anurajms/meta_analysis huggingface dataset:
primary outcome:
Silicone gel sheeting for treating hypertrophic scars
Severity of hypertrophic scars as assessed by health professionals or other staff, measured using a specific scale (as defined by the authors): for example Vancouver Scar Scale (VSS), Manchester Scar Scale or Patient and Observer Scar Assessment Scale (POSAS) (Draaijers 2004; Idriss 2009). The VSS ranges from 0 to 14, and POSAS ranges from 11 to 110; a higher score means worse outcome, that is a more severe scar.Severity of hypertrophic scars, validated by the participant using a specific scale (as defined by the authors): for example POSAS (Draaijers 2004; Idriss 2009).Adverse events (measured using survey/questionnaire/data capture process or visual analogue scale (VAS)), where a clear methodology for the collection of adverse event data was provided. This included making it clear whether (i) events were reported at the participant level or if multiple events per person were reported; and (ii) an appropriate adjustment was made for data clustering. Where available, we extracted data on all serious and all non‐serious adverse events. We did not extract individual types of adverse events, such as pain or infection, which require specific assessment under this outcome, but rather we used the assessment of any event classed as adverse by the participant or health professional, or both, during the trial.
primary outcome:
Botulinum toxin type A for facial wrinkles
Four‐point scale (Carruthers 2003)Patient Frown Wrinkle Severity (PFWS) scale (Bertucci 2020)Facial Line Treatment Satisfaction (FTS) Questionnaire (14‐item) (Cox 2003)Facial Line Outcomes Questionnaire (FLO‐7) (Cox 2003; Fagien 2007b)Self perception of age (SPA) (Fagien 2007b; Fagien 2008)5‐point Merz Aesthetic Scale (Rzany 2006)
primary outcome:
Topical benzoyl peroxide for acne
Participant global self‐assessment of acne improvement. Treatment success was defined as any greater improvement above the first category of improvement on a Likert or Likert‐like scale. For example, if there is a 5‐point Likert‐like scale ‐ much worse, worse, same, improved, much improved ‐ we counted "much improved" as treatment success. For a similar 6‐point scale, we compared everything better than "improved" versus the restWithdrawal due to adverse events over the whole course of a trial
primary outcome:
Hygiene and emollient interventions for maintaining skin integrity in older people in hospital and residential care settings
Frequency of skin damage (e.g. complete loss of integrity such as tears or ulcerations, partial loss of integrity such as fissuring)Side effects of intervention, frequency of cutaneous reaction (irritant or allergic) to intervention (emollient or cleanser use)
primary outcome:
Interventions for chronic palmoplantar pustulosis
Proportion of participants cleared or almost cleared, preferably measured as an objective measure of disease severity (e.g. predefined disease severity score) at two timings: short term and long termProportion of participants with adverse effects serious or severe enough to have caused withdrawal of participants from the study
primary outcome:
Topical and device‐based treatments for fungal infections of the toenails
Complete cure rate: the proportion of participants with 0% nail plate involvement and mycological cure at follow‐up.Adverse events: the proportion of participants who reported at least one event, whether or not related to the intervention. In addition and where possible, we reported adverse events based on the likelihood of their being related to the interventions, as judged by the study investigator(s).
primary outcome:
Lifestyle changes for treating psoriasis
Severity of psoriasis: the proportion of participants achieving at least 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75). A European consensus proposed PASI 75 as a treatment goal for psoriasis (Mrowietz 2011). We also reported the proportion of participants achieving at least 50%, 90%, or 100% improvement from baseline in PASI (i.e. PASI 50, PASI 90, and PASI 100, respectively) when relevant data were available. If none of these were available, we would use other validated assessment tools for psoriasis, including Body Surface Area (BSA), Physician Global Assessment (PGA), Lattice System Physician's Global Assessment (LS‐PGA), Self‐Administered Psoriasis Area Severity Index (SAPASI), Salford Psoriasis Index (SPI), Copenhagen Psoriasis Severity Index (CoPSI), and other validated assessment tools for psoriasis (Puzenat 2010).Adherence to the intervention (i.e. following the assigned intervention): the proportion of participants adhering to their allocated treatment.
primary outcome:
Interventions for hand eczema
Percentage of participants with self‐rated good/excellent control of symptoms.Percentage of participants with investigator‐rated good/excellent control of symptoms.Adverse events: adverse effects (long‐ and short‐term) of the intervention. Long‐term adverse events are defined as adverse events occurring after completion of the treatment phase; short‐term adverse events occur during the treatment phase.
primary outcome:
Non‐antistreptococcal interventions for acute guttate psoriasis or an acute guttate flare of chronic psoriasis
Percentage of participants clear or almost clear, i.e. obtaining PASI 100/90 and/or PGA of 0 or 1 in the short term (up to 8 weeks of treatment).Percentage of participants with adverse effects and severe adverse effects.
