Interventions for enhancing medication adherence
Referencias
References to studies included in this review
References to studies excluded from this review
References to studies awaiting assessment
References to ongoing studies
Additional references
References to other published versions of this review
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Methods | Patients were randomly assigned to the intervention or control group using a sealed envelope technique. | |
| Participants | Seventy‐six dyspeptic patients, who at endoscopy were found to have gastritis, duodenitis or ulceration, and a positive H. pylori urease test, were recruited. Patients were excluded if they were unsuitable for eradication therapy or hypersensitive to its ingredients. | |
| Interventions | After diagnosis and enrollment, all patients were to be prescribed a 1‐week regimen of lansoprazole 30 mg/d, amoxicillin 1 g bid, and clarithromycin 500 mg bid. p Control patients were treated according to normal hospital procedures. They were given a letter to be given to their GP with the recommendation to start triple‐therapy and a letter explaining the nature of infection, the need for treatment and the importance of compliance (ambiguous in the article, but it seems that the latter letter went to the patient rather than (just) their doctor). | |
| Outcomes | Compliance Measurements 1) Patient interview by telephone (structured questionnaire) by the same pharmacist for both groups, after the intended end of the eradication course 2) Pill counts on returned medication when patients returned for a urea breath test. Patient clinical outcome measures included: | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | If children coming in on Monday received pre‐packed tablets, those who came in on Tuesday received syrup. The formulation assigned to a particular day changed from week to week. 155 received pre‐packed chloroquine tablets, and 146 received syrup. | |
| Participants | Children aged 0‐‐5 years diagnosed with malaria at the clinic over a 6‐week period received either pre‐packed tablets or syrup by random assignment (n=301). | |
| Interventions | Chloroquine tablets were dispensed in polythene packages divided into three parts each containing the daily dose. The brand of tablets used for this study easily dissolved in water to form a homogenous suspension. Caregivers were advised at the dispensary to crush the tablets and to add a little honey or sugar to the mixture to mask its bitter taste. Staff of the health centres pre‐packed the chloroquine on a weekly basis. Packages were available for eight treatment regimes based on weight. The other group got chloroquin syrup. | |
| Outcomes | The measure used to dispense the medication (in the case of syrups), frequency and duration of administration. A standard graded measuring syringe was used to assess the volume of the implement used for measuring the dose at home, and then compared adherence to treatment and its cost between the two groups. | |
| Notes | They did vary which day of the week was assigned to which intervention ‐ this is closer to a cluster randomized trial. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | D ‐ Not used |
| Methods | Random allocation by sealed envelope technique. Blinding of patients or staff to the experimental treatment that individual patients were receiving was not performed, however, contacts/care givers of control patients were kept separate from those of the intervention group. | |
| Participants | Patients meeting the following diagnostic criteria were included in the study: recurrent episodes of wheezing or dyspnea, objective evidence of significantly increased airflow resistance during episodes, objective evidence of improvement in airflow when symptom free. Patients excluded from the study were those less than 18 years of age, those who refused to participate, or those with another pulmonary or severely debilitating disease that may have confused result interpretation. | |
| Interventions | Patients randomised to the control or usual care group were provided with a standardised set of asthma pamphlets which contained comprehensive information about asthma. No special steps, however, were taken to ensure that patients actually read the pamphlets, and no special counselling, support groups, or systematic encouragement beyond routine physician encouragement were provided. While patients in the interventional self‐management group were also provided with the standardised asthma pamphlets, they in addition were provided with a skill‐oriented self‐help workbook, a one‐to‐one counselling session, and were subject to several adherence‐enhancing strategies, such as attending an asthma support group and receiving telephone calls from a health educator. Physicians emphasised these skills at regular clinic visits. A standard protocol for classifying patients in terms of level of severity and for relating their treatment regimen to their level of severity was employed. | |
| Outcomes | Measurement of adherence: Three outcome measures directly assessed adherence to recommended regimens: a ten‐item observational checklist to assess inhaler use skills, self‐report scales to determine adherence to medications and inhaler use, and subjective assessment on a three‐point scale by a project staff member. Measurement of health care outcomes: Four status scales were employed in assessing health care outcomes: the first assessed the severity of asthma symptoms during the past seven days, the next focused on psychological/psychosomatic aspects of asthma (whether the patients were 'bothered' by asthma in the past seven days), the next scale assessed the number of episodes of respiratory problems/diseases experienced in the last three months, and the final scale measured whether asthma had interfered with the patients' lives in the last three months (prevented them from doing something). | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Random allocation without indication of concealment. | |
| Participants | Mild‐moderate hypertensive patients who, at the time of study entry, were adequately controlled with a regimen of metoprolol 200 mg (range 150‐250 mg) daily, or propranolol 160 mg (range 120‐200 mg) daily, either as monotherapy or in conjunction with a diuretic were included in the study. Patients excluded from the study were those with a condition in which beta‐blockade was contraindicated. | |
| Interventions | Patients were taken off whatever beta‐blocker they were taking at entry and then allocated to one of the 2 interventional groups: (1) Betaloc tablets 100 mg in the morning (0600‐0900 hours), and in the evening (12 hours later), or (2) Betaloc Durules 200 mg every morning (0600‐0900 hours). | |
| Outcomes | Two measurements of adherence were utilised: (1) tablet counts at six and 10 weeks, and (2) spot checks of metoprolol concentration in the urine at six and 10 weeks. The mean heart rate, systolic and diastolic blood pressures were assessed before, during, and after the trial, and compared between the two treatment regimens. | |
| Notes | Outcome assessments not blinded to study group. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Random allocation without an indication of concealment. | |
| Participants | Patients between the ages of 20 and 80 years who were already taking medication for previously diagnosed hypertension, and who had already demonstrated poor blood pressure control (diastolic blood pressure > 90 mm Hg) on at least one visit during the preceding two years were included in the study. Patients who had significant visual, auditory, or mental problems that could interfere with their adherence were excluded. | |
| Interventions | Patients in the control group received all of their antihypertensive medications in the traditional pill vials (separate vials for each pill that were labelled with the drug name, the dosage, the medication instructions, and the physician's name), whereas patients assigned to the experimental group received all their medications in the special packaging format (all pills taken together were packaged in a single plastic blister sealed with a foil backing on which was printed the day of the week and the time of day at which each medication was to be taken). All medications for both groups were provided free of charge to ensure that all patients would receive their medications. | |
| Outcomes | Patient self‐reports of adherence, where patients were asked non‐threatening, non‐judgemental questions about their adherence behaviour (patients who admitted less than perfect adherence were considered non‐adherent), and pill counts (patients were considered adherent if they had taken 80% or more of their prescribed medication) were employed in order to assess adherence. Blood pressure was taken three times during each visit. The first measure was discarded and an average of the second and third measures was used as the blood pressure measurement for that visit. Blood pressure control was defined as diastolic blood pressure less than 90 mm Hg. | |
| Notes | All data collection was done by a nurse research assistant prior to regular office visits. Physicians caring for patients were aware that adherence studies were in progress, but were not told the aims of the study nor the group to which an individual patient had been assigned. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | 37 patients were randomized 1:1 to either the home intervention or control group using the Small Table of Random Digits. The randomization process was number‐based, with patient names not identified. The randomization list was held by the clinical coordinator of the HIV program and kept in a locked file. | |
| Participants | All eligible HIV‐positive patients (n = 37) followed in the program. Informed consent was obtained from each participant's legal guardian. Children ranged in age between 1.5 to 12 years of age (mean 8.7 years) for the intervention group and 5 to 11 years (mean 8.4 years) in the control group. Assent was obtained from all minors older than 7 years of age. | |
| Interventions | The intervention group received eight structured home visits over a 3‐month period by the same home care experienced registered nurse. | |
| Outcomes | Knowledge and adherence were measured at the beginning of the study and at the end of the intervention. Changes in viral load and CD4 counts were measured at baseline and after treatment, or for 6 to 11 months beyond the initial study period. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | The method of random allocation was not described. | |
| Participants | Patients were men < or = 65 years of age at high risk for future cardiac events by virtue of: 1) an elevated apoprotein B > or = 125 mg/dl, 2) at least one coronary lesion > or = 50% stenosis or 2 lesions > or = 30% stenosis as documented by baseline angiogram, and 3) a family history of premature cardiovascular events. | |
| Interventions | Regular niacin (qid) versus polygel controlled release niacin (bid). All patients received lovastatin 20 mg bid, colestipol 10 g bid, and niacin 500 mg qid for 12 months, with dosage adjustment to target cholesterol of 150 to 175 mg/dl, and to minimize side effects. At 12 months, patients were randomly assigned to 1) continue with regular niacin at a dose identical to that established during the 12 month dose‐finding period, or 2) change to polygel controlled‐release niacin at that daily dosage, but given twice rather than 4 times/day. At 20 months, groups 1) and 2) were reversed (crossover). This regimen continued for 8 more months. | |
| Outcomes | Compliance with the recommended (and variable) dosage was calculated for each drug using a computer program that accounted for all drug supplies given, the recommended dosage, and a count of returned medication. It is expressed as a percentage of the dose recommended for the patient at the time. Clinical outcome measurements included plasma very low‐density lipoprotein (VLDL), LDL, and HDL cholesterol, triglycerides, apolipoprotein B, and asparate aminotransferase measured at baseline and every 4 months. Other laboratory measurements included uric acid, fasting glucose, fasting insulin, creatinine kinase and fibrinogen at entry (before treatment), 6 months, 12 months, 20 months, 28 months, and 6 weeks after stopping the triple‐drug regimen. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Patients were allocated at random to experimental (n=29) or control group (n=31). The randomisation was carried out blockwise per rheumatologist. No statement concerning concealment of allocation. Outcome assessors were blinded for allocation. | |
| Participants | Patients suffering from RA (ACR Criteria) for less than three years. Active disease defined by an erythrocyte sedimentation rate (ESR) greater than 28 mm 1st hour, the presence of six or more painful joints, and the presence of three or more swollen joints. DMARD therapy with sulphasalazine had to be indicated by the attending rheumatologist and agreed for by the patients. Patients who had used any DMARD other than hydroxychloroquine were excluded. | |
| Interventions | The experimental group attended six patient education meetings. The education programme focused on compliance with sulphasalazine therapy, physical exercises, endurance activities (walking, swimming, bicycling), advice on energy conservation, and joint protection. Four (two hour) meetings were offered during the first months. Reinforcement meetings were given after four and eight months. The programme was implemented in groups and partners were invited to attend the meetings. One instructor (HB) provided information on RA, attendant problems, and basic treatment. The related beliefs of the patients were discussed and, when necessary, corrected. If patients anticipated problems with the applications of any of the treatments, these were discussed, including possible solutions. A training was given in proper execution of physical exercise. Patients were encouraged to plan their treatment regimens. Their intentions were discussed and help was given in recasting unrealistic ones. Patients made contracts with themselves regarding their intentions. Feedback on the eventual implementaion fo therapeutic advice was included in each meeting. | |
| Outcomes | Compliance with sulfasalazine therapy was evaluated at 3, 6, and 12 months. Medical records and pharmacy records were the source of data on the number of tablets prescribed and the number of tablets obtained. At each evaluation, the number of remaining tablets were counted. Compliance was defined as the number of tablets that had been taken during the preceding period divided by the number of tablets prescribed Disease activity was measured by the disease activity score (DAS). This is a function of ESR, Ritchie score (0‐78) and number of swollen joints (0‐52). The DAS ranges from 0‐10, where o represents the lowest level of disease activity possible, and 10 the highest. Physical funtions was measured by a Dutch version of the M‐HAQ. The Dutch‐AIMS questionnaire was used to assess physical function, psychological function, pain and social activities. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | After the initial injection (Depo‐Provera), 350 patients were randomised to receive either structured counseling or routine indications about the method (175 women in counseling group and 175 woman in control group). | |
| Participants | The study was conducted at the Family Planning Clinic of the "Centro de Investigaciones Hideyo Noguchi" in Merida, Yucatan, Mexico. Women were eligible if they were between the ages of 18 and 35 years old and living in a rural area. They had to have proven fertility, have regular menstrual cycles during the previous 6 months, not breastfeeding, and have at least one child. They also had to have normal PAP smears of grade CI, CII, and willing to use DMPA as the only contraceptive agent during the course of the study and be willing to return to the clinic every 3 months. Exclusion criteria included current or a history of thrombophlebitis, thromboembolic disorders, hypertension, cerebral vascular disease, active or | |
| Interventions | The initial injection (Depo‐Provera) was given within the first 5 days of the menstrual cycle. The women in the first group (counseling group) received a structured pretreatment counseling with indications about the mode of action of DMPA, the common side effects of the drug, including the possibility of irregular menstrual periods, heavy bleeding, spotting, and amenorrhea. To mentally prepare users for potential side effects, it was stressed that these side effects would be not detrimental to their health. These indications were repeated at each follow‐up visit. Women were encouraged to return to the | |
| Outcomes | Women of both groups were evaluated in the clinic and had gynecological examinations. They were instructed to fill out the diary cards. | |
| Notes | The pregnancy rates were not measured. Injectable DMPA is the prevention of pregnancy. Maybe author thought the compliant rates of two groups were the outcome of clinical health. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Patients were randomly assigned to 2 groups of 28 patients each. No statement concerning concealment of randomization. | |
| Participants | Patients were included if they had an ICD‐10 diagnosis of functional psychosis, were clinically stable, living in the community, and receiving anti‐psychotic medication for at least 6 months. Patients were excluded if they were prescribed clozipine or were hospital in‐patients. Sixty patients were approached. Fifty‐six patients agreed to participate. | |
| Interventions | The study group participated in a discussion about the risks and benefits of neuroleptic medications based on individual semi‐structured educational sessions with reference to a standardised information sheet modified from Kleinman et al (1989). The patients were asked whether they had heard of tardive dyskinesia. The common movements of TD were modelled and the patients were asked whether they thought they had the condition or had seen others with it. They were informed that they were receiving an antipsychotic drug and were given information about extrapyramidal symptoms and TD, its risk factors, prevalence, treatment, potential irreversibility and the 1% risk of TD in non‐antipsychotic‐treated patients. They were told that gradual discontinuation of antipsychotic medication was the best way to prevent the condition but if done abruptly carries a high risk of relapse and of precipitating TD. It was stated that the optimum maintenance treatment, taking into account its risks and benefits, was to use the lowest dose of antipsychotic drug that would keep them well. Most importantly, they were asked not to make any changes to their treatment without discussion with their psychiatrist. Finally, they were given the opportunity to ask questions in an informal interactive session lasting 30 minutes, and were given an information sheet for reference. The control group received usual care. | |
| Outcomes | 1. Relapse, defined as a period of hospitalization, evidence of clear clinical deterioration in the case‐notes or in discussion with the keyworker, or evidence of deterioration at follow‐up interview. 2. Increase in antipsychotic dose of >200 mg chlorpromazine equivalents. 3. If the patient missed more than 2 weeks of their antipsychotic meds they were considered non‐compliant. | |
