Poor Compliers Research Articles

Randomised trial of laxatives in treatment of childhood encopresis

Primary faecal incontinence (encopresis) in children is usually treated with laxative medication and a behaviour modification programme aimed at promoting regular toileting, but the effectiveness of laxatives has never been adequately investigated. 169 children with encopresis and evidence of stool on plain abdominal radiograph were randomly allocated to receive multimodal (MM) therapy (laxatives plus behaviour modification; n=83) or behaviour modification alone (BM; n=86). Mean (SD) follow-up was 55·1 (27·0) weeks and 56·7 (32·0) weeks, respectively. By 12 months follow-up 42 (51%) of the MM group and 31 (36%) of the BM group (p=0·079) had achieved remission (at least one 4 week period with no soiling episodes) and 52 (63%) vs 37 (43%) (p=0·016) had achieved at least partial remission (soiling no more than once a week). MM subjects achieved remission significantly sooner than BM subjects, and the difference in the Kaplan-Meier remission curves was most striking in the first 30 weeks of follow-up (p=0·012). The patterns of compliance with toileting in the treatment groups were almost identical, although about 1 in 8 children overall did not comply with the sitting programme. After exclusion of the 24 poor compliers, there was no significant difference between BM and MM groups. This study shows a clear advantage overall for the use of laxative medication, although the benefit may not be as great for children who are able to maintain regular toileting.

Liver copper concentration in Wilson‘s disease: Effect of treatment with ‘anti‐copper’ agents

Serial copper determinations have been made on the livers of 10 patients with Wilson's disease. Two were studied before and eight after the start of treatment in order to assess the effect, if any, on the concentration of the metal. In two patients who were receiving no therapy and in one in whom it had been discontinued, the level of copper rose. In the latter patient, resumption of treatment then resulted in a fall in the level of copper in the liver. A similar fall was seen in seven patients on continuous therapy. In one patient, a very poor complier, there was a tendency for the liver copper concentration to rise over a 5-year period. All three therapies investigated--penicillamine, trientine and tetrathiomolybdate--when taken regularly, appear to be effective in reducing liver copper levels. Sixty-nine single determinations of liver copper have been plotted against time on treatment. This shows that the copper concentration falls rapidly in the first year. Thereafter, there is no linear relationship between the duration of treatment and liver copper. Poor compliers have a higher liver copper concentration than do good compliers. Determinations made from different portions of the liver showed that in only one of 19 examples was there an overlap between the near normal and the abnormal range. The principal mechanism of action of 'anti-copper' agents in Wilson's disease appears to be the mobilization of copper from the tissues, but a secondary detoxifying action may come into play later.

A Randomized Placebo-Controlled Trial of Cysteamine Eye Drops in Nephropathic Cystinosis

Eighteen patients with nephropathic cystinosis who were younger than 42 months and 11 patients 4 to 31 years of age were entered into a double-masked, randomized, placebo-controlled trial of topical cysteamine eye drops between November 1985 and September 1989. Eight of the younger patients and 2 of the older patients showed marked clearing of corneal crystals in one eye compared with the fellow eye. When the code was broken, all 10 patients were found to have received cysteamine eye drops in the improved eye. Of the remaining 19 patients 4 were unavailable for follow-up. In 15 patients no marked difference was noted between the two eyes. Eight have presumably been in the protocol for too short a time and several have been poor compliers with the therapy. These results not only demonstrate the potential for primary prevention of corneal crystal deposition but also, for the first time, offer the possibility of reversing the corneal complications of cystinosis in older patients.

The use of a run‐in to enhance compliance

With a run-in, potential subjects are given practice with all or part of the study protocol prior to randomization. The purpose is to exclude poor compliers from the trial and randomize only proven, good compliers. The feasibility of a run-in and the net benefit derived from that strategy depend upon the difficulty of the protocol; the availability of compliance aids during the trial; and the impact of the chosen common practices for all subjects during the run-in on the post-randomization event rates of the groups and the post-randomization blinding of study subjects to their treatment assignments. Two detailed examples of the use of a run-in are presented along with six general recommendations to guide the use of a run-in.

Effectiveness of iron supplementation compared to iron treatment during pregnancy

This study presents the evaluation of an iron supplementation program in a community by comparing 478 pregnant women who received iron supplementation from the 4th month of pregnancy, with 392 pregnant women who received iron treatment only if their Hb level was less than 12 gm/dl, and had no supplementation. In the supplementation group, no statistically significant associations were found between compliance with age, education, social class or parity. Pregnant women of European-American origin showed higher rates of good compliance than those of Asian-African origin. The mean decrease of haemoglobin (Hb) and haematocrit (Hct) between the second and third trimester of pregnancy was smaller in the supplementation group (-0.9 gm/dl Hb, -2.1% Hct) than in the treatment group (-1.1 gm/dl Hb; -3.3% Hct). The differences between the two groups were significant only for the Hct levels (P = 0.022). The mean Hb and Hct levels during the third trimester of pregnancy were higher for good compliers (11.7 gm/dl Hb; 33.6% Hct) than for poor compliers (11.4 gm/dl Hb, 32.6% Hct).

