub, 2013.
  3. Andreasen, Nancy C., and Michael Flaum. “Schizophrenia: the characteristic symptoms.” Schizophrenia bulletin 17.1 (1991): 27.
  4. Buckley, Peter F., et al. “Psychiatric comorbidities and schizophrenia.” Schizophrenia bulletin 35.2 (2008): 383-402.
  5. Casamassimo, Paul S. “Relationships between oral and systemic health.” Pediatric Clinics 47.5 (2000): 1149-1157.
  6. Dickinson, Dwight, et al. “General and specific cognitive deficits in schizophrenia.” Biological psychiatry 55.8 (2004): 826-833.
  7. Fischer, Bernard A., and Robert W. Buchanan. “Schizophrenia in adults: Clinical manifestations, course, assessment, and diagnosis.” (2012).
  8. Hendricson, William D., and Peter A. Cohen. “Oral health care in the 21st century: implications for dental and medical education.” Academic Medicine 76.12 (2001): 1181-1206.
  9. Kane, John M., and James M. Smith. “Tardive dyskinesia: prevalence and risk factors, 1959 to 1979.” Archives of General Psychiatry 39.4 (1982): 473-481.
  10. Keltner, Norman L., and Joan S. Grant. “Smoke, smoke, smoke that cigarette.” Perspectives in psychiatric care 42.4 (2006): 256-261.
  11. Kirkpatrick, Brian, et al. “The NIMH-MATRICS consensus statement on negative symptoms.” Schizophrenia bulletin 32.2 (2006): 214-219.
  12. McGrath, John, et al. “Schizophrenia: a concise overview of incidence, prevalence, and mortality.” Epidemiologic reviews 30.1 (2008): 67-76.
  13. Mohamed, Somaia, et al. “Randomized trial of the effect of four second-generation antipsychotics and one first-generation antipsychotic on cigarette smoking, alcohol, and drug use in chronic schizophrenia.” The Journal of nervous and mental disease 203.7 (2015): 486-492.
  14. Murray, Christopher JL, Alan D. Lopez, and World Health Organization. “The global burden of disease: a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020: summary.” (1996).
  15. Palmer, Barton W., et al. “Assessment of capacity to consent to research among older persons with schizophrenia, Alzheimer disease, or diabetes mellitus: comparison of a 3-item questionnaire with a comprehensive standardized capacity instrument.” Archives of General Psychiatry 62.7 (2005): 726-733.
  16. Paulhus, Delroy L. “Measurement and control of response bias.” (1991).
  17. Resnick, Sandra G., et al. “Employment outcomes in a randomized trial of second-generation antipsychotics and perphenazine in the treatment of individuals with schizophrenia.” The journal of behavioral health services & research 35.2 (2008): 215-225.
  18. Rosenheck, Robert, and Haiqun Lin. “Noninferiority of perphenazine vs. three second-generation antipsychotics in chronic schizophrenia.” The Journal of nervous and mental disease 202.1 (2014): 18.
  19. Teng, Po-Ren, Miao-Jean Lin, and Ling-Ling Yeh. “Utilization of dental care among patients with severe mental illness: a study of a National Health Insurance database.” BMC oral health 16.1 (2016): 87.
  20. Thomas, P., et al. “Correlates of hallucinations in schizophrenia: a cross‐cultural evaluation.” Schizophrenia research 92.1 (2007): 41-49.
  21. Van Staden, C. W., and C. Krüger. “Incapacity to give informed consent owing to mental disorder.” Journal of Medical Ethics 29.1 (2003): 41-43

APPENDIX A: Figures

Figure 1. Dental photography of patient: Smiling

Figure 2. Dental photography of patient: Intraoral series

APPENDIX B: Literature appraisal forms

Appendix B1: Addington et al.

APPRAISAL TOOL

For Original Studies (except diagnostic studies)

 

A.   Are the results of the study valid?

1. Did the study ask a clearly-focused question?                                 YES      O NO    O N/A

What is the research question or aim of the study (Questions 1-5  of LAF form)

What is the “focused” question:

P: The population or problem studied                              Individuals with schizophrenia

I: The intervention or exposure (Independent variable)     Second-generation antipsychotics

C: The comparison (Independent variable)                       Perphenazine

O: The outcomes considered (Dependent variable)           Degree of depression

What is the Null Hypothesis                                             There is no difference in degree of depression for individuals with schizophrenia treated with second-generation antipsychotics versus perphenazine.

 

2. Was the type of study appropriate to answer the question?  YES      O NO     O N/A

What type of study is this:

O Lab Studies        O Case history   O Descriptive Epi

Analytical Epi:          O Cross-sectional  O Case Control O Retrospective Cohort O Prospective Cohort

Experimental Epi:    ☑ Randomized Clinical Trial     O Other type of clinical trial.