| Notes | In this study, the intent was not to increase compliance; rather it tested whether information about benefits and adverse effects of the treatment would decrease compliance. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Random allocation without an indication of concealment. | |
| Participants | All children (aged 1‐15) presenting to a pediatric outpatient clinic with streptococcal pharyngitis were included except those known to have received previous antimicrobial therapy of any type during the previous month, or those known to be allergic to penicillin. | |
| Interventions | The parents of the 'normally informed' group were given instructions that the penicillin was to be taken three times per day for ten days, and any questions that they had were answered. Parents of the 'optimally informed' group received specific counselling stressing the necessity that the penicillin be taken for the full ten days in order to achieve the best cure/prevent relapse, and further, were given written instructions. | |
| Outcomes | There was a single measurement of adherence: Sarcina lutea growth inhibition by urine (a test for the presence of antimicrobial activity). Throat cultures were obtained at nine days, three and six weeks post‐treatment. As well, the incidence of relapse was estimated in the various patient groups. | |
| Notes | No indication of blinding of outcome measures. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | The method of random allocation was not described. | |
| Participants | Patients were 16 years of age or older, with moderate to severe asthma and the need to take daily anti‐inflammatory agent. The diagnosis of asthma was confirmed by either a documented reversibility greater than 15% in FEV1 or a PC20 methacholine less than or equal to 8 mg/ml when determined by the method described by Cockcroft and coworkers. | |
| Interventions | The intervention is an asthma education program with an action plan based on peak‐flow monitoring (Group P) or an action plan based on asthma symptoms (Group S). The Control group (Group C) received instructions from their pulmonologists regarding medication use and influence of allergenic and nonallergenic triggers. They were taught how to use their inhaler properly by the educator. A verbal action plan could be given by the physician. Groups P and S received the same education as the Controls plus individual counselling with the specialized educator during a 1‐hour session. All participants received a book entitled "Understand and Control Your Asthma" at no extra charge. Group P received a self‐management plan based on peak expiratory flow (PEF). They were asked to continue measuring PEF twice a day and to keep a diary of the results. Each time, subjects only recorded the best of three measurements. Every attempt was made to ensure that patients knew how to interpret the measurement and how to respond to a change in PEF. At each follow‐up visit, the patient's diary card was reviewed, and if the action plan had not been implemented when required, further explanations were given regarding when treatment should be modified. Group S received a self‐management plan based on asthma symptom monitoring. These patients were asked to keep a daily diary of asthma symptom scores, using a scale of 0 (no symptoms) to 3 (nighttime asthma symptoms, severe daily symptoms preventing usual activities), and adjust their medications according to the severity of respiratory symptoms using the guidelines of the action plan. | |
| Outcomes | Adherence was assessed at each follow‐up by weighing the used medication canisters. Patients were unaware of this. Treatment outcome was assessed, in terms of asthma morbidity, by a count of the days missed from work or school, the number of hospitalizations or visits to the emergency room for asthma, and the number of oral corticosteroids courses used since their last visit. These were self‐reported in a diary and recorded at each of the 1, 3, 6, 9, and 12 month visits after randomization. Data regarding the number of visits to the emergency room, number of hospitalizations, and absenteeism at work or school during the 12 months prior to enrollment in the study were also collected for all patients by administering a questionnaire and reviewing the medical charts. Knowledge of asthma was also measured pre‐run‐in, at randomization and at the final visit using a questionnaire. | |
| Notes | To reduce financial barriers to treatment adherence, the investigators supplied asthma medication at no charge throughout the trial. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | All patients were stratified for treatment center. The first 45 patients among 126 patients were recruited in the control group to avoid contamination. Subsequent eligible patients were randomized in the two educated groups. Only the randomized groups are eligible for our review. | |
| Participants | 126 patients were enrolled in the study, but 105 showed up for randomization. Patients (aged > 18years) with an acute exacerbation of asthma who had not previously taken part in any asthma educational program. Patients older than 40 yr of age in whom the best forced expiratory volume in 1 s (FEV1) was lower than 80% of predicted were excluded. All patients with concurrent medical illnesses that in the judgment of the investigators contraindicated study participation | |
| Interventions | The patients in Group C (control) received the usual treatment given for an acute asthma exacerbation. In addition to standard treatment as for Group C treatment, patients in Group Limited Education (LE) were given a self‐action plan that was explained by the on call physician. The action plan used "traffic lights" (green, yellow, red) to describe specific states of asthma control based on Peak Expiratory Flow and symptoms and actions that the patient should take for each state (pages 1415‐1416). Subjects were all instructed by a respiratory therapist or study nurse in the proper use of an inhaler. In addition to what patients in Group LE received, the patients in Group Structured Education participated in a structured asthma educational program based on the PRECEDE model of health education within 2 weeks after their randomization. Structured educational intervention group Group SE. In addition to what patients in Group LE received, the patients in Group SE participated in a structured asthma educational program based on the PRECEDE model of health education within 2 weeks after their randomization. Briefly, this model takes into consideration three different issues that are important when dealing with health‐related behaviors: predisposing factors (belief, attitude, knowledge); enabling factors (community resource, family support); and reinforcement. The teaching was provided individually or in small groups according to patient preference. The intervention focused mainly on self‐management. To increase patient self‐confidence in making his or her own treatment decisions, the interaction with the patient was based on the self‐efficacy theory of Bandura. Reinforcement was provided at the 6‐month follow‐up visit. | |
| Outcomes | Compliance with inhaled corticosteroids was evaluated according to the patient's own estimation at 2 weeks and 12 months. Patient outcome measures included number of urgent visits for an acute exacerbation of asthma, lung function tests, knowledge, use of an action plan, compliance with inhaled corticosteroids, quality of life score. | |
| Notes | The method of measuring adherence is very insensitive ‐ only indicates whether the person had a prescription for inhaled corticosteriods, not whether they used it. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | 319 patients were randomized by the researchers after giving informed consent. 165 patients were in the mentoring group and 154 in the control group. Eligible patients were stratified by sex, disease modality (myocardial infarction or angina) and location (five areas identified). | |
| Participants | Patients aged 60 or over that had been either admitted to hospital, or had attended the outpatient department, with a clinical diagnosis of ischaemic heart disease (IHD). Exclusion criteria were terminal illness, an abbreviated mental health test score <8, inability to complete 3 minutes of Bruce Protocol exercise tolerance testing, awaiting angioplasty or coronary artery bypass grafting, participation in another clinical study involving coronary risk factor modification or at the request of their consultant or general practitioner. | |
| Interventions | Intervention consisted of participation in a mentor‐led group, through attending monthly 2 hour long meetings in community facilities over a 1‐year period. There was an average of 10 patients per group, each led by two mentors. Both intervention and control groups continued to receive standard care. The core activities covered in the programme were lifestyle risk factors of smoking, diet and exercise; blood pressure and cholesterol; understanding of and ability to cope with IHD; and drug concordance. Each mentored group was also encouraged to develop its own agenda. Input was provided from a pharmacist, cardiac rehabilitation specialist nurse, dietician, welfare benefits advisor and Recreation Services. Volunteer lay health mentors, aged 54‐74 recruited from the local community led the groups. | |
| Outcomes | Perceived change in taking of medication was measured using a five point Likert scale in the exit questionnaire. Outcome measures were changes in blood pressure, cholesterol and medication, and cardiovascular events; non‐medical support requirement, health status and psychological functioning, and social inclusion. | |
| Notes | This is self‐reported concordance and there was no attempt to standardize the regimens, so may be explained by differences in medications or insensitive/biased measure of adherence or low power. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | D ‐ Not used |
| Methods | Randomization was accomplished using a randomized block design in which block size was randomly allocated between 2 and 4 to ensure that the size of the intervention and control groups was equivalent. Randomization was not balanced on any other variables. Random group assignments were generated and were placed in sequentially numbered envelopes. Envelopes were not opened to reveal group assignments until informed consent was obtained and enrollment (baseline) interviews were completed. | |
| Participants | 56 subjects to be included in the study, subjects were between the ages of 2 to 18 years, had State of Louisiana Medicaid insurance, had a telephone at home, had a history of asthma, had not been intubated or mechanically ventilated for asthma, did not have other clinically significant (i.e., moderate to severe) chronic illness, presented to the ED when an investigator was available, had informed consent provided by a parent or guardian, child voluntarily assents to participation in the study if older than 12 years. | |
| Interventions | Subjects in the intervention group received basic asthma education; instructions on use of a metered‐dose inhaler with holding chamber; a written asthma self‐management plan illustrated by zones colored green, yellow, and red; a sample age‐appropriate holding chamber; and prescriptions for medication needed to implement the plan. This medication included an inhaled corticosteroid drug for everyday use and a quick‐acting bronchodilator for use as needed. The importance of seeking urgent medical care in the red zone was emphasized. Three brief followup phone calls were placed to patients in the intervention group at 1‐2 weeks, 4‐6 week and 3 months after enrollment. | |
| Outcomes | Self‐reported method to measure the compliance plus pharmacy refills. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | Random allocation using a paired randomization protocol. | |
| Participants | Patients were 60 years or older, under the care of a physician for hypertension and prescribed an antihypertensive medication. They needed to have systolic blood pressure greater than or equal to 160 mmHg or a diastolic blood pressure greater than or equal to 90 mmHg based on an average of two determinations taken 5 minutes apart. | |
| Interventions | Control patients received regular medical care. | |
| Outcomes | Antihypertensive medication adherence was assessed by home pill count conducted by the field technicians. Clinical outcome measures included change in systolic and diastolic blood pressure. Outcome measures were recorded by the field technicians, at the two home visits performed 6 months apart. The measures were also reported on a weekly basis by the participant. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | THis paper desribes the same patients as Gallefoss & Bakke 1999b. Random allocation. Concealment of allocation unclear. Outcome assessors were blinded to allocation group. | |
| Participants | Eligible subjects were patients with bronchial asthma and COPD between 18 and 70yr of age, not suffering from any serious disease such as unstable coronary heart disease, heart failure, serious hypertension, diabetes mellitus, kidney or liver failure. Subjects with asthma were to have a FEV1 equal to or higher than 80% of predicted value in stable phase. Furthermore a positive reversibility test, a documented 20% spontaneous variability (PEF and FEV), or a positive metacholine test were required. | |
| Interventions | The intervention group received a specially made 19‐page booklet with essential information about asthma/COPD, medication , compliance, self‐care, and self‐management plan. Instructions in the recoding of PEF and symptoms in a diary were given to both asthmatics and patients with COPD. The asthmatics and patients with COPD were educated in separate groups. The COPD group received more information about tobacco weaning, but besides this the educational interventions were comparable. The education consisted of two 2‐h group sessions of five to eight persons on two separate days. The subjects then had one to two individual sessions by a nurse and one to two individual sessions by a physiotherapist. | |
| Outcomes | 4 simple HRQoL questions were asked at baseline. FEV measured via spirometry prior to randomization and at 12 months. | |
| Notes | Same study as Gallefosse and Bakke 1999b. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | At inclusion, patients signed a written consent and were then randomized to an intervention group or a control group. Concealment of allocation was unclear. Technical staff assessing bronchodilator spirometry were blinded for control and intervention patients. | |
| Participants | Eligible subjects were patients with bronchial asthma or COPD between 18 and 70 yrs. of age, not suffering from any serious disease, such as unstable coronary heart disease, heart failure, serious hypertension, diabetes mellitus, kidney or liver failure. Participants with stable asthma were to have a prebronchodilator FEV1 equal to or higher than 80% of predicted value "in stable phase". Furthermore, either a positive reversibility test, a documented 20% spontaneous variability (PEF or FEV1 ) or a positive methacholine test (provocative dose causing a 20% decrease in FEV1 [PD20] was required. A positive reversibility test required at least a 20% increase (FEV1 or PEF) after inhalation of 400ug salbutamol. Subjects with COPD were to have a prebronchodilator FEV1 equal to or higher than 40% and lower than 80% of predicted. | |
| Interventions | The control group were followed by their GPs and the intervention group received an education program and were then also transferred to a 1‐yr. follow‐up by their GPs. | |
| Outcomes | Compliance of regular medication was calculated as a % age: (dispensed Defined Daily Dosage/ Prescribed Defined Daily Dosage) x 100 during the 1‐year follow‐up. Patients were defined as compliant when dispensed regular medication was greater than 75% of prescribed regular medication during the study period. Prebronchodilator spirometry was performed before randomization and at 12 month follow‐up by standard methods. | |
| Notes | Patients who failed to attend all group sessions or who failed to meet at individual sessions were withdrawn. There was no similar "faintness of heart" procedure for the control group. Thus, 38 of 39 control asthma patients were included in the compliance assessment but only 30 of 39 intervention group patients. (2p=0.014 by Fisher's exact test) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | 101 patients were randomized into three groups: A (n=30) with drug therapy alone, B | |
| Participants | One hundred and one patients (62 male, 39 female, age range 12±60 years) had suffered for at least 2 years from Seasonal Asthma and Rhinitis (SAR) solely due to pollens (grasses, birch, Parietaria, and Compositae), Patients with sensitization to multiple pollens were included, whereas sensitization to cat dander, mites, or mold was a reason for exclusion. Exclusion criteria were as follows: anatomical abnormalities of the upper respiratory airways (septal deviation, polyposis), previous or ongoing immunotherapy, pregnancy/ lactation, chronic treatment with systemic corticosteroids, malignancies, and major psychiatric disorders. | |
| Interventions | The first group of patients (group A=30 patients) was given only the drug with the instructions provided by the manufacturer. The second group (group B=35 patients) received a brief training on how to use the nasal spray and were given simplified written instructions on the use of the device. The third group (group | |
| Outcomes | All patients completed a symptom diary, recording the presence and severity of their symptoms (self‐reported). The compliance with therapy was evaluated on the basis of the returned diaries and canisters. Symptoms were subdivided as | |
| Notes | 8 week‐follow‐up during the whole pollen season is O.K. for the seasonal disease. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | RCT: Consenting patients were randomized to the ED (intervention) or pharmacy (control) group. | |
| Participants | The study was conducted from November 2001 to May 2002. During the 6‐month study period, all adult patients (>18 years old) presenting to the ED for whom an outpatient | |
| Interventions | Patients in the ED group were provided a full course of azithromycin (6 X 250 mg) at no charge and given instructions on the proper dose and frequency before discharge | |
| Outcomes | The primary outcome was compliance of obtaining medication as determined by pharmacy records. A secondary outcome was compliance in completing the course of medication as determined by a telephone survey. Measurement of Clinical Health Outcomes: Return visits to the ED and hospitalization. | |
| Notes | The Rx filling rate for the control group is based on the assumption that control patients used a participating pharmacy 8 blocks away that provided the drug free of charge ‐ patients were apparently not asked if they filled their prescription elsewhere. The "course completed" rate is based on self report on a telephone call ‐ no indication that interviewers were blinded to group; nor was the exact question given (if there was one). Technically, this study qualified for the review, but the reliability and credibility of the measures are suspect. At least the question of the control group's filling of prescriptions could have been cleared up. The intervention is also impractical in any setting where giving drugs out for free isn't possible. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Randomization was conducted by an independent advisor by resampling without replacement after the placebo run‐in period. The study was not double‐blind because one outcome was the difference in compliance between once‐daily and twice‐daily regimens. However, the investigator responsible for analyzing the results was blinded as to the treatment phase. | |