Preventive use of exercise rehabilitation after myocardial infarction.

Randomized controlled clinical trials of exercise after myocardial infarction, although difficult to compare, have not shown a reduction in mortality or morbidity. However, physiological and psychological improvements occur that enable patients to improve their quality of life. The effectiveness of exercise programmes is impaired by poor patient compliance. Some characteristics of poor compliers may be identified, but it is safer to assume all participants are potential non-compliers, and to apply compliance-improving strategies within exercise programmes. The authors' experience has indicated that a number of strategies may be followed at little cost. These include a spouse support programme, a written agreement to participate, self-control techniques including self-monitored exercise testing, and group discussion periods.

Differences in dental experiences, practices, and beliefs of inner-city and suburban adolescents.

Inner-city and suburban students' dental experiences, current practices, beliefs, and compliance with two school-based preventive programs were examined. Striking differences were found in the students' dental experiences, practices, and beliefs, but few in their compliance. These findings challenge the notion that inner-city students are poor compliers and suggest ways in which practitioners and public health officials might utilize the differing practices of these populations to plan preventive programs for adolescents.

Patient compliance and the short-term treatment regimen.

Patient compliance is necessary for the delivery of adequate health care. It is a major problem that must be addressed by the medical profession. Good communication between the physician and the patient is essential. Those known to be poor compliers should be identified and special techniques used to overcome particular obstacles. Methods designed to improve patient cooperation are discussed. Emphasis is placed upon the short-term therapeutic regimen and its role in improving compliance.

Emotional disturbance and chronic low back pain.

Treated chronic low back pain patients (N = 102) in a university hospital clinic. Ss were given the EPI, the Recent LIfe Changes Questionnaire, and the Locus of Control Scale in order to isolate the principal dimensions of emotional disturbance in such patients and to see whether derived dimensions were related to response to conservative treatment for back pain. Self-report ratings of current pain intensity were obtained approximately 1 year after the start of treatment. Factor analysis revealed five factors: Distrust and alienation, somatic concern, vulnerability, extraversion, and social desirability; these accounted for 71% of the total variance among patients. Patients with above-average pretreatment distrust and alienation scores more frequently failed to return the follow-up form than patients with below-average scores. Low scores on somatic concern were related to good outcome. Results suggest that patients in alienation and distrust may be prone to be poor compliers. Because only the somatic concern dimension predicted outcome, a single scale that measures this characteristic may be sufficient for effective identification of the potential good vs. poor responders to conservative treatment of low back pain.

Dietary abuse in maintenance hemodialysis patients

Thirty-one patients on maintenance hemodialysis were studied for compliance to prescribed diet, as measured by weight gain between dialyses and changes in weekly predialysis serum potassium levels. Nineteen patients were poor compliers. Patients who remained vocationally active had a significantly higher percentage of good compliance.

Patient non-compliance within the context of seeking medical care for arthritis

The present study reveals that patients who subjectively experience a long wait when coming to see the doctor, particularly those who feel irritated over this situation tend to be poor compliers with regard to taking medications and continuing to come to the doctor as advised. Likewise, those who feel the doctor spends too little time with them, who perceive the doctor to be more businesslike than personal in the treatment relationship or who lack faith in the treatment regimen tend to be poor compliers. Collectively, these findings indicate that compliance is related to the patient's perception of temporal, relational, and treatment factors within the context of seeking medical help. The practical implication of these findings suggests that efforts to reduce prolonged waiting as well as efforts to personalize the treatment relationship and help patients overcome discouragement and pessimism may prove to be worthwhile investments on the part of those treating patients with rheumatoid arthritis. In any case, each of these factors needs further investigation under controlled conditions to more carefully determine their direct effects on compliance when some of the variables mentioned in this study are altered towards securing more compliant behavior.

Pupillary reflex shapes and topical clinical diagnosis.

We pursued the possibility that Mycobacterium kansasii might be an aetiological agent in Crohn9s disease by carrying out a trial of treatment with antimycobacterial drugs. Twenty seven patients with Crohn9s disease took part in a two year randomised double blind, crossover, controlled trial of rifampicin plus ethambutol against placebo. Fourteen patients completed the trial; four required an operation; five were withdrawn as poor compliers, and four because of adverse effects. There was no significant difference in response to the active drugs compared with placebo when expressed in terms of a Crohn9s disease activity index or any clinical indicator of disease activity. There was no suggestion that any subgroup of patients - for example, different regions of bowel affected or previous operation - were favourably affected by the drugs. There was no consistent pattern of change in prednisolone requirements although eight patients on long term sulphasalazine had a significant reduction in their plasma sulphapyridine concentrations during the active treatment period. A significant reduction in total white blood count and an increase in plasma ALT were seen during active therapy. The results of the study do not suggest that rifampicin and ethambutol have a role to play in the treatment of Crohn9s disease.