primary outcome:
Antistreptococcal interventions for guttate and chronic plaque psoriasis
Time to resolution (time between inclusion and resolution), where resolution was defined as participants achieving clear or almost clear skin (Physician Global Assessment (PGA) 0 or 1; or Psoriasis Area and Severity Index (PASI) 90, which refers to at least 90% reduction, or PASI 100, which refers to 100% reduction in the PASI score)Proportion of participants with adverse effects, and severe adverse effects
primary outcome:
Support surfaces for treating pressure ulcers
Healing rates of existing pressure ulcers was the primary outcome examined. Currently, there is no consensus regarding the most valid and reliable means of measuring healing rates of pressure ulcers. Therefore, trials were included if they measured healing by some objective method, such as time to complete healing, rate of change in the area/volume of the ulcer(s), or number of ulcers healed.
primary outcome:
Education of healthcare professionals for preventing pressure ulcers
Change in healthcare professionals' knowledge (pre‐ and post‐test assessment following intervention, as defined by each study).Change in healthcare professionals' clinical behaviour, as defined by each study (e.g. performing routine skin inspections, enhanced repositioning or mobilisation schedules, changing sitting or lying surfaces, educating patients on skin care, instruction in pressure relief manoeuvres and transfers).Incidence of new pressure ulcers (as reported by each study using numerical counts, or percentages of patients developing any pressure ulcer of any stage).
primary outcome:
Foam dressings for treating pressure ulcers
Incidence of healed pressure ulcers (proportion of participants in whom a pressure ulcer healed)Time to complete healingAdverse events per participant (such as wound or systematic infection, or both, or increase in ulcer size and severity)
primary outcome:
Systemic antibiotics for treating malignant wounds
Malodour (measured by a validated assessment tool, e.g. the TELER system (Grocott 2001b) which assesses malignant wounds using a 0 to 5 ordinal scale on a number of indicators, for example skin condition, wound exudate and odour. For odour, a score of 0 indicates odour that is obvious in the house/hospital ward. A score of 5 indicates no odour).Adverse effects of treatment (e.g. nausea, vomiting, rash or any other adverse effect as reported by the trial authors).
primary outcome:
Anabolic steroids for treating pressure ulcers
time to complete healing/rate of healing (as defined in the trial);proportion of wounds completely healed in a specified time period (as defined in the trial).
primary outcome:
Scalpel versus electrosurgery for major abdominal incisions
Wound infection.Time to wound healing.Wound dehiscence.
primary outcome:
Drugs for discoid lupus erythematosus
Percentage of people with complete resolution of skin lesions (i.e. return to normal skin appearance).Percentage of people with clearing of erythema in at least 50% of lesions (post‐inflammatory pigmentation could persist).Improvement in patient satisfaction/quality of life measures.
primary outcome:
Emollients and moisturisers for eczema
Change in disease severity from baseline as assessed by study participants using a recognised or validated rating scale (e.g. POEM and Patient Oriented SCORAD (PO‐SCORAD)), visual analogue scale (VAS) score, Likert scale, or similar scale. If data were available we evaluated change in scores for itch separately.Participant satisfaction using any generic Likert scale or similar scale.Adverse events (proportion of participants reporting an adverse event); we reviewed the nature of adverse events (e.g. itching, stinging, sensitisation) and reported them narratively.
primary outcome:
Wound drainage for lower limb arterial surgery
Incidence of any surgical site infection (superficial or deep, or both); incidence of all types of surgical site infection (if type not specified). Surgical site infection: as defined by the Centers for Disease Prevention and Control (CDC) (Mangram 1999), is an infection that occurs within 30 days after surgery in the part of the body where the surgery took place. Surgical site infections can be superficial, involving the skin only, or they can be deep, involving tissues under the skin, organs, or implanted material (Mangram 1999).
primary outcome:
Bed rest for pressure ulcer healing in wheelchair users
SHORT TERM: those occurring before eight weeks;MEDIUM TERM; those occurring between eight and 26 weeks; andLONG TERM: those occurring after 26 weeks.
primary outcome:
Antibiotics and antiseptics for pressure ulcers
Time to complete wound healing (correctly analysed using survival, time‐to‐event approaches). Ideally the outcome will be adjusted (by study authors) for appropriate covariates e.g. baseline ulcer area/duration.Proportion of wounds completely healed during follow‐up (frequency of complete healing).
primary outcome:
Interventions for acne scars
Participant‐reported scar improvement: measured by a scar improvement, grading, or severity scale.Participants with adverse effects serious or severe enough to have caused their withdrawal from the study. We define 'serious' adverse effects' as events that pose a threat to a participant's life or functioning whereas 'severe' adverse effects are defined by their intensity.
primary outcome:
Antibiotics and antiseptics for surgical wounds healing by secondary intention
Time to complete wound healing (correctly analysed using survival, time‐to‐event approaches).Proportion of wounds completely healed during follow‐up (frequency of complete healing).Short term: 8 weeksMedium term: > 8 weeks but ≤ 24 weeksLong term: > 24 weeks.
primary outcome:
Surgical hand antisepsis to reduce surgical site infection
Occurrence of postoperative SSI, as defined by the CDC (Mangram 1999) or the study authors. We did not differentiate between superficial and deep‐incisional infection.
primary outcome:
Anti‐TNF agents for paediatric psoriasis
Investigator‐assessed improvement: proportion of participants achieving PASI 75. (If this scale was not available, we planned to use PASI 50 or PASI 90) (see Differences between protocol and review).Improvement in quality of life: assessed using a recognised instrument (generic, dermatology‐specific (such as CDLQI), Pediatric Quality of Life Inventory, or a disease‐specific instrument).Proportion of participants having any minor or major adverse outcomes.