| Participants | 27 Patients with a history of mild hypertension (well controlled on monotherapy), with a diastolic bp between 90‐110 mmHg were included. Patients were excluded if they had secondary hypertension or significant end organ damage, were pregnant or lactating mothers, had cardiovascular complications in addition to hypertension (e.g. MI within the past 6 months), stroke, congestive heart failure, angina pectoris, had poor renal function, a history of renal artery stenosis, were obese (weighing over 125% of ideal body weight) had hyperkalemia, had a history of angioneurotic oedema, had any contraindication or hypersensitivity to ACE inhibitors, or if they were taking NSAIDS, corticosteroids or any other medication that would significantly alter blood pressure | |
| Interventions | Patients were randomly assigned to a sequence of enalapril 20mg once daily or 10mg twice daily in three 4‐week periods following a 4‐week run‐in period. Treatment A comprised enalapril 20mg once daily, and treatment B comprised enalapril 10 mg twice daily. The first two periods in each group constituted a conventional 2‐period crossover design. The third treatment period was included to detect any carryover effects between the periods without having to incorporate a washout phase between treatments. The 4 study arms were organized as follows (each period lasted 4 weeks): | |
| Outcomes | Measurement of Compliance: Patient compliance was measured via pill counts and electronic monitoring using MEMS, which record the exact date and time of each opening and closing of the drug container. Measurement of Clinical Health Outcomes: Blood pressure reduction was measured at each visit. Patients were asked not to take their blood pressure tablet on the morning of the clinical visit until after the investigator had measured their blood pressure so that the BP readings were trough values. Two readings were taken after 10 min rest in the seated position. The arm was supported at heart level and the diastolic blood pressure taken as the disappearance of the Korotkoff sounds (phase V). Ambulatory blood pressure was measured at the end of the placebo run‐in period and at the end of periods 1 and 2. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Random allocation by 'minimisation', a method stated to be impervious to bias. | |
| Participants | This was the second phase of a two phase study. Male steel company employees with high blood pressure (when sitting quietly on three separate days, a standard series of fifth phase diastolic blood‐pressures were >95 mm Hg) who were treated with antihypertensive medications during the first phase of the study were included in the second phase if they were nonadherent with prescribed antihypertensive therapy (pill counts less than 80%), and not at goal blood pressures (fifth phase < 90 mm Hg) in the sixth month of treatment of phase 1. | |
| Interventions | Patients in the experimental group were all taught the correct method to measure their own blood pressures, were asked to chart their home blood pressures and pill taking, and taught how to tailor pill taking to their daily habits and rituals. These men also visited fortnightly at the worksite a high‐school graduate with no formal health professional training who reinforced the experimental manoeuvres and rewarded improvements in adherence and blood pressure. Rewards included allowing participants to earn credit, for improvements in adherence and blood pressure, that could be applied towards the eventual purchase of the blood pressure apparatus they had been loaned for the trial. Control patients received none of these interventions. | |
| Outcomes | An unobtrusive pill count done in the patient's home by a home visitor was the method of determining medication adherence. Adherence rates are reported as the proportion of pills prescribed for the twelfth month of therapy which were removed from their containers and, presumably, swallowed by the patients. In the twelfth month of treatment, patients were evaluated for adherence and blood pressure both at home and at the mill by examiners who were 'blind' to their experimental group allocation. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | 119 patients were randomly allocated to intervention (n=60) and control (n=59) groups. The trial was single blinded in that, although patients were aware of the names of the study medication and the fact the study was an H. Pylori treatment trial, they were unaware of either the differences between the treatment groups or the compliance enhancing purpose of the trial. | |
| Participants | All adult patients over the age of 18 years with H. Pylori infection were screened for eligibility. Patient exclusion criteria included inability or refusal to give informed consent, contraindication to the study medication, consultant's recommendation not to treat patient, consultant wish to use an H. pylori therapy other than the study medication, and inpatient status as patient compliance is imposed in this situation. | |
| Interventions | ALL patients received 10 days of omeprazole 20 mg b.d., amoxycillin 500 mg t.d.s., and metronidazole 400 mg t.d.s., as well as verbal advice on medication use and possible side effects, in an initial 20 minute consultation. In addition, patients in the intervention group received medication in dose‐dispensing units, an information sheet on H. Pylori treatment, and a medication chart. Compliance in intervention group patients was also encouraged by a phone call 2 days after the start of therapy. | |
| Outcomes | Measurement of compliance: Compliance was assessed by phone interview on day 10 of therapy, and by returned tablet count at the follow‐up C‐urea breath test (C‐UBT) visit. Patients were defined as compliant if they were assessed by both pill count and interview as taking =80% of study medications. Total percentage of tablets taken in both groups was assessed by taking the lower of the two estimates of tablet consumption (pill count or interview data) for each patient. Measurement for health care outcomes: Patients were considered H. Pylori‐ positive if the CLO‐test, histopathology, or 13C‐UBT was positive. 13C‐UBT test using kits sent to a single central laboratory for analysis was performed for more than one month after cessation of H. pylori treatment and any other antimicrobial therapy (including bismuth), 2 weeks after cessation of proton‐pump inhibitor therapy and 1 week after cessation of histamine‐receptor antagonists. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Patients were stratified into bands of low, medium, or high knowledge of their RA by means of a validated patient knowledge questionnaire. 21 Patients in each band were randomly allocated to the Education Group and Control Group using a separate computer generated code for each band. This was done to ensure that the two groups had comparable levels of initial knowledge. Allocation was carried out by a clerk who had no study input or patient contact. | |
| Participants | Rheumatologists referred 100 patients with active RA; all were deemed to require D‐penicillamine (DPA) as their slow acting antirheumatic drugs (SAARD). | |
| Interventions | The chosen intervention was a Patient Education programme taught by a rheumatology nurse practitioner. Where practicable, variables that could confound the results were eliminated. All patients took the same SAARD, were given the same number and length of appointments, and were seen by the same rheumatology nurse practitioner. All patients were seen by the rheumatology nurse practitioner for a 30 minute appointment at monthly intervals over a six month period comprising seven visits. The Education Group received a comprehensive programme of Patient education based on the theory of self efficacy: a person's confidence in their ability to perform a specific task or achieve a certain objective. The non‐education cohort received the same DPA drug information leaflet as the intervention group. This was in question and answer format and supplied information about DPA, how and when to take it, unwanted side effects, | |
| Outcomes | Clinical Health Outcomes included: PV, | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | Method of randomisation not stated. The physician educating the patients was not blinded, whereas the office nurse questioning patients in the follow‐up period was blinded as to which patient was in which group. | |
| Participants | All patients over 18 years treated with erythromycin for an acute illness were included, while patients with a history of allergy/intolerance to erythromycin were excluded. | |
| Interventions | Informed patients were told of six possible side‐effects of treatment with erythromycin, while control (uninformed) patients were not made aware of potential side effects of treatment. | |
| Outcomes | The occurrence of side effects both before and after treatment. | |
| Notes | Adherence measured as the mean number of erythromycin pills taken per day, patients reporting that they missed at least one pill, and mean number of pills taken out of 40 pills. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Random allocation in a 2x2 factorial design. No statement concerning concealment of randomisation. | |
| Participants | Volunteers from shopping centre blood pressure screening in Canada, with follow‐up by usual family doctors. Men and women aged 35‐65 who had been receiving antihypertensive medications for at least one year, but whose diastolic blood pressure had remained elevated. | |
| Interventions | The interventions consisted of (1) self‐recording and monthly home visits, (2) self recording only, (3) monthly home visits, and the control group consisted of (4) neither self‐recording nor home visits. Subjects in groups (1) and (2) received a blood pressure kit and instruction in self‐recording. Patients in the self‐recording groups were to keep charts of their daily blood pressure readings and were instructed to bring these charts to their physician at each appointment. Subjects in groups (1) and (3) had their blood pressure measured in their homes every four weeks, and the results were reported to both the patient and the physician. | |
| Outcomes | Adherence with therapy was assessed by interview and pill counts (the percentage of prescribed pills that had been consumed was estimated by comparing pills on hand at a home visit with prescription records of pills dispensed and the regimen prescribed). Changes in mean diastolic blood pressure (mm Hg) were assessed. Since the initial blood pressure bears an important relation to the change in blood pressure over time, the change scores were adjusted for differences in entry values by covariance analysis. Outcome assessors were blinded to study group. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Patients were randomized to the relapse prevention intervention vs. usual care in blocks of 8. Within each block, the randomization sequence was computer‐generated. The telephone survey team conducting the follow‐up assessments (at 3,6,9 and 12 months) were blinded to randomization status. Patients could not be blinded due to the nature of the intervention (i.e. patient education, visits with depression specialist, telephone monitoring and follow‐up). The primary care physicians were also not blinded. | |
| Participants | Patients between the ages of 18 and 80 years who received a new antidepressant prescription (no prior prescriptions within the previous 120 days) from a primary care physician for the diagnosis of depression or anxiety were eligible for the study. Inclusion criteria for the relapse prevention study obtained during the baseline interview included patients with fewer than 4 DSM‐IV major depressive symptoms and a history or 3 or more episodes of major depression or dysthymia or 4 residual depressive symptoms but with a mean SCL‐20 depression score of less than 1.0 and a history a major depression/dysthymia. Exclusion criteria included having a screening score of 2 or more on the CAGE alcohol screening questionnaire, pregnancy or currently nursing, planning to disenroll from GHC within the next 12 months, currently seeing a psychiatrist, limited command of English, or recently using lithium or antipsychotic medication. | |
| Interventions | The intervention included patient education, 2 visits with a depression specialist, and telephone monitoring and follow‐up. Before the first study visit, the intervention patients were provided a book and videotape developed by the study team that was aimed at increasing patient education and enhancing self‐treatment of their depression. They were also scheduled for 2 visits with a depression specialist (one 90‐minute initial session and one 60‐minute follow‐up session) in the primary care clinic. Three addition telephone visits at 1, 4, and 8.5 months from session 2 with the depression specialist and 4 personalized mailings (2,6,10 and 12 months) were scheduled over the following year. The mailed personalized feedback contained a graph of patients' Beck Depression scores over the course of the intervention program and checklists for patients to send back to the depression specialist, including early warning signs of depression and whether they were still adhering to their medication plan. The depression specialist reviewed monthly automated pharmacy data on antidepressant refills and alerted the primary care physician and telephoned the patients when mailed feedback or automated data indicated they were symptomatic and/or had discontinued medication. The ultimate aim of the intervention was to have each patient complete and follow a 2‐page written personal relapse prevention plan, which was also shared with his/her primary care provider. Follow‐up telephone calls and mailings were geared toward monitoring progress and adherence to each patient's plan. | |
| Outcomes | Measurement of Compliance: Patients' adherence to antidepressant medication was measured at 3,6,9 and 12 months after randomization by a telephone interviewer. Based on computerized automated data from prescription refills, patients were rated as adherent at the 3‐, 6‐, 9‐ and 12‐month follow‐up periods as well as whether they received adequate dosage of antidepressant medication for 90 days or more during the 1‐year period. The lowest dosages in the ranges recommended in the Agency for health Care Policy and Research guidelines developed for newer agents were used to define a minimum dosage standard. Measurement of Clinical Health Outcomes: Baseline and follow‐up interviews assessing depressive symptoms (at 3‐, 6‐, 9‐ and 12‐months) included the SCL‐20 depression items (scored on a 0‐4 scale), the dysthymia and current depression modules of the SCID, the NEO Personality Inventory Neuroticism Scale and the Longitudinal Interval Follow‐up Evaluation to measure incidence and duration of episodes within each 3‐month block of time. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Random allocation by means of a table of random numbers. | |
| Participants | Patients between the ages of 18 and 65 who were admitted to hospital with acute psychosis over eight months. DSM III‐R diagnoses of subjects included schizophrenia, severe affective disorders, schizophreniform, schizoaffective disorder, delusional disorders, and psychotic disorder not otherwise classified. Non‐English speakers and subjects with low IQ scores, deafness, or organic brain disease were excluded. | |
| Interventions | Control group treatment consisted of 4 to 6 supportive counselling sessions with the same therapist. Therapists listened to patient concerns but declined to discuss treatment. | |
| Outcomes | Adherence scores were measured using a 7‐point scale (1 = complete refusal to 7= active participation and ready acceptance). Measures were obtained preintervention, postintervention, at 3 month follow‐up and at 6 month follow‐up. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | Random allocation by means of a table of random numbers. | |
| Participants | Patients between the ages of 18 and 65 who were admitted to hospital with acute psychosis over 14 months. DSM III‐R diagnoses of subjects included schizophrenia, severe affective disorders, schizophreniform, schizoaffective disorder, delusional disorders, and psychotic disorder not otherwise classified. Non‐English speakers and subjects with low IQ scores, deafness, or organic brain disease were excluded. | |
| Interventions | Control group treatment consisted of 4 to 6 supportive counselling sessions with the same therapist. Therapists listened to patients' concerns but when medication issues were broached, patients were directed to discuss such issues with their treatment teams. | |
| Outcomes | Adherence scores were measured using a 7‐point scale (1 = complete refusal to 7= active participation and ready acceptance of regimen). The clinical outcome measures included ratings on a brief psychiatric rating scale, global functioning assessment, schedule for assessment of insight, drug attitudes inventory, attitude to medication questionnaire, Simpson‐Angus Scale for extrapyramidal side‐effects. | |
| Notes | Initial compliance was rated by the patient's primary nurse. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | Patients were randomly allocated using a 2:1 (control:intervention) ratio. There are no details about the randomization procedure or whether it allowed for concealment of allocation. The study was not blinded. | |
| Participants | There are no exclusion criteria. Inclusion criteria: all patients with HIV infection demonstrated by plasma viral load > 5000 copies/mL AND CD4+ lymphocyte count < 600 X 106/L initiating treatment with indinavir (800 mg q8h), zidovudine (300 mg q12h), and lamivudine (150 mg q12h). They included all patients with HIV infection receiving prescription for this combination of agents from 7/96 to 12/97. | |
| Interventions | All patients were treated with zidovudine + lamivudine + indinavir. Control patients (n=110) received conventional care in addition to the drug regimen (new refill every 2 months). Intervention patients (n=60) received individualized counseling/assessments which consisted of adaptation of treatment to the patient's lifestyle, detailed information about highly active antiretroviral therapy, phone support (for questions or medication‐related problems), and monthly visits to the HIV day clinic. | |
| Outcomes | Measurement of Compliance: Compliance was estimated every 2 months using a structured interview and by pill counts. The same person conducted all compliance evaluations blind to viral load (not to allocation). Patients were considered to be compliant when: (1) they took more than 90% of their drugs; AND (2) >90% of pill intakes should be according to a pre‐specified schedule (hours between doses, relation between doses and meals); AND (3) less than 2 mistakes in pill intake per day. Clinical Health Outcomes: | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | A 2 by 2 factorial design with patients randomly allocated to warfarin (long half‐life) or acenocoumarol (short‐half life) and to either intensive education or standard education. Allocation concealment was achieved by central computerized randomization balanced in blocks of 2, 4 and 6 patients. | |
