Introduction To Health Science For Randomized Controlled Trial – Critical Appraisal

Critical Appraisal of Randomized controlled trial

Discuss about the Introduction to Health Science for Randomized Controlled Trial.

Critical appraisal identifies the strong point and weak point of a research article for assessing the effectiveness and validity of the findings of that article. It is the systematic process that examine research evidence by judging its value, relevance and trustworthiness in a particular framework (LoBiondo-Wood& Haber, 2017).The given case study critically appraises two research articles based on randomized controlled trial and qualitative research respectively.

Reference: Wang, C., Schmid, C. H., Fielding, R. A., Harvey, W. F., Reid, K. F., Price, L. L., … &McAlindon, T. (2018). Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial. bmj, 360, k851.

Question 1: Did the trial address a clearly focused issue?

Yes, the trial had a focused issue to determine the efficiency of tai chi interventions in comparison with aerobic exercise amongst patients suffering from fibromyalgia. It also determined whether any dosage or duration of tai chi effects its function. Participants were randomly assigned to aerobic exercise (the comparator)and one of the four classic Yang styleadministered tai chiintervention. The outcome of the study was that the improvement in symptoms in case of Tai Chi mind-body treatment is more as compared to the mostcurrent prescribed treatment, that is,aerobic exercise. It also pointed out that longer administration of tai chi treatment showed greater improvement.

Question 2: Was the assignment of patients to treatments randomized?

Yes, patients were assigned randomly. The importance of randomization is to protect against biasness(Rosenberger &Lachin2015).It was 52 weeks, single blinded trial and was conducted in Boston, Massachusetts, at Tufts Medical Center that is a tertiary care hospital. Recruitment of patients were done by advertisements combined with enrollment via clinics in that area. Before screening, patients were telephonically contactedand were called onsite for clinical examinations based on standardized protocol. After giving an informed consent, participants who were more than 20 yearswere enrolledaccording to their eligibility criteria. These criteria were minimum three months bilateral musculoskeletal pain in waist, specific tender point pain and digital palpation with mild or more tenderness.

Moreover, they should have pain index 7 or 3-6 and the score of symptom severity should be 5 or 9 or more. They should be willing to complete the trial within stipulated timeframe of 12 weeks or 24 weeks. Exclusion criteria excludesthose patients who had already participated in this type of trial in the past six months, those who are under serious medical treatment, women who were planning to get pregnant or who were pregnant and lastly who were unable to speak English. A group of 40 to 50 participants were randomized in six consecutive enrollment cycles. Each of this cycle consisted of two intervention groups, one of aerobic exercise and other with tai chi intervention groups.Educational informations about physical activity and home practiceswere given to five groups. A session of tai chi for 60 minutes were conductedonce or two times a week to participants for twelve weeks or twenty-four weeks and aerobic exercise lasted for almost 60 minutes two times a week for twenty-four weeks. Participants were told to perform these tai chi or aerobic exercise at least 30 minutes a day and even after 12 or 24 weeks session, they should continue this for 52 weeks of follow-up. Their attendance were maintained in an attendance sheet and staffs contacted them telephonically in every month for encouraging them to perform these regularly.

Question 1: Did the trial address a clearly focused issue?

The allocation system was concealed to researchers only. Clinical trials are conducted in anyone of the three ways, that is, un-blinded where both patient and researchers are aware about everything about the study, double-blinded where both patient and researchers are unaware and lastly single-blinded, where only researchers are aware but participants are unaware of it. This is a single- blind trial where the subject was ignorant about their assigned group whereas researchers aware of this and vice-versa (Friedman et al., 2015). Here two groups were considered within which one in aerobic exercise intervention group and other with tai chi intervention group. Researchers were unaware of this.

Question-3Were all of the patients who entered the trial properly accounted for at its conclusion?

867 patients were prescreened telephonically, amongst them,some were excluded and some declined to participate. 272participants were assessed who met all eligibility criteria. Finally 226 participants were randomized, among them 151 were assigned to tai chi groups and 75 were assigned to aerobic exercise group. Among 151 participants of tai chi group, 105 participants completed 52 weeks and among 75 participants, 53 participants completed 52 weeks.

Question-4 Were patients, health workers and study personnel ‘blind’ to treatment?

Study personnel and health workers were blind to this treatment and patients were awareas this is a single blinded trial.

Question-5 Were the groups similar at the start of the trial?

Yes, it was consisted of participants of 21 years or more from the day of screening. 52 years was the mean age of the participant, women were 92% and diverse racial or ethnic composition was present that is 61% white.

Question-6 Aside from the experimental intervention, were the groups treated equally?

Yes, groups were treated equally beside experimental interventions.Twelve or twenty four weeks of Tai chi interventions were given once or two times a week for 60 minutes andtwenty four weeks of aerobic exercise interventions were given two times a week.