primary outcome:
Interventions for hidradenitis suppurativa
Quality of life, measured by a validated dermatology‐specific scale.Adverse effects (AEs) of interventions.
primary outcome:
Wound‐care teams for preventing and treating pressure ulcers
We planned to consider primary and secondary outcomes under two categories, prevention and treatment.
primary outcome:
Oral fumaric acid esters for psoriasis
Psoriasis Area and Severity Index (PASI) score: scale range from 0 (no disease) to 72 (maximal disease).The proportion of participants who discontinued treatment due to adverse effects that are common but sufficiently serious that the drug has had to be stopped, such as severe diarrhoea, infections, or cutaneous malignancy.
primary outcome:
Negative pressure wound therapy for treating surgical wounds healing by secondary intention
The primary outcomes for this review were complete wound healing and adverse events.The reported median time to healing in the NPWT group was 57 days compared with a median time to healing in the alginate group of 104 days. The number of healing events were not presented, neither were variation data (only ranges around the medians were supplied, see Table 1). We considered these data to be of limited value as they did not seem to have been calculated in an appropriate way for time‐to‐event data. As a result of this we have not analysed these data further.It was not clear how adverse event data had been collected. The study summarised data on death and amputation. There was no evidence of a difference in the number of participants with amputation between the NPWT group (0%: 0/10) and the alginate group (10%: 1/10): RR 1.50 (95% CI 0.32 to 7.14; Analysis 1.1). The study was very small and was underpowered for this comparison, which is imprecise and uncertain. There was no evidence of a difference in the number of participants who died between the NPWT group (30%: 3/10) and the alginate group (20%: 2/10): RR 0.33 (95% CIs 0.02 to 7.32; Analysis 1.2). Again the limited sample size and lack of outcome events mean this comparison is also underpowered and uncertain.We considered these data to be of very low quality due to imprecision.No data on other review outcomes were presentedThe reported median time to healing in the NPWT group was 84 days. This was compared with a median time to healing in the silicone group of 93 days. The number of healing events were not presented, neither were variation data (only ranges around the medians were supplied, see Table 1). We considered these data to be of limited value as it was not clear how they had been calculated. As a result of this we have not presented them further here.
primary outcome:
Interventions for rosacea
Change in health‐related quality of life (HRQOL) at end of studyParticipant‐assessed changes in rosacea severity at end of studyProportion of participants who reported an adverse event throughout the study period
primary outcome:
Preoperative skin antiseptics for preventing surgical wound infections after clean surgery
Occurance of postoperative SSI as defined by the CDC criteria (Horan 2008), or the authors' definition of SSI. We did not differentiate between superficial and deep‐incisional infection.Study outcome data are as reported above for relevant comparisons. For this analysis data were pooled using a fixed effects meta‐analysis (I2 = 0%). Results showed evidence of a difference in number of SSIs following skin preparation with alcoholic solutions compared with aqueous solutions: RR 0.77, 95% CI 0.51 to 1.17 (Analysis 12.1).Summary: Alcoholic solutions compared with aqueous solutionsData from six studies showed no statistically significant difference in the number of SSIs following skin preparation with alcoholic or aqueous solutions.
primary outcome:
Interventions for vitiligo
Quality of life measured using a validated tool e.g. DLQI (Dermatology Quality of Life Index), CDLQI (Children's Dermatology Quality of Life Index), Skindex‐29Percentage of repigmentation (restoration of normal skin colour) of vitiliginous skin: success rate in terms of more than 75% repigmentation of individual patches or of total body surface area, measured by objective means (e.g. photographs, planimetry, rule of nines). This could be reported as: 75%, >75%, ≥75%, 75% to 90%/100% or 76% to 90%/100%Adverse effects
primary outcome:
Repositioning for treating pressure ulcers
We considered trials if they reported at least one of the primary outcomes. The primary outcomes were objective measures of pressure ulcer healing and included: time to complete healing; absolute or percentage change in pressure ulcer area or volume over time; proportion of pressure ulcers healed at the completion of the trial period; or healing rate.
primary outcome:
Negative pressure wound therapy for partial‐thickness burns
time to complete healing;rate of change in wound area;proportion of wound completely healed within the trial period.
primary outcome:
Recombinant human growth hormone for treating burns and donor sites
Burn wound healing. Objective measures of the healing of transplanted and non‐operated burn wounds included the time to complete wound healing or the proportion of the burn wound that healed completely (epithelialised) within a specific time period.Donor site healing. Objective measures of donor site healing included the healing time (in days) for the first and successive donor sites or the number of wounds that healed completely during the trial period.Wound infection (as defined by the trial authors).Mortality rate.
primary outcome:
Removal of nail polish and finger rings to prevent surgical infection
Incidence of surgical wound infections.
primary outcome:
Topical agents and dressings for fungating wounds
Quality of life as measured by a recognised generic or disease‐specific tool (e.g. SF36)
primary outcome:
Pressure‐relieving devices for treating heel pressure ulcers
Proportion of heel ulcers healed within a defined time period.Time to complete healing of heel ulcers.