| Participants | Patients over 18 years old were enrolled if they needed at least 3‐month oral anticoagulant therapy (OAT) following IV infusion for a thromboembolic disease. Patients were excluded if they were pregnant, had any contra‐indication to anticoagulant therapy, recent surgery (<4days) or progressive bleeding. | |
| Interventions | Patients assigned to warfarin received a dose of 6mg (up to 70 years old) or 4mg (> 70 years) those assigned to acenocoumarol received a dose of 4 mg (up to 70 years old) or 3 mg (>70 years). Subsequent doses were adjusted to maintain the INR within the target range of 2 to 3. Patients took a single dose of the OA daily at 8pm. The standard education group received the minimum information consistent with ethical OAT with no particular emphasis on the necessity of strict compliance. Patients in the intensive education group received information about the causes of anticoagulation instability and the importance of strict adherence. The intensive education group were provided information through visual material, were visited daily by nurses and physicians to repeat some items, and were tested daily about their education. The education, either standard or intensive was given until hospital discharge. | |
| Outcomes | The number of tablets left in the bottle were recorded at follow‐up at 1, 2 and 3 | |
| Notes | The follow‐up period was only 3‐months but since the results proved to be negative it still meets the criteria for inclusion in the review. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | Patients were randomized consecutively into intervention and control groups using equal blocks of four generated using the Clinstat program. This was done by the two nurses at their respective hospitals, by first producing two patient lists, by date order of receipt of their consent forms i) completed when attending or ii) returned by post. 108 patients were randomly allocated into the control group, and 103 patients were randomly allocated into the intervention group. Study nurses were not blinded wrt allocation AFTER randomization occurred. | |
| Participants | 211 patients over 18 years old attending emergency room department for asthma were included. Exclusion criteria not specified, except that patients with a previously recorded diagnosis of COPD were excluded. | |
| Interventions | The intervention group was invited to attend a 1h consultation with one of the nurses beginning 2 weeks after entry to the study, followed by two or more lasting half an hour, at 6‐weekly intervals. The second and third could be substituted by a telephone call. Patients were phoned, by the nurse before each appointment in order to improve attendance rates. Patient's asthma control and management were assessed followed by education on recognition and self‐treatment of episodes of asthma. The patients were taught to step‐up medication when they recognized uncontrolled asthma using PEF or symptoms. The advice was in accordance with national guideline. Prescriptions were obtained from one of the doctors in the clinic or by providing the patient with a letter to their general practitioner. Patients presenting with severe asthma (severe symptoms of PEF below 60% of their best/normal)were referred immediately to the consultant. Patients in the control group continued with their usual medical treatment and were not offered any intervention during the study period. | |
| Outcomes | Measurement of Compliance: The primary outcome was the patients' reported, appropriate adherence to self‐management of mild attacks within the previous 2 weeks or severe attacks in the previous 6 weeks. Measurement for Clinical Health Outcomes: Home peak flow and symptom diaries. Patients recorded the best of 3 PEF readings in the morning and evening, and also recorded symptom scores daily for 7 days. QOL was also assessed using the SGRQ, and patients use of medical services was assessed. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | The same study as Katon 2001 | |
| Participants | ||
| Interventions | ||
| Outcomes | ||
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | A controlled, randomized clinical trial was conducted in 6 primary care centers in Huelva province of Spain. | |
| Participants | 126 people diagnosed with hypercholesterolaemia according to Spanish Consensus criteria were chosen: 63 in Control Group and 63 in Intervention Group. Recruitment took place from January to June 2001. | |
| Interventions | The Control Group (CG) of 63 patients, who received the doctor's normal treatment, which included oral information about hypercholesterolemia, advice about its control, brochures about dietary recommendations, 3 month‐long prescriptions for a cholesterol‐lowering medication, and titration of that medication if indicated at 3 months. The Intervention Group (IG) of 63 patients received this care, and in addition, received a telephone call at 7‐10 days, 2 months, and 4 months. The goal of the intervention was to establish the level of compliance, categorize this as adequate or inadequate, and make recommendations based on that. Level of compliance was determined by comparing the number of pills consumed to the number that should have been consumed (calculated using self‐reported information about the number of pills remaining, number of pills dispensed, and fill date of the prescription). Compliance was defined as taking 80‐110% of the pills that should have been taken thus far. Compliant patients were congratulated and encouraged to continue their good level of compliance as it would lower their risk of heart disease. Noncompliant patients were notified their behavior was considered noncompliant and encouraged to better comply with therapy as it would lower their risk of heart disease. | |
| Outcomes | Pills were counted in person at 3 and 6 month follow‐up visits to estimate compliance over the previous 3 months. Cholesterol, triglycerides, HDL‐C and LDL‐C were measured at the start, and at the third and sixth months. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | Patients were block‐randomized, stratified for gender and for illness duration. The randomization was carried out by an independent institution. Due to the nature of the intervention, patients could not be blinded. Ratings of psychopathology and psychosocial function were performed by researchers who were not informed of treatment allocation. Relapse and compliance outcomes were assessed by researchers blind to the allocation of the patients. | |
| Participants | Patients aged 18‐49 years and a clinical ICD‐10 diagnosis of schizophrenia and in treatment at the time of recruitment were included. Patients were included based on a clinical diagnosis, validated by the use of OPCRIT (operational criteria checklist for psychotic and affective illness) on case records. | |
| Interventions | The control group received usual treatment provided in community psychiatry. The experimental group received an 8‐session intervention using a mainly didactic interactive method. The programme was standardized with a manual for group leaders, overhead presentations and a booklet for participants. Patient and relative interventions were conducted separately, with group sizes in both patient and relative groups of 5 to 8 participants. The programme was the same for both patients and relatives, and sessions were conducted weekly. | |
| Outcomes | Compliance Measurements: Compliance measures were made at baseline and at follow‐up (12 months after start of intervention). A non‐compliance episode was rated if the case notes indicated that the patient did not receive medication for a period of 14 days. Measurement of Clinical Health Outcomes: Patient outcome measures included knowledge, relapse, psychosocial function, insight and satisfaction. The following scales were used: Also, knowledge of schizophrenia was evaluated | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | The subjects were randomized into two groups: one receiving subsequent visits from the asthma nurse until discharge from hospital (n=35) and a control group (n=30) which received `routine care' from medical and nursing staff but no further intervention from the asthma nurse. | |
| Participants | A group of 80 patients (53 women), with an age range of 16‐72 years (mean 36.1 years) were recruited. Patients who had been admitted on the general medical take to a large teaching hospital with a documented primary diagnosis of acute asthma were recruited for the study. Patients were not permitted to participate if they: (1) had underlying chronic obstructive pulmonary disease; (2) had previously participated in an educational programme from a hospital‐based asthma nurse; (3) were unable or unwilling to complete a series of follow‐up questionnaires. | |
| Interventions | The education programme took place over a minimum of two separate sessions, lasting on average 30min each and was carried out on an individual basis. The first session involved discussion on the basic mechanisms of asthma, including common triggers and an explanation of the changes which occur to the airways resulting in the symptoms experienced by the patient. This was supported by illustrations in the `RegularTherapy with Asthma' booklet (11) which was given to each intervention group patient. Lifestyle influences, such as occupation and leisure activities were discussed where appropriate to the individual. The need for `preventer' and `reliever' | |
| Outcomes | Compliance was measured by questionnaire at 6 months. Clinical Health Outcomes included: (1) Occasions of GP call‐outs and Re‐admission; (2) Patients percentage of claiming to have a writing management plan; (3) Percentage of the compliance of using ß‐agonist inhaler regularly everyday; (4) first line action. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | D ‐ Not used |
| Methods | Patients were independently randomized by the health authority's central community pharmacy office using computer‐generated random numbers. 165 patients were eligible at baseline in the intervention group and 151 patients were eligible in the control group. They used blocked randomization, stratified by trial centre, to ensure equal numbers of participants in each randomized group. | |
| Participants | From June 1995 to March 1997, patients discharged from elderly‐care wards were asked by the hospital pharmacist to give informed consent. 362 patients were recruited. Patients over 75 years who were taking four or more medicines at discharge were asked to join the study. Patients who could not speak English or were too ill were excluded. | |
| Interventions | Between 7 and 14 days after discharge, community pharmacists visited the patients at home. This visit allowed the pharmacist to check for discrepancies between the medicines the patient was taking and those prescribed on discharge. The pharmacist assessed the patient's understanding of and adherence to the medication regimen and intervened when appropriate. Interventions included counseling patients or carers on the purpose and appropriate doses of the medication, disposing of excess medicines and liaising with general practitioners. The pharmacists arranged further community visits at their discretion. All assessments and interventions were sent to the hospital‐based liaison pharmacist. A revised care plan was issued if a patient was re‐admitted to hospital during the 6‐month study period. Patients randomized to the control group were discharged from hospital following standard procedures. These included a discharge letter to the general practitioner who indicated the diagnosis, investigations and current medications. The pharmacists did not provide a review of discharge medication or follow‐up in the community. | |
| Outcomes | Compliance measures were made at baseline and at follow‐up (3 and 6 months after start of intervention). The primary outcome was re‐admission to hospital in the follow‐up period. Secondary outcomes were number of deaths, attendances at hospital outpatient clinics and general practice (at home or in the surgery) and days in hospital as a percentage of days of follow‐up. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Random allocation of consenting patients to compliance therapy or control groups using odd and even digits from a standard random numbers table. The researcher obtaining outcome measures was blinded to the intervention. | |
| Participants | 54 of 96 consecutive people with psychosis, who had been admitted to St. John of God Hospital, Dublin, agreed to join the study. Patients aged 18‐65 years, an IQ greater then 80, fluent in English, with no evidence of organic disturbance and diagnosed with schizophrenia. Each person who signed for informed consent took part in a structured clinical interview to determine their diagnosis according to the Diagnostic and Statistical manual of Mental Disorders. | |
| Interventions | The control group received non‐specific counseling compromising of 5‐sessions lasting 30‐60 minutes. The experimental group received 5‐sessions of compliance therapy, each session lasting 30‐60 minutes. The sessions covered a review of the patient's illness history, understanding of the illness and his or her ambivalence to treatment, maintenance medication and stigma. Compliance therapy is a cognitive behaviour intervention with techniques adapted from motivational interviewing, other cognitive therapies and psychoeducation. | |
| Outcomes | A structured clinical interview was used to assess compliance 1‐month prior to the intervention and 1‐year post‐intervention. Patient outcome measures included attitude towards medication, symptomatology, insight, functioning, quality of life and psychiatric hospital bed occupancy. The following scales were used: | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Coin toss randomisation. | |
| Participants | Adult and teenage epileptic patients who were consecutive attenders at outpatient clinics during a four month period, who were responsible for their own medication, and who possessed a hospital pharmacy prescription book were included in the study. | |
| Interventions | Patients in the intervention group received several adherence‐improving strategies: patients were counselled on the goals of anticonvulsant therapy and the importance of good adherence in achieving these goals, a schedule of medication taking was devised that corresponded with the patient's everyday habits, patients were given a copy of an educational leaflet, each patient was provided with a 'Dosett' medication container and counselled on its utility, patients were instructed to use a medication/seizure diary, and patients were reminded by mail of upcoming appointments and of missed prescription refills. The control group received none of these interventions. The mean daily dosages of the most commonly prescribed anticonvulsant drugs (phenytoin, carbamazepine, and sodium valproate) were not significantly different between the two groups. | |
| Outcomes | Each patient had plasma anticonvulsant levels measured (provided that the patient's medication regimen had not been altered in the preceding two weeks), the patient's prescription record book was checked to assess prescription refill frequency (if the refill frequency was one or more weeks later than expected at least once during the previous six months, the patient was considered non‐adherent), and patient appointment keeping frequency (patients who had attended all their scheduled appointments in the previous six months were considered compliant) were assessed. The median number of self‐recorded seizures experienced by each patient was compared between the control and intervention groups. | |
| Notes | Physicians were blinded to the intervention group of their patients. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Random allocation, not otherwise specified. | |
| Participants | 210 eligible patients with established cardiovascular disease and an acute cardiovascular /cerebrovascular‐related admission, and discharged from the hospital between April and | |
| Interventions | Patients in the intervention group were visited at home monthly by a pharmacist, who educated the patients on the goals of lipid‐lowering treatment and the importance of lifestyle issues in dyslipidaemia and compliance with therapy, assessed patients for drug‐related problems, and measured total blood cholesterol levels using point‐of‐care testing. | |
| Outcomes | Self‐reported compliance at 6 months. Measurement of Clinical Health Outcomes: the total cholesterol levels. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | D ‐ Not used |
| Methods | Immediately after referral patients were individually randomized in blocks of 8 to one of four treatment groups by prearranged random number sequence, stratified by drug type, in a factorial design. Patients were unaware of their allocation at first interview and were asked not to reveal drug‐counseling sessions to the interviewer subsequently. | |
| Participants | Patients were included if they were aged 18 or over and starting new courses of treatment with dothiepin or amitriptyline. Inclusion was based on clinical diagnosis of depressive illness. Patients were excluded if they had received either drug within 3 months, had a contraindication (allergy, heart disease, glaucoma, or pregnancy) or were receiving other incompatible drugs. Any patients at high risk of suicide were also excluded. | |
| Interventions | The four treatment groups were as follows: treatment as usual, leaflet, drug counseling, or both interventions. The information leaflet contained information about the drug, unwanted side effects, and what to do in the event of a missing dose. Patients were given drug counseling by a nurse at weeks 2 and 8, according to a written protocol. Sessions included assessment of daily routine and lifestyle, attitudes to treatment, and understanding of the reasons for treatment. Education was given about depressive illness and related problems, self‐help and local resources. The importance of drug treatment was emphasized, and side effects and their management discussed. Advice was given about the use of reminders and cues, the need to continue treatment for up to 6 months, and what to do in the event of forgetting a dose, and the feasibility of involving family or friends with medicine taking was explored. | |
| Outcomes | Measurement of Compliance: At 6 weeks, self‐reported adherence was assessed and was reassessed at the final visit. To check the reliability of self‐reported adherence, adherence was measured in a subgroup using a MEMS monitor. Patients were seen at 3 weeks to resupply drugs and pills were counted. At 6 weeks the container was collected and the cap data was downloaded. Measurement of Clinical Health Outcomes: Depressive symptoms were measured by the hospital anxiety and depression scale and functional status was measured by the SF‐36 health survey. Interviews were conducted at baseline, 6 weeks, and when drugs were discontinued at 12 weeks (whichever was sooner). Also, at 6 weeks depressive symptoms and unwanted effects of treatment were assessed. At the final visit, satisfaction with treatment and unwanted effects were reassessed and the SF‐36 repeated. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | Of the 588 patients identified as potentially eligible, 280 patients were enrolled and randomized to a treatment arm, 137 to intervention, 143 to control. Randomization was based on a table of randomly permuted numbers. Patients, care givers, and outcome assessors were not blinded to patient allocation. | |