Question-7 How large was the treatment effect?

Evaluation of each participant was done at baseline, 12, 24 and 52 weeks of trial. Crucial clinical outcomes that mainly concentrated on severity of symptoms score and pain indexwere assessed. Moreover, evaluation of secondary, physical andpsychosomaticaspects of fibromyalgia were also done.

Primary outcome was clearly specified. It measured the modification in revisedFibromyalgia Impact Questionnaire (FIQR)overall score from the day of screening to 24 weeks visit. A multidimensional instrument, FIQR, usually measures the severityof fibromyalgia and the score ranges from 0-100(Salaffi et al., 2015). Low score means less severity whereas high score indicates greater impact of symptoms.In comparison to baseline, FIQR score improvedmore in case of participants who undertook tai chi interventions at the end of 24 weeks.A slow improvement is observed in case of participants who undertook aerobic intervention.The difference between groups as observed by FIQR score is 5.5 points. As compared to participants who received aerobic exercise interventions, tai chi interventions for 24 weeks showed greater improvement. The difference in their score is 9.6 points.

Question 2: Was the assignment of patients to treatments randomized?

Secondary outcome is based on the measurement done during baseline, and at 12, 24 and 52 weeks of clinical trial. Patients’ global assessment was done using visual analog scale and the score was 0.9 points,, HADS (hospital anxiety and depression scale) score was 1.2 points, the arthritis self-efficacy scale score was 1.0 points and coping strategies score was 2.6 points.

Question-8 How precise was the estimate of the treatment effect?

This study had some confidence limits. Researchers informed patients that the study was designed to test the efficacy of two different types of exercise programs to eliminate the risks of previousbeliefs and prospects. Patient also missed many classes and there is a difference in attendance between two groups. This effected the evaluation result. There were many instances of considerable loss to follow up of participants and henceaffected correct estimation of result. Another main issue of tai chi intervention was that it always required an extensive instructions and practice for its effective implementation. Many participants failed to continue that.

Question-9 Can the results be applied to the local population, or in your context?

This treatment can be applied to the local population if they are trained properly. Based on inclusion and exclusion criteria, participants will be selected and excluded. One of the main requirement of this trial is the availability of proper instructors who has been trained to work with a physically weakened population. Moreover, tai chi is a Chinese martial art that is not so familiar to many potential users (McAnulty et al.,2016).

Question-10Were all clinically important outcomes considered?

More or less all clinically important outcomes were considered. Both primary and secondary outcomes were analyzed considerably. This trial also considered some adverse events and some safety proceduresduring the intervention period that are also clinically important. Moreover, this also recorded changes in usage of analgesics, antidepressants and many others and recommended no changes in medical therapy.

Question-11Are the benefits worth the harms and costs?

Tai chi is a non-drug therapy and an ancient form of exercise. It has shown its benefits on different physical and psychological aspects(Hall et al., 2017).Fibromyalgia is a chronic disorder that is marked by the presence of musculoskeletal pain, sleep disturbance, fatigue and psychological impairment (Dolan, Tung, &Raizada, 2016).). No such curable treatment has yet been identified that has a long-term effect. Drug administration includes the usage of various analgesics. Manypatient discontinue their therapies due to intolerance to the drug, low efficacy and toxicity(Allen, 2017). Administration of opioids for long time carries risk of dependency (Anderson, 2017).Pharmacology thus failed to improve the condition of patients with fibromyalgia. Tai chi, on the other hand is a natural way to cure the disease if performed regularly. Though it is a slow process, requires proper training and also costly, many trials suggested that it is the most effective way to decrease acute pain in Fibromyalgia patients(Segura-Jiménez et al., 2014).

Question-3 Were all of the patients who entered the trial properly accounted for at its conclusion?

Reference: Livingston, G., Leavey, G., Manela, M., Livingston, D., Rait, G., Sampson, E., …& Cooper, C. (2010). Making decisions for people with dementia who lack capacity: qualitative study of family carers in UK. BMJ, 341, c4184.

Yes, this research had a clear statement and it identifies some difficult decisions that family carers made for people suffering from dementia and the benefits and barriers to such decisions.There is an increase in worldwide mortality rates of dementia. Patient need sufficient care in the last phase of their life (Hendriks et al., 2014). This study mentioned some information for overcoming those barriers. This research helped in decisions implementation by several strategies. It introduced a slow change and organized some legal changes for both carer and the patient. It also involved a professional to encourage the patient for service acceptation and emphasized on an improved, non-impeded and independent service. The relevance of this research was that it also suggested some strategies to access these services. It mentioned that carers should prepare patients’ general practice appointment, shouldaccompany them to the surgery, pointed out signsand symptoms, should interact with patient to gain permissions for obtaining confidential informations and should use professional’s authority for gaining agreement from patient. 