primary outcome:
Narrow‐band ultraviolet B phototherapy versus broad‐band ultraviolet B or psoralen‐ultraviolet A photochemotherapy for psoriasis
Participant‐rated global improvement.Percentage of participants reaching Psoriasis Area and Severity Index (PASI) 75 (which meant equal to or more than 75% reduction in PASI score).Withdrawal due to side‐effects.Clearance rate. (Clearance was defined as no lesions of psoriasis or minimal residual activity (MRA)).
primary outcome:
Antibiotic prophylaxis for preventing burn wound infection
Outcome 1:Burn wound infection: studies reporting an objective measure of burn wound infection. Diagnosis should rely on clinical examination (burn wound appearance) and culture data, if possible, however, burn wound infections diagnosed only by clinical examination were also eligible.Outcome 2: Invasive infections, such as pneumonia, urinary tract infections (UTI), bacteraemia or blood infections (sepsis), or central venous catheter‐associated bloodstream infections. We admitted any measure for quantifying infections, such as incidence rate or incidence density rate.Outcome 3: Infection‐related mortality: i.e. mortality due to infection of burn wounds, sepsis, or another infective complication.Outcome 4: Adverse events: those considered by the study investigators to be related to antibiotic prophylaxis, such as toxicity, allergies, antibiotic‐associated diarrhoea due to the overgrowth of toxigenic strains of Clostridium difficile, etc.
primary outcome:
Psychosocial and pharmacologic interventions to reduce harmful alcohol use in low‐ and middle‐income countries
Reduction in harmful alcohol use. We selected this as the primary outcome given that this outcome has been commonly used in research on alcohol use in LMICs (Ghosh 2022; Joseph 2017; Preusse 2020; Sileo 2021). Harmful alcohol use must have been measured using a self‐report measurement tool.Retention, defined as number of participants who completed treatment.
primary outcome:
Baclofen for alcohol use disorder
Relapse: return to any drinking, measured by the number of people who had returned to any drinking at the end of the study.Frequency of use: measured as mean number or percentage of abstinent days (ratio of the total sum of days with abstinence, related to the entire duration of the study, multiplied by 100; and mean number or percentage of heavy drinking days (HDD)).Amount of use: number of drinks per drinking day or drinking occasion.Adverse events: measured by number of people with at least one adverse event, both subjectively and objectively assessed.Dropouts from treatment: number of participants who did not complete the study protocol.Dropouts from treatment due to adverse events.
primary outcome:
Opioid agonist treatment for people who are dependent on pharmaceutical opioids
Illicit opioid use, as measured by: days of unsanctioned opioid use at the end of the intervention period.Illicit opioid use at end of treatment completion (defined as point prevalence of opioid use at end of treatment by self‐report and with urine drug screen).Retention.Adverse effects (participants experiencing any adverse event or serious adverse event).
primary outcome:
Music therapy for people with substance use disorders
Psychological symptoms (e.g. depression, anxiety, anger; e.g. measured by Beck Depression Inventory (BDI; Beck 1996), Hamilton Rating Scale for Depression (HRSD; Hamilton 1960), state portion of the State‐Trait Anxiety Inventory (STAI), or visual analogue scales).Substance craving (e.g. measured by Brief Substance Craving Scale (BSCS; Somoza 1995), or visual analogue scales).Motivation for treatment/change (e.g. measured by Readiness to Change Questionnaire (RTCQ; Heather 1999), Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES; Miller 1996), University of Rhode Island Change Assessment Scale (URICA; McConnaughy 1983), or visual analogue scales).Motivation to stay sober/clean (e.g. measured by Commitment to Sobriety Scale (CSS; Kelly 2014), or visual analogue scales).
primary outcome:
Strategies to improve smoking cessation rates in primary care
The primary outcome measure was smoking abstinence at long‐term follow‐up in participants who reported smoking at baseline. To be eligible for inclusion, studies had to measure smoking status at least six months from the start of the intervention. We excluded studies with abstinence measured at less than six months' follow‐up.In trials with more than one measure of abstinence, we preferred the measure using the longest follow‐up and the strictest criteria, in line with the Russell Standard (West 2005). We used sustained or continuous abstinence over point prevalence abstinence, and biochemically‐validated abstinence, such as exhaled carbon monoxide (CO), over self‐report. We favored biochemically‐validated point prevalence abstinence over self‐reported continuous or prolonged abstinence. We considered participants lost to follow‐up to be still smoking, in line with the practice of the Cochrane Tobacco Addiction Group.We chose smoking abstinence as the primary outcome, as this is the most clinically relevant outcome; an increase in the number of people quitting is the ultimate goal of any attempt to increase the implementation of smoking cessation treatment.
primary outcome:
Interventions to reduce tobacco use in people experiencing homelessness
Tobacco abstinence assessed at three time points:Short‐term abstinence: < 3 months after quit day;Medium‐term abstinence: ≥ 3 months and < 6 months after quit day;Long‐term abstinence: ≥ 6 months after quit day.