 

Does the study address:

☑ Time sequence (before/after) ☑ Effect size O  Dose-response O  Consistency

O Biological plausibility   O  Uniqueness  O Alternate explanation____________________

The inherent potential for this type of study to make a statement of causation is:

☑  Very strong    O  Strong       O  Moderate    Non existent

3.  For clinical study were patients appropriately recruited and assigned?      YES      O NO    O N/A

Randomized Controlled Trial

O Computer assigned   O Randomization list ☑  Other: Not specified

Cohort Study

O  Recruitment O  Selection  O  Inclusion   O  Exclusion

Case Control Study

O  Recruitment O  Selection  O  Inclusion   O  Exclusion

 

4.  Was blinding adequate?                                                                         YES     O NO    O N/A

☑ Patients blinded ☑ Clinicians blinded ☑ Health workers blinded  O Outcome assessor

 

5.  Were the groups similar at start of the study?                    O YES     O NO    ☑ Not Specified

O Table, or  O Data, with baseline characteristics in:          O Methods    O  Results

 

 

6.  Except for intervention or comparison, were groups treated similarly? YES     O NO   O N/A

 

Were the controls selected in an acceptable way? (for randomized control trials)

☑ Yes  O  No

Were comparison groups appropriately selected? (for cohort studies and case-control studies)

O Yes  O  No

 

7. Was the follow up of the subjects complete enough?                               O YES     ☑ NO   O N/A

 

Were all  of the patients who entered the study properly accounted for at its conclusion

O Yes  ☑  No

Was the follow up of subjects long enough

O Yes  ☑  No

B. What are the results? (Questions 6 -14 of LAF form)

 

8.What are the overall results?

How are the results quantitatively expressed  O Odds ratio  O Relative Risk    ☑  ARR

Other outcome measure:                              ______________________

Are the results statistically significant             ☑ YES      O NO     O N/A

Are the results clinically significant                ☑ YES      O NO     O N/A

What are the numerical results                      See Table 1 attached for 32 values

 

9. How precise are the results?                                                                                               

Is a confidence interval provided                   O YES      ☑ NO     O N/A

What is the confidence interval                     ________________________

10.  Discussion and conclusion (Discussion and conclusion LAF form)

Is there a cause-effect statement                  O YES      ☑ NO     O N/A 

Were the findings of practical importance?        O YES      ☑ NO     O N/A

 

C. Will the results help locally?  ( Questions 15-16 of LAF form)

 

11.  Can the results be applied to the local population?                               ☑ YES     O NO    O N/A

(What is the utility of this article for your dental practice from LAF form)                             

Can you provide the same intervention in your settings          O YES      ☑ NO                  O N/A

Can the results be extrapolated to your population             ☑ YES      O NO        O N/A

Do they meet the needs and circumstances of your patients   O YES      ☑ NO                  O N/A

 

12.  Do the benefits outweigh the potential harm and actual costs?    O YES         NO    O N/A                                                        

What is the primary benefit:  Improved neurologic side-effect profile

What is the potential harm:   Weight gain, metabolic syndrome

What is the actual cost:          Increased financial cost

11.  How will this information help you with your patient? Please explain in 180 words or less.

 

This information will not be useful for my patient due to its null result. If more research in this vein were to have clinically significant findings, they could be beneficial to my patient who has experienced depression.

12.  Will you alter/support the treatment plan after reading this information and why? Please explain in 180 words or less.

At this time, this study will have no effect on my treatment plan due to its null result. My patient does report experiencing depression, but this study does not find any differences in the efficacy of the tested antipsychotics except for between risperidone and quietapine in patients suffering a major depressive episode. I would be concerned if my patient were taking risperidone, given the significant relative benefit of quietapine. It is heartening, however, that the patients in all treatment groups did display significant improvement during treatment.

Appendix B2: Mohamed et al.

APPRAISAL TOOL

For Original Studies (except diagnostic studies)

 

A.   Are the results of the study valid?

1. Did the study ask a clearly-focused question?                                 YES      O NO    O N/A

What is the research question or aim of the study (Questions 1-5  of LAF form)

What is the “focused” question:

P: The population or problem studied                              Patients with schizophrenia who abuse substances

I: The intervention or exposure (Independent variable)     Second-generation antipsychotics

C: The comparison (Independent variable)                       Perphenazine

O: The outcomes considered (Dependent variable)           Use of cigarettes, alcohol, and illicit drugs

What is the Null Hypothesis                                             There is no difference in the amount of substance abuse in patients with schizophrenia given second-generation antipsychotics versus first-generation antipsychotics.