The qualitative methodology is quite appropriate. The methodology defined the family carer as an adult member or friend of a family who was willing to give an unpaid support to people who are suffering from dementia. It has selected individual with diverse socioeconomic characteristics that is of different sex, age, religion, education level and ethnicity. Moreover, both newly referred and experienced carerare selected in order to cover the broad spectrum of experiences and views and achieve maximum variation.

Yes, researchers clearly defined the methods of conducting the study. It was conducted in two phases. Initial phase was based on generation of a list of common areas reported by family carersfor making difficult decisionsfor recipient of care. Second phase was based on an interview where each domain was discussed in depths with the family carers who had trouble in making decisions in those particular topics.For identifying patient in primary and secondary care in each phase, researchers used slightly different approaches. In primary care, they identified patients with dementia by general practices and wrote to their carer to know whether they are willing toapproach. In secondary care, researcherwrote to the carers directly to the known carers who were already agreed to participate in the study. The clinician latter explained the study to the carer and provide them an information sheet. During the interview, there was an one-to-one interaction with participants about many aspects of decision making. The researchers identified many dilemmas and they gave proper advices to overcome their problems. Interview session was continued until a saturated data was obtained and analyzed.

Question-4 Were patients, health workers and study personnel ‘blind’ to treatment?

The recruitment strategy included two phases. First phase included the allocation of participants to focus group. In this group, participants who shared similar experience were included for maintaining a homogeneity. It comprised of people who cared their parents, spouses, people who were living in home cares and people with early onset dementias. Researcher facilitated discussions based on some topic that guide carers’ attitude, experiences, feelings and some belief. Second phase included individual interviews that covered topics such as choices, obstacles and helpers in the process of decision-making, some spiritual, cultural and religious beliefs and practices. It also included some dilemmas that a person gone through during decision-making, consequences and some advice that would help them to overcome. Interviews were conductedfor many days until researchers obtained a saturation level in collected data.

The setting for the data collection was justified. The researchers recorded the entire interview and discussion, transcribed them exactly and preserved anonymity by removing identifiable informations.

They also gave a clear view about how data were collected. They organized focus group and semi-structured interview. As mentioned before, in focus group a sufficient homogeneity was maintained that enabled them to provide information by using a topic guide. Individual interview covered all the five areas and subjects that were identified in focus group. They discussed with the participants about their personal accounts of making decisions deeply and gave them advices and suggestions to overcome their problems.

The researcher hadclarified the interview method in detail. There was an indication of how interviews are conducted. They used a topic guide to facilitate the discussion that highlighted the areas such as carers’ experiences, feelings, attitudes,cultural, social and religious beliefs and practices. Interview process followed one-to-one interaction and deeply discussed these topics and about the facilitators and barriers in decision making processes. Methods were not modified during the study.The form of data was clear and was analyzed explicitly. The interview was digitally recorded, anonymity preserved and exactly transcribed. They used Atlas.ti 5.2, a research software program for coding, managing and analyzing data. Transcripts of individual interviews were sent to participants for further alterations. It was ensured by the participants that the transcript was a true record of what they desired to say. Moreover, informed consent was given by the carers and they could not been identified since researchers deliberately gave non-specific demographic informations. The researcher mentioned saturation of datawas achieved only after many rounds of interviews.

Question-5 Were the groups similar at the start of the trial?

The researcher critically examined their own role during formulation of the research questions. In both focus group and in individual interview an interaction between researchers and participants taken place. There was an interactive session where participants shared all their problems and barriers they faced during the process of decision-making. In phase 1, their problems on five particular areas were identified after discussion and in phase 2, researchers interact with individual participants to resolve those problems more deeply by giving them some advices. Participants were from inner and outer London.

Researchers analyzed the focus group data to yield a broad range of views on current barriers of decision-making. In individual interviews, they developed their coding frame to cover all previously raised subjects and areas. Two separate raters were usedthat code all data independently and ensure consistency.To cope up with the emergent themes and frames the team met periodically to refine interviews.

Yes, researchers gave all the participants an informed consent to order to get their permission. Informed consent covered all the topics and methods to be covered during the study in detail. Ethics committee has an important role in clinical studies (Resnik, 2015). They approved the study protocol and allowed researchers to conduct the study.

There was an in-depth description of the analysis process. They recorded the interview process and preserved privacy. They used research software programme Atlas .ti 5.2 for proper analysis. The researcher explained that the data presented were selected from the original sample to validate the analysis process. They developed two raters that coded all data independently to ensure trustworthiness. In case of any disagreements between the raters, a discussion process was held between participants and researchers to resolve this. Sufficient data were presented to support the findings. Interviews were conducted continuously until and unless a saturation of data was obtained. In case of any contradictory data, researchers discussed with the participants to resolve it.