primary outcome:
Dihydrocodeine for detoxification and maintenance treatment in individuals with opiate use disorders
Abstinence from illicit opiate use after detoxification or maintenance therapy, either through self‐report or urinalysis, measured as the number of participants abstinent at the end of treatment and at follow‐up.Number of participants who experienced serious adverse events. According to the guidelines, serious adverse events include events that result in death, are life‐threatening, require hospitalisation or an extension of existing hospitalisation, result in persistent or significant disability or incapacity, result in congenital problems or any other event that may put the participant's health in jeopardy and may require medical or surgical intervention to prevent this (OHRP 2007). This includes the development of drug abuse or dependency on DHC.Number of participants who experienced adverse events. Including any unfavourable medical occurrences that participants experience at least partly due to their participation in the study. This includes both physical and psychological events (OHRP 2007).
primary outcome:
Smoking cessation intervention for reducing disease activity in chronic autoimmune inflammatory joint diseases
Smoking cessation: self‐reported or biochemically validated (with biochemically verified favoured over self‐reported), at longest follow‐up, measured, analysed, and reported according to the intention‐to‐treat principle. Smoking abstinence was to be reported at least six months following baseline for studies to be eligible for inclusion. When multiple measures of cessation were reported, we used the strictest definition of smoking cessation (i.e. continuous over point prevalence)Disease activity score at longest follow‐up. Disease activity could be measured by DAS28 (Disease Activity Score based on 28 swollen and tender joint counts, C‐reactive protein, and Visual Analog Global score) for RA and PsA (Prevoo 1995); and by BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) (Garrett 1994); BASFI (Bath Ankylosing Spondylitis Functional Index) (Calin 1994); or ASDAS (Ankylosing Spondylitis Disease Activity Score) for AS and SpA (Lukas 2009). Minimal clinically important differences (MCIDs) have been reported as follows: change of 0.6 on DAS28 (van Riel 2004), 10 mm or 22.5% on BASDAI, 7 mm or 17.5% on BASFI (Pavy 2005), and 1.1 on ASDAS (Machado 2011)Adverse events, including serious adverse events
primary outcome:
Additional behavioural support as an adjunct to pharmacotherapy for smoking cessation
Following the standard methodology of the Cochrane Tobacco Addiction Group, the primary outcome was smoking cessation at the longest follow‐up using the strictest definition of abstinence, i.e. preferring sustained over point prevalence abstinence and using biochemically‐validated rates, where available. In addition we noted any other abstinence outcomes reported, and conducted sensitivity analyses if the choice of outcome in a study might have altered the results of a meta‐analysis. We excluded studies which did not set out to assess smoking cessation at six months or longer.
primary outcome:
Cognitive‐behavioural treatment for amphetamine‐type stimulants (ATS)‐use disorders
Abstinence rate measured by urine samples or self‐reported drug use, or both.Drug use measured as: amount of drug use, frequency of drug use, continuous using days or other measures of actual drug‐using behaviour. We only used measures of drug‐use behaviour within the past 30‐days or less.Dropout from treatment as measured as number of participants who did not complete the study protocol.
primary outcome:
Antidepressants for the treatment of people with co‐occurring depression and alcohol dependence
Depression severity measured as group mean scores in continuous: interviewer‐rated scales (e.g. Hamilton Rating Scale for Depression (HRSD)) and self‐administered scales (e.g. Beck Depression Inventory (BDI)).Response to antidepressive treatment (defined using interviewer‐rated scales as the number of people showing greater than 50% reduction in depression severity from baseline, according to the definition of the study authors, or a 'very much improved' or 'much improved' on the Clinical Global Impression (CGI) improvement scale).Full remission of depression (defined according to a prespecified score in interviewer‐rated continuous depression scales).Consumption of alcohol as number of participants who reported use during treatment, or number of participants with positive breath alcohol analysis or urine analyses positive for alcohol, or both.Liver enzyme levels (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and γ‐glutamyltransferase (GGT)).Acceptability indicated by all‐cause dropouts from the treatment as number of participants who did not complete treatment.Tolerability of treatment as withdrawal for medical reasons, total number of adverse events, and type of adverse events experienced during treatment.Suicide and suicide attempts.
primary outcome:
Effectiveness of brief alcohol interventions in primary care populations
Self‐reported or other reports of drinking quantity (e.g. drinks per week).Self‐reported or other reports of binge drinking frequency (e.g. number of binges per week).Self‐reported or other reports of drinking frequency (e.g. drinking days per week).Self‐reported or other reports of drinking intensity (e.g. number of drinks per drinking day).Self‐reported or other reports of drinking within recommended limits (e.g. government recommended limits). Although limits vary among countries, practitioners tend to use the national government recommended limits as a guide.
primary outcome:
Personalised digital interventions for reducing hazardous and harmful alcohol consumption in community‐dwelling populations
Many types of outcome measures are available in the alcohol literature. Our primary outcome was quantity of alcohol consumed, which we converted into grams of alcohol per week using either definitions in the trial report where available, or from governmental definitions (listed in Kalinowski 2016). We considered trials reporting outcomes at one month or longer post‐intervention, but separated trials according to follow‐up time, as well as by longest follow‐up time.
primary outcome:
Opioid antagonists with minimal sedation for opioid withdrawal
Severity of the withdrawal syndrome experienced (peak withdrawal scores and average withdrawal score over the duration of withdrawal treatment).Duration of treatment.Nature and incidence of adverse effects.Completion of treatment.