| Participants | Patients included had a diagnosis of diabetes mellitus or an active prescription for a hypoglycemic agent. Patients were excluded if they were > 75 years of age, had a diagnosed psychotic disorder, disabling sensory impairment, or life expectancy of <12 months, or whose primary language was neither English nor Spanish. Patients were also excluded is they controlled their blood glucose levels without hypoglycemic medication, were newly diagnosed with diabetes (< 6 mos), planned to discontinue receiving services from the clinic within the 12‐month follow‐up period, or did not have a touch‐tone telephone. | |
| Interventions | The intervention consisted of a series of automated telephone assessments designed to identify patients with health and self‐care problems (Teleminder Model IV automated telephone messaging computer). Calls were made on a biweekly basis, up to 6 attempted calls, and involved a 5 to 8‐minute assessment. During each assessment, patients used the touch‐tone keypad to report information about self‐monitored blood glucose readings, self‐care, perceived glycemic control, and symptoms of poor glycemic control, foot problems, chest pain, and breathing problems, with automated prompts for out‐of‐range errors. The automated telephone calls were also used to deliver, at the patient's option, 1 of 30 targeted and tailored self‐care education messages at the end of each telephone session. Patients only received a 1‐page instruction sheet on the use of the phone. Each week, the automated assessment system generated reports organized according to the urgency of the reported problems, and a diabetes nurse educator used these reports to prioritize contacts for a telephone follow‐up. During follow‐up calls, the nurse addressed problems reported during the assessments and provided more general self‐care information. After several months, intervention group patients were offered additional automated self‐care calls that focused on glucose self‐monitoring, foot care and medication adherence. In the medication adherence part of these sessions, patients were asked about their adherence to insulin, oral hypoglycemic medications, antihypertensive medications, and antilipidemic medications. For each type of medication, patients without adherence problems received positive feedback and reinforcement. Patients reporting less than optimal adherence were asked about specific barriers and were given advice from the nurse about overcoming each barrier. The nurse was located outside the clinic and had no access to medical records other than the baseline info collected at enrollment and her own notes. She did not have any face‐to‐face contact with patients. The nurse addressed problems raised by patients in the automated calls and also gave general self‐care education. The nurse also checked on patients who rarely responded to automated calls. A small no. of patients initiated calls to the nurse by toll free no. She referred these to the primary care physician as appropriate. During the course of the trial, patients in the intervention groups averaged 1.4 automated calls per month and had 6 minutes of nurse contact per month. | |
| Outcomes | Measurement of Compliance: At baseline and 12 months, patients were surveyed by trained interviewers over the telephone. Patients were considered to have a problem with medication adherence if they reported that they "sometimes forget to take their medication", "sometimes stop taking their medication when they feel better", or " sometimes stop taking their medication when they feel worse". Measurement of Health Care Outcomes: A 5‐point Likert scale was used to measure self‐care items such as glucose self‐monitoring, foot inspection and weight monitoring. During interviews, patients reported whether they experienced each of 22 diabetes‐related symptoms in the prior week (including symptoms of hyperglycemia, hypoglycemia, vascular problems, or other problems). Glycosylated hemoglobin and serum glucose levels were measured at baseline and a 12 months. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | RCT: Patients were randomized into the intervention group (IG) and the control group (CG). | |
| Participants | All HIV‐infected patients who had medical follow‐up at the Nice University Hospital between September 1999 and December 1999 were approached for the study participation. Patients were included if they were: | |
| Interventions | The intervention combined an educational and counseling approach that was founded on the principles of motivational psychology, client centred therapy and the use of an "empathic therapeutic to enhance participants' self efficacy". The intervention focused on cognitive, emotional, social and behavioural determinants affecting adherence. The intervention consisted of 3 individually delivered sessions by nurses lasting 45‐60 minutes. To standardize the intervention, IG manuals for the nurses were prepared and the | |
| Outcomes | This data was collected using a self‐administered questionnaire at month ) (M0) and month 6 (M6). Measurement of Clinical Health Outcomes: | |
| Notes | The clinical significance of these findings is unclear ‐ adherence rate was on self‐report in an unblinded trial, the mean HIV RNA was no different at 6 months for the 2 groups and no actual clinical outcomes were reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Cluster RCT: A random numbers table achieved block randomisation using townships as units. Xinle and Huaqiao were randomly selected into the family intervention group (FIG) (drug treatment plus psychoeducational family intervention), Anxi and Taiping townships into the drug treatment group (MG) (drug treatment only), and Xinyi and Longma townships into the control group (CG) (no intervention). | |
| Participants | 357 persons with schizophrenia from the six townships meeting the inclusion criteria were randomized. In fact, 127 received intervention (FIG) 105 patients received medication (MG) and 115 received no intervention (CG). | |
| Interventions | The interventions were as follows: 1. Family education conducted once per month for 9 months. The purpose was to provide specific advice, support and information to the family. During each visit, which lasted 1.5‐3 h, patients' relatives were taught basic knowledge of mental diseases, treatment and rehabilitation. Advice and information were given according to the patient's specific condition, such as the stage of illness, recent onset or chronic. The patient was encouraged to join the meeting. The major content of the family education component included: a) definitions of a schizophrenic disorder; b) a description of the various symptoms; c) comprehensive basis of the illness; d) general prognosis of the illness; e) treatment recommendations concerning pharmacotherapy; and f) long‐term management of the illness including relapse prevention and social functioning rehabilitation. 2. Multiple family workshops were held once every 3 months. During the workshop, general questions were discussed, and relatives shared the experiences of caring for patients. 3. Crisis intervention conducted when necessary (e. g. for attempted suicide, aggressive and destructive behaviour). The local village broadcast network was also employed for health education during the first 2 months. Trained psychiatrists and village doctors conducted all these above‐family interventions. Village doctors did not get the same training as psychiatrists, but assisted with the interventions. | |
| Outcomes | Medication compliance was defined as the therapist's dichotomous rating (based on all available information) of the extent to which the | |
| Notes | Although there was contamination bias between MG and CG (the participants might go to see the other doctors in local area and then take medication by themselves), it didn't impact the comparison between FIG and MG. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | D ‐ Not used |
| Methods | Consenting patients were randomized 1:1 to receive either an EI (4 modules of the Tools for Health Empowerment course) plus routine counseling (RC) (EI + RC) or RC alone. | |
| Participants | A 24‐week open‐label clinical trial was conducted in 195 HIV‐infected adults commonly underrepresented in research (35% female, 71% African American, 21% Hispanic, and 20% injection drug users [IDUs]) | |
| Interventions | The THE course is an 11‐module educational program for HIV‐infected patients and "The RC consisted of provision of the following information at each study visit: names and physical descriptions of the study drugs; instructions on how best to take the study drugs, | |
| Outcomes | Adherence was measured using MEMS track caps which monitored and electronically recorded the date and time each medication was removed from the bottle. The primary efficacy measure was the proportion of patients attaining plasma HIV‐1 RNA levels below the 40‐ copy/mL lower limit of quantitation (LLOQ) of the NucliSens assay and below the 400‐copy/mL LLOQ of the HIV‐1 MONITOR version 1.0 polymerase chain reaction (PCR) assay (Roche, Nutley, NJ) at 24 weeks after starting treatment with COM + ABC. Viral load response (HIV‐1 RNA in plasma) was the primary study end point. A secondary efficacy measure was an assessment of changes in the number of CD4 lymphocyte counts (immunologic response). Patients were also monitored for adverse events, lab abnormalities and HIV‐related illnesses at week 5, 8, 12, 16 and 24. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | The selected patients were randomly assigned to the study group (n=80), which received the CMFT, or control group (n=86), which received the BFT. Allocation was unblinded for treating psychiatrist and patient; outcome assessments were done by independent, blinded psychiatrists. | |
| Participants | Recently discharged patients from the University Hospital with the diagnosis of schizophrenia (DSM‐IV). Inclusion criteria included: at least 2 previous psychiatric admissions (including the latest admission), aged between 17‐55 years, staying with a responsible relative who is willing to be involved in the study, stabilized for at least 4 weeks (stabilization was defined as rating of 4 or less on the BPRS psychotic items). Exclusion criteria not specified. | |
| Interventions | The CMFT consists of a sociocultural approach of family education, drug intervention programme and problem‐solving skills. The sociocultural approaches to family education include explanations of the concept of schizophrenia from a cultural perspective and an attempt to correct negative attitudes toward modern treatment. The family education and drug intervention was delivered as a package. The drug intervention programme includes drug counseling, [from Table 1] clear instruction about dose, frequency and possible side effects, the role of carers in supervision of medication at home, and close monitoring of compliance by a drug intake check‐list presented in every follow‐up visit. Both groups of patients received routine prescription of medication. It should be noted that the one psychiatrist treated the intervention group throughout the study, and a second psychiatrist treated the control group throughout the study. Patients in each group were followed‐up on the same schedule; monthly for the first 3 months and then every 6 weeks in the next 9 months. | |
| Outcomes | Measurement of Compliance: Measured at the end of 6 months and 1 year after initiation of the intervention. Medication compliance was assessed through a semi‐structured interview with the carer and examination of the amount of unused medication. A home visit was made to assess unused medication "in doubtful cases". Drug compliance was measured globally as a percentage of the total prescribed drug dosage actually taken during the previous 6 months. The compliance was reported on a 6‐point ordinal scale, with 1 indicating non‐compliant, 2‐25% compliant, 3‐50% compliant, 4‐75% compliant, 5‐90% compliant and 6‐100% compliant. 90% compliance was considered to be an ideal level. Measurement of Clinical Health Outcomes: Measured at the end of 6 months and 1 year after initiation of the intervention. Frequency of symptoms exacerbation, psychosocial functioning and behavioral difficulties were measured. Symptomatic exacerbation was determined by BPRS ratings. A rating of 5 or above in one or more of the psychoticism scales indicated an exacerbation. Overall psychosocial function was rated using the Global Assessment of Function (GAF) of DSM‐IV, while the Social Behavior Schedule (SBS) measured the behavioral difficulties. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Random allocation, 2x2 factorial design, no indication of concealment. | |
| Participants | Male steel company employees who exhibited persistently elevated diastolic blood pressure on repeated examination (at or above 95 mm Hg (fifth phase)), were free of secondary forms of hypertension, were taking no daily medication, and had not been prescribed antihypertensive medications for at least six months before the trial were eligible for the study. | |
| Interventions | Subjects in augmented convenience saw company physicians, rather than their family physicians, for hypertensive and follow‐up care during paid working hours. The second intervention, mastery learning, was designed to give the facts about hypertension, its effects upon target organs, health, and life expectancy, the benefits of antihypertensive therapy, the need for adherence with medications and some simple reminders for taking pills (this information was provided in a slide‐tape format, and reinforced by a secondary‐school graduate 'patient educator'). | |
| Outcomes | Adherence was calculated by comparing the number of tablets prescribed with medications still on hand, by the semi‐quantitative identification of drugs and metabolites in the urine, by the identification of characteristic changes in serum potassium and uric acid in men on thiazide drugs, and by patient self‐report. Adherence is reported in terms of the percent of medication prescribed for the sixth month which was removed from the bottle and, presumably, consumed by the patient. Patients whose pill counts were consistent with adherence levels of 80% or more were considered 'compliant'. Blood pressure control was assessed by trained observers. Only patients whose diastolic blood pressure was below 90 mm Hg at six months would be designated as being 'at goal blood pressure'. Outcome assessors were blinded to study group. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Participants were recruited using flyers posted throughout the health science center campus, within the university student health center, and in health departments within the county. In an effort to approximate the ethnicity of the surrounding county, which is 19% African American, the principal investigator also recruited participants personally in an African American church. There were 46 participants at the beginning of the study. A computerized randomization protocol was used to assign participants to one of 4 treatment groups. | |
| Participants | There were 46 participants at the beginning of the study. English‐speaking adults aged 18 to 65, whose reported use of preventive medication for asthma during the 3 months prior to the study indicated that they had mild persistent to moderate persistent asthma according to the U.S. NAEPP (2002) guidelines. Individuals were excluded if they reported daily oral steroid use, diagnosis of COPD, or symptomatic cardiac disease. | |
| Interventions | Four treatment groups: (a) standard provider education (control) (n=13); (b) audiotape alone (n=10); (c) National Heart Lung and Blood Institute (NHLBI) booklet alone (n=12); and (d) audiotape plus NHLBI booklet (n=11). | |
| Outcomes | Compliance Measurements: self‐reported and pharmacy verified adherence to preventive medication. | |
| Notes | The ACQ is a 7‐item Likert‐type scale designed to measure asthma treatment adequacy as measured by minimization of symptoms, bronchoconstriction, and short‐acting beta‐agonist use. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | Patients who tested positive for H pylori were randomly assigned to either usual care or special counseling using a computer‐generated random sequence. The partcipating pharmacies were provided with a supply of opaque randomization envelopes, and the pharmacists were trained to open the top envelope to determine the treatment assignment for each research participant. | |
| Participants | 325 adult dyspeptic patients with positive for H pylori paricipated in the study. | |
| Interventions | All the patients were provided a standard antibiotic regimen and randomly assigned to receive either usual‐care counseling from a pharmacist (The control group participants met with the dispensing pharmacist for 5‐minutes. The pharmacist described the proper protocol for taking the medication. This is consistent with standard care.) or a longer adherence counseling session and a follow‐up phone call from the pharmacist during drug treatment (Patients received a 15‐minutes counseling session with the pharmacist, including a detailed review of possibe side effects, emphasis on the importance about possible barriers to adherence and coping stratagies, and encouragement to call the pharmacist in the event of any problems. The pharmacist also scheduled a follow‐up telephone call with the patient 2 to 3 days after the start of therapy to check on adherence to the drug regimen.). All subjects were given the same 7‐day course of omeprazole, bismuth subsalicylate, metronidazole, and tetracycline hydrochloride (OBMT). | |
| Outcomes | All the patients were contacted by telephone and were asked to report their adherence to regimen and their current symptoms | |
| Notes | The big problems with this study are that a) both groups got blister packs with daily doses clearly marked; b) both groups got counseling, although this was longer and more detailed for the IC than CG; c) self‐report was used for measuring adherence (insensitive). All these factors would bias towards no difference. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | Random allocation, not otherwise specified. | |
| Participants | Recently discharged patients with Present State Examination/CATEGO diagnoses of schizophrenia who were living with at least one parent who exhibited high 'expressed emotion' on the Camberwell Family Interview. | |
| Interventions | All patients had scheduled therapy and monthly medication appointments. Patients were allocated to family therapy or individual support sessions. All patients received oral neuroleptic medication (usually chlorpromazine). | |
| Outcomes | All patients were seen monthly by the prescribing psychiatrist, blinded to the group assignment, where medication status and adherence were assessed. Medication was adjusted based on mental status, side effects, and blood plasma levels. Patients with poor compliance for oral medications were given fluphenazine decanoate injections. Adherence was defined in six ways: number of missed appointments with psychiatrist; number of patients change to intramuscular depot medication; tablet‐taking compliance (pill counts, self‐reports by patient or family, and blood plasma levels); variability in plasma levels; mean and modal doses prescribed for each treatment group; mean plasma level in each group. Relapse was the treatment outcome (no information on how measured). | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | 116 patients were randomly allocated (no statement of allocation concealment) to one of two arms. 61 patients were randomized to the control group, and 55 were randomized to the "psychoeducative intervention" group. There is no statement in the report about blinding of physicians. Patients and psychologists weren't blinded, and, if there was a separate outcome assessor, it isn't stated. | |