Findings describe the socio-demographic features of 43 focus group participants and 46 individual interviewees. As per the objective, it identified five problematic areas of decision making in dementia patient for family members. These included

• patient’s refusal to help for accessing health and social services in dementia,
• problem in timing, quality of care,previous beliefs in cultural values and promises obstructfor home care placement,
• problem in maintaining autonomy and taking new role in legal matters,
• ethical, cultural and timing problemfor deciding on non-dementia related health care,
• Problem in quality of care if the carer was too ill to care.

It also identified some facilitators for decision making as well. Carers should accompany patients to professionals, they should give them social support and both professionals and carers should allow the service to develop slowly.

This is a valuable research as it deals with each barriers of decision making in detail. It also identifies various facilitators in decision making after interacting with family carers practically via interview process. It pointed out that their active resistance intensified difficulties in decision making for people suffering from dementia. Always legal authority is not enough to cope with this. Family members have to give immense care to these people. Psychological intervention is more effective as compared to medicines (Brooks et al., 2017). This study also mentions many strategies for carers and professionals.

Question-6 Aside from the experimental intervention, were the groups treated equally?

This study raises some new areas of research.Some unanswered questions are should doctors routinely ask patient to tell their medical details to their close friends, or under certain circumstances? Researchers produced leaflets to help the participants, but the impact of these leaflets were yet to be evaluated in further research.

References:

Allen, L. M. (2017). Prior Authorization of Analgesics, Narcotic Long Acting and Analgesics, Narcotic Short Acting–Pharmacy Services.

Anderson, T. (2017). Curbing prescription opioid dependency: an epidemic of overdoses and deaths from opioids is fuelled by increased prescribing and sales in North America. Bulletin of the World Health Organization, 95(5), 318.

Brooks, D., Fielding, E., Beattie, E., Edwards, H., & Hines, S. (2017). Effectiveness of psychosocial interventions on the psychological health and wellbeing of family carers of people with dementia following residential care placement: a systematic review protocol. Jbi database of systematic reviews and implementation reports, 15(5), 1228-1235.

Dolan, L., Tung, L. D., &Raizada, S. R. (2016). Fibromyalgia in the Context of Rheumatoid Arthritis: A Review. Fibrom Open Access, 1(103), 2.

Friedman, L. M., Furberg, C., DeMets, D. L., Reboussin, D., & Granger, C. B. (2015). Fundamentals of clinical trials. Springer-Verlag.

Hall, A., Copsey, B., Richmond, H., Thompson, J., Ferreira, M., Latimer, J., & Maher, C. G. (2017). Effectiveness of tai chi for chronic musculoskeletal pain conditions: updated systematic review and meta-analysis. Physical therapy, 97(2), 227-238.

Hendriks, S. A., Smalbrugge, M., Hertogh, C. M., & van der Steen, J. T. (2014). Dying with dementia: symptoms, treatment, and quality of life in the last week of life. Journal of Pain and Symptom Management, 47(4), 710-720.

Livingston, G., Leavey, G., Manela, M., Livingston, D., Rait, G., Sampson, E., …& Cooper, C. (2010). Making decisions for people with dementia who lack capacity: qualitative study of family carers in UK. BMJ, 341, c4184.

LoBiondo-Wood, G., & Haber, J. (2017). Nursing Research-E-Book: Methods and Critical Appraisal for Evidence-Based Practice. Elsevier Health Sciences.

McAnulty, S., McAnulty, L., Collier, S., Souza-Junior, T. P., & McBride, J. (2016). Tai Chi and Kung-Fu practice maintains physical performance but not vascular health in young versus old participants. The Physician and sports medicine, 44(2), 184-189.

Resnik, D. B. (2015, December). What is ethics in research & why is it important. In ideas.

Rosenberger, W. F., &Lachin, J. M. (2015). Randomization in clinical trials: theory and practice. John Wiley & Sons.

Salaffi, F., Ciapetti, A., Gasparini, S., Atzeni, F., Sarzi-Puttini, P., &Baroni, M. (2015). Web/Internet-based telemonitoring of a randomized controlled trial evaluating the time-integrated effects of a 24-week multicomponent intervention on key health outcomes in patients with fibromyalgia. Clinical and experimental rheumatology, 33(1Suppl 88), S93-101.

Segura-Jiménez, V., Romero-Zurita, A., Carbonell-Baeza, A., Aparicio, V. A., Ruiz, J. R., & Delgado-Fernández, M. (2014). Effectiveness of tai-chi for decreasing acute pain in fibromyalgia patients. International journal of sports medicine, 35(05), 418-423.

Wang, C., Schmid, C. H., Fielding, R. A., Harvey, W. F., Reid, K. F., Price, L. L., … &McAlindon, T. (2018). Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial. bmj, 360, k851.