primary outcome:
Supervised dosing with a long‐acting opioid medication in the management of opioid dependence
Retention in treatment defined as the number of participants who complete the study protocol (at any duration).Abstinence from unsanctioned opioid use (measured by urine drug screen or self‐report use).Diversion, defined as inappropriate use of medication by those for whom it has been prescribed, for example the selling or sharing of medication by patients to the illicit drug market.Frequency of unsanctioned opioid use at the end of the intervention period.
primary outcome:
Psychostimulant drugs for cocaine dependence
Reduction of cocaine use, assessed by mean (standard deviation (SD)) proportion of negative urinalysis across the study per participantSustained cocaine abstinence (number of patients who achieved sustained cocaine abstinence)Retention in treatment (number of patients who finished the study)
primary outcome:
Psychosocial interventions for cannabis use disorder
Self reported use of cannabis (number of days, rate of abstinence, times per day) with or without confirmation by objective means (urinalysis or hair/saliva analyses, as well as collateral reports).Severity of cannabis use disorder observed as an index measured by a standardised questionnaire (such as the Addiction Severity Index (ASI) (McLellan 1980) or the Severity of Dependence Scale (SDS) (Swift 1998)) or as a count of symptoms of dependence following clinical assessment.Level of cannabis‐related problems such as medical problems, legal problems, social and family relations, employment and support (typically assessed by questionnaires such as the Marijuana Problem Scale (Stephens 2000) or the Cannabis Problems Questionnaire (Copeland 2005)).Retention in treatment, including average number of sessions received and/or proportion of participants completing the full number of planned sessions.
primary outcome:
Alpha2‐adrenergic agonists for the management of opioid withdrawal
withdrawal syndrome (intensity, time course, predominant signs and symptoms);duration of treatment;nature and incidence of adverse effects; andcompletion of treatment.
primary outcome:
Antipsychotic medications for cocaine dependence
Dropouts from treatment, defined as the number of participants who did not complete the treatmentAcceptability of the treatment, defined as the number and type of side effects experienced during the treatmentUse of primary substance of abuse, defined as the number of participants that reported the use of cocaine during the treatment, and/or the number of participants with urine samples positive or negative for cocaineResults at follow‐up, defined as the number of participants using cocaine at follow‐up
primary outcome:
Dopamine agonists for the treatment of cocaine dependence
Dropouts as number of participants who did not complete the treatment;Acceptability of the treatment as number of participants experiencing adverse effect;Dropouts due to adverse effects;Abstinence self reported or number of participants with urine samples negative for cocaine, or both;Results at follow‐up as number of participants abstinent at follow‐up.
primary outcome:
Anticonvulsants for cocaine dependence
Dropouts from treatment as the number of participants who did not complete the study protocol.Use of primary substance of abuse as the number of participants who reported use of cocaine during treatment and/or the number of participants with urine samples positive for cocaine.Acceptability of treatment as the number of participants reporting at least one side effect and types of side effects experienced during treatment.
primary outcome:
Universal school‐based prevention for illicit drug use
Use of drugs (self reported, specific tests)MarijuanaHard drugs (heroin, cocaine, crack)Other drugsAny drug
primary outcome:
Restricting or banning alcohol advertising to reduce alcohol consumption in adults and adolescents
Reduction in alcohol consumption
primary outcome:
Maintenance treatments for opiate ‐dependent adolescents
Drop‐outs, measured as the number of participants that did not complete the maintenance treatmentUse of primary substance, measured as number of participants with opiate‐positive urinalysis during and at the end of treatment or using self reported data, or bothResults at follow‐up, measured as the number of participants relapsed at the end of follow‐up
primary outcome:
Anticonvulsants for alcohol dependence
Efficacy: use of alcohol as number of participants who reported use during treatment and/or number of participants with positive breath alcohol analysis.Safety: number and type of adverse events experienced during treatment.Acceptability: dropouts from treatment as number of participants who did not complete treatment.Results at follow‐up as number of participants using alcohol at follow‐up.
primary outcome:
Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence
Primary outcomesSecondary outcomes
primary outcome:
Efficacy of psychostimulant drugs for amphetamine abuse or dependence
Efficacy primary outcomes.Amphetamine use (definition 1). Mean (standard deviation (SD)) negative urinalyses (UA) across the study.Amphetamine use (definition 2). Amphetamine concentration in hair analysis.Sustained amphetamine abstinence. Number of participants who achieved sustained amphetamine abstinence.
primary outcome:
Bladder training for treating overactive bladder in adults
Participant‐reported cure or improvement (assessed by validated self‐reported questionnaires such as the Patient Global Impression of Improvement (PGI‐I) Index (Busner 2007). In studies that did not use validated scales, we included author‐defined data regarding the number of participants who perceived cure or improvement. For studies in which participants reported more than a single level of improvement (e.g. much better and somewhat better), we entered data for the greater degree of improvement reported).Symptom‐ and condition‐related quality of life (QoL) (assessed using validated questionnaires, such as Overactive Bladder Questionnaire (Coyne 2002) and King's Health Questionnaire (Kelleher 1997)).Any adverse events (e.g. dry mouth, constipation, nausea, headache, dizziness, deceased visual acuity, and urinary tract infection).