 

2. Was the type of study appropriate to answer the question?  YES      O NO     O N/A

What type of study is this:

O Lab Studies        O Case history   O Descriptive Epi

Analytical Epi:          O Cross-sectional  O Case Control O Retrospective Cohort O Prospective Cohort

Experimental Epi:    ☑ Randomized Clinical Trial     O Other type of clinical trial.

 

Does the study address:

☑ Time sequence (before/after) ☑ Effect size O  Dose-response O  Consistency

O Biological plausibility   O  Uniqueness  O Alternate explanation____________________

The inherent potential for this type of study to make a statement of causation is:

☑  Very strong    O  Strong       O  Moderate    Non existent

3.  For clinical study were patients appropriately recruited and assigned?      YES      O NO    O N/A

Randomized Controlled Trial

O Computer assigned   O Randomization list ☑  Other: Not specified

Cohort Study

O  Recruitment O  Selection  O  Inclusion   O  Exclusion

Case Control Study

O  Recruitment O  Selection  O  Inclusion   O  Exclusion

 

4.  Was blinding adequate?                                                                         YES     O NO    O N/A

☑ Patients blinded ☑ Clinicians blinded ☑ Health workers blinded  O Outcome assessor

 

5.  Were the groups similar at start of the study?                                         YES     O NO   O N/A

O Table, or  O Data, with baseline characteristics in:          O Methods    ☑  Results

 

 

6.  Except for intervention or comparison, were groups treated similarly? YES     O NO   O N/A

 

Were the controls selected in an acceptable way? (for randomized control trials)

☑ Yes  O  No

Were comparison groups appropriately selected? (for cohort studies and case-control studies)

O Yes  O  No

 

7. Was the follow up of the subjects complete enough?                               O YES     ☑ NO   O N/A

 

Were all  of the patients who entered the study properly accounted for at its conclusion

O Yes  ☑  No

Was the follow up of subjects long enough

O Yes  ☑  No

B. What are the results? (Questions 6 -14 of LAF form)

 

8.What are the overall results?

How are the results quantitatively expressed  O Odds ratio  O Relative Risk    ☑  ARR

Other outcome measure:

Are the results statistically significant             O YES      ☑ NO     O N/A

Are the results clinically significant                O YES      ☑ NO     O N/A

What are the numerical results                      See Table 1 of attached for 55 values

 

9. How precise are the results?                                                                                               

Is a confidence interval provided                   O YES      ☑ NO     O N/A

What is the confidence interval                     ________________________

10.  Discussion and conclusion (Discussion and conclusion LAF form)

Is there a cause-effect statement                  O YES      ☑ NO      O N/A 

Were the findings of practical importance?         O YES     ☑ NO                   O N/A

 

C. Will the results help locally?  ( Questions 15-16 of LAF form)

 

11.  Can the results be applied to the local population?                               ☑ YES     O NO    O N/A

(What is the utility of this article for your dental practice from LAF form)                             

Can you provide the same intervention in your settings          O YES      ☑ NO                  O N/A

Can the results be extrapolated to your population             ☑ YES      O NO                  O N/A

Do they meet the needs and circumstances of your patients   ☑ YES      O NO                  O N/A

 

12.  Do the benefits outweigh the potential harm and actual costs?    O YES         NO    O N/A                                                        

What is the primary benefit:  Improved neurologic side-effect profile

What is the potential harm:   Weight gain, metabolic syndrome

What is the actual cost:          Increased financial cost

11.  How will this information help you with your patient? Please explain in 180 words or less.

 

This study would be most applicable to my patient if she were currently smoking and drinking or using drugs of abuse. She reports no having smoked in decades and that she does not drink or use drugs, so this information would become of interest if she were to disclose a new substance habit. Even in such a case, the null efficacy result of this study would not support any change in her antipsychotic medication.

12.  Will you alter/support the treatment plan after reading this information and why? Please explain in 180 words or less.

This study will have no effect on my treatments. It shows no significant differences in intention-to-treat analysis between the experimental groups. A finding of interest to me, although it was not the objective of the article, is that all groups underwent significant improvements over time during the course of treatment. This solidifies my belief in the value of psychiatric treatment for schizophrenia, despite not finding any specific antipsychotic medication having better outcomes than any other.

Appendix B3: Resnick et al.