| Participants | 116 patients who initiated their first or second‐line HAART at a general university hospital's HIV‐outpatient unit were included. Exclusion criteria not specified. | |
| Interventions | The experimental group received a psychoeducative assessment in addition to the regular clinical follow‐up. The individual(s) who delivered the intervention is not identified, but is apparently, a psychologist, rather than the treating physician. The intervention was intended "primarily to improve patients' knowledge and customs in handling medication to increase self‐efficacy". Patients in this arm received explanations about the reasons for starting treatment and the relevance of appropriate adherence to prevent replication of viral mutations and the development of antiretroviral drug resistance. Patients' doubts about medication intake were solved and a dosage schedule was developed with the patients' input. Study subjects were also taught to manage medication and tackle problems such as forgetting, delays, side effects and changes in the daily routine. A phone number was also given should any questions arise before the next interview. During follow‐up visits, adherence was verbally reinforced and strategies were developed to deal with problems that had appeared to that point, including rescheduling dose schedules to overcome adherence problems, providing skills to deal with minor adverse effects. Patients in the control group received a standard assessment consisting of an interview with a psychologist following the regular medical visit, in which only variables related to adherence were recorded. The control group received only normal clinical follow‐up. Both groups were interviewed for data collection at 0, 4, 24, and 48 weeks of follow‐up. | |
| Outcomes | Measurement of Compliance: Self‐reported adherence was registered at each visit. The proportion of compliance was calculated by dividing the number of pills taken during the month before by the number of pills prescribed during the same period. Patients who consumed > 95% of medication prescribed were considered "adherent patients". Randomized blood analyses were also performed without warning in 40% of the patients to measure plasma levels of protease inhibitors (PI). Plasma levels of PI > 0.01mg/L indicated adequate compliance, PI levels <0.01 mg/dL indicated noncompliance. Measurement for Clinical Health Outcomes: HIV‐1 RNA levels (copies/ml). | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Patients were randomly allocated to either usual care by a paediatrician (control group) or the intervention programme (experimental group). Randomization was stratified according to hospital. Allocation was concealed. Due to the nature of the intervention, paediatricians and patients were not blinded. | |
| Participants | The criteria for inclusion were: asthma diagnosed by a physician, treatment prescribed by a paediatrician with daily inhalation of prophylactic asthma medication during a preceding period of at least two months, between 11‐18 years of age, attending secondary school, and the ability to fill in a questionnaire in Dutch. | |
| Interventions | Control Group: All patients received usual care from the paediatricians, who were instructed to provide the same care as they normally gave to adolescent patients with asthma. Patients visited the paediatrician every four months. The paediatricians agreed not to refer participants in the control group to an asthma nurse. | |
| Outcomes | Measurement of Compliance: Self‐reported adherence was assessed by asking participants to score their adherence on a 1 to 10‐point scale (range: 1‐never take the meds, 10 ‐always takes prophylactic meds as prescribed). Expert‐reported adherence was assessed by asking the participant's physician to rate the adherence of the patients on a visual analogue scale (VAS) on a 100% scale. The physicians were asked to estimate the adherence of the patient during the previous two months. Measurement of Clinical Health Outcomes: Lung function was measured via FEV. Subjective severity of asthma was assessed by asking the participant one question with a 5‐point scale (1‐not at all bothered, no symptoms 5 ‐severely bothered, unable to function). Morbidity variables (# admissions to hospital, # prescriptions or oral steroids for an exacerbation) were also recorded. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | Cluster randomized trial with pharmacies as the unit of randomization. Two of the 16 pharmacies were located two blocks apart in the same rural community. To minimize the risk of sample contamination between these two pharmacies, they were included in the same study group. One pair from the same community were assigned as a block. Eight pharmacies were randomly placed in the treatment group and 8 pharmacies were randomly to be in the control group. | |
| Participants | Ambulatory elderly (> or = 65 years of age) patients (n=60) covered under Alberta Health & Wellness's senior drug benefit plan and who were concurrently using three or more medications according to pharmacy profiles. | |
| Interventions | In intervention group, pharmacists used the Pharmacist's Management of Drug‐Related Problems (PMDRP) instrument to summarize the information collected during the patient interview and prepared a "SOAP" record (Subjective, Objective, Assessment, and Plan) to document actions and follow‐up. Pharmacists at control pharmacies continued to provide traditional pharmacy care. | |
| Outcomes | Adherence to medication regimens was assessed using a four item self‐report measure. HRQOL was assessed using the SF‐36 health survey. The SF‐36 has been used extensively to evaluate the success of clinical interventions. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | The same study as Katon 2001 | |
| Participants | ||
| Interventions | ||
| Outcomes | ||
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | RCT: individual patients were contacted by telephone through a third party (who was unaware of any information about the patient) at the research‐team office, with a list of random allocations computer‐generated by the research team. To allow for the possibility of failed telephone contact, facilities were also provided with pre‐prepared allocations sealed in opaque envelopes. After randomisation, the enrolment officer and the patient discussed and agreed on the details of the selected treatment protocol. | |
| Participants | 497 patients were enrolled in the trial. Each adult (aged 15 years or older) whose initial diagnosis at the diagnostic centre was as a new case of sputum‐positive pulmonary tuberculosis was sent to the enrolment officer who interviewed the patient to confirm eligibility for enrolment; in particular, to confirm that no | |
| Interventions | 170 were assigned DOTS with direct observation of treatment by health workers; 165 were assigned DOTS with direct observation of treatment by family members; and 162 were assigned self‐administered treatment. The first, and prevailing, strategy was self‐administered treatment, in which each patient collects drugs fortnightly from the most convenient health facility. The second was health‐worker direct observation of treatment‐ie, supervision by a health worker at a health facility when the patient met criteria for access to the facility, and by a community health worker at or near the patient's home | |
| Outcomes | "Defaulted" in Table 2 as a proxy for "noncompliant". Default was defined as failing to collect treatment from the health centre for 2 consecutive months during the course of treatment. : The outcome measures used were cure, and cure plus treatment completion. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | Random allocation, not otherwise specified. | |
| Participants | 60 HIV patients were randomized by the researchers after giving informed consent. Inclusion and Exclusion Criteria: therapy containing a combination of at least three different antiretroviral drugs of at least two different drug classes, viral load below 50 copies/ml documented within the previous 3 months and at screening visit, participation in the Swiss HIV cohort study, no intravenous drug use or on stable methadone maintenance in case of drug addiction. | |
| Interventions | Participants were randomly assigned to a psychotherapist and given the contact information to schedule their own first appointment. Protocol defined a minimum of three and a maximum of 25 sessions within the 1‐year study period. Participant and psychotherapist determined the frequency of appointments and set their own goals for future interventions. The method of intervention had to be based on concepts of cognitive behaviour therapy. Both intervention and control groups continued to receive standard care. Standard care included monthly visits for 12 months with assessments of clinical and laboratory data, course of treatment, drug adverse events and HIV‐1 RNA. | |
| Outcomes | An electronic medication exposure monitoring system was used to measure adherence. Outcome measures included virological and immunological outcomes, CD4 lymphocyte end‐points, change in antiretroviral therapy during study, and psychosocial measures. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
| Methods | A cluster RCT: The 36 drugstores were divided into 12 clusters of 3 geographically proximal drugstores ("triplets"). The 3 drugstores within each triplet were matched on percentage of Medicaid‐insured adults with reactive airways disease (to control for customers' socioeconomic status) and number of prescriptions filled (high vs low volume). Within each triplet, a random‐number chart was used to assign drugstores to 1 of 3 study groups. | |
| Participants | 1113 eligible patients were enrolled. 453 were COPD patients and 660 were asthma. Patients were censored from the study if they died, were placed in a nursing home, moved away permanently from Indianapolis, their insurance no longer covered using these drugstores, or they lost telephone access. Customers were eligible if they (1) filled a prescription for methylxanthines, inhaled corticosteroids, inhaled or oral sympathomimetics, inhaled parasympathetic antagonists, or inhaled cromolyn sodium during the preceding 4 months; (2) reported having COPD or asthma as an active problem; (3) were 18 years or older; (4) received 70% or more of their medications from a single study drugstore; (5) reported no significant impairment in vision, hearing, or speech that precluded participation; (6) did not reside in an institution (eg, nursing home); and (7) provided written informed consent. | |
| Interventions | Components of intervention in Pharmaceutical care program group (Group 1) included: 1).Computer Display of Patient‐Specific Data. When a study patient filled any prescription (not only breathing medications), the drugstore computer alerted pharmacists to review patient‐specific data contained in a separate study computer behind the counter. To safeguard patients' confidentiality, access to patient‐specific data required pharmacists' individualized passwords. Study computers contained: (1) contact information for patients and 1 to 2 physicians caring for their breathing problem; (2) graphical display of all PEFR data gathered during monthly interviews; (3) dates and locations of recent ED visits and hospitalizations; and (4) breathing medications (including compliance rates and refill histories). These data were obtained during monthly telephone interviews. Pharmacists were encouraged to document their pharmaceutical care activities at the bottom of the screen. Patients in the usual‐care group received neither peak flow meters nor instructions in their use; during monthly telephone interviews, PEFR rates were not elicited. Pharmacists in both control groups also had a 4‐hour training session although the topics were different and they received no components of the pharmaceutical care program . | |
| Outcomes | Compliance measures were made at baseline, at 6 month and 12 months by face‐to‐face interview using 2 validated measures: a single‐item indicator (proportion of noncompliance), and a 4‐item scale ranging from 0 (low) to 4 (high) noncompliance. Self‐report had been found to be valid when inquiries were made in a nonthreatening manner. Clinical Health Outcomes included: Peak expiratory flow rates, breathing‐related ED or hospital visits, health‐related quality of life (HRQOL), medication compliance, and patient satisfaction. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | At the end of baseline evaluation, a research assistant randomly assigned each family to one of the three groups. Randomization was stratified by the adolescent's sex and by the treatment center. (no statement of concealment of allocation). It is also unclear whether outcomes assessors were blinded. Due to the nature of the intervention, patients could not be blinded. It should be noted that despite randomization the three treatment groups differed demographically at baseline. The BFST group included significantly fewer intact families and more single‐parents families than did the other two groups. | |
| Participants | Inclusion criteria included the following: 12‐17 years of age, having Type I diabetes > 1 year, no other major chronic diseases, no mental retardation, not incarcerated in foster care or in residential psychiatric treatment, no diagnoses of psychosis major depression or substance abuse disorder in adolescents or parents during the previous 6 months. Also, at least one family member had to obtain a score on the Diabetes Responsibility and Conflict scale > 24 or a score > 5 on the Conflict Behavior Questionnaire. | |
| Interventions | Families were randomized to three months of treatment with either Behavioral‐Family Systems Therapy (BFST), an education and support (ES) group, or current therapy (CT). Monetary incentive ‐ To maximize completion of data collection, families were paid $100 ($50 for parent, $50 for adolescent) on completion of each evaluation. ES and BFST families could earn another $100 if they completed all 10 scheduled intervention sessions. | |
| Outcomes | Measurement of Compliance: A 14‐item, validated Self‐Care Inventory (SCI) was used to measure diabetes treatment adherence during the preceding 3 months. Higher scores indicate better treatment adherence. Questionnaires were given at baseline, at posttreatment (3 months) and at 6 and 12 months after treatment ended. Measurement of Clinical Health Outcomes: Glycated Hemoglobin (GHb) assays were conducted using affinity chromatography to index recent glycemic control. General parent‐adolescent relationships were assessed via the Parent‐Adolescent Relationship Questionnaire (PARQ), and Type I diabetes‐specific psychological adjustment was assessed via the Teen Adjustment to Diabetes Scale (TADS). Questionnaires were given at baseline, at posttreatment (3 months) and at 6 and 12 months after treatment ended. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Random allocation, not otherwise specified. | |
| Participants | 63 DSM‐III‐R Chinese schizophrenic patients living with family members. | |
| Interventions | Standard care (medication prescription at hospital discharge plus laissez faire follow‐up on patient's or family's initiative) vs. a family based intervention that included monthly 45 minute counselling sessions focussed on the management of social and occupational problems, medication management, family education, family group meetings, and crisis intervention. | |
| Outcomes | Medication usage was assessed by family member reports. Time for which the patient took >50% of prescribed dosage was the measure for comparison of groups. Psychiatric outcomes were assessed at six, 12, and 18 months following hospital discharge by observers who were trained clinical researchers, blinded to study group allocation. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Methods | Random allocation not otherwise specified. | |
| Participants | Men discharged after their first admission to the hospital for schizophrenia. Schizophrenia was defined according to the Chinese Medical Association criteria. Inclusion criteria were no serious concurrent medical illnesses, living within commuting distance of the hospital, and willingness to attend regular family intervention sessions. Mean age for the 78 men who were followed was 24 years. Occupation was the only baseline characteristic that was not the same in each group. | |
| Interventions | Men in both groups came to the outpatient department by their own choice; no regular appointments were made and there was no routine follow‐up. Medication was obtained at these visits. Families and patients in the family intervention group were assigned to one of two counsellors for their ongoing care, were invited to come to a discharge session that focussed on education about the management of the patient’s treatment, asked to come to a family group counselling session with other families three months after discharge, and then attend three‐monthly group sessions with other families with similar patient problems. Non‐attendance triggered a visit from study staff. Each family was contacted at least once during the 18‐month follow‐up. Control group patients received no family interventions. | |
| Outcomes | All patients were seen every three months by staff physicians, blinded to the group assignment, where medication status and adherence were assessed. Adherence was defined as taking at least 33% of dose prescribed at the time of the index discharge for at least six days/week. Non‐adherence was anything else. Readmission to hospital and the mean hospital free period for those who were readmitted were the treatment outcomes assessed. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| Confounded comparison groups | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| Follow‐up rate < 80% | |
| No measure of treatment outcome | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| Follow‐up rate < 80% | |
| Only 2 months of follow‐up | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| No measure of compliance with medication at baseline. | |
| No measure of medication adherence | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| Confounded comparison groups | |
| No specific disease/disorder being treated. | |
| Study duration too short. | |
| Follow‐up too short or on less than 80% of participants | |
| Missing data on adherence | |
| Follow‐up too short or on less than 80% of participants | |
| Confounded comparison groups | |
| Study duration too short | |
| No compliance data presented and < 80% follow‐up | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up too short or on less than 80% of participants | |
| Confounded comparison groups | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| Missing description of disease outcome | |
| No measure of compliance with medications | |
| Confounded comparison groups | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| Confounded comparison groups | |
| No measurement of adherence | |