primary outcome:
Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women
Participant‐reported subjective improvement or cure of POP symptoms, measured with tools such as a visual analogue scale (VAS; Ulrich 2014) or the Patient Global Impression of Improvement (PGI‐I; Srikrishna 2010)
primary outcome:
Conservative interventions for managing urinary incontinence after prostate surgery
Subjective cure or improvement (patient‐reported as defined by the trialists)Condition‐specific quality of life assessed using validated questionnaires (e.g. International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ‐UI‐SF) or ICIQ‐SF)
primary outcome:
Transurethral microwave thermotherapy for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia
Urologic symptom scores (continuous outcome)Quality of life (continuous outcome)Major adverse events (dichotomous outcome)
primary outcome:
Anticholinergics combined with alpha‐blockers for treating lower urinary tract symptoms related to benign prostatic obstruction
Urologic symptom scores: change from baseline assessed with a validated scale (such as the IPSS; an MCID of 3 points in the IPSS was used to assess the clinically meaningful improvement, as defined by the AUA (AUA 2018)). For studies that only reported final values, we combined these final values with changes from baseline for meta‐analysis.QoL: change from baseline assessed with IPSS bother score (we used an MCID of 1 point for IPSS‐QoL (AUA 2018)). For studies that only reported final values, we combined these final values with changes from baseline for meta‐analysis.Adverse events: adverse events graded as the Common Terminology Criteria for Adverse Events (CTCAE): Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life‐threatening or disabling; Grade 5 = death‐related; we considered the definition the trial authors used in each clinical trial). We considered the MCID for adverse events as a relative risk reduction of at least 25% (Guyatt 2011a).
primary outcome:
Convective radiofrequency water vapour thermal therapy for lower urinary tract symptoms in men with benign prostatic hyperplasia
Urologic symptom scores (continuous outcome)Quality of life (QoL; continuous outcome)Major adverse events (dichotomous outcome)
primary outcome:
Bipolar versus monopolar transurethral resection of the prostate for lower urinary tract symptoms secondary to benign prostatic obstruction
Urological symptoms as measured by the International Prostate Symptom Score (IPSS) questionnaire score at 12 monthsBother as measured by a health‐related quality of life (HRQoL) questionnaire score at 12 monthsTransurethral resection (TUR) syndrome
primary outcome:
Prostatic urethral lift for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia
Urological symptom scores.Quality of life.Major adverse events.
primary outcome:
Physical activity for lower urinary tract symptoms secondary to benign prostatic obstruction
Symptom score for LUTS using a validated instrument (e.g. IPSS, BPH Impact Index (BII)).Response rate, defined as 20% improvement in symptom score (measured by authors’ report or imputation).Withdrawal due to adverse events.
primary outcome:
Antimicrobial agents for preventing urinary tract infections in adults undergoing cystoscopy
Systemic UTI (sepsis, fever 38 °C or greater, and documented bacteruria). Bacteruria was defined as midstream urine culture with more than 105 colony‐forming units (CFU)/mL of uropathogens, or greater than 104 CFU/mL of a single organism cultured, or greater than 104 CFU/mL uropathogens in a midstream sample of urine in men, catheterized urine culture 102 CFU/mL or greater.Symptomatic UTI defined as a composite of both systemic and localized UTI.Serious adverse events (e.g. Stevens‐Johnson syndrome, anaphylaxis, renal toxicity, and hepatotoxicity).
primary outcome:
Ureteral stent versus no ureteral stent for ureteroscopy in the management of renal and ureteral calculi
Unplanned return visit to emergency/urgent care departmentPostoperative discomfort (pain or irritative voiding complaints, or both) as measured by visual analogue scaleSecondary interventions (e.g. stent placement/exchange, percutaneous nephrostomy tube placement, secondary ureteroscopy)
primary outcome:
Phosphodiesterase inhibitors for lower urinary tract symptoms consistent with benign prostatic hyperplasia
Total International Prostate Symptom (IPSS‐total) scoreBenign Prostatic Hyperplasia Impact Index (BPHII) scoreAdverse events (AEs)
primary outcome:
Naftopidil for the treatment of lower urinary tract symptoms compatible with benign prostatic hyperplasia
Urological symptom scores.QoL.Treatment withdrawals for any reason.
primary outcome:
Non‐pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome
Prostatitis symptoms.Adverse events.
primary outcome:
Electrical stimulation with non‐implanted devices for stress urinary incontinence in women
Cure: number of women with self‐reported continence (no urinary incontinence, as reported by women)Cure or improvement: number of women with self‐reported cure or improvement in urinary incontinenceIncontinence‐specific quality of life (QoL) measures (however defined by authors or by any validated measurement scales such as the International Consultation on Incontinence Questionnaire)
primary outcome:
Silodosin for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia
Urologic symptom scoresQuality of lifeTreatment withdrawals for any reason
primary outcome:
Desmopressin for treating nocturia in men
Number of nocturnal voids.Quality of life.Major adverse events.