APPRAISAL TOOL

For Original Studies (except diagnostic studies)

 

A.   Are the results of the study valid?

1. Did the study ask a clearly-focused question?                                 YES      O NO    O N/A

1. Did the study ask a clearly-focused question?                                ☑ YES      O NO    O N/A

What is the research question or aim of the study (Questions 1-5  of LAF form)

What is the “focused” question:

P: The population or problem studied                              Individuals with schizophrenia

I: The intervention or exposure (Independent variable)     Second-generation antipsychotics

C: The comparison (Independent variable)                       Perphenazine

O: The outcomes considered (Dependent variable)           employment and participation in psychosocial rehabilitation

What is the Null Hypothesis                                             There is no difference in employment or participation in psychosocial rehabilitation for individuals with schizophrenia treated with second-generation antipsychotics versus perphenazine.

 

2. Was the type of study appropriate to answer the question?  YES      O NO     O N/A

What type of study is this:

O Lab Studies        O Case history   O Descriptive Epi

Analytical Epi:          O Cross-sectional  O Case Control O Retrospective Cohort O Prospective Cohort

Experimental Epi:    ☑ Randomized Clinical Trial     O Other type of clinical trial.

 

Does the study address:

☑ Time sequence (before/after) ☑ Effect size O  Dose-response O  Consistency

O Biological plausibility   O  Uniqueness  O Alternate explanation____________________

The inherent potential for this type of study to make a statement of causation is:

☑  Very strong    O  Strong       O  Moderate    Non existent

3.  For clinical study were patients appropriately recruited and assigned?      YES      O NO    O N/A

Randomized Controlled Trial

O Computer assigned   O Randomization list ☑  Other: Not specified

Cohort Study

O  Recruitment O  Selection  O  Inclusion   O  Exclusion

Case Control Study

O  Recruitment O  Selection  O  Inclusion   O  Exclusion

 

4.  Was blinding adequate?                                                                         O YES     O NO    O N/A

☑ Patients blinded ☑ Clinicians blinded ☑ Health workers blinded     O Outcome assessor

 

5.  Were the groups similar at start of the study?                                         YES     O NO   O N/A

☑ Table, or  O Data, with baseline characteristics in:         O Methods    ☑  Results

 

6.  Except for intervention or comparison, were groups treated similarly? YES     O NO   O N/A

 

Were the controls selected in an acceptable way? (for randomized control trials)

☑ Yes  O  No

Were comparison groups appropriately selected? (for cohort studies and case-control studies)

O Yes  O  No

 

7. Was the follow up of the subjects complete enough?                               O YES     ☑ NO   O N/A

 

Were all  of the patients who entered the study properly accounted for at its conclusion

O Yes  ☑  No

Was the follow up of subjects long enough

O Yes  ☑  No

B. What are the results? (Questions 6 -14 of LAF form)

 

8.What are the overall results?

How are the results quantitatively expressed  ☑ Odds ratio O Relative Risk    O  ARR

Other outcome measure:

Are the results statistically significant             O YES      ☑ NO     O N/A

Are the results clinically significant                O YES      ☑ NO     O N/A

What are the numerical results                      See Table 2 in attached article for 24 outcome values

 

9. How precise are the results?                                                                                               

Is a confidence interval provided                   ☑ YES      O NO     O N/A

What is the confidence interval                     See Table 2 in attached article for 24 outcome values

10.  Discussion and conclusion (Discussion and conclusion LAF form)

Is there a cause-effect statement                  O YES      ☑ NO     O N/A 

Were the findings of practical importance?        O YES      ☑ NO     O N/A

 

C. Will the results help locally?  ( Questions 15-16 of LAF form)

 

11.  Can the results be applied to the local population?                               ☑ YES     O NO    O N/A

(What is the utility of this article for your dental practice from LAF form)                             

Can you provide the same intervention in your settings          O YES      ☑ NO                  O N/A

Can the results be extrapolated to your population             ☑ YES      O NO                  O N/A

Do they meet the needs and circumstances of your patients   ☑ YES      O NO                  O N/A

 

12.  Do the benefits outweigh the potential harm and actual costs?    O YES         O NO    N/A                                                           

What is the primary benefit:  Improved neurologic side-effect profile

What is the potential harm:   Weight gain, metabolic syndrome

What is the actual cost:          Increased financial cost

11.  How will this information help you with your patient? Please explain in 180 words or less.

 

This study affirms to me the appropriateness of using an older, first generation antipsychotic. I have, on the basis of this article, no reason to believe that a second generation antipsychotic would cause any improvement in the patient’s condition relative to her existing treatment.

 

12.  Will you alter/support the treatment plan after reading this information and why? Please explain in 180 words or less.

This null result will have no influence on the treatment plans that I make for my patients with schizophrenia. I would support continuing on her current psychiatric medication provided the continued absence of neurologic symptoms, because it is not of worse efficacy but it does cost less than newer antipsychotics.

 

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