| Only 5 weeks of follow‐up | |
| 10‐week follow‐up | |
| Confounded comparison groups | |
| Follow‐up too short or on less than 80% of participants | |
| Confounded comparison groups | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up in < 80% | |
| No measure of treatment outcome | |
| No measure of treatment outcome | |
| Confounded comparison groups | |
| Confounded comparison groups | |
| No measure of treatment outcome | |
| Confounded comparison groups | |
| No measure of medication adherence | |
| Less than 80% follow‐up | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| 38 patients were randomized, before consent. When consent was requested, only 28 (74%) agreed so that the maximu, follow‐up was less than 80%. 2 additional patients dropped out following giving consent. | |
| Follow‐up in < 80% | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| No measurement of adherence | |
| Follow‐up rate < 80% | |
| Follow‐up rate < 80% | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| Missing description of disease outcome | |
| Confounding of physician adherence intervention with patient adherence intervention | |
| Confounded comparison groups | |
| No measure of treatment outcome | |
| No measure of medication adherence | |
| Follow‐up too short (8 weeks) | |
| Confounded comparison groups | |
| Follow‐up too short (only 2 months) | |
| Study too short duration | |
| Confounded comparison groups | |
| Follow‐up too short (only 2 months) | |
| Confounded comparison groups | |
| No measure of medication adherence | |
| Follow‐up too short (only 8 weeks) | |
| Follow‐up too short or on less than 80% of participants | |
| Regimen/follow‐up too short (only 16 weeks for HIV therapy) | |
| Follow‐up too short or on less than 80% of participants | |
| Confounded comparison groups | |
| Missing data on adherence | |
| Confounded comparison groups | |
| Confounded comparison groups | |
| Confounded comparison groups | |
| Confounded comparison groups | |
| Follow‐up too short or on less than 80% of participants | |
| No measure of treatment outcome | |
| No measure of treatment outcome | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| No patients are prescribed medication for a medical (incl psych.) disorder | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| Confounded comparison groups | |
| Missing description of disease outcome | |
| Confounded comparison groups | |
| The intervention is confounded. | |
| Missing description of disease outcome | |
| Missing description of disease outcome | |
| No measure of medication adherence | |
| No measure of treatment outcome | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up was <80% | |
| Confounded comparison groups | |
| Only 4 months follow‐up | |
| Follow‐up was <80% | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| No measure of treatment outcome | |
| No measure of treatment outcome | |
| No measure of treatment outcome | |
| No measure of medication adherence | |
| Confounded comparison groups | |
| No measure of treatment outcome | |
| Less than 80% follow‐up at 6 months | |
| Patients are not prescribed a medication | |
| In addition to 3 asthma clinic sessions, a GP consultation (where meds could be altered?) was added to the intervention group. Also, it is unclear whether medication adherence is actually measured (i.e. paper only states that 'medication use' is assessed) | |
| Confounded comparison groups | |
| No measure of treatment outcome | |
| Patients initially randomized into treatment groups. However, these groups were re‐arranged (not randomly) for the purposes of analysis. | |
| No outcomes measured | |
| Confounded comparison groups | |
| Confounded intervention group (combined adherence intervention with adjustments to medications) | |
| Study too short duration | |
| 10 weeks of follow‐up | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| Confounded comparison groups | |
| Confounded comparison groups | |
| Confounded comparison groups | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up too short or on less than 80% of participants | |
| Confounded comparison groups | |
| No measure of adherence | |
| Confounded comparison groups | |
| No measure of medication adherence | |
| Confounded comparison groups | |
| Follow‐up less than 80% of participants | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| No measure of adherence | |
| Intervention was 12‐18 sessions of cognitive therapy, which is a confounder. | |
| Confounded comparison groups | |
| No measurement of adherence | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| Study too short duration | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| Different meds in the 2 arms (rifamp+pyraz vs IHN) as well as different durations (2 months versus 6 months) | |
| Confounded comparison groups | |
| Missing data on adherence | |
| Follow‐up too short or on less than 80% of participants | |
| No measure of treatment outcome | |
| Missing description of disease outcome | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up less than 80% | |
| Follow‐up less than 80% | |
| No measure of treatment outcome | |
| Missing description of disease outcome | |
| No measure of treatment outcome | |
| Follow‐up too short or on less than 80% of participants | |
| No measure of treatment outcome | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| Confounded comparison groups | |
| Confounded: patients in education group also visited 'super‐specialist' doctors, while the control group received no eduation and also only visited regular primary doctors. Therefore, can't separate effects of the education from the effects of having different physicians. | |
| Confounded comparison groups | |
| Follow‐up too short or on less than 80% of participants | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| Follow‐up too short or on less than 80% of participants | |
| Study duration too short | |
| Follow‐up too short or on less than 80% of participants | |
| Less than 80% follow‐up | |
| Less than 80% follow‐up | |
| No measure of medication adherence | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up too short or on less than 80% of participants | |
| Missing data on adherence | |
| Missing description of disease outcome | |
| No measure of treatment outcome | |
| No measure of treatment outcome | |
| No measure of treatment outcome | |
| Less than 80% follow‐up at 6 months | |
| No measure of treatment outcome | |
| Missing description of disease outcome | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up too short or on less than 80% of participants | |
| No measure of treatment outcome reported | |
| Follow‐up too short or on less than 80% of participants | |
| Confounded comparison groups | |
| 76% follow‐up rate | |
| Non‐randomised trial | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up was less than 80% | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up was less than 80% | |
| No measurement of treatment outcome | |
| No measurement of adherence | |
| Follow‐up was less than 80% | |
| Follow‐up too short or on less than 80% of participants | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| Follow‐up less than 80% of participants | |
| Missing description of disease outcome | |
| Compliance measured to determine eligibility, but not measured through the course of the study | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up too short or on less than 80% of participants | |
| Follow up too short or on less than 80% of participants | |
| No measure of medication adherence | |
| No measure of medication adherence | |
| Follow up less than 6 months, and trial is not definitively negative since there are less than 50 patients per group | |
| Confounded comparison groups | |
| Follow‐up too short or on less than 80% of participants | |
| Follow‐up too short or on less than 80% of participants | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| Follow‐up time was only 4 months | |
| 78.5% follow‐up rate | |
| Confounded" part of intervention included pharmacotherapy with a SSRI, whereas usual care patients received 'treatment as usual' from their physician. Therefore, control and intervention groups may have different drug regimens. | |
| Confounded comparison groups | |
| Follow‐up too short or on less than 80% of participants | |
| Confounded comparison groups | |
| Missing description of disease outcome | |
| Follow‐up too short or on less than 80% of participants | |
| Confounded comparison groups | |
| Follow‐up less than 80% of participants | |
| No measure of medication adherence | |
| Confounded comparison groups | |
| Missing description of disease outcome | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| Less than 80% follow‐up (78.8%) | |
| No treatment outcome measured | |
| Confounded comparison groups | |
| No measure of treatment outcome | |
| Confounded comparison groups | |
| Confounded comparison groups | |
| Missing description of disease outcome | |
| Missing data on adherence | |
| No measure of medication adherence | |
| Confounded comparison groups and no intervention intended to affect adherence with prescribed, self‐Administered medications | |
| No random assignment to treatment groups. | |
| No measure of medication adherence | |
| Missing description of disease outcome | |
| Follow‐up too short or on less than 80% of participants | |
| No measure of medication adherence | |
| Missing description of disease outcome | |
| Follow‐up too short or on less than 80% of participants | |
| Missing description of disease outcome | |
| Study too short duration | |
| No measure of treatment outcome | |
| No measure of treatment outcome | |
| Follow‐up too short or on less than 80% of participants | |
| No measure of medication adherence | |
| No measure of medication adherence | |
| No measure of treatment outcome | |
| Follow‐up too short or on less than 80% of participants | |
| Missing data on adherence | |
| Study too short duration | |
| Follow‐up too short or on less than 80% of participants | |
| The interventions are mainly directed at enhancing therapy though reviewing patients' drug regimens. Enhancing adherence is a secondary objective; for the outcomes measured, the independent effects of the adherence part can't be separated out. | |
| Confounded comparison groups | |
| Follow‐up too short or on less than 80% of participants | |
| Confounded comparison groups | |
| Confounded comparison groups | |
| No measure of treatment outcome | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| No measure of medication adherence | |
| No measure of medication adherence | |
| No measure of treatment outcome | |
| Confounded comparison groups and no intervention intended to affect adherence with prescribed, self‐Administered medications | |
| No measure of treatment outcome | |
| Follow‐up too short or on less than 80% of participants | |
| No measure of medication adherence | |
| Follow‐up too short or on less than 80% of participants | |
| No treatment outcome reported | |
| No compliance intervention, since patients in control group received clarithromycin 250 mg twice daily, while patients in intervention group received clarithromycin 500mg (modified release) once daily PLUS placebo | |
| Confounded: the intervention included both changing medications as needed and compliance counselling. | |
| Study duration too short | |
| No measure of treatment outcome | |
| Confounded: different medications and different medication schedule in intervention and control groups | |
| Confounded comparison groups | |
| Follow‐up rate less than 80% of participants | |
| Confounded comparison groups | |
| Missing description of disease outcome | |
| Missing description of disease outcome | |
| Follow‐up too short or on less than 80% of participants | |
| Missing description of disease outcome | |
| No measure of medication adherence | |
| Follow‐up too short or on less than 80% of participants | |
| No intervention intended to affect adherence with prescribed, self‐Administered medications | |
| No measure of medication adherence | |
| No Measure of medication adherence | |
| Study too short duration | |
| Patients are not prescribed medication for a medical (incl psych.) disorder | |
| No measure of treatment outcome |
Characteristics of ongoing studies [ordered by study ID]
| Trial name or title | A randomized controlled trial to improve medication compliance among |
| Methods | |
| Participants | 440 adults with documented coronary heart disease in an |
| Interventions | 2x2 factorial design testing 1) an illustrated pill card that |
| Outcomes | Primary outcome is 12‐month refill adherence calculated from |
| Starting date | April 2004; enrollment completed April 2005 |
| Contact information | Sunil Kripalani, MD, MSc; Emory University School of |
| Notes |
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1 Adherence and Outcome Show forest plot | Other data | No numeric data | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Analysis 1.1
Comparison 1 Studies That Met Criteria, Outcome 1 Adherence and Outcome. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Study | Clinical Problem | Intervention | Control | Effect on Adherence | Effect on Outcome |
| Al‐Eidan 2002 | Helicobacter pylori | Intervention patients (n=38) received their medicines via the hospital pharmacy and were counselled (and followed up) by a hospital pharmacist. | Control patients (n=38) were given a standard advice sheet and referred to their GP who prescribed the same therapy. | Yes for improving compliance to a 1‐week course of triple therapy to eradicate H‐pylori. | Yes for improving clinical outcomes for the intervention group who had a significantly higher rate of H‐pylori eradication. |
| Ansah 2001 | Malaria | The use of pre‐packed chloroquine tablets (n=155). | The use of chloroquine syrup (n=144). | Yes. The tablet form of medicine resulted in higher adherence rates, but it isn't established whether this is due to the formulation or the lack of provision of a standard measuring device. | No, there was no difference in the clinical outcomes. |
| Bailey 1990 | Asthma | Pamphlet, workbook, counselling, phone follow‐up, support group, and reinforcement of adherence (n=132) | Instructional pamphlet alone (n=135) | Yes. | Yes. |
| Baird 1984 | Hypertension | Once daily metoprolol (n=196) | Twice daily metoprolol (n=193) | Yes. | No. |
| Becker 1986 | Hypertension | Special "reminder" pill packaging (n=86) | Separate vials for each medication (n=85) | No. | No. |
| Berrien 2004 | HIV | The intervention in intervention group (n=20) consisted of eight structured home visits over a 3‐month period by the same home care experienced registered nurse. | In the clinic setting for control group (n=17), the physician, nurse and social worker provided standard medication adherence education at clinic appointments generally scheduled at 3‐month intervals. Phone follow‐ups and a single home visit were planned if the staff felt they were needed. Visual aids for remembering medications, medication boxes, beepers, and general technical and emotional support were regularly offered. The clinic nurse contacted the family by telephone when the patient was starting a new medication, was having difficulty with adherence, or needed clarification and support. A single home visit was planned when and if the clinic staff believed medication adherence was poor despite the implementation of the above listed techniques. | Yes for pharmacy report of refill frequency; | No. |
| Brown 1997a | Hyperlipidemia and coronary artery disease | Controlled release niacin bid (n=31) | Regular niacin qid (n=31) | Yes. | Yes. |
| Brus 1998 | Rheumatoid Arthritis | Six patient education meetings. The education programme focused on compliance with sulphasalazine therapy, physical exercises, endurance activities (walking, swimming, bicycling), advice on energy conservation, and joint protection. Four (two hour) meetings were offered during the first months. Reinforcement meetings were given after four and eight months. The programme was implemented in groups and partners were invited to attend the meetings. (n=29) | The control group received a brochure on RA, as provided by the Dutch League against Rheumatism. This brochure gives comprehensive information on medication, physical and occupational therapy. (n=31) | No. | No. |
| Canto De Cetina 2001 | Contraception | 175 received detailed structured pretreatment counseling about the hormonal effects of the injectable. | 175 received routine counseling on duration of use and efficacy of the method. | Yes for the cumulative termination rates. | Yes for the cumulative termination rates. |
| Chaplin 1998 | Schizophrenia | Individual semi‐structured educational sessions discussing the benefits and adverse effects of antipsychotic drugs, including tardive dyskinesia (n=28). | Usual care (n=28). | No. | No. |
| Colcher 1972 | Strep throat | Special counselling and written instructions on need to take all pills (n=100) | Usual care (n=100) | Yes. | Yes. |
| Cote 1997 | Asthma | Extensive asthma education program plus written self‐managed action plan based on PEF (n=50) or based on asthma symptom monitoring (n=45) | Basic information provided plus verbal action plan could be given by physician (n=54) | No for each intervention. | No for each intervention. |
| Cote 2001 | Asthma | Patients in Group Limited Education (LE) (n=30) were given a self‐action plan that was explained by the on call physician. The action plan used "traffic lights" (green, yellow, red) to describe specific states of asthma control based on Peak Expiratory Flow and symptoms and actions that the patient should take for each state. Subjects were all instructed by a respiratory therapist or study nurse in the proper use of an inhaler. In addition to what patients in Group LE received, the patients in Group Structured Education (SE n=33) participated in a structured asthma educational program based on the PRECEDE model of health education within 2 weeks after their randomization. | The patients in Group C (control, n = 35) received the usual treatment given for an acute asthma exacerbation. | No. | No. |
| Coull 2004 | Ischaemic heart disease | Intervention consisted of participation in a mentor‐led group (n=165), through attending monthly 2 hour long meetings in community facilities over a 1‐year period. There was an average of 10 patients per group, each led by two mentors. The core activities covered in the programme were lifestyle risk factors of smoking, diet and exercise; blood pressure and cholesterol; understanding of and ability to cope with IHD; and drug concordance. Each mentored group was also encouraged to develop its own | Both intervention and control groups (n=154) continued to receive standard care. | Yes. | No. |
| Farber 2004 | Asthma | Subjects in the intervention group (n=28) received basic asthma education; instructions on use of a metered‐dose inhaler with holding chamber; a written asthma self‐management plan illustrated by zones colored green, yellow, and red; a sample age‐appropriate holding chamber; and prescriptions for medication needed to implement the plan. This medication included an inhaled corticosteroid drug for everyday use and a quick‐acting bronchodilator for use as needed. The importance of seeking urgent medical care in the red zone was emphasized. Three brief followup phone calls were placed to patients in the intervention group at 1‐2 weeks, 4‐6 week and 3 months after enrollment. | The control group (n=28) received routine care. | Yes (based on dispensing). | No. |