primary outcome:
Surgery versus non‐surgical management for unilateral ureteric‐pelvic junction obstruction in newborns and infants less than two years of age
Split renal function based on any appropriate imaging test
primary outcome:
Antimicrobial therapy for chronic bacterial prostatitis
Microbiological efficacy, defined as yielding at test‐of‐cure (TOC) visit sterile cultures of expressed prostatic secretions or post‐massage urine, or positive cultures with a bacterial load inferior to a defined threshold (e.g., 103 colony‐forming units (CFU)/mL).Clinical efficacy, defined as cure, resolution or improvement of signs and symptoms of CBP at the TOC visit or at follow‐up, or assessed with strategies based on subjective or objective findings:subjective clinical outcomes included symptom scores, bother scores, quality of life (QoL) scores, global urinary or systemic symptom reports, or patient self‐declared status (e.g., improved, unchanged or worsened);objective clinical outcomes included the results of urodynamic or sonographic evaluations, prostate examination (tenderness, size, consistency, symmetry), microscopy of specimens of lower urinary tract segmented tests (white blood cell counts), biochemical markers (e.g., prostate‐specific antigen (PSA)).Adverse effects of treatment subgrouped or not for type, severity, or drug class.
primary outcome:
Reconstructive surgery for treating pressure ulcers
Complete wound healing. We accepted study authors' definitions of wound healing. We had planned to record whether healing was defined immediately following surgery or not confirmed until after a specific timeframe following surgery, when the surgery was deemed to be successful. For this review, we regarded the following measures as providing the most relevant and rigorous measures of healing.Time to complete wound healing. We had planned to record whether study authors had analysed this measure correctly, using techniques that account for data censoring and adjusting for prognostic covariates such as baseline size.Proportion of ulcers healed (frequency of complete healing).Wound breakdown. We presented data on wound breakdown using the following two outcomes, presented separately.Wound dehiscence. We had planned to assess this outcome as the proportion of wounds that dehisced along the wound edges that had been apposed and held together with sutures, staples, etc. in the reconstructive surgery. We had intended to record study authors' definitions of wound dehiscence.Wound recurrence, defined as occurrence of a new pressure ulcer on the same site as a previous ulcer.
primary outcome:
Timing of antibiotic administration, wound debridement, and the stages of reconstructive surgery for open long bone fractures of the upper and lower limbs
Limb function using validated PROMs at six months and 12 months; for example, the Lower Extremity Functional Scale (Binkley 1999) and Enneking Score (Enneking 1993).Health‐related quality of life (HRQoL) using PROMs at six months and 12 months; for example, the patient‐reported EuroQol 5 Dimensional Score (EQ‐5D) (Brooks 1996; Dolan 1997), Disability Rating Index (Salen 1994), Sickness Impact Profile (Bergner 1981; de Bruin 1994) and the 36‐Item Short‐Form Health Survey (SF‐36) (Brazier 2002; Jenkinson 1999).Deep surgical site infection (SSI). In preference, we used the internationally recognised Centers for Disease Control and Prevention (CDC) definition of a deep SSI (Horan 2008), i.e. a wound infection involving the tissues below the skin that occurs within 30 days of injury. We considered any infection that required continuing medical intervention for 30 days after surgery without an implant, or 90 days after surgery using an implant, to be a deep infection. In the event that study authors did not define the type of infection, we made judgements about whether it was a deep infection from other information in the study report.
primary outcome:
Reactive air surfaces for preventing pressure ulcers
Our primary outcome was pressure ulcer incidence. We recorded two outcome measures (the proportion of participants developing a new pressure ulcer; and time to pressure ulcer incidence), where available. We considered the proportion of participants developing a new pressure ulcer as the primary outcome for this review. Our preferred measure was time to pressure ulcer incidence; however, we did not expect it to be reported in many studies. We extracted and analysed time‐to‐event data but focused on the binary outcome in our conclusions. We accepted the study authors' definitions of an incident ulcer regardless of which pressure ulcer severity classification system was used to measure or grade new pressure ulcers. We also considered the outcome of pressure ulcer incidence irrespective of whether studies reported ulcers by stages or as a non‐stratified value.We did not consider subjective outcome measures (e.g. 'better' or 'worse' skin condition) as measures of pressure ulcer incidence.
primary outcome:
Intracavity lavage and wound irrigation for prevention of surgical site infection
Surgical site infection measured as: occurrence of postoperative surgical site infection (SSI) as defined by the CDC criteria (Horan 2008), or the study authors' definition of SSI. We did not differentiate between superficial and deep incisional infection. We planned to document septicaemia or septic shock under this outcome.Wound dehiscence within 30 days of operation. This included both superficial dehiscence (involving skin and subcutaneous tissues) or deep dehiscence (burst abdomen or dehiscence of fascia). Postoperative wound dehiscence refers to wound disruption resulting from poor wound healing. This may be caused by various factors, including infection, as well as the type of incision and patient characteristics, such as diabetes or smoking (Sandy‐Hodgetts 2015).
primary outcome:
Topical phenytoin for treating pressure ulcers
Time to complete healing (we defined complete healing as intact skin)Proportion of ulcers healed within trial period.
primary outcome:
Interventions for treating gas gangrene
Amputation due to gas gangrene.Infection‐related fatality attributed to gas gangrene.Quality of life: measured by a standardised generic questionnaire such as EQ‐5D, SF‐36, or SF‐6, or SF‐12.