| Friedman 1996 | Hypertension | Telephone‐linked computer system (TLC) ‐ an interactive computer‐based telecommunications system that converses with patients in their homes between office visits to their physicians (n=156). | Regular medical care (n=145). | Yes. | Yes. |
| Gallefoss 1999b | Asthma & COPD | An educational intervention consisting of a specially constructed patient brochure, two 2‐hour group sessions (separate groups for asthmatics and patients with COPD) concentrating on pathophysiology, antiobstructive medication, symptom awareness, treatment plans, and physiotherapy. One or two 40‐min individual sessions were supplied by both a nurse and a physiotherapist. At the final teaching the patients received an individual treatment plan on the basis of the acquired personal information and 2 weeks of peak flow monitoring (n=39 asthmatics, n=32 COPD patients). | Usual care from GP (n=39 asthmatics, n=32 COPD patients). | No. | No. |
| Gani 2001 | Seasonal rhinitis and asthma | B group (n=35) with drug therapy plus training on the use of nasal spray, and C group (n=36) | A group (n=30) with drug therapy alone. | Yes for A versus B+C | Yes: between group A and group C in respiratory symptoms. |
| Ginde 2003 | Macrolide antibiotic treatment | Patients in the ED group (n=38) were provided a full course of azithromycin (6 X 250 mg) at no charge and given instructions on the proper dose and frequency before discharge | Patients in the pharmacy group (n=36) received a written prescription for a full course of azithromycin before discharge from the ED. | No. | No. The Rx filling rate for the control group is based on the assumption that control patients used a participating pharmacy 8 blocks away that provided the drugs free of charge ‐ patients were apparently not asked if they filled their prescription elsewhere. The "course completed" rate is based on self report on a telephone call ‐ no indication that interviewers were blinded to group; nor was the exact question given (if there was one). Technically, this study qualified for the review, but the reliability and credibility of the measures are suspect. At least the question of the control group's filling of prescriptions could have been cleared up. The intervention is also impractical in any setting where giving drugs out for free isn't possible. |
| Girvin 1999 | Hypertension | Enalapril 20mg od (n=27). Cross‐over study, with 4 week study periods. | Enalapril 10mg bid (n=27). Cross‐over study. | Yes. | No. |
| Haynes 1976 | Hypertension | Tailoring, self‐monitoring of pills and blood pressure, rewards for higher adherence and lower blood pressure (n=20). | Usual care (n=18). | Yes. | No. |
| Henry 1999 | H. Pylori infection | 10 days of omeprazole 20mg bd, amoxicillin 500mg tds and metronidazole 400 mg tds, verbal advice on medication use and its possible side effects in an initial 20 minute consultation. Patients also received medication in dose‐dispensing units, an information sheet on H. Pylori treatment, and a medication chart. Compliance in intervention group patients was also encouraged by a phone call 2 days after the start of therapy (n = 60). | 10 days of omeprazole 20mg bd, amoxicillin 500mg tds and metronidazole 400 mg tds, verbal advice on medication use and its possible side effects in an initial 20 minute consultation. (n=59) | No. | No. |
| Hill 2001 | Rheumatoid arthritis | The intervention group (n=51) received 7 x 30 minute one to one sessions of patient education. | The control group (n=49) received standard management. | Yes for improving adherence to DPA for rheumatoid arthritis. | No for improving clinical outcomes of plasma viscosity, c‐reactive protein, articular index, morning stiffness and pain score. |
| Howland 1990 | Acute infections | Warnings about potential adverse effects of drugs (n=50). | No warnings about adverse effects of drugs (n=48). | No. | No. |
| Johnson 1978 | Hypertension | (a). Self‐monitoring of blood pressure at home (n=34). | Neither intervention (n=34). | No for each intervention. | No for each intervention. |
| Katon 2001 | Depression | Patient education, 2 visits with a depression specialist, telephone monitoring and follow‐up (n= 194) | Usual care (n=192) | Yes | Yes for SCL‐20 scores and depressive symptomsNo for episodes of relapse/recurrence |
| Kemp 1996 | Acute psychosis. | 4‐6 session compliance therapy that focused on illness, conceptualisation of the problem, symptoms, side effects of treatment, and the stigma of drug treatment (n=25) | 4‐6 session nonspecific counselling (n=22) | Yes. | Yes for global functioning assessment. |
| Kemp 1998 | Psychotic disorders | 4‐6 session compliance therapy that focused on illness, conceptualisation of the problem, symptoms, side effects of treatment, and the stigma of drug treatment (n=39) | 4‐6 session nonspecific counselling (n=35) | Yes, at 12 months. | No, at 12 months, for the 7‐item version of the Brief Psychiatric Rating Scale. |
| Knobel 1999 | HIV | Zidovudine + lamivudine + indinavir PLUS individualised counselling/assessments which consisted of adaptation of treatment to the patient's lifestyle and detailed information about highly active antiretroviral therapy (n=60) | Zidovudine+ lamivudine + indinavir plu conventional care (n=120) | Yes | Yes for reduction of viral load. |
| Laporte 2003 | Compliance and stability of INR of two oral anticoagulants with different half‐lives | The standard education group received the minimum information consistent with ethical OAT with no particular emphasis on the necessity of strict compliance. Patients in the intensive education group received information about the causes of anticoagulation instability and the importance of strict adherence. The intensive education group were provided information through visual material, were visited daily by nurses and physicians to repeat some items, and were tested daily about their education. The education, either standard or intensive, was given until hospital discharge. | A 2 by 2 factorial design with patients randomly allocated to warfarin (long half‐life, n=43) or acenocoumarol (short‐half life, n=43) and to either intensive education (n=43) or standard education (n=43). | No. | No. |
| Levy 2000 | Acute Asthma | 1 hour structured asthma consultation with study nurse 2 weeks after entry into study, followed by 2 or more 30 minute consultations at 6‐weekly intervals (n=103). | Usual care (n=108) | Yes for use of inhaled topical steroids and rescue medication for severe attacks. Not statistically significant for use of inhaled topical steroids and rescue medication for mild attacks. | Yes. |
| Ludman 2003 | Depression (The same study as Katon 2001) | ||||
| MarquezContreras2004 | Hypercholesterolaemia | The Intervention group (IG) of 63 patients received the standard care given to control group, and in addition received a telephone call at 7‐10 days, 2 months, and 4 months. The goal of the intervention was to establish the level of compliance, categorize this as adequate or inadequate, and make recommendations based on that. Level of compliance was determined by comparing the number of pills consumed to the number that should have been consumed (calculated using self‐reported information about the number of pills remaining, number of pills dispensed, and fill date of the prescription). Compliance was defined as taking 80‐110% of the pills that should have been taken thus far. Compliant patients were congratulated and encouraged to continue their good level of compliance as it would lower their risk of heart disease. Noncompliant patients were notified their behavior was considered noncompliant and encouraged to better comply with therapy as it would lower their risk of heart disease. | The control group (CG) of 63 patients, who received the doctor's normal treatment, which included oral information about hypercholesterolemia, advice about its control, brochures about dietary recommendations, 3 month‐long prescriptions for a cholesterol‐lowering medication, and titration of that medication if indicated at 3 months. | Yes. | Yes for the 6‐month decrease in total cholesterol and LDL‐C was significantly different between IG and CG (Table 3). No for the 6‐month decrease in triglycerides and HDL‐C. |
| Merinder 1999 | Schizophrenia | 8‐session psychoeducational programme for schizophrenic patients and their relatives, conducted using a mainly didactic interactive method (n=23) | Usual treatment provided in community psychiatry (n=23). | No. | Yes for knowledge of schizophrenia and for VSSS subscore satisfaction with relatives' involvement. There was also a trend towards reduced BPRS score in intervention group (p=0.07). |
| Morice 2001 | Asthma | Subsequent visits from the asthma nurse until discharge from hospital (n=35). | 'Routine care' from medical and nursing staff but no further intervention from the asthma nurse (n=30). | No (on the contrary, medication compliance of ß‐agonist inhaler in intervention group was lower than in control group). | No for the total occasions of GP call‐out and re‐admission. |
| Nazareth 2001 | Complex regimens in the elderly (aged 75 years and older on four or more medicines who had been discharged) | The hospital pharmacist developed discharge plans which gave details of medication and support required by the patient. A copy was given to the patient and to all relevant professionals and carers. This was followed by a domiciliary assessment by a community pharmacist. (n=165) | In the control group, patients were discharged from hospital following standard procedures that included a discharge letter to the general practitioner listing current medications (n=151). | No. | No. |
| O'Donnell 2003 | Schizophrenia | The experimental group (n=28) received 5 sessions of compliance therapy, each session lasting 30‐60 minutes. The sessions covered a review of the patient's illness history, understanding of the illness and his or her ambivalence to treatment, maintenance medication and stigma. Compliance therapy is a cognitive behaviour intervention with techniques adapted from motivational interviewing, other cognitive therapies and psychoeducation. | The control group (n=28) received non‐specific counseling comprising of 5 sessions lasting 30‐60 minutes. | No. | No. |
| Peterson 1984 | Epilepsy | Counselling, leaflet, self‐monitoring of pill taking and seizures, mailed reminders for appointments and missed drugs refills (n=27). | Usual care (n=26). | Yes. | No. |
| Peterson 2004 | Dyslipidemia. | Patients in the intervention group (n=45) were visited at home monthly by a pharmacist, who educated the patients on the goals of lipid‐lowering treatment and the importance of lifestyle issues in dyslipidaemia and compliance with therapy, assessed patients for drug‐related problems, and measured total blood cholesterol levels using point‐of‐care testing. | Patients in the control group (n=49) received standard medical care. There was no further contact with patients in the control group after the initial collection of baseline data, until 6 months had lapsed. At that time, their final total blood cholesterol level was measured, and the current medication regimen and self‐reported | No. | No. |
| Peveler 1999 | Depression | Treatment information leaflet (n=53), drug counseling (n=52) or both leaflet and counseling (n=53) | Usual care (n=55) | Yes for counseling (at 12 weeks) | No for counseling |
| Piette 2000 | Diabetes | Automated telephone assessment and self‐care education calls with nurse follow‐up (n=137) | Usual care (n=143) | Yes. | Yes. |
| Pradier 2003 | HIV | Patients (n=100) in the intervention group (IG) were offered three individual sessions by trained nurses. | No mention was made of the care that was provided for the control group (n=102). | Yes | No. The clinical significance of these findings is unclear ‐ adherence rate was on self‐report in an unblinded trial, the mean HIV RNA was no different at 6 months for the 2 groups and no actual clinical outcomes were reported. |
| Ran 2003 | Schizophrenia | Family education sessions monthly (FIG, n=127). A second group received meds only (MG, n=105). | Usual care (CG, n=115). | Yes for FIG versus both other groups | Yes for relapse rate for FIG versus other groups. FIG and MG both better than control for symptoms. |
| Rawlings 2003 | HIV | 4 modules of the Tools for Health and Empowerment HIV education intervention (EI) plus routine counseling (RC) (EI + RC; n = 96) | Routine counseling alone (RC; n = 99). | No. | No. |
| Razali 2000 | Schizophrenia | Culturally modified family therapy (CMFT), which consists of a sociocultural approach of family education, drug intervention programme and problem‐solving skills (n=80). | Behavior Family Therapy (BFT) (n=86) | Yes | No at 6 months. |
| Sackett 1975 | Hypertension | (a). Care at worksite by occupational health physicians (n=37) | Neither intervention (n=25)* | No. | No. |
| Schaffer 2004 | Asthma | (a). Audiotape alone (n=10) | Standard provider education (control) (n=13) | Yes for positive effect on adherence by pharmacy‐refill measure for booklet vs control, and for booklet + audiotape versus control, but not for audiotape versus control, at 6 months. | No. |
| Stevens 2002 | Helicobacter pylori | A longer adherence counseling session and a follow‐up phone call from the pharmacist during drug treatment (n=163). All subjects were given the same 7‐day course of omeprazole, bismuth subsalicylate, metronidazole, and tetracycline hydrochloride (OBMT). | A standard antibiotic regimen and randomly assigned to receive usual‐care counseling from a pharmacist (n=162). All subjects were given the same 7‐day course of omeprazole, bismuth subsalicylate, metronidazole, and tetracycline hydrochloride (OBMT). | No. | No. (The big problems with this study are that a) both groups got blister packs with daily doses clearly marked; b) both groups got counseling, although this was longer and more detailed for the IC than CG; c) self‐report was used for measuring adherence (insensitive). All these factors would bias towards no difference. ) |
| Strang 1981 | Schizophrenia | Family therapy (n=17). | Individual supportive therapy (n=15). | Yes. | Yes. |
| Tuldra 2000 | HIV | Psychoeducative intervention to implement adherence i.e. explanations about reasons for starting treatment and the relevance of appropriate adherence, development of a dosage schedule with patients' input, patients were taught how to manage various other aspects of medication taking in HAART (i.e. forgetting, side effects, changes in daily routine). Phone number was given should patients have any questions before next interview. Verbal reinforcement of adherence at follow‐up visits (n=55). | Usual medical follow‐up (n=61) | No. | No. |
| van Es 2001 | Asthma | Usual care + pediatrician discussed "asthma management zone system" with participants + pediatrician discussed PEF readings from prior 2 weeks + 4 individual sessions with the asthma nurse + 3 educational group sessions with asthma nurse (n= 58). | Usual care ‐ pediatrician every 4 months (n=54). | No at T1 (12 months). | No. |
| Volume 2001 | Ambulatory elderly (> or = 65 years of age) | Pharmacists (in n=8 pharmacies, 159 patients) used the Pharmacist's Management of Drug‐Related Problems (PMDRP) instrument to summarize the information collected during the patient interview and the subjective, objective, assessment, and plan record to document actions and follow‐up. | Pharmacists at control pharmacies (n=8 pharmacies, 204 patients) continued to provide traditional pharmacy care. | No. | No. |
| Von Korff 2003 | Depression (The same study as Katon 2001) | ||||
| Walley 2001 | Tuberculosis | 170 were assigned DOTS with direct observation of treatment by health workers; 165 were assigned DOTS with direct observation of treatment by family members. | 162 were assigned self‐administered treatment. | No. | No. |
| Weber 2004 | Intervention group participants received cognitive behavior therapy in addition to usual care. | Participants were randomly assigned to a psychotherapist and given the contact information to schedule their own first appointment. Protocol defined a minimum of three and a maximum of 25 sessions within the 1‐year study period. Participant and psychotherapist determined the frequency of appointments and set their own goals for future interventions. Intervention group participants (n=32) received cognitive behavior therapy in addition to usual care, while control group participants (n=28) received usual care alone. | Both intervention and control groups continued to receive standard care. Standard care included monthly visits for 12 months with assessments of clinical and laboratory data, course of treatment, drug adverse events and HIV‐1 RNA. | No. | No. |
| Weinberger 2002 | Asthma or chronic obstructive pulmonary disease (COPD) | The pharmaceutical care program (n = 447) provided pharmacists with recent patient‐specific clinical data (peak expiratory flow rates [PEFRs], emergency department [ED] visits, hospitalizations, and medication compliance), training, customized patient educational materials, and resources to facilitate program implementation. | The PEFR monitoring control group (n = 363) received a peak flow meter, instructions about its use, and monthly calls to elicit PEFRs. However, PEFR data were not provided to the pharmacist. Patients in the usual care group (n = 303) received neither peak flow meters nor instructions in their use; during monthly telephone interviews, PEFR rates were not elicited. Pharmacists in both control groups had a training session but received no components of the pharmaceutical care intervention. | Yes, for within‐group at 6 and 12 months; no for between‐group | Yes. At 12 months, patients receiving pharmaceutical care had significantly higher peak flow rates than the usual care group (P =0.02) but not than PEFR monitoring controls (P =0.28). There were no significant between‐group differences in HRQOL, but patients participating in our program were significantly more satisfied with their pharmacists than the other two groups. |
| Wysocki 2001 | Diabetes | Behavioral‐Family Systems Therapy (BFST) ‐10 sessions consisting of 4 therapy components: problem solving training, communication skills training, cognitive restructuring and functional and structural family therapy, plus $100 monetary incentive for attending all 10 intervention sessions. (n=38). Education and Support (ES) ‐ families attended 10 group diabetes education and social support meetings (45 minute educational presentation by diabetes professional + 45 min interaction among the families), plus $100 monetary incentive for attending all 10 intervention sessions (n=40). | Current Therapy (n=41) ‐ standard pediatric endocrinology follow‐up and self‐management training. | No for BFST and ES at posttreatmentYes for BFST at 6 and 12‐monthsNo for ES at 6 and 12‐months | No for BFST in diabetic control or adjustment to diabetes. Yes for BFST on PARQ scales at posttreatment, 6 and 12 months. No for ES. |
| Xiong 1994 | Schizophrenia | Family counselling and close follow‐up (n=34). | Prescription of medication without formal follow‐up (n=29). | No. | Yes. |
| Zhang 1994 | Schizophrenia | Family intervention (n=42). | Prescription of medication without formal follow‐up (n=41). | No. | Yes. |
Comparison 1 Studies That Met Criteria, Outcome 1 Adherence and Outcome.
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Adherence and Outcome Show forest plot | Other data | No numeric data | ||
